{"id":"sl-2008-42","name":"Medicines, Poisons and Therapeutic Goods Regulation 2008","slug":"medicines-poisons-and-therapeutic-goods-regulation-2008","collection":"regulation","jurisdiction":"act","status":"in_force","isInForce":true,"actNumber":"42 of 2008","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":173545,"registerId":"act-sl-2008-42-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"861A","sectionType":"section","heading":"Dealings with regulated substances and regulated therapeutic goods","content":"861A Dealings with regulated substances and regulated therapeutic goods\nby public employees under director-general authorisation—Act,\ns 20 (1) (d) and s 22 (1) (d) 227\n862 Certain containers not to be used for human-use substances—Act,\ns 63 (1) (b) 228\n863 Disapplication of Legislation Act, s 47 (6) 228\n864 Exemption of piper methysticum (kava)—Act, s 190 (1) (a) 230\nSchedule 1 Medicines—health-related occupations\nauthorisations 232\nPart 1.1 Ambulance services, officers and paramedics 232\n\nPage\ncontents 21\nPart 1.2 Dentists, dental hygienists, dental therapists and oral\nhealth therapists 233\nPart 1.3 Doctors 236\nPart 1.4 Health practitioners at institutions 238\nPart 1.4A Medical radiation practitioners 239\nPart 1.5 Midwives 240\nPart 1.6 Nurses 241\nPart 1.7 Opioid dependency treatment centres operated by\nTerritory 243\nPart 1.8 Optometrists 244\nPart 1.9 Pharmacists and employees 245\nPart 1.10 Podiatrists 248\nPart 1.11 Residential care facilities 249\nPart 1.12 Sales representatives for medicines manufacturers\nand wholesalers 251\nPart 1.13 Veterinary practitioners and employees 252\nSchedule 3 ACT listed appendix D medicines—standing\napprovals 254\nPart 3.1 Approval conditions 254\n3.1 Definitions—sch 3 254\nPart 3.2 Standing approvals for ACT listed appendix D\nmedicines 256\nSchedule 4 Dangerous poisons—manufacturing etc\nauthorisations 260\nSchedule 5 Requirements for storage receptacles 263\nPart 5.1 Medicines cabinets 263\n5.1 Medicines cabinets—general requirements 263\n\nPage\ncontents 22 Medicines, Poisons and Therapeutic Goods\n5.2 Medicines cabinets—body requirements 263\n5.3 Medicines cabinets—door requirements 263\n5.4 Medicines cabinets—lock requirements 264\n5.5 Medicines cabinets—mounting requirements 264\n","sortOrder":0},{"sectionNumber":"Part 5","sectionType":"part","heading":"2 Safes, strong rooms and vaults 265","content":"Part 5.2 Safes, strong rooms and vaults 265\n5.6 Requirements for safes 265\n5.7 Requirements for strong rooms 265\n5.8 Requirements for vaults 265\nDictionary 266\n1 About the endnotes 279\n2 Abbreviation key 279\n3 Legislation history 280\n4 Amendment history 289\n5 Earlier republications 306\n\n1 Name of regulation\nThis regulation is the Medicines, Poisons and Therapeutic Goods\nRegulation 2008.\n","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Dictionary","content":"3 Dictionary\nThe dictionary at the end of this regulation is part of this regulation.\nNote 1 The dictionary at the end of this regulation defines certain terms used in\nthis regulation, and includes references (signpost definitions) to other\nterms defined elsewhere.\nFor example, the signpost definition ‘young detainee—see the Children\nand Young People Act 2008, section 95.’ means that the term ‘young\ndetainee’ is defined in that section and the definition applies to this\nNote 2 A definition in the dictionary (including a signpost definition) applies to\nthe entire regulation unless the definition, or another provision of the\nregulation, provides otherwise or the contrary intention otherwise appears\n(see Legislation Act, s 155 and s 156 (1)).\n","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Notes","content":"4 Notes\nA note included in this regulation is explanatory and is not part of this\nNote See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.\n\nPreliminary Chapter 1\n","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Offences against regulation—application of Criminal","content":"5 Offences against regulation—application of Criminal\nCode etc\nOther legislation applies in relation to offences against this\nNote 1 Criminal Code\nThe Criminal Code, ch 2 applies to all offences against this regulation\n(see Code, pt 2.1).\nThe chapter sets out the general principles of criminal responsibility\n(including burdens of proof and general defences), and defines terms used\nfor offences to which the Code applies (eg conduct, intention,\nrecklessness and strict liability).\nNote 2 Penalty units\nThe Legislation Act, s 133 deals with the meaning of offence penalties\nthat are expressed in penalty units.\n","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Overview of things to which medicines and poisons","content":"6 Overview of things to which medicines and poisons\nstandard does not apply\n(1) The medicines and poisons standard applies to regulated substances\n(see the Act, pt 3.1 and s 17).\n(2) However, the medicines and poisons standard sets out the following\nthings to which it does not apply (unless there is a contrary intention\nin the standard):\n(a) a substance in a preparation or product included in the standard,\nappendix A;\n(b) a substance and the reason for its entry in the standard,\nappendix B;\n(c) a substance to which the standard, appendix G applies;\n(d) certain low concentrations of substances included in the\nstandard, schedules 1 to 6 if the substance is not also included in\nschedule 7 or 8;\n(e) certain impurities in pesticides.\n\nChapter 2 Medicines—authorisations\nPart 2.1 Overview of medicines\n10 General overview of authorisations for medicines\n(1) The Act requires that a person must not deal with a medicine in a\nparticular way unless the person is authorised to deal with the\nthe Act, s 35 is about obtaining certain substances (which include medicines)\nNote The Act, s 19 sets out when a person deals with a medicine.\n(2) The Act, section 20 sets out when a person is authorised to deal with\na medicine.\n(3) This regulation authorises certain dealings with medicines.\nNote An authorisation is not required to deal with the following:\n• a substance excluded from the medicines and poisons standard by\nthe standard;\n• a substance mentioned in the medicines and poisons standard,\nsch 2, 3, 4 or 8 if none of the schedules apply to the substance\nbecause of an exception in the standard (eg Aspirin in packets\navailable from supermarkets).\n(4) An authorisation under this regulation may be subject to limitations.\nExamples—s (4)\n1 a health practitioner’s authorisation is subject to any condition or restriction to\nwhich the health practitioner is subject to under the Health Practitioner\nRegulation National Law (ACT) (see s 20)\n2 the authorisation of a person to prescribe a medicine is subject to any\nrestriction included in sch 1 in relation to the person (see s 30 (1) (b))\nNote For the power to impose other restrictions, see the Act, ch 8.\n\n","sortOrder":5},{"sectionNumber":"11","sectionType":"section","heading":"Overview of medicines authorisations etc under this","content":"11 Overview of medicines authorisations etc under this\nregulation\nMedicines authorisations, approvals and endorsements are given\nunder the following provisions of this regulation:\n(a) section 30 (which is about authorisations under schedule 1 to\nprescribe medicines);\n(b) section 50 (which is about authorisations under schedule 1 to\nissue requisitions for medicines);\n(c) section 60 (which is about authorisations under schedule 1 to\nissue purchase orders for medicines);\n(d) section 70 (which is about authorisation of CHO to issue\nstanding orders for supply of medicines in public health\nemergencies);\n(e) section 71 (which is about authorisation of CHO to issue\nstanding orders for administration of medicines for public health\nmatters);\n(f) section 75 (which is about authorisation of doctors to issue\nstanding orders for administration of medicines at institutions);\n(g) section 77 (which is about authorisation of CHO to issue\nstanding orders for supply and administration of medicines at\nwalk-in centres);\n(h) section 110 (which is about authorisations under schedule 1 to\nsupply medicines);\nNote Supply includes dispense on prescription (see Act, s 24).\n(i) section 251 (which is about authorisation of pharmacists to\nsupply certain medicines without prescription in emergencies);\n(j) section 255 (which is about authorisation of approved\npharmacists to supply certain medicines without prescription);\n\n(k) section 260 (which is about authorisation to supply medicines to\npharmacists for disposal);\n(l) section 261 (which is about authorisation to supply medicines to\ncommercial disposal operators for disposal);\n(m) section 350 (which is about authorisations under schedule 1 for\npeople in health-related occupations to administer medicines);\n(n) section 352 (which is about authorisation of pharmacists and\nintern pharmacists to administer vaccines without prescription);\n(o) section 353 (which is about authorisation of nurses and\nmidwives to administer vaccines without prescription);\n(p) section 360 (which is about authorisation for self-administration\nof medicines);\n(q) section 361 (which is about authorisation for the administration\nof medicines by assistants);\n(r) section 370 (which is about authorisations under schedule 1 to\nobtain and possess medicines);\n(s) section 371 (which is about authorisation to obtain and possess\nmedicines for certain personal use-related dealings);\n(t) section 380 (which is about authorisations under schedule 1 to\nmanufacture medicines);\n(u) section 390 (3) (which is about authorisation to discard\ncontrolled medicines in certain ways);\n(v) section 400 (which is about authorisation to deliver medicines\nunder supply authorities);\n(w) section 401 (which is about authorisation for commercial\ndisposal operators for disposal of medicines);\n(x) section 410 (which is about authorisation to supply and\nadminister adrenaline, naloxone and salbutamol);\n\n(y) section 420 (which is about authorisations for CYP authorised\npeople);\n(z) section 421 (which is about authorisations for corrections\nofficers);\n(za) section 422 (which is about authorisations for court and police\ncell custodians);\n(zb) section 430 (which is about authorisations for non-controlled\nmedicines research and education);\n(zc) section 440 (which is about authorisations under controlled\nmedicines research and education program licences);\n(zd) section 450 (which is about authorisations under first-aid kit\nlicences);\n(ze) section 460 (which is about authorisations under medicines\nwholesalers licences);\n(zf) section 470 (which is about authorisations under opioid\ndependency treatment licences);\n(zg) section 480 (which is about authorisations under pharmacy\nmedicines rural communities licences);\n(zh) section 490 (which is about authorisations for endorsed health\npractitioners);\n(zi) section 490A (which is about authorisations for health\npractitioners for certain dealings approved by CHO);\n(zj) section 554 (which is about standing CHO approvals of classes\nof designated prescribers to prescribe controlled medicines in\ncertain circumstances);\n(zk) section 555 (which is about standing approval of designated\nprescribers to prescribe controlled medicines for hospital\nin‑patient or patient discharge);\n\n(zl) section 556 (which is about standing approval of designated\nprescribers to prescribe controlled medicines for short-term\ntreatment);\n(zm) section 557 (which is about standing interim approval of\ndesignated prescribers to prescribe buprenorphine and\nmethadone for patients of certain institutions);\n(zn) division 13.1.3 (which is about CHO approvals of designated\nprescribers to prescribe controlled medicines for individuals);\n(zo) division 13.1.4 (which is about endorsement by CHO of\ndesignated prescribers to treat drug-dependency);\n(zp) section 591 (which is about standing approvals of certain\nprescribers under schedule 3 to prescribe ACT listed appendix D\nmedicines);\n(zq) section 593 (which is about CHO approval of prescribers to\nprescribe appendix D medicines);\n(zr) section 860 (which is about authorisation of public employees\nexercising functions under the Act for certain dealings);\n(zs) section 861 (which is about authorisation of public employees\nfor certain dealings under CHO permit);\n(zt) section 861A (which is about authorisation of public employees\nfor certain dealings under director-general authorisation).\n","sortOrder":6},{"sectionNumber":"12","sectionType":"section","heading":"General overview of authorisation conditions for","content":"12 General overview of authorisation conditions for\n(1) The Act, section 44 requires a person who is authorised to deal with\na medicine to comply with any condition to which the authorisation\nis subject.\nSection 31 sets out the authorisation conditions for a person or endorsed health\npractitioner who is authorised to prescribe a medicine.\n\n(2) The conditions are additional to other restrictions on a person’s or\nendorsed health practitioner’s authority to deal with a medicine.\nNote Conditions may also be imposed under other provisions of the Act\nincluding, for example, s 89 which sets out conditions on licences.\n\nPart 2.2 Relationship with registration laws\nPart 2.2 Relationship with registration\nlaws\n20 Medicines authorisations subject to Health Practitioner\nRegulation National Law (ACT) restrictions\nA health practitioner’s authorisation under the Act to deal with a\nmedicine is subject to any condition or other restriction to which the\nhealth practitioner is subject under the Health Practitioner\nRegulation National Law (ACT).\nSection 31 places conditions on the prescribing of medicines by a health practitioner\nauthorised to prescribe the medicines. If a particular health practitioner’s\nregistration under the Health Practitioner Regulation National Law (ACT) is\nsubject to the condition or restriction that the person may not prescribe certain\nmedicines, the health practitioner’s authorisation under the Medicines, Poisons and\nTherapeutic Goods Act 2008 to prescribe medicines is also subject to that condition\nor restriction.\nNote A reference to an Act includes a reference to the statutory instruments\nmade or in force under the Act, including any regulation (see Legislation\nAct, s 104).\n","sortOrder":7},{"sectionNumber":"21","sectionType":"section","heading":"Medicines authorisations subject to Veterinary Practice","content":"21 Medicines authorisations subject to Veterinary Practice\nAct 2018 restrictions\nA veterinary practitioner’s authorisation under the Act to deal with a\nmedicine is subject to any condition or other restriction to which the\nveterinary practitioner is subject under the Veterinary Practice\nAct 2018.\n\n","sortOrder":8},{"sectionNumber":"30","sectionType":"section","heading":"Authorisation under sch 1 to prescribe medicines—Act,","content":"30 Authorisation under sch 1 to prescribe medicines—Act,\ns 40 (1) (b), (2) (b) and (3) (b)\n(1) A person mentioned in schedule 1, column 2 is authorised to prescribe\n(a) prescribing the medicine is included in the schedule, column 3\nin relation to the person; and\n(b) the prescribing is consistent with any restriction for the\nprescribing mentioned in the schedule, column 3.\n(2) However, a person is not authorised to self-prescribe a medicine if—\n(a) the person is a trainee dentist, intern doctor or endorsed health\n(b) the medicine is a restricted medicine.\nprescribe includes self-prescribe.\nrestricted medicine means—\n(a) an anabolic steroid; or\n(b) an appendix D medicine; or\n(c) a monitored medicine.\n\n","sortOrder":9},{"sectionNumber":"31","sectionType":"section","heading":"Authorisation conditions for prescribing medicines—Act,","content":"31 Authorisation conditions for prescribing medicines—Act,\n(1) A prescriber’s authorisation under section 30 or section 490 to\nprescribe a medicine is subject to the following conditions:\n(a) the medicine is prescribed in accordance with the Act, section 7\n(Appropriate prescription and supply of medicines);\n(b) if the prescription is a written prescription—\n(i) the prescription complies with section 40 (General\nrequirements for written prescriptions); and\n(ii) the prescription (other than a national residential\nmedication chart prescription) includes the particulars\nmentioned in section 41 on the front of the prescription;\nand\n(iii) if the prescription is a national residential medication chart\nprescription in a national residential medication chart––the\nchart includes the particulars mentioned in section 41; and\n(iv) if the prescription is faxed by a prescriber to a\npharmacist—the prescriber sends the original prescription\nto the pharmacist not later than 7 days after the prescriber\nfaxes the prescription to the pharmacist;\nNote 1 For the endorsement of faxed prescriptions, see s 41 (1) (i).\n(c) if the prescription is an oral prescription—\n(i) the prescriber believes on reasonable grounds that giving\nan oral prescription for the medicine is reasonably\nnecessary for the patient’s treatment; and\n\n(ii) if the prescription is for an unusual or dangerous dose of a\nmedicine—the prescription includes a statement telling the\nperson who is to dispense or administer the medicine that\nthe prescription is for an unusual or dangerous dose; and\n(iii) the prescription includes the particulars mentioned in\nsection 41; and\n(iv) the prescriber sends a written prescription for the medicine\nto the pharmacist not later than 24 hours after the prescriber\ngives the oral prescription to the pharmacist;\nNote For the endorsement of written prescriptions confirming\noral prescriptions, see s 41 (1) (j).\n(d) if the medicine is a controlled medicine for human use—\n(i) the prescriber complies with the additional requirements\nunder section 32 for prescribing a controlled medicine; and\n(ii) if the controlled medicines approval is an oral approval—\nthe prescriber sends the chief health officer a written\napplication for the approval in accordance with section 561\n(Requirements for CHO controlled medicines approval\napplications) not later than 7 days after the day the oral\napproval is given;\n(e) if the medicine is an appendix D medicine—\n(i) the prescriber has an appendix D medicines approval to\nprescribe the medicine; and\napproval (including any conditions in schedule 3, part 3.2,\ncolumn 4 in relation to the medicine).\n\nnational residential medication chart means a medication chart\nwithin the meaning of the National Health (Pharmaceutical Benefits)\nRegulations 2017 (Cwlth), section 41 (4), as in force from time to\ntime.\nNote The National Health (Pharmaceutical Benefits) Regulations 2017\n(Cwlth) does not need to be notified under the Legislation Act because\ns 47 (6) does not apply (see s 863).\n","sortOrder":10},{"sectionNumber":"31A","sectionType":"section","heading":"Variation of authorisation condition during","content":"31A Variation of authorisation condition during\nCommonwealth special arrangement period\n(1) This section applies to a prescriber of a prescription if—\n(a) the prescription is faxed by the prescriber to a pharmacist; and\n(b) the prescription is for the supply of a medicine in accordance\nwith a Commonwealth special arrangement; and\n(c) the Commonwealth special arrangement requires the prescriber\nto keep the original of the prescription.\n(2) The prescriber is not required to send the original of the prescription\nunder section 31 (1) (b) (iv).\nCommonwealth special arrangement means a special arrangement\nmade under the National Health Act 1953 (Cwlth), section 100, as in\nforce from time to time.\nNote Commonwealth special arrangements are accessible at\n\n","sortOrder":11},{"sectionNumber":"32","sectionType":"section","heading":"Additional requirements for prescribing controlled","content":"32 Additional requirements for prescribing controlled\nmedicines for human use\nThe following are the additional requirements for prescribing a\ncontrolled medicine for human use:\n(a) the prescriber has a controlled medicines approval to prescribe\nNote For controlled medicines approvals, see pt 13.1.\n(b) if the approval is for a particular form of the medicine—the\nprescription is for the form of the medicine approved or a\nbioequivalent form;\n(c) if the approval is for a particular strength of the medicine—the\nprescription is for the strength approved or a weaker strength;\n(d) if the approval is for a maximum daily dose of the medicine—\nthe prescription is for not more than the maximum daily dose\napproved;\n(e) the prescriber complies with each condition (if any) of the\napproval;\n(f) if the controlled medicine is dronabinol for human use—\n(i) the prescriber also has an authorisation under the\nTherapeutic Goods Act 1989 (Cwlth), section 19 to supply\nthe medicine; and\nauthorisation.\nIf a slow release form of a medicine is approved, the prescriber is not authorised to\nprescribe an immediate release form of the medicine.\n\nExample—par (c) and par (d)\nIf a doctor is given an approval to prescribe 25 morphine 20mg capsules, the doctor\nmay prescribe 5 20mg capsules and 10 15mg capsules. Later, if the approval is still\nin force, the doctor may prescribe not more than 10 morphine capsules of any\nstrength up to and including 20mg.\nNote A prescription may provide for a medicine to be dispensed or\nadministered (see Act, dict, def prescription).\n","sortOrder":12},{"sectionNumber":"40","sectionType":"section","heading":"General requirements for written prescriptions","content":"40 General requirements for written prescriptions\nA written prescription for a medicine must—\n(a) be signed by the prescriber; and\nNote The prescription must be signed with the prescriber’s usual\nsignature (see Act, dict, def signs).\n(b) if the prescriber amends the prescription—be initialled and\ndated beside the amendment by the prescriber; and\n(c) be written in terms and symbols used in ordinary professional\npractice; and\n(d) if the prescription is for an unusual or dangerous dose—include\nthe prescriber’s initials beside an underlined reference to the\ndose.\n","sortOrder":13},{"sectionNumber":"41","sectionType":"section","heading":"Particulars for prescriptions","content":"41 Particulars for prescriptions\n(1) A prescription must include the following particulars:\n(a) the prescriber’s name, professional qualifications and business\naddress and telephone number;\n(b) the date the prescription is given;\n\nPrescriptions Division 3.1.2\nmedicine, to be dispensed or administered under the\n(d) the name, date of birth and address of the person for whom the\nmedicine is prescribed;\n(e) directions about the use of the medicine, including the dose and\nregimen of the medicine, that are adequate to allow the medicine\nto be taken or administered safely;\n(f) the number of times the medicine may be dispensed or\nadministered under the prescription;\n(g) if the prescription is for a controlled medicine for human use—\n(i) if the medicine is dronabinol—the relevant TGA\nauthorisation particulars; and\n(ii) if the prescription is a repeat prescription—the period that\nmust elapse between each dispensing or administration of\n(h) if the prescriber is a veterinary practitioner—\n(i) the words ‘for animal treatment only’; and\n(ii) the species of the animal for which the medicine is to be\ndispensed; and\n(iii) if possible, a way of identifying the animal;\n(i) if the prescription is an original of a prescription that was faxed\nby a prescriber to a pharmacist—the prescription is endorsed\nwith words to the effect that the prescription was faxed to a\nnamed pharmacy on a stated date;\n\n(j) if the prescription is a written prescription under\nsection 31 (1) (c) (iv) (which is about oral prescriptions)—the\nprescription is endorsed with words to the effect that the\nprescription is a confirmation copy of an oral prescription issued\nto a named pharmacist on a stated date.\n(2) However, if the prescription is written for an in-patient at a hospital\nin the patient’s medical records, the prescription need not include the\nprescriber’s professional qualifications and business address and\ntelephone number.\nNote 1 Hospital means a public hospital, private hospital or day hospital and\nincludes a body prescribed by regulation as a hospital (see Act, dict).\nNote 2 A hospice is a hospital (see The Macquarie Dictionary, 4th ed).\n(3) Also, if the prescription is a national residential medication chart\nprescription, the prescription need not include either of the following:\n(a) the prescriber’s professional qualifications;\n(b) the quantity of the medicine to be dispensed or administered\nunder the prescription.\nrelevant TGA authorisation particulars means the words ‘TGA\nauthorisation’ followed by—\n(a) the identifying number for the authorisation; or\n(b) if no identifying number is given for the authorisation—the date\nof the approval.\n\nRequisitioning medicines Part 3.2\nAuthorisation to issue requisitions Division 3.2.1\n","sortOrder":14},{"sectionNumber":"Div 3","sectionType":"division","heading":"2.1 Authorisation to issue requisitions","content":"Division 3.2.1 Authorisation to issue requisitions\n","sortOrder":15},{"sectionNumber":"49","sectionType":"section","heading":"Meaning of issuer—pt 3.2","content":"49 Meaning of issuer—pt 3.2\nissuer means the following:\n(a) a person who is authorised under section 50 to issue a requisition\nfor a medicine;\n(b) an endorsed health practitioner who is authorised under\nsection 490 to issue a requisition for a medicine.\n","sortOrder":16},{"sectionNumber":"50","sectionType":"section","heading":"Authorisation under sch 1 to issue requisitions for","content":"50 Authorisation under sch 1 to issue requisitions for\nmedicines—Act, s 41 (b)\nA person mentioned in schedule 1, column 2 is authorised to issue a\nrequisition for a medicine if—\n(a) issuing the requisition is included in the schedule, column 3 in\n(b) the issue of the requisition is consistent with any restriction for\nthe issue of the requisition mentioned in the schedule, column 3.\n","sortOrder":17},{"sectionNumber":"51","sectionType":"section","heading":"Authorisation conditions for issuing requisitions for","content":"51 Authorisation conditions for issuing requisitions for\nAn authorisation under section 50 or section 490 to issue a requisition\nfor a medicine is subject to the following conditions:\n(a) if the requisition is a written requisition—the requisition\n\n(b) if the requisition is an oral requisition—\n(i) the issuer believes on reasonable grounds that issuing the\nrequisition is reasonably necessary for the treatment of a\n(ii) the quantity of the medicine requisitioned is not more than\nthe amount reasonably necessary for the person’s\ntreatment; and\n(iii) the requisition complies with section 56.\n","sortOrder":18},{"sectionNumber":"55","sectionType":"section","heading":"General requirements for written requisitions","content":"55 General requirements for written requisitions\nA written requisition for a medicine must be—\n(a) signed by the issuer of the requisition; and\nNote The requisition must be signed with the issuer’s usual signature\n(b) if the issuer amends the requisition—initialled and dated by the\nissuer beside the amendment.\n","sortOrder":19},{"sectionNumber":"56","sectionType":"section","heading":"Particulars for requisitions","content":"56 Particulars for requisitions\nA requisition must include the following particulars:\n(a) the issuer’s name;\n(b) the capacity in which the issuer is issuing the requisition;\n(c) the date the requisition is issued;\n\nRequisitioning medicines Part 3.2\nRequisitions Division 3.2.2\n(d) the medicine, and the form, strength and quantity of the\nmedicine, to be supplied on the requisition;\n(e) the pharmacy or ward to which the medicine is to be supplied.\nNote Ward—see the Act, dictionary.\n\nDivision 3.3.1 Authorisation to issue purchase orders\nDivision 3.3.1 Authorisation to issue purchase\n60 Authorisation under sch 1 to issue purchase orders for\nmedicines—Act, s 38 (1) (b) and (2) (a)\nA person mentioned in schedule 1, column 2 is authorised to issue a\npurchase order for a medicine if—\n(a) issuing the purchase order is included in the schedule, column 3\nin relation to the person; and\n(b) the issue of the purchase order is consistent with any restriction\nfor the issue of the purchase order mentioned in the schedule,\ncolumn 3.\n","sortOrder":20},{"sectionNumber":"61","sectionType":"section","heading":"Authorisation conditions for issuing purchase orders for","content":"61 Authorisation conditions for issuing purchase orders for\n(1) An authorisation under section 60 or section 490 to issue a purchase\norder for a medicine is subject to the following conditions:\n(a) the purchase order complies with section 62 (General\nrequirements for medicines purchase orders—Act, s 38 (2) (c));\nNote A purchase order must be in writing (see Act, dict, def purchase\norder).\n(b) the issuer must, not later than 24 hours after they receive the\nmedicine, send the supplier a document signed by the issuer\nacknowledging receipt of the medicine.\nExample—document\na copy of the supplier’s delivery docket signed by the issuer\nissuer—see section 62 (1) (a).\n\nMedicines purchase orders Part 3.3\nPurchase orders Division 3.3.2\nDivision 3.3.2 Purchase orders\n","sortOrder":21},{"sectionNumber":"62","sectionType":"section","heading":"General requirements for medicines purchase orders—","content":"62 General requirements for medicines purchase orders—\nAct, s 38 (2) (c)\n(1) A purchase order for a medicine must be—\n(2) A purchase order for a medicine must include the following:\nmedicine, to be supplied on the order.\n\n","sortOrder":22},{"sectionNumber":"70","sectionType":"section","heading":"Authorisation of CHO to issue standing orders for supply","content":"70 Authorisation of CHO to issue standing orders for supply\nof medicines in public health emergencies—Act, s 42 (b)\n(1) The chief health officer is authorised to issue a standing order for the\nsupply of a medicine in an emergency relating to public health.\nNote 2 A standing order must be in writing (see Act, dict, def standing order).\n(2) To remove any doubt, a standing order may be issued under\nsubsection (1) even if no emergency declaration under the Public\nHealth Act 1997 is in force.\n","sortOrder":23},{"sectionNumber":"71","sectionType":"section","heading":"Authorisation of CHO to issue standing orders for","content":"71 Authorisation of CHO to issue standing orders for\nadministration of medicines for public health matters—\nAct, s 42 (b)\nThe chief health officer is authorised to issue a standing order for the\nadministration of a medicine in relation to a public health matter.\nNote A standing order must be in writing (see Act, dict, def standing order).\n","sortOrder":24},{"sectionNumber":"72","sectionType":"section","heading":"Particulars for CHO standing orders for administration of","content":"72 Particulars for CHO standing orders for administration of\nmedicines for public health matters\nA standing order under section 71 must include the following\n(a) a description of the public health matter to which the order\nrelates;\n(b) the date of effect of the order and the date (not longer than 2\nyears after the date of effect) when the order ends;\n\nStanding orders for medicines Part 3.4\nStanding orders for institutions Division 3.4.2\n(c) the clinical circumstances in which the medicine may be\n(d) a description of the people to whom the medicine may be\n(e) the medicine’s approved name and, if applicable, brand name;\n(f) if applicable, the form and strength of the medicine;\n(g) the dose and route of administration;\n(h) if applicable, the frequency of administration.\nExample—par (e) and par (f)\nAdrenaline (EpiPen) 300 micrograms in 0.3mL pre-filled syringe\nNote Institution includes a correctional centre and a CYP detention place (see\ns 652).\n","sortOrder":25},{"sectionNumber":"75","sectionType":"section","heading":"Authorisation of doctors to issue standing orders for","content":"75 Authorisation of doctors to issue standing orders for\nadministration of medicines at institutions—Act, s 42 (b)\n(1) A doctor is authorised to issue a standing order for the administration\nof a medicine to patients at an institution if—\n(a) a medicines and therapeutics committee for the institution has\napproved the order; and\n(b) the order is signed by the chair of the committee.\nmedicines and therapeutics committee, for an institution, means a\nbody—\n(a) established by the institution to approve standing orders for the\nadministration of medicines to patients at the institution; and\n\n(b) that includes (but is not limited to) a doctor, nurse and\npharmacist.\nNote 1 Doctor and pharmacist do not include an intern (see dict).\nNote 2 Nurse does not include an enrolled nurse (see Legislation Act, dict,\n","sortOrder":26},{"sectionNumber":"76","sectionType":"section","heading":"Particulars for standing orders for administration of","content":"76 Particulars for standing orders for administration of\nmedicines at institutions\nA standing order under section 75 must include the following\n(a) an approval number for the order that is different from the\nnumber given to each other standing order approved for the\n(b) the date of effect of the order and the date (not longer than\n2 years after the date of effect) when the order ends;\n(c) each ward to which the order applies;\n(d) the clinical circumstances in which the medicine may be\n(e) a description of the people to whom the medicine may be\n(f) the medicine’s approved name and, if applicable, brand name;\n(g) if applicable, the form and strength of the medicine;\n(h) the dose and route of administration;\n(i) if applicable, the frequency of administration.\nExample—par (f) and par (g)\nAdrenaline (EpiPen) 300 micrograms in 0.3mL pre-filled syringe\n\nStanding orders for medicines Part 3.4\nStanding orders for walk-in centre Division 3.4.3\n","sortOrder":27},{"sectionNumber":"77","sectionType":"section","heading":"Authorisation of CHO to issue standing orders for supply","content":"77 Authorisation of CHO to issue standing orders for supply\nand administration of medicines at walk-in centre—Act,\ns 42 (b)\nThe chief health officer is authorised to issue a standing order for—\n(a) the supply of a medicine at a walk-in centre; and\n(b) the administration of a medicine at a walk-in centre.\nNote 2 A standing order must be in writing (see Act, dict, def standing order).\n","sortOrder":28},{"sectionNumber":"78","sectionType":"section","heading":"Particulars for CHO standing orders for supply and","content":"78 Particulars for CHO standing orders for supply and\nadministration of medicines at walk-in centre\nA standing order under section 77 must include the following\n(a) an approval number for the order that is different from the\nnumber given to each other standing order approved for the\nwalk-in centre;\n(b) the date of effect of the order and the date (not longer than 2\nyears after the date of effect) when the order ends;\n(c) each walk-in centre to which the order applies;\n(d) the clinical circumstances in which the medicine may be\nsupplied or administered;\n(e) a description of the people to whom the medicine may be\nsupplied or administered;\n(f) the medicine’s approved name and, if applicable, brand name;\n(g) if applicable, the form and strength of the medicine;\n(h) the dose and route of administration of the medicine;\n\n(i) if applicable, the frequency of administration of the medicine;\n(j) if applicable, the maximum duration of supply or administration\nof the medicine;\n(k) if applicable, the maximum quantity of the medicine for supply\nor administration.\n\nMedicines supply authorities generally Part 3.5\n","sortOrder":29},{"sectionNumber":"Part 3","sectionType":"part","heading":"5 Medicines supply authorities","content":"Part 3.5 Medicines supply authorities\n","sortOrder":30},{"sectionNumber":"80","sectionType":"section","heading":"Cancellation of invalid supply authorities—Act,","content":"80 Cancellation of invalid supply authorities—Act,\ns 30 (2) (d)\n(1) A paper-based supply authority is cancelled by a person if the\nperson—\n(a) marks the word ‘cancelled’, and the person’s name and business\naddress, on the front of the supply authority; and\n(b) signs and dates the cancellation of the supply authority.\n(2) An electronic supply authority is cancelled by a person if the\nperson—\n(a) marks the word ‘cancelled’ on the supply authority; and\n(b) links an electronic document to the supply authority that\nincludes the person’s name and business address and signature.\n","sortOrder":31},{"sectionNumber":"81","sectionType":"section","heading":"Information for CHO about monitored medicines supplied","content":"81 Information for CHO about monitored medicines supplied\non supply authorities—Act, s 31 (1) (b) and (4),\ndef required information\n(1) A person (the supplier) who supplies a monitored medicine on a\nsupply authority must, not later than 7 days after the day when the\nmedicine is supplied, give the chief health officer the following\ninformation in writing:\n(a) the supplier’s name, business address and telephone number;\n(b) the name of the person who issued the supply authority;\n(c) the date of the supply authority;\n(d) the name, date of birth and address of the person to whom the\nmedicine is supplied;\n\nPart 3.5 Medicines supply authorities generally\n(e) the date of supply;\n(f) the monitored medicine, and the form, strength and quantity of\nthe medicine, supplied.\n(2) However, this section does not apply to any of the following who\nreport the supply of a monitored medicine on a supply authority to\nthe Therapeutic Goods Administration:\n(a) a medicines wholesalers licence-holder;\n(b) a person who is authorised (however described) under a\nCommonwealth or State law to manufacture a monitored\nmedicine or supply a monitored medicine by wholesale.\n\nPreliminary Part 4.1\n","sortOrder":32},{"sectionNumber":"Part 4","sectionType":"part","heading":"1 Preliminary","content":"Part 4.1 Preliminary\n","sortOrder":33},{"sectionNumber":"100","sectionType":"section","heading":"Overview of supply authorisations for medicines","content":"100 Overview of supply authorisations for medicines\nThe following provisions of this chapter authorise a person to supply\na medicine:\n(a) section 110 (which is about supply authorisations set out in\nschedule 1, including dispensing on prescription, supply on\nrequisition, purchase order and standing order and supply during\nconsultations);\n(b) section 251 (which is about authorisation of pharmacists to\nsupply certain prescription only medicines without a\nprescription in emergencies);\n(c) section 255 (which is about authorisation of approved\npharmacists to supply certain medicines without prescription);\n(d) section 260 (which is about authorisation to supply medicines to\npharmacists for disposal).\nNote A person may also be authorised to supply a medicine in a way mentioned\nin s 11 (Overview of medicines authorisations etc under this regulation)\n(including under a licence, see pt 9.5).\n\nDivision 4.2.1 Sch 1 medicines supply authorisations\nPart 4.2 Medicines—supply\nauthorisations under sch 1\nDivision 4.2.1 Sch 1 medicines supply\n110 Authorisation under sch 1 to supply medicines—Act,\ns 26 (1) (b) and (2) (b)\n(1) A person mentioned in schedule 1, column 2 is authorised to supply\n(a) supplying the medicine is included in the schedule, column 3 in\n(b) the supply is consistent with any restriction for the supply\nmentioned in the schedule, column 3.\n(2) However, a pharmacist is not authorised under schedule 1 to supply a\nmedicine if—\n(a) the pharmacist is working for, or providing services to, a\ncorporation when supplying the medicine; and\n(b) the corporation is not—\n(i) a pharmacist; or\n(ii) a complying pharmacy corporation under the Public\nHealth Act 1997, part 3B (Pharmacies).\nNote Supply includes dispense (see Act, s 24).\n\n","sortOrder":34},{"sectionNumber":"120","sectionType":"section","heading":"Authorisation conditions for dispensing medicines—Act,","content":"120 Authorisation conditions for dispensing medicines—Act,\n(1) An authorisation under section 110 or section 490 to dispense a\n(a) the medicine is dispensed in accordance with the requirements\nof section 121;\nNote Only a pharmacist may dispense a medicine (see sch 1).\n(b) if the prescription is dispensed under section 121 (2), the\npharmacist notes on the prescription the reasons that the\npharmacist was satisfied that it was not practicable for a\ncomplying prescription to be issued for the medicine;\n(c) if the prescription is changed by a pharmacist at the oral\ndirection of the prescriber—the note of the change complies\nwith section 122;\n(d) the medicine is labelled in accordance with section 123;\n(e) the dispensed prescription is marked in accordance with\nsection 124;\n(f) the dispensing of the prescription is recorded in accordance with\nsection 125;\n(g) if the prescription is an oral prescription for the dispensing of\nthe medicine, or is faxed by a prescriber to a pharmacist, and the\npharmacist does not receive an original of the prescription\nwithin 14 days after the day the prescription is given—the\npharmacist must, within 24 hours after the end of the 14-day\nperiod, tell the chief health officer, in writing, of the failure to\nreceive the original prescription;\n\n(h) the prescription, if completed, and the record for paragraph (f),\nare kept at the pharmacy or, if the chief health officer approves\nin writing another place, the place approved by the chief health\nofficer, for at least 2 years after the day the prescription becomes\na completed prescription.\n(2) However, subsection (1) (d), (e), (f) and (h) do not apply if the\nprescription is written for an in-patient at a hospital in the patient’s\nmedical records.\ncompleted—a prescription is completed when—\n(a) for a single prescription—the prescription is dispensed; or\n(b) for a repeat prescription—the last repeat of the prescription is\ndispensed; or\n(c) for a national residential medication chart prescription––the\nprescription is dispensed for the last time.\n","sortOrder":35},{"sectionNumber":"120A","sectionType":"section","heading":"Variation of authorisation condition for dispensing","content":"120A Variation of authorisation condition for dispensing\nmedicines during Commonwealth special arrangement\nperiod\n(1) This section applies to a pharmacist who receives a written\nprescription if—\n(a) the prescription is faxed by a prescriber to the pharmacist; and\n(b) the prescription is for the supply of a medicine in accordance\nwith a Commonwealth special arrangement; and\n(c) the Commonwealth special arrangement requires the prescriber\nto keep the original of the prescription.\n(2) The pharmacist is not required to tell the chief health officer of a\nfailure to receive the original prescription under section 120 (1) (g).\n\nCommonwealth special arrangement means a special arrangement\nunder the National Health Act 1953 (Cwlth), section 100, as in force\nfrom time to time.\nNote Commonwealth special arrangements are accessible at\n","sortOrder":36},{"sectionNumber":"121","sectionType":"section","heading":"How medicines are dispensed","content":"121 How medicines are dispensed\n(1) The following are the requirements for dispensing a medicine:\n(a) the prescription is issued by an authorised prescriber;\nNote Authorised prescriber—see s (4).\n(b) the prescription complies with the applicable provisions of\ndivision 3.1.2 (Prescriptions);\n(c) the medicine is dispensed in accordance with the prescription\n(including the prescription as changed by a pharmacist at the\noral direction of the prescriber).\nNote 1 Dispensed in accordance with the prescription—see s (4).\nNote 2 For changes to a prescription by the dispenser, see the Act, s 29 (3).\nNote 3 Pharmacist does not include an intern pharmacist (see dict).\n(2) However, a pharmacist may dispense a prescription that does not\ninclude all of the applicable provisions for subsection (1) (b) if—\n(a) the prescription is issued by an authorised prescriber; and\n(b) the medicine is—\n(i) dispensed in accordance with the prescription; and\n(ii) if the prescription is changed by a pharmacist at the oral\ndirection of the prescriber—the prescription complies with\nsection 122; and\n\n(c) the medicine is supplied in a package that is labelled in\naccordance with section 123; and\n(d) the pharmacist is satisfied that, because of a circumstance\naffecting the prescriber or the person for whom the medicine is\nto be dispensed, it is not practicable for a complying prescription\nto be issued for the medicine.\n(3) Also, a pharmacist may dispense a prescription that does not comply\nwith section 41 (1) if the reason it does not comply is because it does\nnot include the date of birth or address of the person for whom the\nmedicine is prescribed.\nNote The dispensing pharmacist must ensure a written record is made of the\nname, date of birth and address of the person for whom the medicine is\ndispensed (see s 125 (g)).\nauthorised prescriber means—\n(a) for a prescription prescribing buprenorphine or methadone for\ntreatment of opioid dependency—a prescriber approved under\ndivision 13.1.3 to prescribe the medicine for the treatment of\nopioid dependency; or\n(b) for any other prescription—a prescriber.\nExample—paragraph (a)\nA doctor employed by an alcohol and drug service prescribing buprenorphine or\nmethadone to treat the opioid dependency for a patient.\nExample—paragraph (b)\nA doctor practising as a general practitioner prescribing buprenorphine or\nmethadone to treat chronic pain for a patient.\ndispensed in accordance with the prescription, for a prescribed\nmedicine, includes dispensing another brand of the medicine that is a\nbioequivalent form of the prescribed medicine.\n\n","sortOrder":37},{"sectionNumber":"122","sectionType":"section","heading":"Noting changes to prescriptions on oral direction of","content":"122 Noting changes to prescriptions on oral direction of\nprescriber—Act, s 27 (2) (b) (ii)\nThe following must be noted, in writing, on the prescription:\n(a) the name of the prescriber giving the oral direction to change the\n(b) the change to the prescription;\n(c) the date the oral direction is given;\n(d) the pharmacist’s signature.\nNote The notation must be made as soon as possible (see Legislation Act,\ns 151B).\n","sortOrder":38},{"sectionNumber":"123","sectionType":"section","heading":"Labelling dispensed medicines—Act, s 60 (1) (c) (i)","content":"123 Labelling dispensed medicines—Act, s 60 (1) (c) (i)\nThe dispensed medicine must have a label that includes the following:\n(a) the name of the person for whom the medicine is dispensed;\n(b) if the prescriber is a veterinary practitioner—\n(i) words to the effect of ‘for animal treatment only’; and\n(ii) the species of the animal for which the medicine is\ndispensed; and\n(iii) if a way of identifying the animal is stated on the\nprescription—the way of identifying the animal;\n(c) the medicine’s approved name and brand name;\n(d) the form, strength and quantity of the medicine dispensed;\n(e) if the package of the dispensed medicine is not a manufacturer’s\n(f) the date the medicine is dispensed;\n\n(g) the name and the business address and telephone number of the\npharmacy from which the medicine is dispensed;\n(h) the initials or other identification of the dispensing pharmacist;\n(i) a number that is different from the number given to each other\nprescription dispensed at the pharmacy;\n(j) directions about the use of the medicine that are adequate to\n(k) words to the effect of ‘keep out of reach of children’.\nExample—par (c) and par (d)\nWarfarin tablets (Coumadin) 5mg 50\n","sortOrder":39},{"sectionNumber":"124","sectionType":"section","heading":"Marking dispensed prescriptions","content":"124 Marking dispensed prescriptions\n(1) This section does not apply to—\n(a) a prescription written in the medical records of an in-patient at a\nhospital; or\n(b) an electronic prescription, within the meaning of the National\nHealth (Pharmaceutical Benefits) Regulations 2017 (Cwlth),\nsection 5.\n(2) A dispensed paper-based prescription for a medicine must be marked\n(a) if the prescription is a single prescription, the last repeat of a\nrepeat prescription, or a national residential medication chart\nprescription dispensed for the last time––the word ‘cancelled’\non the front of the prescription; and\n(b) the prescribed particulars.\n\n(3) A dispensed electronic prescription (other than an electronic\nprescription mentioned in subsection (1) (b)) for a medicine must be\nmarked with—\n(a) if the prescription is a single prescription, the last repeat of a\nrepeat prescription, or a national residential medication chart\nprescription dispensed for the last time––the word ‘cancelled’;\nand\n(b) a link to an electronic document containing the prescribed\nparticulars.\nnational residential medication chart—see section 31 (2).\npaper-based prescription includes a faxed copy of a prescription.\nprescribed particulars, for a dispensed prescription for a medicine,\nmeans—\n(a) the date the medicine is dispensed; and\n(b) the name and business address of the dispensing pharmacy; and\n(c) if another brand of the medicine is dispensed for the prescribed\nmedicine—the brand name of the medicine dispensed; and\n(d) for a repeat prescription—the number of the repeat dispensed;\nand\n(e) the prescription’s number under section 123 (i); and\n(f) the pharmacist’s initials or signature.\nsingle prescription means a prescription that is not a repeat\nprescription.\n\n","sortOrder":40},{"sectionNumber":"125","sectionType":"section","heading":"Recording dispensing of medicines","content":"125 Recording dispensing of medicines\nThe dispensing pharmacist must ensure that a written record is made\nof the following information in relation to the dispensing of the\nmedicine:\n(a) the pharmacist’s name;\n(b) the date of the prescription;\n(c) the prescriber’s name;\n(d) the date the prescription is dispensed;\n(e) for a repeat prescription—the number of the repeat dispensed;\n(f) the prescription’s number under section 123 (i);\n(g) the name, date of birth and address of the person for whom the\nmedicine is dispensed;\n(h) the medicine’s approved name and brand name;\n(i) the form, strength and quantity of the medicine dispensed.\nNote For authorisation to issue a requisition, see s 50.\n","sortOrder":41},{"sectionNumber":"130","sectionType":"section","heading":"Authorisation conditions for supplying medicines on","content":"130 Authorisation conditions for supplying medicines on\nrequisitions—Act, s 44 (1) (b) and (2) (b)\nAn authorisation under section 110 or section 490 to supply a\nmedicine on a requisition is subject to the following conditions:\n(a) the medicine is supplied in accordance with the requirements\nunder section 131;\naccordance with section 132;\n\nSupplying medicines on requisitions Division 4.2.3\n(c) the filled requisition is marked in accordance with section 133;\n(d) the supply is recorded in accordance with section 134;\n(e) the filled requisition and record under section 134 are kept at the\ninstitution where the medicine is supplied or, if the chief health\nofficer approves in writing another place, the place approved by\nthe chief health officer, for at least 2 years after the day the\nmedicine is supplied.\n","sortOrder":42},{"sectionNumber":"131","sectionType":"section","heading":"Supplying medicines on requisitions","content":"131 Supplying medicines on requisitions\n(1) The following are the requirements for the supply of a medicine on a\nrequisition:\n(a) the medicine is supplied in accordance with the requisition\n(including the requisition as changed by the person supplying\nthe medicine at the oral direction of the person issuing the\nrequisition);\nNote For changes to a requisition by the person supplying a medicine on\na requisition (see Act, s 29 (3)).\n(b) if the requisition is a written requisition—the requisition\n(c) if the requisition is an oral requisition—the requisition complies\nwith section 56.\n(2) However, if the requisition does not comply with section 55 or\nsection 56 (as appropriate), a pharmacist may supply the medicine on\nthe requisition if satisfied that it is not practicable for a complying\nrequisition to be issued for the medicine.\n\nsupplied in accordance with the requisition, for a requisitioned\nmedicine, includes supplying another brand of the medicine that is a\nbioequivalent form of the requisitioned medicine.\n","sortOrder":43},{"sectionNumber":"132","sectionType":"section","heading":"Labelling medicines supplied on requisition—Act,","content":"132 Labelling medicines supplied on requisition—Act,\nThe package of a medicine supplied on requisition to a ward for the\nsupply to a patient must have a label that includes the following:\n(a) the medicine’s approved name or brand name;\n(b) the form, strength and quantity of the medicine;\n(c) if the package of the medicine is not a manufacturer’s pack—\n(i) the batch number or numbers of the medicine; and\n(ii) the relevant expiry date for the medicine;\n(d) the name or other identifier of the pharmacy or ward from which\nthe medicine is supplied;\n(e) if the medicine is a controlled medicine—a number that is\ndifferent from the number given to each other requisition\nsupplied from the pharmacy or ward.\nExamples—par (a) and par (b)\n1 Warfarin tablets 5mg 50\n2 Coumadin tablets 5mg 50\n133 Marking filled requisitions\n(1) A filled paper-based requisition for a medicine must be marked\n(a) the name or other identifier of the pharmacy or ward from which\nthe medicine is supplied; and\n\nSupplying medicines on requisitions Division 4.2.3\n(b) if the medicine is a controlled medicine—the requisition’s\nnumber under section 132 (e); and\n(c) the supplier’s initials or signature.\n(2) A filled electronic requisition for a medicine must be marked with a\nlink to an electronic document containing—\n(a) the name or other identifier of the pharmacy or ward from which\nthe medicine is supplied; and\n(b) if the medicine is a controlled medicine—the requisition’s\nnumber under section 132 (e); and\n(c) the supplier’s initials or signature.\n(3) However, subsection (1) (a) and (2) (a) do not apply to a requisition\nfilled at a pharmacy at an institution.\npaper-based requisition includes a faxed copy of a requisition.\n","sortOrder":44},{"sectionNumber":"134","sectionType":"section","heading":"Recording supply of medicines on requisitions","content":"134 Recording supply of medicines on requisitions\nA person or endorsed health practitioner who supplies a medicine to\nsomeone else on requisition (a supplier) must make a written record\nof the following information:\n(a) the date of the requisition;\n(b) the name of the person who issued the requisition;\n(c) the date the requisition is filled;\n(d) the medicine, and the form, strength and quantity of the\nmedicine, supplied;\n(e) the supplier’s name or initials.\n\nDivision 4.2.4 Supplying medicines on purchase orders\nDivision 4.2.4 Supplying medicines on purchase\nNote For authorisation to issue a purchase order, see s 60.\n140 Authorisation conditions for supplying medicines on\npurchase orders—Act, s 44 (1) (b) and (2) (b)\nAn authorisation under section 110 or section 490 to supply a\nmedicine on a purchase order is subject to the following conditions:\n(a) the purchase order is a complying purchase order;\n(b) the medicine is supplied in accordance with the requirements of\nsection 141;\n(c) the supply is recorded in accordance with section 142;\n(d) if the supplier does not receive a document signed by the buyer\nacknowledging receipt of the medicine within 7 days after the\nday the medicine is delivered—the supplier must, within\n24 hours after the end of the 7-day period, tell the chief health\nofficer, in writing, of the failure to receive the document;\n(e) the following are kept at the supplier’s business premises or, if\nthe chief health officer approves in writing another place, the\nafter the day the medicine is supplied:\n(ii) the delivery acknowledgment under paragraph (d) or\nsection 141 (1) (d) (ii);\n(iii) the record for section 142.\n\nSupplying medicines on purchase orders Division 4.2.4\n","sortOrder":45},{"sectionNumber":"141","sectionType":"section","heading":"Supplying medicines on purchase orders","content":"141 Supplying medicines on purchase orders\n(1) The following are the requirements for the supply of a medicine on a\npurchase order:\n(a) the medicine is supplied in manufacturer’s packs that comply\n(i) section 501 (Packaging of supplied manufacturer’s packs\nof medicines—Act, s 59 (1) (c) (i) and (2) (c) (i)); or\n(i) section 502 (Labelling of supplied manufacturer’s packs of\nmedicines—Act, s 60 (1) (c) (i) and (2) (c) (i)); or\n(ii) an approval under the Act, section 193;\n(c) the manufacturer’s packs are securely wrapped and packed;\n(d) if the medicine is delivered in person by the supplier to the\nbuyer—\n(i) the medicine is delivered to an adult; and\n(ii) the delivery is acknowledged by the adult signing and\ndating a copy of the purchase order;\n(e) if the medicine is not delivered in person by the supplier to the\nbuyer—the medicine is delivered to the buyer by a person whose\nprocedures require the delivery of the medicine to be signed for\nby the buyer or an adult employee of the buyer.\n(2) However, subsection (1) (a), (b) and (c) do not apply in relation to a\nmedicine supplied by a pharmacist to a prescriber who is authorised\nto supply the medicine during a consultation if the medicine is\nsupplied in a package that is labelled with the following particulars:\n(a) the approved name and brand name of the medicine;\n\n(b) the form, strength and quantity of the medicine, supplied;\n(c) if the package of the medicine is not a manufacturer’s pack—\nthe relevant expiry date for the medicine.\n","sortOrder":46},{"sectionNumber":"142","sectionType":"section","heading":"Recording supply of medicines on purchase orders","content":"142 Recording supply of medicines on purchase orders\nA person or endorsed health practitioner who supplies a medicine to\nsomeone else on a purchase order must make a written record of the\nfollowing information:\n(a) the date of the order;\n(c) the name, and the business address and telephone number, of the\nperson to whom the medicine is supplied;\n(d) the date the order is supplied;\n(e) the medicine, and the form, strength and quantity of the\nmedicine, supplied.\n","sortOrder":47},{"sectionNumber":"Div 4","sectionType":"division","heading":"2.5 Supplying medicines on standing","content":"Division 4.2.5 Supplying medicines on standing\nNote 1 For the issue of a standing order, see pt 3.4.\nNote 2 Supply does not include administer (see Act, s 24).\n","sortOrder":48},{"sectionNumber":"150","sectionType":"section","heading":"Authorisation conditions for supplying medicines on","content":"150 Authorisation conditions for supplying medicines on\nstanding orders—Act, s 44 (1) (b) and (2) (b)\n(1) An authorisation under section 110 or section 490 to supply a\nmedicine on a standing order is subject to the following conditions:\n(a) the medicine is supplied in accordance with the requirements of\nsection 151;\n(b) the supply is recorded in accordance with section 153;\n\nSupplying medicines on standing orders Division 4.2.5\n(c) the record for section 153 is kept at the supplier’s business\npremises or, if the chief health officer approves in writing\nat least 2 years after the day the medicine is supplied;\n(d) if the supplier is not the person who would ordinarily have\nprescribed the medicine for the recipient, the required\ninformation is given in writing to—\n(i) the prescriber (the usual prescriber) who would ordinarily\nhave prescribed the medicine for the recipient not later than\n24 hours after supplying the medicine; or\n(ii) if the recipient does not have a usual prescriber—the\nrecipient.\n(2) However, subsection (1) (c) and (d) do not apply if the record is made\nin a patient’s medical records.\nrequired information, for the supply of a medicine on a standing\norder, means—\n(a) the supplier’s name; and\n(b) the date the medicine is supplied; and\n(c) the name and address of the person to whom the medicine is\n(d) the medicine’s approved name and brand name; and\n(e) the form, strength and quantity of the medicine supplied.\nsupplier—see section 153 (1).\n\n","sortOrder":49},{"sectionNumber":"151","sectionType":"section","heading":"Supplying medicines on standing orders","content":"151 Supplying medicines on standing orders\nThe following are the requirements for the supply of a medicine on a\nstanding order:\n(a) the medicine is supplied in accordance with the standing order;\naccordance with section 152.\n","sortOrder":50},{"sectionNumber":"152","sectionType":"section","heading":"Labelling medicines supplied on standing order—Act,","content":"152 Labelling medicines supplied on standing order—Act,\nThe package of a medicine supplied on a standing order must have a\nlabel that includes the following:\n(a) the name of the person to whom the medicine is to be supplied;\nmedicine, supplied;\n(d) if the package of the dispensed medicine is not a manufacturer’s\npack—\n(i) the batch number or numbers of the medicine; and\n(ii) the relevant expiry date for the medicine;\n(e) the supplier’s name, business address and telephone number;\n(f) directions about the use of the medicine that are adequate to\n(g) words to the effect of ‘keep out of reach of children’.\n\nSupplying medicines on standing orders Division 4.2.5\n","sortOrder":51},{"sectionNumber":"153","sectionType":"section","heading":"Recording supply of medicines on standing orders","content":"153 Recording supply of medicines on standing orders\n(1) A person (the supplier) who supplies a medicine to a person\n(the patient) on a standing order must make a written record of the\nfollowing information:\n(a) the supplier’s name;\n(b) the patient’s name and address;\n(c) the date the medicine is supplied;\n(d) the medicine’s approved name and brand name;\n(e) the form, strength and quantity of the medicine;\n(f) the date of the standing order.\n(2) However, subsection (1) (b) does not apply if the record is made in\nthe patient’s medical records.\n\nDivision 4.2.6 Supplying medicines during\nconsultations\nNote Supply does not include administer (see Act, s 24).\n","sortOrder":52},{"sectionNumber":"160","sectionType":"section","heading":"Authorisation conditions for supplying medicines during","content":"160 Authorisation conditions for supplying medicines during\nconsultations—Act, s 44 (1) (b) and (2) (b)\nA prescriber’s authorisation under section 110 or section 490 to\nsupply a medicine during a consultation is subject to the following\nconditions:\n(a) the medicine is supplied in accordance with the Act, section 7\n(Appropriate prescription and supply of medicines);\n(b) if the medicine is a controlled medicine for human use—\n(i) the prescriber complies with the additional requirements\nunder section 163 (Additional requirements for supplying\ncontrolled medicines for human use during consultations)\nin relation to the supply; and\n(ii) if the medicine is dronabinol—the prescriber has an\nauthorisation under the Therapeutic Goods Act 1989\n(Cwlth), section 19 to supply the medicine; and\nNote Dronabinol cannot be prescribed for veterinary use because\nit is a prohibited substance (see medicines and poisons\nstandard, sch 9, entry for tetrahydrocannabinols).\n(iii) the prescriber complies with section 164 (Information for\nCHO about monitored medicines supplied during\nconsultations—Act, s 31 (2) (b) and (4), def required\ninformation);\n(c) if the medicine is an appendix D medicine—\n(i) the prescriber has an appendix D medicines approval to\nprescribe the medicine; and\n\nSupplying medicines during consultations Division 4.2.6\napproval (including any conditions in the schedule,\npart 3.2, column 4 in relation to the medicine);\n(d) the medicine is labelled in accordance with section 161;\n(e) the supply is recorded in accordance with section 162;\n(f) the record is kept at the prescriber’s business premises or, if the\nchief health officer approves in writing another place, the place\nday the medicine is supplied.\n","sortOrder":53},{"sectionNumber":"161","sectionType":"section","heading":"Labelling medicines supplied during consultations","content":"161 Labelling medicines supplied during consultations\nThe supplied medicine must have a label that includes the following:\n(c) the prescriber’s name, business address and telephone number;\n(d) the medicine’s approved name or brand name;\n(e) the form, strength and quantity of the medicine;\n(f) if the package of the supplied medicine is not a manufacturer’s\n(g) directions about the use of the medicine that are adequate to\n(h) words to the effect of ‘keep out of reach of children’;\n(i) if the prescriber is a veterinary practitioner—\n(i) words to the effect of ‘for animal treatment only’; and\n\n(ii) the species of the animal for which the medicine is\n(iii) if possible, a way of identifying the animal.\nExamples—par (d) and par (e)\n1 Warfarin tablets 5mg 50\n2 Coumadin tablets 5mg 50\n162 Recording medicines supplied during consultations\nA prescriber who supplies a medicine during a consultation must\nmake a written record of the following information in the medical\nrecords of the person to whom, or animal to which, the consultation\nrelated:\n(a) the date the medicine is supplied;\n(b) the medicine’s approved name or brand name;\n(c) the form, strength and quantity of the medicine;\n(d) the directions given to the person for the use of the medicine.\n","sortOrder":54},{"sectionNumber":"163","sectionType":"section","heading":"Additional requirements for supplying controlled","content":"163 Additional requirements for supplying controlled\nmedicines for human use during consultations\nThe following are the additional requirements for supplying a\ncontrolled medicine for human use during a consultation:\n(a) the prescriber has a controlled medicines approval to prescribe\nNote For controlled medicines approvals, see pt 13.1.\n(b) if the approval is for a particular form of the medicine—the\nsupply is for the form of the medicine approved or a\nbioequivalent form;\n\nSupplying medicines during consultations Division 4.2.6\n(c) if the approval is for a particular strength of the medicine—the\nsupply is for the strength approved or a weaker strength;\n(d) if the approval is for a maximum daily dose of the medicine—\nthe supply is for not more than the maximum daily dose\napproved;\n(e) the prescriber complies with each condition (if any) of the\napproval.\nIf a slow release form of a medicine is approved, the prescriber is not authorised to\nprescribe an immediate release form of the medicine.\n","sortOrder":55},{"sectionNumber":"164","sectionType":"section","heading":"Information for CHO about monitored medicines supplied","content":"164 Information for CHO about monitored medicines supplied\nduring consultations—Act, s 31 (2) (b) and (4),\ndef required information\n(1) This section applies if a prescriber supplies a monitored medicine for\nhuman use during a consultation.\nNote Supply does not include administer (see Act, s 24).\n(2) The prescriber must, not later than 7 days after the end of the month\nwhen the monitored medicine is supplied, give the chief health officer\nthe following information in writing:\n(a) the prescriber’s name, business address and telephone number;\n(b) the name, date of birth and address of the person to whom the\nmedicine is supplied;\n(c) the date of supply;\n(d) the monitored medicine, and the form, strength and quantity of\nthe medicine, supplied.\n\n","sortOrder":56},{"sectionNumber":"170","sectionType":"section","heading":"Meaning of retail sale—div 4.2.7","content":"170 Meaning of retail sale—div 4.2.7\nIn this division:\nretail sale does not include supply on prescription.\n","sortOrder":57},{"sectionNumber":"171","sectionType":"section","heading":"Authorisation conditions for retail sale of","content":"171 Authorisation conditions for retail sale of\npseudoephedrine—Act, s 44 (1) (b) and (2) (b)\nA person’s authorisation under section 110 to supply\npseudoephedrine is subject to the following conditions if the\npseudoephedrine is sold by retail sale:\n(a) the pseudoephedrine is supplied in accordance with the Act,\nsection 7 (Appropriate prescription and supply of medicines);\n(b) the seller complies with section 172;\n(c) the seller makes a record (the pseudoephedrine record) of the\nrequired information under section 173;\nNote For how the record must be made, see the Act, s 46.\n(d) the record is kept at the seller’s business premises or, if the chief\nhealth officer approves in writing another place, the place\nday the sale is made;\n(e) if the buyer of the pseudoephedrine asks the seller to see the\nrecord during the period it is kept under paragraph (d), the\nseller—\n(i) allows the buyer to see the record within a reasonable\nperiod of a request being made by the buyer; and\n(ii) if satisfied that the record is incorrect, amends the record;\n\nSelling pseudoephedrine by retail Division 4.2.7\n(f) the seller complies with—\n(i) a request under section 174 (4) (b) (Failure to amend\npseudoephedrine sales record); and\n(ii) a direction under section 175 (Pseudoephedrine sales\nrecord—decision by CHO) to amend the record.\n","sortOrder":58},{"sectionNumber":"172","sectionType":"section","heading":"Requirement to tell buyer about pseudoephedrine sales","content":"172 Requirement to tell buyer about pseudoephedrine sales\nrecord\n(1) The authorised person selling pseudoephedrine by retail sale, must\ntell the buyer the following:\n(a) the seller is required to make a record of the sale;\n(b) the buyer may refuse to provide information for the record but,\nif the buyer refuses, the seller must not sell pseudoephedrine to\nthe buyer;\n(c) the record may be made available to the following people:\n(i) a police officer;\n(ii) a public servant who is a member of the administrative unit\nto which the chief health officer belongs;\n(iii) a Commonwealth or State public servant (however\ndescribed) who is a member of an administrative unit\n(however described) that administers legislation about\nmedicines;\nNote State includes the Northern Territory (see Legislation Act,\ndict, pt 1).\n(iv) anyone other than the seller who supplies pseudoephedrine\nto the public in Australia;\n(v) the Pharmacy Guild of Australia;\n(d) the buyer has the right to see the record and have any mistake\ncorrected.\n\npolice officer includes a member of a police force (however\ndescribed) of a State.\n","sortOrder":59},{"sectionNumber":"173","sectionType":"section","heading":"Required information for pseudoephedrine sales records","content":"173 Required information for pseudoephedrine sales records\n(1) The following is the required information for a pseudoephedrine\nrecord:\n(a) the date of sale;\n(b) the brand name, form, strength and quantity of pseudoephedrine\nsold;\n(c) the buyer’s name and address;\n(d) a unique identification number for the buyer from—\n(i) a photo identification document produced to the seller by\nthe buyer; or\n(ii) if the buyer does not produce a photo identification\ndocument—\n(A) the buyer’s birth certificate; or\n(B) an Australian or New Zealand seniors card for the\nbuyer;\n(e) the kind of identification the buyer produces.\nExample—unique identification number\na person’s driver licence number\nAustralian student identification card means a card issued to a\nperson who is a student at an Australian secondary or tertiary\neducation institution to identify the person as a student at the\ninstitution.\n\nSelling pseudoephedrine by retail Division 4.2.7\nbirth certificate, for a person, means—\n(a) the person’s birth certificate, or a certified extract from the\nregister about the person’s birth, under the Births, Deaths and\nMarriages Registration Act 1997; or\n(b) a document issued under a law of a State, an external Territory\nor New Zealand that corresponds to a birth certificate or extract\nmentioned in paragraph (a) if the document identifies the issuing\njurisdiction and states its date of issue.\nphoto identification document, for a person, means any of the\nfollowing documents for the person if it is current and contains the\nperson’s photograph:\n(a) an Australian driver licence or external driver licence within the\nmeaning of the Road Transport (Driver Licensing) Act 1999;\n(b) a passport, other than an Australian passport;\n(c) a proof of identity card;\n(d) an Australian student identification card.\nproof of identity card means a proof of identity card issued under—\n(a) the Liquor Act 2010, section 210 (Proof of identity cards); or\n(b) the law of a State, an external territory or New Zealand.\n","sortOrder":60},{"sectionNumber":"174","sectionType":"section","heading":"Failure to amend pseudoephedrine sales record","content":"174 Failure to amend pseudoephedrine sales record\n(1) This section applies if the seller of pseudoephedrine does not amend\na pseudoephedrine record in accordance with section 171 (e) (ii)\n(Authorisation conditions for retail sale of pseudoephedrine—Act,\ns 44 (1) (b) and (2) (b)).\n(2) The buyer may, in writing, apply to the chief health officer for a\ndirection to the seller to make the amendment.\n\n(3) The application must give reasons why the buyer thinks the record is\nincorrect.\n(4) The chief health officer must—\n(a) give a copy of the application to the seller; and\n(b) ask the seller to—\n(i) make the amendment and tell the chief health officer; or\n(ii) if the seller is satisfied that the amendment should not be\nmade—send written reasons to the chief health officer not\nlater than 10 working days after the day the seller receives\nthe application why the amendment should not be made.\n","sortOrder":61},{"sectionNumber":"175","sectionType":"section","heading":"Pseudoephedrine sales record—decision by CHO","content":"175 Pseudoephedrine sales record—decision by CHO\n(1) After considering an application under section 174 (2) and any\nreasons given in accordance with the request under\nsection 174 (4) (b) (ii), the chief health officer must—\n(a) direct the seller to amend the pseudoephedrine record—\n(i) in accordance with the application; or\n(ii) in a stated way other than in accordance with the\napplication; or\n(b) refuse the application.\n(2) The chief health officer must give the buyer and seller written notice\nof the decision.\n\nSupplying pharmacist only medicines Division 4.2.8\nDivision 4.2.8 Supplying pharmacist only medicines\n","sortOrder":62},{"sectionNumber":"180","sectionType":"section","heading":"Authorisation conditions for supply of pharmacist only","content":"180 Authorisation conditions for supply of pharmacist only\n(1) This section does not apply to the supply of a pharmacist only\nmedicine—\n(a) at an institution; or\n(b) on a supply authority.\nNote 2 Supply authority includes a written prescription or requisition or a\npurchase order or standing order (see Act, s 23).\n(2) An authorisation under section 110 or section 490 to supply a\npharmacist only medicine is subject to the following conditions:\n(a) the supplier personally hands the medicine to a recipient\nattending in person;\n(b) the supplier gives the recipient adequate instructions, either\norally or in writing, for the medicine’s use at the time of supply.\nsupplier means the following:\n(a) a person who is authorised under section 110 to supply a\npharmacist only medicine;\n(b) an endorsed health practitioner who is authorised under\nsection 490 to supply a pharmacist only medicine.\n\nPart 4.3 Authorisation to supply without prescription in emergencies\nPart 4.3 Authorisation to supply without\nprescription in emergencies\n250 Meaning of designated prescription only medicine—pt 4.3\ndesignated prescription only medicine means a prescription only\nmedicine other than—\n(a) an anabolic steroid; and\n(b) an appendix D medicine; and\n(c) a benzodiazepine.\nNote Prescription only medicine does not include a controlled medicine (see\nAct, s 11)\n","sortOrder":63},{"sectionNumber":"251","sectionType":"section","heading":"Authorisation to supply certain medicines without","content":"251 Authorisation to supply certain medicines without\nprescription in emergencies—Act, s 26 (1) (b)\nA pharmacist is authorised to supply a designated prescription only\nmedicine to someone else without a prescription if the pharmacist is\nsatisfied that—\n(a) the person is undergoing treatment essential to the person’s\nhealth or wellbeing; and\n(b) the designated prescription only medicine has previously been\nprescribed for the person’s treatment by a prescriber; and\n(c) the person is in immediate need of the medicine to continue the\ntreatment; and\n(d) because of an emergency, it is not practicable for the person to\nobtain a prescription for the medicine from a prescriber.\n\nAuthorisation to supply without prescription in emergencies Part 4.3\n","sortOrder":64},{"sectionNumber":"252","sectionType":"section","heading":"Authorisation conditions for supplying of certain","content":"252 Authorisation conditions for supplying of certain\nmedicines without prescription in emergencies—Act,\n(1) A pharmacist’s authorisation under section 251 to supply a designated\nprescription only medicine without a prescription is subject to the\nfollowing conditions:\n(a) the quantity supplied is—\n(i) if the medicine is a liquid, aerosol, cream, ointment or\nanovulant tablet packaged in a manufacturer’s pack—the\nsmallest manufacturer’s pack in which the medicine is\ngenerally available; or\n(ii) in any other case—not more than the quantity required for\n3 days treatment for the person;\naccordance with section 253;\n(c) the supply is recorded in accordance with section 254;\n(d) the record of the supply is kept at the pharmacy or, if the chief\nhealth officer approves in writing another place, the place\nday medicine is supplied;\n(e) the pharmacist sends the prescriber who would have ordinarily\nprescribed the medicine for the recipient the required\ninformation for the supply in writing not later than 24 hours after\nsupplying the medicine.\nrequired information, for the supply of a designated prescription\nonly medicine, means—\n(a) the pharmacist’s name; and\n\nPart 4.3 Authorisation to supply without prescription in emergencies\n(b) the name, business address and telephone number of the\npharmacy from which the medicine is supplied; and\n(c) the date the medicine is supplied; and\n(d) the name and address of the person to whom the medicine is\n(e) the medicine’s approved name or brand name; and\n(f) the form, strength and quantity of the medicine supplied.\n","sortOrder":65},{"sectionNumber":"253","sectionType":"section","heading":"Labelling medicines supplied without prescription in","content":"253 Labelling medicines supplied without prescription in\nemergencies—Act, s 60 (1) (c) (i) and (2) (c) (i)\nThe package of a designated prescription only medicine supplied to a\nperson under section 251 must have a label that includes the\n(c) the name, business address and telephone number of the\npharmacy from which the medicine is supplied;\n(d) the initials or other identification of the pharmacist supplying\n(f) the form, strength and quantity of the medicine;\n(g) if the package of the supplied medicine is not a manufacturer’s\n(h) directions about the use of the medicine that are adequate to\n\nAuthorisation to supply without prescription in emergencies Part 4.3\n(i) words to the effect of ‘keep out of reach of children’.\nExample—par (e) and par (f)\nWarfarin tablets (Coumadin) 5mg 3\n","sortOrder":66},{"sectionNumber":"254","sectionType":"section","heading":"Recording medicines supplied without prescription in","content":"254 Recording medicines supplied without prescription in\nemergencies\nA pharmacist who supplies a designated prescription only medicine\nto a person under section 251 must make a written record of the\nfollowing information in relation to the supply of the medicine:\n(a) the pharmacist’s name;\n(b) the name of the prescriber who would ordinarily have prescribed\n(c) the date the medicine is supplied;\n(d) the name and address of the person to whom the medicine is\nsupplied;\n(f) the form, strength and quantity of the medicine supplied.\n\nPart 4.3A Authorisation to supply certain medicines without prescription—continued\nPart 4.3A Authorisation to supply certain\nmedicines without prescription—\ncontinued dispensing\n","sortOrder":67},{"sectionNumber":"255","sectionType":"section","heading":"Authorisation to supply certain medicines without","content":"255 Authorisation to supply certain medicines without\nprescription by approved pharmacist––Act, s 185 (1) (g)\n(1) An approved pharmacist is authorised to supply a designated\nprescription only medicine to a person without prescription if––\n(a) the designated prescription only medicine is listed as a\npharmaceutical benefit under a continued dispensing\ndetermination; and\n(b) the pharmacist supplies the designated prescription only\nmedicine to the person in accordance with the determination.\ndesignated prescription only medicine—see section 250.\n","sortOrder":68},{"sectionNumber":"256","sectionType":"section","heading":"Labelling certain medicines supplied without prescription","content":"256 Labelling certain medicines supplied without prescription\nby approved pharmacist––Act, s 185 (1) (j)\nThe medicine supplied to a person under section 255 must have a\nlabel that includes the following:\n(c) the name, business address and telephone number of the\npharmacy from which the medicine is supplied;\n(d) the initials or other identification of the pharmacist supplying\n\nAuthorisation to supply certain medicines without prescription—continued\nPart 4.3A\n(f) the form, strength and quantity of the medicine;\n(g) if the package of the supplied medicine is not a manufacturer’s\n(h) a number that is different from the number given to any\nprescription dispensed at the pharmacy;\n(i) directions about the use of the medicine that are adequate to\n(j) words to the effect of ‘keep out of reach of children’.\nExample—pars (e) and (f)\nMicrolut 28 tablets (Levonorgestrel) 30mcg 3\n\nPart 4.4 Authorisation to supply medicines for disposal\nPart 4.4 Authorisation to supply\nmedicines for disposal\n260 Authorisation to supply medicines to pharmacists for\ndisposal—Act, s 26 (1) (b)\nA person is authorised to supply a medicine to a pharmacist for\ndisposal.\n","sortOrder":69},{"sectionNumber":"261","sectionType":"section","heading":"Authorisation to supply medicines to commercial","content":"261 Authorisation to supply medicines to commercial\ndisposal operators for disposal—Act, s 26 (1) (b)\nA person is authorised to supply a medicine to another person for\ndisposal if the other person—\n(a) holds an environmental authorisation for the disposal of the\nNote For related authorisations, see pt 9.1.\n\nWholesale supply of medicines under corresponding laws Part 4.5\nPart 4.5 Wholesale supply of medicines\nunder corresponding laws\n","sortOrder":70},{"sectionNumber":"270","sectionType":"section","heading":"Conditions for wholesalers supplying medicines under","content":"270 Conditions for wholesalers supplying medicines under\ncorresponding laws—Act, s 20 (4) (c)\nThe following conditions apply to a person who supplies medicines\nby wholesale under a corresponding law:\n(a) the person must comply with, and must ensure that the person’s\nagents and employees comply with—\n(i) the Australian code of good wholesaling practice for\nmedicines in schedules 2, 3, 4 and 8; and\n(ii) the medicines Australia code of conduct;\nNote Australian code of good wholesaling practice for medicines in\nschedules 2, 3, 4 and 8 and medicines Australia code of conduct—\nsee the dictionary.\n(b) the person must not supply sample packs of a controlled\nmedicine;\n(c) the person must not supply a medicine to someone else (the\nbuyer) unless—\n(i) the buyer is authorised to possess the medicine; and\n(ii) the supply is in accordance with section 140 (Authorisation\nconditions for supplying medicines on purchase orders—\nAct, s 44 (1) (b) and (2) (b));\n(d) the person must store medicines—\n(i) within the manufacturer’s recommended storage\ntemperature range; and\n(ii) in any other environmental condition that is necessary to\npreserve the medicine’s stability and therapeutic quality.\n\nPart 5.1 Authorisations for health-related\noccupations\n","sortOrder":71},{"sectionNumber":"350","sectionType":"section","heading":"Authorisation under sch 1 for people in health-related","content":"350 Authorisation under sch 1 for people in health-related\noccupations to administer medicines—Act, s 37 (1) (b)\nA person mentioned in schedule 1, column 2 is authorised to\nadminister a medicine if—\n(a) administering the medicine is included in the schedule,\ncolumn 3 in relation to the person; and\n(b) the administration is consistent with any restriction for the\nadministration mentioned in the schedule, column 3.\nNote For authorisation to self-administer a medicine, see s 360.\n","sortOrder":72},{"sectionNumber":"351","sectionType":"section","heading":"Authorisation conditions for administration of medicines","content":"351 Authorisation conditions for administration of medicines\nat institutions by people in health-related occupations—\nAct, s 44 (1) (b) and (2) (b)\n(1) An authorisation under section 350 or section 490 to administer a\n(a) if the medicine is administered under a standing order to a\npatient at an institution—the administration is recorded in the\npatient’s medical records;\nNote Institution includes a correctional centre and a CYP detention\nplace (see s 652).\n\nAuthorisations for health-related occupations Part 5.1\n(b) if the medicine is a controlled medicine administered to a patient\nat an institution—\n(i) the medicine is not removed from a storage receptacle until\nimmediately before its administration; and\n(ii) the administration is witnessed by a prescribed\nadministration witness or, if a prescribed administration\nwitness is not reasonably available to witness the\nadministration, the administration is witnessed by another\nNote The witness must sign the record of the administration as\nwitness (see Act, s 53 (e)).\n(iii) the administration is recorded in—\n(A) the patient’s medical records; and\n(B) the applicable controlled medicines register\nmentioned in section 543 (3) (Making entries in\ncontrolled medicines registers—Act, s 51 (1) (b)).\n(2) However, subsection (1) (b) does not apply in relation to a controlled\nmedicine dispensed in a dose administration aid for—\n(a) a patient at a residential aged care facility or residential\ndisability care facility; or\n(b) a detainee at a correctional centre; or\n(c) a young detainee at a CYP detention place.\nprescribed administration witness means a person prescribed under\nsection 544 (Prescribed witnesses for administration of controlled\nmedicines—Act, s 53 (a) and (b)) for the administration of a\ncontrolled medicine.\n\n","sortOrder":73},{"sectionNumber":"352","sectionType":"section","heading":"Authorisation for pharmacist and intern pharmacist to","content":"352 Authorisation for pharmacist and intern pharmacist to\nadminister vaccine without prescription—Act, s 37 (1) (b)\n(1) A pharmacist is authorised to administer a vaccine to a person without\nprescription if the pharmacist administers the vaccine in accordance\nwith a direction by the chief health officer.\n(2) An intern pharmacist is authorised to administer a vaccine to a person\nwithout prescription if—\n(a) the intern pharmacist administers the vaccine in accordance with\na direction by the chief health officer; and\n(b) the intern pharmacist is under the direct supervision of a\npharmacist authorised to administer a vaccine under\nsubsection (1).\n(3) The chief health officer may give directions for the administration of\na vaccine to a person without prescription by a pharmacist or intern\npharmacist.\n(4) A direction is a disallowable instrument.\nvaccine means—\n(a) a vaccine for human therapeutic use to which the medicines and\npoisons standard, schedule 4 applies; and\n(b) a vaccine specified separately under that schedule for human\ntherapeutic use.\n","sortOrder":74},{"sectionNumber":"353","sectionType":"section","heading":"Authorisation for nurse or midwife to administer vaccine","content":"353 Authorisation for nurse or midwife to administer vaccine\nwithout prescription—Act, s 37 (1) (b)\n(1) A nurse or midwife is authorised to administer a vaccine to a person\nwithout prescription if the nurse or midwife administers the vaccine\nin accordance with a direction by the chief health officer.\n\nAuthorisations for health-related occupations Part 5.1\n(2) The chief health officer may give directions for the administration of\na vaccine to a person without prescription by a nurse or midwife.\n(3) A direction is a disallowable instrument.\nvaccine—see section 352 (5).\n\nPart 5.2 Other administration authorisations\nPart 5.2 Other administration\n360 Authorisation for self-administration etc of medicines—\nAct, s 37 (2) (b) and (3) (b)\n(1) This section applies in relation to a medicine obtained by a person\nfrom someone who is authorised to supply the medicine to the person.\n(2) The following dealings by the person with the medicine are\nauthorised:\n(a) if the person is a prescriber and the medicine is a restricted\nmedicine—self-administration of a medicine prescribed or\nsupplied by another prescriber who is not—\n(i) a trainee dentist, intern doctor or endorsed health\n(ii) related to or employed by the person;\n(b) if the person is a prescriber and the medicine is not a restricted\nmedicine—self-administration of the medicine;\n(c) if the person is not a prescriber and the medicine is supplied for\nthe person’s own use—self-administration of the medicine;\n(d) if the person is the custodian of an animal and the medicine is\nsupplied for the animal’s use—administering the medicine to the\nanimal.\nNote Custodian, of an animal—see the dictionary.\nrestricted medicine—see section 30 (3).\n\nOther administration authorisations Part 5.2\n","sortOrder":75},{"sectionNumber":"361","sectionType":"section","heading":"Authorisation for administration of medicines by","content":"361 Authorisation for administration of medicines by\nassistants—Act, s 37 (1) (b)\n(1) A person (the assistant) is authorised to administer a medicine to\nsomeone else (the assisted person) if—\n(a) the medicine is obtained by or for the assisted person from\nsomeone who is authorised to supply the medicine to the assisted\n(b) the medicine is administered in accordance with the directions\non the medicine’s labelling; and\n(c) if the assisted person is not a person under a legal disability—\nthe assisted person asks for the assistant’s help to take the\n(d) if the assisted person is a person under a legal disability—the\nassistant is authorised by the assisted person’s parent or\nguardian to administer the medicine.\nimpaired decision-making ability—a person has impaired\ndecision-making ability if the person’s decision-making ability is\nimpaired because of a physical, mental, psychological or intellectual\ncondition or state, whether or not the condition or state is a\ndiagnosable illness.\nperson under a legal disability means—\n(a) a child; or\n(b) a person with impaired decision-making ability in relation to a\nmatter relating to the person’s health.\n\n","sortOrder":76},{"sectionNumber":"Part 6","sectionType":"part","heading":"Obtaining and possessing medicines","content":"Chapter 6 Obtaining and possessing medicines\nChapter 6 Obtaining and possessing\nNote An endorsed health practitioner may be authorised to obtain and possess\na medicine in accordance with an endorsement of the health practitioner’s\nregistration (see s 490).\n","sortOrder":77},{"sectionNumber":"370","sectionType":"section","heading":"Authorisation under sch 1 to obtain and possess","content":"370 Authorisation under sch 1 to obtain and possess\nmedicines—Act, s 35 (1) (b), (2) (b) and s 36 (b)\n(1) A person mentioned in schedule 1, column 2 is authorised to obtain a\nmedicine if obtaining the medicine—\n(a) is included in the schedule, column 3 in relation to the person;\nand\n(b) is consistent with any restriction for obtaining the medicine\nmentioned in the schedule, column 3.\n(2) A person mentioned in schedule 1, column 2 is authorised to possess\n(a) possessing the medicine is included in the schedule, column 3 in\n(b) the possession is consistent with any restriction for the\npossession mentioned in the schedule, column 3.\n\nObtaining and possessing medicines Chapter 6\n","sortOrder":78},{"sectionNumber":"371","sectionType":"section","heading":"Authorisation to obtain and possess medicines for","content":"371 Authorisation to obtain and possess medicines for\ncertain personal use-related dealings—Act, s 35 (1) (b),\n(2) (b) and s 36 (b)\n(1) A person is authorised to obtain or possess a medicine if the person\nobtains the medicine from someone who is authorised to supply the\nmedicine to the person.\n(2) Subsection (1) applies in relation to a person whether the medicine is\nobtained by the person for the person’s own use or as an agent for\nsomeone else.\n\n","sortOrder":79},{"sectionNumber":"380","sectionType":"section","heading":"Authorisation under sch 1 to manufacture medicines—","content":"380 Authorisation under sch 1 to manufacture medicines—\nAct, s 33 (b)\nA person mentioned in schedule 1, column 2 is authorised to\nmanufacture a medicine if—\n(a) manufacturing the medicine is included in the schedule,\ncolumn 3 in relation to the person; and\n(b) the manufacturing is consistent with any restriction for the\nmanufacturing mentioned in the schedule, column 3.\n\nDiscarding medicines Chapter 8\n","sortOrder":80},{"sectionNumber":"Part 8","sectionType":"part","heading":"Discarding medicines","content":"Chapter 8 Discarding medicines\n","sortOrder":81},{"sectionNumber":"390","sectionType":"section","heading":"Discarding controlled medicines—Act, s 34 (1) (a)","content":"390 Discarding controlled medicines—Act, s 34 (1) (a)\n(1) A controlled medicine must be discarded in accordance with this\nsection.\nNote See also the Drugs of Dependence Act 1989, div 11.4 about the disposal\nof seized substances.\n(2) A prescribed discarding witness may discard a controlled medicine in\nthe presence of another prescribed discarding witness.\n(3) However, a person or endorsed health practitioner who is authorised\nto administer a controlled medicine may discard the residue of the\nmedicine after administration in the presence of a person who is not\na prescribed discarding witness if no other prescribed discarding\nwitness is reasonably available to witness its discarding.\n(4) A person complies with this section if the person destroys the\nmedicine so that it is unable to be used.\nprescribed discarding witness means a person prescribed under\nsection 545 (Prescribed witnesses for discarding of controlled\nmedicines—Act, s 54 (a) and (b)) for the discarding of a controlled\nNote A medicine must not be discarded in a way that creates a risk to the health\nor safety of people or is likely to cause damage to property or the\nenvironment (see Act, s 34 (3)).\n\n","sortOrder":82},{"sectionNumber":"Part 9","sectionType":"part","heading":"1 Authorisations for delivery people and commercial disposal operators","content":"Part 9.1 Authorisations for delivery people and commercial disposal operators\nPart 9.1 Authorisations for delivery\npeople and commercial disposal\noperators\n","sortOrder":83},{"sectionNumber":"400","sectionType":"section","heading":"Authorisations to deliver medicines under supply","content":"400 Authorisations to deliver medicines under supply\nauthorities—Act, s 26 (1) (b), (2) (b), s 35 (1) (b), (2) (b)\nand s 36 (b)\n(1) This section applies to an adult (the delivery person), other than a\nhealth practitioner, at an institution, who is—\n(a) engaged to transport and deliver a medicine supplied on a supply\nauthority; or\n(b) acting for a person mentioned in paragraph (a).\nNote For health practitioners at institutions, see sch 1, pt 1.4.\n(2) The delivery person is authorised to—\n(a) obtain and possess the medicine for the purposes of transporting\nand delivering the medicine as engaged; and\n(b) supply the medicine to the entity named as the recipient in the\nsupply authority or the entity’s agent.\nExamples—delivery person\n1 a hospital employee who is not a health practitioner\n2 an employee of a courier service\nExample—agent\nthe guardian of a child for a prescription dispensed for the child\nNote Entity includes a person (see Legislation Act, dict, pt 1).\n\nAuthorisations for delivery people and commercial disposal operators Part 9.1\n","sortOrder":84},{"sectionNumber":"401","sectionType":"section","heading":"Authorisations for commercial disposal operators—Act,","content":"401 Authorisations for commercial disposal operators—Act,\ns 26 (1) (b) and (2) (b), s 35 (1) (b) and (2) (b) and s 36 (b)\n(1) This section applies to a person who—\n(a) holds an environmental authorisation for the disposal of a\n(2) The person is authorised to obtain and possess the medicine for the\npurposes of disposing of the medicine as engaged.\n\nPart 9.2 Emergency supply and administration of adrenaline, naloxone and\nsalbutamol\nPart 9.2 Emergency supply and\nadministration of adrenaline,\nnaloxone and salbutamol\n","sortOrder":85},{"sectionNumber":"410","sectionType":"section","heading":"Authorisations to supply and administer adrenaline,","content":"410 Authorisations to supply and administer adrenaline,\nnaloxone and salbutamol—Act, s 26 (1) (b) and s 37 (1) (b)\n(1) A person is authorised to do 1 or more of the following for someone\nelse (the assisted person) who is in immediate need of adrenaline,\nnaloxone or salbutamol:\n(a) supply authorised adrenaline, naloxone or authorised salbutamol\nto the assisted person;\n(b) supply authorised adrenaline, naloxone or authorised salbutamol\nto someone else for immediate administration to the assisted\nperson;\n(c) administer authorised adrenaline, naloxone or authorised\nsalbutamol to the assisted person.\nauthorised adrenaline means adrenaline in an automatic injector or\nintranasal delivery device that delivers a predetermined dose of\nadrenaline.\nauthorised salbutamol means salbutamol in, or for, a metered\ninhaler.\n\nMedicines authorisations for corrections functions Part 9.3\nPart 9.3 Medicines authorisations for\ncorrections functions\n","sortOrder":86},{"sectionNumber":"420","sectionType":"section","heading":"Authorisations for CYP authorised people—Act,","content":"420 Authorisations for CYP authorised people—Act,\ns 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)\nA CYP authorised person is authorised, within the scope of the\nperson’s employment, to do any of the following in relation to a\nmedicine supplied for a young detainee by a person who is authorised\nto supply the medicine:\n(a) obtain the medicine;\n(b) possess the medicine (including possess the medicine outside a\nCYP detention place for the purpose of administering the\nmedicine to a young detainee while the young detainee is\nlawfully outside the place);\n(c) administer the medicine to the young detainee;\n(d) supply the medicine to a person who is authorised to obtain the\nmedicine for the young detainee.\nExample—young detainee lawfully outside CYP detention place\nthe detainee is on local leave escorted by a CYP authorised person\nNote 1 CYP authorised person and CYP detention place—see the dictionary.\nNote 2 Young detainee—see the Children and Young People Act 2008, s 95.\n","sortOrder":87},{"sectionNumber":"421","sectionType":"section","heading":"Authorisations for corrections officers—Act, s 26 (1) (b),","content":"421 Authorisations for corrections officers—Act, s 26 (1) (b),\ns 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)\nA corrections officer is authorised, within the scope of the officer’s\nemployment, to do any of the following in relation to a medicine\nsupplied for a detainee by a person who is authorised to supply the\nmedicine:\n(a) obtain the medicine;\n\nPart 9.3 Medicines authorisations for corrections functions\n(b) possess the medicine (including possess the medicine outside a\ncorrectional centre for the purpose of administering the\nmedicine to a detainee while the detainee is lawfully outside the\ncentre);\n(c) administer the medicine to the detainee;\n(d) supply the medicine to a person who is authorised to obtain the\nmedicine for the detainee.\nNote 1 See the example and notes to s 420.\nNote 2 Detainee—see the Corrections Management Act 2007, s 6.\n","sortOrder":88},{"sectionNumber":"422","sectionType":"section","heading":"Authorisations for court and police cell custodians—Act,","content":"422 Authorisations for court and police cell custodians—Act,\ns 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)\n(1) A custodian is authorised, within the scope of the custodian’s\nemployment, to do any of the following in relation to a medicine\nsupplied for a person in custody at court cells or police cells by\nsomeone who is authorised to supply the medicine:\n(a) obtain the medicine at the cells;\n(b) possess the medicine at the cells;\n(c) administer the medicine to the person in custody at the cells;\n(d) supply the medicine to someone who is authorised to obtain the\nmedicine for the person in custody.\ncourt cell—see the Corrections Management Act 2007, section 29.\ncustodian means—\n(a) a person in charge of a court cell or police cell; or\n(b) a person acting under the direct supervision of the person in\ncharge.\n\nMedicines authorisations for corrections functions Part 9.3\nperson in custody means—\n(a) a detainee; or\n(b) a young detainee; or\n(c) a person detained at a police cell under the Corrections\nManagement Act 2007, section 30; or\n(d) a person detained at a court cell under the Corrections\nManagement Act 2007, section 33.\npolice cell—see the Corrections Management Act 2007, section 29.\n\nPart 9.4 Authorisations for medicines research and education program purposes\nPart 9.4 Authorisations for medicines\nresearch and education program\npurposes other than controlled\nNote A licence is required for research and education programs in relation to\ncontrolled medicines (see pt 14.2).\n","sortOrder":89},{"sectionNumber":"430","sectionType":"section","heading":"Authorisations for non-controlled medicines research","content":"430 Authorisations for non-controlled medicines research\nand education—Act, s 26 (1) and (2) (b)\n(1) A scientifically qualified person employed at a recognised research\ninstitution (other than a hospital operated by the Territory) is\nauthorised to do the following for the purposes of an authorised\nactivity at the institution:\n(a) issue a purchase order for a relevant medicine;\n(b) obtain on a purchase order a relevant medicine;\n(c) possess a relevant medicine;\n(d) supply a relevant medicine to a person (a relevant person) who\nis taking part in the authorised activity at the institution.\nNote 1 Scientifically qualified person—see the dictionary.\nNote 2 Recognised research institution—see the Act, s 20 (5).\n(2) A scientifically qualified person employed at a hospital operated by\nthe Territory is authorised to do the following for the purposes of an\nauthorised activity at the hospital:\n(a) issue a written requisition for a relevant medicine;\n(b) obtain on a written requisition a relevant medicine;\n(c) possess a relevant medicine;\n\nAuthorisations for medicines research and education program purposes\nPart 9.4\n(d) supply a relevant medicine to a person (also a relevant person)\nwho is taking part in the authorised activity at the hospital.\n(3) A relevant person is authorised to do the following in relation to a\nrelevant medicine for the purposes of an authorised activity:\n(a) obtain the medicine from the scientifically qualified person for\nthe activity;\n(b) possess the medicine for the purposes of the activity;\n(c) supply the medicine to the scientifically qualified person for the\nactivity.\nauthorised activity, in relation to a relevant medicine at a recognised\nresearch institution, means the conduct of any of the following if it\ndoes not involve the administration of the medicine to a person:\n(a) medical or scientific research in relation to the medicine at the\n(b) instruction involving the medicine at the institution;\n(c) quality control or analysis of the medicine at the institution;\n(d) if the relevant medicine is integral to genuine medical or\nscientific research at the institution—reasonable use of the\nmedicine to carry out the research.\nrelevant medicine means a medicine other than a controlled\n\nPart 9.4 Authorisations for medicines research and education program purposes\n","sortOrder":90},{"sectionNumber":"431","sectionType":"section","heading":"Authorisation conditions for non-controlled medicines","content":"431 Authorisation conditions for non-controlled medicines\nresearch and education—Act, s 44 (1) (b) and (2) (b)\nA scientifically qualified person’s authorisation under section 430 is\nsubject to the following conditions:\n(a) the person has written approval for the conduct of the authorised\nactivity from the person in charge of—\n(i) the recognised research institution; or\n(ii) a faculty or division of the institution;\n(b) if the recognised research institution employing the person is a\nhospital operated by the Territory—\n(i) a requisition for the relevant medicine issued by the person\nand\n(ii) the requisition is for an amount of the medicine approved\nin writing by the person in charge; and\n(iii) the requisition is for an amount of the medicine used solely\nfor the purpose approved in writing by the person in\ncharge;\n(c) if the person is employed at a recognised research institution\nother than a hospital operated by the Territory—\n(i) a purchase order for the relevant medicine complies with\nsection 62; and\n(ii) the purchase order is for an amount of the medicine\napproved in writing by the person in charge;\n(d) the medicine is obtained from someone who is authorised to\nsupply the medicine to the person.\n\nControlled medicines research and education program licence\nDivision 9.5.1\nPart 9.5 Authorisations under medicines\nDivision 9.5.1 Controlled medicines research and\neducation program licence\nNote 1 For authorisation for research and education for other medicines, see\npt 9.4.\nNote 2 For other provisions about controlled medicines research and education\nprogram licences, see pt 14.2.\n","sortOrder":91},{"sectionNumber":"440","sectionType":"section","heading":"Authorisations under controlled medicines research and","content":"440 Authorisations under controlled medicines research and\neducation program licences—Act, s 20 (1) (a)\n(1) A controlled medicines research and education program licence\n(other than for a program conducted at a hospital operated by the\nTerritory) authorises—\n(i) issue a purchase order for a controlled medicine\n(the licensed controlled medicine) stated in the licence for\nthe program stated in the licence; and\n(ii) obtain a licensed controlled medicine on a purchase order\nfor the program; and\n(iii) possess a licensed controlled medicine for the program at\n(iv) supply a licensed controlled medicine to anyone taking part\n\n","sortOrder":92},{"sectionNumber":"Div 9","sectionType":"division","heading":"5.1 Controlled medicines research and education program licence","content":"Division 9.5.1 Controlled medicines research and education program licence\nto deal with the licensed controlled medicine as authorised by\nthe licence at the premises stated in the licence.\n(2) A controlled medicines research and education program licence for a\nprogram conducted at a hospital operated by the Territory\n(i) issue a written requisition for a controlled medicine\n(the licensed controlled medicine) stated in the licence for\nthe program stated in the licence; and\n(ii) obtain a licensed controlled medicine on a written\nrequisition for the program; and\n(iii) possess a licensed controlled medicine for the program at\n(iv) supply a licensed controlled medicine to anyone taking part\nto deal with the licensed controlled medicine as authorised by\nthe licence at the hospital.\n","sortOrder":93},{"sectionNumber":"441","sectionType":"section","heading":"Authorisation condition for controlled medicines","content":"441 Authorisation condition for controlled medicines\nresearch and education program licences—Act,\nA licence-holder’s authorisation to obtain a controlled medicine\nunder a controlled medicines research and education program licence\nis subject to the condition that the medicine is—\n(a) if the licence is for a program conducted at a hospital operated\nby the Territory—obtained on a requisition that complies with\nsection 55 (General requirements for written requisitions) and\nsection 56 (Particulars for requisitions); or\n\nFirst-aid kit licence authorisations Division 9.5.2\n(b) in any other case—purchased on a complying purchase order.\nDivision 9.5.2 First-aid kit licence authorisations\nNote For other provisions about first-aid kit licences, see pt 14.3.\n","sortOrder":94},{"sectionNumber":"450","sectionType":"section","heading":"Authorisations under first-aid kit licences—Act,","content":"450 Authorisations under first-aid kit licences—Act,\ns 20 (1) (a)\nauthorised medicine, for a first-aid kit, means—\n(a) a medicine stated in the first-aid kit licence for the kit; and\n(b) a pharmacy medicine or pharmacist only medicine for the kit.\n(2) A first-aid kit licence authorises—\n(i) issue a purchase order for an authorised medicine for the\nfirst-aid kit; and\n(ii) obtain on a purchase order an authorised medicine for the\nfirst-aid kit; and\n(b) the licence-holder, and anyone else authorised to deal with a\nmedicine by the licence, to—\n(i) possess an authorised medicine as part of the first-aid kit\nfor the emergency treatment of a person’s medical\ncondition; and\n(ii) supply an authorised medicine to someone else who is\nauthorised under the licence to administer the medicine;\nand\n\n(iii) administer an authorised medicine in the first-aid kit if the\nperson believes on reasonable grounds that the\nadministration of the medicine is necessary for the\nemergency treatment of a person’s medical condition.\n","sortOrder":95},{"sectionNumber":"451","sectionType":"section","heading":"Authorisation condition for first-aid kit licences—Act,","content":"451 Authorisation condition for first-aid kit licences—Act,\nA licence-holder’s authorisation to obtain a medicine under a first-aid\nkit licence is subject to the condition that the medicine is purchased\non a complying purchase order.\nNote For other provisions about wholesalers licences, see pt 14.4.\n","sortOrder":96},{"sectionNumber":"460","sectionType":"section","heading":"Authorisations under medicines wholesalers licences—","content":"460 Authorisations under medicines wholesalers licences—\nAct, s 20 (1) (a)\n(1) A medicines wholesalers licence authorises the licence-holder to do\nany of the following in relation to a medicine (the licensed medicine)\nstated in the licence at the premises (the licensed premises) stated in\nthe licence:\n(a) issue a purchase order for a licensed medicine;\n(b) obtain a licensed medicine on a purchase order for sale by\nwholesale from the licensed premises;\n(c) possess a licensed medicine for sale by wholesale from the\nlicensed premises;\n(d) sell a licensed medicine by wholesale (whether or not for resale)\nfrom the licensed premises to—\n(i) a person authorised to issue a purchase order for the\n\nWholesalers licence authorisations Division 9.5.3\n(ii) someone in another State who may obtain the medicine by\nwholesale under the law of the other State; or\nmedicine by wholesale in the other country;\nNote The medicines must be sold on a purchase order in accordance with\ns 140 (see s 461).\n(e) unless the licensed medicine is a controlled medicine—supply\nthe medicine in accordance with the medicines Australia code\nof conduct provisions for product starter packs.\nNote Medicines Australia code of conduct—see the dictionary.\n(3) Also, subsection (1) (d) (iii) does not apply in relation to a licensed\nmedicine that is a prohibited export under the Customs Act 1901\n(Cwlth).\n","sortOrder":97},{"sectionNumber":"461","sectionType":"section","heading":"Authorisation conditions for medicines wholesalers","content":"461 Authorisation conditions for medicines wholesalers\nlicences—Act, s 44 (1) (b) and (2) (b)\nA licence-holder’s authorisation under a medicines wholesalers\nlicence is subject to the following conditions:\n(a) the dealings with a medicine authorised by the licence will be\ncarried out under the supervision of an individual approved\nunder section 616 (1) (Restrictions on issuing of medicines\nwholesalers licences—Act, s 85 (1) (a));\n(b) the licence-holder must comply with, and the licence-holder\nmust ensure that the licence-holder’s agents and employees\ncomply with—\n(i) the Australian code of good wholesaling practice for\nmedicines in schedules 2, 3, 4 and 8; and\n\nDivision 9.5.4 Opioid dependency treatment licence authorisations\n(ii) the medicines Australia code of conduct;\nNote Australian code of good wholesaling practice for medicines in\nschedules 2, 3, 4 and 8 and medicines Australia code of conduct—\nsee the dictionary.\n(c) a medicine obtained under the licence is purchased on a\ncomplying purchase order;\n(d) a medicine sold under the licence is sold on a complying\npurchase order in accordance with section 141 (Supplying\nmedicines on purchase orders).\nDivision 9.5.4 Opioid dependency treatment licence\nNote For other provisions about opioid dependency treatment licences, see\npt 14.5.\n","sortOrder":98},{"sectionNumber":"470","sectionType":"section","heading":"Authorisations under opioid dependency treatment","content":"470 Authorisations under opioid dependency treatment\n(1) An opioid dependency treatment licence issued to a pharmacist\nauthorises the licence-holder, and any other pharmacist at the\ncommunity pharmacy (the licensed pharmacy) to which the licence\nrelates, to do any of the following for the purpose of treating a\nperson’s drug-dependency:\n(a) issue a purchase order for buprenorphine or methadone;\n(b) obtain buprenorphine or methadone on a purchase order for\nadministration at the licensed pharmacy;\n(c) possess buprenorphine and methadone;\n(d) dispense buprenorphine and methadone in accordance with a\n\nOpioid dependency treatment licence authorisations Division 9.5.4\n(e) supply buprenorphine and methadone to a nurse at the licensed\npharmacy for administration at the pharmacy under the\nsupervision of a pharmacist;\n(f) administer buprenorphine and methadone at the licensed\npharmacy in accordance with a prescription (including the\nprescription as changed by a pharmacist at the oral direction of\nthe prescriber).\n(2) An opioid dependency treatment licence issued to a pharmacist\nauthorises a nurse to administer buprenorphine and methadone at the\nlicensed pharmacy under the supervision of a pharmacist and in\naccordance with a prescription (including the prescription as changed\nby a pharmacist at the oral direction of the prescriber).\nNote 1 Nurse does not include an enrolled nurse (see Legislation Act, dict, pt 1).\n(3) To remove any doubt, an authorisation under this section does not, by\nimplication, limit a pharmacist’s or nurse’s authorisations under\nschedule 1 (Medicines—health-related occupations authorisations) in\nrelation to other dealings with buprenorphine and methadone.\n","sortOrder":99},{"sectionNumber":"471","sectionType":"section","heading":"Authorisation condition for opioid dependency treatment","content":"471 Authorisation condition for opioid dependency treatment\nlicences—Act, s 44 (1) (b) and (2) (b)\n(1) A licence-holder’s authorisation under an opioid dependency\ntreatment licence is subject to the following conditions:\n(a) the licence-holder must ensure that a person to whom\nbuprenorphine or methadone is administered under the licence\nsigns a written acknowledgment in accordance with\nsubsection (2) that the medicine has been administered to the\nperson;\n\n(b) a purchase order issued by the licence-holder to obtain\nbuprenorphine or methadone under the licence is a complying\npurchase order.\nNote 1 Written includes in electronic form (see Act, dict).\nNote 2 For licence conditions, see the Act, s 89.\n(2) For subsection (1) (a), the acknowledgment must include the\n(a) the approved name or brand name of the medicine administered;\n(b) the form, strength and quantity of the medicine administered;\n(c) the date the medicine is administered.\nDivision 9.5.5 Pharmacy medicines rural\ncommunities licences\nNote For other provisions about pharmacy medicines rural communities\nlicences, see pt 14.6.\n","sortOrder":100},{"sectionNumber":"480","sectionType":"section","heading":"Authorisations under pharmacy medicines rural","content":"480 Authorisations under pharmacy medicines rural\ncommunities licences—Act, s 20 (1) (a)\nA pharmacy medicines rural communities licence authorises—\n(i) issue a purchase order for a pharmacy medicine\n(the licensed medicine) stated in the licence for retail sale\nfrom the premises (the licensed premises) stated in the\n(ii) obtain the licensed medicine on a purchase order for retail\nsale from the licensed premises; and\n(iii) possess the licensed medicine at the licensed premises for\nretail sale from the licensed premises; and\n\nPharmacy medicines rural communities licences Division 9.5.5\n(iv) sell the licensed medicine by retail from the licensed\npremises to customers attending in person at the licensed\npremises; and\n(b) an employee of the licence-holder to—\n(i) possess the medicine at the licensed premises for retail sale\nfrom the licensed premises; and\n(ii) sell the medicine by retail from the licensed premises to\ncustomers attending in person at the licensed premises.\nExamples—sales to which par (a) (iv) and par (b) (ii) do not apply\nsales over the internet or by mail\nNote For other requirements in relation to medicines sold under rural\ncommunities licences—see s 500 (3), s 502 (4) and s 522.\n","sortOrder":101},{"sectionNumber":"481","sectionType":"section","heading":"Authorisation conditions for pharmacy medicines rural","content":"481 Authorisation conditions for pharmacy medicines rural\ncommunities licences—Act, s 44 (1) (b) and (2) (b)\nA licence-holder’s authorisation under a pharmacy medicines rural\ncommunities licence is subject to the following conditions:\n(a) a pharmacy medicine obtained under the licence is purchased on\na complying purchase order;\n(b) the pharmacy medicines to which the licence relates are sold in\nthe manufacturer’s packs;\n(c) the packs are labelled in accordance with—\n(i) section 502 (Labelling of supplied manufacturer’s packs of\nmedicines—Act, s 60 (1) (c) (i) and (2) (c) (i)); or\n\n(d) the pharmacy medicines to which the licence relates are sold\nfrom the premises stated in the licence to customers attending in\n\nMedicines authorisations for health practitioners Part 9.6\nPart 9.6 Medicines authorisations for\nhealth practitioners\n","sortOrder":102},{"sectionNumber":"490","sectionType":"section","heading":"Authorisations for endorsed health practitioners—Act,","content":"490 Authorisations for endorsed health practitioners—Act,\ns 20 (1) (d)\n(1) This section applies to a health practitioner whose registration is\nendorsed under the Health Practitioner Regulation National Law\n(ACT), division 8 (Endorsement of registration) if the endorsement\nprovides for dealing with a medicine (an endorsed health\npractitioner).\n(2) The endorsed health practitioner is authorised to deal with the\nmedicine in accordance with the endorsement.\n(3) If there is an inconsistency between the endorsement and this\nregulation, the endorsement prevails to the extent of the\ninconsistency.\n","sortOrder":103},{"sectionNumber":"490A","sectionType":"section","heading":"Authorisations for health practitioners to deal with","content":"490A Authorisations for health practitioners to deal with\nmedicines with CHO approval—Act, s 20 (1) (c)\n(1) A health practitioner is authorised to deal with a medicine if the health\npractitioner is approved under this section to deal with the medicine.\n(2) The chief health officer may approve a health practitioner, or a class\nof health practitioners, to deal with a medicine if the chief health\nofficer is satisfied that the approval is appropriate in the\ncircumstances.\n(3) The approval must be in writing and include the following\n(a) the health practitioner or the class of health practitioners to\nwhom the approval relates;\n(b) the dealing to which the approval relates;\n\nPart 9.6 Medicines authorisations for health practitioners\n(c) the medicine to which the approval relates;\n(d) any conditions to which the approval is subject;\n(e) a unique identifying number for the approval;\n(f) the date the approval starts;\n(g) if the approval applies for a stated period—the stated period.\n(4) An approval is a notifiable instrument.\n\nPackaging and labelling of medicines generally Chapter 10\n","sortOrder":104},{"sectionNumber":"Part 10","sectionType":"part","heading":"Packaging and labelling of","content":"Chapter 10 Packaging and labelling of\nmedicines generally\n","sortOrder":105},{"sectionNumber":"500","sectionType":"section","heading":"When pharmacy medicines and pharmacist only","content":"500 When pharmacy medicines and pharmacist only\nmedicines to be supplied in manufacturer’s packs—Act,\nhealth practitioner does not include—\n(a) a pharmacist, or intern pharmacist, at a hospital; or\n(b) a prescriber who supplies a medicine during a consultation.\nsupply does not include dispense.\n(2) A health practitioner or employee acting under the direction of a\nhealth practitioner, must supply a pharmacy medicine or pharmacist\nonly medicine in a whole manufacturer’s pack of the medicine.\n(3) A pharmacy medicines rural communities licence-holder, or an\nemployee acting under the direction of the licence-holder, must sell a\npharmacy medicine stated in the licence in a whole manufacturer’s\npack of the medicine.\n","sortOrder":106},{"sectionNumber":"501","sectionType":"section","heading":"Packaging of supplied manufacturer’s packs of","content":"501 Packaging of supplied manufacturer’s packs of\nmedicines—Act, s 59 (1) (c) (i) and (2) (c) (i)\nA manufacturer’s pack of a medicine supplied must be packaged—\n(b) in a container in which the medicine may be sold under a\ncorresponding law.\nNote A manufacturer’s pack of a medicine supplied may also be packaged in\naccordance with an approval under the Act, s 193 (Approval of\nnon-standard packaging and labelling) (see Act, s 59 (1) (c) (ii) and\n(2) (c) (ii)).\n\nChapter 10 Packaging and labelling of medicines generally\n","sortOrder":107},{"sectionNumber":"502","sectionType":"section","heading":"Labelling of supplied manufacturer’s packs of","content":"502 Labelling of supplied manufacturer’s packs of\nmedicines—Act, s 60 (1) (c) (i) and (2) (c) (i)\nsupply, a medicine, does not include—\n(a) dispense the medicine; or\n(b) supply the medicine on a requisition or standing order.\n(2) A manufacturer’s pack of a supplied medicine must be labelled in\naccordance with—\n(b) a corresponding law.\nNote A manufacturer’s pack of a medicine supplied may also be labelled in\naccordance with an approval under the Act, s 193 (Approval of\nnon-standard packaging and labelling) (see Act, s 60 (1) (c) (ii) and\n(2) (c) (ii)).\n(3) A manufacturer’s pack of a pharmacist only medicine sold by retail\nat a community pharmacy must be labelled with the pharmacy’s\nname, business address and telephone number.\n(4) A manufacturer’s pack of a pharmacy medicine sold at premises\nlicensed under a pharmacy medicines rural communities licence must\nbe labelled with the licence-holder’s name, business address and\ntelephone number.\n\nPreliminary Part 11.1\n","sortOrder":108},{"sectionNumber":"510","sectionType":"section","heading":"Meaning of prescribed person—ch 11","content":"510 Meaning of prescribed person—ch 11\nFor this chapter, each of the following is a prescribed person:\npractitioner or veterinary practitioner;\nNote 1 Dentist and doctor does not include an intern or trainee (see defs\nof these terms in dict).\nNote 2 Medical radiation practitioner does not include a person holding\nstudent, limited or provisional registration to practise in the\nprofession (see dict).\n(b) a pharmacist responsible for the management of a community\npharmacy;\n(c) the chief pharmacist at an institution;\n(d) a medicines wholesalers licence-holder;\n(e) a pharmacy medicines rural communities licence-holder;\n(f) an approved analyst;\nNote Approved analyst—see the dictionary.\n(g) a medicines and poisons inspector (including a police officer);\n(h) a controlled medicines research and education program\nlicence-holder;\n(i) a person in charge of any of the following:\n(i) an ambulance service (whether or not operated by the\nCommonwealth, the Territory or a State);\n(ii) a correctional centre;\n\n(iii) a CYP detention place;\n(iv) a health centre operated by the Territory;\n(v) a residential aged care facility without a pharmacy;\n(vi) a residential disability care facility without a pharmacy;\n(vii) a ward (including an opioid dependency treatment centre\noperated by the Territory).\nNote 2 Residential aged care facility and residential disability care facility—\nsee the Act, dictionary.\n","sortOrder":109},{"sectionNumber":"511","sectionType":"section","heading":"Meaning of key—ch 11","content":"511 Meaning of key—ch 11\nkey includes an electronic swipe card or electronic proximity device.\n\nStorage requirements for medicines generally Part 11.2\n","sortOrder":110},{"sectionNumber":"Part 11","sectionType":"part","heading":"2 Storage requirements for","content":"Part 11.2 Storage requirements for\nmedicines generally\n","sortOrder":111},{"sectionNumber":"515","sectionType":"section","heading":"Storage of medicines generally—Act, s 61 (b) and (c)","content":"515 Storage of medicines generally—Act, s 61 (b) and (c)\n(1) A prescribed person must ensure that a medicine in the person’s\npossession is stored—\n(a) within the manufacturer’s recommended storage temperature\nrange; and\n(b) in any other environmental condition that is necessary to\npreserve the medicine’s stability and therapeutic quality.\n(2) To remove any doubt, this section does not apply to a prescribed\n\nPart 11.3 Additional storage requirements for medicines other than controlled\nPart 11.3 Additional storage requirements\nfor medicines other than\n520 Storage of medicines other than controlled medicines in\ncommunity pharmacies—Act, s 61 (b) and (c)\n(1) The pharmacist responsible for the management of a community\npharmacy must ensure that each pharmacy medicine at the pharmacy\nis stored—\n(a) if the medicine is for retail sale—within 4m of, and in sight of,\nthe pharmacy’s dispensary; and\n(b) in any other case—so that public access to the medicine is\nrestricted.\n(2) The pharmacist responsible for the management of a community\npharmacy must ensure that each pharmacist only medicine and\nprescription only medicine at the pharmacy is stored—\n(a) in a part of the premises to which the public does not have\naccess; and\n(b) so that only a pharmacist, or a person under the direct\nsupervision of a pharmacist, has access to the medicine.\n","sortOrder":112},{"sectionNumber":"521","sectionType":"section","heading":"Storage of medicines other than controlled medicines by","content":"521 Storage of medicines other than controlled medicines by\nother people—Act, s 61 (b) and (c)\nprescribed person does not include a pharmacist responsible for the\nmanagement of a community pharmacy.\n\nAdditional storage requirements for medicines other than controlled\nPart 11.3\n(2) A prescribed person must ensure that a medicine (other than a\ncontrolled medicine) in the person’s possession is stored so that\npublic access to it is restricted.\n(3) To remove any doubt, this section does not apply to a prescribed\n","sortOrder":113},{"sectionNumber":"522","sectionType":"section","heading":"Storage of pharmacy medicines by pharmacy medicines","content":"522 Storage of pharmacy medicines by pharmacy medicines\nrural communities licence-holders—Act, s 61 (b) and (c)\nA pharmacy medicines rural communities licence-holder must store\na pharmacy medicine for retail sale so that public access to the\nmedicine is restricted.\n\nPart 11.4 Additional storage requirements\nfor controlled medicines\n","sortOrder":114},{"sectionNumber":"530","sectionType":"section","heading":"Meaning of personal custody—pt 11.4","content":"530 Meaning of personal custody—pt 11.4\npersonal custody, of a key by a person, includes keeping the key in a\ncombination-operated key safe, the combination of which the person\nkeeps confidential.\n","sortOrder":115},{"sectionNumber":"531","sectionType":"section","heading":"Storage of controlled medicines by wholesalers","content":"531 Storage of controlled medicines by wholesalers\nlicence-holders—Act, s 61 (b) and (c)\n(1) A wholesalers licence-holder must store a controlled medicine in the\nperson’s possession (other than a controlled medicine required for\nimmediate supply) in a vault that—\n(a) complies with, or is more secure than a vault that complies with,\nthe requirements for a vault in schedule 5, section 5.8\n(Requirements for vaults); and\n(b) is fitted with an alarm system.\n(2) However, if the chief health officer is satisfied that the total amount\nof controlled medicine held by the licence-holder at any time is not\nlarge enough to need to be stored in a vault, the chief health officer\nmay approve, in writing, the storage of the controlled medicine in a\nsafe or strong room.\n(3) If the chief health officer gives an approval under subsection (2)—\n(a) if the approval is for a safe—the safe must comply with, or be\nmore secure than a safe that complies with, the requirements for\na safe in schedule 5, section 5.6 (Requirements for safes); and\n\n(b) if the approval is for a strong room—the strong room must\ncomply with, or be more secure than a strong room that complies\nwith, the requirements for a strong room in schedule 5,\nsection 5.7 (Requirements for strong rooms); and\n(c) the safe or strong room must be fitted with an alarm system.\n","sortOrder":116},{"sectionNumber":"532","sectionType":"section","heading":"Storage of controlled medicines for certain health-related","content":"532 Storage of controlled medicines for certain health-related\noccupations—Act, s 61 (b) and (c)\ndesignated person means—\npractitioner or veterinary practitioner (other than 1 of those\nhealth practitioners at an institution); or\n(b) an ambulance officer or paramedic employed by the\n(c) a first-aid kit licence-holder; or\n(d) a controlled medicines research and education program\nNote 1 Dentist and doctor does not include an intern or trainee (see defs of these\nNote 2 Medical radiation practitioner and paramedic does not include a person\nholding student, limited or provisional registration to practise in the\nprofession (see defs of these terms in dict).\n\n(2) A designated person who possesses a controlled medicine must store\nthe controlled medicine as follows:\n(a) the person must ensure that the controlled medicine is stored\nin—\n(i) a locked container that prevents ready access to the\ncontainer’s contents and is securely attached to a building;\nor\n(ii) a locked drawer, cupboard, room or vehicle; or\n(iii) if the controlled medicine is required to be stored in a\nrefrigerator—a locked refrigerator;\n(b) if the controlled medicine is kept in a container or refrigerator\nthat is unlocked by a combination lock—the person must keep\nthe combination confidential;\n(c) if the controlled medicine is kept in a container or refrigerator\nthat is unlocked by a key—the person must keep personal\ncustody of the key;\n(d) if the controlled medicine is kept in a drawer, cupboard, room\nor vehicle—the person must keep personal custody of the key to\nthe drawer, cupboard, room or vehicle;\n(e) if the controlled medicine is required to be stored in a\nrefrigerator—the person must ensure that the refrigerator in\nwhich the medicine is kept is used only to store medicines\nrequiring refrigeration.\n(3) However, subsection (2) does not apply to a controlled medicine if—\n(a) the controlled medicine is being carried by a designated person\nin—\n(i) a locked first-aid kit; or\n\n(ii) an unlocked first-aid kit that is in immediate use; and\n(b) the person keeps personal custody of the key to the first-aid kit.\n","sortOrder":117},{"sectionNumber":"533","sectionType":"section","heading":"Storage of controlled medicines by certain other","content":"533 Storage of controlled medicines by certain other\nprescribed people—Act, s 61 (b) and (c)\nexcluded person means—\npractitioner or veterinary practitioner at an institution; or\n(b) the person in charge of an ambulance service (whether or not\noperated by the Commonwealth, the Territory or a State); or\n(c) the person in charge of a residential aged care facility or\nresidential disability care facility in relation to a controlled\nmedicine dispensed in a dose administration aid for a patient at\nthe facility; or\n(d) the person in charge of a correctional centre in relation to a\ncontrolled medicine dispensed for a detainee in a dose\nadministration aid; or\n(e) the person in charge of a CYP detention place in relation to a\ncontrolled medicine dispensed for a young detainee in a dose\nadministration aid.\nNote 2 Correctional centre—see the Legislation Act, dictionary, pt 1.\nNote 3 Detainee—see the Corrections Management Act 2007, s 6.\nNote 4 Young detainee—see the Children and Young People Act 2008, s 95.\nNote 5 State includes the Northern Territory (see Legislation Act, dict, pt 1).\n\n(2) This section applies to a prescribed person, other than an excluded\nperson, in relation to a controlled medicine in the person’s possession\nif the medicine is not for immediate administration.\n(3) The person must ensure that—\n(a) the controlled medicine is stored in a medicines cabinet, safe,\nstrong room or vault (a storage receptacle) that complies with,\nor is more secure than a storage receptacle that complies with,\nthe requirements for the receptacle in schedule 5 (Requirements\nfor storage receptacles); and\n(b) the storage receptacle is kept securely locked when not in\nimmediate use; and\n(c) if the storage receptacle is unlocked by a combination lock—the\nperson keeps the combination confidential; and\n(d) if the storage receptacle is unlocked by a key—the person keeps\npersonal custody of the key; and\n(e) if the prescribed person is the chief pharmacist at an\ninstitution—the storage receptacle is fitted with an alarm\nsystem.\n(4) However, if the controlled medicine is required to be stored in a\nrefrigerator, the prescribed person must ensure—\n(a) if the refrigerator has a lock—the refrigerator is kept securely\nlocked when not under the supervision of the prescribed person;\nand\n(b) if the refrigerator does not have a lock—the room or enclosure\nwhere the refrigerator is located is kept securely locked when\nthe room or enclosure is not under the supervision of the\nprescribed person; and\n\n(c) if the refrigerator, or the room or enclosure where the\nrefrigerator is located, is unlocked by a combination lock—the\nprescribed person keeps the combination confidential; and\n(d) if the refrigerator, or the room or enclosure where the\nrefrigerator is located, is unlocked by a key—the prescribed\nperson keeps personal custody of the key; and\n(e) the refrigerator is used only to store medicines requiring\nrefrigeration.\n(5) If a controlled medicine is stored in a refrigerator, the prescribed\nperson may leave the refrigerator, or the room or enclosure where the\nrefrigerator is located, unlocked if—\n(a) the refrigerator, room or enclosure is under the supervision of\nthe prescribed person; and\n(b) the controlled medicine is kept in a metal container that prevents\nready access to the container’s contents and is securely fixed\ninside the refrigerator; and\n(c) the metal container is kept securely locked when not in\nimmediate use; and\n(d) if the metal container is unlocked by a combination lock—the\nprescribed person keeps the combination confidential; and\n(e) if the metal container is unlocked by a key—the prescribed\nperson keeps personal custody of the key.\n(6) To remove any doubt, this section does not apply to a prescribed\n\n","sortOrder":118},{"sectionNumber":"533A","sectionType":"section","heading":"Storage of buprenorphine or methadone by opioid","content":"533A Storage of buprenorphine or methadone by opioid\ndependency treatment licence-holders etc—Act, s 61 (b)\nand (c)\n(1) This section applies to a pharmacist authorised under an opioid\ndependency treatment licence to possess buprenorphine or\nmethadone.\n(2) Despite section 533, the pharmacist may, during the business hours\nfor the pharmacy to which the opioid dependency treatment licence\nrelates, store buprenorphine or methadone that is not for immediate\nadministration in a medicines cupboard or drawer if—\n(a) the medicines cupboard or drawer is securely fixed to a wall or\nfloor (or both); and\n(b) the medicines cupboard or drawer is kept securely locked when\nnot in immediate use; and\n(c) the medicines cupboard or drawer is under the direct supervision\nof the pharmacist at all times the medicines cupboard or drawer\ncontains buprenorphine or methadone; and\n(d) for a medicines cupboard or drawer that is unlocked by a\ncombination lock—the pharmacist keeps the combination\nconfidential; and\n(e) for a medicines cupboard or drawer that is unlocked by a key—\nthe pharmacist keeps personal custody of the key; and\n(f) the door of the medicines cupboard or drawer is not in direct\nview of a member of the public attending the pharmacy.\n\n","sortOrder":119},{"sectionNumber":"540","sectionType":"section","heading":"Keeping of controlled medicines registers by certain","content":"540 Keeping of controlled medicines registers by certain\npeople—Act, s 48 (a) and s 50 (1) (b) and (2) (b)\n(1) A person mentioned in table 540, column 2 who possesses a\ncontrolled medicine must keep a controlled medicines register.\nNote Also, a pharmacist responsible for the management of a community\npharmacy must keep a controlled medicines register for controlled\nmedicines kept at the pharmacy (see Act, s 48).\n(2) However, subsection (1) does not apply to the person in relation to—\n(a) a controlled medicine in a first-aid kit kept by the person; or\n(b) if the person is the person in charge of a residential aged care\nfacility or residential disability care facility—a controlled\nmedicine dispensed for the patient in a dose administration aid;\nor\n(c) if the person is the person in charge of a correctional centre—a\ncontrolled medicine dispensed for a detainee in a dose\nadministration aid; or\n(d) if the person is the person in charge of a CYP detention place—\na controlled medicine dispensed for a young detainee in a dose\nadministration aid.\nNote 2 Correctional centre—see the Legislation Act, dictionary, pt 1.\nNote 3 Detainee—see the Corrections Management Act 2007, s 6.\nNote 4 Young detainee—see the Children and Young People Act 2008, s 95.\nNote 5 For keeping controlled medicines in a first-aid kit, see s 541.\n(3) A person to whom subsection (1) applies must keep a controlled\nmedicines register for a controlled medicine at the place prescribed in\ntable 540, column 3 for the person.\n\n(4) A pharmacist responsible for the management of a community\npharmacy at which controlled medicines are kept must keep the\ncontrolled medicines register for the controlled medicines at the\npharmacy.\nNote For the requirement for a controlled medicine register to be kept for a\ncommunity pharmacy, see the Act, s 48.\nTable 540 Keeping controlled medicines registers\nitem\n1 person in charge of ambulance service the premises where the controlled\nmedicine is kept\n2 approved analyst the analyst’s laboratory\n3 person in charge of correctional centre the correctional centre\n4 person in charge of CYP detention place the detention place\n5 dentist the dentist’s surgery\n6 doctor the doctor’s surgery\n7 medicines wholesalers licence-holder the licensed premises under s 460\n8 medicines and poisons inspector (other\nthe place directed in writing by\nthe chief health officer\n9 person in charge of residential aged care\nthe facility\n10 person in charge of residential disability\ncare facility without pharmacy\nthe facility\n11 supervisor of program under controlled\nmedicines research and education\nprogram licence\nthe premises where program is\nbeing conducted\n12 veterinary practitioner the practitioner’s registered\nveterinary premises\n\nitem\n13 person in charge of ward (including an\nopioid dependency treatment centre\noperated by the Territory)\nthe ward\n14 endorsed health practitioner the endorsed health practitioner’s\nplace of practice\n15 medical radiation practitioner the medical radiation\npractitioner’s place of practice\n","sortOrder":120},{"sectionNumber":"541","sectionType":"section","heading":"Keeping of controlled medicines registers by first-aid kit","content":"541 Keeping of controlled medicines registers by first-aid kit\nholders—Act, s 48 (a) and s 50 (1) (b) and (2) (b)\ndesignated person means—\n(a) a dentist, doctor, endorsed health practitioner or veterinary\n(b) an ambulance officer or paramedic employed by the\n(c) a first-aid kit licence-holder.\nNote 1 Dentist and doctor does not include an intern or trainee (see defs of these\nNote 2 Paramedic does not include a person holding student, limited or\nprovisional registration to practise in the profession (see dict).\n(2) A designated person who possesses a first-aid kit containing a\ncontrolled medicine must keep the controlled medicines register for\nthe controlled medicine with the first-aid kit.\n\n","sortOrder":121},{"sectionNumber":"542","sectionType":"section","heading":"Form of controlled medicines registers—Act, s 49 (1) (b)","content":"542 Form of controlled medicines registers—Act, s 49 (1) (b)\n(1) Each page in a controlled medicines register must relate to a single\nform and strength of a controlled medicine.\n(2) If a controlled medicines register is kept electronically, a separate\nrecord must be used for each form and strength of controlled medicine\nkept.\n","sortOrder":122},{"sectionNumber":"543","sectionType":"section","heading":"Making entries in controlled medicines registers—Act,","content":"543 Making entries in controlled medicines registers—Act,\n(1) The following details for a dealing with a controlled medicine are\nmedicine, dealt with;\n(d) if the dealing is receiving the medicine—the name and address\nof the supplier;\n(e) if the dealing is supplying the medicine—the name and address\nof the person to whom it is supplied;\n(f) if the medicine is supplied on a prescription—the prescriber’s\nname and suburb and the prescription’s number under\nsection 123 (i) (Labelling dispensed medicines—Act,\ns 60 (1) (c) (i) and (2) (c) (i));\n(g) if the medicine is supplied on a requisition—the requisition’s\nnumber under section 132 (e) (Labelling medicines supplied on\nrequisition—Act, s 60 (1) (c) (i) and (2) (c) (i));\n(h) if the medicine is supplied on a purchase order—the date of the\npurchase order;\n\n(i) if the Act, section 53 (Registers—witnessing administration of\nmedicines) applies to the dealing—the name of the person to\nwhom the medicine is administered;\n(j) the quantity of the medicine held after the dealing.\n(2) However, subsection (1) (i) does not apply in relation to a controlled\nmedicine dispensed in a dose administration aid for—\n(a) a patient at a residential aged care facility or residential\ndisability care facility; or\n(b) a detainee at a correctional centre; or\n(c) a young detainee at a CYP detention place.\n(3) A dealing with a controlled medicine must be entered in—\n(a) if the dealing happens in a pharmacy at an institution—the\ncontrolled medicines register kept at the pharmacy; or\n(b) if the dealing happens in a ward at an institution—the controlled\nmedicines register kept at the ward; or\n(c) if the person must keep both a controlled medicines register for\na first-aid kit and another controlled medicines register—\n(i) for a dealing with a controlled medicine to which the\nfirst-aid kit relates—the controlled medicines register for\nthe kit; or\n(ii) for any other dealing by the person—the other controlled\nmedicines register; or\n(d) in any other case—the controlled medicines register the person\nmust keep.\n\n","sortOrder":123},{"sectionNumber":"544","sectionType":"section","heading":"Prescribed witnesses for administration of controlled","content":"544 Prescribed witnesses for administration of controlled\nmedicines—Act, s 53 (a) and (b)\nadministration of a controlled medicine:\n(a) if the medicine is administered by an intern doctor—\n(i) an ambulance officer or paramedic employed by the\n(ii) a dentist; or\n(iii) a doctor; or\n(iv) a medical radiation practitioner; or\n(v) a midwife; or\n(vi) a nurse; or\n(vii) a pharmacist;\nNote 1 Dentist, doctor and pharmacist does not include an intern or\ntrainee (see defs of these terms in dict).\nNote 2 Medical radiation practitioner and paramedic does not include a\nperson holding student, limited or provisional registration to\npractise in the profession (see defs of these terms in dict).\nNote 3 Nurse does not include an enrolled nurse (see Legislation Act, dict,\nNote 4 State includes the Northern Territory (see Legislation Act, dict,\n(b) if the medicine is administered by a person who is not an intern\ndoctor—\n(i) a person prescribed under paragraph (a); or\n(ii) an intern doctor or enrolled nurse.\n\n(2) However, a person mentioned in subsection (1) is not prescribed as a\nwitness to the administration of a controlled medicine if the person\nis—\n(a) related to, a close friend of or employed by the person\nadministering the medicine; or\n(b) the supervisor of the person administering the medicine; or\n(c) supervised by the person administering the medicine.\n","sortOrder":124},{"sectionNumber":"545","sectionType":"section","heading":"Prescribed witnesses for discarding of controlled","content":"545 Prescribed witnesses for discarding of controlled\nmedicines—Act, s 54 (a) and (b)\ndiscarding of a controlled medicine:\n(a) an ambulance officer or paramedic employed by the\nCommonwealth, the Territory or a State;\n(b) an approved analyst;\n(c) a dentist;\n(d) a doctor;\n(e) a medical radiation practitioner;\n(f) a medicines and poisons inspector;\n(g) a midwife;\n(h) a nurse;\n(i) a nurse practitioner;\n(j) a pharmacist;\n(k) a veterinary practitioner.\nNote 1 Approved analyst—see the dictionary.\nNote 2 Dentist and doctor does not include an intern or trainee (see defs of these\n\nNote 3 Medical radiation practitioner and paramedic does not include a person\nholding student, limited or provisional registration to practise in the\nprofession (see defs of these terms in dict).\nNote 4 Nurse does not include an enrolled nurse (see Legislation Act, dict, pt 1).\nNote 5 See s 390 for the discarding of the residue of a controlled medicine left\nafter administration.\n(2) However, a person mentioned in subsection (1) is not prescribed as a\nwitness to the discarding of a controlled medicine if the person is—\nthe medicine; or\n(b) the supervisor of the person discarding the medicine; or\n(c) supervised by the person discarding the medicine.\n","sortOrder":125},{"sectionNumber":"546","sectionType":"section","heading":"Changes etc to entries in controlled medicines","content":"546 Changes etc to entries in controlled medicines\nregisters—Act, s 55 (2) (b)\n(1) An entry in a paper-based controlled medicines register may be\n(b) if the entry relates to administering a controlled medicine—\n(i) the amendment being witnessed by a person prescribed\nunder section 544 (Prescribed witnesses for administration\nof controlled medicines—Act, s 53 (a) and (b)); and\n(ii) the witness signing the amendment as witness; and\n(c) if the entry relates to the discarding of a controlled medicine—\n(i) the amendment being witnessed by a person prescribed\nunder section 545 (Prescribed witnesses for discarding of\ncontrolled medicines—Act, s 54 (a) and (b)); and\n\n(2) An entry in an electronic controlled medicines register may be\namended by the person who made the entry by the person attaching\nor linking, by electronic means, a document that includes—\n(b) if the entry relates to administering a controlled medicine—the\nsignature as witness of a person prescribed under section 544;\nand\n(c) if the entry relates to the discarding of a controlled medicine—\nthe signature as witness of a person prescribed under\nsection 545.\n\nuse\n","sortOrder":126},{"sectionNumber":"Part 13","sectionType":"part","heading":"Controlled medicines and","content":"Chapter 13 Controlled medicines and\nappendix D medicines\napprovals for human use\nNote It is a condition of an authorisation to prescribe a controlled medicine for\nhuman use that the prescriber has an approval under this part (see\ns 31 (1) (d)).\n","sortOrder":127},{"sectionNumber":"550","sectionType":"section","heading":"Meaning of controlled medicines approval","content":"550 Meaning of controlled medicines approval\ncontrolled medicines approval means an approval to prescribe a\ncontrolled medicine under—\n(a) division 13.1.2 (Standing controlled medicines approvals); or\n(b) division 13.1.3 (Chief health officer controlled medicines\napprovals).\n","sortOrder":128},{"sectionNumber":"551","sectionType":"section","heading":"Meaning of designated prescriber—pt 13.1","content":"551 Meaning of designated prescriber—pt 13.1\ndesignated prescriber means the following:\n(a) a prescriber (other than a veterinary practitioner) in relation to\nwhom prescribing a controlled medicine is included in\nschedule 1, column 3;\n\nuse\nStanding controlled medicines approvals Division 13.1.2\n(b) an endorsed health practitioner if prescribing a controlled\nmedicine is—\n(i) in accordance with the endorsement of their registration;\nand\n(ii) if not inconsistent with the endorsement of their\nregistration—allowed under this regulation.\n","sortOrder":129},{"sectionNumber":"Div 13","sectionType":"division","heading":"1.2 Standing controlled medicines","content":"Division 13.1.2 Standing controlled medicines\n","sortOrder":130},{"sectionNumber":"554","sectionType":"section","heading":"Standing CHO approvals to prescribe controlled","content":"554 Standing CHO approvals to prescribe controlled\nmedicines in certain circumstances—Act, s 20 (1) (c)\n(1) A designated prescriber is approved to prescribe a controlled\nmedicine for a patient of the prescriber if the prescriber—\n(a) is a member of a class of designated prescribers approved under\nthis section to prescribe the controlled medicine; and\n(b) believes on reasonable grounds that the patient is not a\ndrug-dependant person in relation to a controlled medicine or\nprohibited substance.\n(2) The chief health officer may approve a class of designated prescribers\nto prescribe a controlled medicine, or category of controlled\nmedicine, if the chief health officer is satisfied that the approval is\nappropriate in the circumstances.\n(3) The approval must be in writing and include the following\n(a) the class of designated prescribers to whom the approval relates;\n(b) the controlled medicine, or category of controlled medicine, to\nwhich the approval relates;\n\nuse\n(c) if the approval is for a particular form of the controlled\nmedicine—the form of the medicine;\n(d) if the approval is for a particular strength of the controlled\nmedicine—the strength of the medicine;\n(e) if the approval is for a maximum daily dose of the controlled\nmedicine—the maximum daily dose of the medicine;\n(f) any condition to which the approval is subject;\n(g) a unique identifying number for the approval;\n(h) the date the approval starts;\n(i) if the approval applies for a stated period—the stated period.\n(4) An approval is a notifiable instrument.\n","sortOrder":131},{"sectionNumber":"555","sectionType":"section","heading":"Standing approval to prescribe controlled medicines for","content":"555 Standing approval to prescribe controlled medicines for\nhospital in-patient or patient discharge\nA designated prescriber is approved to prescribe a controlled\nmedicine for a patient of the prescriber if—\n(a) the patient is an in-patient at a hospital; or\n(b) the prescription is issued—\n(i) as part of the patient’s discharge from a hospital; and\n(ii) for the patient’s use of the controlled medicine for a period\nof not more than 7 days.\nNote A hospice is a hospital (see Macquarie Dictionary, 8th ed, def hospice).\n\nuse\nStanding controlled medicines approvals Division 13.1.2\n","sortOrder":132},{"sectionNumber":"556","sectionType":"section","heading":"Standing approval to prescribe controlled medicines for","content":"556 Standing approval to prescribe controlled medicines for\nshort-term treatment\n(1) A designated prescriber is approved to prescribe a controlled\nmedicine for a patient of the prescriber during a short-term treatment\nperiod if—\n(a) the prescriber believes on reasonable grounds that the patient—\n(i) is not a drug-dependant person in relation to a controlled\nmedicine or prohibited substance; and\n(ii) has not been prescribed the same controlled medicine by\nanother prescriber in the 2-month period immediately\nbefore the day the prescriber prescribes the controlled\n(b) the prescriber has not prescribed the same controlled medicine\nto the patient in the 2-month period immediately before the\nshort-term treatment period; and\n(c) the prescriber prescribes the controlled medicine for the\npatient’s use during the short-term treatment period only.\nNote For prescribing controlled medicines for more than a short-term treatment\nperiod, see division 13.1.3.\nshort-term treatment period, for a patient to be prescribed a\ncontrolled medicine, means a consecutive 2-month period beginning\non the day the prescriber first prescribes the controlled medicine for\nthe period.\n","sortOrder":133},{"sectionNumber":"556A","sectionType":"section","heading":"Controlled medicines to which standing approvals do not","content":"556A Controlled medicines to which standing approvals do not\napply\n(1) The chief health officer may declare a controlled medicine to which\napprovals under section 555 and section 556 do not apply.\n(2) A declaration is a notifiable instrument.\n\nuse\n","sortOrder":134},{"sectionNumber":"557","sectionType":"section","heading":"Standing interim approval to prescribe buprenorphine","content":"557 Standing interim approval to prescribe buprenorphine\nand methadone for patients of certain institutions\ndesignated prescriber includes an intern doctor only if the intern\ndoctor is acting under the direct supervision of a doctor.\n(2) A designated prescriber is approved (the interim approval) to\nprescribe buprenorphine or methadone if—\n(a) the designated prescriber—\n(i) is working at a hospital and prescribes the medicine for an\noutpatient at the hospital; or\n(ii) is working at any of the following institutions and\nprescribes the medicine for a patient of the institution:\n(A) a correctional centre;\n(B) a CYP detention place;\n(C) an opioid dependency treatment centre operated by\nthe Territory; or\nNote Institution includes a correctional centre and a CYP\ndetention place (see s 652).\n(iii) prescribes the medicine for a person in police custody; and\n(b) the buprenorphine or methadone is prescribed in accordance\nwith the opioid dependency treatment guidelines; and\nNote Opioid dependency treatment guidelines—see the dictionary.\n(c) the designated prescriber makes an application under\nsection 560 to prescribe the medicine not later than 72 hours\nafter the designated prescriber first prescribes buprenorphine or\nmethadone for the patient.\n\nuse\n(3) The interim approval ends—\n(a) if the chief health officer approves the application under\ndivision 13.1.3—when the designated prescriber is given notice\nof the approval; or\n(b) if the application under section 560 is withdrawn—on the\nwithdrawal of the application; or\n(c) if the chief health officer refuses to approve the application and\nthe 7-day period mentioned in section 565 (2) (Applications for\nreview of unfavourable CHO decisions for approvals) ends\nwithout an application for review being made—at the end of the\n7-day period; or\n(d) if the chief health officer refers the application to the medicines\nadvisory committee or an application is made to the committee\nunder section 565—when the designated prescriber is given\nnotice of the chief health officer’s decision under section 573\n(Medicines advisory committee—recommendations to CHO).\nDivision 13.1.3 Chief health officer controlled\nmedicines approvals\n","sortOrder":135},{"sectionNumber":"559","sectionType":"section","heading":"Application—div 13.1.3—standing CHO approvals to","content":"559 Application—div 13.1.3—standing CHO approvals to\nprescribe controlled medicines in certain circumstances\nThis division does not apply in relation to a controlled medicines\napproval by the chief health officer under section 554.\n","sortOrder":136},{"sectionNumber":"560","sectionType":"section","heading":"Applications for CHO controlled medicines approvals","content":"560 Applications for CHO controlled medicines approvals\n(1) A designated prescriber may apply to the chief health officer for\napproval to prescribe a controlled medicine.\n(2) An application under subsection (1) must—\n(a) be for approval to prescribe a controlled medicine for a single\nindividual; and\n\nuse\n(b) be made in a way determined by the chief health officer.\nExamples\ntelephone, email and fax\n(3) An application under subsection (1) may be made—\n(a) on the applicant’s own behalf; or\n(b) on the applicant’s own behalf and on behalf of 1 or more other\nnamed designated prescribers; or\n(c) on behalf of a group of designated prescribers that includes the\napplicant and who practise at the same premises.\nthe doctors practising at a suburban medical practice so that if a person’s\nusual doctor is unavailable another doctor at the practice can, under the\napproval, prescribe the controlled medicine\n(4) A determination under subsection (2) (b) is a notifiable instrument.\n","sortOrder":137},{"sectionNumber":"561","sectionType":"section","heading":"Requirements for CHO controlled medicines approval","content":"561 Requirements for CHO controlled medicines approval\napplications\n(1) An application by a designated prescriber for an approval to prescribe\na controlled medicine for a patient must include the following:\n(a) the designated prescriber’s name and address;\n(b) if the application is made on behalf of a group of designated\nprescribers—the names of the designated prescribers or a\ndescription of the group;\n(c) the medicine, and either—\n(i) the form, strength and maximum daily dose of the\nNote Other forms and strengths of the medicine, and a daily dose\nless than the maximum daily dose, may be prescribed in\naccordance with s 32.\n\nuse\n(ii) for an approval authorised under a category approval under\nsection 575—details of the approval sought;\n(d) the patient’s name and home address;\n(e) the condition from which the patient is suffering that, in the\ndesignated prescriber’s opinion, requires treatment with the\nmedicine;\n(f) whether, in the designated prescriber’s opinion, based on\nreasonable grounds, the patient is a drug-dependent person in\nrelation to a controlled medicine or prohibited substance.\n(2) To remove any doubt, the application may include any other\ninformation the designated prescriber considers relevant.\n(3) The chief health officer may ask the designated prescriber for any\nother information reasonably required to decide the application,\nincluding, for example, further information about the patient’s\n","sortOrder":138},{"sectionNumber":"562","sectionType":"section","heading":"CHO decision on applications to prescribe controlled","content":"562 CHO decision on applications to prescribe controlled\n(1) On application under section 560, the chief health officer must—\n(a) approve the application in the terms applied for; or\n(b) approve the application in terms different from those applied\nfor; or\n(c) refuse to approve the application; or\n(d) refer the application to the medicines advisory committee.\nNote 1 An approval may include conditions (see s 570).\nNote 2 For the form of a controlled medicines approval by the chief health\nofficer, see s 571.\n\nuse\n(2) However, the chief health officer need not decide the application if\nthe chief health officer has asked for information under section 561\n(3) and the information has not been given.\n(3) The chief health officer must give the applicant written notice of the\nchief health officer’s decision not later than 7 days after the day the\ndecision is made.\n(4) If the decision is made under subsection (1) (b) or (c), the notice must\ninclude information about the applicant’s right to seek review of the\ndecision under section 565 (Applications for review of unfavourable\nCHO decisions for approvals).\n","sortOrder":139},{"sectionNumber":"563","sectionType":"section","heading":"Restrictions on CHO power to approve applications for","content":"563 Restrictions on CHO power to approve applications for\ndesignated prescriber does not include an intern doctor.\n(2) In making a decision under section 562, the chief health officer—\n(a) must comply with any guidelines approved under section 574\n(Guidelines for CHO decisions on applications); and\n(b) must comply with any standards determined under section 575\n(Controlled medicines prescribing standards); and\n(c) must not approve an application to prescribe buprenorphine or\nmethadone to treat a drug-dependent person’s drug-dependency\nunless the applicant is—\n(i) a designated prescriber who is working at a hospital, or an\ninstitution mentioned in section 557 (2) (a) (ii) (Standing\ninterim approval to prescribe buprenorphine and\nmethadone for patients of certain institutions); or\n\nuse\n(ii) an intern doctor who is working at a hospital, or an\ninstitution mentioned in section 557 (2) (a) (ii), and who is\nacting under the direct supervision of a doctor at the\nhospital or institution; or\n(iii) a designated prescriber who is treating a person held in\npolice custody; or\n(iv) a designated prescriber who holds an endorsement under\nsection 582 (CHO decisions on applications for\nendorsement to treat drug-dependency); or\n(v) a designated prescriber who is prescribing continuing\nopioid dependency treatment for up to 5 drug-dependent\npeople if—\n(A) the people have already undergone opioid\ndependency treatment for at least 14 consecutive days\n(the initial treatment); and\n(B) the initial treatment was prescribed by a designated\nprescriber holding an endorsement under section 582.\n(3) However, the decision of the chief health officer under section 562\nneed not comply with a controlled medicines prescribing standard if\nthe decision—\n(a) is in accordance with a recommendation of the medicines\nadvisory committee that the prescribing standard not apply in\nthe particular circumstances; or\n(b) is in accordance with an entry for a controlled medicine listed in\nthe Australian Register of Therapeutic Goods; or\n(c) is necessary for the continuation of the patient’s treatment in the\nparticular circumstances.\n\nuse\nAustralian Register of Therapeutic Goods means the register\nmaintained under the Therapeutic Goods Act 1989 (Cwlth).\nNote The Australian Register of Therapeutic Goods can be accessed at\nwww.tga.gov.au.\n","sortOrder":140},{"sectionNumber":"564","sectionType":"section","heading":"Term of CHO controlled medicines approvals","content":"564 Term of CHO controlled medicines approvals\nA controlled medicines approval under this division is for the period\nstated in the approval.\n","sortOrder":141},{"sectionNumber":"565","sectionType":"section","heading":"Applications for review of unfavourable CHO decisions","content":"565 Applications for review of unfavourable CHO decisions\nfor approvals\n(1) This section applies if, under section 562, the chief health officer—\n(a) approves an application for a controlled medicines approval in\nterms different from those applied for; or\n(b) refuses to approve the application for an approval.\n(2) The applicant for the approval may, not later than 7 days after the day\nthe person receives written notice of the decision, apply to the\nmedicines advisory committee for review of the decision.\n(a) must be in writing signed by the applicant; and\n(c) may include any information that the applicant considers\nappropriate for the review.\n\nuse\n","sortOrder":142},{"sectionNumber":"566","sectionType":"section","heading":"Medicines advisory committee—referred applications and","content":"566 Medicines advisory committee—referred applications and\nreview of unfavourable CHO decisions\n(1) This section applies to an application—\n(a) for approval to prescribe a controlled medicine referred to the\nmedicines advisory committee under section 562 (1) (d); or\n(b) under section 565 for review of a decision of the chief health\nofficer on an application for a controlled medicines approval.\n(2) The medicines advisory committee may, in writing, ask the applicant\nto give the committee further information about the treatment of the\nperson to whom the application relates not later than a stated\nreasonable time.\n(3) After considering the application and any further information\nprovided in accordance with a notice under subsection (2), the\nmedicines advisory committee must—\n(a) for an application for review of a decision by the chief health\nofficer—\n(i) recommend that the chief health officer confirm the\ndecision made; or\n(ii) do both of the following:\n(A) recommend that the chief health officer revoke the\ndecision made;\n(B) make a recommendation under paragraph (b) (i), (ii)\nor (iii); or\n(b) recommend that the chief health officer—\n(i) approve the application to prescribe a controlled medicine\nin the terms applied for; or\n(ii) approve the application in terms different from those\napplied for; or\n\nuse\n(iii) refuse to approve the application.\nNote 1 The medicines advisory committee may recommend that the chief health\nofficer include conditions in the approval (see s 570 (2)).\nNote 2 The chief health officer must consider the committee’s recommendation\n(4) A recommendation must be in writing.\n","sortOrder":143},{"sectionNumber":"567","sectionType":"section","heading":"Amendment and revocation of controlled medicines","content":"567 Amendment and revocation of controlled medicines\n(1) The chief health officer may amend or revoke a controlled medicines\napproval on the chief health officer’s own initiative and without\nconsulting the medicines advisory committee.\n(2) The medicines advisory committee may recommend that the chief\nhealth officer amend or revoke a controlled medicines approval,\nwhether or not the approval was given on the recommendation of the\n(3) A recommendation must be in writing.\n(4) The chief health officer must send the approval-holder written notice\nof the chief health officer’s decision not later than 7 days after the day\nthe decision is made.\n(5) If the decision is to amend or revoke a controlled medicines approval\nunder subsection (1), the notice must include information about the\napproval-holder’s right to seek review of the decision under\nsection 568.\n(6) In this section:\namend, a controlled medicines approval, includes imposing a\ncondition on, or changing a condition of, the approval.\n\nuse\n","sortOrder":144},{"sectionNumber":"568","sectionType":"section","heading":"Application for review of amendment and revocation on","content":"568 Application for review of amendment and revocation on\nCHO initiative\n(1) This section applies if the chief health officer amends or revokes a\ncontrolled medicines approval under section 567 (1).\n(2) The person to whom the approval was given may, not later than\n7 days after the day the person is given written notice of the\namendment or revocation, apply to the medicines advisory committee\nfor review of the decision.\n(a) must be in writing signed by the applicant; and\n(c) may include any information that the applicant considers\nappropriate for the review.\n(4) To remove any doubt, the decision to which the application relates\ncontinues to operate despite the making of the application until the\nday the chief health officer’s decision following a recommendation\nunder section 569 (3) takes effect.\n","sortOrder":145},{"sectionNumber":"569","sectionType":"section","heading":"Medicines advisory committee—review of amendment or","content":"569 Medicines advisory committee—review of amendment or\nrevocation on CHO initiative\n(1) This section applies if an application is made to the medicines\nadvisory committee under section 568 to review a decision\n(the original decision) of the chief health officer to amend or revoke\na controlled medicines approval.\n(2) The medicines advisory committee may, in writing, ask the\ndesignated prescriber to give the committee further information about\nthe treatment of the person to whom the application relates not later\nthan a stated reasonable time.\n\nuse\n(3) After considering the application for review and any further\ninformation provided in accordance with a notice under\nsubsection (2), the medicines advisory committee must recommend\nthat the chief health officer—\n(a) confirm the original decision; or\n(b) revoke the original decision; or\n(c) revoke the original decision and approve the application as\nrecommended by the committee.\nNote 1 The medicines advisory committee may recommend that the chief health\nofficer include conditions in the approval (see s 570 (2)).\nNote 2 The chief health officer must consider the committee’s recommendation\n(4) A recommendation must be in writing.\n","sortOrder":146},{"sectionNumber":"570","sectionType":"section","heading":"Conditional controlled medicines approvals","content":"570 Conditional controlled medicines approvals\n(1) The chief health officer may include conditions for the safe or proper\nuse of a controlled medicine in a controlled medicines approval.\n(2) The medicines advisory committee may recommend that the chief\nhealth officer include conditions for the safe or proper use of a\ncontrolled medicine in a controlled medicines approval.\n","sortOrder":147},{"sectionNumber":"571","sectionType":"section","heading":"Form of CHO controlled medicines approvals","content":"571 Form of CHO controlled medicines approvals\n(1) A controlled medicines approval given by the chief health officer\nmust include the following:\n(a) the name of the controlled medicine to which the approval\nrelates;\n\nuse\n(b) either—\n(i) the form, strength and maximum daily dose of the\nmedicine that may be prescribed under the approval; or\n(ii) for an approval authorised under a category approval under\nsection 575—details of the approval given;\n(c) the period when the medicine may be prescribed under the\napproval or when the approval ends;\n(d) any condition to which the approval is subject.\nNote If the approval is an oral approval, the prescriber must send the chief\nhealth officer a written application (see s 31 (1) (d) (ii)).\n(2) Also, for subsection (1) (b), if the controlled medicines approval\nrelates to the treatment of a drug-dependent person with\nbuprenorphine or methadone for their drug-dependency, the approval\nmay state the maximum daily dose that may be prescribed for the\n","sortOrder":148},{"sectionNumber":"572","sectionType":"section","heading":"When controlled medicines approvals etc take effect","content":"572 When controlled medicines approvals etc take effect\n(1) A controlled medicines approval takes effect when the applicant\nreceives notice of the approval or, if the approval states a later day,\non the later day.\n(2) An amendment or revocation of a controlled medicines approval\ntakes effect when the approval-holder receives notice of the\namendment or revocation or, if the notice of the amendment or\nrevocation states a later day, on the later day.\n\nuse\n","sortOrder":149},{"sectionNumber":"573","sectionType":"section","heading":"Medicines advisory committee—recommendations to","content":"573 Medicines advisory committee—recommendations to\nCHO\n(1) This section applies if the medicines advisory committee\nrecommends that the chief health officer make a decision in relation\nto—\n(a) an application for a controlled medicines approval; or\n(b) a controlled medicines approval; or\n(c) an application under section 581 (Applications for CHO\nendorsement to treat drug-dependency).\n(2) The chief health officer must—\n(a) make the decision after considering the medicines advisory\ncommittee’s recommendation; and\n(b) send the applicant or approval holder written notice of the\ndecision not later than 7 days after the day the chief health\nofficer makes the decision.\n","sortOrder":150},{"sectionNumber":"574","sectionType":"section","heading":"Guidelines for CHO decisions on applications","content":"574 Guidelines for CHO decisions on applications\n(1) The medicines advisory committee may give draft guidelines to the\nchief health officer in relation to decisions on applications under\nsection 560 (Applications for CHO controlled medicines approvals).\n(2) The chief health officer may approve a draft guideline.\n(3) An approved guideline is a notifiable instrument.\n","sortOrder":151},{"sectionNumber":"575","sectionType":"section","heading":"Controlled medicines prescribing standards","content":"575 Controlled medicines prescribing standards\n(1) The chief health officer may determine standards setting out the\ncircumstances in which approval may be given (the controlled\nmedicines prescribing standards) to prescribe the following:\n(a) a category of controlled medicine (a category approval);\n\nuse\nEndorsements to treat drug-dependency Division 13.1.4\n(b) a form, strength and maximum daily dose of a controlled\napproval to prescribe all forms or strengths, up to a maximum daily dose, of\ncertain controlled medicines for people with terminal illness\n(2) The controlled medicines prescribing standards are a notifiable\ninstrument.\nDivision 13.1.4 Endorsements to treat\n","sortOrder":152},{"sectionNumber":"580","sectionType":"section","heading":"Meaning of endorsement—div 13.1.4","content":"580 Meaning of endorsement—div 13.1.4\nIn this division:\nendorsement means an endorsement under section 582 to prescribe\nbuprenorphine and methadone to treat a drug-dependent person’s\ndrug-dependency.\nNote An endorsement is not required by designated prescribers and certain\nintern doctors who are working at particular institutions, see s 563 (c).\n","sortOrder":153},{"sectionNumber":"581","sectionType":"section","heading":"Applications for CHO endorsement to treat","content":"581 Applications for CHO endorsement to treat\n(1) A designated prescriber may, in writing, apply to the chief health\nofficer for an endorsement.\n(2) The application must include the following:\n(a) the designated prescriber’s name and business address and\ntelephone number;\n(b) the designated prescriber’s qualifications and experience in\ntreating drug-dependency.\n(3) The chief health officer may ask the designated prescriber for any\nother information reasonably required to decide the application.\n\nuse\nDivision 13.1.4 Endorsements to treat drug-dependency\ndesignated prescriber does not include an intern doctor.\n","sortOrder":154},{"sectionNumber":"582","sectionType":"section","heading":"CHO decisions on applications for endorsement to treat","content":"582 CHO decisions on applications for endorsement to treat\n(1) The chief health officer must give, or refuse to give, an endorsement\nto a designated prescriber who applies under section 581.\n(2) The chief health officer must not give a designated prescriber an\nendorsement unless satisfied that the designated prescriber has the\nqualifications and experience to treat drug-dependency.\n(3) An endorsement is subject to any condition included in the\nendorsement by the chief health officer.\n(4) The chief health officer must give the designated prescriber written\nnotice of the chief health officer’s decision not later than 7 days after\nthe day the decision is made.\n(5) If the chief health officer refuses the application, the notice must\ninclude information about the designated prescriber’s right to seek\nreview of the decision under section 584.\n","sortOrder":155},{"sectionNumber":"583","sectionType":"section","heading":"Form of CHO endorsements to treat drug-dependency","content":"583 Form of CHO endorsements to treat drug-dependency\nAn endorsement by the chief health officer must include the\n(a) the designated prescriber’s name;\n(b) an identifying number for the endorsement;\n(c) any condition to which the endorsement is subject.\n\nuse\nEndorsements to treat drug-dependency Division 13.1.4\n","sortOrder":156},{"sectionNumber":"584","sectionType":"section","heading":"Medicines advisory committee—review of CHO decisions","content":"584 Medicines advisory committee—review of CHO decisions\nto refuse endorsements to treat drug-dependency\n(1) This section applies if the chief health officer refuses under\nsection 582 to give an endorsement to a designated prescriber.\n(2) The designated prescriber may, not later than 28 days after the day\nthe designated prescriber receives written notice of the decision,\napply to the medicines advisory committee for review of the decision.\n(a) must be in writing signed by the designated prescriber; and\n(c) may include any information that the designated prescriber\nconsiders appropriate for the review.\n(4) The medicines advisory committee may, in writing, ask the\ndesignated prescriber to give the committee further information that\nthe committee reasonably needs to decide the application.\n(5) After considering the application and any further information\nprovided in accordance with a notice under subsection (4), the\nmedicines advisory committee must—\n(a) recommend that the chief health officer confirm the decision\nmade; or\n(b) recommend that the chief health officer revoke the decision\nmade and approve the application as recommended by the\n(6) A recommendation must be in writing.\n\nuse\nNote It is a condition of an authorisation to prescribe an ACT listed appendix D\nmedicine for the prescriber to have an approval under this part (see\ns 31 (1) (e)).\n","sortOrder":157},{"sectionNumber":"588","sectionType":"section","heading":"Modification of medicines and poisons standard—Act,","content":"588 Modification of medicines and poisons standard—Act,\ns 15 (1), def medicines and poisons standard\nappendix D medicine—\n(a) means a medicine included in the medicines and poisons\nstandard, appendix D; but\n(b) does not include a controlled medicine.\n","sortOrder":158},{"sectionNumber":"589","sectionType":"section","heading":"Meaning of ACT listed appendix D medicine","content":"589 Meaning of ACT listed appendix D medicine\nACT listed appendix D medicine means an appendix D medicine\nlisted in schedule 3, part 3.2, column 3.\n","sortOrder":159},{"sectionNumber":"590","sectionType":"section","heading":"Meaning of appendix D medicines approval","content":"590 Meaning of appendix D medicines approval\nappendix D medicines approval means an approval under section 591\nor section 593.\n","sortOrder":160},{"sectionNumber":"591","sectionType":"section","heading":"Standing approval to prescribe ACT listed appendix D","content":"591 Standing approval to prescribe ACT listed appendix D\n(1) A prescriber mentioned in schedule 3, part 3.2, column 2 is approved\nto prescribe an ACT listed appendix D medicine mentioned in column\n3 in relation to the prescriber.\n\nuse\nAppendix D medicines approvals Part 13.2\n(2) However, the prescriber must only prescribe the medicine—\n(a) for a purpose (if any) mentioned in schedule 3, part 3.2,\ncolumn 3; and\n(b) in accordance with a condition (if any) mentioned in schedule 3,\npart 3.2, column 4.\nIf sch 3, pt 3.2, col 4 includes a condition requiring a prescriber to advise a woman\nof child-bearing age to avoid becoming pregnant during or for a certain period after\nthe completion of treatment, the prescriber is authorised to prescribe the medicine\nonly if the prescriber gives the patient the advice.\n","sortOrder":161},{"sectionNumber":"592","sectionType":"section","heading":"Applications for CHO approval to prescribe appendix D","content":"592 Applications for CHO approval to prescribe appendix D\n(1) A prescriber may, in writing, apply to the chief health officer for\napproval to prescribe an appendix D medicine.\n(2) The application must include the following:\n(a) the medicine’s name;\n(b) the prescriber’s name, business address and telephone number;\n(c) if the prescriber is a specialist—the specialist area in which the\nprescriber practises;\n(d) if the prescriber is not a specialist—the prescriber’s\nqualifications and experience in relation to the medicine.\n(3) The chief health officer may ask the prescriber for any other\ninformation reasonably required to decide the application.\n","sortOrder":162},{"sectionNumber":"593","sectionType":"section","heading":"CHO decisions on applications to prescribe appendix D","content":"593 CHO decisions on applications to prescribe appendix D\n(1) The chief health officer must approve, or refuse to approve, an\napplication by a prescriber under section 592 for approval to prescribe\nan appendix D medicine.\n\nuse\n(2) An approval under subsection (1) to prescribe an appendix D\n(a) if the medicine is an ACT listed appendix D medicine—that the\nprescriber complies with any conditions in schedule 3, part 3.2,\ncolumn 4 in relation to the medicine;\n(b) any other condition included in the approval by the chief health\nofficer.\nExample—par (a)\nIf sch 3, pt 3.2, col 4 includes a condition requiring a prescriber to advise a woman\nof child-bearing age to avoid becoming pregnant during or for a certain period after\nthe completion of treatment, the prescriber is authorised to prescribe the medicine\nonly if the prescriber gives the patient the advice.\n(3) For this section, the chief health officer—\n(a) must have regard to the specialist area (if any) in which the\nprescriber practises and the requirements (if any) stated in the\nmedicines and poisons standard, appendix D for the medicine to\nwhich the application relates; and\n(b) may have regard to anything else the chief health officer\nconsiders appropriate.\n(4) The chief health officer must send the prescriber written notice of the\nchief health officer’s decision not later than 7 days after the day the\ndecision is made.\n","sortOrder":163},{"sectionNumber":"594","sectionType":"section","heading":"Form of CHO appendix D medicines approvals","content":"594 Form of CHO appendix D medicines approvals\nAn appendix D medicines approval given by the chief health officer\nmust include the following:\n(a) the prescriber’s name;\n(b) the name of the medicine to which the approval relates;\n\nuse\nAppendix D medicines approvals Part 13.2\n(c) an identifying number for the approval;\n(d) any condition included in the approval by the chief health\nofficer.\n\n","sortOrder":164},{"sectionNumber":"600","sectionType":"section","heading":"Medicines licences that may be issued—Act, s 78 (2)","content":"600 Medicines licences that may be issued—Act, s 78 (2)\nThe following licences for medicines may be issued:\n(a) a licence for a program of research or education in relation to a\ncontrolled medicine (a controlled medicines research and\neducation program licence);\n(b) a licence for medicines for first-aid kits (a first-aid kit licence);\n(c) a licence for the supply by wholesale of a medicine (a medicines\nwholesalers licence);\n(d) a licence for the treatment of opioid dependency with\nbuprenorphine or methadone (an opioid dependency treatment\nlicence);\n(e) a licence for the sale by retail of pharmacy medicines by a\nperson who is not a pharmacist (a pharmacy medicines rural\ncommunities licence).\nNote Other medicines licences may also be issued (see Act, s 78 (3)).\n\nControlled medicines research and education program licences Part 14.2\n","sortOrder":165},{"sectionNumber":"Part 14","sectionType":"part","heading":"2 Controlled medicines research","content":"Part 14.2 Controlled medicines research\nand education program licences\nNote For research and education activities in relation to other medicines, see\npt 9.4.\n","sortOrder":166},{"sectionNumber":"605","sectionType":"section","heading":"Applications for controlled medicines research and","content":"605 Applications for controlled medicines research and\n(1) An application for a controlled medicines research and education\nprogram licence for a controlled medicine must be in writing, signed\nby the applicant, and include the following:\n(e) the controlled medicine, and the form and strength of the\nmedicine, for which the licence is sought;\n(f) the maximum quantity of the medicine that would be possessed\nunder the licence at any time;\nof the medicine;\n\nPart 14.2 Controlled medicines research and education program licences\n","sortOrder":167},{"sectionNumber":"606","sectionType":"section","heading":"Restrictions on issuing of controlled medicines research","content":"606 Restrictions on issuing of controlled medicines research\nand education program licences—Act, s 85 (1) (a)\nThe chief health officer must not issue a controlled medicines\nresearch and education program licence to a person unless—\n(b) the program is approved by a person mentioned in\nsection 605 (2); and\n(i) cannot be carried out without the use of the controlled\nmedicine to which the licence application relates; and\n","sortOrder":168},{"sectionNumber":"607","sectionType":"section","heading":"Additional information for controlled medicines research","content":"607 Additional information for controlled medicines research\nand education program licences—Act, s 88 (1) (k)\nThe following additional information is prescribed for a controlled\nmedicines research and education program licence:\n(c) the dealings with a controlled medicine authorised by the\n\nControlled medicines research and education program licences Part 14.2\n(e) the maximum quantity of the controlled medicine that may be\n(f) the total quantity of the controlled medicine that may be\npossessed for the program during the period of the licence;\n(g) the form and strength of the controlled medicine that may be\n\nNote This part is not applicable to a health practitioner who is authorised\nelsewhere under this regulation to possess etc medicines for a first-aid\nkit.\n","sortOrder":169},{"sectionNumber":"610","sectionType":"section","heading":"Applications for first-aid kit licences","content":"610 Applications for first-aid kit licences\n(1) An application for a first-aid kit licence must be in writing, signed by\nthe applicant, and include the following:\n(a) the full name, address and occupation of the applicant;\n(b) the full name, address and occupation of each other person\nproposed to be authorised to deal with a medicine under the\n(c) the prescription only medicines and controlled medicines (each\nof which are relevant medicines), and the form and strength of\nthe relevant medicines, for which the licence is sought;\nNote Pharmacy medicines and pharmacist only medicines are authorised\nfor the kit under s 450.\n(d) the maximum quantity of the relevant medicines that would be\n(e) the first-aid services provided, or proposed to be provided, to the\ncommunity by the applicant;\n(f) the situations in which it is proposed the medicines in the\nfirst-aid kit will be used;\n(g) the period for which the licence is sought.\n(2) The application must be accompanied by—\n(a) evidence of the qualifications mentioned in section 611 (a) for\nthe applicant and each person included in the application under\nsubsection (1) (b); and\n\nFirst-aid kit licences Part 14.3\n(b) a letter of support from a doctor who will provide medical\ndirection and support to the applicant.\n","sortOrder":170},{"sectionNumber":"611","sectionType":"section","heading":"Restrictions on issuing of first-aid kit licences—Act,","content":"611 Restrictions on issuing of first-aid kit licences—Act,\ns 85 (1) (a)\nThe chief health officer must not issue a first-aid kit licence to a\nperson unless—\n(a) each person to be authorised under the licence has successfully\ncompleted a course that qualifies the person to be registered as\na nurse or employed as an ambulance paramedic; and\n(b) the chief health officer is satisfied that the person provides, or\nwill be providing, first-aid services to the community, for\nexample, at a workplace or as part of a privately operated\nambulance service approved under the Emergencies Act 2004,\npart 4.6 (Other approved providers); and\n(c) the medicines to which the licence application relates are\nreasonably necessary to provide the first-aid services.\n","sortOrder":171},{"sectionNumber":"612","sectionType":"section","heading":"Additional information for first-aid kit licences—Act,","content":"612 Additional information for first-aid kit licences—Act,\ns 88 (1) (k)\n(1) The following additional information is prescribed for a first-aid kit\nlicence:\n(a) the full name and home address of each person who is authorised\nto deal with a medicine under the licence;\n(b) the maximum quantity of each relevant medicine that may be\n(c) the total quantity of each relevant medicine that may be\npossessed during the period of the licence;\n\n(d) the form and strength in which each relevant medicine may be\nobtained, possessed and administered under the licence.\nrelevant medicines—see section 610.\n\nMedicines wholesalers licences Part 14.4\nNote This part is applicable to an interstate wholesaler only if the Act, s 20 (4)\ndoes not apply to the wholesaler.\n","sortOrder":172},{"sectionNumber":"615","sectionType":"section","heading":"Applications for medicines wholesalers licences","content":"615 Applications for medicines wholesalers licences\n(1) An application for a medicines wholesalers licence must be in\nwriting, signed by the applicant, and include the following:\n(a) the medicines to which the application relates;\nwith the medicines under the licence;\n(a) where it is proposed to store the medicines; and\n(b) the location and nature of security devices.\n","sortOrder":173},{"sectionNumber":"616","sectionType":"section","heading":"Restrictions on issuing of medicines wholesalers","content":"616 Restrictions on issuing of medicines wholesalers\n(1) The chief health officer must not issue a medicines wholesalers\nlicence to a person unless dealings with medicines under the licence\nwill be supervised by an individual nominated by the applicant and\napproved, in writing, by the chief health officer.\n\n(a) is a suitable person to hold a medicines wholesalers licence; and\nexperience appropriate for the sale of medicines.\n","sortOrder":174},{"sectionNumber":"617","sectionType":"section","heading":"Additional information for medicines wholesalers","content":"617 Additional information for medicines wholesalers\nlicences—Act, s 88 (1) (k)\nThe name of the person approved under section 616 (1) to supervise\nthe dealings with medicines authorised by the licence is prescribed\nfor a medicines wholesalers licence.\n\nOpioid dependency treatment licences Part 14.5\nPart 14.5 Opioid dependency treatment\n","sortOrder":175},{"sectionNumber":"620","sectionType":"section","heading":"Applications for opioid dependency treatment licences","content":"620 Applications for opioid dependency treatment licences\nAn application for an opioid dependency treatment licence must be in\nwriting, signed by the applicant, and include the applicant’s full name\nand business address.\n","sortOrder":176},{"sectionNumber":"621","sectionType":"section","heading":"Restriction on issuing of opioid dependency treatment","content":"621 Restriction on issuing of opioid dependency treatment\nThe chief health officer must not issue an opioid dependency\ntreatment licence to a person unless the person is a pharmacist at a\ncommunity pharmacy.\n","sortOrder":177},{"sectionNumber":"622","sectionType":"section","heading":"Witnessing not required for administration under opioid","content":"622 Witnessing not required for administration under opioid\ndependency treatment licence—Act, s190 (1) (a)\nThe Act, section 53 (e) (Registers—witnessing administration of\nmedicines) does not apply to the administration of buprenorphine or\nmethadone under an opioid dependency treatment licence if\nsection 471 is complied with in relation to the administration.\n\nPart 14.6 Pharmacy medicines rural communities licences\nPart 14.6 Pharmacy medicines rural\ncommunities licences\n625 Applications for pharmacy medicines rural communities\nAn application for a pharmacy medicines rural communities licence\nmust—\n(a) be in writing signed by the applicant; and\n(b) include—\n(i) the applicant’s full name, business address and telephone\nnumber; and\n(ii) the pharmacy medicines proposed to be sold under the\nlicence.\n","sortOrder":178},{"sectionNumber":"626","sectionType":"section","heading":"Restrictions on issuing of pharmacy medicines rural","content":"626 Restrictions on issuing of pharmacy medicines rural\ncommunities licences—Act, s 85 (1) (a)\nThe chief health officer must not issue a pharmacy medicines rural\ncommunities licence to a person unless—\n(a) the person is carrying on the business of selling goods by retail;\nand\n(b) the premises from which the medicines will be sold under the\nlicence is more than 25km by the shortest practical route to the\nnearest community pharmacy.\n\nOpioid dependency treatment Part 15.1\n","sortOrder":179},{"sectionNumber":"630","sectionType":"section","heading":"Guidelines for treatment of opioid dependency","content":"630 Guidelines for treatment of opioid dependency\n(1) The Minister may approve guidelines for the treatment of opioid\ndependency.\n(2) Without limiting subsection (1), approved guidelines may make\nprovision in relation to the prescribing and administration of\nbuprenorphine and methadone to drug-dependent people.\n(3) An approval is a notifiable instrument.\n","sortOrder":180},{"sectionNumber":"631","sectionType":"section","heading":"Minister may exempt certain people dealing with","content":"631 Minister may exempt certain people dealing with\nbuprenorphine or methadone from Act—Act, s 190 (1) (b)\n(1) The Minister may exempt a person from the Act if the person—\n(a) is an agent of an ODT person; and\n(b) is dealing with buprenorphine or methadone for the ODT\nNote An exemption may be conditional (see the Act, s 190 (2)).\n(2) An exemption is a disallowable instrument.\nagent, of an ODT person, means a person nominated as the ODT\nperson’s agent under the ODT contingency guidelines.\nODT contingency guidelines means guidelines issued under the Act,\nsection 192 that make provision about the circumstances in which an\nagent for an ODT person may deal with buprenorphine or methadone\nfor the ODT person.\n\nODT person means a person who—\n(a) is dependent on opioids; and\n(b) is being treated for their dependency with buprenorphine or\nmethadone.\n\nNote The medicines advisory committee is established under the Act, s 194.\n","sortOrder":181},{"sectionNumber":"635","sectionType":"section","heading":"Medicines advisory committee—membership","content":"635 Medicines advisory committee—membership\n(1) The medicines advisory committee consists of the members\nappointed by the director-general.\nNote For laws about appointments, see the Legislation Act, pt 19.3.\n(2) The director-general must appoint a chair of the medicines advisory\ncommittee from the members appointed under subsection (1).\n(3) A person, other than a person mentioned in subsection (4) (e), is\neligible to be appointed as a member of the medicines advisory\ncommittee only if the person is a health practitioner.\n(4) The medicines advisory committee must include—\n(a) at least 1 member who has had experience in the teaching or\npractice of psychiatry; and\n(b) at least 1 member who has had experience in the teaching or\npractice of pain or addiction medicine; and\n(c) at least 1 member who is a general practitioner; and\n(d) at least 1 member who is a pharmacist; and\n(e) 1 member who represents consumers; and\n(f) at least 1 member nominated by the Australian Capital Territory\nBranch of the Australian Medical Association.\n\n(5) However, for subsection (4) only, if the appointment of a member (a\nformer member) is ended before the last day of the period for which\nthe former member was appointed, the medicines advisory committee\nis taken to still include the former member until the earlier of—\n(a) 4 months from the day the former member’s appointment ended;\nor\n(b) a member is appointed to replace the former member.\n(6) The instrument appointing, or evidencing the appointment of, a\nmedicines advisory committee member must state whether the person\nis appointed as the chair, or as another member, of the committee.\n","sortOrder":182},{"sectionNumber":"636","sectionType":"section","heading":"Medicines advisory committee—term of appointments","content":"636 Medicines advisory committee—term of appointments\nThe appointment of a medicines advisory committee member must\nbe for not longer than 3 years.\nNote A person may be reappointed to a position if the person is eligible to be\nappointed to the position (see Legislation Act, s 208 and dict, pt 1,\ndef appoint).\n","sortOrder":183},{"sectionNumber":"637","sectionType":"section","heading":"Medicines advisory committee—conditions of","content":"637 Medicines advisory committee—conditions of\nappointments\nThe conditions of appointment of a medicines advisory committee\nmember are the conditions agreed between the director-general and\nthe member, subject to any determination under the Remuneration\nTribunal Act 1995.\n","sortOrder":184},{"sectionNumber":"638","sectionType":"section","heading":"Medicines advisory committee—time and place of","content":"638 Medicines advisory committee—time and place of\nmeetings\n(1) Meetings of the medicines advisory committee are to be held when\nand where the committee decides.\n(2) The chair of the medicines advisory committee may at any time call\na meeting.\n\n(3) The chair must give the other members reasonable notice of the time\nand place of a meeting called by the chair.\n(4) The medicines advisory committee may adjourn a proceeding, for any\nreason it considers appropriate, to a time and place decided by the\n","sortOrder":185},{"sectionNumber":"639","sectionType":"section","heading":"Medicines advisory committee—presiding member","content":"639 Medicines advisory committee—presiding member\n(1) The chair presides at a meeting of the medicines advisory committee.\n(2) If the chair is absent, the member chosen by the members present\npresides.\n","sortOrder":186},{"sectionNumber":"640","sectionType":"section","heading":"Medicines advisory committee—quorum","content":"640 Medicines advisory committee—quorum\nBusiness may be carried out at a meeting of the medicines advisory\ncommittee only if at least 4 members are present.\n","sortOrder":187},{"sectionNumber":"641","sectionType":"section","heading":"Medicines advisory committee—voting","content":"641 Medicines advisory committee—voting\n(1) At a meeting of the medicines advisory committee each member has\na vote on each question to be decided.\n(2) A question is decided by a majority of the votes of members present\nand voting but, if the votes are equal, the presiding member has the\ndeciding vote.\n","sortOrder":188},{"sectionNumber":"642","sectionType":"section","heading":"Medicines advisory committee—conduct of meetings","content":"642 Medicines advisory committee—conduct of meetings\n(1) The medicines advisory committee may conduct its meetings as the\ncommittee considers appropriate.\n(2) A meeting of the medicines advisory committee may be held using a\nmethod of communication, or a combination of methods of\ncommunication, that allows each member taking part to hear what\neach other member taking part says without the members being in\neach other’s presence.\nExamples\na phone link, a satellite link, an internet or intranet link\n\n(3) A medicines advisory committee member who takes part in a meeting\nconducted under subsection (2) is taken to be present at the meeting.\n(4) A resolution is a valid resolution of the medicines advisory\ncommittee, even if it is not passed at a meeting of the committee, if\nall members agree to the proposed resolution in writing.\n(5) The medicines advisory committee must keep minutes of its\nmeetings.\n","sortOrder":189},{"sectionNumber":"643","sectionType":"section","heading":"Medicines advisory committee—disclosure of interests","content":"643 Medicines advisory committee—disclosure of interests\nby members\n(1) If a medicines advisory committee member has a material interest in\nan issue being considered, or about to be considered, by the\ncommittee, the member must disclose the nature of the interest at a\ncommittee meeting as soon as possible after the relevant facts have\ncome to the member’s knowledge.\n(2) The disclosure must be recorded in the medicines advisory\ncommittee’s minutes and, unless the committee otherwise decides,\nthe member must not—\n(a) be present when the medicines advisory committee considers the\nissue; or\n(b) take part in a decision of the committee on the issue.\nDavid, Emile and Fiona are members of the medicines advisory committee. They\nhave an interest in an issue being considered at a committee meeting and they\ndisclose the interest as soon as they become aware of it. David’s and Emile’s\ninterests are minor but Fiona has a direct financial interest in the issue.\nThe medicines advisory committee considers the disclosures and decides that\nbecause of the nature of the interests:\n• David may be present when the committee considers the issue but not take part\nin the decision\n\n• Emile may be present for the consideration and take part in the decision.\nThe medicines advisory committee does not make a decision allowing Fiona to be\npresent or take part in the committee’s decision. Accordingly, Fiona cannot be\npresent for the consideration of the issue or take part in the decision.\n(3) Any other medicines advisory committee member who also has a\nmaterial interest in the issue must not be present when the committee\nis considering its decision under subsection (2).\n(4) In deciding under subsection (2) whether a member may be present\nwhen the medicines advisory committee decides the issue or take part\nin a decision of the committee on the issue, and despite section 640\n(Medicines advisory committee—quorum), the committee may\nconsist of the members who do not have a material interest in the\nissue.\nif 6 members are present at the meeting and 2 members disclose a material interest,\nthe other 4 members may decide whether the members who made the disclosure\ncan take part in a decision by the committee\nassociate, of a person, means—\n(a) the person’s business partner; or\n(b) a close friend of the person; or\n(c) a family member of the person.\nexecutive officer, of a corporation, means a person (however\ndescribed) who is concerned with, or takes part in, the corporation’s\nmanagement (whether or not the person is a director of the\ncorporation).\nindirect interest—without limiting the kind of indirect interest a\nperson may have, a person has an indirect interest in an issue if any\nof the following has an interest in the issue:\n(a) an associate of the person;\n\n(b) a corporation with not more than 100 members that the person,\nor an associate of the person, is a member of;\n(c) a subsidiary of a corporation mentioned in paragraph (b);\n(d) a corporation that the person, or an associate of the person, is an\nexecutive officer of;\n(e) the trustee of a trust that the person, or an associate of the person,\nis a beneficiary of;\n(f) a member of a firm or partnership that the person, or an associate\nof the person, is a member of;\n(g) someone else carrying on a business if the person, or an\nassociate of the person, has a direct or indirect right to\nparticipate in the profits of the business.\nmaterial interest—a medicines advisory committee member has a\nmaterial interest in an issue if the member has—\n(a) a direct or indirect financial interest in the issue; or\n(b) a direct or indirect interest of any other kind if the interest could\nconflict with the proper exercise of the member’s functions in\nrelation to the committee’s consideration of the issue.\n","sortOrder":190},{"sectionNumber":"644","sectionType":"section","heading":"Medicines advisory committee—ending appointments","content":"644 Medicines advisory committee—ending appointments\n(1) The director-general may end the appointment of a medicines\nadvisory committee member—\n(a) if the member contravenes a territory law; or\n(b) for misbehaviour; or\n(c) if the member becomes bankrupt or personally insolvent; or\nNote Bankrupt or personally insolvent—see the Legislation Act,\ndictionary, pt 1.\n\n(d) if the member is convicted, in the ACT, of an offence punishable\nby imprisonment for at least 1 year; or\n(e) if the member is convicted outside the ACT, in Australia or\nelsewhere, of an offence that, if it had been committed in the\nACT, would be punishable by imprisonment for at least 1 year;\nor\n(f) if the member contravenes section 643 (Medicines advisory\ncommittee—disclosure of interests by members).\nNote A member’s appointment also ends if the member resigns (see\nLegislation Act, s 210).\n(2) The director-general must end the appointment of a medicines\nadvisory committee member—\n(a) if the member (other than a member mentioned in section 635\n(4) (e)) ceases to be a health practitioner; or\n(b) if, on 3 consecutive occasions, the member fails, without the\nchair’s agreement, to make himself or herself available for a\nproposed meeting of the committee; or\n(c) if the member fails to take all reasonable steps to avoid being\nplaced in a position where a conflict of interest arises during the\nexercise of the member’s functions; or\n(d) for physical or mental incapacity, if the incapacity substantially\naffects the exercise of the member’s functions.\n\n","sortOrder":191},{"sectionNumber":"650","sectionType":"section","heading":"Advertising controlled medicines—Act, s 66 (3) (b)","content":"650 Advertising controlled medicines—Act, s 66 (3) (b)\nA pricelist published by a pharmacist that includes a controlled\nmedicine is prescribed if the pricelist complies with the Price\nInformation Code of Practice, published by the Therapeutic Goods\nAdministration, as in force from time to time.\nNote The Price Information Code of Practice is accessible at www.tga.gov.au.\n","sortOrder":192},{"sectionNumber":"651","sectionType":"section","heading":"Advertising other medicines","content":"651 Advertising other medicines\n(1) A person commits an offence if—\n(a) the person publishes an advertisement; and\n(b) the advertisement promotes or encourages the use of a declared\nMaximum penalty: 30 penalty units.\n(2) A person commits an offence if—\n(a) the person publishes an advertisement; and\n(b) the advertisement indicates that someone is willing or authorised\nto supply a declared medicine.\nMaximum penalty: 30 penalty units.\n(3) This section does not apply to—\n(a) an advertisement for a declared medicine in a publication\npublished primarily for dentists, doctors, pharmacists or\nveterinary practitioners; or\n(b) a pricelist published by a pharmacist that includes a declared\nmedicine if the pricelist complies with the Price Information\nCode of Practice, published by the Therapeutic Goods\nAdministration, as in force from time to time.\n\nOther medicines provisions Part 15.3\nadvertisement—see the Act, section 66.\ndeclared medicine means—\n(a) a pharmacist only medicine other than a pharmacist only\nmedicine to which the medicines and poisons standard,\nappendix H applies; or\n(b) a prescription only medicine.\n","sortOrder":193},{"sectionNumber":"652","sectionType":"section","heading":"Prescribed institutions—Act, dict, def institution, par (b)","content":"652 Prescribed institutions—Act, dict, def institution, par (b)\nThe following are prescribed:\n(a) a correctional centre;\n(b) a CYP detention place.\n\n","sortOrder":194},{"sectionNumber":"Part 16","sectionType":"part","heading":"Low and moderate harm","content":"Chapter 16 Low and moderate harm\n","sortOrder":195},{"sectionNumber":"660","sectionType":"section","heading":"Meaning of relevant law—ch 16","content":"660 Meaning of relevant law—ch 16\nrelevant law means—\n(a) a corresponding law; or\n(b) the Agricultural and Veterinary Chemicals Act 1994 (Cwlth); or\n(c) the Therapeutic Goods Act 1989 (Cwlth).\nNote 1 Corresponding law includes a law of a State that corresponds, or\nsubstantially corresponds, to the Act (see Act, dict).\nNote 2 State includes the Northern Territory (see Legislation Act, dict, pt 1).\n\nLow and moderate harm poisons Chapter 16\nAuthorisation to supply low and moderate harm poisons Part 16.2\nPart 16.2 Authorisation to supply low and\nmoderate harm poisons\n","sortOrder":196},{"sectionNumber":"661","sectionType":"section","heading":"Authorisation to supply low and moderate harm","content":"661 Authorisation to supply low and moderate harm\npoisons—Act, s 26 (1) (b) and (2) (b)\nAnyone is authorised to supply a low harm poison or moderate harm\npoison.\n","sortOrder":197},{"sectionNumber":"662","sectionType":"section","heading":"Authorisation condition for supplying low and moderate","content":"662 Authorisation condition for supplying low and moderate\nharm poisons—Act, s 44 (1) (b) and (2) (b)\nA person’s authorisation under section 661 to supply a low harm\npoison or moderate harm poison is subject to the following\nconditions:\n(a) the poison is supplied in manufacturer’s packs that comply\n(i) section 665 (Packaging of supplied manufacturer’s packs\nof low and moderate harm poisons—Act, s 59 (1) (c) (i)\nand (2) (c) (i)); or\n(i) section 666 (Labelling of supplied manufacturer’s packs of\nlow and moderate harm poisons—Act, s 60 (1) (c) (i)\nand (2) (c) (i)); or\n(ii) an approval under the Act, section 193.\n\nPart 16.3 Authorisation to manufacture low and moderate harm poisons\nPart 16.3 Authorisation to manufacture low\nand moderate harm poisons\n663 Authorisation to manufacture low and moderate harm\npoisons—Act, s 33 (b)\nA person is authorised to manufacture a low harm poison or moderate\nharm poison if the person is authorised to manufacture the poison\nunder a relevant law.\n","sortOrder":198},{"sectionNumber":"664","sectionType":"section","heading":"Authorisation condition for manufacturing low and","content":"664 Authorisation condition for manufacturing low and\nmoderate harm poisons—Act, s 44 (1) (b) and (2) (b)\nA person’s authorisation under section 663 to manufacture a low\nharm poison or moderate harm poison is subject to the condition that,\nif a condition or restriction applies to the person under the relevant\nlaw, the person manufactures the poison in accordance with the\ncondition and restriction.\n\nLow and moderate harm poisons Chapter 16\nPackaging and labelling of low and moderate harm poisons Part 16.4\nPart 16.4 Packaging and labelling of low\nand moderate harm poisons\n","sortOrder":199},{"sectionNumber":"665","sectionType":"section","heading":"Packaging of supplied manufacturer’s packs of low and","content":"665 Packaging of supplied manufacturer’s packs of low and\nmoderate harm poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)\n(1) A manufacturer’s pack of a supplied low harm poison or moderate\nharm poison must be packaged—\n(b) in a container in which the poison may be sold under a relevant\nlaw.\nNote A manufacturer’s pack of a low or moderate harm poison supplied may\nalso be packaged in accordance with an approval under the Act, s 193\n(Approval of non-standard packaging and labelling) (see Act,\ns 59 (1) (c) (ii) and (2) (c) (ii)).\n(2) However, if the poison is camphor or naphthalene for domestic use,\nit must also be packaged in a way that, in normal use, prevents—\n(a) removal of the camphor or naphthalene from the packaging; or\n(b) ingestion of the camphor or naphthalene.\n","sortOrder":200},{"sectionNumber":"666","sectionType":"section","heading":"Labelling of supplied manufacturer’s packs of low and","content":"666 Labelling of supplied manufacturer’s packs of low and\nmoderate harm poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)\nA manufacturer’s pack of a supplied low harm poison or moderate\nharm poison must be labelled in accordance with—\n(b) a relevant law.\nNote A manufacturer’s pack of a low or moderate harm poison supplied may\nalso be labelled in accordance with an approval under the Act, s 193\n(Approval of non-standard packaging and labelling) (see Act,\ns 60 (1) (c) (ii) and (2) (c) (ii)).\n\nPart 17.1 Overview of dangerous poisons authorisations\nChapter 17 Dangerous poisons\nPart 17.1 Overview of dangerous poisons\n670 General overview of authorisations for dangerous\n(1) The Act requires that a person must not deal with a dangerous poison\nin a particular way unless the person is authorised to deal with the\npoison.\nthe Act, s 35 about obtaining certain substances (which include dangerous poisons)\nNote The Act, s 19 sets out when a person deals with a dangerous poison.\n(2) The Act, section 20 sets out when a person is authorised to deal with\na dangerous poison.\n(3) This regulation authorises certain dealings with dangerous poisons.\nNote An authorisation is not required to deal with the following:\n• a substance excluded from the medicines and poisons standard by\nthe standard;\n• a substance mentioned in the medicines and poisons standard, sch 7\nif the schedule does not apply to the substance because of an\nexception in the standard.\n(4) An authorisation under this regulation may be subject to limitations.\na purchase order issued by a person mentioned in sch 4, col 2 must comply with\ns 721 (see s 690 (2) (c))\nNote For the power to impose other restrictions, see the Act, ch 8.\n\nOverview of dangerous poisons authorisations Part 17.1\n","sortOrder":201},{"sectionNumber":"671","sectionType":"section","heading":"Overview of dangerous poisons authorisations under this","content":"671 Overview of dangerous poisons authorisations under this\nregulation\nDangerous poisons authorisations under this regulation are given by\nthe following provisions:\n(a) section 675 (which is about authorisations under dangerous\npoisons manufacturers licences);\n(b) section 680 (which is about authorisations under dangerous\npoisons research and education program licences);\n(c) section 685 (which is about authorisations under dangerous\npoisons suppliers licences);\n(d) section 690 (which is about authorisations for manufacturing\nand other purposes);\n(e) section 692 (which is about authorisation to deliver dangerous\npoisons under purchase orders);\n(f) section 693 (which is about authorisation for commercial\ndisposal operators for disposal of dangerous poisons);\n(g) section 695 (which is about authorisations for dangerous poisons\nresearch and education programs by scientifically qualified\npeople).\n","sortOrder":202},{"sectionNumber":"672","sectionType":"section","heading":"General overview of authorisation conditions for","content":"672 General overview of authorisation conditions for\ndangerous poisons\n(1) The Act, section 44 requires a person who is authorised to deal with\na dangerous poison to comply with any condition to which the\nauthorisation is subject.\nSection 676 sets out the authorisation conditions for an authorised person to\nmanufacture a dangerous poison.\n\n","sortOrder":203},{"sectionNumber":"Part 17","sectionType":"part","heading":"1 Overview of dangerous poisons authorisations","content":"Part 17.1 Overview of dangerous poisons authorisations\n(2) The conditions are additional to other restrictions on an authorised\nperson’s authority to deal with a dangerous poison.\nNote Conditions may also be imposed under other provisions of the Act\nincluding, for example, s 89 which sets out conditions on licences.\n\nDangerous poisons manufacturers licence authorisations Division 17.2.1\nPart 17.2 Authorisations under dangerous\npoisons licences\n","sortOrder":204},{"sectionNumber":"Div 17","sectionType":"division","heading":"2.1 Dangerous poisons manufacturers","content":"Division 17.2.1 Dangerous poisons manufacturers\nNote For other provisions about dangerous poisons manufacturers licences, see\npt 18.2.\n","sortOrder":205},{"sectionNumber":"675","sectionType":"section","heading":"Authorisations under dangerous poisons manufacturers","content":"675 Authorisations under dangerous poisons manufacturers\n(1) A dangerous poisons manufacturers licence authorises the holder to\ndo any of the following in relation to a dangerous poison (the licensed\ndangerous poison) stated in the licence at the premises (the licensed\npremises) stated in the licence:\n(a) manufacture the licensed dangerous poison;\n(b) possess the licensed dangerous poison for sale by wholesale\nfrom the licensed premises;\n(c) sell the licensed dangerous poison by wholesale (whether or not\nfor resale) to—\n(i) a person authorised to issue a purchase order for the\n(ii) someone in another State who may obtain the dangerous\npoison by wholesale under the law of the other State; or\ndangerous poison by wholesale in the other country;\nNote The dangerous poison must be sold on a purchase order in\naccordance with s 720 (see s 676).\n\nDivision 17.2.1 Dangerous poisons manufacturers licence authorisations\n(d) obtain a dangerous poison, other than a licensed dangerous\npoison, for manufacturing a licensed dangerous poison at the\nlicensed premises;\n(e) possess a dangerous poison, other than a licensed dangerous\npoison, at the licensed premises for manufacturing a licensed\ndangerous poison.\n(3) Also, subsection (1) (c) (iii) does not apply in relation to a licensed\ndangerous poison that is a prohibited export under the Customs\nAct 1901 (Cwlth).\n","sortOrder":206},{"sectionNumber":"676","sectionType":"section","heading":"Authorisation conditions for dangerous poisons","content":"676 Authorisation conditions for dangerous poisons\nmanufacturers licences—Act, s 44 (1) (b) and (2) (b)\nA licence-holder’s authorisation under a dangerous poisons\nmanufacturers licence is subject to the following conditions:\n(a) the dealings with a dangerous poison authorised by the licence\nwill be carried out under the supervision of an individual\napproved under section 706 (1) (Restrictions on issuing of\ndangerous poisons manufacturers licences—Act, s 85 (1) (a));\n(b) a dangerous poison obtained under the licence is purchased on a\ncomplying purchase order;\n(c) a licensed dangerous poison will be supplied for a\nnon-household (including a non-household garden) purpose\nonly;\n(d) a dangerous poison sold under the licence will be sold on a\npurchase order in accordance with section 720 (Supplying\ndangerous poisons on purchase orders);\n\nDangerous poisons manufacturers licence authorisations Division 17.2.1\n(e) if the supplier does not receive a document signed by the buyer\nacknowledging receipt of the dangerous poison within 7 days\nafter the day the dangerous poison is delivered—the supplier\nmust, within 24 hours after the end of the 7-day period, tell the\nchief health officer, in writing, of the failure to receive the\ndocument;\n(f) the following are kept at the supplier’s business premises or, if\nthe chief health officer approves, in writing, another place, the\nafter the day the poison is supplied:\n(ii) the delivery acknowledgment under paragraph (e) or\nsection 720 (d) (ii);\n(g) the record for section 722 is kept at the supplier’s business\npremises or, if the chief health officer approves, in writing,\nat least 5 years after the day the poison is supplied;\n(h) if a dangerous poison sold under the licence is liquid containing\nparaquat—the poison is coloured blue or green and has an\noffensive smell.\n\nDivision 17.2.2 Dangerous poisons—research and education program licence\nDivision 17.2.2 Dangerous poisons—research and\neducation program licence\nNote 1 For authorisation for research and education programs by scientifically\nqualified people, see div 17.3.3.\nNote 2 For other provisions about dangerous poisons research and education\nprogram licences, see pt 18.3.\n","sortOrder":207},{"sectionNumber":"680","sectionType":"section","heading":"Authorisations under dangerous poisons research and","content":"680 Authorisations under dangerous poisons research and\neducation program licences—Act, s 20 (1) (a)\nA dangerous poisons research and education program licence\n(i) issue a purchase order for a dangerous poison (the licensed\ndangerous poison) stated in the licence for the program\nstated in the licence; and\n(ii) obtain a licensed dangerous poison on a purchase order for\nthe program; and\n(iii) possess a licensed dangerous poison for the program at the\npremises to which the licence relates; and\n(iv) supply a licensed dangerous poison to anyone taking part\nto deal with the licensed dangerous poison as authorised by the\nlicence at the premises stated in the licence.\n\nDangerous poisons—research and education program licence\nDivision 17.2.2\n","sortOrder":208},{"sectionNumber":"681","sectionType":"section","heading":"Authorisation condition for dangerous poisons research","content":"681 Authorisation condition for dangerous poisons research\nand education program licences—Act, s 44 (1) (b)\nA licence-holder’s authorisation to obtain a dangerous poison under\na dangerous poisons research and education program licence is\nsubject to the condition that the poison is purchased on a complying\npurchase order.\n\nDivision 17.2.3 Dangerous poisons suppliers licence\nNote For other provisions about dangerous poisons suppliers licences, see\npt 18.4.\n","sortOrder":209},{"sectionNumber":"685","sectionType":"section","heading":"Authorisations under dangerous poisons suppliers","content":"685 Authorisations under dangerous poisons suppliers\nlicences—Act, s 20 (1) (b)\n(1) A dangerous poisons suppliers licence authorises the holder to do any\nof the following in relation to a dangerous poison (the licensed\ndangerous poison) stated in the licence at the premises (the licensed\npremises) stated in the licence:\n(a) issue a purchase order for a licensed dangerous poison;\n(b) obtain a licensed dangerous poison on a purchase order for sale\nfrom the licensed premises;\n(c) possess a licensed dangerous poison for sale from the licensed\npremises;\n(d) sell a licensed dangerous poison on a purchase order to—\n(i) someone authorised to issue a purchase order for the\n(ii) someone in another State who may obtain the dangerous\npoison under the law of the other State; or\ndangerous poison in the other country.\nNote The dangerous poison must be sold on a purchase order in\naccordance with s 720 (see s 686).\n\nDangerous poisons suppliers licence authorisations Division 17.2.3\n(3) Also, subsection (1) (d) (iii) does not apply in relation to a licensed\ndangerous poison that is a prohibited export under the Customs\nAct 1901 (Cwlth).\n","sortOrder":210},{"sectionNumber":"686","sectionType":"section","heading":"Authorisation conditions for dangerous poisons","content":"686 Authorisation conditions for dangerous poisons\nsuppliers licences—Act, s 44 (1) (b) and (2) (b)\nA licence-holder’s authorisation under a dangerous poisons suppliers\nlicence is subject to the following conditions:\n(a) the dealings with a dangerous poison authorised by the licence\nwill be carried out under the supervision of an individual\napproved under section 716 (1) (Restrictions on issuing of\ndangerous poisons suppliers licences—Act, s 85 (1) (a));\n(b) a dangerous poison sold under the licence will be sold on a\npurchase order in accordance with section 720 (Supplying\ndangerous poisons on purchase orders);\n(c) a dangerous poison sold under the licence will be supplied for a\nnon-household (including a non-household garden) purpose\nonly;\n(d) if a dangerous poison sold under the licence is subject to the\nmedicines and poisons standard, appendix J—the poison will be\nsupplied only to a person who is allowed to use the poison under\nthe appendix;\n(e) if the supplier does not receive a document signed by the buyer\nacknowledging receipt of the dangerous poison within 7 days\nafter the day the dangerous poison is delivered—the supplier\nmust, within 24 hours after the end of the 7-day period, tell the\nchief health officer, in writing, of the failure to receive the\ndocument;\n\n(f) the following are kept at the supplier’s business premises or, if\nthe chief health officer approves, in writing, another place, the\nafter the day the poison is supplied:\n(ii) the delivery acknowledgment under paragraph (e) or\nsection 720 (d) (ii);\n(g) the record for section 722 is kept at the supplier’s business\npremises or, if the chief health officer approves, in writing,\nat least 5 years after the day the poison is supplied;\n(h) if a dangerous poison sold under the licence is liquid containing\nparaquat—the poison is coloured blue or green and has an\noffensive smell.\n\nAuthorisations for manufacturing etc purposes Division 17.3.1\nPart 17.3 Other dangerous poisons\nDivision 17.3.1 Authorisations for manufacturing etc\npurposes\n690 Manufacturing etc authorisations for dangerous\npoisons—Act, s 20 (2) (a)\nrelevant dealing, with a dangerous poison, means any of the\n(a) issuing a purchase order for the poison;\n(b) obtaining the poison;\n(c) possessing the poison;\n(d) discarding the poison.\n(2) A person mentioned in schedule 4 (Dangerous poisons—\nmanufacturing etc authorisations), column 2 is authorised for a\nrelevant dealing with a dangerous poison mentioned in column 3 in\nrelation to the person if—\n(a) the poison is for a purpose mentioned in column 4 in relation to\nthe person; and\n(b) the dealing is consistent with any condition or restriction for the\ndealing mentioned in column 3; and\n(c) if the dealing is issuing a purchase order for the poison—the\npurchase order complies with section 721 (General requirements\nfor dangerous poisons purchase orders—Act, s 38 (2) (c)).\nNote A purchase order must be in writing (see Act, dict, def purchase\norder).\n\nDivision 17.3.2 Authorisations for delivery people and commercial disposal operators\n(3) Also, the chief health officer may determine that a person is\nauthorised for a relevant dealing with a dangerous poison mentioned\nin schedule 4, column 3.\n(4) A determination is a disallowable instrument.\nDivision 17.3.2 Authorisations for delivery people\nand commercial disposal operators\n","sortOrder":211},{"sectionNumber":"692","sectionType":"section","heading":"Authorisations to deliver dangerous poisons under","content":"692 Authorisations to deliver dangerous poisons under\npurchase orders—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b),\n(2) (b) and s 36 (b)\n(1) This section applies to an adult (the delivery person) who is—\n(a) engaged to transport and deliver a dangerous poison supplied on\na purchase order; or\n(b) acting for a person mentioned in paragraph (a).\n(2) The delivery person is authorised to—\n(a) obtain and possess the dangerous poison for the purpose of\ntransporting and delivering the dangerous poison as engaged;\nand\n(b) supply the dangerous poison to the entity named as the recipient\nin the purchase order or the entity’s agent.\nExample—delivery person\nan employee of a courier service\nNote Entity includes a person (see Legislation Act, dict, pt 1).\n\nAuthorisations for delivery people and commercial disposal operators Division 17.3.2\n","sortOrder":212},{"sectionNumber":"693","sectionType":"section","heading":"Authorisation to supply dangerous poisons to","content":"693 Authorisation to supply dangerous poisons to\ncommercial disposal operator for disposal—Act,\ns 26 (1) (b)\nA person is authorised to supply a dangerous poison for disposal to\nanother person if the other person—\n(a) holds an environmental authorisation for the disposal of the\nNote For related authorisations, see pt 9.1.\n","sortOrder":213},{"sectionNumber":"694","sectionType":"section","heading":"Authorisations for commercial disposal operators—Act, s","content":"694 Authorisations for commercial disposal operators—Act, s\n26 (1) (b) and (2) (b), s 35 (1) (b) and (2) (b) and s 36 (b)\n(1) This section applies to a person who—\n(a) holds an environmental authorisation for the disposal of a\n(2) The person is authorised to obtain and possess the dangerous poison\nfor disposing of the poison as engaged.\n\nDivision 17.3.3 Authorisations for dangerous poisons research and education programs\nby scientifically qualified people\nDivision 17.3.3 Authorisations for dangerous poisons\nresearch and education programs by\nscientifically qualified people\nNote A licence is required for research and education programs in relation to\nan administration-related dealing for human use (see Act, s 20 (3)).\n","sortOrder":214},{"sectionNumber":"695","sectionType":"section","heading":"Authorisations for dangerous poisons research and","content":"695 Authorisations for dangerous poisons research and\neducation—Act, s 26 (1) and (2) (b)\n(1) A scientifically qualified person employed at a recognised research\ninstitution is authorised to do the following for the purposes of an\nauthorised activity at the institution:\n(a) issue a purchase order for a dangerous poison;\n(b) obtain on a purchase order a dangerous poison;\n(c) possess a dangerous poison;\n(d) supply a dangerous poison to a person (a relevant person) who\nis taking part in the authorised activity at the institution.\nNote 1 Scientifically qualified person—see the dictionary.\nNote 2 Recognised research institution—see the Act, s 20 (5).\n(2) A relevant person is authorised to do the following in relation to a\ndangerous poison for the purposes of an authorised activity:\n(a) obtain the poison from the scientifically qualified person for the\nactivity;\n(b) possess the poison for the purposes of the activity;\n(c) supply the poison to the scientifically qualified person for the\nactivity.\n\nAuthorisations for dangerous poisons research and education programs\nby scientifically qualified people\nDivision 17.3.3\nadministration-related dealing, in relation to a dangerous poison—\nsee the Act, section 20 (5).\nauthorised activity, in relation to a dangerous poison at a recognised\nresearch institution, means the conduct of any of the following if it\ndoes not involve an administration-related dealing of the poison for\nhuman use:\n(a) medical or scientific research in relation to the poison at the\n(b) instruction involving the poison at the institution;\n(c) quality control or analysis of the poison at the institution;\n(d) if the poison is integral to genuine medical or scientific research\nat the institution—reasonable use of the poison to carry out the\nresearch.\n","sortOrder":215},{"sectionNumber":"696","sectionType":"section","heading":"Authorisation conditions for dangerous poisons research","content":"696 Authorisation conditions for dangerous poisons research\nand education—Act, s 44 (1) (b) and (2) (b)\nA scientifically qualified person’s authorisation under section 695 is\nsubject to the following conditions:\n(a) the person has written approval for the conduct of the authorised\nactivity from the person in charge of—\n(i) the recognised research institution; or\n(ii) a faculty or division of the institution;\n(b) a dangerous poison is purchased on a complying purchase order;\n(c) the purchase order is for an amount of the poison approved in\nwriting by the person in charge;\n(d) the dangerous poison is obtained from someone who is\nauthorised to supply the poison to the person.\n\nPart 18.1 Dangerous poisons licences generally\nPart 18.1 Dangerous poisons licences\n700 Dangerous poisons licences that may be issued—Act,\ns 78 (2)\nThe following licences for dangerous poisons may be issued:\n(a) a licence for the manufacture of a dangerous poison\n(a dangerous poisons manufacturers licence);\n(b) a licence for a program of research or education in relation to a\ndangerous poison (a dangerous poisons research and\neducation program licence);\n(c) a licence for the supply of dangerous poisons (a dangerous\npoisons suppliers licence).\nNote Other dangerous poisons licences may also be issued (see Act, s 78 (3)).\n\nDangerous poisons manufacturers licences Part 18.2\n","sortOrder":216},{"sectionNumber":"Part 18","sectionType":"part","heading":"2 Dangerous poisons","content":"Part 18.2 Dangerous poisons\nmanufacturers licences\n","sortOrder":217},{"sectionNumber":"705","sectionType":"section","heading":"Applications for dangerous poisons manufacturers","content":"705 Applications for dangerous poisons manufacturers\n(1) An application for a dangerous poisons manufacturers licence must\nbe in writing, signed by the applicant, and include the following:\n(a) the dangerous poisons to which the application relates;\nwith the poisons under the licence;\n(a) each part of the premises where a process in the manufacture of\nthe dangerous poisons is proposed to be carried out and the\nnature of the process; and\n(b) where it is proposed to store the dangerous poisons to which the\napplication relates and any other dangerous poisons obtained for\nthe manufacture of those dangerous poisons; and\n(c) the location and nature of security devices.\n\nPart 18.2 Dangerous poisons manufacturers licences\n","sortOrder":218},{"sectionNumber":"706","sectionType":"section","heading":"Restrictions on issuing of dangerous poisons","content":"706 Restrictions on issuing of dangerous poisons\nmanufacturers licences—Act, s 85 (1) (a)\n(1) The chief health officer must not issue a dangerous poisons\nmanufacturers licence to a person unless dealings with dangerous\npoisons under the licence will be supervised by an individual\nnominated by the applicant and approved, in writing, by the chief\nhealth officer.\n(a) is a suitable person to hold a dangerous poisons manufacturers\nexperience appropriate for the manufacture of dangerous\npoisons.\n","sortOrder":219},{"sectionNumber":"707","sectionType":"section","heading":"Additional information for dangerous poisons","content":"707 Additional information for dangerous poisons\nmanufacturers licences—Act, s 88 (1) (k)\nThe name of the person approved under section 706 (1) to supervise\nthe dealings with dangerous poisons authorised by the licence is\nprescribed for a dangerous poisons manufacturers licence.\n\nDangerous poisons research and education program licences Part 18.3\nPart 18.3 Dangerous poisons research and\n","sortOrder":220},{"sectionNumber":"710","sectionType":"section","heading":"Applications for dangerous poisons research and","content":"710 Applications for dangerous poisons research and\n(1) An application for a dangerous poisons research and education\nprogram licence for a dangerous poison must be in writing, signed by\nthe applicant, and include the following:\n(e) the dangerous poison, and the form and strength of the poison,\nfor which the licence is sought;\n(f) the maximum quantity of the dangerous poison that would be\nof the dangerous poison;\n\nPart 18.3 Dangerous poisons research and education program licences\n","sortOrder":221},{"sectionNumber":"711","sectionType":"section","heading":"Restrictions on issuing of dangerous poisons research","content":"711 Restrictions on issuing of dangerous poisons research\nand education program licences—Act, s 85 (1) (a)\nThe chief health officer must not issue a dangerous poisons research\nand education program licence to a person unless—\n(b) the program is approved by a person mentioned in section 710\n(2); and\n(i) cannot be carried out without the use of the dangerous\npoison to which the licence application relates; and\n","sortOrder":222},{"sectionNumber":"712","sectionType":"section","heading":"Additional information for dangerous poisons research","content":"712 Additional information for dangerous poisons research\nand education licences—Act, s 88 (1) (k)\nThe following additional information is prescribed for a dangerous\npoisons research and education licence:\n(c) the dealings with a dangerous poison authorised by the licence;\n\nDangerous poisons research and education program licences Part 18.3\n(e) the maximum quantity of the dangerous poison that may be\n(f) the total quantity of the dangerous poison that may be possessed\nfor the program during the period of the licence;\n(g) the form and strength of the dangerous poison that may be\n\nPart 18.4 Dangerous poisons suppliers licences\nPart 18.4 Dangerous poisons suppliers\n715 Applications for dangerous poisons suppliers licences\n(1) An application for a dangerous poisons suppliers licence must be in\nwriting, signed by the applicant, and include the following:\n(a) the dangerous poisons to which the application relates;\nwith the poisons under the licence;\n(a) where it is proposed to store the dangerous poisons; and\n(b) the location and nature of security devices.\n\nDangerous poisons suppliers licences Part 18.4\n","sortOrder":223},{"sectionNumber":"716","sectionType":"section","heading":"Restrictions on issuing of dangerous poisons suppliers","content":"716 Restrictions on issuing of dangerous poisons suppliers\n(1) The chief health officer must not issue a dangerous poisons suppliers\nlicence to a person unless dealings with dangerous poisons under the\nlicence will be supervised by an individual nominated by the\napplicant and approved, in writing, by the chief health officer.\n(a) is a suitable person to hold a dangerous poisons suppliers\nexperience appropriate for the sale of dangerous poisons.\n","sortOrder":224},{"sectionNumber":"717","sectionType":"section","heading":"Additional information for dangerous poisons suppliers","content":"717 Additional information for dangerous poisons suppliers\nlicences—Act, s 88 (1) (k)\nThe name of the person approved under section 716 (1) to supervise\nthe dealings with dangerous poisons authorised by the licence is\nprescribed for a dangerous poisons suppliers licence.\n\nPart 19.1 Dangerous poisons purchase orders\nChapter 19 Dangerous poisons—other\nprovisions\nPart 19.1 Dangerous poisons purchase\n720 Supplying dangerous poisons on purchase orders\nThe following are the requirements for the supply of a dangerous\npoison on a purchase order:\n(a) the dangerous poison is supplied in manufacturer’s packs that\ncomply with—\n(i) section 731 (Packaging of supplied manufacturer’s packs\nof dangerous poisons—Act, s 59 (1) (c) (i) and (2) (c) (i));\nor\n(i) section 732 (Labelling of supplied manufacturer’s packs of\ndangerous poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)); or\n(ii) an approval under the Act, section 193;\n(c) the manufacturer’s packs are securely wrapped and packed;\n(d) if the dangerous poison is delivered in person by the supplier to\nthe buyer—\n(i) the poison is delivered to an adult; and\n(ii) the delivery is acknowledged by the adult signing and\ndating a copy of the purchase order;\n\nDangerous poisons purchase orders Part 19.1\n(e) if the dangerous poison is not delivered in person by the supplier\nto the buyer—the poison is delivered to the buyer by a person\nwhose procedures require the delivery of the poison to be signed\nfor by the buyer or an adult employee of the buyer.\n","sortOrder":225},{"sectionNumber":"721","sectionType":"section","heading":"General requirements for dangerous poisons purchase","content":"721 General requirements for dangerous poisons purchase\norders—Act, s 38 (2) (c)\n(1) A purchase order for a dangerous poison must be—\n(2) A purchase order for a dangerous poison must include the following:\n(c) the dangerous poison, and the form, strength and quantity of the\npoison, to be supplied on the order.\n","sortOrder":226},{"sectionNumber":"722","sectionType":"section","heading":"Recording supply of dangerous poisons","content":"722 Recording supply of dangerous poisons\nA person who supplies a dangerous poison on a purchase order to\nsomeone else must keep a written record of the supply in accordance\nwith the medicines and poisons standard.\n\n","sortOrder":227},{"sectionNumber":"Part 19","sectionType":"part","heading":"2 Wholesale supply of dangerous poisons under corresponding laws","content":"Part 19.2 Wholesale supply of dangerous poisons under corresponding laws\nPart 19.2 Wholesale supply of dangerous\npoisons under corresponding\nlaws\n","sortOrder":228},{"sectionNumber":"725","sectionType":"section","heading":"Conditions for wholesalers supplying dangerous poisons","content":"725 Conditions for wholesalers supplying dangerous poisons\nunder corresponding laws—Act, s 20 (4) (c)\nThe following conditions apply to a person who supplies dangerous\npoisons by wholesale under a corresponding law:\n(a) the person must not supply a dangerous poison to someone else\n(the buyer) unless—\n(i) the buyer is authorised to possess the poison; and\n(ii) the supply is in accordance with section 686 (Authorisation\nconditions for dangerous poisons suppliers licences—Act,\ns 44 (1) (b) and (2) (b));\n(b) the poison is supplied for a non-household (including a\nnon-household garden) purpose only;\n(c) if the poison is liquid containing paraquat—the poison is\ncoloured blue or green and has an offensive smell.\nNote 1 A purchase order must be in writing (see Act, dict, def purchase order).\nNote 2 See pt 19.1 for other requirements in relation to supply of dangerous\npoisons on purchase orders.\n\nPackaging and labelling of dangerous poisons Part 19.3\nPart 19.3 Packaging and labelling of\ndangerous poisons\n","sortOrder":229},{"sectionNumber":"730","sectionType":"section","heading":"Meaning of relevant law—pt 19.3","content":"730 Meaning of relevant law—pt 19.3\nrelevant law means—\n(a) a corresponding law; or\n(b) the Agricultural and Veterinary Chemicals Act 1994 (Cwlth); or\n(c) the Therapeutic Goods Act 1989 (Cwlth).\nNote 1 Corresponding law includes a law of a State that corresponds, or\nsubstantially corresponds, to the Act (see Act, dict).\nNote 2 State includes the Northern Territory (see Legislation Act, dict, pt 1).\n","sortOrder":230},{"sectionNumber":"731","sectionType":"section","heading":"Packaging of supplied manufacturer’s packs of","content":"731 Packaging of supplied manufacturer’s packs of\ndangerous poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)\nA manufacturer’s pack of a supplied dangerous poison must be\npackaged—\n(b) in a container in which the poison may be sold under a relevant\nlaw.\nNote A manufacturer’s pack of a dangerous poison supplied may also be\npackaged in accordance with an approval under the Act, s 193 (Approval\nof non-standard packaging and labelling) (see Act, s 59 (1) (c) (ii)\nand (2) (c) (ii)).\n\nPart 19.3 Packaging and labelling of dangerous poisons\n","sortOrder":231},{"sectionNumber":"732","sectionType":"section","heading":"Labelling of supplied manufacturer’s packs of dangerous","content":"732 Labelling of supplied manufacturer’s packs of dangerous\npoisons—Act, s 60 (1) (c) (i) and (2) (c) (i)\nA manufacturer’s pack of a supplied dangerous poison must be\nlabelled in accordance with—\n(b) a relevant law.\nNote A manufacturer’s pack of a dangerous poison supplied may also be\nlabelled in accordance with an approval under the Act, s 193 (Approval\nof non-standard packaging and labelling) (see Act, s 60 (1) (c) (ii)\nand (2) (c) (ii)).\n\nStorage of dangerous poisons Part 19.4\nPart 19.4 Storage of dangerous poisons\n","sortOrder":232},{"sectionNumber":"735","sectionType":"section","heading":"Storage of dangerous poisons—Act, s 61 (b) and (c)","content":"735 Storage of dangerous poisons—Act, s 61 (b) and (c)\n(1) A person mentioned in table 740, column 2 who possesses a\ndangerous poison is prescribed.\n(2) The dangerous poison must be kept in accordance with the medicines\nand poisons standard.\n\n","sortOrder":233},{"sectionNumber":"740","sectionType":"section","heading":"Keeping of dangerous poisons registers by certain","content":"740 Keeping of dangerous poisons registers by certain\npeople—Act, s 48 and s 50 (1) (b) and (2) (b)\n(1) A person mentioned in table 740, column 2 who possesses a\ndangerous poison must keep a dangerous poisons register.\n(2) A person to whom subsection (1) applies must keep a dangerous\npoisons register for a dangerous poison at the place prescribed in\ntable 740, column 3 for the person.\nTable 740 Keeping dangerous poisons registers\nitem\n1 approved analyst the analyst’s laboratory\n2 dangerous poisons manufacturers\nlicence-holder\nthe licensed premises under s 675\n3 dangerous poisons suppliers\nlicence-holder\nthe licensed premises under s 685\n4 medicines and poisons inspector (other\nthe place directed in writing by the\nchief health officer\n5 person mentioned in sch 4, col 2 the person’s business premises\n6 supervisor of program under dangerous\npoisons research and education program\nlicence\n7 supervisor of program under dangerous\npoisons research and education\nauthorisation under div 17.3.3\n\nDangerous poisons registers Part 19.5\n","sortOrder":234},{"sectionNumber":"741","sectionType":"section","heading":"Form of dangerous poisons registers—Act, s 49 (1) (b)","content":"741 Form of dangerous poisons registers—Act, s 49 (1) (b)\n(1) Each page in a dangerous poisons register must relate to a single form\nand strength of a dangerous poison.\n(2) If a dangerous poisons register is kept electronically, a separate record\nmust be used for each form and strength of dangerous poison kept.\n","sortOrder":235},{"sectionNumber":"742","sectionType":"section","heading":"Making entries in dangerous poisons registers—Act,","content":"742 Making entries in dangerous poisons registers—Act,\n(1) The following details for a dealing with a dangerous poison are\n(c) the poison, and the form, strength and quantity of the poison,\ndealt with;\n(d) if the dealing is receiving the poison—the name and address of\nthe supplier;\n(e) if the dealing is supplying the poison—the name and address of\nthe person to whom it is supplied;\n(f) if the poison is supplied on a purchase order—the date of the\npurchase order;\n(g) the quantity of the poison held after the dealing.\n(2) A dealing with a dangerous poison must be entered in the dangerous\npoisons register the person must keep.\n\n","sortOrder":236},{"sectionNumber":"743","sectionType":"section","heading":"Prescribed witnesses for discarding of dangerous","content":"743 Prescribed witnesses for discarding of dangerous\npoisons—Act, s 54 (a) and (b)\n(1) An adult is prescribed as a witness in relation to the disposal of a\ndangerous poison.\n(2) However, a person mentioned in subsection (1) must not be a\nprescribed witness to the discarding of a dangerous poison if the\nperson is—\nthe poison; or\n(b) the supervisor of the person discarding the poison; or\n(c) supervised by the person discarding the poison.\n","sortOrder":237},{"sectionNumber":"744","sectionType":"section","heading":"Changes to entries in dangerous poisons registers—Act,","content":"744 Changes to entries in dangerous poisons registers—Act,\ns 55 (2) (b)\n(1) An entry in a paper-based dangerous poisons register may be\n(b) if the entry relates to disposing of a dangerous poison—\n(2) An entry in an electronic dangerous poisons register may be amended\nby the person who made the entry by the person attaching or linking,\nby electronic means, a document that includes—\n\nDangerous poisons registers Part 19.5\n(b) if the entry relates to disposing of a dangerous poison—\n\n","sortOrder":238},{"sectionNumber":"750","sectionType":"section","heading":"Manufacture, supply and use of paints containing white","content":"750 Manufacture, supply and use of paints containing white\nlead—Act, s 70 (1) (b), (2) (b) and (3) (b)\nA paint containing basic lead carbonate (white lead) may be\nmanufactured, supplied or used for application as a mirror backing if\nthe paint—\n(a) contains not more than 15% lead in the non-volatile content of\nthe paint; and\n(b) is applied not more than 40μm thick; and\n(c) is covered by a paint that does not contain lead.\nNote μm is the symbol for micron (see National Measurement\nRegulations 1999 (Cwlth), sch 1, pt 4).\n","sortOrder":239},{"sectionNumber":"751","sectionType":"section","heading":"Manufacture, supply and use of first group paints for","content":"751 Manufacture, supply and use of first group paints for\ncertain purposes—Act, s 71 (1)\nA first group paint must not be manufactured, supplied or used for\napplication to—\n(a) a roof or other surface to be used for the collection or storage of\npotable water; or\n(b) furniture; or\n(c) a fence, wall, post, gate or building (including the interior of a\nbuilding), other than a building that is used only for industrial\npurposes or mining or as an oil terminal; or\n(d) premises used for the manufacture, processing, preparation,\npacking or serving of products intended for human or animal\nconsumption.\n\nPaints Chapter 20\n","sortOrder":240},{"sectionNumber":"751A","sectionType":"section","heading":"Manufacture, supply and use of paints or tinters for","content":"751A Manufacture, supply and use of paints or tinters for\ncertain purposes—Act, s 71 (3)\nA paint or tinter is prescribed if it must not be manufactured, supplied\nor used under the medicines and poisons standard if it contains more\nthan a stated amount of lead.\n","sortOrder":241},{"sectionNumber":"752","sectionType":"section","heading":"Manufacture, supply and use of paints for toys—Act,","content":"752 Manufacture, supply and use of paints for toys—Act,\ns 72 (b)\nA paint that complies with the requirements for paints for application\nto toys under the medicines and poisons standard is prescribed.\n","sortOrder":242},{"sectionNumber":"753","sectionType":"section","heading":"Manufacture, supply and use of paints containing","content":"753 Manufacture, supply and use of paints containing\npesticides—Act, s 73 (b)\n(1) A pesticide is prescribed if a paint or tinter containing the pesticide\nmay be manufactured, supplied or used under the medicines and\npoisons standard.\n(2) However, subsection (1) does not apply in relation to a paint for\nhuman therapeutic use.\n\n","sortOrder":243},{"sectionNumber":"Part 21","sectionType":"part","heading":"Prohibited and schedule 10","content":"Chapter 21 Prohibited and schedule 10\nsubstances\n","sortOrder":244},{"sectionNumber":"760","sectionType":"section","heading":"Meaning of prohibited substance—ch 21","content":"760 Meaning of prohibited substance—ch 21\nprohibited substance includes a schedule 10 substance.\nNote Schedule 10 substance and prohibited substance—see the Act, s 13.\n","sortOrder":245},{"sectionNumber":"761","sectionType":"section","heading":"Prohibited substances licences—Act, s 78 (2)","content":"761 Prohibited substances licences—Act, s 78 (2)\nA licence for a program of research or education in relation to a\nprohibited substance (a prohibited substances research and\neducation program licence) may be issued.\nNote Other prohibited substances licences may also be issued (see Act,\ns 78 (3)).\n\nIssue of prohibited substances research and education program licences Division 21.2.1\nPart 21.2 Prohibited substances research\nand education program licences\nDivision 21.2.1 Issue of prohibited substances\nresearch and education program\n765 Applications for prohibited substances research and\n(1) An application for a prohibited substances research and education\nprogram licence for a prohibited substance must be in writing, signed\nby the applicant, and include the following:\n(e) the prohibited substance, and the form and strength of the\nsubstance, for which the licence is sought;\n(f) the maximum quantity of the prohibited substance that would be\n\n","sortOrder":246},{"sectionNumber":"Div 21","sectionType":"division","heading":"2.1 Issue of prohibited substances research and education program licences","content":"Division 21.2.1 Issue of prohibited substances research and education program licences\nof the prohibited substance;\n","sortOrder":247},{"sectionNumber":"766","sectionType":"section","heading":"Restrictions on issuing of prohibited substances","content":"766 Restrictions on issuing of prohibited substances\nresearch and education program licences—Act, s 85 (1)\n(a)\nThe chief health officer must not issue a prohibited substances\nresearch and education program licence to a person unless—\n(b) the program is approved by a person mentioned in\nsection 765 (2); and\n(i) cannot be carried out without the use of the prohibited\nsubstance to which the licence application relates; and\n\nProhibited substances research and education program authorisations Division 21.2.2\n","sortOrder":248},{"sectionNumber":"767","sectionType":"section","heading":"Additional information for prohibited substances","content":"767 Additional information for prohibited substances\nresearch program and education licences—Act,\ns 88 (1) (k)\nThe following additional information is prescribed for a prohibited\nsubstances research and education licence:\n(c) the dealings with a prohibited substance authorised by the\n(e) the maximum quantity of the prohibited substance that may be\n(f) the total quantity of the prohibited substance that may be\npossessed for the program during the period of the licence;\n(g) the form and strength of the prohibited substance that may be\nDivision 21.2.2 Prohibited substances research and\neducation program authorisations\n","sortOrder":249},{"sectionNumber":"768","sectionType":"section","heading":"Authorisations under prohibited substances research","content":"768 Authorisations under prohibited substances research\nand education program licences—Act, s 20 (1) (a)\nA prohibited substances research and education program licence\n(i) issue a purchase order for a prohibited substance\n(the licensed prohibited substance) stated in the licence\nfor the program stated in the licence; and\n\nDivision 21.2.2 Prohibited substances research and education program authorisations\n(ii) obtain a licensed prohibited substance on a purchase order\nfor the program; and\n(iii) possess a licensed prohibited substance for the program at\n(iv) supply a licensed prohibited substance to anyone taking\npart in the program for the program; and\nto deal with the licensed prohibited substance as authorised by\nthe licence at the premises stated in the licence.\n","sortOrder":250},{"sectionNumber":"769","sectionType":"section","heading":"Authorisation condition for prohibited substances","content":"769 Authorisation condition for prohibited substances\nresearch and education program licences—Act,\nA licence-holder’s authorisation to obtain a prohibited substance\nunder a prohibited substances research and education program licence\nis subject to the condition that the substance is obtained on a\ncomplying purchase order.\n\nOther provisions—prohibited substances research and education\nDivision 21.2.3\nDivision 21.2.3 Other provisions—prohibited\nsubstances research and education\n770 Approvals of dealings for prohibited substances research\nand education program licences—Act, s 20 (1) (c)\nrelevant dealing, with a prohibited substance for a prohibited\nsubstances research and education program licence, means any of the\n(a) obtaining the substance;\n(b) possessing the substance;\n(c) issuing a purchase order for the substance;\n(d) supplying the substance on a complying purchase order to the\n(2) The chief health officer may approve a person for a relevant dealing\nwith a prohibited substance to which a prohibited substances research\nand education program licence relates.\n(3) An approval—\n(a) must be in writing; and\n(b) may be conditional; and\n(c) may apply for a stated period or until a stated event happens.\n\nDivision 21.2.3 Other provisions—prohibited substances research and education\n","sortOrder":251},{"sectionNumber":"771","sectionType":"section","heading":"Authorisation condition for approval-holders—Act,","content":"771 Authorisation condition for approval-holders—Act,\nAn approval-holder’s authorisation under section 770 is subject to the\ncondition that the following are kept at the approval-holder’s business\npremises or, if the chief health officer approves in writing another\nplace, the place approved by the chief health officer, for at least\n2 years after the day a prohibited substance is supplied:\n(a) the filled purchase order;\n(b) the record for section 773.\n","sortOrder":252},{"sectionNumber":"772","sectionType":"section","heading":"General requirements for prohibited substances","content":"772 General requirements for prohibited substances\npurchase orders—Act, s 38 (2) (c)\n(1) A purchase order for a prohibited substance must be—\n(2) A purchase order for a prohibited substance must include the\n(c) the prohibited substance, and the form, strength and quantity of\nthe substance, to be supplied on the order.\n\nOther provisions—prohibited substances research and education\nDivision 21.2.3\n","sortOrder":253},{"sectionNumber":"773","sectionType":"section","heading":"Recording supply of prohibited substances on purchase","content":"773 Recording supply of prohibited substances on purchase\nA person who supplies a prohibited substance to someone else on a\npurchase order must make a written record of the following\n(a) the date of the order;\n(c) the name, and the business address and telephone number, of the\nperson to whom the prohibited substance is supplied;\n(d) the date the order is supplied;\n(e) the prohibited substance, and the form, strength and quantity of\nthe substance, supplied.\n","sortOrder":254},{"sectionNumber":"774","sectionType":"section","heading":"Information for CHO about supplied prohibited","content":"774 Information for CHO about supplied prohibited\nsubstances research and education program licences—\nAct, s 31 (1) (a) (ii), (1) (b), (2) (a) (ii), (2) (b) and (4)\n(1) This section applies if a person supplies a prohibited substance to a\nprohibited substances research and education program\n(2) The person must, not later than 7 days after the end of the month when\nthe prohibited substance is supplied, give the chief health officer the\nfollowing information in writing:\n(a) the person’s name, business address and telephone number;\n(b) the name of the person who issued the supply authority;\n(c) the date of the supply authority;\n(d) the name and address of the person to whom the substance is\nsupplied;\n\nDivision 21.2.3 Other provisions—prohibited substances research and education\n(e) the date of supply;\n(f) the substance, and the form, strength and quantity of the\nsubstance, supplied.\n\nProhibited substances registers Part 21.3\n","sortOrder":255},{"sectionNumber":"775","sectionType":"section","heading":"Keeping of prohibited substances registers by certain","content":"775 Keeping of prohibited substances registers by certain\npeople—Act, s 48 and s 50 (1) (b) and (2) (b)\n(1) A person mentioned in table 775, column 2 who possesses a\nprohibited substance must keep a prohibited substances register.\n(2) A person to whom subsection (1) applies must keep a prohibited\nsubstances register for a prohibited substance at the place prescribed\nin table 775, column 3 for the person.\nTable 775 Keeping prohibited substances registers\nitem\n1 approved analyst the analyst’s laboratory\n2 medicines and poisons inspector (other\nthe place directed in writing by the\nchief health officer\n3 supervisor of program under prohibited\nsubstances research and education\nprogram licence\n","sortOrder":256},{"sectionNumber":"776","sectionType":"section","heading":"Form of prohibited substances registers—Act, s 49 (1) (b)","content":"776 Form of prohibited substances registers—Act, s 49 (1) (b)\n(1) Each page in a prohibited substances register must relate to a single\nform and strength of a prohibited substance.\n(2) If a prohibited substances register is kept electronically, a separate\nrecord must be used for each form and strength of prohibited\nsubstance kept.\n\n","sortOrder":257},{"sectionNumber":"777","sectionType":"section","heading":"Making entries in prohibited substances registers—Act,","content":"777 Making entries in prohibited substances registers—Act,\n(1) The following details for a dealing with a prohibited substance are\n(c) the prohibited substance, and the form, strength and quantity of\nthe substance, dealt with;\n(d) if the dealing is receiving the substance—the name and address\nof the supplier;\n(e) if the dealing is supplying the substance—the name and address\nof the person to whom it is supplied;\n(f) the quantity of the substance held after the dealing.\n(2) A dealing with a prohibited substance must be entered in the\nprohibited substances register the person must keep.\n","sortOrder":258},{"sectionNumber":"778","sectionType":"section","heading":"Prescribed witnesses for discarding of prohibited","content":"778 Prescribed witnesses for discarding of prohibited\nsubstances—Act, s 54 (a) and (b)\ndisposal of a prohibited substance:\n(a) an approved analyst;\n(b) a medicines and poisons inspector.\nNote Approved analyst—see the dictionary.\n(2) However, a person mentioned in subsection (1) must not be a\nprescribed witness to the discarding of a prohibited substance if the\nperson is—\nthe substance; or\n\nProhibited substances registers Part 21.3\n(b) the supervisor of the person discarding the substance; or\n(c) supervised by the person discarding the substance.\n","sortOrder":259},{"sectionNumber":"779","sectionType":"section","heading":"Changes to entries in prohibited substances registers—","content":"779 Changes to entries in prohibited substances registers—\nAct, s 55 (2) (b)\n(1) An entry in a paper-based prohibited substances register may be\n(b) if the entry relates to disposing of a prohibited substance—\n(2) An entry in an electronic prohibited substances register may be\namended by the person who made the entry by the person attaching\nor linking, by electronic means, a document that includes—\n(b) if the entry relates to disposing of a prohibited substance—\n\n","sortOrder":260},{"sectionNumber":"800","sectionType":"section","heading":"Definitions—ch 22","content":"800 Definitions—ch 22\noptical device means any of the following:\n(a) corrective contact lenses;\n(b) corrective lenses for spectacles;\n(c) non-corrective contact lenses commonly known as plano contact\nlenses.\nprescription, in relation to an optical device, means a written\ndirection (other than a purchase order) to a person who is authorised\nto supply the optical device to dispense the optical device.\n","sortOrder":261},{"sectionNumber":"801","sectionType":"section","heading":"Prescribed regulated therapeutic goods—Act, s 14, def","content":"801 Prescribed regulated therapeutic goods—Act, s 14, def\nregulated therapeutic good, par (b)\nOptical devices are prescribed.\n","sortOrder":262},{"sectionNumber":"802","sectionType":"section","heading":"Authorisation to supply optical devices—Act, s 74 (1) (b)","content":"802 Authorisation to supply optical devices—Act, s 74 (1) (b)\n(1) To the extent necessary to practise optometry and, if employed,\nwithin the scope of employment, an optometrist is authorised to\nsupply optical devices on prescription issued by an optometrist or\ndoctor.\nNote Supply includes dispense (see Act, s 24).\n(2) To the extent necessary to practise as an optician and, if employed,\nwithin the scope of employment, an optician is authorised to supply\noptical devices on prescription issued by an optometrist or doctor.\n\nTherapeutic goods Chapter 22\n(3) Within the scope of employment, an employee of an optometrist is\nauthorised to sell and deliver optical devices supplied under\nsubsection (1) or (2).\n","sortOrder":263},{"sectionNumber":"803","sectionType":"section","heading":"Authorisation conditions for supplying optical devices—","content":"803 Authorisation conditions for supplying optical devices—\nAct, s 75 (1) (b)\nAn optometrist’s, and optician’s, authorisation under section 802 in\nrelation to optical devices is subject to the following conditions:\n(a) the optical devices are supplied on a written prescription by an\noptometrist or doctor;\n(b) if the prescription is for contact lenses (whether corrective or\nplano)—the prescription is issued not more than 1 year before\nthe date the lenses are supplied;\n(c) if the prescription is for corrective lenses for spectacles—the\nprescription is issued not more than 2 years before the date the\nlenses are supplied.\n\n","sortOrder":264},{"sectionNumber":"Part 23","sectionType":"part","heading":"Notification and review of","content":"Chapter 23 Notification and review of\ndecisions\n","sortOrder":265},{"sectionNumber":"850","sectionType":"section","heading":"Meaning of reviewable decision—ch 23","content":"850 Meaning of reviewable decision—ch 23\nreviewable decision means a decision mentioned in table 850,\ncolumn 3 under a provision of this regulation mentioned in column 2\nin relation to the decision.\nTable 850 Reviewable decisions—chief health officer\nitem\nsection\ndecision\nentity\n1 120 (1) (h) refuse approval of other\n2 130 (e) refuse approval of other\n3 140 (e) refuse approval of other\n4 150 (1) (c) refuse approval of other\n5 160 (f) refuse approval of other\n6 171 (d) refuse approval of other\n7 175 (1) (a) (ii)\nand (b)\namend pseudoephedrine\nrecord in way other than in\naccordance with\napplication/refuse application\napplicant for amendment\n8 252 (1) (d) refuse approval of other\n\nNotification and review of decisions Chapter 23\nitem\nsection\ndecision\nentity\n9 531 (2) refuse approval to store a\ncontrolled medicine in a safe\nor strongroom\n10 616 (1) refuse approval of nominated\nindividual for medicines\nwholesales licence\n11 676 (f) refuse approval of other\n12 686 (f) refuse approval of other\n13 706 (1) refuse approval of nominated\nindividual for dangerous\npoisons manufacturers licence\n14 716 (1) refuse approval of nominated\nindividual for dangerous\npoisons suppliers licence\n15 771 refuse approval of other\nNote For ACAT review of other decisions in relation to licences, see the Act,\nch 9 and sch 1.\n","sortOrder":266},{"sectionNumber":"851","sectionType":"section","heading":"Reviewable decision notices","content":"851 Reviewable decision notices\nIf a person makes a reviewable decision, the person must give a\nreviewable decision notice to each entity mentioned in table 850,\ncolumn 4 in relation to the decision.\nNote The person must also take reasonable steps to give a reviewable decision\nnotice to any other person whose interests are affected by the decision\n(see ACT Civil and Administrative Tribunal Act 2008, s 67A).\n\n","sortOrder":267},{"sectionNumber":"852","sectionType":"section","heading":"Applications for review","content":"852 Applications for review\nThe following may apply to the ACAT for a review of a reviewable\ndecision:\n(a) an entity mentioned in table 850, column 4 in relation to the\ndecision;\n(b) any other person whose interests are affected by the decision.\n\n","sortOrder":268},{"sectionNumber":"860","sectionType":"section","heading":"Supply etc of certain declared substances by public","content":"860 Supply etc of certain declared substances by public\nemployee exercising functions under Act—Act,\ns 26 (1) (b) etc\n(1) This section applies to a public employee who is exercising a function\nunder the Act.\nNote Function includes authority, duty and power (see Legislation Act, dict,\n(2) To the extent necessary to exercise the function and within the scope\nof employment, the public employee is authorised to do any of the\n(a) obtain a regulated substance;\n(b) possess a regulated substance;\n(c) supply a regulated substance or regulated therapeutic good to a\nperson for discarding if the person is authorised to obtain the\nsubstance or good;\nExample—person authorised to obtain\na person who holds an environmental authorisation for the disposal of the\nsubstance (see, eg s 693)\n(d) supply a regulated substance or regulated therapeutic good, for\nlaw enforcement purposes, to—\n(i) someone else who is authorised to obtain the substance or\ngood; or\n(ii) a law enforcement officer.\nNote Public employee—see the Legislation Act, dictionary, pt 1.\nlaw enforcement officer—see the Criminal Code, section 700.\n\n","sortOrder":269},{"sectionNumber":"861","sectionType":"section","heading":"Dealings with regulated substances and regulated","content":"861 Dealings with regulated substances and regulated\ntherapeutic goods by public employees under chief\nhealth officer permit—Act, s 20 (1) (a) etc\n(1) A public employee is authorised to deal with a regulated substance,\nor regulated therapeutic good, in accordance with a permit issued by\nthe chief health officer to the employee.\n(2) The permit must be in writing and include the following information:\n(a) the dealings with regulated substances or regulated therapeutic\ngoods authorised by the permit;\n(b) the regulated substances or regulated therapeutic goods to which\nthe permit relates;\n(c) the public employee or employees authorised under the permit;\n(d) any condition included in the permit by the chief health officer\nto which the permit is subject;\n(e) a unique identifying number;\n(f) when the permit ends.\n(3) For subsection (2) (c), the permit may identify a public employee\nauthorised under the permit by—\n(a) naming the employee; or\n(b) nominating the occupant of a position (however described), at a\nparticular time or from time to time.\npublic employee includes a police officer.\n\n861A Dealings with regulated substances and regulated\ntherapeutic goods by public employees under\ndirector-general authorisation—Act, s 20 (1) (d) and\ns 22 (1) (d)\n(1) Dealing with a regulated substance or regulated therapeutic good is\nauthorised if the person who deals with the substance or good is—\n(a) a public employee or a member of a class of public employees\n(however described); and\n(b) authorised by the director-general to deal with the substance or\ngood within the scope of the person’s employment.\nNote Power to make an authorisation includes power to make different\nprovision in relation to different matters or different classes of matters\n(see Legislation Act, s 48).\n(2) The authorisation must be in writing and include the following\n(a) the dealings with regulated substances or regulated therapeutic\ngoods authorised;\n(b) the regulated substances or regulated therapeutic goods to which\nthe authorisation relates;\n(c) the public employee or the class of employees authorised;\n(d) any condition to which the authorisation is subject;\n(e) a unique identifying number for the authorisation;\n(f) the date the authorisation begins and the date when the\nauthorisation ends.\n(3) For subsection (2) (c), the authorisation may identify a public\nemployee by—\n(a) naming the employee; or\n\n(b) nominating the occupant of a position (however described), at a\nparticular time or from time to time.\nNote 1 The director-general may delegate the director-general’s function under\nthis section to a public employee or another person (see Public Sector\nManagement Act 1994, s 20).\nNote 2 The instrument making or evidencing a delegation may provide that the\ndelegation has effect only in stated circumstances or subject to stated\nconditions, limitations or directions (see Legislation Act, s 234).\n(4) An authorisation is a notifiable instrument.\npublic employee includes a police officer.\n","sortOrder":270},{"sectionNumber":"862","sectionType":"section","heading":"Certain containers not to be used for human-use","content":"862 Certain containers not to be used for human-use\nsubstances—Act, s 63 (1) (b)\nA container that must not be used to supply a human-use product\nunder the medicines and poisons standard is prescribed.\n","sortOrder":271},{"sectionNumber":"863","sectionType":"section","heading":"Disapplication of Legislation Act, s 47 (6)","content":"863 Disapplication of Legislation Act, s 47 (6)\nThe Legislation Act, section 47 (6) does not apply to the following:\n(a) the Australian code of good wholesaling practice for medicines\nin schedules 2, 3, 4 and 8;\n(b) the medicines Australia code of conduct;\n(c) the National Health Act 1953 (Cwlth);\n(d) the National Health (Pharmaceutical Benefits)\nRegulations 2017 (Cwlth);\n(e) a continued dispensing determination;\n(f) the MRP registration standard;\n(g) Australian Immunisation Handbook;\n\n(h) Australian Technical Advisory Group on Immunisation\n(ATAGI) Clinical guidance on use of COVID-19 vaccine in\nAustralia;\n(i) National guidelines for medication-assisted treatment of opioid\ndependence;\n(j) National Immunisation Education Framework for Health\nProfessionals;\n(k) National Vaccine Storage Guidelines: Strive for 5.\nNote 1 An instrument and a law of another jurisdiction mentioned in this section\ndo not need to be notified under the Legislation Act because s 47 (6) does\nnot apply (see Legislation Act, s 47 (7)).\nNote 2 A reference to an Act includes a reference to the statutory instruments\nmade or in force under the Act, including any regulation (see Legislation\nAct, s 104).\nNote 3 The following are accessible at www.health.gov.au:\n• The Australian Immunisation Handbook\n• The clinical guidance on use of COVID-19 vaccine\n• The National guidelines for medication-assisted treatment of opioid\ndependence\n• The National Immunisation Education Framework for Health\nProfessionals\n• The National Vaccine Storage Guidelines: Strive for 5.\nNote 4 The Australian Code of Good Wholesaling Practice for Medicines in\nSchedules 2, 3, 4 and 8 is accessible at www.tga.gov.au.\nNote 5 The Medicines Australia Code of Conduct is accessible at\nwww.medicinesaustralia.com.au.\nNote 6 A law of another jurisdiction mentioned in this section is accessible at\nNote 7 The MRP registration standard is accessible at\nhttps://www.medicalradiationpracticeboard.gov.au.\n\n","sortOrder":272},{"sectionNumber":"864","sectionType":"section","heading":"Exemption of piper methysticum (kava)—Act, s 190 (1) (a)","content":"864 Exemption of piper methysticum (kava)—Act, s 190 (1) (a)\n(1) Piper methysticum (kava) in the following forms is exempt from the\nAct:\n(a) raw or dried whole or peeled rhizome for use in aqueous\ndispersions or aqueous extracts intended for oral use by humans;\n(b) powder made from the dried rhizome for use in aqueous\ndispersions or aqueous extracts intended for oral use by humans;\n(c) preparations for oral use by humans containing aqueous\ndispersions or aqueous extracts of the raw or dried whole or\npeeled rhizome;\n(d) preparations for oral use by humans containing aqueous\ndispersions or aqueous extracts of powder made from the dried\nrhizome.\n(2) However, the exemption applies only if—\n(a) the kava is prepared, possessed and consumed in accordance\nwith the customs of the Pacific Islands; and\nExamples—customs of the Pacific Islands relating to use of kava\n1 consuming kava as part of a traditional ceremony, in a kava circle or\notherwise\n2 serving kava from a traditional bowl\n(b) the kava is prepared, possessed and consumed in connection\nwith an event declared by the Minister; and\n(c) any conditions stated in the declaration are complied with.\n(3) The Minister may declare an event only if satisfied it is a public event.\nNational Multicultural Festival\n\n(4) A declaration may include conditions about any of the following:\n(a) the dates and times when the kava may be prepared or\nconsumed;\n(b) the way in which the kava may be prepared or consumed;\n(c) the places where the kava may be prepared or consumed;\n(d) the minimum age of people who may consume the kava;\n(e) signage for the event;\n(f) anything else the Minister considers appropriate.\n(5) A declaration is a notifiable instrument.\n\n","sortOrder":273},{"sectionNumber":"Part 1","sectionType":"part","heading":"1 Ambulance services, officers and paramedics","content":"Part 1.1 Ambulance services, officers and paramedics\n","sortOrder":274},{"sectionNumber":"Sch 1","sectionType":"schedule","heading":"Medicines—health-related","content":"Schedule 1 Medicines—health-related\noccupations authorisations\n(see s 30, s 50, s 60, s 110, s 350, s 370 and s 380)\nPart 1.1 Ambulance services, officers and\nparamedics\nitem\n1 ambulance officer or paramedic\nemployed by Commonwealth,\nTerritory or State\nwithin scope of employment, do any of\n(a) obtain medicines;\n(c) administer medicines\nNote Paramedic does not include a person holding student, limited or provisional registration to\npractise in the profession (see dict).\n2 person in charge of ambulance\nservice operated by\nCommonwealth, Territory or\nState\nwithin scope of employment, do any of\n(a) issue purchase orders for medicines;\n(b) obtain medicines mentioned in\n(d) supply medicines to ambulance\nofficers and paramedics in\nambulance service\n\nDentists, dental hygienists, dental therapists and oral health therapists Part 1.2\nPart 1.2 Dentists, dental hygienists,\ndental therapists and oral health\ntherapists\nitem\n1 dentist to the extent necessary to practise dentistry\n(c) possess medicines\n(f) supply medicines to patients during\nwith s 161;\n(g) supply medicines for administration to\npatients at dental surgery to people\nauthorised to administer them\nNote Dentist does not include a trainee dentist (see dict).\n2 trainee dentist to the extent necessary to practise dentistry or\nundertake training, and under supervision of\ndentist, do any of the following:\nwith prescription (whether or not\nissued by themself or dentist);\n(d) prescribe medicines for administration\nat institution or dental surgery\n\nPart 1.2 Dentists, dental hygienists, dental therapists and oral health therapists\nitem\n3 dental hygienist within the scope of employment, to the\nextent necessary to practise as dental\nhygienist, and in a structured professional\n(a) obtain medicines from dentist\nauthorised to possess them;\n(b) possess medicines mentioned in\n(c) administer medicines mentioned in\npar (a) in accordance with dentist’s\nprescription\n4 dental therapist within the scope of employment, to the\nextent necessary to practise as dental\ntherapist, and in a structured professional\nfor medicines for topical dental use\nand for local anaesthetics;\n(b) obtain medicines mentioned in par (a);\n(d) administer medicines mentioned in\npar (a)\n\nDentists, dental hygienists, dental therapists and oral health therapists Part 1.2\nitem\n5 oral health therapist within the scope of employment, to the\nextent necessary to practise as an oral health\ntherapist, and in a structured professional\nfor medicines for topical dental use\nand for local anaesthetics;\n(b) obtain medicines mentioned in par (a);\n(d) administer medicines mentioned in\npar (a)\n\nPart 1.3 Doctors\nPart 1.3 Doctors\nitem\n1 doctor to the extent necessary to practise medicine\n(f) supply medicines to patients during\nconsultations;\n(g) supply medicines for administration to\npatients to people authorised to\nadminister them;\n(h) supply medicines dispensed for patient\n(i) supply medicines dispensed for patient\n(j) supply medicines to patients during\nwith s 161\nNote For authorisation to issue standing\norders for administration of medicines at\ninstitutions, see s 75.\n\nDoctors Part 1.3\nitem\n2 intern doctor to the extent necessary to practise medicine\nor undertake training or supervised practice,\nand under supervision of doctor, do any of\nwith prescription (whether or not\nissued by themself or another\nprescriber);\n(d) prescribe medicines for administration\nat institution or surgery;\n(e) prescribe medicines for patient on\npatient’s discharge from institution;\n\nPart 1.4 Health practitioners at institutions\nPart 1.4 Health practitioners at\ninstitutions\nitem\n1 health practitioner employed\nat institution\nthe following for the delivery of medicines\nwithin the institution to a health practitioner\nor health professional authorised to obtain\nthe medicines:\n(a) obtain the medicines;\n(b) possess the medicines;\n(c) supply the medicines\n\nMedical radiation practitioners Part 1.4A\nPart 1.4A Medical radiation practitioners\nitem\n1 medical radiation practitioner to the extent necessary to practise as a\nmedical radiation practitioner in accordance\nwith the MRP registration standard and, if\nemployed, within the scope of employment,\n(d) administer medicines\nNote Medical radiation practitioner does not include a person holding student, limited or\nprovisional registration to practise in the profession (see dict).\n\nPart 1.5 Midwives\nPart 1.5 Midwives\nitem\n1 midwife to the extent necessary to practise midwifery\n(a) issue requisitions for medicines;\n(b) obtain medicines on requisition;\n(d) administer medicines in accordance\nwith prescription or standing order;\n(e) supply medicines in accordance with a\nstanding order issued by chief health\nofficer or a requisition;\n\nNurses Part 1.6\nPart 1.6 Nurses\nitem\n1 nurse to the extent necessary to practise nursing\n(a) issue requisitions for medicines;\n(b) obtain medicines on requisition;\n(d) administer medicines in accordance\nwith prescription or standing order;\n(e) supply medicines in accordance with a\nstanding order issued by chief health\nofficer or a requisition;\nNote Nurse does not include enrolled nurse (see Legislation Act, dict, pt 1).\n2 trainee nurse if successfully completed pharmacology\nunits of nursing studies, to the extent\nnecessary to practise nursing as trainee nurse\nor undertake training, and under supervision\nof nurse or midwife, do any of the following:\n(c) administer medicines to patients in\naccordance with prescription\n\nPart 1.6 Nurses\nitem\n3 enrolled nurse to the extent necessary to practise nursing as\nenrolled nurse and, if employed, within the\nscope of employment, do any of the\nwith prescription\n\nOpioid dependency treatment centres operated by Territory Part 1.7\nPart 1.7 Opioid dependency treatment\ncentres operated by Territory\nitem\n1 person in charge of opioid\ndependency treatment centre\noperated by Territory\nto the extent necessary to treat patients of\ncentre and within the scope of employment,\nfor buprenorphine and methadone;\n(b) obtain buprenorphine and methadone\non purchase orders and requisitions;\n(c) supply buprenorphine and methadone\nto health practitioners at centre for\npatients of centre\n2 doctor or nurse at opioid\ndependency treatment centre\noperated by Territory\nto the extent necessary to treat patients of\ncentre and within the scope of employment,\nsupply buprenorphine and methadone to\npatients of centre for self-administration\noutside centre if—\n(a) supply is in accordance with\nprescription; and\n(b) medicine is labelled as if dispensed\n(c) labelled medicine checked by another\nhealth practitioner before supply\nNote 1 For authorisation of doctor to issue\nstanding orders for administration of\nmedicines at centre, see s 75.\nNote 2 For labelling of dispensed medicines, see\ns 123.\n\nPart 1.8 Optometrists\nPart 1.8 Optometrists\nitem\n1 optometrist to the extent necessary to practise optometry\nemployment, to deal as follows with\nmedicines mentioned in the medicines and\npoisons standard, schs 2, 3 and 4:\n(a) issue purchase orders for the\nmedicines;\n(b) issue requisitions for the medicines;\n(c) obtain the medicines;\n(d) possess the medicines;\n(e) administer the medicines\n\nPharmacists and employees Part 1.9\nPart 1.9 Pharmacists and employees\nitem\n1 pharmacist to the extent necessary to practise pharmacy\n(d) dispense medicines;\n(e) administer medicines;\n(f) manufacture medicines to dispense or\nsupply them on requisition;\n(g) supply pharmacy medicines;\n(h) if pharmacist at institution—supply\npharmacist only medicines without\n(i) if pharmacist at community\npharmacy—supply pharmacist only\nmedicines without prescription but in\naccordance with the Act, s 7;\n(j) supply medicines on purchase order,\nrequisition or standing order\nNote 1 Manufacture—see the Act, dictionary.\n\nPart 1.9 Pharmacists and employees\nitem\n2 intern pharmacist to the extent necessary to practise pharmacy\nor undertake training or supervised practice,\n(a) under direct supervision of pharmacist\ndo 1 or more of the following:\n(i) administer medicines;\n(ii) if intern pharmacist at\ninstitution—supply pharmacist\nonly medicines without\n(iii) if intern pharmacist at\ncommunity pharmacy—supply\npharmacist only medicines\nwithout prescription but in\naccordance with the Act, s 7;\n(iv) to obtain, possess and supply\nmedicines for the purpose of\nassisting pharmacist to dispense\n(b) under supervision of pharmacist, do\n1 or more of the following:\n(i) obtain medicines;\n(ii) possess medicines;\n(iii) supply pharmacy medicines;\n(iv) supply medicines on requisition\n3 employee assisting pharmacist\nemployed at hospital\nwithin the scope of employment and under\ndirect supervision of pharmacist, do any of\n(a) obtain medicines;\n(c) to obtain, possess and supply\nmedicines for the purpose of assisting\npharmacist to dispense them;\n(d) supply medicines on requisition\n\nPharmacists and employees Part 1.9\nitem\n4 employee at a community\npharmacy\nwithin the scope of employment and—\n(a) under supervision of pharmacist,\nsupply—\n(i) pharmacy medicines; or\n(ii) pharmacist only medicines\nsupplied in person to customer\nby pharmacist if supply is for\npurpose of sale of medicine; or\n(iii) medicines dispensed at the\npharmacy if the delivery or sale\nis to the person for whom the\nmedicine is prescribed or the\nperson’s agent; and\n(b) under supervision of pharmacist,\nobtain and possess medicines for\npurpose of par (a); and\n(c) under direct supervision of pharmacist,\ndo any of the following for purpose of\nassisting pharmacist to dispense\nmedicines:\n(i) obtain the medicines;\n(ii) possess the medicines\n\nPart 1.10 Podiatrists\nPart 1.10 Podiatrists\nitem\n1 podiatrist to the extent necessary to practise podiatry\nfor adrenaline and local anaesthetics;\n(b) obtain adrenaline and local\nanaesthetics;\n(c) possess adrenaline and local\nanaesthetics;\n(d) administer adrenaline and local\nanaesthetics\n\nResidential care facilities Part 1.11\nPart 1.11 Residential care facilities\nitem\n1 director of nursing for\nresidential aged care facility\nwithout pharmacy\nmedical superintendent for\nresidential aged care facility\nwithout pharmacy\n(a) issue purchase orders for following\nmedicines for emergency\nadministration to residents at facility\nunder direction of prescriber:\n(i) pharmacy medicines, pharmacist\nonly medicines and prescription\nonly medicines;\n(ii) not more than 30 ampoules, each\nof 1mL or less, of morphine\nsulphate, at a concentration of\n30mg or less of morphine\nsulphate per mL;\n(iii) not more than 5 ampoules, each\nof 1mL or less, of\nhydromorphone, at a\nconcentration of 2mg or less of\nhydromorphone per mL;\n(b) obtain the medicines mentioned in\n(c) possess the medicines mentioned in\n(d) supply medicines mentioned in par (a)\nto health practitioner at facility for\nadministration to residents\nNote 1 No authorisation is required for\ncertain dealings with residents’ own\nmedicines, see s 371.\n\nPart 1.11 Residential care facilities\nitem\nNote 2 For the administration of medicines\nby staff, see s 361.\nNote 3 For authorisation of doctor to issue\nstanding orders for administration of\nmedicines at facility, see s 75.\n2 director of nursing for\nresidential disability care\nmedical superintendent for\nresidential disability care\n(a) issue purchase orders for medicines\n(other than controlled medicines) for\nemergency administration to residents\nat facility under direction of\nprescriber;\n(b) obtain the medicines;\n(c) possess the medicines;\n(d) supply the medicines to health\npractitioner at facility for\nadministration to residents\nNote See the notes to item 1.\n\nSales representatives for medicines manufacturers and wholesalers Part 1.12\nPart 1.12 Sales representatives for\nmedicines manufacturers and\nwholesalers\nitem\n1 representative of person\nauthorised (however described)\nunder corresponding law to\nmanufacture medicines\nrepresentative of medicines\nwholesalers licence-holder\nrepresentative of person\nauthorised to supply medicines\nunder the Act, s 20 (4) (which is\nabout wholesalers who do not\nhave a place of business in the\nACT)\nfor purpose of supplying medicines (other\nthan controlled medicines) under\nmedicines Australia code of conduct, and\n(a) obtain manufacturer’s packs of\nmedicines (other than controlled\nmedicines) from manufacturer or\nwholesaler;\n(b) possess medicines obtained under\n(c) supply manufacturer’s packs of\nmedicines in accordance with\nmedicines Australia code of conduct\n\nPart 1.13 Veterinary practitioners and employees\nPart 1.13 Veterinary practitioners and\nemployees\nitem\n1 veterinary practitioner to the extent necessary to practise veterinary medicine\nand, if employed, within the scope of employment, do\nany of the following:\n(a) issue purchase orders for medicines;\n(f) supply—\n(i) pharmacy medicines if labelled with words\nto the effect of ‘for animal treatment only’;\nor\n(ii) pharmacist only medicines supplied in\nperson by a veterinary practitioner if\nlabelled with words to the effect of ‘for\nanimal treatment only’; or\n(iii) medicines to custodians of animals during\nwith s 161\nNote Custodian, of an animal—see the dictionary.\n\nVeterinary practitioners and employees Part 1.13\nitem\n2 veterinary\npractitioner’s\nemployee\npublic employee\nassisting veterinary\npractitioner who is\npublic employee\nwithin the scope of employment and under supervision\nof veterinary practitioner, do any of the following:\n(a) obtain medicines from veterinary practitioner\nauthorised to possess them;\n(b) possess medicines mentioned in par (a);\n(c) administer medicines mentioned in par (a) in\naccordance with veterinary practitioner’s\n(d) supply pharmacy medicines if labelled with\nwords to the effect of ‘for animal treatment\nonly’;\n(e) supply pharmacist only medicines supplied in\nperson by a veterinary practitioner if supply is\nfor purpose of sale or delivery of medicine;\n(f) supply medicines supplied in person by a\nveterinary practitioner at the place of\nemployment if labelled in accordance with\ns 161\n\nPart 3.1 Approval conditions\nSection 3.1\n","sortOrder":275},{"sectionNumber":"Sch 3","sectionType":"schedule","heading":"ACT listed appendix D","content":"Schedule 3 ACT listed appendix D\nmedicines—standing\n(see s 31, s 41, s 160, s 591, s 592 and s 593)\nPart 3.1 Approval conditions\n3.1 Definitions—sch 3\nIn this schedule:\napproved indication means an indication that is accepted by the\nSecretary of the Australian Government Department of Health in\nrelation to the medicine in the Australian Register of Therapeutic\nGoods.\nNote Approved indications are shown in the public summary of the Australian\nRegister of Therapeutic Goods on the Therapeutic Goods Administration\nwebsite at www.tga.gov.au.\ncondition 1, for a prescriber prescribing or supplying an ACT listed\nprescriber must ensure that the possibility of pregnancy by the woman\nhas been excluded prior to commencement of treatment.\ncondition 2, for a prescriber prescribing or supplying an ACT listed\nduring, or for a period of 1 month after the completion of, treatment.\ncondition 3, for a prescriber prescribing or supplying an ACT listed\nduring, or for a period of 3 months after the completion of, treatment.\n\nApproval conditions Part 3.1\nSection 3.1\ncondition 4, for a prescriber prescribing or supplying an ACT listed\nduring, or for a period of 24 months after the completion of,\n\nPart 3.2 Standing approvals for ACT listed appendix D medicines\nPart 3.2 Standing approvals for ACT\nlisted appendix D medicines\nitem\n1 specialist practising\ndermatology\nacitretin for human use\nalefacept for human use\nbexarotene for human use\netretinate for human use\nisotretinoin for human oral\nuse\nthalidomide for human use\n2 specialist practising\nendocrinology,\ngynaecology or\nobstetrics\nclomiphene for human use\ncorifollitropin alfa for human\nuse\ncyclofenil for human use\ndinoprost for human use\ndinoprostone for human use\nfollitropin alpha\n(recombinant human\nfollicle-stimulating hormone)\nfollitropin beta (recombinant\nhuman follicle-stimulating\nhormone) for human use\nfollitropin delta (recombinant\nhuman follicle-stimulating\nhormone) for human use\nluteinising hormone for\nhuman use\nurofollitropin (human\nfollicle-stimulating hormone)\n\nStanding approvals for ACT listed appendix D medicines Part 3.2\nitem\n3 specialist practising\nmental health\ndoctor employed by\nTerritory and\nworking under\nsupervision of chief\npsychiatrist under\nMental Health Act\nclozapine for human use\n4 specialist physician ambrisentan for human use\nacitretin for human use\netretinate for human use\nbexarotene for human use\nbosentan for human use\nenzalutamide for human use\nisotretinoin for human oral\nuse\nlenalidomide for human use\nmacitentan for human use\npomalidomide\nriociguat for human use\nsitaxentan for human use\nteriparatide for human use\nthalidomide for human use\ntretinoin for human oral use\n\nPart 3.2 Standing approvals for ACT listed appendix D medicines\nitem\n5 specialist practising\ndentistry,\ndermatology,\nintensive care\nmedicine,\npaediatrics and\nchild health,\nphysician,\nemergency\nhydroxychloroquine for initial treatment\n6 prescriber hydroxychloroquine (a) for treatment initiated\nbefore commencement\nof the Poisons Standard\nAmendment\n(Hydroxychloroquine\nand Salbutamol)\nInstrument 2020\n(Cwlth)\n(F2020L00291);or\n(b) for continuation of\ntreatment initiated by a\nspecialist under item 5\n7 specialist practising\ndermatology,\ngastroenterology\nand hepatology,\ninfectious diseases,\npaediatric\ngastroenterology\nand hepatology,\npaediatric\ninfectious diseases\nivermectin for initial treatment for an\nindication that is not an\napproved indication\n\nStanding approvals for ACT listed appendix D medicines Part 3.2\nitem\n8 prescriber ivermectin (a) for initial and continued\ntreatment for an\nindication that is an\napproved indication; or\n(b) for continuation of\ntreatment initiated by a\nspecialist under item 7\n9 prescriber nicotine for human use\nNote 1 Specialist includes a doctor training in a specialist area—see the dictionary.\nNote 2 The Poisons Standard Amendment (Hydroxychloroquine and Salbutamol) Instrument\n2020 (Cwlth) (F2020L00291) commenced on 24 March 2020.\n\n","sortOrder":276},{"sectionNumber":"Sch 4","sectionType":"schedule","heading":"Dangerous poisons—manufacturing etc authorisations","content":"Schedule 4 Dangerous poisons—manufacturing etc authorisations\nSchedule 4 Dangerous poisons—\nmanufacturing etc\n(see s 690)\nitem\n1 manufacturers of glass arsenic manufacturing glass\nmetallurgists manufacturing alloys\n2 manufacturers of dyes or\nbenzene manufacturing dyes or\nmanufacturers of lacquers,\nlinoleum, protective cloths\nor varnishes\nmanufacturing lacquers,\nlinoleum, protective\ncloths or varnishes\n3 manufacturers of\nchemicals or\ncarbon tetrachloride manufacturing\nchemicals or\nmanufacturers of lacquers,\nmanufacturing lacquers,\n4 managers of swimming\npools, other than domestic\nswimming pools\nchlorine purifying water in pools\nmanufacturers of\nchemicals, plastics or\nsynthetic rubber\nmanufacturing\nchemicals, plastics or\nsynthetic rubber\nmetallurgists cleaning metals\npeople working at sewage\ntreating sewage at\npeople working at water\npurifying water at\n\nDangerous poisons—manufacturing etc authorisations Schedule 4\nitem\n5 electroplaters cyanides electroplating\njewellers manufacturing gold\njewellery\nminers extracting or processing\ngold\n6 manufacturers of lacquers,\nepichlorohydrin manufacturing lacquers,\n7 manufacturers of\nchemicals or detergents\nethylene oxide manufacturing\nchemicals or detergents\nsterilising technologists sterilising surgical\n8 glass workers hydrofluoric acid etching glass\nmasons cleaning building\nmaterials\nmetal workers cleaning or etching\nmetals\nminers extracting or processing\ngold\npotters cleaning ceramics\n9 manufacturers of lamps,\nmirrors or scientific\nmercury manufacturing of lamps,\nmirrors or scientific\nmanufacturers of mercury\nsalts or organic\ncompounds\nmanufacturing mercury\nsalts or organic\ncompounds\nminers extracting metals from\nores\n10 manufacturers of plastics 4, 4’-methylenebis\n[2-chloroaniline]\n(MOCA)\nmanufacturing plastics\n\nSchedule 4 Dangerous poisons—manufacturing etc authorisations\nitem\n11 manufacturers of\ndetergents, lubricants or\norganic compounds\npropylene oxide manufacturing\ndetergents, lubricants or\norganic compounds\n12 manufacturers of organic\ncompounds, paints, rust\nremovers or varnishes\ntetrachloroethane manufacturing organic\ncompounds, paints, rust\nremovers or varnishes\n13 manufacturers of dyes ortho-tolidine manufacturing dyes\n14 manufacturers of\ndisinfectants, household\ncleaners or industrial\ndeodorants\ntrichloroisocyanuric acid manufacturing\ndisinfectants, household\ncleaners or industrial\ndeodorants\n\nRequirements for storage receptacles Schedule 5\nMedicines cabinets Part 5.1\nSection 5.1\n","sortOrder":277},{"sectionNumber":"Sch 5","sectionType":"schedule","heading":"Requirements for storage","content":"Schedule 5 Requirements for storage\nreceptacles\n(see s 531 and s 533)\nPart 5.1 Medicines cabinets\n5.1 Medicines cabinets—general requirements\nA medicines cabinet must be constructed to prevent ready access to\nthe cabinet’s contents by cutting, sawing or unbolting.\n5.2 Medicines cabinets—body requirements\n(1) The body of a medicines cabinet must be constructed of a single layer\nof black mild steel plate at least 10mm thick and with continuous\nwelding of all joints.\n(2) The body must have, for installation—\n(a) 4 suitably sized holes in the cabinet’s back plate; or\n(b) 2 suitably sized holes in the back plate and 2 suitably sized holes\nin the cabinet’s base.\n5.3 Medicines cabinets—door requirements\n(1) The door of a medicines cabinet must be constructed of black mild\nsteel plate at least 10mm thick.\n(2) When the medicines cabinet door is closed, the door must—\n(a) fit flush with the cabinet; and\n(b) have a clearance around the door of not more than 1.5mm.\n(3) The door must be fitted with a fixed locking bar, welded to the inside\nface of the door near the hinge edge, that engages in a rebate in the\ncabinet when closed.\n\nSchedule 5 Requirements for storage receptacles\nPart 5.1 Medicines cabinets\nSection 5.4\n(4) The hinges on the door must be—\n(a) constructed of heavy duty steel; and\n(b) continuous welded to the door and body of the cabinet.\n5.4 Medicines cabinets—lock requirements\n(1) A medicines cabinet lock must be—\n(a) a 6-lever pick-proof lock; or\n(b) a lock mechanism of a level of security equal to, or greater than,\na 6-lever pick-proof lock.\n(2) The lock must be securely attached to the inside face of the door.\n5.5 Medicines cabinets—mounting requirements\n(1) A medicines cabinet must be—\n(a) embedded in a floor of reinforced concrete of at least 10mpa\ncompressive strength; or\n(b) securely fixed to a wall or floor (or both) in accordance with this\nsection.\n(2) If the wall and floor are brick or concrete, the medicines cabinet must\nbe fixed to the wall or floor (or both) by at least 4 expanding bolts.\n(3) If the wall is timber, but the floor is brick or concrete, the medicines\ncabinet must be fixed—\n(a) to the floor by at least 4 expanding bolts; and\n(b) to the wall by at least 2 coach screws into the studs as close to\nthe top of the wall face as is possible.\n(4) If the wall and floor are timber, the medicines cabinet must be fixed\nto the timber frame of the wall or floor in a way that will ensure that\nthe cabinet cannot be removed from the floor or wall within\n30 minutes.\n\nRequirements for storage receptacles Schedule 5\nSafes, strong rooms and vaults Part 5.2\nSection 5.6\n(5) The bolts and coach screws must be at least 10mm in diameter.\nPart 5.2 Safes, strong rooms and vaults\n5.6 Requirements for safes\n(1) A safe must be constructed to prevent ready access to the safe’s\ncontents by cutting, sawing or unbolting.\n(2) When locked, a safe must reasonably be expected to resist attempts\nto gain entry by tools, torch or explosives for at least 30 minutes.\n(3) A safe—\n(a) may be freestanding if it weighs more than 350kg; or\n(b) must be securely attached to, or embedded in, a concrete floor\nor a concrete or brick wall in a way that will ensure that the\ncabinet cannot be removed from the floor or wall within\n30 minutes.\n5.7 Requirements for strong rooms\n(1) The walls, floor and ceiling of a strong room must be brick or\nconcrete.\n(2) The strong room must be fitted with a door.\n(3) When locked, the strong room must reasonably be expected to resist\nattempts to gain entry by tools, torch or explosives for at least 1 hour.\n5.8 Requirements for vaults\n(1) The walls, floor and ceiling of a vault must be reinforced concrete.\n(2) The vault must be fitted with a door.\n(3) When locked, the vault must reasonably be expected to resist attempts\nto gain entry by tools, torch or explosives for at least 1 hour.\n\n(see s 3)\nNote 1 The Legislation Act contains definitions and other provisions relevant to\nthis regulation.\nNote 2 For example, the Legislation Act, dict, pt 1, defines the following terms:\n• ACAT\n• chief health officer\n• child\n• contravene\n• corporation\n• correctional centre\n• dentist\n• doctor\n• enrolled nurse\n• health practitioner\n• home address\n• midwife\n• Minister (see s 162)\n• nurse\n• nurse practitioner\n• optometrist\n• pharmacist\n• public employee\n• reviewable decision notice\n• under.\nNote 3 Terms used in this regulation have the same meaning that they have in\nthe Medicines, Poisons and Therapeutic Goods Act 2008 (see Legislation\nAct, s 148). For example, the following terms are defined in the\nMedicines, Poisons and Therapeutic Goods Act 2008, dictionary:\n• authorised, to deal with a regulated substance (see s 20)\n• controlled medicine (see s 11)\n\n• dangerous poison (see s 12)\n• day hospital\n• deals, with a regulated substance (see s 19)\n• deals, with a regulated therapeutic good (see s 21)\n• dispense\n• hospital\n• institution\n• medicine (see s 11)\n• medicines advisory committee\n• medicines and poisons standard (see s 15)\n• monitored medicine (see s 97A)\n• opioid dependency treatment centre\n• pharmacist only medicine (see s 11)\n• possess, for a regulated substance (see s 24)\n• prescribe\n• prescription only medicine (see s 11)\n• prohibited substance (see s 13)\n• purchase order\n• register, for a regulated substance\n• regulated substance (see s 10)\n• requisition\n• residential aged care facility\n• signs\n• supply (see s 24)\n• supply authority (see s 23)\n• ward\n• written.\nACT listed appendix D medicine—see section 589.\nappendix D medicine—see section 588.\nappendix D medicines approval—see section 590.\n\napproved analyst means—\n(a) an analyst appointed under the Public Health Act 1997,\nsection 15 who is authorised under that Act to exercise a\nfunction under the Act; or\n(b) an analyst appointed or authorised under another territory law or\na law of the Commonwealth, a State or another Territory.\napproved pharmacist––see the National Health Act 1953 (Cwlth),\nsection 84 (1), as in force from time to time.\nNote The National Health Act 1953 (Cwlth) does not need to be notified under\nthe Legislation Act because s 47 (6) does not apply (see s 863).\nAustralian code of good wholesaling practice for medicines in\nschedules 2, 3, 4 and 8 means the Australian Code of Good\nWholesaling Practice for Medicines in Schedules 2, 3, 4 and 8\nprepared by the National Coordinating Committee on Therapeutic\nGoods, as in force from time to time.\nNote The Australian Code of Good Wholesaling Practice for Medicines in\nSchedules 2, 3, 4 and 8 is accessible at www.tga.gov.au.\nauthorised midwife—see the National Health Act 1953 (Cwlth),\nsection 84 (1), definition of authorised midwife.\nbioequivalent—a form of a substance is the bioequivalent of another\nform of the substance if the forms are physiologically equivalent in\ntheir clinical effect.\nchief pharmacist, for an institution with a pharmacy, means the\npharmacist having the supervision of all other pharmacists employed\nat the institution.\nCHO means chief health officer.\ncommunity pharmacy means a pharmacy at a place other than an\ninstitution.\n\ncomplying purchase order means—\n(a) for a medicine—a purchase order that complies with section 62;\nor\n(b) for a dangerous poison—a purchase order that complies with\nsection 721; or\n(c) for a schedule 10 substance or prohibited substance—see\nsection 772.\ncondition 1, for a prescriber prescribing or supplying an ACT listed\ncondition 2, for a prescriber prescribing or supplying an ACT listed\ncondition 3, for a prescriber prescribing or supplying an ACT listed\ncondition 4, for a prescriber prescribing or supplying an ACT listed\n\ncontinued dispensing determination means a determination made by\nthe Minister under the National Health Act 1953 (Cwlth), section 89A\n(When pharmaceutical benefits may be supplied by approved\npharmacists without prescription), as in force from time to time, about\nthe supply of a pharmaceutical benefit to a person by an approved\npharmacist without a prescription.\nNote See the National Health (Continued Dispensing) Determination 2012\n(Cwlth). The determination does not need to be notified under the\nLegislation Act because s 47 (6) does not apply (see s 863).\ncontrolled medicines approval—see section 550.\ncontrolled medicines prescribing standards—see section 575.\ncontrolled medicines register means a register for controlled\nmedicines.\ncontrolled medicines research and education program licence—see\nsection 600.\ncustodian, of an animal, means—\n(a) an adult who has lawful custody of the animal; or\n(b) if the animal is owned by a child or a person with a guardian—\na parent or guardian of the child or person.\nCYP authorised person—see the Children and Young People\nAct 2008, dictionary, definition of authorised person.\nCYP detention place means a detention place under the Children and\nYoung People Act 2008.\ndangerous poisons manufacturers licence—see section 700.\ndangerous poisons register means a register for dangerous poisons.\ndangerous poisons research and education program licence—see\nsection 700.\ndangerous poisons suppliers licence—see section 700.\n\ndentist does not include a trainee dentist.\nNote See the definition of trainee.\ndesignated prescriber, for part 13.1 (Controlled medicines\napprovals)—see section 551.\ndesignated prescription only medicine, for part 4.3 (Authorisation to\nsupply without prescription in emergencies)—see section 250.\ndetainee—see the Corrections Management Act 2007, section 6.\ndisability care means care that is provided to a person with a disability\nin a residential facility in which the person is also provided with\naccommodation that includes—\n(a) appropriate staff to meet the nursing and personal care needs of\nthe person; and\n(b) meals and cleaning services; and\n(c) furnishings, furniture and equipment for the provision of the\ncare and accommodation.\ndoctor does not include an intern doctor.\nNote See the definition of intern.\ndrug-dependent person, in relation to a controlled medicine or\nprohibited substance, means a person with a condition—\n(a) who, as a result of the administration of the medicine or\nsubstance, demonstrates, in relation to the person’s use of the\nmedicine or substance—\n(i) impaired control; or\n(ii) drug-seeking behaviour that suggests impaired control; and\n(b) who, as a result of the cessation of the administration of the\nmedicine or substance, is likely to experience symptoms of\nmental or physical distress or disorder.\nendorsed health practitioner—see section 490 (1).\n\nendorsement, for division 13.1.4 (Endorsements to treat\ndrug-dependency)—see section 580.\nenvironmental authorisation means—\n(a) an environmental authorisation under the Environment\nProtection Act 1997; or\n(b) an authorisation (however described) under a Commonwealth or\nState law that corresponds to the environmental authorisation\nmentioned in paragraph (a).\nfirst-aid kit includes a portable bag or container of medicines and\nother medical supplies kept by a person for health care or emergency\nfirst-aid kit licence—see section 600.\nin-patient, at an institution, includes—\n(a) a patient being treated at an emergency department of the\ninstitution; and\n(b) for a correctional centre—a detainee; and\n(c) for a CYP detention place—a young detainee.\nNote A correctional centre and a CYP detention place is an institution (see\ns 652).\nintern, in relation to a doctor or pharmacist, means—\n(a) for a doctor—a person holding limited or provisional\nregistration to practise in the medical profession under the\nHealth Practitioner Regulation National Law (ACT), for the\npurpose of undertaking a period of supervised practice that the\nperson has started; and\n\n(b) for a pharmacist—a person holding limited or provisional\nregistration to practise in the pharmacy profession under the\nHealth Practitioner Regulation National Law (ACT), for the\npurpose of undertaking a period of supervised practice or course\nof training, or both, to allow the person to be registered to\npractise without supervision.\nissuer, for part 3.2 (Requisitioning medicines)—see section 49.\nkey, for chapter 11 (Storage of medicines)—see section 511.\nmanufacturer’s pack means a primary pack for a medicine that is\nsupplied by a manufacturer.\nmedical radiation practitioner—\n(a) means a person holding registration to practise in the medical\nradiation practice profession under the Health Practitioner\nRegulation National Law (ACT); but\n(b) does not include a person holding student, limited or provisional\nregistration for the purpose of undertaking a period of\nsupervised practice or course of training, or both, to allow the\nperson to be registered to practise without supervision.\nmedical records includes—\n(a) for a person at an institution—the person’s clinical records and\na medication chart for the person at the institution; and\n(b) for a person who is not at an institution and is being treated by a\nprescriber—any record the prescriber keeps about the person.\nmedicines Australia code of conduct means the Medicines Australia\nCode of Conduct, authorised by the Australian Competition and\nConsumer Commission, as in force from time to time.\nNote The Medicines Australia Code of Conduct is accessible at\nwww.medicinesaustralia.com.au.\nmedicines wholesalers licence—see section 600.\n\nMRP registration standard means the Professional Capabilities for\nMedical Radiation Practitioners developed by the Medical Radiation\nPractice Board of Australia and approved by the Ministerial Council\nunder the Health Practitioner Regulation National Law (ACT), as in\nforce from time to time.\nNote The Professional Capabilities for Medical Radiation Practitioners\n(also referred to as the Professional Capabilities for Medical\nRadiation Practice) is accessible at\nhttps://www.medicalradiationpracticeboard.gov.au.\nnational residential medication chart prescription means a\nmedication chart prescription within the meaning of the National\nHealth (Pharmaceutical Benefits) Regulations 2017 (Cwlth),\nsection 41 (4), as in force from time to time.\nNote The National Health (Pharmaceutical Benefits) Regulations 2017\n(Cwlth) does not need to be notified under the Legislation Act because\ns 47 (6) does not apply (see s 863).\nnurse practitioner, for chapter 11 and chapter 12, does not include a\nperson holding limited or provisional registration to practise as a\nnurse practitioner.\nopioid dependency treatment guidelines means the guidelines\napproved under section 630 (Guidelines for treatment of opioid\ndependency).\nopioid dependency treatment licence—see section 600.\noptical device, for chapter 22 (Therapeutic goods)—see section 800.\nparamedic—\n(a) means a person holding registration to practise in the\nparamedicine profession under the Health Practitioner\nRegulation National Law (ACT); but\n\n(b) does not include a person holding student, limited or provisional\nregistration for the purpose of undertaking a period of\nsupervised practice or course of training, or both, to allow the\nperson to be registered to practise without supervision.\npersonal custody, of a key by a person, for part 11.4 (Additional\nstorage requirements for controlled medicines)—see section 530.\npharmaceutical benefit—see the National Health Act 1953 (Cwlth),\nsection 84 (1), as in force from time to time.\nNote The National Health Act 1953 (Cwlth) does not need to be notified under\nthe Legislation Act because s 47 (6) does not apply (see s 863).\npharmaceutical benefits scheme means the scheme for the supply of\npharmaceutical benefits established under the National Health\nAct 1953 (Cwlth), part 7.\npharmacist does not include an intern pharmacist.\nNote See the definition of intern.\npharmacy medicines rural communities licence—see section 600.\nprescribed person, for chapter 11 (Storage of medicines)—see\nsection 510.\nprescriber, in relation to a medicine, means the following:\n(a) a person in relation to whom prescribing the medicine is\nincluded in schedule 1, column 3 in relation to the person;\n(b) an endorsed health practitioner if prescribing the medicine is—\n(i) in accordance with the endorsement of their registration;\nand\n(ii) if not inconsistent with the endorsement of their\nregistration—allowed under this regulation.\n\nprescription, in relation to an optical device, for chapter 22\n(Therapeutic Goods)—see section 800.\nNote Prescription, in relation to a medicine—see the Act, dictionary.\nprohibited substance, for chapter 21 (Prohibited and schedule 10\nsubstances)—see section 760.\nprohibited substances register means a register for prohibited\nsubstances.\nprohibited substances research and education program licence—\nsee section 761.\npseudoephedrine record—see section 171 (c).\nrecognised research institution—see the Act, section 20 (5).\nrelevant expiry date, for a medicine, means—\n(a) if the medicine is from 1 batch—the expiry date for the batch;\nor\n(b) if the medicine is from more than 1 batch—the expiry date that\nis closest to the date of dispensing.\nrelevant law—\n(a) for chapter 16 (Low and moderate harm poisons)—see\nsection 660; and\n(b) for part 19.3 (Packaging and labelling of dangerous poisons)—\nsee section 730.\nrequisition includes issue a requisition.\nreviewable decision, for chapter 23 (Notification and review of\ndecisions)—see section 850.\nretail sale, for division 4.2.7 (Selling pseudoephedrine by retail)—\nsee section 170.\n\nschedule 1—a reference to schedule 1 includes a reference to a\nprovision of the schedule.\nscientifically qualified person means—\n(a) a dentist, doctor, pharmacist, or veterinary practitioner; or\n(b) a person who has been awarded a doctorate for scientific studies\nby the person.\nNote Dentist, doctor and pharmacist does not include an intern or trainee (see\ndefs of these terms).\nscope of employment includes scope of engagement as a contractor.\nspecialist means—\n(a) a person holding specialist registration to practise in the medical\nprofession under the Health Practitioner Regulation National\nLaw (ACT); or\n(b) a person holding limited or provisional registration to practise in\nthe medical profession under the Health Practitioner Regulation\nNational Law (ACT), for the purpose of undertaking a period of\nsupervised practice under the supervision of a person mentioned\nin paragraph (a), the successful completion of which means that\nthe person is eligible for specialist registration under that Law.\nspecialist area means a recognised specialty in a health profession\nunder the Health Practitioner Regulation National Law (ACT).\nterminal illness—a person has a terminal illness if a specialist\ndiagnoses the person as having a terminal illness and estimates the\nperson’s life expectancy to be less than 1 year.\nNote Specialist includes a doctor training in a specialist area (see def\nspecialist).\n\ntrainee, in relation to a health practitioner (other than a doctor or\npharmacist), means a person holding limited or provisional\nregistration to practise in a health profession under the Health\nPractitioner Regulation National Law (ACT) for the purpose of\nundertaking a period of supervised practice or course of training, or\nboth, to allow the person to be registered to practise without\nsupervision.\nExamples—references to trainee\n• trainee dentist\n• trainee nurse\nNote For doctors and pharmacists, see the definition of intern.\nveterinary practitioner means a registered veterinary practitioner\nunder the Veterinary Practice Act 2018, section 9.\nwalk-in centre means a non-residential facility operated by the\nTerritory for the treatment and care for people with minor illness or\ninjury.\nyoung detainee—see the Children and Young People Act 2008,\nsection 95.\n\nAbout the endnotes 1\n","sortOrder":278},{"sectionNumber":"1","sectionType":"section","heading":"About the endnotes","content":"1 About the endnotes\nAmending and modifying laws are annotated in the legislation history and the\namendment history. Current modifications are not included in the republished law\nbut are set out in the endnotes.\nNot all editorial amendments made under the Legislation Act 2001, part 11.3 are\nannotated in the amendment history. Full details of any amendments can be\nobtained from the Parliamentary Counsel’s Office.\nUncommenced amending laws are not included in the republished law. The details\nof these laws are underlined in the legislation history. Uncommenced expiries are\nunderlined in the legislation history and amendment history.\nIf all the provisions of the law have been renumbered, a table of renumbered\nprovisions gives details of previous and current numbering.\nThe endnotes also include a table of earlier republications.\n","sortOrder":279},{"sectionNumber":"2","sectionType":"section","heading":"Abbreviation key","content":"2 Abbreviation key\nA = Act NI = Notifiable instrument\nAF = Approved form o = order\nam = amended om = omitted/repealed\namdt = amendment ord = ordinance\nAR = Assembly resolution orig = original\nch = chapter par = paragraph/subparagraph\nCN = Commencement notice pres = present\ndef = definition prev = previous\nDI = Disallowable instrument (prev...) = previously\ndict = dictionary pt = part\ndisallowed = disallowed by the Legislative r = rule/subrule\nAssembly reloc = relocated\ndiv = division renum = renumbered\nexp = expires/expired R[X] = Republication No\nGaz = gazette RI = reissue\nhdg = heading s = section/subsection\nIA = Interpretation Act 1967 sch = schedule\nins = inserted/added sdiv = subdivision\nLA = Legislation Act 2001 SL = Subordinate law\nLR = legislation register sub = substituted\nLRA = Legislation (Republication) Act 1996 underlining = whole or part not commenced\nmod = modified/modification or to be expired\n\nMedicines, Poisons and Therapeutic Goods Regulation 2008\nSL2008-42\nnotified LR 15 September 2008\ns 1, s 2 commenced 15 September 2008 (LA s 75 (1))\nremainder commenced 14 February 2009 (s 2 and see Medicines,\nPoisons and Therapeutic Goods Act 2008 A2008-26, s 2 and LA s 79)\nas amended by\n2009 (No 1) SL2009-27\nnotified LR 5 June 2009\ns 1, s 2 commenced 5 June 2009 (LA s 75 (1))\nremainder commenced 6 June 2009 (s 2)\nStatute Law Amendment Act 2009 (No 2) A2009-49 sch 3 pt 3.51\nnotified LR 26 November 2009\ns 1, s 2 commenced 26 November 2009 (LA s 75 (1))\nsch 3 pt 3.51 commenced 17 December 2009 (s 2)\n2010 (No 1) SL2010-1\nnotified LR 21 January 2010\ns 1, s 2 commenced 21 January 2010 (LA s 75 (1))\nremainder commenced 22 January 2010 (s 2)\n2010 (No 2) SL2010-2\nnotified LR 21 January 2010\ns 1, s 2 commenced 21 January 2010 (LA s 75 (1))\nremainder commenced 22 January 2010 (s 2)\nHealth Practitioner Regulation National Law (ACT) Act 2010 A2010-10\nsch 2 pt 2.15\nnotified LR 31 March 2010\ns 1, s 2 commenced 31 March 2010 (LA s 75 (1))\nsch 2 pt 2.15 commenced 1 July 2010 (s 2 (1) (a))\n\n2010 (No 3) SL2010-16\nnotified LR 10 May 2010\ns 1, s 2 commenced 10 May 2010 (LA s 75 (1))\nsch 1 commenced 1 July 2010 (s 2 (2) and see Health Practitioner\nRegulation National Law (ACT) Act 2010 A2010-10 s 2 (1) (a))\nremainder commenced 11 May 2010 (s 2 (1))\n2010 (No 4) SL2010-20\nnotified LR 3 June 2010\ns 1, s 2 commenced 3 June 2010 (LA s 75 (1))\nremainder commenced 1 July 2010 (s 2 and see Health Practitioner\nRegulation National Law (ACT) Act 2010 A2010-10 s 2 (1) (a))\nLiquor (Consequential Amendments) Act 2010 A2010-43 sch 1 pt 1.14\nnotified LR 8 November 2010\ns 1, s 2 commenced 8 November 2010 (LA s 75 (1))\nsch 1 pt 1.14 commenced 1 December 2010 (s 2 (4) and see Liquor\nAct 2010 A2010-35, s 2 (3) (as am by A2010-43 amdt 1.19) and\nCN2010-14)\n2010 (No 5) SL2010-45\nnotified LR 22 November 2010\ns 1, s 2 commenced 22 November 2010 (LA s 75 (1))\nremainder commenced 23 November 2010 (s 2)\nJustice and Community Safety Legislation Amendment Act 2010\n(No 4) A2010-50 sch 1 pt 1.6\nnotified LR 14 December 2010\ns 1, s 2 commenced 14 December 2010 (LA s 75 (1))\nsch 1 pt 1.6 commenced 21 December 2010 (s 2 (1))\nStatute Law Amendment Act 2011 (No 3) A2011-52 sch 1 pt 1.5\nnotified LR 28 November 2011\ns 1, s 2 commenced 28 November 2011 (LA s 75 (1))\nsch 1 pt 1.5 commenced 12 December 2011 (s 2)\n\n2012 (No 1) SL2012-5\nnotified LR 9 February 2012\ns 1, s 2 commenced 9 February 2012 (LA s 75 (1))\nremainder commenced 10 February 2012 (s 2)\nMedicines, Poisons and Therapeutic Goods (Prescribing\nAuthorisation—Optometrists) Amendment Regulation 2012 (No 1)\nSL2012-34\nnotified LR 2 August 2012\ns 1, s 2 commenced 2 August 2012 (LA s 75 (1))\nremainder commenced 3 August 2012 (s 2)\nMedicines, Poisons and Therapeutic Goods (Kava Exemption)\nAmendment Regulation 2013 (No 1) SL2013-1\nnotified LR 25 January 2013\ns 1, s 2 commenced 25 January 2013 (LA s 75 (1))\nremainder commenced 26 January 2013 (s 2)\n2013 (No 1) SL2013-24\nnotified LR 29 August 2013\ns 1, s 2 commenced 29 August 2013 (LA s 75 (1))\nremainder commenced 1 September 2013 (s 2)\n2013 (No 2) SL2013-28\nnotified LR 4 November 2013\ns 1, s 2 commenced 4 November 2013 (LA s 75 (1))\nremainder commenced 5 November 2013 (s 2)\nStatute Law Amendment Act 2013 (No 2) A2013-44 sch 1 pt 1.3\nnotified LR 11 November 2013\ns 1, s 2 commenced 11 November 2013 (LA s 75 (1))\nsch 1 pt 1.3 commenced 25 November 2013 (s 2)\n\n2014 (No 1) SL2014-23\nnotified LR 25 September 2014\ns 1, s 2 commenced 25 September 2014 (LA s 75 (1))\ns 11 commenced 1 October 2014 (s 2 (2))\nremainder commenced 26 September 2014 (s 2 (1))\n2014 (No 2) SL2014-26\nnotified LR 22 October 2014\ns 1, s 2 commenced 22 October 2014 (LA s 75 (1))\nremainder commenced 23 October 2014 (s 2)\n2015 (No 1) SL2015-19\nnotified LR 21 May 2015\ns 1, s 2 commenced 21 May 2015 (LA s 75 (1))\ns 5 commenced 21 July 2015 (s 2 (2))\nremainder commenced 22 May 2015 (s 2 (1))\nVeterinary Surgeons Act 2015 A2015-29 sch 2 pt 2.10\nnotified LR 20 August 2015\ns 1, s 2 commenced 20 August 2015 (LA s 75 (1))\nsch 2 pt 2.10 commenced 1 December 2015 (s 2 (1) and CN2015-22)\nMental Health Act 2015 A2015-38 sch 2 pt 2.4 div 2.4.11\nnotified LR 7 October 2015\ns 1, s 2 commenced 7 October 2015 (LA s 75 (1))\nsch 2 pt 2.4 div 2.4.11 commenced 1 March 2016 (s 2 (1) and see\nMental Health (Treatment and Care) Amendment Act 2014 A2014-51,\ns 2 (as am by A2015-38 amdt 2.54))\n2015 (No 2) SL2015-36\nnotified LR 23 November 2015\ns 1, s 2 commenced 23 November 2015 (LA s 75 (1))\nremainder commenced 24 November 2015 (s 2)\n\nStatute Law Amendment Act 2015 (No 2) A2015-50 sch 1 pt 1.3, sch 3\npt 3.24\nnotified LR 25 November 2015\ns 1, s 2 commenced 25 November 2015 (LA s 75 (1))\nsch 1 pt 1.3, sch 3 pt 3.24 commenced 9 December 2015 (s 2)\n2016 (No 1) SL2016-5\nnotified LR 29 February 2016\ns 1, s 2 commenced 29 February 2016 (LA s 75 (1))\nremainder commenced 1 March 2016 (s 2)\nJustice Legislation Amendment Act 2016 A2016-7 sch 1 pt 1.5\nnotified LR 29 February 2016\ns 1, s 2 commenced 29 February 2016 (LA s 75 (1))\nsch 1 pt 1.5 commenced 29 August 2016 (s 2 and LA s 79)\nMedicines, Poisons and Therapeutic Goods (Controlled Medicines)\nAmendment Regulation 2016 (No 1) SL2016-16\nnotified LR 30 June 2016\ns 1, s 2 commenced 30 June 2016 (LA s 75 (1))\nremainder commenced 31 July 2016 (s 2)\n2017 (No 1) SL2017-27\nnotified LR 24 August 2017\ns 1, s 2 commenced 24 August 2017 (LA s 75 (1))\nremainder commenced 25 August 2017 (s 2)\nMedicines, Poisons and Therapeutic Goods Amendment Act 2018\nA2018-23 pt 3\nnotified LR 14 June 2018\ns 1, s 2 commenced 14 June 2018 (LA s 75 (1))\npt 3 commenced 15 June 2018 (s 2)\nVeterinary Practice Act 2018 A2018-32 sch 3 pt 3.12\nnotified LR 30 August 2018\ns 1, s 2 commenced 30 August 2018 (LA s 75 (1))\nsch 3 pt 3.12 commenced 21 December 2018 (s 2 and CN2018-12)\n\nStatute Law Amendment Act 2018 A2018-42 sch 3 pt 3.24\nnotified LR 8 November 2018\ns 1, s 2 taken to have commenced 1 July 2018 (LA s 75 (2))\nsch 3 pt 3.24 commenced 22 November 2018 (s 2 (1))\nMedicines, Poisons and Therapeutic Goods Regulation 2019 (No 1)\nSL2019-23\nnotified LR 12 September 2019\ns 1, s 2 commenced 12 September 2019 (LA s 75 (1))\nremainder commenced 13 September 2019 (s 2)\nMedicines, Poisons and Therapeutic Goods (Continued Dispensing)\nAmendment Regulation 2020 (No 1) SL2020-3\nnotified LR 20 January 2020\ns 1, s 2 commenced 20 January 2020 (LA s 75 (1))\nremainder commenced 21 January 2020 (s 2)\n2020 (No 1) SL2020-13\nnotified LR 3 April 2020\ns 1, s 2 commenced 3 April 2020 (LA s 75 (1))\nremainder commenced 4 April 2020 (s 2)\nCOVID-19 Emergency Response Act 2020 A2020-11 sch 1 pt 1.14\nnotified LR 7 April 2020\ns 1, s 2 commenced 7 April 2020 (LA s 75 (1))\nsch 1 pt 1.14 commenced 8 April 2020 (s 2 (1))\n2020 (No 2) SL2020-21\nnotified LR 19 June 2020\ns 1, s 2 commenced 19 June 2020 (LA s 75 (1))\nremainder commenced 20 June 2020 (s 2)\n2020 (No 3) SL2020-24\nnotified LR 26 June 2020\ns 1, s 2 commenced 26 June 2020 (LA s 75 (1))\nremainder commenced 27 June 2020 (s 2)\n\n2020 (No 4) SL2020-31\nnotified LR 20 August 2020\ns 1, s 2 commenced 20 August 2020 (LA s 75 (1))\nremainder commenced 21 August 2020 (s 2)\n2020 (No 5) SL2020-39\nnotified LR 9 September 2020\ns 1, s 2 commenced 9 September 2020 (LA s 75 (1))\nremainder commenced 10 September 2020 (s 2)\nStatute Law Amendment Act 2021 A2021-12 sch 3 pt 3.36\nnotified LR 9 June 2021\ns 1, s 2 commenced 9 June 2021 (LA s 75 (1))\nsch 3 pt 3.36 commenced 23 June 2021 (s 2 (1))\n2021 (No 1) SL2021-19\nnotified LR 17 August 2021\ns 1, s 2 commenced 17 August 2021 (LA s 75 (1))\nremainder commenced 18 August 2021 (s 2)\n2021 (No 2) SL2021-28\nnotified LR 4 November 2021\ns 1, s 2 commenced 4 November 2021 (LA s 75 (1))\nremainder commenced 5 November 2021 (s 2)\n2023 (No 1) SL2023-5\nnotified LR 6 April 2023\ns 1, s 2 commenced 6 April 2023 (LA s 75 (1))\nremainder commenced 7 April 2023 (s 2)\nHealth Infrastructure Enabling Act 2023 A2023-17 sch 2 pt 2.3\nnotified LR 2 June 2023\ns 1, s 2 commenced 2 June 2023 (LA s 75 (1))\nsch 2 pt 2.3 commenced 3 July 2023 (s 2 (2) and see s 7 (1) (a))\n\n2023 (No 2) SL2023-17\nnotified LR 7 August 2023\ns 1, s 2 commenced 7 August 2023 (LA s 75 (1))\nremainder commenced 8 August 2023 (s 2)\n2023 (No 3) SL2023-34\nnotified LR 11 December 2023\ns 1, s 2 commenced 11 December (LA s 75 (1))\nremainder commenced 12 December 2023 (s 2)\nHealth (Improved Abortion Access) Amendment Act 2024 A2024-30\ns 10\nnotified LR 9 July 2024\ns 1, s 2 commenced 9 July 2024 (LA s 75 (1))\ns 10 commenced 10 July 2024 (s 2 (1))\n2024 (No 1) SL2024-36\nnotified LR 12 December 2024\ns 1, s 2 commenced 12 December 2024 (LA s 75 (1))\nss 6-8 commenced 12 June 2025 (s 2 (2))\nremainder commenced 13 December 2024 (s 2 (1))\n2025 (No 1) SL2025-7\nnotified LR 16 June 2025\ns 1, s 2 commenced 16 June 2025 (LA s 75 (1))\nremainder commenced 17 June 2025 (s 2)\nStatute Law Amendment Act 2025 A2025-29 sch 4 pt 4.125\nnotified LR 6 November 2025\ns 1, s 2 commenced 6 November 2025 (LA s 75 (1))\nsch 4 pt 4.125 commenced 26 December 2025 (s 2 (7))\nHealth Legislation Amendment Act 2025 (No 2) A2025-33 pt 5\nnotified LR 12 November 2025\ns 1, s 2 commenced 12 November 2025 (LA s 75 (1))\npt 5 commenced 26 November 2025 (s 2 (3))\n\nMedicines, Poisons and Therapeutic Goods Amendment\nRegulation 2025 (No 2) SL2025-29\nnotified LR 15 December 2025\ns 1, s 2 commenced 15 December 2025 (LA s 75 (1))\nremainder commenced 16 December 2025 (s 2)\n\nCommencement\ns 2 om LA s 89 (4)\ns 3 am A2015-29 amdt 2.73\nOverview of things to which medicines and poisons standard does not apply\ns 6 am A2025-33 ss 12-16\nGeneral overview of authorisations for medicines\ns 10 am A2010-10 amdt 2.85; A2025-33 s 17\nOverview of medicines authorisations etc under this regulation\ns 11 am SL2010-2 s 4; pars renum R4 LA; SL2013-28 s 4; pars\nrenum R17 LA; SL2014-23 s 11; SL2015-19 s 4; SL2016-5\ns 4; pars renum R27 LA; SL2024-36 s 4; SL2025-7 s 4\nsub SL2025-29 s 4\nGeneral overview of authorisation conditions for medicines\ns 12 am SL2012-34 s 4; SL2025-29 s 5, s 6\nRelationship with registration laws\npt 2.2 hdg sub A2010-10 amdt 2.86\nMedicines authorisations subject to Health Practitioner Regulation National\nLaw (ACT) restrictions\ns 20 sub A2010-10 amdt 2.86\nam A2015-29 amdt 2.74\nMedicines authorisations subject to Veterinary Practice Act 2018 restrictions\ns 21 ins A2010-10 amdt 2.86\nsub A2015-29 amdt 2.75; A2018-32 amdt 3.38\nAuthorisation under sch 1 to prescribe medicines—Act, s 40 (1) (b), (2) (b)\ns 30 am SL2010-45 s 4; SL2019-23 s 4; SL2024-36 s 5; SL2025-29\ns 7, s 8\nAuthorisation conditions for prescribing medicines—Act, s 44 (1) (b)\ns 31 am SL2013-28 ss 5-7; pars renum R17 LA; SL2019-23 s 5;\nSL2020-21 s 4; SL2021-28 s 4; SL2025-29 s 9\nVariation of authorisation condition during Commonwealth special\narrangement period\ns 31A ins SL2020-21 s 5\nAdditional requirements for prescribing controlled medicines for human use\ns 32 am SL2025-29 s 10\n\nAdditional requirements for designated appendix D medicines prescriptions\ns 33 om SL2019-23 s 6\nParticulars for prescriptions\ns 41 am SL2010-1 s 4; SL2010-45 s 5; pars renum R8 LA;\nSL2013–28 s 8; ss renum R17 LA; SL2016-16 ss 4-6; pars\nrenum R28 LA; A2018-32 amdt 3.52; SL2019-23 ss 7-10;\npars renum R34 LA; SL2021-28 s 5; SL2024-36 s 6;\nSL2025-29 s 11; pars renum R56 LA\nMeaning of issuer—pt 3.2\ns 49 ins SL2025-29 s 12\nAuthorisation conditions for issuing requisitions for medicines—Act, s 44 (1)\n(b) and (2) (b)\ns 51 am SL2025-29 s 13, s 14\nGeneral requirements for written requisitions\ns 55 am SL2025-29 s 15\nParticulars for requisitions\ns 56 am SL2025-29 s 16\nAuthorisation conditions for issuing purchase orders for medicines—Act,\ns 61 am SL2025-29 ss 17-20\nParticulars for CHO standing orders for administration of medicines for\npublic health matters\ns 72 am A2025-33 s 35\nParticulars for standing orders for administration of medicines at institutions\ns 76 am A2025-33 s 35\nStanding orders for walk-in centre\ndiv 3.4.3 hdg ins SL2010-2 s 5\nAuthorisation of CHO to issue standing orders for supply and administration\nof medicines at walk-in centre—Act, s 42 (b)\ns 77 ins SL2010-2 s 5\nParticulars for CHO standing orders for supply and administration of\nmedicines at walk-in centre\ns 78 ins SL2010-2 s 5\nam A2025-33 s 35\nInformation for CHO about monitored medicines supplied on supply\nauthorities—Act, s 31 (1) (b) and (4), def required information\ns 81 am SL2015-19 s 5\nsub A2018-23 s 13\n\nOverview of supply authorisations for medicines\ns 100 am SL2013–28 s 9; pars renum R17 LA; SL2025-29 s 21\nAuthorisation under sch 1 to supply medicines—Act, s 26 (1) (b) and (2) (b)\ns 110 am A2010-10 amdt 2.87; A2013-44 amdt 1.31\nAuthorisation conditions for dispensing medicines—Act, s 44 (1) (b)\ns 120 am SL2013–28 s 10; SL2020-21 s 6; SL2025-29 s 22\nVariation of authorisation condition for dispensing medicines during\nCommonwealth special arrangement period\ns 120A ins SL2020-21 s 7\nHow medicines are dispensed\ns 121 am A2010-10 amdt 2.88, amdt 2.89; A2015-50 amdt 3.126;\nSL2021-28 s 6; SL2024-36 s 7; ss renum R53 LA\nLabelling dispensed medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)\ns 123 am SL2010-45 s 6; pars renum R8 LA; A2018-32 amdt 3.52;\nA2025-33 s 35, s 36; SL2025-29 s 23; pars renum R56 LA\nMarking dispensed prescriptions\ns 124 am SL2013–28 s 11, s 12; SL2021-28 ss 7-9\nRecording dispensing of medicines\ns 125 am SL2024-36 s 8; A2025-33 s 35\nAuthorisation conditions for supplying medicines on requisitions—Act,\ns 130 am SL2025-29 s 24\nLabelling medicines supplied on requisition—Act, s 60 (1) (c) (i) and (2) (c) (i)\ns 132 am A2025-33 s 35\nRecording supply of medicines on requisitions\ns 134 am SL2025-29 s 25, s 26\nAuthorisation conditions for supplying medicines on purchase orders—Act,\ns 140 am SL2025-29 s 27\nSupplying medicines on purchase orders\ns 141 am A2025-33 s 35\nRecording supply of medicines on purchase orders\ns 142 am SL2025-29 s 28\nAuthorisation conditions for supplying medicines on standing orders—Act,\ns 150 am SL2025-29 ss 29-31\n\nLabelling medicines supplied on standing order—Act, s 60 (1) (c) (i)\ns 152 am A2025-33 s 36\nAuthorisation conditions for supplying medicines during consultations—Act,\ns 160 am SL2019-23 s 11; SL2025-29 s 32\nLabelling medicines supplied during consultations\ns 161 am SL2010-45 s 7; pars renum R8 LA; A2018-32 amdt 3.52;\nA2025-33 s 35, s 36; SL2025-29 s 33; pars renum R56 LA\nRecording medicines supplied during consultations\ns 162 am A2025-33 s 35\nAdditional requirements for supplying controlled medicines for human use\nduring consultations\ns 163 am SL2025-29 s 34, s 35\nInformation for CHO about monitored medicines supplied during\nconsultations—Act, s 31 (2) (b) and (4), def required information\ns 164 sub A2018-23 s 14\nRequirement to tell buyer about pseudoephedrine sales record\ns 172 am A2021-12 amdt 3.87\nRequired information for pseudoephedrine sales records\ns 173 am A2010-43 amdt 1.57; A2016-7 amdts 1.9-1.11; A2021-12\namdt 3.87\nAuthorisation conditions for supply of pharmacist only medicines—Act, s 44\n(1) (b) and (2) (b)\ns 180 am SL2025-29 s 36\nMeaning of designated prescription only medicine—pt 4.3\ns 250 am SL2019-23 s 12\nLabelling medicines supplied without prescription in emergencies—Act,\ns 253 am A2025-33 s 35, s 36\nAuthorisation to supply certain medicines without prescription—continued\npt 4.3A ins SL2013–28 s 13\nAuthorisation to supply certain medicines without prescription by approved\npharmacist––Act, s 185 (1) (g)\ns 255 ins SL2013–28 s 13\nam SL2020-3 s 4, s 5\n\nLabelling certain medicines supplied without prescription by approved\npharmacist––Act, s 185 (1) (j)\ns 256 ins SL2013–28 s 13\nam A2025-33 s 35, s 36\nConditions for wholesalers supplying medicines under corresponding\nlaws—Act, s 20 (4) (c)\ns 270 am SL2014-23 s 4, s 5\nAuthorisation conditions for administration of medicines at institutions by\npeople in health-related occupations—Act, s 44 (1) (b) and (2) (b)\ns 351 am SL2025-29 s 37\nAuthorisation for pharmacist and intern pharmacist to administer vaccine\nwithout prescription—Act, s 37 (1) (b)\ns 352 ins SL2016-5 s 5\nam SL2020-13 s 4; A2025-29 amdt 4.126\nAuthorisation for nurse or midwife to administer vaccine without\nprescription—Act, s 37 (1) (b)\ns 353 ins SL2020-31 s 4\nAuthorisation for self-administration etc of medicines—Act, s 37 (2) (b)\ns 360 am SL2010-45 s 8; SL2025-29 s 38, s 39\nObtaining and possessing medicines\nch 6 hdg note ins SL2025-29 s 40\nDiscarding controlled medicines—Act, s 34 (1) (a)\ns 390 am SL2025-29 s 41\nAuthorisations to deliver medicines under supply authorities—Act,\ns 26 (1) (b), (2) (b), s 35 (1) (b), (2) (b) and s 36 (b)\ns 400 am A2010-10 amdts 2.90-2.92; A2015-29 amdts 2.76-2.78\nEmergency supply and administration of adrenaline, naloxone and\nsalbutamol\npt 9.2 hdg sub SL2024-36 s 9\nAuthorisations to supply and administer adrenaline, naloxone and\nsalbutamol—Act, s 26 (1) (b) and s 37 (1) (b)\ns 410 hdg sub SL2024-36 s 10\ns 410 am SL2024-36 s 11; SL2025-29 s 42\nAuthorisations for non-controlled medicines research and education—Act,\ns 26 (1) and (2) (b)\ns 430 am SL2021-28 s 10; A2025-33 s 18\n\nAuthorisation conditions for non-controlled medicines research and\neducation—Act, s 44 (1) (b) and (2) (b)\ns 431 am A2025-33 s 18\nAuthorisations under controlled medicines research and education program\ns 440 am A2025-33 s 18\nAuthorisation condition for controlled medicines research and education\nprogram licences—Act, s 44 (1) (b) and (2) (b)\ns 441 am A2025-33 s 18\nAuthorisation conditions for medicines wholesalers licences—Act,\ns 461 am SL2014-23 s 6, s 7\nMedicines authorisations for health practitioners\npt 9.6 hdg ins SL2015-19 s 6\nsub SL2025-7 s 5\nAuthorisations for endorsed health practitioners—Act, s 20 (1) (d)\ns 490 ins SL2015-19 s 6\nsub SL2025-29 s 43\nAuthorisations for health practitioners to deal with medicines with CHO\napproval—Act, s 20 (1) (c)\ns 490A ins SL2025-7 s 6\nAuthorisations for dealing with COVID-19 vaccines\npt 9.7 hdg ins SL2021-19 s 4\nAuthorisation for dealing with COVID-19 vaccine during public health\nemergency—Act, s 20 (1) (c)\ns 491 ins SL2021-19 s 4\nExpiry—pt 9.7\ns 492 ins SL2021-19 s 4\nWhen pharmacy medicines and pharmacist only medicines to be supplied in\nmanufacturer’s packs—Act, s 59 (1) (c) (i) and (2) (c) (i)\ns 500 am A2010-10 amdt 2.93; A2015-29 amdts 2.79-2.81;\nA2018-32 amdt 3.39\nPackaging of supplied manufacturer’s packs of medicines—Act,\ns 501 am A2015-50 amdt 1.10; A2025-33 s 19\n\nLabelling of supplied manufacturer’s packs of medicines—Act, s 60 (1) (c) (i)\ns 502 am A2015-50 amdt 1.11; A2025-33 s 20\nMeaning of prescribed person—ch 11\ns 510 am SL2010-16 s 4, s 5, amdt 1.1; SL2010-45 s 9; A2018-32\namdt 3.40, amdt 3.52; SL2020-39 s 4; SL2025-29 s 44\nStorage of controlled medicines for certain health-related occupations—Act,\ns 61 (b) and (c)\ns 532 am SL2010-16 s 6, s 7, amdt 1.1; A2018-32 amdt 3.41, amdt\n3.52; SL2020-39 s 5; SL2023-34 ss 4-8; SL2025-29 s 45,\ns 46\nStorage of controlled medicines by certain other prescribed people—Act,\ns 61 (b) and (c)\ns 533 am SL2010-16 s 8; A2018-32 amdt 3.52; SL2020-39 s 6;\nSL2023-34 s 9; ss renum R50 LA; SL2025-29 s 47, s 48;\npars renum R56 LA\nStorage of buprenorphine or methadone by opioid dependency treatment\nlicence-holders etc—Act, s 61 (b) and (c)\ns 533A ins SL2023-34 s 10\nKeeping of controlled medicines registers by certain people—Act, s 48 (a)\nand s 50 (1) (b) and (2) (b)\ns 540 table 540 am SL2010-16 s 9; A2018-32 amdt 3.42; SL2020-39\ns 7; SL2025-29 s 49\nKeeping of controlled medicines registers by first-aid kit holders—Act,\ns 48 (a) and s 50 (1) (b) and (2) (b)\ns 541 am SL2010-16 s 10, s 11, amdt 1.1; A2018-32 amdt 3.43;\nA2018-32 amdt 3.52; SL2025-29 s 50, s 51\nPrescribed witnesses for administration of controlled medicines—Act,\ns 53 (a) and (b)\ns 544 am SL2010-20 s 4; SL2020-39 s 8\nsub SL2025-29 s 52\nPrescribed witnesses for discarding of controlled medicines—Act, s 54 (a)\nand (b)\ns 545 am A2018-32 amdt 3.44, amdt 3.52; SL2020-39 s 9; pars\nrenum R41 LA; SL2025-29 ss 53-55\nMeaning of designated prescriber—pt 13.1\ns 551 am A2018-32 amdt 3.44; SL2025-29 s 56\nStanding CHO approvals to prescribe controlled medicines in certain\ncircumstances—Act, s 20 (1) (c)\ns 554 ins SL2025-29 s 57\n\nStanding approval to prescribe controlled medicines for hospital in-patient\nor patient discharge\ns 555 sub SL2021-28 s 11\nStanding approval to prescribe controlled medicines for short-term\ntreatment\ns 556 sub SL2021-28 s 11\nControlled medicines to which standing approvals do not apply\ns 556A ins SL2023-17 s 4\nStanding interim approval to prescribe buprenorphine and methadone for\npatients of certain institutions\ns 557 hdg sub SL2010-1 s 5\ns 557 am SL2010-1 s 6; pars renum R4 LA; SL2014-26 s 4;\nSL2017-27 s 4, s 5\nApplication—div 13.1.3—standing CHO approvals to prescribe controlled\nmedicines in certain circumstances\ns 559 ins SL2025-29 s 58\nApplications for CHO controlled medicines approvals\ns 560 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nRequirements for CHO controlled medicines approval applications\ns 561 am SL2016-16 s 7, s 8; ss and pars renum R28 LA;\nSL2019-23 s 13; SL2021-28 s 12; SL2025-29 s 59\nRestrictions on CHO power to approve applications for approvals\ns 563 am SL2010-1 s 7; SL2014-26 s 5; SL2016-16 s 9; pars renum\nR28 LA; SL2017-27 ss 6-10; ss renum R30 LA; SL2019-23\ns 14, s 15; pars renum R34 LA\nTerm of CHO controlled medicines approvals\ns 564 am SL2016-16 s 10; SL2025-29 s 60\nMedicines advisory committee—referred applications and review of\nunfavourable CHO decisions\ns 566 am SL2014-26 s 6\nAmendment and revocation of controlled medicines approvals\ns 567 am SL2014-26 s 7\nApplication for review of amendment and revocation on CHO initiative\ns 568 am SL2014-26 s 8\nMedicines advisory committee—review of amendment or revocation on CHO\ninitiative\ns 569 am SL2014-26 s 9\nConditional controlled medicines approvals\ns 570 am SL2014-26 s 10\n\nForm of CHO controlled medicines approvals\ns 571 am SL2016-16 ss 11-13; ss and pars renum R28 LA;\nSL2019-23 s 16; SL2025-29 s 61\nMedicines advisory committee—recommendations to CHO\ns 573 hdg sub SL2014-26 s 11\ns 573 am SL2014-26 s 12, s 13\nGuidelines for CHO decisions on applications\ns 574 sub SL2014-26 s 14\nControlled medicines prescribing standards\ns 575 ins SL2016-16 s 14\nsub SL2019-23 s 17\nam SL2025-29 s 62; A2025-29 amdt 4.126\nMeaning of endorsement—div 13.1.4\ns 580 am SL2017-27 s 11\nApplications for CHO endorsement to treat drug-dependency\ns 581 am SL2017-27 ss 12-15; A2021-12 amdt 3.87\nCHO decisions on applications for endorsement to treat drug-dependency\ns 582 am SL2017-27 s 16, s 17\nForm of CHO endorsements to treat drug-dependency\ns 583 am SL2017-27 s 18\nMedicines advisory committee—review of CHO decisions to refuse\nendorsements to treat drug-dependency\ns 584 am SL2017-27 s 19\nAppendix D medicines approvals\npt 13.2 hdg note am SL2019-23 s 18\nModification of medicines and poisons standard—Act, s 15 (1), def\nmedicines and poisons standard\ns 588 ins SL2019-23 s 19\nMeaning of ACT listed appendix D medicine\ns 589 ins SL2019-23 s 19\nStanding approval to prescribe ACT listed appendix D medicines\ns 591 sub SL2019-23 s 20\nApplications for CHO approval to prescribe appendix D medicines\ns 592 hdg sub SL2019-23 s 21\ns 592 am SL2019-23 ss 22-24; A2021-12 amdt 3.87\nCHO decisions on applications to prescribe appendix D medicines\ns 593 sub SL2019-23 s 25\n\nForm of CHO appendix D medicines approvals\ns 594 am SL2019-23 s 26\nApplications for controlled medicines research and education program\ns 605 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nFirst-aid kit licences\npt 14.3 hdg note am A2010-10 amdt 2.104; A2015-29 amdt 2.82\nApplications for first-aid kit licences\ns 610 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nAdditional information for first-aid kit licences—Act, s 88 (1) (k)\ns 612 am A2009-49 amdt 3.121\nApplications for medicines wholesalers licences\ns 615 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nApplications for opioid dependency treatment licences\ns 620 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nApplications for pharmacy medicines rural communities licences\ns 625 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nOpioid dependency treatment\npt 15.1 hdg sub SL2020-24 s 4\nGuidelines for treatment of opioid dependency\ns 630 am A2025-29 amdt 4.126\nMinister may exempt certain people dealing with buprenorphine or\nmethadone from Act—Act, s 190 (1) (b)\ns 631 ins SL2020-24 s 5\nCertain people exempt from Act during COVID-19 emergency—Act,\ns 190 (1) (a)\ns 632 ins SL2020-24 s 5\nexp 30 September 2022 (s 632 (3))\nMedicines advisory committee—membership\ns 635 am SL2014-26 ss 16-19; ss and pars renum R21 LA;\nSL2021-28 s 13, s 14; SL2024-36 s 12, s 13; ss renum\nR52 LA\nMedicines advisory committee—conditions of appointments\ns 637 am SL2021-28 s 15\nMedicines advisory committee—quorum\ns 640 am SL2014-26 s 20\n\nMedicines advisory committee—disclosure of interests by members\ns 643 am SL2014-26 s 21, s 22\nMedicines advisory committee—ending appointments\ns 644 am A2011-52 amdt 1.8; SL2014-26 s 23; pars renum R21 LA;\nSL2021-28 s 15; SL2024-36 s 14; pars renum R52 LA\nAdvertising controlled medicines—Act, s 66 (3) (b)\ns 650 am SL2014-23 s 8\nAdvertising other medicines\ns 651 am A2018-32 amdt 3.46\nPackaging of supplied manufacturer’s packs of low and moderate harm\npoisons—Act, s 59 (1) (c) (i) and (2) (c) (i)\ns 665 am A2015-50 amdt 1.12; A2025-33 s 21\nLabelling of supplied manufacturer’s packs of low and moderate harm\npoisons—Act, s 60 (1) (c) (i) and (2) (c) (i)\ns 666 am A2015-50 amdt 1.13; A2025-33 s 22\nGeneral overview of authorisations for dangerous poisons\ns 670 am A2025-33 s 23\nAuthorisation conditions for dangerous poisons manufacturers licences—\nAct, s 44 (1) (b) and (2) (b)\ns 676 am A2015-50 amdt 1.14; pars renum R26 LA\nAuthorisation conditions for dangerous poisons suppliers licences—Act,\ns 686 am A2015-50 amdt 1.14; pars renum R26 LA; A2025-33 s 24\nManufacturing etc authorisations for dangerous poisons—Act, s 20 (2) (a)\ns 690 am SL2024-36 s 15, s 16; pars renum R52 LA\nAuthorisations for dangerous poisons research and education—Act, s 26 (1)\ns 695 am SL2021-28 s 16\nApplications for dangerous poisons manufacturers licences\ns 705 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nApplications for dangerous poisons research and education program\ns 710 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nApplications for dangerous poisons suppliers licences\ns 715 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nRecording supply of dangerous poisons\ns 722 sub A2015-50 amdt 1.15\nam A2025-33 s 25\n\nPackaging of supplied manufacturer’s packs of dangerous poisons—Act,\ns 731 am A2015-50 amdt 1.16; A2025-33 s 26\nLabelling of supplied manufacturer’s packs of dangerous poisons—Act,\ns 732 am A2015-50 amdt 1.17; A2025-33 s 27\nStorage of dangerous poisons—Act, s 61 (b) and (c)\ns 735 am A2015-50 amdt 1.18; A2025-33 s 28\nManufacture, supply and use of first group paints for certain purposes—Act,\ns 71 (1)\ns 751 hdg sub A2025-33 s 29\ns 751 am A2015-50 amdt 1.19, amdt 1.20; A2025-33 s 30, s 35\nManufacture, supply and use of paints or tinters for certain purposes—Act,\ns 71 (3)\ns 751A ins A2025-33 s 31\nManufacture, supply and use of paints for toys—Act, s 72 (b)\ns 752 am SL2013–28 s 14, s 15\nsub A2015-50 amdt 1.21; A2025-33 s 31\nManufacture, supply and use of paints containing pesticides—Act, s 73 (b)\ns 753 sub A2015-50 amdt 1.22\nam A2025-33 s 32\nProhibited and schedule 10 substances\nch 21 hdg am A2015-50 amdt 1.23\nMeaning of prohibited substance—ch 21\ns 760 am A2015-50 amdt 1.24, amdt 1.25\nApplications for prohibited substances research and education program\ns 765 am A2021-12 amdt 3.87; A2025-29 amdt 4.126\nMeaning of reviewable decision—ch 23\ns 850 am SL2009-27 s 4\nReviewable decision notices\ns 851 sub SL2009-27 s 5\nApplications for review\ns 852 sub SL2009-27 s 5\nSupply etc of certain declared substances by public employee exercising\nfunctions under Act—Act, s 26 (1) (b) etc\ns 860 hdg sub SL2023-5 s 4\n\nDealings with regulated substances and regulated therapeutic goods by\npublic employees under chief health officer permit—Act, s 20 (1) (a) etc\ns 861 hdg sub SL2023-5 s 5\ns 861 am SL2010-45 s 10\nDealings with regulated substances and regulated therapeutic goods by\npublic employees under director-general authorisation—Act, s 20 (1) (d)\nand s 22 (1) (d)\ns 861A ins SL2023-5 s 6\nam A2023-17 amdt 2.9\nCertain containers not to be used for human-use substances—Act,\ns 63 (1) (b)\ns 862 sub A2025-33 s 33\nDisplacement of Legislation Act, s 47 (6)\ns 863 am SL2012-34 s 5, s 6\nsub SL2013–28 s 16\nam SL2014-23 s 9, s 10; pars renum R19 LA; SL2015-19 s 7;\npars renum R22 LA; A2015-50 amdt 1.26, amdt 1.27; pars\nrenum R26 LA; SL2020-39 s 10, s 11; SL2021-28 ss 17-19\nExemption of piper methysticum (kava)—Act, s 190 (1) (a)\ns 864 om LA s 89 (3)\nins SL2012-5 s 4\nexp 12 February 2012 (s 864 (3))\nins SL2013-1 s 4\nTransitional\nch 30 hdg exp 31 March 2010 (s 1008)\nDefinitions—ch 30\ns 1000 exp 31 March 2010 (s 1008)\ndef DODA exp 31 March 2010 (s 1008)\ndef PADA exp 31 March 2010 (s 1008)\nDODA wholesaler’s licences—Act, s 520 (2)\ns 1001 exp 31 March 2010 (s 1008)\nPoisons Act licences—Act, s 520 (2)\ns 1002 exp 31 March 2010 (s 1008)\nPADA licences—Act, s 520 (2)\ns 1003 exp 31 March 2010 (s 1008)\nDODA authorisations—Act, s 522 (2)\ns 1004 exp 31 March 2010 (s 1008)\nPADA authorisations—Act, s 522 (2)\ns 1005 exp 31 March 2010 (s 1008)\n\nPublic Health (Prohibited Drugs) Act authorisations—Act, s 522 (2)\ns 1006 exp 31 March 2010 (s 1008)\nDODA approvals to prescribe drugs of dependence—Act, s 531 (2)\ns 1007 exp 31 March 2010 (s 1008)\nExpiry—ch 30\ns 1008 exp 31 March 2010 (s 1008)\nModification of Act\nch 31 hdg ins SL2009-27 s 6\nModification of Act, ch 14—Act, s 501 (2)\ns 1100 ins SL2009-27 s 6\nExpiry—ch 31\ns 1110 ins SL2009-27 s 6\nAmbulance services, officers and paramedics\nsch 1 pt 1.1 hdg sub SL2025-29 s 63\nsch 1 pt 1.1 am SL2025-29 ss 64-66\nDentists, dental hygienists, dental therapists and oral health therapists\nsch 1 pt 1.2 hdg sub SL2015-36 s 4\nsch 1 pt 1.2 am A2010-10 amdt 2.104; SL2015-36 s 5, s 6\nDoctors\nsch 1 pt 1.3 am A2010-10 amdt 2.104; SL2023-5 s 7; pars renum R46 LA\nHealth practitioners at institutions\nsch 1 pt 1.4 hdg sub A2015-29 amdt 2.83\nsch 1 pt 1.4 sub A2010-10 amdt 2.94\nam A2015-29 amdt 2.84\nMedical radiation practitioners\nsch 1 pt 1.4A ins SL2020-39 s 12\nam SL2025-29 s 67\nMidwives\nsch 1 pt 1.5 am A2010-10 amdt 2.104; SL2010-45 s 11; A2015-29\namdt 2.85; A2024-30 s 10; SL2025-29 s 68\nNurses\nsch 1 pt 1.6 am SL2010-16 s 12; A2010-10 amdt 2.104; SL2010-20 s 5;\nitems renum R7 LA; A2018-42 amdt 3.74; SL2025-29 s 69,\ns 70\nOpioid dependency treatment centres operated by Territory\nsch 1 pt 1.7 am A2010-10 amdt 2.104\n\nOptometrists\nsch 1 pt 1.8 am A2010-10 amdt 2.95; SL2012-34 s 7; SL2015-19 s 8\nResidential care facilities\nsch 1 pt 1.11 am A2010-10 amdt 2.104; SL2021-28 s 20\nVeterinary practitioners and employees\nsch 1 pt 1.13 sub A2018-32 amdt 3.47\nOptometry medicines\nsch 2 am A2010-10 amdt 2.96\nom SL2012-34 s 8\nACT listed appendix D medicines—standing approvals\nsch 3 hdg sub SL2019-23 s 27\nsch 3 am SL2010-45 s 12; SL2013-24 s 4, s 5; SL2014-23 s 11;\nA2015-38 amdt 2.80; SL2019-23 s 28, s 29; A2020-11\namdt 1.60; SL2021-28 ss 21-25\nHealth Professionals Regulation 2004\nsch 6 om LA s 89 (3)\nModification—Crimes Act 1900\nsch 10 ins SL2009-27 s 7\nom A2010-50 amdt 1.14\ndict am SL2009-27 s 8; A2009-49 amdt 3.122; A2010-10\namdt 2.97, amdt 2.98; SL2013–28 s 17; A2018-42\namdts 3.75-3.77; SL2019-23 s 30; SL2020-24 s 6;\nSL2023-34 s 11; SL2024-36 s 17; SL2025-29 s 71\ndef ACT listed appendix D medicine ins SL2019-23 s 31\ndef appendix D medicine ins SL2019-23 s 31\ndef approved pharmacist ins SL2013–28 s 18\ndef Australian code of good wholesaling practice for\nmedicines in schedules 2, 3, 4 and 8 ins SL2014-23 s 12\ndef Australian code of good wholesaling practice for\ntherapeutic goods for human use om SL2014-23 s 13\ndef authorised midwife ins SL2010-45 s 13\ndef chief pharmacist reloc from Medicines, Poisons and\nTherapeutic Goods Act 2008 dict by A2013-44 amdt 3.110\ndef complying purchase order am A2015-50 amdt 1.28\ndef condition 1 sub SL2019-23 s 32\ndef condition 2 sub SL2019-23 s 32\ndef condition 3 sub SL2019-23 s 32\ndef condition 4 sub SL2019-23 s 32\ndef continued dispensing determination ins SL2013–28\ns 18\n\ndef controlled medicines prescribing standards ins\nSL2019-23 s 33\ndef day hospital om A2018-42 amdt 3.78\ndef designated appendix D medicine ins SL2019-23 s 34\ndef drug-dependent person reloc from Medicines, Poisons\nand Therapeutic Goods Act 2008 dict by A2013-44\namdt 3.112\ndef eligible midwife ins SL2010-45 s 13\nom SL2025-29 s 72\ndef endorsed health practitioner ins SL2025-29 s 73\ndef enrolled nurse om SL2010-20 s 6\ndef enrolled nurse (medications) sub A2010-10 amdt 2.99\nom SL2010-20 s 7\ndef health profession sub A2010-10 amdt 2.100\nsub A2015-29 amdt 2.86\nom A2018-42 amdt 3.79\ndef health professional om A2015-29 amdt 2.87\ndef intern sub A2010-10 amdt 2.101\ndef issuer ins SL2025-29 s 73\ndef manufacturer’s pack am A2025-33 s 35\ndef medical radiation practitioner ins SL2020-39 s 13\ndef medicines Australia code of conduct am SL2014-23\ns 14\ndef MRP registration standard ins SL2020-39 s 13\ndef national list ins SL2012-34 s 9\nom SL2015-19 s 9\ndef national residential medication chart prescription ins\nSL2013–28 s 18\nsub SL2021-28 s 26\ndef nurse practitioner ins SL2010-16 s 13\nam SL2010-16 amdt 1.1\ndef Optometry endorsement scheduled medicines\nregistration standard ins SL2012-34 s 9; SL2014-23 s 15\nom SL2015-19 s 9\ndef paramedic ins SL2025-29 s 73\ndef pharmaceutical benefit ins SL2013–28 s 18\ndef pharmaceutical benefits scheme ins SL2010-45 s 13\ndef prescriber sub SL2025-29 s 74\ndef primary pack om A2025-33 s 34\ndef prohibited substance am A2015-50 amdt 1.29\ndef scientifically qualified person sub A2018-32 amdt 3.49\ndef specialist sub A2010-10 amdt 2.102\ndef specialist area sub A2010-10 amdt 2.102; A2015-29\namdt 2.88; A2018-42 amdt 3.80\ndef trainee am A2010-10 amdt 2.103\nsub A2015-29 amdt 2.89\n\ndef veterinary practitioner ins A2018-32 amdt 3.50\ndef veterinary surgeon om A2018-32 amdt 3.51\ndef walk-in centre ins SL2010-2 s 6\n\nSome earlier republications were not numbered. The number in column 1 refers to\nthe publication order.\nSince 12 September 2001 every authorised republication has been published in\nelectronic pdf format on the ACT legislation register. A selection of authorised\nrepublications have also been published in printed format. These republications are\nmarked with an asterisk (*) in column 1. Electronic and printed versions of an\nauthorised republication are identical.\nfor\n14 Feb 2009\n14 Feb 2009–\nnot amended new regulation\n6 June 2009–\n16 Dec 2009\nSL2009-27 amendments by\nSL2009-27\n17 Dec 2009\n17 Dec 2009–\n21 Jan 2010\nA2009-49 amendments by\nA2009-49\n22 Jan 2010\n22 Jan 2010–\n31 Mar 2010\nSL2010-2 amendments by\nSL2010-1 and\nSL2010-2\n1 Apr 2010\n1 Apr 2010–\nA2010-10 commenced expiry\n11 May 2010–\nSL2010-16 amendments by\nSL2010-16\n1 July 2010–\n22 Nov 2010\nSL2010-20 amendments by\nA2010-10,\nSL2010-16 and\nSL2010-20\n23 Nov 2010\n23 Nov 2010–\n30 Nov 2010\nSL2010-45 amendments by\nSL2010-45\n1 Dec 2010\n1 Dec 2010–\n20 Dec 2010\nSL2010-45 amendments by\nA2010-43\n21 Dec 2010\n21 Dec 2010–\n11 Dec 2011\nA2010-50 amendments by\nA2010-50\n12 Dec 2011\n12 Dec 2011–\n9 Feb 2012\nA2011-52 amendments by\nA2011-52\n\nEarlier republications 5\nfor\n10 Feb 2012\n10 Feb 2012–\n12 Feb 2012\nSL2012-5 amendments by\nSL2012-5\n13 Feb 2012\n13 Feb 2012–\n2 Aug 2012\nSL2012-5 expiry of provision\n(s 864)\n3 Aug 2013\n3 Aug 2013–\n25 Jan 2013\nSL2012-34 amendments by\nSL2012-34\n26 Jan 2013\n26 Jan 2013–\n31 Aug 2013\nSL2013-1 amendments by\nSL2013-1\n1 Sept 2013\n1 Sept 2013–\n4 Nov 2013\nSL2013-24 amendments by\nSL2013-24\n5 Nov 2013\n5 Nov 2013–\n24 Nov 2013\nSL2013-28 amendments by\nSL2013-28\n25 Nov 2013\n25 Nov 2013–\n25 Sept 2013\nA2013-44 relocation of\nprovisions from\nA2008-26 and\nother amendments\nby A2013-44\n26 Sept 2014\n26 Sept 2014–\n30 Sept 2014\nSL2014-23 amendments by\nSL2014-23\n1 Oct 2014\n1 Oct 2014–\n22 Oct 2014\nSL2014-23 amendments by\nSL2014-23\n23 Oct 2014\n23 Oct 2014–\nSL2014-26 amendments by\nSL2014-26\n22 May 2015–\nSL2015-19 amendments by\nSL2015-19\n21 July 2015–\n23 Nov 2015\nSL2015-19 amendments by\nSL2015-19\n24 Nov 2015\n24 Nov 2015–\n30 Nov 2015\nSL2015-36 amendments by\nSL2015-36\n1 Dec 2015\n1 Dec 2015–\n8 Dec 2015\nSL2015-36 amendments by\nA2015-29\n9 Dec 2015\n9 Dec 2015–\n29 Feb 2016\nA2015-50 amendments by\nA2015-50\n\nfor\n1 Mar 2016\n1 Mar 2016–\nSL2016-5 amendments by\nA2015-38\nand SL2016-5\n31 July 2016–\n28 Aug 2016\nSL2016-16 amendments by\nSL2016-16\n29 Aug 2016\n29 Aug 2016–\n24 Aug 2017\nSL2016-16 amendments by\nA2016-7\n25 Aug 2017\n25 Aug 2017–\nSL2017-27 amendments by\nSL2017-27\n15 June 2018–\n21 Nov 2018\nA2018-23 amendments by\nA2018-23\n22 Nov 2018\n22 Nov 2018–\n20 Dec 2018\nA2018-42 amendments by\nA2018-42\n21 Dec 2018\n21 Dec 2018–\n12 Sept 2019\nA2018-42 amendments by\nA2018-32\n13 Sept 2019\n13 Sept 2019–\n20 Jan 2020\nSL2019-23 amendments by\nSL2019-23\n21 Jan 2020\n21 Jan 2020–\n3 Apr 2020\nSL2020-3 amendments by\nSL2020-3\n4 Apr 2020\n4 Apr 2020–\n7 Apr 2020\nSL2020-13 amendments by\nSL2020-13\n8 Apr 2020\n8 Apr 2020–\nA2020-11 amendments by\nA2020-11\n20 June 2020–\nSL2020-21 amendments by\nSL2020-21\n27 June 2020–\n20 Aug 2020\nSL2020-24 amendments by\nSL2020-24\n21 Aug 2020\n21 Aug 2020–\n9 Sept 2020\nSL2020-31 amendments by\nSL2020-31\n10 Sept 2020\n10 Sept 2020–\nSL2020-39 amendments by\nSL2020-39\n23 June 2021–\n17 Aug 2021\nA2021-12 amendments by\nA2021-12\n\nEarlier republications 5\nfor\n18 Aug 2021\n18 Aug 2021–\n4 Nov 2021\nSL2021-19 amendments by\nSL2021-19\n5 Nov 2021\n5 Nov 2021–\n30 Sept 2022\nSL2021-28 amendments by\nSL2021-28\n1 Oct 2022\n1 Oct 2022–\n6 Apr 2023\nSL2021-28 expiry of provision\n(s 632)\n7 Apr 2023\n7 Apr 2023–\nSL2023-5 amendments by\nSL2023-5\n3 July 2023–\n7 Aug 2023\nA2023-17 amendments by\nA2023-17\n8 Aug 2023\n8 Aug 2023–\n29 Sept 2023\nSL2023-17 amendments by\nSL2023-17\n30 Sept 2023\n30 Sept 2023–\n11 Dec 2023\nSL2023-17 expiry of provisions\n(pt 9.7)\n12 Dec 2023\n12 Dec 2023–\nSL2023-34 amendments by\nSL2023-34\n10 July 2024–\n12 Dec 2024\nA2024-30 amendments by\nA2024-30\n13 Dec 2024\n13 Dec 2024–\nSL2024-36 amendments by\nSL2024-36\n12 June 2025–\nSL2024-36 amendments by\nSL2024-36\n17 June 2025–\n25 Nov 2025\nSL2025-7 amendments by\nSL2025-7\n26 Nov 2025\n26 Nov 2025–\n15 Dec 2025\nA2025-33 amendments by\nA2025-33\n16 Dec 2025\n16 Dec 2025–\n25 Dec 2025\nSL2025-29 amendments by\nSL2025-29","sortOrder":280}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"kimi_summary":{"_metrics":{"completionTokens":1126},"content_quality":"ok","complexity_score":9,"scope_assessment":{"changed":true,"description":"The regulation has expanded significantly beyond its original 2008 scope. The current version (Republication No 57, effective December 2025) includes substantial additions for: opioid dependency treatment licences and buprenorphine/methadone administration (Part 14.5, s 470-471); continued dispensing by approved pharmacists (Part 4.3A, s 255-256); emergency supply of adrenaline, naloxone and salbutamol (Part 9.2, s 410); specific COVID-19 and pandemic-related provisions; and enhanced pseudoephedrine tracking (Division 4.2.7). The Medicines Advisory Committee provisions (Part 15.2) have also grown considerably from basic establishment rules to detailed governance, conflict of interest, and review procedures. These additions reflect evolving public health priorities around opioid harm reduction, emergency preparedness, and methamphetamine precursor control."},"complexity_factors":["Extensive cross-referencing between the Act and Regulation, with over 200 sections and multiple schedules","47 defined terms in the dictionary plus numerous signpost definitions to other legislation","Nested conditional logic throughout—exceptions to exceptions, particularly for controlled medicines and emergency supplies","Multiple parallel regulatory schemes: medicines (with 5 sub-categories), poisons (3 tiers), prohibited substances, and therapeutic goods","Schedule 1 alone contains 13 parts with granular authorisations for 15+ health professions, each with different permitted activities","Controlled medicines require: standing approvals OR individual CHO approvals OR endorsements for drug-dependency treatment, each with different application processes and conditions","Storage requirements vary by substance type, quantity, and holder—spanning 5 pages of technical specifications for cabinets, safes, strong rooms and vaults","Record-keeping mandates include 5 different register types (controlled medicines, dangerous poisons, prohibited substances, pseudoephedrine sales, and general dispensing records)","Integration with Commonwealth law (Therapeutic Goods Act, National Health Act) and other ACT legislation (Health Practitioner Regulation, Veterinary Practice, Corrections Management, Children and Young People Acts)","Review and appeal mechanisms involving both the Chief Health Officer and Medicines Advisory Committee with multiple pathways and time limits"],"plain_english_summary":"This ACT regulation governs how medicines, poisons and therapeutic goods are prescribed, supplied, manufactured, stored and disposed of in the Territory, affecting doctors, pharmacists, various health practitioners, wholesalers, pharmacies and researchers.  \n\nIt imposes tighter controls—approvals, licences, secure storage and detailed records—for controlled, high‑risk and prohibited substances to protect public health, prevent misuse, diversion and accidental harm while allowing regulated access to needed treatments."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":9,"scope_assessment":{"changed":false,"description":"The Regulation remains a comprehensive implementation instrument for the Medicines, Poisons and Therapeutic Goods Act: its core scope — regulating who may deal with medicines, poisons and certain therapeutic goods and how — is unchanged. What has occurred over time is accretion of targeted, topic‑specific additions (examples: emergency/continued‑dispensing paths and Commonwealth special‑arrangement variations: ss 31A, 120A; COVID‑era temporary authorisations and vaccine administration directions: ss 352–353; expanded controlled‑medicine governance and CHO approval procedures: pt 13.1; opioid dependency treatment specifics and related licence types: pts 14.5 and 15.1). Those amendments broaden the operational detail and discretionary mechanisms available to the CHO and to licence regimes but do not move the instrument beyond its original regulatory purpose of controlling medicines, poisons and therapeutic goods in the ACT. The practical effect is significant added complexity and more discretionary public‑health tools, not a change in the statute’s fundamental scope."},"complexity_factors":["Large structure: 24 chapters, multiple parts/divisions and 5 schedules (including detailed technical schedules such as schedule 5 for storage receptacles); section numbering up to s 864","Extensive defined terms and dictionary cross‑references (dozens of specific definitions: 'prescribed person', 'designated prescriber', 'controlled medicines approval', 'bi‑equivalent', etc.)","Many licence and authorisation pathways (schedule 1 occupation authorisations; multiple licence types in ch 14; CHO approvals; standing approvals and endorsements) creating nested eligibility and conditions","High degree of cross‑referencing to external Commonwealth and State laws and instruments (National Health Act, Therapeutic Goods Act, Health Practitioner Regulation National Law, TGA codes, Medicines Australia code) (see s 863, ss 31A/120A)","Layered conditional logic and temporal exceptions (standing approvals vs CHO discretionary approvals; emergency / Commonwealth special arrangement variations—ss 31A, 120A; temporary emergency provisions added during COVID period)","Multiple, overlapping record‑keeping regimes (controlled medicines registers ch 12; dangerous poisons registers ch 19; pseudoephedrine sales records ss 170–175; purchase order and delivery acknowledgement rules ss 141, 140, 676, 686, 722)","Administrative review and advisory structure with multiple review routes (medicines advisory committee functions, CHO decisions and amendment powers, ACAT reviewable decisions—pt 13.1, ch 23)","Technical, prescriptive security and storage standards (schedule 5: specific construction, mounting and resistance requirements for cabinets, safes, strong rooms and vaults)","Numerous exceptions and exclusions (first‑aid kit rules, institutional variations, dose administration aid exceptions) that require contextual application and raise interpretation burdens"],"plain_english_summary":"**What this regulation does (mechanics first)\n\n- Sets out who may lawfully prescribe, requisition, purchase, supply (including dispense), administer, obtain, possess, manufacture, store and discard medicines, poisons and certain therapeutic goods in the ACT. (See chs 2–9, 11–13, 22; schedule 1.)\n- Implements multiple routes of authorisation: schedule‑1 occupation-based authorisations, licences (first‑aid kits, wholesalers, opioid dependency treatment, research programs, dangerous poisons, prohibited substances), written CHO (Chief Health Officer) approvals, and standing orders. (See s 110; ch 14; pt 13.1; ss 70–78; ss 490–490A.)\n- Imposes operational conditions: prescription content, labelling, packaging, record‑keeping, registers for controlled/dangerous/prohibited substances, reporting obligations, delivery and purchase‑order requirements, and detailed storage/security standards (including safes, strong rooms and vaults). (Key provisions: ss 40–41 (prescriptions); ss 121–125 (dispensing & records); ss 540–546 (controlled medicines registers); ss 720–722 (dangerous poisons purchase orders & records); ch 11 and schedule 5 (storage receptacles).)\n- Establishes a procedural framework for regulated high‑risk medicines: controlled‑medicine approvals (CHO and standing approvals), endorsements to treat opioid dependency, medicines advisory committee review and recommendation processes, and review rights (including ACAT). (See pt 13.1, ss 554–575, ss 581–584, ch 23.)\n- Provides emergency and special arrangements: CHO standing orders for public‑health matters and emergencies, pharmacist emergency supply and continued dispensing pathways, and temporary variations to procedural requirements during Commonwealth special arrangements. (See ss 70–78; ss 251–256; ss 31A, 120A.)\n\nWhy it matters and who it affects\n\n- Directly affects health practitioners (doctors, nurses, midwives, pharmacists, optometrists, vets, paramedics), pharmacies, wholesalers, licensed manufacturers and research institutions, disposal operators, and institutions (hospitals, correctional centres, residential care). (See schedule 1; chs 9, 14.)\n- Matters for business operators: wholesalers and suppliers face code compliance, storage and delivery rules and additional record‑keeping; community pharmacies face dispensing, labelling, storage and record duties; non‑pharmacist retailers that qualify for rural licences are constrained by distance rules (s 626) and pack/label requirements (ss 500–502).\n- Matters for patients and consumers: rules determine who may obtain regulated medicines without prescription in emergencies or via continued‑dispensing (ss 251, 255), limit retail access to some products (pseudoephedrine sales record regime, ss 170–175), and set conditions on prescribing for high‑risk drugs (controlled medicines approvals, pt 13.1).\n\nOfficial rationale (as stated) and testing it against costs and incentives\n\n- Claimed purpose: protect public health by controlling who handles medicines/poisons, ensuring safe prescribing/supply/storage and enabling targeted public‑health responses (CHO standing orders, controlled medicines approvals). (See ch 1 intro and relevant authorising provisions.)\n\n- Trade‑offs / implementation issues:\n  - Compliance and transaction costs: detailed labelling, multi‑year retention of records, controlled‑medicine registers and witness rules increase administrative burden on pharmacies, hospitals and wholesalers (ss 123–125; ch 12; ss 543–546). These are paid by regulated entities (pharmacies, licence‑holders). (See ss 120(1)(h), 125, 540–546.)\n  - Capital and operating costs: technical storage requirements (schedule 5) and vault/safe standards for wholesalers and institutions impose capital expenditure and maintenance costs. (See ch 11; schedule 5.)\n  - Discretion and timeliness risk: the CHO has substantial discretion (approvals, amendments, standing orders, exemptions) supported by a medicines advisory committee; discretion increases administrative workload for applicants and creates potential timing risk for patient treatment where approvals are required (pt 13.1; ss 559–573). (See ss 562–564, 567–572, 573–575.)\n  - Concentrated benefits / market effects: licence regimes create enforceable privileges (wholesaler licences, rural community pharmacy licences with a 25 km rule, opioid dependency treatment licences) that benefit licence‑holders but impose compliance costs and market entry constraints on others; those are concentrated benefits with diffuse compliance costs across the sector. (See pt 14; s 626.)\n  - Public‑health responsiveness vs regulatory friction: emergency paths (CHO standing orders, pharmacist emergency supply, Commonwealth special arrangement variations) reduce friction during crises but introduce temporary procedural differences that suppliers must track (ss 70–78; ss 251–256; ss 31A, 120A). If navigation of these exceptions is slow, service delivery may be affected.\n  - Cross‑jurisdictional interaction: many provisions rely on Commonwealth and interstate instruments and codes (National Health Act, Therapeutic Goods Act, Health Practitioner Regulation National Law, TGA and Medicines Australia codes) which complicates compliance for businesses operating across borders and increases legal complexity. (See ss 31A, 120A; s 270; ch 22; s 863.)\n\nBehavioral effects and substitution risks\n\n- Prescribers and pharmacists will preserve records and follow formal pathways; some prescribers will seek CHO approvals for controlled medicines where longer treatment is clinically required (pt 13.1). Administrative burden may push some suppliers to use wholesale channels with larger compliance teams or to source from jurisdictions with different rules where lawful.\n- Restrictions on retail pseudoephedrine (ID + sales records, ss 170–175) limit casual retail access and push consumers toward prescriptions or alternate products.\n\nImplementation risk and oversight\n\n- High: numerous cross‑references, multiple licence types, technical storage standards and witness rules require active regulatory oversight (medicines advisory committee and CHO) and a considerable compliance function inside regulated entities. (See chs 12, 13, 14, schedule 5.)\n\nConcrete mechanisms worth noting (examples and section pointers)\n\n- CHO standing orders give the CHO power to permit supply/administration in public‑health circumstances (ss 70–78).\n- Controlled medicines require CHO approvals or standing approvals for non‑short term treatment; applications, conditions and review are set out (pt 13.1; ss 560–575).\n- Pharmacists can supply certain prescription medicines in emergencies (ss 251–254) and approved pharmacists may continue dispensing under a Commonwealth continued‑dispensing determination (ss 255–256).\n- Wholesalers and interstate suppliers must comply with codes of good wholesaling practice and keep records and delivery acknowledgments (s 270; ss 141, 140, 461).\n- Pseudoephedrine retail sales are recorded, buyers identified and records kept for audit and possible CHO directions (ss 171–175).\n\nBottom line (practical takeaways)\n\n- The regulation is an operational, detailed rulebook implementing the Medicines, Poisons and Therapeutic Goods Act in the ACT. If you run or advise a pharmacy, wholesaler, clinic, research lab or an institution that stores/administers regulated medicines, expect: licensing requirements for some activities; significant labelling, packaging, storage and registration duties; reporting to the CHO for certain supplies; and CHO/licensing discretion for controlled or high‑risk medicines. Key compliance points to check first are the storage specs (schedule 5), controlled medicines register obligations (ch 12), prescription and dispensing minimums (ss 40–41, 121–125) and CHO approval pathways for controlled medicines (pt 13.1)."}},"importantCases":[],"_links":{"self":"/api/acts/medicines-poisons-and-therapeutic-goods-regulation-2008","history":"/api/acts/medicines-poisons-and-therapeutic-goods-regulation-2008/history","analysis":"/api/acts/medicines-poisons-and-therapeutic-goods-regulation-2008/analysis","conflicts":"/api/acts/medicines-poisons-and-therapeutic-goods-regulation-2008/conflicts","importantCases":"/api/acts/medicines-poisons-and-therapeutic-goods-regulation-2008/important-cases","documents":"/api/acts/medicines-poisons-and-therapeutic-goods-regulation-2008/documents"}}