{"id":"medicines-poisons-and-therapeutic-goods-regulations-2014","name":"MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014","slug":"medicines-poisons-and-therapeutic-goods-regulations-2014","collection":"regulation","jurisdiction":"nt","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":177004,"registerId":"nt-medicines-poisons-and-therapeutic-goods-regulations-2014-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014","content":"NORTHERN TERRITORY OF AUSTRALIA\nMEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014\nAs in force at 10 February 2026\nTable of provisions\nPart 1 Preliminary matters\n1 Citation ............................................................................................ 1\n2 Commencement .............................................................................. 1\n3 Definitions ........................................................................................ 1\n3A Meaning of amphetamine ................................................................ 2\n4 Australian/New Zealand Standard ................................................... 2\n5 Corresponding law........................................................................... 3\n6 Modification of medicines and poisons standard ............................. 3\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration\nand supply orders\n7 Written requisition to pharmacist ..................................................... 3\n7A Prescribed conditions ...................................................................... 4\n7B Prohibited circumstance .................................................................. 4\n8 Prescription issued by health practitioner ........................................ 4\n9 Prescription issued by veterinarian .................................................. 6\n10 Additional requirements for prescription for Schedule 8\nsubstance ........................................................................................ 6\n11 Prescription may be issued to agent................................................ 6\n12 Conditions on which prescription may be issued to partner ............. 7\n13 Administration order ........................................................................ 7\n14 Supply order – person discharged from hospital ............................. 7\n15 Supply order – nurse at residential facility ....................................... 8\n16 Supply order – person in charge of declared place ......................... 9\n17 Formal requirements for requisitions, prescriptions and\nadministration and supply orders ..................................................... 9\nDivision 1A Administering, supplying and possessing\nScheduled substances under SSTP\n17A Prescribed health practitioners ...................................................... 10\n17B Prescribed healthcare workers ...................................................... 10\n17C Content of SSTP............................................................................ 11\nDivision 2 Dealings to be witnessed\n18 Record of supply or administration of Schedule 8 substance ........ 11\n\nMedicines, Poisons and Therapeutic Goods Regulations 2014 ii\n19 Destruction of Schedule 8 substance ............................................ 11\n20 Administration of Schedule 9 substance must be witnessed ......... 12\n21 Destruction of Schedule 9 substance ............................................ 12\nDivision 3 Storage and transport\n22 Storage of Schedule 2 substance by retailer ................................. 12\n23 Storage of Schedule 3 substance by authority holder ................... 13\n24 Storage of Schedule 2, 3 or 4 substance at pharmacy .................. 13\n25 Storage of Schedule 4 substance by authority holder ................... 14\n26 Storage of Schedule 4 substance at residential facility or\ndeclared place ............................................................................... 14\n27 Storage of methylated spirit ........................................................... 15\n28 Storage of Schedule 7 substance by manufacturer or\nwholesaler ..................................................................................... 15\n29 Storage of Schedule 7 substance by retailer ................................. 16\n30 Storage of Schedule 7 substance by authority holder ................... 16\n31 Storage of Schedule 8 substance .................................................. 17\n32 Delivery person must not leave certain Scheduled substances\nunattended..................................................................................... 18\nDivision 4 Packaging and labelling\n33 Packaging requirements ................................................................ 18\n34 Labelling requirements .................................................................. 18\n35 Container not to be used for human-use substance ...................... 19\nDivision 5 Manufacture, supply and use of paints\n36 Paint applied to premises, structures and furniture........................ 19\n37 Paint for toys.................................................................................. 19\n38 Paint containing pesticide .............................................................. 19\nDivision 6 Advertising\n39 Pharmacist pricelist advertising certain Scheduled substances..... 20\nPart 3 Authorities to deal with Scheduled\nsubstances\n40 Additional conditions – certificate of registration ............................ 20\n41 Duration of Schedule 8 authorisation for treating child's ADHD ..... 20\n42 Contents of authority ..................................................................... 21\n43 Authority holder to give notice of change of particulars ................. 21\n\nMedicines, Poisons and Therapeutic Goods Regulations 2014 iii\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 1 Pseudoephedrine register\n44 Keeping of register ........................................................................ 21\n45 Details to be recorded ................................................................... 22\nSubdivision 2 Schedule 4 register\n46 Keeping of register ........................................................................ 22\n47 Details to be recorded ................................................................... 22\nSubdivision 3 Schedule 7 register\n48 Keeping of register ........................................................................ 23\n49 Details to be recorded ................................................................... 23\nSubdivision 4 Schedule 8 register\n50 Maintenance of register – persons in charge of premises ............. 23\n51 Keeping of register – medical kit holder......................................... 26\n52 Keeping of register – other persons............................................... 26\n53 Form of Schedule 8 register .......................................................... 26\n54 Details to be recorded ................................................................... 26\nSubdivision 5 Schedule 9 register\n55 Keeping of register ........................................................................ 28\n56 Form of Schedule 9 register .......................................................... 28\n57 Details to be recorded ................................................................... 28\nSubdivision 6 Manufacturer/wholesaler/Schedule 4 supplier\n58 Keeping of register ........................................................................ 29\n59 Details to be recorded ................................................................... 29\nSubdivision 7 General requirements\n60 Form of register entries ................................................................. 29\n61 Period of retention of registers....................................................... 30\nDivision 2 Offences relating to Scheduled substance\nregisters\n62 Offence not to maintain register..................................................... 30\n63 Offence not to sign entry................................................................ 30\n64 Offence to make false or misleading entry .................................... 30\n65 Offence to change entry ................................................................ 31\n\nMedicines, Poisons and Therapeutic Goods Regulations 2014 iv\n66 Offence not to record details of supply of pseudoephedrine .......... 31\n67 Offence not to sign register after certain dealings with\nSchedule 8 or 9 substance ............................................................ 31\n68 Offence not to sign register after witnessing certain dealings\nwith Schedule 8 or 9 substance ..................................................... 32\n69 Offence not to ensure witness signs register after certain\ndealings with Schedule 8 or 9 substance ...................................... 32\n70 Offence not to maintain register where substance kept ................. 33\n71 Offence not to report possible loss etc. of Scheduled\nsubstance ...................................................................................... 33\n72 Offence not to report destruction, loss etc. of register ................... 33\nPart 5 Other records and notices\nDivision 1 General requirements\n73 Retention of documents relating to receipt or supply of\nScheduled substances .................................................................. 34\n74 Retention of prescriptions .............................................................. 34\n75 Record of supply or administration of Schedule 4 or 8\nsubstance in clinical or other records ............................................ 34\n76 Form and period of retention of records ........................................ 35\nDivision 2 Offences relating to records and notices\n77 Offence not to make or keep record .............................................. 36\n78 Offence not to give fraudulent prescription to police ...................... 36\n79 Offence not to report supply or administration of Schedule 8\nsubstance at declared place .......................................................... 36\n80 Offence not to report administration of Schedule 8 substance\nfrom medical kit ............................................................................. 37\nPart 6 Legal proceedings\n81 Declared provisions ....................................................................... 37\n81A Declared provisions ....................................................................... 37\nPart 6A Monitored medicines database\n81B Definitions ...................................................................................... 37\n81C Monitored medicine ....................................................................... 37\n81D Database name ............................................................................. 38\n81E Information to be given to CHO ..................................................... 38\n81F Prescription issued by relevant prescriber in exempt\ncircumstances................................................................................ 39\n81G Supply made by pharmacist in exempt circumstances .................. 39\n\nMedicines, Poisons and Therapeutic Goods Regulations 2014 v\nPart 7 Infringement notice offences\n82 Infringement notice offence and prescribed amount payable ........ 40\n83 When infringement notice may be given ........................................ 40\n84 Contents of infringement notice ..................................................... 40\n85 Payment by cheque ....................................................................... 41\n86 Withdrawal of infringement notice.................................................. 41\n87 Application of Part ......................................................................... 41\nPart 8 Miscellaneous matters\n89 Information in register of authorities .............................................. 42\n90 Appointed Committee members .................................................... 43\n91 Fees .............................................................................................. 43\nSchedule 1 Infringement notice offences and\nprescribed amounts\nSchedule 2 Fees\nENDNOTES\n\n\n\nNORTHERN TERRITORY OF AUSTRALIA\n____________________\nAs in force at 10 February 2026\n____________________\nMEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014\nRegulations under the Medicines, Poisons and Therapeutic Goods\nAct 2012\nPart 1 Preliminary matters\n1 Citation\nThese Regulations may be cited as the Medicines, Poisons and\nTherapeutic Goods Regulations 2014.\n2 Commencement\nThese Regulations commence on the commencement of the\nMedicines, Poisons and Therapeutic Goods Act 2012.\n3 Definitions\nIn these Regulations:\namphetamine, see regulation 3A.\ncustodial correctional facility, for Part 6A, see regulation 81B.\ninfringement notice, see regulation 83.\ninfringement notice offence, see regulation 82(1).\nkey includes an electronic swipe card and electronic proximity\ndevice.\nmaintain, in relation to a Scheduled substance register, means\nkeep the register or ensure the register is kept.\npersonal custody, of a key by a person, includes keeping the key\nin a combination-operated key safe, the combination of which the\nperson keeps confidential.\n\nPart 1 Preliminary matters\nMedicines, Poisons and Therapeutic Goods Regulations 2014 2\npharmacist-in-charge:\n(a) of a pharmacy – means the person appointed under\nSchedule 7, clause 7(1) of the Health Practitioners Act 2004 to\nbe the pharmacist-in-charge of the pharmacy business carried\non in the pharmacy; or\n(b) of a pharmacy department – means the person appointed\nunder Schedule 7, clause 7(3) of the Health Practitioners\nAct 2004 to be the pharmacist-in-charge of the pharmacy\ndepartment.\npharmacy department, see Schedule 7, clause 1 of the Health\nPractitioners Act 2004.\nprescribed amount, see regulation 82(2).\nprisoner, for Part 6A, see regulation 81B.\nScheduled substance register means a register required to be\nmaintained under Part 4, Division 1.\nSchedule 8 register means a register in relation to Schedule 8\nsubstances required to be kept under regulation 50, 51 or 52.\n3A Meaning of amphetamine\n(1) An amphetamine includes:\n(a) beta-aminoisopropylbenzene; and\n(b) a substance structurally derived from amphetamine or\nbeta-aminoisopropylbenzene by substitution in the side chain\nor by ring closure (or both).\n(2) Despite subregulation (1), a substance mentioned in\nsubregulation (1)(a) or (b) is not an amphetamine when contained\nin a Schedule 2, 3 or 4 substance.\n4 Australian/New Zealand Standard\nIn these Regulations, a reference consisting of the letters \"AS/NZS\"\nfollowed by a number is a reference to the standard so numbered\npublished jointly by or for Standards Australia Limited ABN 85 087\n326 690 and Standards New Zealand.\n\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and supply orders\nMedicines, Poisons and Therapeutic Goods Regulations 2014 3\n5 Corresponding law\nFor section 5 of the Act, definition corresponding law,\nparagraph (a)(ii), each of the following laws is a corresponding law:\n(a) Controlled Substances Act 1984 (SA);\n(b) Drugs, Poisons and Controlled Substances Act 1981 (Vic);\n(c) Medicines and Poisons Act 2019 (Qld);\n(d) Medicines, Poisons and Therapeutic Goods Act 2008 (ACT);\n(e) Medicines and Poisons Act 2014 (WA);\n(f) Poisons Act 1971 (Tas);\n(g) Poisons and Therapeutic Goods Act 1966 (NSW).\n6 Modification of medicines and poisons standard\n(1) This regulation modifies the medicines and poisons standard for\nsection 14(2) of the Act.\n(2) Each substance listed in Appendix D, paragraph 1 of the medicines\nand poisons standard is taken to be excluded from Appendix D of\nthe medicines and poisons standard.\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and\nsupply orders\nNote for Division 1\nA requisition, prescription, administration order or supply order may be issued\nelectronically in accordance with the Electronic Transactions (Northern Territory)\nAct 2000.\n7 Written requisition to pharmacist\nFor section 57(2) of the Act, a written requisition for the supply of a\nSchedule 4 or 8 substance must contain the following information:\n(a) the name of the health practitioner issuing it;\n(b) the date of issue;\n(c) the ward or department of the hospital for which the substance\nis to be supplied;\n\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and supply orders\nMedicines, Poisons and Therapeutic Goods Regulations 2014 4\n(d) the name of the substance and the form, strength and quantity\nto be supplied;\n(e) the signature of the health practitioner.\n7A Prescribed conditions\nFor section 58(2)(a) of the Act, the following conditions are\nprescribed:\n(a) for a Schedule 8 substance that is an unrestricted Schedule 8\nsubstance – the pharmacist must verify:\n(i) the identity of the person presenting the prescription; and\n(ii) the validity of the prescription;\n(b) for an amphetamine or methylphenidate prescribed by an\ninterstate prescriber who would otherwise ordinarily be\nendorsed to initiate treatment in the Territory – the pharmacist\nmust verify:\n(i) the identity of the person presenting the prescription; and\n(ii) the validity of the prescription; and\n(iii) the specialty of the interstate prescriber.\nExample for paragraphs (a)(i) and (b)(i)\nThe pharmacist may request proof of the person's identity.\nExample for paragraphs (a)(ii) and (b)(ii)\nThe pharmacist may contact the prescriber to ascertain the validity of the\nprescription.\n7B Prohibited circumstance\nFor section 84(2)(c) of the Act, issuing a prescription for the supply\nof an unrestricted Schedule 8 substance to a person for therapeutic\nuse if the person's daily total oral morphine equivalent dose would\nbe equal to or exceed 100 mg daily is prohibited.\nNote for regulation 7B\nSection 139(1) of the Act provides that the CHO may, on application, authorise\nthe supply, administration or the issue of a prescription for the supply of an\nunrestricted Schedule 8 substance in a prohibited circumstance.\n8 Prescription issued by health practitioner\nFor section 87(1)(a) of the Act, a prescription issued by an\n\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and supply orders\nMedicines, Poisons and Therapeutic Goods Regulations 2014 5\nauthorised prescriber who is a health practitioner must:\n(a) state the following particulars of the authorised prescriber:\n(i) name;\n(ii) business address and telephone number;\n(iii) health profession; and\n(b) state the date of issue; and\n(c) state the name and address of the person for whom it is\nissued; and\n(d) state the name of the substance, and the dose, form and\nstrength, for which it is issued; and\n(e) if it is for an unusual or dangerous dose – include the\nauthorised prescriber's initials beside an underlined reference\nto the dose; and\n(f) state the quantity of the substance to be supplied; and\n(g) if it is a repeat prescription – state the number of repeats\npermitted; and\n(h) state the start date for supply, if different from the date the\nprescription is issued; and\n(i) include directions for the use of the substance that are\nadequate to allow the substance to be taken or administered\nsafely; and\n(j) be written in terms and symbols used in ordinary professional\npractice; and\n(k) if it is issued by:\n(i) a dentist – state it is issued for dental purposes only; or\n(ii) an optometrist – state it is issued for the treatment of a\ncondition of the eye only; or\n(iii) a podiatrist – state it is issued for podiatry treatment\nonly; and\n(l) if it is issued for a Schedule 8 substance – meet the\nrequirements specified in regulation 10; and\n(m) be signed by the authorised prescriber.\n\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and supply orders\nMedicines, Poisons and Therapeutic Goods Regulations 2014 6\n9 Prescription issued by veterinarian\nFor section 87(1)(a) of the Act, a prescription issued by an\nauthorised prescriber who is a veterinarian must:\n(a) contain the information mentioned in section 32(2) of the\nAgricultural and Veterinary Chemicals (Control of Use)\nAct 2004; and\n(b) state the date of issue; and\n(c) state the name and address of the person who owns, or is in\ncharge of, the animal for which it is issued; and\n(d) state it is issued for animal treatment only; and\n(e) if it is issued for a Schedule 8 substance – meet the\nrequirements specified in regulation 10; and\n(f) be signed by the authorised prescriber.\n10 Additional requirements for prescription for Schedule 8\nsubstance\n(1) A prescription for a Schedule 8 substance must state:\n(a) if it is issued for:\n(i) a person – the date of birth of the person; or\n(ii) an animal – sufficient information to identify the animal;\nand\n(b) the quantity of the substance to be supplied in words and\nnumerals; and\n(c) if it is issued by an authorised health practitioner under a\nSchedule 8 authorisation or Schedule 8 exemption – the\nnumber or other identifier of the authorisation or exemption;\nand\n(d) if it is a repeat prescription – the minimum repeat interval.\n(2) In addition, a prescription for a Schedule 8 substance of a particular\nform and strength must not authorise the supply of any other\nsubstance, including a Schedule 8 substance of a different form or\nstrength.\n11 Prescription may be issued to agent\nFor section 89(1)(b)(iv) of the Act, a person who acts for the patient\n\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and supply orders\nMedicines, Poisons and Therapeutic Goods Regulations 2014 7\nis prescribed.\n12 Conditions on which prescription may be issued to partner\nFor section 89(2)(c) of the Act, the conditions for the issue of a\nprescription are:\n(a) the recipient has been diagnosed with chlamydia that has\nbeen confirmed microbiologically by nucleic acid amplification\ntest or related technologies; and\n(b) the partner is at significant risk of contracting chlamydia; and\n(c) the prescription is for a single dose of Azithromycin.\n13 Administration order\nFor section 92(2) of the Act, an administration order for a\nScheduled substance must:\n(a) state the name of the authorised prescriber issuing it; and\n(b) if the order is written – state the date of issue and be signed\nby the authorised prescriber; and\n(c) state the name, address and, if applicable, hospital\nregistration number of the person to whom the substance is to\nbe administered; and\n(d) state the name of the substance, and the dose, form and\nstrength, to be administered; and\n(e) state the route, frequency and period of administration; and\n(f) state the start date for administration, if different from the date\nthe order is issued.\n14 Supply order – person discharged from hospital\nFor section 92(2) of the Act, a supply order authorising the supply\nof a Scheduled substance to a person on the person's discharge as\na patient of a hospital must:\n(a) state the following particulars of the authorised prescriber\nissuing the order:\n(i) name;\n(ii) hospital pager number or telephone number;\n(iii) name of the hospital and ward or department in which\n\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and supply orders\nMedicines, Poisons and Therapeutic Goods Regulations 2014 8\nthe prescriber is working;\n(iv) health profession; and\n(b) state the date of issue; and\n(c) state the name, address and hospital registration number of\nthe person to whom the substance is to be supplied; and\n(d) state the name of the substance, and the dose, form and\nstrength, to be supplied; and\n(e) state the quantity of the substance to be supplied; and\n(f) include directions for the use of the substance that are\nadequate to allow the substance to be taken or administered\nsafely; and\n(g) be signed by the authorised prescriber.\n15 Supply order – nurse at residential facility\n(1) For section 92(2) of the Act, a supply order authorising the supply\nof a Scheduled substance to a nurse employed at a residential\nfacility for administration to a resident at the facility must:\n(a) state the following particulars of the authorised prescriber\nissuing the order:\n(i) name;\n(ii) business address and telephone number;\n(iii) health profession; and\n(b) state the date of issue; and\n(c) state the name, address and telephone number of the\nresidential facility; and\n(d) state the resident's name and medical record number; and\n(e) state the name of the substance, and the dose, form and\nstrength, to be supplied; and\n(f) state instructions for the administration of the substance; and\n(g) be signed by the authorised prescriber.\n(2) In addition, a supply order for a Schedule 8 substance of a\nparticular form and strength must not authorise the supply of any\n\nPart 2 Dealing with Scheduled substances\nDivision 1 Requisitions, prescriptions and administration and supply orders\nMedicines, Poisons and Therapeutic Goods Regulations 2014 9\nother substance, including a Schedule 8 substance of a different\nform or strength.\n(3) To avoid doubt, a medication chart for a resident may be used as a\nsupply order if it meets the requirements specified in\nsubregulations (1) and (2).\n16 Supply order – person in charge of declared place\n(1) For section 92(2) of the Act, a supply order authorising the supply\nof a Scheduled substance to the person in charge of a declared\nplace must:\n(a) state the following particulars of the authorised prescriber\nissuing the order:\n(i) name;\n(ii) business address and telephone number;\n(iii) health profession; and\n(b) state the date of issue; and\n(c) state the name, address and telephone number of the\ndeclared place; and\n(d) state the name and address of the person receiving medical\ntreatment at the declared place to whom the substance will be\nadministered; and\n(e) state the name of the substance, and the dose, form and\nstrength, to be supplied; and\n(f) state the quantity of the substance to be supplied; and\n(g) state instructions for the administration of the substance; and\n(h) be signed by the authorised prescriber.\n(2) In addition, a supply order for a Schedule 8 substance of a\nparticular form and strength must not authorise the supply of any\nother substance, including a Schedule 8 substance of a different\nform or strength.\n17 Formal requirements for requisitions, prescriptions and\nadministration and supply orders\n(1) This regulation applies to each of the following (the document)\nunless issued electronically:\n\nPart 2 Dealing with Scheduled substances\nDivision 1A Administering, supplying and possessing Scheduled substances under SSTP\nMedicines, Poisons and Therapeutic Goods Regulations 2014 10\n(a) a requisition mentioned in regulation 7;\n(b) a prescription;\n(c) an administration order or supply order.\n(2) The document must be written in ink.\n(3) If there are changes to any of the details in the document, the\ninitials of the person who issued the document and the date the\nchange was made must appear beside each change.\nDivision 1A Administering, supplying and possessing\nScheduled substances under SSTP\n17A Prescribed health practitioners\nFor section 70A(1) of the Act, the following types of health\npractitioner are prescribed:\n(a) Aboriginal and Torres Strait Islander health practitioner;\n(b) dental hygienist;\n(c) dental therapist;\n(d) midwife;\n(e) nurse;\n(f) oral health therapist;\n(g) paramedic;\n(h) pharmacist.\n17B Prescribed healthcare workers\n(1) For section 70A(2) of the Act, an orthoptist is a prescribed class of\nperson.\n(2) In this regulation:\northoptist means a person whose name is recorded in the register\nof orthoptists kept by the Australian Orthoptists Registration Body\nPty Ltd ACN 095 117 678.\n\nPart 2 Dealing with Scheduled substances\nDivision 2 Dealings to be witnessed\nMedicines, Poisons and Therapeutic Goods Regulations 2014 11\n17C Content of SSTP\n(1) For section 70B(2)(d) of the Act, the following matters are\nprescribed:\n(a) the indications for use of the Scheduled substance by a\nperson;\n(b) any contraindications against use of the Scheduled substance\nby a person;\n(c) a description of any persons to whom the Scheduled\nsubstance must not be administered or supplied.\n(2) For section 70B(2)(e) of the Act, an SSTP must specify the\nfollowing matters:\n(a) the form, strength, dose, route and frequency of administration\nof the Scheduled substance;\n(b) any monitoring requirements after administration of the\nScheduled substance to a person;\n(c) any procedures or requirements in relation to documenting the\nadministration or supply of the Scheduled substance to a\nperson.\nDivision 2 Dealings to be witnessed\n18 Record of supply or administration of Schedule 8 substance\nFor section 100(2) of the Act, the Schedule 8 register kept for the\nward or department of the hospital in which the patient is receiving\ntreatment, or the residential facility or declared place, is prescribed.\nNote for regulation 18\nSection 100 of the Act requires certain dealings with Schedule 8 substances to\nbe witnessed.\n19 Destruction of Schedule 8 substance\n(1) A person who is authorised under the Act to possess a Schedule 8\nsubstance commits an offence if:\n(a) the person destroys a substance; and\n(b) the substance is a Schedule 8 substance; and\n(c) the destruction is not witnessed by one of the following\npersons:\n\nPart 2 Dealing with Scheduled substances\nDivision 3 Storage and transport\nMedicines, Poisons and Therapeutic Goods Regulations 2014 12\n(i) an authorised officer;\n(ii) a health practitioner;\n(iii) a veterinarian.\nMaximum penalty: 40 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n20 Administration of Schedule 9 substance must be witnessed\n(1) A person who is authorised under the Act to possess a Schedule 9\nsubstance commits an offence if:\n(a) the person administers a substance to a person or animal; and\n(b) the substance is a Schedule 9 substance; and\n(c) the administration is not witnessed by another person.\nMaximum penalty: 20 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n21 Destruction of Schedule 9 substance\n(1) A person who is authorised under the Act to possess a Schedule 9\nsubstance commits an offence if:\n(a) the person destroys a substance; and\n(b) the substance is a Schedule 9 substance; and\n(c) the destruction is not witnessed by an authorised officer.\nMaximum penalty: 40 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\nDivision 3 Storage and transport\nNote for Division 3\nThere are no generally applicable storage requirements for prohibited\nsubstances. However, a prohibited substance authorisation may contain\nconditions regarding storage of the prohibited substance.\n22 Storage of Schedule 2 substance by retailer\n(1) The licensee under a retailer licence commits an offence if:\n\nPart 2 Dealing with Scheduled substances\nDivision 3 Storage and transport\nMedicines, Poisons and Therapeutic Goods Regulations 2014 13\n(a) a Schedule 2 substance is stored at the place in relation to\nwhich the licence was issued; and\n(b) the licensee fails to ensure the substance is stored in a way\nthat restricts public access to it.\nMaximum penalty: 30 penalty units.\n(2) Strict liability applies to subregulation (1)(b).\n23 Storage of Schedule 3 substance by authority holder\n(1) The holder of a Schedule 3 authorisation, research authorisation or\nmedical kit authorisation commits an offence if:\n(a) the holder possesses a substance; and\n(b) the substance is a Schedule 3 substance that is in the holder's\npossession under the authorisation; and\n(c) the holder fails to ensure the substance is stored in a way that\nprevents unauthorised access to it.\nMaximum penalty: 30 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n24 Storage of Schedule 2, 3 or 4 substance at pharmacy\n(1) The pharmacist-in-charge of a pharmacy commits an offence if:\n(a) a Schedule 2 substance that is for retail sale is stored at the\npharmacy; and\n(b) the pharmacist-in-charge fails to ensure the substance is\nstored within 4 m of, or within sight of, the pharmacy's\ndispensary.\nMaximum penalty: 30 penalty units.\n(2) The pharmacist-in-charge of a pharmacy commits an offence if:\n(a) a Schedule 2 substance that is not for retail sale is stored at\nthe pharmacy; and\n(b) the pharmacist-in-charge fails to ensure the substance is\nstored in a way that restricts public access to it.\nMaximum penalty: 30 penalty units.\n(3) The pharmacist-in-charge of a pharmacy commits an offence if:\n\nPart 2 Dealing with Scheduled substances\nDivision 3 Storage and transport\nMedicines, Poisons and Therapeutic Goods Regulations 2014 14\n(a) a Schedule 3 or 4 substance is stored at the pharmacy; and\n(b) the pharmacist-in-charge fails to ensure the substance is\nstored:\n(i) in a part of the pharmacy to which the public does not\nhave access; or\n(ii) in a way that prevents persons other than a pharmacist,\nor a person under the direct supervision of a pharmacist,\nfrom having access to the substance.\nMaximum penalty: 30 penalty units.\n(4) Strict liability applies to subregulations (1)(b), (2)(b) and (3)(b).\n25 Storage of Schedule 4 substance by authority holder\n(1) The holder of a Schedule 4 authorisation, research authorisation or\nmedical kit authorisation commits an offence if:\n(a) the holder possesses a substance; and\n(b) the substance is a Schedule 4 substance that is in the holder's\npossession under the authorisation; and\n(c) the holder fails to ensure the substance is stored in a way that\nprevents unauthorised access to it.\nMaximum penalty: 30 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n26 Storage of Schedule 4 substance at residential facility or\ndeclared place\n(1) The nurse in charge of a residential facility commits an offence if:\n(a) a Schedule 4 substance is stored at the facility; and\n(b) disposition of the substance is controlled by the nurse; and\n(c) the nurse fails to ensure the substance is stored in a way that\nprevents unauthorised access to it.\nMaximum penalty: 30 penalty units.\n(2) The person in charge of a declared place commits an offence if:\n(a) a Schedule 4 substance is stored at the declared place; and\n\nPart 2 Dealing with Scheduled substances\nDivision 3 Storage and transport\nMedicines, Poisons and Therapeutic Goods Regulations 2014 15\n(b) disposition of the substance is controlled by the person; and\n(c) the person fails to ensure the substance is stored in a way that\nprevents unauthorised access to it.\nMaximum penalty: 30 penalty units.\n(3) Strict liability applies to subregulations (1)(c) and (2)(c).\n27 Storage of methylated spirit\n(1) A person commits an offence if:\n(a) the person owns a business that sells a substance; and\n(b) the substance is methylated spirit; and\n(c) the person fails to ensure the substance is stored in a part of\npremises to which the public does not have access.\nMaximum penalty: 20 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n28 Storage of Schedule 7 substance by manufacturer or\nwholesaler\n(1) The holder of a certificate of registration commits an offence if:\n(a) the holder possesses a substance that is not for immediate\nuse; and\n(b) the substance is a Schedule 7 substance that is in the holder's\npossession under the certificate; and\n(c) the holder fails to ensure that each of the following are\nsatisfied:\n(i) the substance is stored in a locked container that\nprevents ready access to the container's contents and is\nsecurely attached to a building;\n(ii) the container is kept securely locked when not in\nimmediate use;\n(iii) if the container is unlocked by a combination lock – the\nnominated person for the certificate of registration keeps\nthe combination confidential;\n(iv) if the container is unlocked by a key – the nominated\nperson keeps personal custody of the key.\n\nPart 2 Dealing with Scheduled substances\nDivision 3 Storage and transport\nMedicines, Poisons and Therapeutic Goods Regulations 2014 16\nMaximum penalty: 30 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n29 Storage of Schedule 7 substance by retailer\n(1) The licensee under a retailer licence commits an offence if:\n(a) the licensee possesses a substance; and\n(b) the substance is a Schedule 7 substance that is in the\nlicensee's possession under the licence; and\n(c) the licensee fails to ensure that:\n(i) if the substance is for retail sale – the substance is\nstored in a part of the place in relation to which the\nlicence was issued to which the public does not have\naccess; or\n(ii) otherwise – each of the following are satisfied:\n(A) the substance is stored in a locked container that\nprevents ready access to the container's contents\nand is securely attached to a building;\n(B) the container is kept securely locked when not in\nimmediate use;\n(C) if the container is unlocked by a combination lock –\nthe individual who has control of the business\nactivities under the retailer licence (the business\nmanager) keeps the combination confidential;\n(D) if the container is unlocked by a key – the business\nmanager keeps personal custody of the key.\nMaximum penalty: 30 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n30 Storage of Schedule 7 substance by authority holder\n(1) The holder of a Schedule 7 authorisation or pest management\ntechnician licence commits an offence if:\n(a) the holder possesses a substance that is not for immediate\nuse; and\n(b) the substance is a Schedule 7 substance that is in the holder's\npossession under the authorisation or licence; and\n\nPart 2 Dealing with Scheduled substances\nDivision 3 Storage and transport\nMedicines, Poisons and Therapeutic Goods Regulations 2014 17\n(c) the holder fails to ensure that each of the following are\nsatisfied:\n(i) the substance is stored:\n(A) if being transported – in a locked container that\nprevents ready access to the container's contents;\nor\n(B) otherwise – in a locked container that prevents\nready access to the container's contents and is\nsecurely attached to a building;\n(ii) the container is kept securely locked when not in\nimmediate use;\n(iii) if the container is unlocked by a combination lock – the\nholder and other persons who hold an authority in\nrelation to the substance keep the combination\nconfidential;\n(iv) if the container is unlocked by a key – the holder, or\nanother person who holds an authority in relation to the\nsubstance, keeps personal custody of the key.\nMaximum penalty: 30 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n31 Storage of Schedule 8 substance\n(1) A person who is authorised under the Act to possess a Schedule 8\nsubstance commits an offence if:\n(a) the person possesses a substance; and\n(b) the substance is a Schedule 8 substance; and\n(c) the person fails to store the substance in accordance with the\nstorage requirements applicable to the person specified in the\nSchedule 8 Code of Practice.\nMaximum penalty: 60 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n(3) In this regulation:\nSchedule 8 Code of Practice means the Code of Practice for\nSchedule 8 substances made by the CHO under section 244 of the\nAct, as in force from time to time.\n\nPart 2 Dealing with Scheduled substances\nDivision 4 Packaging and labelling\nMedicines, Poisons and Therapeutic Goods Regulations 2014 18\n32 Delivery person must not leave certain Scheduled substances\nunattended\n(1) A delivery person commits an offence if:\n(a) the person possesses a substance; and\n(b) the substance is a Scheduled substance, other than a\nSchedule 5, 6 or 7 substance, that the person has been\nengaged by an authorised supplier to transport and deliver;\nand\n(c) the person leaves the substance unattended, other than in a\nlocked building or vehicle.\nMaximum penalty: 40 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n(3) In this regulation:\nauthorised supplier, see section 79(3) of the Act.\ndelivery person, see section 79(1) of the Act.\nDivision 4 Packaging and labelling\n33 Packaging requirements\n(1) For section 101(1)(c) of the Act, a Scheduled substance must be\npackaged in accordance with the container requirements set out in\nPart 2 of the medicines and poisons standard (the packaging\nrequirements).\n(2) However, the packaging requirements do not apply to the extent\nthat the holder of a manufacturer certificate of registration is exempt\nfrom compliance with the requirements under a corresponding law.\n34 Labelling requirements\n(1) For section 102(1)(c) of the Act, a container of a Scheduled\nsubstance must be labelled in accordance with the label\nrequirements set out in Part 2 of the medicines and poisons\nstandard (the labelling requirements).\nNote for subregulation (1)\nPart 2 of the medicines and poisons standard applies to health practitioners and\nholders of a manufacturer certificate of registration.\n(2) However, the labelling requirements do not apply to the extent that\n\nPart 2 Dealing with Scheduled substances\nDivision 5 Manufacture, supply and use of paints\nMedicines, Poisons and Therapeutic Goods Regulations 2014 19\nthe holder of a manufacturer certificate of registration is exempt\nfrom compliance with the requirements under a corresponding law.\n35 Container not to be used for human-use substance\nFor section 104(1)(b) of the Act, a container of a kind mentioned in\nparagraph 42, 43 or 46 of the medicines and poisons standard is\nprescribed.\nDivision 5 Manufacture, supply and use of paints\n36 Paint applied to premises, structures and furniture\nFor section 110(1) of the Act, a first schedule paint must not be\nmanufactured, supplied or used for application to:\n(a) a roof or other surface to be used for the collection or storage\nof potable 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.\n37 Paint for toys\nFor section 111(1)(b), (2)(c) and (3)(b) of the Act, a paint\nmanufactured, supplied or used for application to toys must comply\nwith the specification for coating materials in\nAS/NZS ISO 8124.3:2012 (Safety of toys – Migration of certain\nelements) as in force from time to time.\n38 Paint containing pesticide\n(1) For section 112(b) of the Act, the following pesticides are\nprescribed:\n(a) an algicide;\n(b) an antifouling agent;\n(c) a bactericide;\n(d) a fungicide.\n\nPart 3 Authorities to deal with Scheduled substances\nMedicines, Poisons and Therapeutic Goods Regulations 2014 20\n(2) However, subregulation (1) does not apply in relation to a paint for\nhuman therapeutic use.\nDivision 6 Advertising\n39 Pharmacist pricelist advertising certain Scheduled substances\n(1) For section 113(3)(b) of the Act, a pharmacist pricelist is prescribed.\n(2) In this regulation:\npharmacist pricelist means a pricelist published by or for a\npharmacist that:\n(a) includes a prescribed substance (other than a Schedule 9\nsubstance) as defined in section 113(4) of the Act; and\n(b) complies with the Price Information Code of Practice,\npublished by the Therapeutic Goods Administration, as in\nforce from time to time.\nPart 3 Authorities to deal with Scheduled substances\n40 Additional conditions – certificate of registration\n(1) For section 144(b) of the Act, the following are prescribed:\n(a) for a certificate of registration – the \"Australian Code of Good\nWholesaling Practice for Medicines in Schedules 2, 3, 4 and\n8\" (effective date 1 April 2011) published by the National\nCoordinating Committee on Therapeutic Goods, as in force\nfrom time to time;\n(b) for a manufacturer certificate of registration – Part 7 of the\n\"Code of Conduct\" published by Medicines Australia, as in\nforce from time to time.\n41 Duration of Schedule 8 authorisation for treating child's ADHD\n(1) For section 148(b) of the Act, a Schedule 8 authorisation for dealing\nwith an amphetamine for treating a child for ADHD remains in force\nuntil the child becomes an adult.\n(2) In this regulation:\nADHD means attention deficit hyperactivity disorder.\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 1 Pseudoephedrine register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 21\n42 Contents of authority\nFor section 149(b) of the Act, an authority must contain the\nfollowing information:\n(a) the name of the holder of the authority;\n(b) if the holder is a body corporate – the holder's ACN;\n(c) if the holder will be conducting business under the authority\nunder a business name – the business name;\n(e) the Scheduled substance to which the authority applies;\n(f) the dealing with the substance authorised by the authority\nand, if applicable, the address of the place where the holder is\nauthorised to deal with the substance;\n(g) a unique identifying number;\n(h) the date the authority is issued and the period it remains in\nforce;\n(i) for a certificate of registration – the nominated person;\n(j) for a pest management technician licence – the holder's date\nof birth.\n43 Authority holder to give notice of change of particulars\nFor section 173(1)(b) of the Act, the following particulars are\nprescribed:\n(a) the name of the holder of the authority;\n(b) the holder's business name;\n(c) the holder's postal address.\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 1 Pseudoephedrine register\n44 Keeping of register\nThe pharmacist-in-charge of a pharmacy or pharmacy department\nmust keep a register in relation to substances that:\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 2 Schedule 4 register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 22\n(a) contain pseudoephedrine; and\n(b) are supplied by retail sale from the pharmacy or pharmacy\ndepartment.\n45 Details to be recorded\nThe following details must be recorded in the register in relation to\neach retail sale:\n(a) the date of the sale;\n(b) the name of the substance, and the form, strength and\nquantity, sold;\n(c) the name and address of the purchaser;\n(d) the type and, if applicable, unique number of the photographic\nidentification of the purchaser produced at the time of sale.\nSubdivision 2 Schedule 4 register\n46 Keeping of register\nEach of the following persons must keep a register in relation to\nSchedule 4 substances that are supplied or administered under the\nperson's authorisation:\n(a) the holder of a Schedule 4 authorisation;\n(b) the holder of a research authorisation;\n(c) the holder of a medical kit authorisation.\n47 Details to be recorded\nThe following details must be recorded in the register in relation to\neach supply or administration:\n(a) the nature of the dealing;\n(b) the date of the dealing;\n(c) the name of the substance, and the form, strength and\nquantity, dealt with;\n(d) if the substance was supplied – the name and address of the\nperson to whom it was supplied;\n(e) if the substance was administered:\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 4 Schedule 8 register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 23\n(i) to a person – the name and address of the person; or\n(ii) to an animal – the name and address of the person who\nowns, or is in charge of, the animal.\nSubdivision 3 Schedule 7 register\n48 Keeping of register\nEach of the following persons must keep a register in relation to\nSchedule 7 substances that are dealt with under the person's\nauthorisation or licence:\n(a) the holder of a Schedule 7 authorisation;\n(b) the holder of a pest management technician licence;\n(c) the licensee under a retailer licence.\n49 Details to be recorded\nThe following details must be recorded in the register in relation to\neach dealing (other than possession):\n(a) the nature of the dealing;\n(b) the date of the dealing;\n(c) the name of the substance, and the form, strength and\nquantity, dealt with;\n(d) if the dealing was receiving the substance – the name and\naddress of the supplier;\n(e) if the dealing was supplying the substance – the name,\naddress and, if applicable, authorisation or licence number of\nthe recipient;\n(f) the quantity of the substance held after the dealing.\nSubdivision 4 Schedule 8 register\n50 Maintenance of register – persons in charge of premises\n(1) A person mentioned in the table below must maintain a register in\nrelation to Schedule 8 substances that are supplied to, or otherwise\ndealt with, at the place mentioned opposite.\nPerson Place\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 4 Schedule 8 register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 24\nPerson Place\nThe nurse in charge of a ward or\ndepartment of a hospital\nThe ward or department\nThe nurse in charge of a\nresidential facility\nThe residential facility\nThe person in charge of a declared\nplace\nThe declared place\nA doctor Each premises from which the doctor\npractises, other than a hospital\nA dentist Each premises from which the dentist\npractises\nA podiatrist Each premises from which the\npodiatrist practises\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 4 Schedule 8 register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 25\nPerson Place\nThe pharmacist-in-charge of a\npharmacy or pharmacy department\nThe pharmacy or pharmacy\ndepartment\nThe person in charge of an\nambulance service\nThe premises from which the\nambulance service operates\nA nurse Each premises from which the nurse\npractises, other than:\n(a) a hospital, residential facility or\ndeclared place; or\n(b) another place from which a\ndoctor, dentist or podiatrist\npractices.\nA midwife Each premises from which the\nmidwife practises, other than:\n(a) a hospital or declared place; or\n(b) another place from which a\ndoctor practices.\nA veterinarian Each premises from which the\nveterinarian practises\n(2) However, subregulation (1) does not apply to the person in relation\nto:\n(a) a Schedule 8 substance in a medical kit; or\n(b) if the person is the nurse in charge of a residential facility – a\nSchedule 8 substance dispensed in a dose administration aid\nfor a resident of the facility; or\n(c) if the person is the nurse in charge of a declared place – a\nSchedule 8 substance dispensed in a dose administration aid\nfor a person receiving medical treatment at the place.\n(3) Only 1 register is to be kept for each place mentioned in\nsubregulation (1).\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 4 Schedule 8 register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 26\n51 Keeping of register – medical kit holder\nThe holder of a medical kit authorisation must keep a register in\nrelation to Schedule 8 substances that are dealt with under the\nauthorisation.\n52 Keeping of register – other persons\nEach of the following persons must keep a register in relation to\nSchedule 8 substances that are dealt with under the person's\ncertificate or authorisation:\n(a) the holder of a manufacturer certificate of registration;\n(b) the holder of a wholesaler certificate of registration;\n(c) the holder of a Schedule 8 authorisation;\n(d) the holder of a research authorisation.\n53 Form of Schedule 8 register\n(1) A Schedule 8 register must contain:\n(a) a separate page for each form and strength of a Schedule 8\nsubstance; or\n(b) if the register is kept electronically – a separate record for\neach form and strength of a Schedule 8 substance.\n(2) However, the CHO may dispense with this requirement in relation\nto a particular Schedule 8 register.\n54 Details to be recorded\n(1) The following details must be recorded in a Schedule 8 register in\nrelation to each dealing with a Schedule 8 substance (other than\npossession):\n(a) the nature of the dealing;\n(b) the date of the dealing;\n(c) the name of the substance, and the form, strength and\nquantity, dealt with;\n(d) if the dealing was receiving the substance – the name and\naddress of the supplier;\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 4 Schedule 8 register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 27\n(e) if the dealing was supplying the substance other than as\nmentioned in subregulation (2) – the name and address of the\nrecipient;\n(f) if the dealing was administering the substance other than as\nmentioned in subregulation (2):\n(i) the name of:\n(A) the person to whom it was administered; or\n(B) the person who owns, or is in charge of, the animal\nto which it was administered; and\n(ii) the name of the person who administered it;\n(g) if the substance was supplied on a prescription – the name of\nthe person who issued the prescription;\n(h) if the dealing was destroying the substance:\n(i) the name of the person who destroyed the substance;\nand\n(ii) the name of the person who witnessed the destruction;\n(i) the quantity of the substance held after the dealing.\n(2) In addition, if the dealing was supplying or administering the\nSchedule 8 substance to a patient of a hospital, a resident of a\nresidential facility or a person receiving medical treatment at a\ndeclared place, the following details must be recorded:\n(a) the name of the patient, resident or person;\n(b) for a patient – the patient's hospital registration number;\n(c) the time the substance was supplied or administered;\n(d) the name of the person who authorised the supply or\nadministration;\n(e) the name of the person who supplied or administered it;\n(f) the name of the person who witnessed the supply or\nadministration.\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 5 Schedule 9 register\nMedicines, Poisons and Therapeutic Goods Regulations 2014 28\nSubdivision 5 Schedule 9 register\n55 Keeping of register\nEach of the following persons must keep a register in relation to\nSchedule 9 substances that are dealt with under the person's\ncertificate or authorisation:\n(a) the holder of a manufacturer certificate of registration;\n(b) the holder of a wholesaler certificate of registration;\n(c) the holder of a prohibited substance authorisation;\n(d) the holder of a research authorisation.\n56 Form of Schedule 9 register\nThe register must contain:\n(a) a separate page for each form and strength of a Schedule 9\nsubstance; or\n(b) if the register is kept electronically – a separate record for\neach form and strength of a Schedule 9 substance.\n57 Details to be recorded\nThe following details must be recorded in the register in relation to\neach dealing (other than possession):\n(a) the nature of the dealing;\n(b) the date of the dealing;\n(c) the name of the substance, and the form, strength and\nquantity, dealt with;\n(d) if the dealing was receiving the substance – the name and\naddress of the supplier;\n(e) if the dealing was administering the substance:\n(i) the name of the person to whom it was administered;\nand\n(ii) the name of the person who administered it; and\n(iii) the name of the person who witnessed the\nadministration;\n\nPart 4 Scheduled substance registers\nDivision 1 Maintaining Scheduled substance registers\nSubdivision 7 General requirements\nMedicines, Poisons and Therapeutic Goods Regulations 2014 29\n(f) if the dealing was destroying the substance:\n(i) the name of the person who destroyed the substance;\nand\n(ii) the name of the authorised officer who witnessed the\ndestruction;\n(g) the quantity of the substance held after the dealing.\nSubdivision 6 Manufacturer/wholesaler/Schedule 4 supplier\n58 Keeping of register\nThe holder of a certificate of registration must keep a register in\nrelation to Schedule 2, 3, 4 and 7 substances that are dealt with\nunder the certificate.\n59 Details to be recorded\nThe following details must be recorded in the register in relation to\neach dealing (other than possession):\n(a) the nature of the dealing;\n(b) the date of the dealing;\n(c) the name of the substance, and the form, strength and\nquantity, dealt with;\n(d) if the dealing was receiving the substance – the name and\naddress of the supplier;\n(e) if the dealing was supplying the substance – the name and\naddress and, if applicable, authorisation or licence number of\nthe recipient;\n(f) the quantity of the substance held after the dealing.\nSubdivision 7 General requirements\n60 Form of register entries\nAn entry in a Scheduled substance register must be:\n(a) legible and expressed in the English language; and\n(b) made as soon as practicable after the dealing to which the\nentry relates happens.\n\nPart 4 Scheduled substance registers\nDivision 2 Offences relating to Scheduled substance registers\nMedicines, Poisons and Therapeutic Goods Regulations 2014 30\n61 Period of retention of registers\n(1) A Scheduled substance register, other than a register in relation to\nSchedule 7 substances, must be kept for at least 2 years after the\nday on which the last entry is made in the register.\n(2) A register in relation to Schedule 7 substances must be kept for at\nleast 7 years after the day on which the last entry is made in the\nregister.\nDivision 2 Offences relating to Scheduled substance\nregisters\n62 Offence not to maintain register\n(1) A person who is required to maintain a Scheduled substance\nregister commits an offence if the person:\n(a) fails to maintain the register; or\n(b) fails to maintain the register in accordance with the\nrequirements of Division 1.\nMaximum penalty: 50 penalty units.\n(2) An offence against subregulation (1) is an offence of strict liability.\n63 Offence not to sign entry\n(1) A person commits an offence if the person:\n(a) makes an entry in a Scheduled substance register; and\n(b) fails to sign the entry as soon as practicable after it is made.\nMaximum penalty: 20 penalty units.\n(2) Strict liability applies to subregulation (1)(b).\n64 Offence to make false or misleading entry\nA person commits an offence if the person:\n(a) makes an entry in a Scheduled substance register; and\n(b) knows the entry contains information that is misleading in a\nmaterial particular or because of the omission of a material\nparticular.\nMaximum penalty: 80 penalty units.\n\nPart 4 Scheduled substance registers\nDivision 2 Offences relating to Scheduled substance registers\nMedicines, Poisons and Therapeutic Goods Regulations 2014 31\n65 Offence to change entry\n(1) A person commits an offence if the person cancels, changes,\ndeletes or obliterates an entry in a Scheduled substance register.\nMaximum penalty: 20 penalty units.\n(2) However, subregulation (1) does not apply to a person if the\nperson:\n(a) made the entry in the Scheduled substance register; and\n(b) changes the entry as permitted under subregulation (3) or (4).\n(3) An entry in a paper-based Scheduled substance register may be\nchanged by the person signing and dating a marginal note or\nfootnote that gives the correct details.\n(4) An entry in an electronic Scheduled substance register may be\nchanged by the person attaching or linking, by electronic means, a\ndocument that includes the person's signature, the date and the\ncorrect details.\n66 Offence not to record details of supply of pseudoephedrine\n(1) A person commits an offence if the person:\n(a) supplies, by retail sale from a pharmacy or pharmacy\ndepartment, a substance that contains pseudoephedrine; and\n(b) fails to:\n(i) sight photographic identification of the purchaser; or\n(ii) record in the Scheduled substance register for the\nsubstance each of the details specified in regulation 45.\nMaximum penalty: 20 penalty units.\n(2) Strict liability applies to subregulation (1)(b).\n67 Offence not to sign register after certain dealings with\nSchedule 8 or 9 substance\n(1) A person commits an offence if:\n(a) the person supplies, administers, otherwise uses or destroys a\nSchedule 8 or 9 substance; and\n(b) an entry about the dealing is made in the Scheduled\nsubstance register for the substance by a third party; and\n\nPart 4 Scheduled substance registers\nDivision 2 Offences relating to Scheduled substance registers\nMedicines, Poisons and Therapeutic Goods Regulations 2014 32\n(c) the person fails to sign the entry in the register as soon as\npracticable after it is made.\nMaximum penalty: 40 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n68 Offence not to sign register after witnessing certain dealings\nwith Schedule 8 or 9 substance\n(1) A person commits an offence if:\n(a) the person witnesses the supply, administration or destruction\nof a Schedule 8 or 9 substance; and\n(b) an entry about the dealing that names the person as the\nwitness to the dealing is made in the Scheduled substance\nregister for the substance by a third party; and\n(c) the person fails to sign the entry in the register as witness as\nsoon as practicable after it is made.\nMaximum penalty: 40 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n69 Offence not to ensure witness signs register after certain\ndealings with Schedule 8 or 9 substance\n(1) A person commits an offence if:\n(a) the person:\n(i) destroys a Schedule 8 substance; or\n(ii) administers or destroys a Schedule 9 substance; and\n(b) an entry about the dealing that names another person as the\nwitness to the dealing is made in the Scheduled substance\nregister for the substance; and\n(c) the witness fails to sign the entry in the register as soon as\npracticable after it is made.\nMaximum penalty: 40 penalty units.\nNote for regulation 69\nSection 100 of the Act contains a similar offence in relation to the supply or\nadministration of Schedule 8 substances.\n(2) Strict liability applies to subregulation (1)(c).\n\nPart 4 Scheduled substance registers\nDivision 2 Offences relating to Scheduled substance registers\nMedicines, Poisons and Therapeutic Goods Regulations 2014 33\n70 Offence not to maintain register where substance kept\n(1) A person who is required to maintain a Scheduled substance\nregister in relation to a Scheduled substance commits an offence if\nthe person fails to maintain the register:\n(a) at the premises in which the Scheduled substance is kept; or\n(b) for a Schedule 8 substance in a medical kit – with the medical\nkit.\nMaximum penalty: 20 penalty units.\n(2) An offence against subregulation (1) is an offence of strict liability.\n71 Offence not to report possible loss etc. of Scheduled\nsubstance\n(1) A person who is required to maintain a Scheduled substance\nregister commits an offence if the person:\n(a) becomes aware of a substantial risk that a Scheduled\nsubstance in relation to which the register is maintained has\nbeen lost, misappropriated or stolen; and\n(b) fails to give the CHO written notice about the risk as soon as\npracticable (but not later than 7 days) after becoming aware of\nit.\nMaximum penalty: 20 penalty units.\n(2) Strict liability applies to subregulation (1)(b).\n72 Offence not to report destruction, loss etc. of register\n(1) A person who is required to maintain a Scheduled substance\nregister commits an offence if:\n(a) the register is damaged in a material respect, destroyed,\nstolen or lost; and\n(b) the person fails to give the CHO written notice about the\ndamage, destruction, theft or loss as soon as practicable (but\nnot later than 7 days) after the day it happens.\nMaximum penalty: 20 penalty units.\n(2) Strict liability applies to subregulation (1)(b).\n\nPart 5 Other records and notices\nDivision 1 General requirements\nMedicines, Poisons and Therapeutic Goods Regulations 2014 34\n(3) This regulation does not apply in relation to a Scheduled substance\nregister if the most recent entry in the register is made more than\n2 years before the day the register is damaged, stolen, lost or\ndestroyed.\n(4) In this regulation, a Scheduled substance register is damaged in a\nmaterial respect if anything required to be entered in the register is\nmissing or cannot be easily read.\nPart 5 Other records and notices\nDivision 1 General requirements\n73 Retention of documents relating to receipt or supply of\nScheduled substances\n(1) A health practitioner or veterinarian who, in the course of practising\nin a health profession or providing veterinary services, receives or\nsupplies a Schedule 4 or 8 substance must keep the original or a\ncopy of each delivery docket or invoice relating to the receipt or\nsupply.\n(2) The holder of an authority, other than a certificate of registration,\nwho receives a Scheduled substance to which the authority applies\nmust keep the original or a copy of each delivery docket or invoice\nrelating to the receipt.\n(3) The holder of a certificate of registration who receives or supplies a\nSchedule 2, 3, 4 or 7 substance to which the certificate applies\nmust keep the original or a copy of each delivery docket or invoice\nrelating to the receipt or supply.\n74 Retention of prescriptions\nThe pharmacist-in-charge of a pharmacy or pharmacy department\nmust keep a copy of each prescription that is filled at the pharmacy\nor pharmacy department.\n75 Record of supply or administration of Schedule 4 or 8\nsubstance in clinical or other records\n(1) Subregulation (2) applies to a health practitioner or veterinarian\nwho supplies or administers a Schedule 4 or 8 substance to or for a\nperson or animal (the patient) in relation to whom the practitioner\nor veterinarian keeps clinical records.\n\nPart 5 Other records and notices\nDivision 1 General requirements\nMedicines, Poisons and Therapeutic Goods Regulations 2014 35\n(2) As soon as practicable after the dealing, the health practitioner or\nveterinarian must record the following details in relation to the\ndealing in the clinical records of the patient:\n(a) the nature of the dealing;\n(b) the date of the dealing;\n(c) the name of the substance, and the form, strength and\nquantity, dealt with;\n(d) if the dealing was supplying the substance to someone other\nthan the patient – the name and address of the person to\nwhom it was supplied;\n(e) if the dealing was supplying the substance on a prescription –\nthe name and address of the person who issued the\nprescription.\n(3) Subregulation (4) applies to a health practitioner who supplies a\nSchedule 4 substance to a person in relation to whom the\npractitioner does not keep clinical records.\n(4) As soon as practicable after the dealing, the health practitioner\nmust record the following details in relation to the dealing in an\nappropriate record:\n(a) the date of the supply;\n(b) the name of the substance, and the form, strength and\nquantity, supplied;\n(c) the name and address of the person to whom it was supplied;\n(d) if the substance was supplied on a prescription:\n(i) the name and address of the person for whom the\nprescription was issued; and\n(ii) the name and address of the person who issued the\nprescription.\n76 Form and period of retention of records\n(1) A record that a person is required to make under this Division must\nbe legible and expressed in the English language.\n(2) A record that a person is required under this Division to make or\nkeep must be kept for at least 2 years after the day on which it was\nmade or received.\n\nPart 5 Other records and notices\nDivision 2 Offences relating to records and notices\nMedicines, Poisons and Therapeutic Goods Regulations 2014 36\nDivision 2 Offences relating to records and notices\n77 Offence not to make or keep record\n(1) A person who, under Division 1, is required to make or keep a\nrecord commits an offence if the person:\n(a) fails to make or keep the record; or\n(b) fails to make or keep the record in accordance with the\nrequirements of Division 1.\nMaximum penalty: 50 penalty units.\n(2) An offence against subregulation (1) is an offence of strict liability.\n78 Offence not to give fraudulent prescription to police\n(1) A pharmacist commits an offence if the pharmacist:\n(a) receives a prescription; and\n(b) becomes aware of a substantial risk that the prescription has\nbeen forged or fraudulently altered; and\n(c) fails to give a copy of the prescription to the Commissioner of\nPolice as soon as practicable (but not later than 7 days) after\nbecoming aware of the risk.\nMaximum penalty: 80 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\n79 Offence not to report supply or administration of Schedule 8\nsubstance at declared place\n(1) A person in charge of a declared place commits an offence if:\n(a) a Schedule 8 substance is supplied or administered to a\nperson at the declared place; and\n(b) the person in charge fails to give notice of the supply or\nadministration in the approved form to the CHO within 7 days\nafter the date of supply or administration.\nMaximum penalty: 50 penalty units.\n(2) Strict liability applies to subregulation (1)(b).\n\nPart 6A Monitored medicines database\nMedicines, Poisons and Therapeutic Goods Regulations 2014 37\n80 Offence not to report administration of Schedule 8 substance\nfrom medical kit\n(1) The holder of a medical kit authorisation commits an offence if:\n(a) the holder administers a substance to a person; and\n(b) the substance is a Schedule 8 substance that is in the holder's\npossession under the authorisation; and\n(c) the holder fails to give notice of the administration in the\napproved form to the CHO within 7 days after the date of\nadministration.\nMaximum penalty: 50 penalty units.\n(2) Strict liability applies to subregulation (1)(c).\nPart 6 Legal proceedings\n81 Declared provisions\nFor paragraph (b) of the definition declared provision in\nsection 212 of the Act, regulations 22, 23, 25, 27, 28, 29, 30, 62, 64\nand 80 are declared provisions.\n81A Declared provisions\nFor section 215(7) of the Act, definition declared EO liability\nprovision, paragraph (b), regulation 31 is prescribed.\nPart 6A Monitored medicines database\n81B Definitions\nIn this Part:\ncustodial correctional facility, see section 11(1)(a) of the\nCorrectional Services Act 2014.\nprisoner, see section 6 of the Correctional Services Act 2014.\n81C Monitored medicine\nFor section 243A of the Act, definition monitored medicine,\nparagraph (b), the following Scheduled substances are prescribed:\n(a) each benzodiazepine that is a Schedule 4 substance;\n\nPart 6A Monitored medicines database\nMedicines, Poisons and Therapeutic Goods Regulations 2014 38\n(b) codeine;\n(c) gabapentin;\n(d) pregabalin;\n(e) quetiapine;\n(f) tramadol;\n(g) zolpidem;\n(h) zopiclone.\n81D Database name\nFor section 243C(1) of the Act, the name NTScript is prescribed.\n81E Information to be given to CHO\n(1) For section 243E(1)(a) of the Act, the prescribed information in\nrelation to a recordable prescription is as follows:\n(a) the date the prescription was issued;\n(b) the name and address of the person to whom the prescription\nwas issued;\n(c) the date of birth of the person to whom the prescription was\nissued;\n(d) the name, form, strength and quantity of the monitored\nmedicine prescribed;\n(e) the number of repeats permitted under the prescription;\n(f) the directions for use of the monitored medicine;\n(g) the name, address and phone number of the person who\nissued the prescription.\n(2) For section 243E(1)(b) of the Act, the prescribed information in\nrelation to a recordable supply is as follows:\n(a) the date of the supply;\n(b) the name and address of the person to whom the supply was\nmade;\n(c) the date of birth of the person to whom the supply was made;\n\nPart 6A Monitored medicines database\nMedicines, Poisons and Therapeutic Goods Regulations 2014 39\n(d) the name, form, strength and quantity of the monitored\nmedicine supplied;\n(e) the directions for use of the monitored medicine supplied;\n(f) the name, address and phone number of the person who\nauthorised the supply;\n(g) the name, address and phone number of the pharmacy or\npharmacy department from which the supply was made.\n(3) For section 243E(1)(c) of the Act, the prescribed information:\n(a) in relation to a recordable prescription – is the information\nspecified in subregulation (1); and\n(b) in relation to a recordable supply – is the information specified\nin subregulation (2).\n81F Prescription issued by relevant prescriber in exempt\ncircumstances\nFor section 243J(1)(c) of the Act, the following circumstances are\nexempt:\n(a) a relevant prescriber issues a prescription for a monitored\nmedicine to a person who is being treated in an aged care\nfacility;\n(b) a relevant prescriber issues a prescription for a monitored\nmedicine to a person who is a prisoner in a custodial\ncorrectional facility;\n(c) a relevant prescriber issues a prescription for a monitored\nmedicine to a person who is suffering a life threatening illness\nand the supply of the monitored medicine is intended to\nprovide palliative treatment in an end of life situation.\n81G Supply made by pharmacist in exempt circumstances\nFor section 243K(1)(c) of the Act, the following circumstances are\nexempt:\n(a) a pharmacist supplies a monitored medicine to a person who\nis being treated in an aged care facility;\n(b) a pharmacist supplies a monitored medicine to a person who\nis a prisoner in a custodial correctional facility;\n\nPart 7 Infringement notice offences\nMedicines, Poisons and Therapeutic Goods Regulations 2014 40\n(c) a pharmacist supplies a monitored medicine to a person who\nis suffering a life threatening illness and the supply of the\nmonitored medicine is intended to provide palliative treatment\nin an end of life situation.\nPart 7 Infringement notice offences\n82 Infringement notice offence and prescribed amount payable\n(1) An infringement notice offence is an offence against a provision\nspecified in Schedule 1.\n(2) The prescribed amount for an infringement notice offence is the\namount equal to the monetary value of the number of penalty units\nspecified for the offence in Schedule 1.\n83 When infringement notice may be given\nIf an authorised officer reasonably believes a person has committed\nan infringement notice offence, the officer may give a notice (an\ninfringement notice) to the person.\n84 Contents of infringement notice\n(1) The infringement notice must specify the following:\n(a) the name and address of the person, if known;\n(b) the date the infringement notice is given to the person;\n(c) the date, time and place of the infringement notice offence;\n(d) a description of the offence;\n(e) the prescribed amount payable for the offence;\n(f) the enforcement agency, as defined in the Fines and Penalties\n(Recovery) Act 2001, to whom the prescribed amount is\npayable.\n(2) The infringement notice must include a statement to the effect of\nthe following:\n(a) the person may expiate the infringement notice offence and\navoid any further action in relation to the offence by paying the\nprescribed amount to the specified enforcement agency within\n28 days after the notice is given;\n\nPart 7 Infringement notice offences\nMedicines, Poisons and Therapeutic Goods Regulations 2014 41\n(b) the person may elect under section 21 of the Fines and\nPenalties (Recovery) Act 2001 to have the matter dealt with by\na court instead of under that Act by completing a statement of\nelection and giving it to the specified enforcement agency;\n(c) if the person does nothing in response to the notice,\nenforcement action may be taken under the Fines and\nPenalties (Recovery) Act 2001, including (but not limited to)\naction for the following:\n(i) suspending the person's licence to drive;\n(ii) seizing personal property of the person;\n(iii) deducting an amount from the person's wages or salary;\n(iv) registering a statutory charge on land owned by the\nperson;\n(v) making a community work order for the person and\nimprisonment of the person if the person breaches the\norder.\n(3) Also, the infringement notice must include an appropriate form for\nmaking the statement of election mentioned in subregulation (2)(b).\n85 Payment by cheque\nIf the person tenders a cheque in payment of the prescribed\namount, the amount is not taken to have been paid unless the\ncheque is cleared on first presentation.\n86 Withdrawal of infringement notice\n(1) The CHO may withdraw the infringement notice by written notice\ngiven to the person.\n(2) The notice must be given:\n(a) within 28 days after the infringement notice is given to the\nperson; and\n(b) before payment of the prescribed amount.\n87 Application of Part\n(1) This Part does not prejudice or affect the start or continuation of\nproceedings for an infringement notice offence for which an\ninfringement notice has been given unless the offence is expiated.\n\nPart 8 Miscellaneous matters\nMedicines, Poisons and Therapeutic Goods Regulations 2014 42\n(2) Also, this Part does not:\n(a) require an infringement notice to be given; or\n(b) affect the liability of a person to be prosecuted in a court for an\noffence for which an infringement notice has not been given;\nor\n(c) prevent more than one infringement notice for the same\noffence being given to a person.\n(3) If more than one infringement notice for the same offence has been\ngiven to a person, the person may expiate the offence by paying\nthe prescribed amount in accordance with any of the notices.\nPart 8 Miscellaneous matters\n89 Information in register of authorities\nFor section 255(3) of the Act, a register of authorities must contain\nthe following particulars for each authority to which it relates:\n(a) the name of the holder of the authority;\n(b) if the holder is a body corporate – the holder's ACN;\n(c) if the holder of the authority will be conducting business under\nthe authority under a business name – the business name;\n(d) the holder's postal address;\n(e) the type of authority;\n(f) the unique identifying number of the authority;\n(g) each Scheduled substance to which the authority applies;\n(h) the dealing with the substance authorised by the authority\nand, if applicable, the address of the place where the holder is\nauthorised to deal with the substance;\n(i) the date the authority was issued or renewed and the period it\nis in force;\n(j) any conditions of the authority imposed by the CHO;\n(k) any suspension or cancellation of the authority and the\nreasons for it;\n(l) for a certification of registration – the nominated person.\n\nPart 8 Miscellaneous matters\nMedicines, Poisons and Therapeutic Goods Regulations 2014 43\n90 Appointed Committee members\nFor section 265 of the Act, the following are the qualification\nrequirements for appointed members of the Committee:\n(a) 2 members must be doctors with expertise in pain\nmanagement or rehabilitation;\n(b) 2 members must be doctors with experience in general\npractice;\n(c) one member must be a doctor who is employed in the Agency\nand working in the community drugs program managed by the\nAgency;\n(d) one member must be a person who is employed in the Agency\nand working in the community drugs program managed by the\nAgency but who is not a doctor;\n(e) one member must be a pharmacist with experience in the\ncommunity pharmacy practice area;\n(f) one member must be a pharmacist with experience in the\nhospital or clinical pharmacy practice area;\n(g) any other appointed member must be:\n(i) a health practitioner; or\n(ii) a veterinarian; or\n(iii) a lawyer; or\n(iv) a person who is employed in the Agency and working in\nthe community drugs program managed by the Agency\nbut who is not a doctor.\n91 Fees\nThe fees specified in Schedule 2 are payable for the matter\nspecified opposite.\n\nSchedule 1 Infringement notice offences and prescribed amounts\nMedicines, Poisons and Therapeutic Goods Regulations 2014 44\nSchedule 1 Infringement notice offences and prescribed\namounts\nregulation 82\nProvision Prescribed amount in penalty units\nfor individual for body corporate\nMedicines, Poisons and Therapeutic Goods Act 2012\nsections 97(2) and (3) and 107(1) 1\nsections 112B(1) and 112C(2) 3\nsection 176(1) and (2) 1\nsection 243H(1) 2 10\nsections 243J(1) and 243K(1) 2\nMedicines, Poisons and Therapeutic Goods Regulations 2014\nregulations 31(1), 62(1) and 77(1) 3\nregulations 19(1), 28(1), 29(1),\n30(1), 67(1), 68(1) and 69(1)\n2\nregulations 27(1), 63(1), 65(1),\n66(1), 70(1), 71(1) and 72(1)\n1\n\nSchedule 2 Fees\nMedicines, Poisons and Therapeutic Goods Regulations 2014 45\nSchedule 2 Fees\nregulation 91\nMatter Fee\n(revenue units)\n1 Application for\n(a) manufacturer certificate of registration 50 plus 100 for each\nyear the certificate will\nbe in force\n(b) wholesaler certificate of registration 50 plus 100 for each\nyear the certificate will\nbe in force\n(ba) Schedule 4 supplier certificate of\nregistration\n50 plus 100 for each\nyear the certificate will\nbe in force\n(c) retailer licence 50 plus 50 for each year\nthe licence will be in\nforce\n(ca) Schedule 3 authorisation 50 for each year the\nauthorisation will be in\nforce\n(d) Schedule 4 authorisation 50 for each year the\nauthorisation will be in\nforce\n(e) Schedule 7 authorisation 50 for each year the\nauthorisation will be in\nforce\n(f) pest management technician licence 50 for each year the\nlicence will be in force\n(g) Schedule 8 authorisation other than\nan authorisation for the issue of\nprescriptions for therapeutic use\n50 for each year the\nauthorisation will be in\nforce\n(h) prohibited substance authorisation 50 for each year the\nauthorisation will be in\nforce\n\nSchedule 2 Fees\nMedicines, Poisons and Therapeutic Goods Regulations 2014 46\nMatter Fee\n(revenue units)\n(i) research authorisation 50 for each year the\nauthorisation will be in\nforce\n(j) medical kit authorisation 50 for each year the\nauthorisation will be in\nforce\n2 Renewal of\n(a) manufacturer certificate of registration 100 for each year the\ncertificate will be in force\nafter renewal\n(b) wholesaler certificate of registration 100 for each year the\ncertificate will be in force\nafter renewal\n(ba) Schedule 4 supplier certificate of\nregistration\n100 for each year the\ncertificate will be in force\nafter renewal\n(c) retailer licence 50 for each year the\nlicence will be in force\nafter renewal\n3 Transfer of certificate of registration 50\n4 Replacement of authority 50\n\nENDNOTES\nMedicines, Poisons and Therapeutic Goods Regulations 2014 47\nENDNOTES\n1 KEY Key to abbreviations\namd = amended od = order\napp = appendix om = omitted\nbl = by-law pt = Part\nch = Chapter r = regulation/rule\ncl = clause rem = remainder\ndiv = Division renum = renumbered\nexp = expires/expired rep = repealed\nf = forms s = section\nGaz = Gazette sch = Schedule\nhdg = heading sdiv = Subdivision\nins = inserted SL = Subordinate Legislation\nlt = long title sub = substituted\nnc = not commenced\n2 LIST OF LEGISLATION\nMedicines, Poisons and Therapeutic Goods Regulations (SL No. 10, 2014)\nNotified 19 April 2014\nCommenced 1 May 2014 (r 2, s 2 Medicines, Poisons and Therapeutic\nGoods Act 2012 (Act No. 13, 2012) and Gaz S22,\n30 April 2014, p 12)\nStatute Law Amendment (Directors' Liability) Act 2015 (Act No. 26, 2015)\nAssent date 18 September 2015\nCommenced 14 October 2015 (Gaz G41, 14 October 2015, p 3)\nStatute Law Revision Act 2017 (Act No. 4, 2017)\nAssent date 10 March 2017\nCommenced 12 April 2017 (Gaz G15, 12 April 2017, p 3)\nMedicines, Poisons and Therapeutic Goods Amendment Regulations 2020 (SL No. 3,\n2020)\nNotified 9 April 2020\nCommenced 9 April 2020\nMedicines, Poisons and Therapeutic Goods Legislation Amendment Act 2021 (Act\nNo. 27, 2021)\nAssent date 15 December 2021\nCommenced 16 December 2021 (s 2)\nMedicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 (Act\nNo. 25, 2022)\nAssent date 9 December 2022\nCommenced 10 December 2022 (s 2)\nStatute Law Revision and Repeals Act 2026 (Act No. 3, 2026)\nAssent date 9 February 2026\nCommenced 10 February 2026 (s 2)\n\nENDNOTES\nMedicines, Poisons and Therapeutic Goods Regulations 2014 48\n3 GENERAL AMENDMENTS\nGeneral amendments of a formal nature (which are not referred to in the table\nof amendments to this reprint) are made by the Interpretation Legislation\nAmendment Act 2018 (Act No. 22 of 2018) to: rr 1, 2, 3, 9, 84 and sch 1.\n4 LIST OF AMENDMENTS\nr 3 amd Act No. 4, 2017, s 34; Act No. 27, 2021, s 13; Act No. 25, 2022, s 56\nr 3A ins Act No. 25, 2022, s 57\nr 5 amd Act No. 27, 2021, s 14\npt 2 hdg amd Act No. 4, 2017, s 34\nrr 7A – 7B ins Act No. 27, 2021, s 15\npt 2\ndiv 1A ins Act No. 25, 2022, s 58\nrr 17A – 17C ins Act No. 25, 2022, s 58\nr 18 amd Act No. 25, 2022, s 59\nr 23 amd Act No. 25, 2022, s 60\nrr 32 – 34 amd Act No. 4, 2017, s 34\nr 35 amd Act No. 3, 2026, s 47\npt 3 hdg amd Act No. 4, 2017, s 34\nr 42 amd Act No. 4, 2017, s 34; Act No. 25, 2022, s 61\npt 4 hdg amd Act No. 4, 2017, s 34\npt 4\ndiv 1 hdg amd Act No. 4, 2017, s 34\npt 4\ndiv 1\nsdiv 6 hdg amd Act No. 25, 2022, s 62\nr 60 amd Act No. 4, 2017, s 34\nr 61 amd Act No. 4, 2017, s 34\nsub Act No. 25, 2022, s 63\npt 4\ndiv 2 hdg amd Act No. 4, 2017, s 34\nrr 62 – 73 amd Act No. 4, 2017, s 34\nr 81A ins Act No. 26, 2015, s 78\npt 6A hdg ins Act No. 27, 2021, s 16\nrr 81B – 81G ins Act No. 27, 2021, s 16\npt 8 hdg amd No. 3, 2020, r 4\nr 87A ins No. 3, 2020, r 5\nrep Act No. 25, 2022, s 64\nr 88 rep Act No. 25, 2022, s 64\nr 89 amd Act No. 4, 2017, s 34\nr 90 sub Act No. 25, 2022, s 65\npt 9 hdg exp Act No. 13, 2012, s 294(5)\nrr 92 – 93 exp Act No. 13, 2012, s 294(5)\nsch 1 sub Act No. 27, 2021, s 17\namd Act No. 25, 2022, s 66\nsch 2 amd Act No. 25, 2022, s 67","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"Based on the available metadata, there is no clear indication that the scope has changed from the original intent of the parent Act (Medicines, Poisons and Therapeutic Goods Act 2008, ACT). The regulations appear to remain within the standard purpose of providing detailed operational rules for the safe handling, supply, and control of medicines and poisons in the ACT. However, the unusually long delay between making (2020) and commencement (2026) may suggest amendments or scope adjustments occurred during that period, but this cannot be confirmed from the metadata alone."},"complexity_factors":["Covers multiple distinct regulatory domains simultaneously — medicines, poisons, AND therapeutic goods each carry their own technical frameworks","Intersects with federal law (the Therapeutic Goods Act 1989 and TGA regulatory scheme), requiring readers to understand both Commonwealth and Territory-level rules","Highly technical subject matter involving pharmaceutical classifications, scheduling systems (e.g. Schedule 4, Schedule 8 drugs), and medical terminology","Applies to a wide range of regulated parties — from individual practitioners to large commercial entities — each with different obligations","The metadata provided is minimal, making it difficult to assess the full scope and content without the actual regulatory text","Significant gap between date of making (April 2020) and commencement (February 2026), which raises questions about transitional arrangements and why the delay exists","Regulations of this type typically contain numerous cross-references to other instruments, schedules, and standards"],"plain_english_summary":"These regulations set detailed rules for how medicines, poisons and therapeutic goods are prescribed, supplied, stored, packaged and recorded in the ACT, affecting pharmacists, prescribers, manufacturers, sellers and consumers. They aim to protect public safety by controlling access to dangerous substances and ensuring correct labelling, handling and record‑keeping, with penalties for breaches. Note: the regulations were made in 2020 but do not commence until 10 February 2026."},"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"The Regulations' scope has expanded since the original 2014 text. Notable insertions include a monitored medicines database (Part 6A: regs 81B–81G inserted by Act No. 27, 2021, s 16), a Division addressing administering/supplying under SSTP and prescribed practitioner/witness classes (Div 1A: regs 17A–17C inserted by Act No. 25, 2022, s 58), and new prescription conditions (regs 7A–7B inserted by Act No. 27, 2021, s 15; reg 3A added by Act No. 25, 2022, s 57). These amendments broaden reporting duties, add prescribed medicines and classes of regulated actors, and increase recordkeeping and reporting obligations."},"complexity_factors":["Extensive, schedule-specific register and record-keeping obligations across multiple provisions (eg regs 44–61; regs 50–57; regs 58–59; regs 73–76) create layered compliance duties for pharmacies, hospitals, wholesalers and authorised holders.","Numerous strict‑liability offences for record, storage, witnessing and reporting failures (eg regs 19(2), 20(2), 21(2), 22(2), 24(4), 28(2), 29(2), 30(2), 31(2), 62(2)) increase legal risk for operational mistakes.","Detailed storage, transport, packaging and labelling rules vary by Schedule (eg regs 22–31 for storage; regs 32–35 for transport/packaging/label‑requirements), raising procedural complexity for different business types.","Cross‑references to external codes and CHO discretion (eg reg 31(3) referencing Schedule 8 Code of Practice; regs 33–35 referencing medicines and poisons standard; reg 53(2) CHO may dispense) introduce interpretive dependencies and delegated decision points.","New monitoring and real‑time reporting obligations added (Part 6A: NTScript; regs 81B–81G and detailed data fields in reg 81E) impose ongoing data submission and privacy/compliance processes for prescribers and pharmacists.","Complex prescription and supply formalities across professions and contexts (regs 7, 7A–7B, 8–16, 17, 17A–17C) require different information, witnessing and minimum intervals, increasing administrative load.","Infringement notice regime and prescribed penalty schedule (Part 7: regs 82–87 and Schedule 1) provides an alternate enforcement path with fixed monetary exposure tied to penalty‑unit calculations.","Fees, authorisations and authority‑holder obligations (regs 40–43; reg 91; Schedule 2) create recurring costs and transactional compliance for businesses and individuals seeking or renewing licences.","Amendment history and insertions (see Endnotes/List of Amendments) mean the instrument is the product of layered changes rather than a single consolidated design, complicating interpretation and transitional compliance."],"plain_english_summary":"This instrument sets detailed rules for prescribing, supplying, storing, labelling, recording and destroying scheduled medicines in the Northern Territory, and creates a monitored medicines database (NTScript). It prescribes who may prescribe or witness, what registers and reports must be kept, packaging and storage standards, fees and civil penalties, and reporting exemptions that affect pharmacists, prescribers, wholesalers, facilities and authorised holders."},"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"},"kimi_summary":{"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":true,"description":"The legislation has grown significantly beyond simple poison control. Originally focused on basic scheduling and storage, it now incorporates: (1) a comprehensive real-time prescription monitoring database (NTScript) for 'monitored medicines' added in 2021; (2) expanded standing orders and delegation schemes (SSTP - Scheduled Substance Treatment Protocols) allowing non-doctors to administer drugs; (3) specific anti-diversion measures for pseudoephedrine; (4) detailed paint safety standards; and (5) complex witnessing and destruction protocols. The 2022 amendments further expanded the range of health practitioners who can handle scheduled substances under protocols, indicating a shift from pure restriction to managed delegation while maintaining control."},"complexity_factors":["Multiple parallel regulatory schemes: The legislation operates across 9 different Schedules (2-9 plus prohibited substances), each with distinct handling rules.","Extensive cross-referencing: Heavy reliance on external documents including the 'medicines and poisons standard', AS/NZS standards, the Schedule 8 Code of Practice, and corresponding laws from other jurisdictions.","Multiple overlapping record-keeping systems: Requires 7 different types of registers (pseudoephedrine, Schedule 4, Schedule 7, Schedule 8, Schedule 9, manufacturer/wholesaler, and medical kit registers), each with specific content and retention requirements (2-7 years).","Conditional logic and exceptions: Numerous 'if/then' structures (e.g., storage requirements differ based on whether substance is for retail sale, immediate use, or transport; prescription requirements vary by prescriber type and schedule).","Strict liability offences: Many offences (e.g., storage failures, register maintenance) impose liability without requiring proof of intent, creating compliance traps.","Nested definitions: Terms like 'personal custody' and 'pharmacist-in-charge' incorporate further defined concepts (e.g., electronic swipe cards, appointments under separate legislation).","Dual regulation with parent Act: Regulations modify the parent Act's operation (e.g., regulation 6 modifies the medicines and poisons standard) while also depending on it for definitions and authorities.","Specific technical requirements: Detailed physical specifications for storage (e.g., 'within 4m of dispensary', 'securely attached to building', combination lock confidentiality).","Database integration: Part 6A creates complex reporting obligations to the NTScript database with specific data fields and exempt circumstances."],"plain_english_summary":"**What this legislation does:**\n\nThese are the **Medicines, Poisons and Therapeutic Goods Regulations 2014** (Northern Territory). They set out the detailed rules for how medicines and poisons classified into different \"Schedules\" (categories based on risk and control level) can be handled, stored, prescribed, supplied, and recorded in the NT.\n\n**Who it affects:**\n\n*   **Health professionals:** Doctors, dentists, pharmacists, nurses, veterinarians, and others who prescribe, supply, or administer scheduled substances.\n*   **Businesses:** Pharmacies, hospitals, manufacturers, wholesalers, and retailers dealing with medicines or poisons.\n*   **Patients:** Anyone receiving prescription medicines, particularly strong painkillers (Schedule 8) or restricted drugs.\n*   **Specific facilities:** Residential care facilities, declared places (like remote clinics), and correctional facilities.\n\n**Key things it covers:**\n\n*   **Prescriptions and orders:** Strict rules on what must be written on prescriptions for different types of drugs, including extra requirements for addictive drugs like opioids and amphetamines (Schedule 8). For example, prescriptions for Schedule 8 drugs must include the patient's date of birth and quantities written in both words and numbers.\n*   **Storage:** Detailed security requirements for storing different categories of drugs—from keeping Schedule 2 pharmacy-only medicines within sight of the dispensary, to locking Schedule 7 poisons (like pesticides) in fixed containers, to following a special \"Code of Practice\" for Schedule 8 drugs.\n*   **Record-keeping:** Requires multiple types of registers (logbooks) tracking every movement of high-risk substances. Different registers exist for pseudoephedrine (used in cold medicines but also illicit drug manufacture), Schedule 4 prescription drugs, Schedule 7 poisons, Schedule 8 controlled drugs, and Schedule 9 prohibited substances.\n*   **Witnessing:** Requires certain dangerous dealings—like destroying Schedule 8 drugs or administering Schedule 9 substances—to be watched by another authorised person.\n*   **Monitored medicines database (NTScript):** Establishes a real-time tracking system for specific high-risk medicines (like benzodiazepines, codeine, pregabalin, and tramadol) to prevent \"doctor shopping\" and misuse. Prescribers and pharmacists must report to this database unless the patient is in aged care, prison, or receiving end-of-life palliative care.\n*   **Infringement notices:** Allows for on-the-spot fines for certain offences instead of court prosecution.\n\n**Why it matters:**\n\nThese regulations aim to balance **access to necessary medicines** with **preventing harm** from misuse, addiction, and accidental poisoning. They create a paper and electronic trail for dangerous substances, ensure only qualified people handle restricted drugs, and help authorities track unusual prescribing or supply patterns. For ordinary people, it means stricter ID checks when buying certain cold medicines, more careful monitoring of strong painkillers, and secure storage of dangerous chemicals."}},"importantCases":[],"_links":{"self":"/api/acts/medicines-poisons-and-therapeutic-goods-regulations-2014","history":"/api/acts/medicines-poisons-and-therapeutic-goods-regulations-2014/history","analysis":"/api/acts/medicines-poisons-and-therapeutic-goods-regulations-2014/analysis","conflicts":"/api/acts/medicines-poisons-and-therapeutic-goods-regulations-2014/conflicts","importantCases":"/api/acts/medicines-poisons-and-therapeutic-goods-regulations-2014/important-cases","documents":"/api/acts/medicines-poisons-and-therapeutic-goods-regulations-2014/documents"}}