Medicines, Poisons and Therapeutic Goods Regulation 2008

861A Dealings with regulated substances and regulated therapeutic goods by public employees under director-general authorisation—Act, s 20 (1) (d) and s 22 (1) (d) 227 862 Certain containers not to be used for human-use substances—Act, s 63 (1) (b) 228 863 Disapplication of Legislation Act, s 47 (6) 228 864 Exemption of piper methysticum (kava)—Act, s 190 (1) (a) 230 Schedule 1 Medicines—health-related occupations authorisations 232 Part 1.1 Ambulance services, officers and paramedics 232

Page contents 21 Part 1.2 Dentists, dental hygienists, dental therapists and oral health therapists 233 Part 1.3 Doctors 236 Part 1.4 Health practitioners at institutions 238 Part 1.4A Medical radiation practitioners 239 Part 1.5 Midwives 240 Part 1.6 Nurses 241 Part 1.7 Opioid dependency treatment centres operated by Territory 243 Part 1.8 Optometrists 244 Part 1.9 Pharmacists and employees 245 Part 1.10 Podiatrists 248 Part 1.11 Residential care facilities 249 Part 1.12 Sales representatives for medicines manufacturers and wholesalers 251 Part 1.13 Veterinary practitioners and employees 252 Schedule 3 ACT listed appendix D medicines—standing approvals 254 Part 3.1 Approval conditions 254 3.1 Definitions—sch 3 254 Part 3.2 Standing approvals for ACT listed appendix D medicines 256 Schedule 4 Dangerous poisons—manufacturing etc authorisations 260 Schedule 5 Requirements for storage receptacles 263 Part 5.1 Medicines cabinets 263 5.1 Medicines cabinets—general requirements 263

Page contents 22 Medicines, Poisons and Therapeutic Goods 5.2 Medicines cabinets—body requirements 263 5.3 Medicines cabinets—door requirements 263 5.4 Medicines cabinets—lock requirements 264 5.5 Medicines cabinets—mounting requirements 264

Part 5.2 Safes, strong rooms and vaults 265 5.6 Requirements for safes 265 5.7 Requirements for strong rooms 265 5.8 Requirements for vaults 265 Dictionary 266 1 About the endnotes 279 2 Abbreviation key 279 3 Legislation history 280 4 Amendment history 289 5 Earlier republications 306

1 Name of regulation This regulation is the Medicines, Poisons and Therapeutic Goods Regulation 2008.

3 Dictionary The dictionary at the end of this regulation is part of this regulation. Note 1 The dictionary at the end of this regulation defines certain terms used in this regulation, and includes references (signpost definitions) to other terms defined elsewhere. For example, the signpost definition ‘young detainee—see the Children and Young People Act 2008, section 95.’ means that the term ‘young detainee’ is defined in that section and the definition applies to this Note 2 A definition in the dictionary (including a signpost definition) applies to the entire regulation unless the definition, or another provision of the regulation, provides otherwise or the contrary intention otherwise appears (see Legislation Act, s 155 and s 156 (1)).

4 Notes A note included in this regulation is explanatory and is not part of this Note See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.

Preliminary Chapter 1

5 Offences against regulation—application of Criminal Code etc Other legislation applies in relation to offences against this Note 1 Criminal Code The Criminal Code, ch 2 applies to all offences against this regulation (see Code, pt 2.1). The chapter sets out the general principles of criminal responsibility (including burdens of proof and general defences), and defines terms used for offences to which the Code applies (eg conduct, intention, recklessness and strict liability). Note 2 Penalty units The Legislation Act, s 133 deals with the meaning of offence penalties that are expressed in penalty units.

6 Overview of things to which medicines and poisons standard does not apply (1) The medicines and poisons standard applies to regulated substances (see the Act, pt 3.1 and s 17). (2) However, the medicines and poisons standard sets out the following things to which it does not apply (unless there is a contrary intention in the standard): (a) a substance in a preparation or product included in the standard, appendix A; (b) a substance and the reason for its entry in the standard, appendix B; (c) a substance to which the standard, appendix G applies; (d) certain low concentrations of substances included in the standard, schedules 1 to 6 if the substance is not also included in schedule 7 or 8; (e) certain impurities in pesticides.

Chapter 2 Medicines—authorisations Part 2.1 Overview of medicines 10 General overview of authorisations for medicines (1) The Act requires that a person must not deal with a medicine in a particular way unless the person is authorised to deal with the the Act, s 35 is about obtaining certain substances (which include medicines) Note The Act, s 19 sets out when a person deals with a medicine. (2) The Act, section 20 sets out when a person is authorised to deal with a medicine. (3) This regulation authorises certain dealings with medicines. Note An authorisation is not required to deal with the following: • a substance excluded from the medicines and poisons standard by the standard; • a substance mentioned in the medicines and poisons standard, sch 2, 3, 4 or 8 if none of the schedules apply to the substance because of an exception in the standard (eg Aspirin in packets available from supermarkets). (4) An authorisation under this regulation may be subject to limitations. Examples—s (4) 1 a health practitioner’s authorisation is subject to any condition or restriction to which the health practitioner is subject to under the Health Practitioner Regulation National Law (ACT) (see s 20) 2 the authorisation of a person to prescribe a medicine is subject to any restriction included in sch 1 in relation to the person (see s 30 (1) (b)) Note For the power to impose other restrictions, see the Act, ch 8.

11 Overview of medicines authorisations etc under this regulation Medicines authorisations, approvals and endorsements are given under the following provisions of this regulation: (a) section 30 (which is about authorisations under schedule 1 to prescribe medicines); (b) section 50 (which is about authorisations under schedule 1 to issue requisitions for medicines); (c) section 60 (which is about authorisations under schedule 1 to issue purchase orders for medicines); (d) section 70 (which is about authorisation of CHO to issue standing orders for supply of medicines in public health emergencies); (e) section 71 (which is about authorisation of CHO to issue standing orders for administration of medicines for public health matters); (f) section 75 (which is about authorisation of doctors to issue standing orders for administration of medicines at institutions); (g) section 77 (which is about authorisation of CHO to issue standing orders for supply and administration of medicines at walk-in centres); (h) section 110 (which is about authorisations under schedule 1 to supply medicines); Note Supply includes dispense on prescription (see Act, s 24). (i) section 251 (which is about authorisation of pharmacists to supply certain medicines without prescription in emergencies); (j) section 255 (which is about authorisation of approved pharmacists to supply certain medicines without prescription);

(k) section 260 (which is about authorisation to supply medicines to pharmacists for disposal); (l) section 261 (which is about authorisation to supply medicines to commercial disposal operators for disposal); (m) section 350 (which is about authorisations under schedule 1 for people in health-related occupations to administer medicines); (n) section 352 (which is about authorisation of pharmacists and intern pharmacists to administer vaccines without prescription); (o) section 353 (which is about authorisation of nurses and midwives to administer vaccines without prescription); (p) section 360 (which is about authorisation for self-administration of medicines); (q) section 361 (which is about authorisation for the administration of medicines by assistants); (r) section 370 (which is about authorisations under schedule 1 to obtain and possess medicines); (s) section 371 (which is about authorisation to obtain and possess medicines for certain personal use-related dealings); (t) section 380 (which is about authorisations under schedule 1 to manufacture medicines); (u) section 390 (3) (which is about authorisation to discard controlled medicines in certain ways); (v) section 400 (which is about authorisation to deliver medicines under supply authorities); (w) section 401 (which is about authorisation for commercial disposal operators for disposal of medicines); (x) section 410 (which is about authorisation to supply and administer adrenaline, naloxone and salbutamol);

(y) section 420 (which is about authorisations for CYP authorised people); (z) section 421 (which is about authorisations for corrections officers); (za) section 422 (which is about authorisations for court and police cell custodians); (zb) section 430 (which is about authorisations for non-controlled medicines research and education); (zc) section 440 (which is about authorisations under controlled medicines research and education program licences); (zd) section 450 (which is about authorisations under first-aid kit licences); (ze) section 460 (which is about authorisations under medicines wholesalers licences); (zf) section 470 (which is about authorisations under opioid dependency treatment licences); (zg) section 480 (which is about authorisations under pharmacy medicines rural communities licences); (zh) section 490 (which is about authorisations for endorsed health practitioners); (zi) section 490A (which is about authorisations for health practitioners for certain dealings approved by CHO); (zj) section 554 (which is about standing CHO approvals of classes of designated prescribers to prescribe controlled medicines in certain circumstances); (zk) section 555 (which is about standing approval of designated prescribers to prescribe controlled medicines for hospital in‑patient or patient discharge);

(zl) section 556 (which is about standing approval of designated prescribers to prescribe controlled medicines for short-term treatment); (zm) section 557 (which is about standing interim approval of designated prescribers to prescribe buprenorphine and methadone for patients of certain institutions); (zn) division 13.1.3 (which is about CHO approvals of designated prescribers to prescribe controlled medicines for individuals); (zo) division 13.1.4 (which is about endorsement by CHO of designated prescribers to treat drug-dependency); (zp) section 591 (which is about standing approvals of certain prescribers under schedule 3 to prescribe ACT listed appendix D medicines); (zq) section 593 (which is about CHO approval of prescribers to prescribe appendix D medicines); (zr) section 860 (which is about authorisation of public employees exercising functions under the Act for certain dealings); (zs) section 861 (which is about authorisation of public employees for certain dealings under CHO permit); (zt) section 861A (which is about authorisation of public employees for certain dealings under director-general authorisation).

12 General overview of authorisation conditions for (1) The Act, section 44 requires a person who is authorised to deal with a medicine to comply with any condition to which the authorisation is subject. Section 31 sets out the authorisation conditions for a person or endorsed health practitioner who is authorised to prescribe a medicine.

(2) The conditions are additional to other restrictions on a person’s or endorsed health practitioner’s authority to deal with a medicine. Note Conditions may also be imposed under other provisions of the Act including, for example, s 89 which sets out conditions on licences.

Part 2.2 Relationship with registration laws Part 2.2 Relationship with registration laws 20 Medicines authorisations subject to Health Practitioner Regulation National Law (ACT) restrictions A health practitioner’s authorisation under the Act to deal with a medicine is subject to any condition or other restriction to which the health practitioner is subject under the Health Practitioner Regulation National Law (ACT). Section 31 places conditions on the prescribing of medicines by a health practitioner authorised to prescribe the medicines. If a particular health practitioner’s registration under the Health Practitioner Regulation National Law (ACT) is subject to the condition or restriction that the person may not prescribe certain medicines, the health practitioner’s authorisation under the Medicines, Poisons and Therapeutic Goods Act 2008 to prescribe medicines is also subject to that condition or restriction. Note A reference to an Act includes a reference to the statutory instruments made or in force under the Act, including any regulation (see Legislation Act, s 104).

21 Medicines authorisations subject to Veterinary Practice Act 2018 restrictions A veterinary practitioner’s authorisation under the Act to deal with a medicine is subject to any condition or other restriction to which the veterinary practitioner is subject under the Veterinary Practice Act 2018.

30 Authorisation under sch 1 to prescribe medicines—Act, s 40 (1) (b), (2) (b) and (3) (b) (1) A person mentioned in schedule 1, column 2 is authorised to prescribe (a) prescribing the medicine is included in the schedule, column 3 in relation to the person; and (b) the prescribing is consistent with any restriction for the prescribing mentioned in the schedule, column 3. (2) However, a person is not authorised to self-prescribe a medicine if— (a) the person is a trainee dentist, intern doctor or endorsed health (b) the medicine is a restricted medicine. prescribe includes self-prescribe. restricted medicine means— (a) an anabolic steroid; or (b) an appendix D medicine; or (c) a monitored medicine.

31 Authorisation conditions for prescribing medicines—Act, (1) A prescriber’s authorisation under section 30 or section 490 to prescribe a medicine is subject to the following conditions: (a) the medicine is prescribed in accordance with the Act, section 7 (Appropriate prescription and supply of medicines); (b) if the prescription is a written prescription— (i) the prescription complies with section 40 (General requirements for written prescriptions); and (ii) the prescription (other than a national residential medication chart prescription) includes the particulars mentioned in section 41 on the front of the prescription; and (iii) if the prescription is a national residential medication chart prescription in a national residential medication chart––the chart includes the particulars mentioned in section 41; and (iv) if the prescription is faxed by a prescriber to a pharmacist—the prescriber sends the original prescription to the pharmacist not later than 7 days after the prescriber faxes the prescription to the pharmacist; Note 1 For the endorsement of faxed prescriptions, see s 41 (1) (i). (c) if the prescription is an oral prescription— (i) the prescriber believes on reasonable grounds that giving an oral prescription for the medicine is reasonably necessary for the patient’s treatment; and

(ii) if the prescription is for an unusual or dangerous dose of a medicine—the prescription includes a statement telling the person who is to dispense or administer the medicine that the prescription is for an unusual or dangerous dose; and (iii) the prescription includes the particulars mentioned in section 41; and (iv) the prescriber sends a written prescription for the medicine to the pharmacist not later than 24 hours after the prescriber gives the oral prescription to the pharmacist; Note For the endorsement of written prescriptions confirming oral prescriptions, see s 41 (1) (j). (d) if the medicine is a controlled medicine for human use— (i) the prescriber complies with the additional requirements under section 32 for prescribing a controlled medicine; and (ii) if the controlled medicines approval is an oral approval— the prescriber sends the chief health officer a written application for the approval in accordance with section 561 (Requirements for CHO controlled medicines approval applications) not later than 7 days after the day the oral approval is given; (e) if the medicine is an appendix D medicine— (i) the prescriber has an appendix D medicines approval to prescribe the medicine; and approval (including any conditions in schedule 3, part 3.2, column 4 in relation to the medicine).

national residential medication chart means a medication chart within the meaning of the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 41 (4), as in force from time to time. Note The National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

31A Variation of authorisation condition during Commonwealth special arrangement period (1) This section applies to a prescriber of a prescription if— (a) the prescription is faxed by the prescriber to a pharmacist; and (b) the prescription is for the supply of a medicine in accordance with a Commonwealth special arrangement; and (c) the Commonwealth special arrangement requires the prescriber to keep the original of the prescription. (2) The prescriber is not required to send the original of the prescription under section 31 (1) (b) (iv). Commonwealth special arrangement means a special arrangement made under the National Health Act 1953 (Cwlth), section 100, as in force from time to time. Note Commonwealth special arrangements are accessible at

32 Additional requirements for prescribing controlled medicines for human use The following are the additional requirements for prescribing a controlled medicine for human use: (a) the prescriber has a controlled medicines approval to prescribe Note For controlled medicines approvals, see pt 13.1. (b) if the approval is for a particular form of the medicine—the prescription is for the form of the medicine approved or a bioequivalent form; (c) if the approval is for a particular strength of the medicine—the prescription is for the strength approved or a weaker strength; (d) if the approval is for a maximum daily dose of the medicine— the prescription is for not more than the maximum daily dose approved; (e) the prescriber complies with each condition (if any) of the approval; (f) if the controlled medicine is dronabinol for human use— (i) the prescriber also has an authorisation under the Therapeutic Goods Act 1989 (Cwlth), section 19 to supply the medicine; and authorisation. If a slow release form of a medicine is approved, the prescriber is not authorised to prescribe an immediate release form of the medicine.

Example—par (c) and par (d) If a doctor is given an approval to prescribe 25 morphine 20mg capsules, the doctor may prescribe 5 20mg capsules and 10 15mg capsules. Later, if the approval is still in force, the doctor may prescribe not more than 10 morphine capsules of any strength up to and including 20mg. Note A prescription may provide for a medicine to be dispensed or administered (see Act, dict, def prescription).

40 General requirements for written prescriptions A written prescription for a medicine must— (a) be signed by the prescriber; and Note The prescription must be signed with the prescriber’s usual signature (see Act, dict, def signs). (b) if the prescriber amends the prescription—be initialled and dated beside the amendment by the prescriber; and (c) be written in terms and symbols used in ordinary professional practice; and (d) if the prescription is for an unusual or dangerous dose—include the prescriber’s initials beside an underlined reference to the dose.

41 Particulars for prescriptions (1) A prescription must include the following particulars: (a) the prescriber’s name, professional qualifications and business address and telephone number; (b) the date the prescription is given;

Prescriptions Division 3.1.2 medicine, to be dispensed or administered under the (d) the name, date of birth and address of the person for whom the medicine is prescribed; (e) directions about the use of the medicine, including the dose and regimen of the medicine, that are adequate to allow the medicine to be taken or administered safely; (f) the number of times the medicine may be dispensed or administered under the prescription; (g) if the prescription is for a controlled medicine for human use— (i) if the medicine is dronabinol—the relevant TGA authorisation particulars; and (ii) if the prescription is a repeat prescription—the period that must elapse between each dispensing or administration of (h) if the prescriber is a veterinary practitioner— (i) the words ‘for animal treatment only’; and (ii) the species of the animal for which the medicine is to be dispensed; and (iii) if possible, a way of identifying the animal; (i) if the prescription is an original of a prescription that was faxed by a prescriber to a pharmacist—the prescription is endorsed with words to the effect that the prescription was faxed to a named pharmacy on a stated date;

(j) if the prescription is a written prescription under section 31 (1) (c) (iv) (which is about oral prescriptions)—the prescription is endorsed with words to the effect that the prescription is a confirmation copy of an oral prescription issued to a named pharmacist on a stated date. (2) However, if the prescription is written for an in-patient at a hospital in the patient’s medical records, the prescription need not include the prescriber’s professional qualifications and business address and telephone number. Note 1 Hospital means a public hospital, private hospital or day hospital and includes a body prescribed by regulation as a hospital (see Act, dict). Note 2 A hospice is a hospital (see The Macquarie Dictionary, 4th ed). (3) Also, if the prescription is a national residential medication chart prescription, the prescription need not include either of the following: (a) the prescriber’s professional qualifications; (b) the quantity of the medicine to be dispensed or administered under the prescription. relevant TGA authorisation particulars means the words ‘TGA authorisation’ followed by— (a) the identifying number for the authorisation; or (b) if no identifying number is given for the authorisation—the date of the approval.

Requisitioning medicines Part 3.2 Authorisation to issue requisitions Division 3.2.1

Division 3.2.1 Authorisation to issue requisitions

49 Meaning of issuer—pt 3.2 issuer means the following: (a) a person who is authorised under section 50 to issue a requisition for a medicine; (b) an endorsed health practitioner who is authorised under section 490 to issue a requisition for a medicine.

50 Authorisation under sch 1 to issue requisitions for medicines—Act, s 41 (b) A person mentioned in schedule 1, column 2 is authorised to issue a requisition for a medicine if— (a) issuing the requisition is included in the schedule, column 3 in (b) the issue of the requisition is consistent with any restriction for the issue of the requisition mentioned in the schedule, column 3.

51 Authorisation conditions for issuing requisitions for An authorisation under section 50 or section 490 to issue a requisition for a medicine is subject to the following conditions: (a) if the requisition is a written requisition—the requisition

(b) if the requisition is an oral requisition— (i) the issuer believes on reasonable grounds that issuing the requisition is reasonably necessary for the treatment of a (ii) the quantity of the medicine requisitioned is not more than the amount reasonably necessary for the person’s treatment; and (iii) the requisition complies with section 56.

55 General requirements for written requisitions A written requisition for a medicine must be— (a) signed by the issuer of the requisition; and Note The requisition must be signed with the issuer’s usual signature (b) if the issuer amends the requisition—initialled and dated by the issuer beside the amendment.

56 Particulars for requisitions A requisition must include the following particulars: (a) the issuer’s name; (b) the capacity in which the issuer is issuing the requisition; (c) the date the requisition is issued;

Requisitioning medicines Part 3.2 Requisitions Division 3.2.2 (d) the medicine, and the form, strength and quantity of the medicine, to be supplied on the requisition; (e) the pharmacy or ward to which the medicine is to be supplied. Note Ward—see the Act, dictionary.

Division 3.3.1 Authorisation to issue purchase orders Division 3.3.1 Authorisation to issue purchase 60 Authorisation under sch 1 to issue purchase orders for medicines—Act, s 38 (1) (b) and (2) (a) A person mentioned in schedule 1, column 2 is authorised to issue a purchase order for a medicine if— (a) issuing the purchase order is included in the schedule, column 3 in relation to the person; and (b) the issue of the purchase order is consistent with any restriction for the issue of the purchase order mentioned in the schedule, column 3.

61 Authorisation conditions for issuing purchase orders for (1) An authorisation under section 60 or section 490 to issue a purchase order for a medicine is subject to the following conditions: (a) the purchase order complies with section 62 (General requirements for medicines purchase orders—Act, s 38 (2) (c)); Note A purchase order must be in writing (see Act, dict, def purchase order). (b) the issuer must, not later than 24 hours after they receive the medicine, send the supplier a document signed by the issuer acknowledging receipt of the medicine. Example—document a copy of the supplier’s delivery docket signed by the issuer issuer—see section 62 (1) (a).

Medicines purchase orders Part 3.3 Purchase orders Division 3.3.2 Division 3.3.2 Purchase orders

62 General requirements for medicines purchase orders— Act, s 38 (2) (c) (1) A purchase order for a medicine must be— (2) A purchase order for a medicine must include the following: medicine, to be supplied on the order.

70 Authorisation of CHO to issue standing orders for supply of medicines in public health emergencies—Act, s 42 (b) (1) The chief health officer is authorised to issue a standing order for the supply of a medicine in an emergency relating to public health. Note 2 A standing order must be in writing (see Act, dict, def standing order). (2) To remove any doubt, a standing order may be issued under subsection (1) even if no emergency declaration under the Public Health Act 1997 is in force.

71 Authorisation of CHO to issue standing orders for administration of medicines for public health matters— Act, s 42 (b) The chief health officer is authorised to issue a standing order for the administration of a medicine in relation to a public health matter. Note A standing order must be in writing (see Act, dict, def standing order).

72 Particulars for CHO standing orders for administration of medicines for public health matters A standing order under section 71 must include the following (a) a description of the public health matter to which the order relates; (b) the date of effect of the order and the date (not longer than 2 years after the date of effect) when the order ends;

Standing orders for medicines Part 3.4 Standing orders for institutions Division 3.4.2 (c) the clinical circumstances in which the medicine may be (d) a description of the people to whom the medicine may be (e) the medicine’s approved name and, if applicable, brand name; (f) if applicable, the form and strength of the medicine; (g) the dose and route of administration; (h) if applicable, the frequency of administration. Example—par (e) and par (f) Adrenaline (EpiPen) 300 micrograms in 0.3mL pre-filled syringe Note Institution includes a correctional centre and a CYP detention place (see s 652).

75 Authorisation of doctors to issue standing orders for administration of medicines at institutions—Act, s 42 (b) (1) A doctor is authorised to issue a standing order for the administration of a medicine to patients at an institution if— (a) a medicines and therapeutics committee for the institution has approved the order; and (b) the order is signed by the chair of the committee. medicines and therapeutics committee, for an institution, means a body— (a) established by the institution to approve standing orders for the administration of medicines to patients at the institution; and

(b) that includes (but is not limited to) a doctor, nurse and pharmacist. Note 1 Doctor and pharmacist do not include an intern (see dict). Note 2 Nurse does not include an enrolled nurse (see Legislation Act, dict,

76 Particulars for standing orders for administration of medicines at institutions A standing order under section 75 must include the following (a) an approval number for the order that is different from the number given to each other standing order approved for the (b) the date of effect of the order and the date (not longer than 2 years after the date of effect) when the order ends; (c) each ward to which the order applies; (d) the clinical circumstances in which the medicine may be (e) a description of the people to whom the medicine may be (f) the medicine’s approved name and, if applicable, brand name; (g) if applicable, the form and strength of the medicine; (h) the dose and route of administration; (i) if applicable, the frequency of administration. Example—par (f) and par (g) Adrenaline (EpiPen) 300 micrograms in 0.3mL pre-filled syringe

Standing orders for medicines Part 3.4 Standing orders for walk-in centre Division 3.4.3

77 Authorisation of CHO to issue standing orders for supply and administration of medicines at walk-in centre—Act, s 42 (b) The chief health officer is authorised to issue a standing order for— (a) the supply of a medicine at a walk-in centre; and (b) the administration of a medicine at a walk-in centre. Note 2 A standing order must be in writing (see Act, dict, def standing order).

78 Particulars for CHO standing orders for supply and administration of medicines at walk-in centre A standing order under section 77 must include the following (a) an approval number for the order that is different from the number given to each other standing order approved for the walk-in centre; (b) the date of effect of the order and the date (not longer than 2 years after the date of effect) when the order ends; (c) each walk-in centre to which the order applies; (d) the clinical circumstances in which the medicine may be supplied or administered; (e) a description of the people to whom the medicine may be supplied or administered; (f) the medicine’s approved name and, if applicable, brand name; (g) if applicable, the form and strength of the medicine; (h) the dose and route of administration of the medicine;

(i) if applicable, the frequency of administration of the medicine; (j) if applicable, the maximum duration of supply or administration of the medicine; (k) if applicable, the maximum quantity of the medicine for supply or administration.

Medicines supply authorities generally Part 3.5

Part 3.5 Medicines supply authorities

80 Cancellation of invalid supply authorities—Act, s 30 (2) (d) (1) A paper-based supply authority is cancelled by a person if the person— (a) marks the word ‘cancelled’, and the person’s name and business address, on the front of the supply authority; and (b) signs and dates the cancellation of the supply authority. (2) An electronic supply authority is cancelled by a person if the person— (a) marks the word ‘cancelled’ on the supply authority; and (b) links an electronic document to the supply authority that includes the person’s name and business address and signature.

81 Information for CHO about monitored medicines supplied on supply authorities—Act, s 31 (1) (b) and (4), def required information (1) A person (the supplier) who supplies a monitored medicine on a supply authority must, not later than 7 days after the day when the medicine is supplied, give the chief health officer the following information in writing: (a) the supplier’s name, business address and telephone number; (b) the name of the person who issued the supply authority; (c) the date of the supply authority; (d) the name, date of birth and address of the person to whom the medicine is supplied;

Part 3.5 Medicines supply authorities generally (e) the date of supply; (f) the monitored medicine, and the form, strength and quantity of the medicine, supplied. (2) However, this section does not apply to any of the following who report the supply of a monitored medicine on a supply authority to the Therapeutic Goods Administration: (a) a medicines wholesalers licence-holder; (b) a person who is authorised (however described) under a Commonwealth or State law to manufacture a monitored medicine or supply a monitored medicine by wholesale.

Preliminary Part 4.1

Part 4.1 Preliminary

100 Overview of supply authorisations for medicines The following provisions of this chapter authorise a person to supply a medicine: (a) section 110 (which is about supply authorisations set out in schedule 1, including dispensing on prescription, supply on requisition, purchase order and standing order and supply during consultations); (b) section 251 (which is about authorisation of pharmacists to supply certain prescription only medicines without a prescription in emergencies); (c) section 255 (which is about authorisation of approved pharmacists to supply certain medicines without prescription); (d) section 260 (which is about authorisation to supply medicines to pharmacists for disposal). Note A person may also be authorised to supply a medicine in a way mentioned in s 11 (Overview of medicines authorisations etc under this regulation) (including under a licence, see pt 9.5).

Division 4.2.1 Sch 1 medicines supply authorisations Part 4.2 Medicines—supply authorisations under sch 1 Division 4.2.1 Sch 1 medicines supply 110 Authorisation under sch 1 to supply medicines—Act, s 26 (1) (b) and (2) (b) (1) A person mentioned in schedule 1, column 2 is authorised to supply (a) supplying the medicine is included in the schedule, column 3 in (b) the supply is consistent with any restriction for the supply mentioned in the schedule, column 3. (2) However, a pharmacist is not authorised under schedule 1 to supply a medicine if— (a) the pharmacist is working for, or providing services to, a corporation when supplying the medicine; and (b) the corporation is not— (i) a pharmacist; or (ii) a complying pharmacy corporation under the Public Health Act 1997, part 3B (Pharmacies). Note Supply includes dispense (see Act, s 24).

120 Authorisation conditions for dispensing medicines—Act, (1) An authorisation under section 110 or section 490 to dispense a (a) the medicine is dispensed in accordance with the requirements of section 121; Note Only a pharmacist may dispense a medicine (see sch 1). (b) if the prescription is dispensed under section 121 (2), the pharmacist notes on the prescription the reasons that the pharmacist was satisfied that it was not practicable for a complying prescription to be issued for the medicine; (c) if the prescription is changed by a pharmacist at the oral direction of the prescriber—the note of the change complies with section 122; (d) the medicine is labelled in accordance with section 123; (e) the dispensed prescription is marked in accordance with section 124; (f) the dispensing of the prescription is recorded in accordance with section 125; (g) if the prescription is an oral prescription for the dispensing of the medicine, or is faxed by a prescriber to a pharmacist, and the pharmacist does not receive an original of the prescription within 14 days after the day the prescription is given—the pharmacist must, within 24 hours after the end of the 14-day period, tell the chief health officer, in writing, of the failure to receive the original prescription;

(h) the prescription, if completed, and the record for paragraph (f), are kept at the pharmacy or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the prescription becomes a completed prescription. (2) However, subsection (1) (d), (e), (f) and (h) do not apply if the prescription is written for an in-patient at a hospital in the patient’s medical records. completed—a prescription is completed when— (a) for a single prescription—the prescription is dispensed; or (b) for a repeat prescription—the last repeat of the prescription is dispensed; or (c) for a national residential medication chart prescription––the prescription is dispensed for the last time.

120A Variation of authorisation condition for dispensing medicines during Commonwealth special arrangement period (1) This section applies to a pharmacist who receives a written prescription if— (a) the prescription is faxed by a prescriber to the pharmacist; and (b) the prescription is for the supply of a medicine in accordance with a Commonwealth special arrangement; and (c) the Commonwealth special arrangement requires the prescriber to keep the original of the prescription. (2) The pharmacist is not required to tell the chief health officer of a failure to receive the original prescription under section 120 (1) (g).

Commonwealth special arrangement means a special arrangement under the National Health Act 1953 (Cwlth), section 100, as in force from time to time. Note Commonwealth special arrangements are accessible at

121 How medicines are dispensed (1) The following are the requirements for dispensing a medicine: (a) the prescription is issued by an authorised prescriber; Note Authorised prescriber—see s (4). (b) the prescription complies with the applicable provisions of division 3.1.2 (Prescriptions); (c) the medicine is dispensed in accordance with the prescription (including the prescription as changed by a pharmacist at the oral direction of the prescriber). Note 1 Dispensed in accordance with the prescription—see s (4). Note 2 For changes to a prescription by the dispenser, see the Act, s 29 (3). Note 3 Pharmacist does not include an intern pharmacist (see dict). (2) However, a pharmacist may dispense a prescription that does not include all of the applicable provisions for subsection (1) (b) if— (a) the prescription is issued by an authorised prescriber; and (b) the medicine is— (i) dispensed in accordance with the prescription; and (ii) if the prescription is changed by a pharmacist at the oral direction of the prescriber—the prescription complies with section 122; and

(c) the medicine is supplied in a package that is labelled in accordance with section 123; and (d) the pharmacist is satisfied that, because of a circumstance affecting the prescriber or the person for whom the medicine is to be dispensed, it is not practicable for a complying prescription to be issued for the medicine. (3) Also, a pharmacist may dispense a prescription that does not comply with section 41 (1) if the reason it does not comply is because it does not include the date of birth or address of the person for whom the medicine is prescribed. Note The dispensing pharmacist must ensure a written record is made of the name, date of birth and address of the person for whom the medicine is dispensed (see s 125 (g)). authorised prescriber means— (a) for a prescription prescribing buprenorphine or methadone for treatment of opioid dependency—a prescriber approved under division 13.1.3 to prescribe the medicine for the treatment of opioid dependency; or (b) for any other prescription—a prescriber. Example—paragraph (a) A doctor employed by an alcohol and drug service prescribing buprenorphine or methadone to treat the opioid dependency for a patient. Example—paragraph (b) A doctor practising as a general practitioner prescribing buprenorphine or methadone to treat chronic pain for a patient. dispensed in accordance with the prescription, for a prescribed medicine, includes dispensing another brand of the medicine that is a bioequivalent form of the prescribed medicine.

122 Noting changes to prescriptions on oral direction of prescriber—Act, s 27 (2) (b) (ii) The following must be noted, in writing, on the prescription: (a) the name of the prescriber giving the oral direction to change the (b) the change to the prescription; (c) the date the oral direction is given; (d) the pharmacist’s signature. Note The notation must be made as soon as possible (see Legislation Act, s 151B).

123 Labelling dispensed medicines—Act, s 60 (1) (c) (i) The dispensed medicine must have a label that includes the following: (a) the name of the person for whom the medicine is dispensed; (b) if the prescriber is a veterinary practitioner— (i) words to the effect of ‘for animal treatment only’; and (ii) the species of the animal for which the medicine is dispensed; and (iii) if a way of identifying the animal is stated on the prescription—the way of identifying the animal; (c) the medicine’s approved name and brand name; (d) the form, strength and quantity of the medicine dispensed; (e) if the package of the dispensed medicine is not a manufacturer’s (f) the date the medicine is dispensed;

(g) the name and the business address and telephone number of the pharmacy from which the medicine is dispensed; (h) the initials or other identification of the dispensing pharmacist; (i) a number that is different from the number given to each other prescription dispensed at the pharmacy; (j) directions about the use of the medicine that are adequate to (k) words to the effect of ‘keep out of reach of children’. Example—par (c) and par (d) Warfarin tablets (Coumadin) 5mg 50

124 Marking dispensed prescriptions (1) This section does not apply to— (a) a prescription written in the medical records of an in-patient at a hospital; or (b) an electronic prescription, within the meaning of the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 5. (2) A dispensed paper-based prescription for a medicine must be marked (a) if the prescription is a single prescription, the last repeat of a repeat prescription, or a national residential medication chart prescription dispensed for the last time––the word ‘cancelled’ on the front of the prescription; and (b) the prescribed particulars.

(3) A dispensed electronic prescription (other than an electronic prescription mentioned in subsection (1) (b)) for a medicine must be marked with— (a) if the prescription is a single prescription, the last repeat of a repeat prescription, or a national residential medication chart prescription dispensed for the last time––the word ‘cancelled’; and (b) a link to an electronic document containing the prescribed particulars. national residential medication chart—see section 31 (2). paper-based prescription includes a faxed copy of a prescription. prescribed particulars, for a dispensed prescription for a medicine, means— (a) the date the medicine is dispensed; and (b) the name and business address of the dispensing pharmacy; and (c) if another brand of the medicine is dispensed for the prescribed medicine—the brand name of the medicine dispensed; and (d) for a repeat prescription—the number of the repeat dispensed; and (e) the prescription’s number under section 123 (i); and (f) the pharmacist’s initials or signature. single prescription means a prescription that is not a repeat prescription.

125 Recording dispensing of medicines The dispensing pharmacist must ensure that a written record is made of the following information in relation to the dispensing of the medicine: (a) the pharmacist’s name; (b) the date of the prescription; (c) the prescriber’s name; (d) the date the prescription is dispensed; (e) for a repeat prescription—the number of the repeat dispensed; (f) the prescription’s number under section 123 (i); (g) the name, date of birth and address of the person for whom the medicine is dispensed; (h) the medicine’s approved name and brand name; (i) the form, strength and quantity of the medicine dispensed. Note For authorisation to issue a requisition, see s 50.

130 Authorisation conditions for supplying medicines on requisitions—Act, s 44 (1) (b) and (2) (b) An authorisation under section 110 or section 490 to supply a medicine on a requisition is subject to the following conditions: (a) the medicine is supplied in accordance with the requirements under section 131; accordance with section 132;

Supplying medicines on requisitions Division 4.2.3 (c) the filled requisition is marked in accordance with section 133; (d) the supply is recorded in accordance with section 134; (e) the filled requisition and record under section 134 are kept at the institution where the medicine is supplied or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the medicine is supplied.

131 Supplying medicines on requisitions (1) The following are the requirements for the supply of a medicine on a requisition: (a) the medicine is supplied in accordance with the requisition (including the requisition as changed by the person supplying the medicine at the oral direction of the person issuing the requisition); Note For changes to a requisition by the person supplying a medicine on a requisition (see Act, s 29 (3)). (b) if the requisition is a written requisition—the requisition (c) if the requisition is an oral requisition—the requisition complies with section 56. (2) However, if the requisition does not comply with section 55 or section 56 (as appropriate), a pharmacist may supply the medicine on the requisition if satisfied that it is not practicable for a complying requisition to be issued for the medicine.

supplied in accordance with the requisition, for a requisitioned medicine, includes supplying another brand of the medicine that is a bioequivalent form of the requisitioned medicine.

132 Labelling medicines supplied on requisition—Act, The package of a medicine supplied on requisition to a ward for the supply to a patient must have a label that includes the following: (a) the medicine’s approved name or brand name; (b) the form, strength and quantity of the medicine; (c) if the package of the medicine is not a manufacturer’s pack— (i) the batch number or numbers of the medicine; and (ii) the relevant expiry date for the medicine; (d) the name or other identifier of the pharmacy or ward from which the medicine is supplied; (e) if the medicine is a controlled medicine—a number that is different from the number given to each other requisition supplied from the pharmacy or ward. Examples—par (a) and par (b) 1 Warfarin tablets 5mg 50 2 Coumadin tablets 5mg 50 133 Marking filled requisitions (1) A filled paper-based requisition for a medicine must be marked (a) the name or other identifier of the pharmacy or ward from which the medicine is supplied; and

Supplying medicines on requisitions Division 4.2.3 (b) if the medicine is a controlled medicine—the requisition’s number under section 132 (e); and (c) the supplier’s initials or signature. (2) A filled electronic requisition for a medicine must be marked with a link to an electronic document containing— (a) the name or other identifier of the pharmacy or ward from which the medicine is supplied; and (b) if the medicine is a controlled medicine—the requisition’s number under section 132 (e); and (c) the supplier’s initials or signature. (3) However, subsection (1) (a) and (2) (a) do not apply to a requisition filled at a pharmacy at an institution. paper-based requisition includes a faxed copy of a requisition.

134 Recording supply of medicines on requisitions A person or endorsed health practitioner who supplies a medicine to someone else on requisition (a supplier) must make a written record of the following information: (a) the date of the requisition; (b) the name of the person who issued the requisition; (c) the date the requisition is filled; (d) the medicine, and the form, strength and quantity of the medicine, supplied; (e) the supplier’s name or initials.

Division 4.2.4 Supplying medicines on purchase orders Division 4.2.4 Supplying medicines on purchase Note For authorisation to issue a purchase order, see s 60. 140 Authorisation conditions for supplying medicines on purchase orders—Act, s 44 (1) (b) and (2) (b) An authorisation under section 110 or section 490 to supply a medicine on a purchase order is subject to the following conditions: (a) the purchase order is a complying purchase order; (b) the medicine is supplied in accordance with the requirements of section 141; (c) the supply is recorded in accordance with section 142; (d) if the supplier does not receive a document signed by the buyer acknowledging receipt of the medicine within 7 days after the day the medicine is delivered—the supplier must, within 24 hours after the end of the 7-day period, tell the chief health officer, in writing, of the failure to receive the document; (e) the following are kept at the supplier’s business premises or, if the chief health officer approves in writing another place, the after the day the medicine is supplied: (ii) the delivery acknowledgment under paragraph (d) or section 141 (1) (d) (ii); (iii) the record for section 142.

Supplying medicines on purchase orders Division 4.2.4

141 Supplying medicines on purchase orders (1) The following are the requirements for the supply of a medicine on a purchase order: (a) the medicine is supplied in manufacturer’s packs that comply (i) section 501 (Packaging of supplied manufacturer’s packs of medicines—Act, s 59 (1) (c) (i) and (2) (c) (i)); or (i) section 502 (Labelling of supplied manufacturer’s packs of medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)); or (ii) an approval under the Act, section 193; (c) the manufacturer’s packs are securely wrapped and packed; (d) if the medicine is delivered in person by the supplier to the buyer— (i) the medicine is delivered to an adult; and (ii) the delivery is acknowledged by the adult signing and dating a copy of the purchase order; (e) if the medicine is not delivered in person by the supplier to the buyer—the medicine is delivered to the buyer by a person whose procedures require the delivery of the medicine to be signed for by the buyer or an adult employee of the buyer. (2) However, subsection (1) (a), (b) and (c) do not apply in relation to a medicine supplied by a pharmacist to a prescriber who is authorised to supply the medicine during a consultation if the medicine is supplied in a package that is labelled with the following particulars: (a) the approved name and brand name of the medicine;

(b) the form, strength and quantity of the medicine, supplied; (c) if the package of the medicine is not a manufacturer’s pack— the relevant expiry date for the medicine.

142 Recording supply of medicines on purchase orders A person or endorsed health practitioner who supplies a medicine to someone else on a purchase order must make a written record of the following information: (a) the date of the order; (c) the name, and the business address and telephone number, of the person to whom the medicine is supplied; (d) the date the order is supplied; (e) the medicine, and the form, strength and quantity of the medicine, supplied.

Division 4.2.5 Supplying medicines on standing Note 1 For the issue of a standing order, see pt 3.4. Note 2 Supply does not include administer (see Act, s 24).

150 Authorisation conditions for supplying medicines on standing orders—Act, s 44 (1) (b) and (2) (b) (1) An authorisation under section 110 or section 490 to supply a medicine on a standing order is subject to the following conditions: (a) the medicine is supplied in accordance with the requirements of section 151; (b) the supply is recorded in accordance with section 153;

Supplying medicines on standing orders Division 4.2.5 (c) the record for section 153 is kept at the supplier’s business premises or, if the chief health officer approves in writing at least 2 years after the day the medicine is supplied; (d) if the supplier is not the person who would ordinarily have prescribed the medicine for the recipient, the required information is given in writing to— (i) the prescriber (the usual prescriber) who would ordinarily have prescribed the medicine for the recipient not later than 24 hours after supplying the medicine; or (ii) if the recipient does not have a usual prescriber—the recipient. (2) However, subsection (1) (c) and (d) do not apply if the record is made in a patient’s medical records. required information, for the supply of a medicine on a standing order, means— (a) the supplier’s name; and (b) the date the medicine is supplied; and (c) the name and address of the person to whom the medicine is (d) the medicine’s approved name and brand name; and (e) the form, strength and quantity of the medicine supplied. supplier—see section 153 (1).

151 Supplying medicines on standing orders The following are the requirements for the supply of a medicine on a standing order: (a) the medicine is supplied in accordance with the standing order; accordance with section 152.

152 Labelling medicines supplied on standing order—Act, The package of a medicine supplied on a standing order must have a label that includes the following: (a) the name of the person to whom the medicine is to be supplied; medicine, supplied; (d) if the package of the dispensed medicine is not a manufacturer’s pack— (i) the batch number or numbers of the medicine; and (ii) the relevant expiry date for the medicine; (e) the supplier’s name, business address and telephone number; (f) directions about the use of the medicine that are adequate to (g) words to the effect of ‘keep out of reach of children’.

Supplying medicines on standing orders Division 4.2.5

153 Recording supply of medicines on standing orders (1) A person (the supplier) who supplies a medicine to a person (the patient) on a standing order must make a written record of the following information: (a) the supplier’s name; (b) the patient’s name and address; (c) the date the medicine is supplied; (d) the medicine’s approved name and brand name; (e) the form, strength and quantity of the medicine; (f) the date of the standing order. (2) However, subsection (1) (b) does not apply if the record is made in the patient’s medical records.

Division 4.2.6 Supplying medicines during consultations Note Supply does not include administer (see Act, s 24).

160 Authorisation conditions for supplying medicines during consultations—Act, s 44 (1) (b) and (2) (b) A prescriber’s authorisation under section 110 or section 490 to supply a medicine during a consultation is subject to the following conditions: (a) the medicine is supplied in accordance with the Act, section 7 (Appropriate prescription and supply of medicines); (b) if the medicine is a controlled medicine for human use— (i) the prescriber complies with the additional requirements under section 163 (Additional requirements for supplying controlled medicines for human use during consultations) in relation to the supply; and (ii) if the medicine is dronabinol—the prescriber has an authorisation under the Therapeutic Goods Act 1989 (Cwlth), section 19 to supply the medicine; and Note Dronabinol cannot be prescribed for veterinary use because it is a prohibited substance (see medicines and poisons standard, sch 9, entry for tetrahydrocannabinols). (iii) the prescriber complies with section 164 (Information for CHO about monitored medicines supplied during consultations—Act, s 31 (2) (b) and (4), def required information); (c) if the medicine is an appendix D medicine— (i) the prescriber has an appendix D medicines approval to prescribe the medicine; and

Supplying medicines during consultations Division 4.2.6 approval (including any conditions in the schedule, part 3.2, column 4 in relation to the medicine); (d) the medicine is labelled in accordance with section 161; (e) the supply is recorded in accordance with section 162; (f) the record is kept at the prescriber’s business premises or, if the chief health officer approves in writing another place, the place day the medicine is supplied.

161 Labelling medicines supplied during consultations The supplied medicine must have a label that includes the following: (c) the prescriber’s name, business address and telephone number; (d) the medicine’s approved name or brand name; (e) the form, strength and quantity of the medicine; (f) if the package of the supplied medicine is not a manufacturer’s (g) directions about the use of the medicine that are adequate to (h) words to the effect of ‘keep out of reach of children’; (i) if the prescriber is a veterinary practitioner— (i) words to the effect of ‘for animal treatment only’; and

(ii) the species of the animal for which the medicine is (iii) if possible, a way of identifying the animal. Examples—par (d) and par (e) 1 Warfarin tablets 5mg 50 2 Coumadin tablets 5mg 50 162 Recording medicines supplied during consultations A prescriber who supplies a medicine during a consultation must make a written record of the following information in the medical records of the person to whom, or animal to which, the consultation related: (a) the date the medicine is supplied; (b) the medicine’s approved name or brand name; (c) the form, strength and quantity of the medicine; (d) the directions given to the person for the use of the medicine.

163 Additional requirements for supplying controlled medicines for human use during consultations The following are the additional requirements for supplying a controlled medicine for human use during a consultation: (a) the prescriber has a controlled medicines approval to prescribe Note For controlled medicines approvals, see pt 13.1. (b) if the approval is for a particular form of the medicine—the supply is for the form of the medicine approved or a bioequivalent form;

Supplying medicines during consultations Division 4.2.6 (c) if the approval is for a particular strength of the medicine—the supply is for the strength approved or a weaker strength; (d) if the approval is for a maximum daily dose of the medicine— the supply is for not more than the maximum daily dose approved; (e) the prescriber complies with each condition (if any) of the approval. If a slow release form of a medicine is approved, the prescriber is not authorised to prescribe an immediate release form of the medicine.

164 Information for CHO about monitored medicines supplied during consultations—Act, s 31 (2) (b) and (4), def required information (1) This section applies if a prescriber supplies a monitored medicine for human use during a consultation. Note Supply does not include administer (see Act, s 24). (2) The prescriber must, not later than 7 days after the end of the month when the monitored medicine is supplied, give the chief health officer the following information in writing: (a) the prescriber’s name, business address and telephone number; (b) the name, date of birth and address of the person to whom the medicine is supplied; (c) the date of supply; (d) the monitored medicine, and the form, strength and quantity of the medicine, supplied.

170 Meaning of retail sale—div 4.2.7 In this division: retail sale does not include supply on prescription.

171 Authorisation conditions for retail sale of pseudoephedrine—Act, s 44 (1) (b) and (2) (b) A person’s authorisation under section 110 to supply pseudoephedrine is subject to the following conditions if the pseudoephedrine is sold by retail sale: (a) the pseudoephedrine is supplied in accordance with the Act, section 7 (Appropriate prescription and supply of medicines); (b) the seller complies with section 172; (c) the seller makes a record (the pseudoephedrine record) of the required information under section 173; Note For how the record must be made, see the Act, s 46. (d) the record is kept at the seller’s business premises or, if the chief health officer approves in writing another place, the place day the sale is made; (e) if the buyer of the pseudoephedrine asks the seller to see the record during the period it is kept under paragraph (d), the seller— (i) allows the buyer to see the record within a reasonable period of a request being made by the buyer; and (ii) if satisfied that the record is incorrect, amends the record;

Selling pseudoephedrine by retail Division 4.2.7 (f) the seller complies with— (i) a request under section 174 (4) (b) (Failure to amend pseudoephedrine sales record); and (ii) a direction under section 175 (Pseudoephedrine sales record—decision by CHO) to amend the record.

172 Requirement to tell buyer about pseudoephedrine sales record (1) The authorised person selling pseudoephedrine by retail sale, must tell the buyer the following: (a) the seller is required to make a record of the sale; (b) the buyer may refuse to provide information for the record but, if the buyer refuses, the seller must not sell pseudoephedrine to the buyer; (c) the record may be made available to the following people: (i) a police officer; (ii) a public servant who is a member of the administrative unit to which the chief health officer belongs; (iii) a Commonwealth or State public servant (however described) who is a member of an administrative unit (however described) that administers legislation about medicines; Note State includes the Northern Territory (see Legislation Act, dict, pt 1). (iv) anyone other than the seller who supplies pseudoephedrine to the public in Australia; (v) the Pharmacy Guild of Australia; (d) the buyer has the right to see the record and have any mistake corrected.

police officer includes a member of a police force (however described) of a State.

173 Required information for pseudoephedrine sales records (1) The following is the required information for a pseudoephedrine record: (a) the date of sale; (b) the brand name, form, strength and quantity of pseudoephedrine sold; (c) the buyer’s name and address; (d) a unique identification number for the buyer from— (i) a photo identification document produced to the seller by the buyer; or (ii) if the buyer does not produce a photo identification document— (A) the buyer’s birth certificate; or (B) an Australian or New Zealand seniors card for the buyer; (e) the kind of identification the buyer produces. Example—unique identification number a person’s driver licence number Australian student identification card means a card issued to a person who is a student at an Australian secondary or tertiary education institution to identify the person as a student at the institution.

Selling pseudoephedrine by retail Division 4.2.7 birth certificate, for a person, means— (a) the person’s birth certificate, or a certified extract from the register about the person’s birth, under the Births, Deaths and Marriages Registration Act 1997; or (b) a document issued under a law of a State, an external Territory or New Zealand that corresponds to a birth certificate or extract mentioned in paragraph (a) if the document identifies the issuing jurisdiction and states its date of issue. photo identification document, for a person, means any of the following documents for the person if it is current and contains the person’s photograph: (a) an Australian driver licence or external driver licence within the meaning of the Road Transport (Driver Licensing) Act 1999; (b) a passport, other than an Australian passport; (c) a proof of identity card; (d) an Australian student identification card. proof of identity card means a proof of identity card issued under— (a) the Liquor Act 2010, section 210 (Proof of identity cards); or (b) the law of a State, an external territory or New Zealand.

174 Failure to amend pseudoephedrine sales record (1) This section applies if the seller of pseudoephedrine does not amend a pseudoephedrine record in accordance with section 171 (e) (ii) (Authorisation conditions for retail sale of pseudoephedrine—Act, s 44 (1) (b) and (2) (b)). (2) The buyer may, in writing, apply to the chief health officer for a direction to the seller to make the amendment.

(3) The application must give reasons why the buyer thinks the record is incorrect. (4) The chief health officer must— (a) give a copy of the application to the seller; and (b) ask the seller to— (i) make the amendment and tell the chief health officer; or (ii) if the seller is satisfied that the amendment should not be made—send written reasons to the chief health officer not later than 10 working days after the day the seller receives the application why the amendment should not be made.

175 Pseudoephedrine sales record—decision by CHO (1) After considering an application under section 174 (2) and any reasons given in accordance with the request under section 174 (4) (b) (ii), the chief health officer must— (a) direct the seller to amend the pseudoephedrine record— (i) in accordance with the application; or (ii) in a stated way other than in accordance with the application; or (b) refuse the application. (2) The chief health officer must give the buyer and seller written notice of the decision.

Supplying pharmacist only medicines Division 4.2.8 Division 4.2.8 Supplying pharmacist only medicines

180 Authorisation conditions for supply of pharmacist only (1) This section does not apply to the supply of a pharmacist only medicine— (a) at an institution; or (b) on a supply authority. Note 2 Supply authority includes a written prescription or requisition or a purchase order or standing order (see Act, s 23). (2) An authorisation under section 110 or section 490 to supply a pharmacist only medicine is subject to the following conditions: (a) the supplier personally hands the medicine to a recipient attending in person; (b) the supplier gives the recipient adequate instructions, either orally or in writing, for the medicine’s use at the time of supply. supplier means the following: (a) a person who is authorised under section 110 to supply a pharmacist only medicine; (b) an endorsed health practitioner who is authorised under section 490 to supply a pharmacist only medicine.

Part 4.3 Authorisation to supply without prescription in emergencies Part 4.3 Authorisation to supply without prescription in emergencies 250 Meaning of designated prescription only medicine—pt 4.3 designated prescription only medicine means a prescription only medicine other than— (a) an anabolic steroid; and (b) an appendix D medicine; and (c) a benzodiazepine. Note Prescription only medicine does not include a controlled medicine (see Act, s 11)

251 Authorisation to supply certain medicines without prescription in emergencies—Act, s 26 (1) (b) A pharmacist is authorised to supply a designated prescription only medicine to someone else without a prescription if the pharmacist is satisfied that— (a) the person is undergoing treatment essential to the person’s health or wellbeing; and (b) the designated prescription only medicine has previously been prescribed for the person’s treatment by a prescriber; and (c) the person is in immediate need of the medicine to continue the treatment; and (d) because of an emergency, it is not practicable for the person to obtain a prescription for the medicine from a prescriber.

Authorisation to supply without prescription in emergencies Part 4.3

252 Authorisation conditions for supplying of certain medicines without prescription in emergencies—Act, (1) A pharmacist’s authorisation under section 251 to supply a designated prescription only medicine without a prescription is subject to the following conditions: (a) the quantity supplied is— (i) if the medicine is a liquid, aerosol, cream, ointment or anovulant tablet packaged in a manufacturer’s pack—the smallest manufacturer’s pack in which the medicine is generally available; or (ii) in any other case—not more than the quantity required for 3 days treatment for the person; accordance with section 253; (c) the supply is recorded in accordance with section 254; (d) the record of the supply is kept at the pharmacy or, if the chief health officer approves in writing another place, the place day medicine is supplied; (e) the pharmacist sends the prescriber who would have ordinarily prescribed the medicine for the recipient the required information for the supply in writing not later than 24 hours after supplying the medicine. required information, for the supply of a designated prescription only medicine, means— (a) the pharmacist’s name; and

Part 4.3 Authorisation to supply without prescription in emergencies (b) the name, business address and telephone number of the pharmacy from which the medicine is supplied; and (c) the date the medicine is supplied; and (d) the name and address of the person to whom the medicine is (e) the medicine’s approved name or brand name; and (f) the form, strength and quantity of the medicine supplied.

253 Labelling medicines supplied without prescription in emergencies—Act, s 60 (1) (c) (i) and (2) (c) (i) The package of a designated prescription only medicine supplied to a person under section 251 must have a label that includes the (c) the name, business address and telephone number of the pharmacy from which the medicine is supplied; (d) the initials or other identification of the pharmacist supplying (f) the form, strength and quantity of the medicine; (g) if the package of the supplied medicine is not a manufacturer’s (h) directions about the use of the medicine that are adequate to

Authorisation to supply without prescription in emergencies Part 4.3 (i) words to the effect of ‘keep out of reach of children’. Example—par (e) and par (f) Warfarin tablets (Coumadin) 5mg 3

254 Recording medicines supplied without prescription in emergencies A pharmacist who supplies a designated prescription only medicine to a person under section 251 must make a written record of the following information in relation to the supply of the medicine: (a) the pharmacist’s name; (b) the name of the prescriber who would ordinarily have prescribed (c) the date the medicine is supplied; (d) the name and address of the person to whom the medicine is supplied; (f) the form, strength and quantity of the medicine supplied.

Part 4.3A Authorisation to supply certain medicines without prescription—continued Part 4.3A Authorisation to supply certain medicines without prescription— continued dispensing

255 Authorisation to supply certain medicines without prescription by approved pharmacist––Act, s 185 (1) (g) (1) An approved pharmacist is authorised to supply a designated prescription only medicine to a person without prescription if–– (a) the designated prescription only medicine is listed as a pharmaceutical benefit under a continued dispensing determination; and (b) the pharmacist supplies the designated prescription only medicine to the person in accordance with the determination. designated prescription only medicine—see section 250.

256 Labelling certain medicines supplied without prescription by approved pharmacist––Act, s 185 (1) (j) The medicine supplied to a person under section 255 must have a label that includes the following: (c) the name, business address and telephone number of the pharmacy from which the medicine is supplied; (d) the initials or other identification of the pharmacist supplying

Authorisation to supply certain medicines without prescription—continued Part 4.3A (f) the form, strength and quantity of the medicine; (g) if the package of the supplied medicine is not a manufacturer’s (h) a number that is different from the number given to any prescription dispensed at the pharmacy; (i) directions about the use of the medicine that are adequate to (j) words to the effect of ‘keep out of reach of children’. Example—pars (e) and (f) Microlut 28 tablets (Levonorgestrel) 30mcg 3

Part 4.4 Authorisation to supply medicines for disposal Part 4.4 Authorisation to supply medicines for disposal 260 Authorisation to supply medicines to pharmacists for disposal—Act, s 26 (1) (b) A person is authorised to supply a medicine to a pharmacist for disposal.

261 Authorisation to supply medicines to commercial disposal operators for disposal—Act, s 26 (1) (b) A person is authorised to supply a medicine to another person for disposal if the other person— (a) holds an environmental authorisation for the disposal of the Note For related authorisations, see pt 9.1.

Wholesale supply of medicines under corresponding laws Part 4.5 Part 4.5 Wholesale supply of medicines under corresponding laws

270 Conditions for wholesalers supplying medicines under corresponding laws—Act, s 20 (4) (c) The following conditions apply to a person who supplies medicines by wholesale under a corresponding law: (a) the person must comply with, and must ensure that the person’s agents and employees comply with— (i) the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8; and (ii) the medicines Australia code of conduct; Note Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 and medicines Australia code of conduct— see the dictionary. (b) the person must not supply sample packs of a controlled medicine; (c) the person must not supply a medicine to someone else (the buyer) unless— (i) the buyer is authorised to possess the medicine; and (ii) the supply is in accordance with section 140 (Authorisation conditions for supplying medicines on purchase orders— Act, s 44 (1) (b) and (2) (b)); (d) the person must store medicines— (i) within the manufacturer’s recommended storage temperature range; and (ii) in any other environmental condition that is necessary to preserve the medicine’s stability and therapeutic quality.

Part 5.1 Authorisations for health-related occupations

350 Authorisation under sch 1 for people in health-related occupations to administer medicines—Act, s 37 (1) (b) A person mentioned in schedule 1, column 2 is authorised to administer a medicine if— (a) administering the medicine is included in the schedule, column 3 in relation to the person; and (b) the administration is consistent with any restriction for the administration mentioned in the schedule, column 3. Note For authorisation to self-administer a medicine, see s 360.

351 Authorisation conditions for administration of medicines at institutions by people in health-related occupations— Act, s 44 (1) (b) and (2) (b) (1) An authorisation under section 350 or section 490 to administer a (a) if the medicine is administered under a standing order to a patient at an institution—the administration is recorded in the patient’s medical records; Note Institution includes a correctional centre and a CYP detention place (see s 652).

Authorisations for health-related occupations Part 5.1 (b) if the medicine is a controlled medicine administered to a patient at an institution— (i) the medicine is not removed from a storage receptacle until immediately before its administration; and (ii) the administration is witnessed by a prescribed administration witness or, if a prescribed administration witness is not reasonably available to witness the administration, the administration is witnessed by another Note The witness must sign the record of the administration as witness (see Act, s 53 (e)). (iii) the administration is recorded in— (A) the patient’s medical records; and (B) the applicable controlled medicines register mentioned in section 543 (3) (Making entries in controlled medicines registers—Act, s 51 (1) (b)). (2) However, subsection (1) (b) does not apply in relation to a controlled medicine dispensed in a dose administration aid for— (a) a patient at a residential aged care facility or residential disability care facility; or (b) a detainee at a correctional centre; or (c) a young detainee at a CYP detention place. prescribed administration witness means a person prescribed under section 544 (Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)) for the administration of a controlled medicine.

352 Authorisation for pharmacist and intern pharmacist to administer vaccine without prescription—Act, s 37 (1) (b) (1) A pharmacist is authorised to administer a vaccine to a person without prescription if the pharmacist administers the vaccine in accordance with a direction by the chief health officer. (2) An intern pharmacist is authorised to administer a vaccine to a person without prescription if— (a) the intern pharmacist administers the vaccine in accordance with a direction by the chief health officer; and (b) the intern pharmacist is under the direct supervision of a pharmacist authorised to administer a vaccine under subsection (1). (3) The chief health officer may give directions for the administration of a vaccine to a person without prescription by a pharmacist or intern pharmacist. (4) A direction is a disallowable instrument. vaccine means— (a) a vaccine for human therapeutic use to which the medicines and poisons standard, schedule 4 applies; and (b) a vaccine specified separately under that schedule for human therapeutic use.

353 Authorisation for nurse or midwife to administer vaccine without prescription—Act, s 37 (1) (b) (1) A nurse or midwife is authorised to administer a vaccine to a person without prescription if the nurse or midwife administers the vaccine in accordance with a direction by the chief health officer.

Authorisations for health-related occupations Part 5.1 (2) The chief health officer may give directions for the administration of a vaccine to a person without prescription by a nurse or midwife. (3) A direction is a disallowable instrument. vaccine—see section 352 (5).

Part 5.2 Other administration authorisations Part 5.2 Other administration 360 Authorisation for self-administration etc of medicines— Act, s 37 (2) (b) and (3) (b) (1) This section applies in relation to a medicine obtained by a person from someone who is authorised to supply the medicine to the person. (2) The following dealings by the person with the medicine are authorised: (a) if the person is a prescriber and the medicine is a restricted medicine—self-administration of a medicine prescribed or supplied by another prescriber who is not— (i) a trainee dentist, intern doctor or endorsed health (ii) related to or employed by the person; (b) if the person is a prescriber and the medicine is not a restricted medicine—self-administration of the medicine; (c) if the person is not a prescriber and the medicine is supplied for the person’s own use—self-administration of the medicine; (d) if the person is the custodian of an animal and the medicine is supplied for the animal’s use—administering the medicine to the animal. Note Custodian, of an animal—see the dictionary. restricted medicine—see section 30 (3).

Other administration authorisations Part 5.2

361 Authorisation for administration of medicines by assistants—Act, s 37 (1) (b) (1) A person (the assistant) is authorised to administer a medicine to someone else (the assisted person) if— (a) the medicine is obtained by or for the assisted person from someone who is authorised to supply the medicine to the assisted (b) the medicine is administered in accordance with the directions on the medicine’s labelling; and (c) if the assisted person is not a person under a legal disability— the assisted person asks for the assistant’s help to take the (d) if the assisted person is a person under a legal disability—the assistant is authorised by the assisted person’s parent or guardian to administer the medicine. impaired decision-making ability—a person has impaired decision-making ability if the person’s decision-making ability is impaired because of a physical, mental, psychological or intellectual condition or state, whether or not the condition or state is a diagnosable illness. person under a legal disability means— (a) a child; or (b) a person with impaired decision-making ability in relation to a matter relating to the person’s health.

Chapter 6 Obtaining and possessing medicines Chapter 6 Obtaining and possessing Note An endorsed health practitioner may be authorised to obtain and possess a medicine in accordance with an endorsement of the health practitioner’s registration (see s 490).

370 Authorisation under sch 1 to obtain and possess medicines—Act, s 35 (1) (b), (2) (b) and s 36 (b) (1) A person mentioned in schedule 1, column 2 is authorised to obtain a medicine if obtaining the medicine— (a) is included in the schedule, column 3 in relation to the person; and (b) is consistent with any restriction for obtaining the medicine mentioned in the schedule, column 3. (2) A person mentioned in schedule 1, column 2 is authorised to possess (a) possessing the medicine is included in the schedule, column 3 in (b) the possession is consistent with any restriction for the possession mentioned in the schedule, column 3.

Obtaining and possessing medicines Chapter 6

371 Authorisation to obtain and possess medicines for certain personal use-related dealings—Act, s 35 (1) (b), (2) (b) and s 36 (b) (1) A person is authorised to obtain or possess a medicine if the person obtains the medicine from someone who is authorised to supply the medicine to the person. (2) Subsection (1) applies in relation to a person whether the medicine is obtained by the person for the person’s own use or as an agent for someone else.

380 Authorisation under sch 1 to manufacture medicines— Act, s 33 (b) A person mentioned in schedule 1, column 2 is authorised to manufacture a medicine if— (a) manufacturing the medicine is included in the schedule, column 3 in relation to the person; and (b) the manufacturing is consistent with any restriction for the manufacturing mentioned in the schedule, column 3.

Discarding medicines Chapter 8

Chapter 8 Discarding medicines

390 Discarding controlled medicines—Act, s 34 (1) (a) (1) A controlled medicine must be discarded in accordance with this section. Note See also the Drugs of Dependence Act 1989, div 11.4 about the disposal of seized substances. (2) A prescribed discarding witness may discard a controlled medicine in the presence of another prescribed discarding witness. (3) However, a person or endorsed health practitioner who is authorised to administer a controlled medicine may discard the residue of the medicine after administration in the presence of a person who is not a prescribed discarding witness if no other prescribed discarding witness is reasonably available to witness its discarding. (4) A person complies with this section if the person destroys the medicine so that it is unable to be used. prescribed discarding witness means a person prescribed under section 545 (Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a) and (b)) for the discarding of a controlled Note A medicine must not be discarded in a way that creates a risk to the health or safety of people or is likely to cause damage to property or the environment (see Act, s 34 (3)).

Part 9.1 Authorisations for delivery people and commercial disposal operators Part 9.1 Authorisations for delivery people and commercial disposal operators

400 Authorisations to deliver medicines under supply authorities—Act, s 26 (1) (b), (2) (b), s 35 (1) (b), (2) (b) and s 36 (b) (1) This section applies to an adult (the delivery person), other than a health practitioner, at an institution, who is— (a) engaged to transport and deliver a medicine supplied on a supply authority; or (b) acting for a person mentioned in paragraph (a). Note For health practitioners at institutions, see sch 1, pt 1.4. (2) The delivery person is authorised to— (a) obtain and possess the medicine for the purposes of transporting and delivering the medicine as engaged; and (b) supply the medicine to the entity named as the recipient in the supply authority or the entity’s agent. Examples—delivery person 1 a hospital employee who is not a health practitioner 2 an employee of a courier service Example—agent the guardian of a child for a prescription dispensed for the child Note Entity includes a person (see Legislation Act, dict, pt 1).

Authorisations for delivery people and commercial disposal operators Part 9.1

401 Authorisations for commercial disposal operators—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b) and (2) (b) and s 36 (b) (1) This section applies to a person who— (a) holds an environmental authorisation for the disposal of a (2) The person is authorised to obtain and possess the medicine for the purposes of disposing of the medicine as engaged.

Part 9.2 Emergency supply and administration of adrenaline, naloxone and salbutamol Part 9.2 Emergency supply and administration of adrenaline, naloxone and salbutamol

410 Authorisations to supply and administer adrenaline, naloxone and salbutamol—Act, s 26 (1) (b) and s 37 (1) (b) (1) A person is authorised to do 1 or more of the following for someone else (the assisted person) who is in immediate need of adrenaline, naloxone or salbutamol: (a) supply authorised adrenaline, naloxone or authorised salbutamol to the assisted person; (b) supply authorised adrenaline, naloxone or authorised salbutamol to someone else for immediate administration to the assisted person; (c) administer authorised adrenaline, naloxone or authorised salbutamol to the assisted person. authorised adrenaline means adrenaline in an automatic injector or intranasal delivery device that delivers a predetermined dose of adrenaline. authorised salbutamol means salbutamol in, or for, a metered inhaler.

Medicines authorisations for corrections functions Part 9.3 Part 9.3 Medicines authorisations for corrections functions

420 Authorisations for CYP authorised people—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b) A CYP authorised person is authorised, within the scope of the person’s employment, to do any of the following in relation to a medicine supplied for a young detainee by a person who is authorised to supply the medicine: (a) obtain the medicine; (b) possess the medicine (including possess the medicine outside a CYP detention place for the purpose of administering the medicine to a young detainee while the young detainee is lawfully outside the place); (c) administer the medicine to the young detainee; (d) supply the medicine to a person who is authorised to obtain the medicine for the young detainee. Example—young detainee lawfully outside CYP detention place the detainee is on local leave escorted by a CYP authorised person Note 1 CYP authorised person and CYP detention place—see the dictionary. Note 2 Young detainee—see the Children and Young People Act 2008, s 95.

421 Authorisations for corrections officers—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b) A corrections officer is authorised, within the scope of the officer’s employment, to do any of the following in relation to a medicine supplied for a detainee by a person who is authorised to supply the medicine: (a) obtain the medicine;

Part 9.3 Medicines authorisations for corrections functions (b) possess the medicine (including possess the medicine outside a correctional centre for the purpose of administering the medicine to a detainee while the detainee is lawfully outside the centre); (c) administer the medicine to the detainee; (d) supply the medicine to a person who is authorised to obtain the medicine for the detainee. Note 1 See the example and notes to s 420. Note 2 Detainee—see the Corrections Management Act 2007, s 6.

422 Authorisations for court and police cell custodians—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b) (1) A custodian is authorised, within the scope of the custodian’s employment, to do any of the following in relation to a medicine supplied for a person in custody at court cells or police cells by someone who is authorised to supply the medicine: (a) obtain the medicine at the cells; (b) possess the medicine at the cells; (c) administer the medicine to the person in custody at the cells; (d) supply the medicine to someone who is authorised to obtain the medicine for the person in custody. court cell—see the Corrections Management Act 2007, section 29. custodian means— (a) a person in charge of a court cell or police cell; or (b) a person acting under the direct supervision of the person in charge.

Medicines authorisations for corrections functions Part 9.3 person in custody means— (a) a detainee; or (b) a young detainee; or (c) a person detained at a police cell under the Corrections Management Act 2007, section 30; or (d) a person detained at a court cell under the Corrections Management Act 2007, section 33. police cell—see the Corrections Management Act 2007, section 29.

Part 9.4 Authorisations for medicines research and education program purposes Part 9.4 Authorisations for medicines research and education program purposes other than controlled Note A licence is required for research and education programs in relation to controlled medicines (see pt 14.2).

430 Authorisations for non-controlled medicines research and education—Act, s 26 (1) and (2) (b) (1) A scientifically qualified person employed at a recognised research institution (other than a hospital operated by the Territory) is authorised to do the following for the purposes of an authorised activity at the institution: (a) issue a purchase order for a relevant medicine; (b) obtain on a purchase order a relevant medicine; (c) possess a relevant medicine; (d) supply a relevant medicine to a person (a relevant person) who is taking part in the authorised activity at the institution. Note 1 Scientifically qualified person—see the dictionary. Note 2 Recognised research institution—see the Act, s 20 (5). (2) A scientifically qualified person employed at a hospital operated by the Territory is authorised to do the following for the purposes of an authorised activity at the hospital: (a) issue a written requisition for a relevant medicine; (b) obtain on a written requisition a relevant medicine; (c) possess a relevant medicine;

Authorisations for medicines research and education program purposes Part 9.4 (d) supply a relevant medicine to a person (also a relevant person) who is taking part in the authorised activity at the hospital. (3) A relevant person is authorised to do the following in relation to a relevant medicine for the purposes of an authorised activity: (a) obtain the medicine from the scientifically qualified person for the activity; (b) possess the medicine for the purposes of the activity; (c) supply the medicine to the scientifically qualified person for the activity. authorised activity, in relation to a relevant medicine at a recognised research institution, means the conduct of any of the following if it does not involve the administration of the medicine to a person: (a) medical or scientific research in relation to the medicine at the (b) instruction involving the medicine at the institution; (c) quality control or analysis of the medicine at the institution; (d) if the relevant medicine is integral to genuine medical or scientific research at the institution—reasonable use of the medicine to carry out the research. relevant medicine means a medicine other than a controlled

Part 9.4 Authorisations for medicines research and education program purposes

431 Authorisation conditions for non-controlled medicines research and education—Act, s 44 (1) (b) and (2) (b) A scientifically qualified person’s authorisation under section 430 is subject to the following conditions: (a) the person has written approval for the conduct of the authorised activity from the person in charge of— (i) the recognised research institution; or (ii) a faculty or division of the institution; (b) if the recognised research institution employing the person is a hospital operated by the Territory— (i) a requisition for the relevant medicine issued by the person and (ii) the requisition is for an amount of the medicine approved in writing by the person in charge; and (iii) the requisition is for an amount of the medicine used solely for the purpose approved in writing by the person in charge; (c) if the person is employed at a recognised research institution other than a hospital operated by the Territory— (i) a purchase order for the relevant medicine complies with section 62; and (ii) the purchase order is for an amount of the medicine approved in writing by the person in charge; (d) the medicine is obtained from someone who is authorised to supply the medicine to the person.

Controlled medicines research and education program licence Division 9.5.1 Part 9.5 Authorisations under medicines Division 9.5.1 Controlled medicines research and education program licence Note 1 For authorisation for research and education for other medicines, see pt 9.4. Note 2 For other provisions about controlled medicines research and education program licences, see pt 14.2.

440 Authorisations under controlled medicines research and education program licences—Act, s 20 (1) (a) (1) A controlled medicines research and education program licence (other than for a program conducted at a hospital operated by the Territory) authorises— (i) issue a purchase order for a controlled medicine (the licensed controlled medicine) stated in the licence for the program stated in the licence; and (ii) obtain a licensed controlled medicine on a purchase order for the program; and (iii) possess a licensed controlled medicine for the program at (iv) supply a licensed controlled medicine to anyone taking part

Division 9.5.1 Controlled medicines research and education program licence to deal with the licensed controlled medicine as authorised by the licence at the premises stated in the licence. (2) A controlled medicines research and education program licence for a program conducted at a hospital operated by the Territory (i) issue a written requisition for a controlled medicine (the licensed controlled medicine) stated in the licence for the program stated in the licence; and (ii) obtain a licensed controlled medicine on a written requisition for the program; and (iii) possess a licensed controlled medicine for the program at (iv) supply a licensed controlled medicine to anyone taking part to deal with the licensed controlled medicine as authorised by the licence at the hospital.

441 Authorisation condition for controlled medicines research and education program licences—Act, A licence-holder’s authorisation to obtain a controlled medicine under a controlled medicines research and education program licence is subject to the condition that the medicine is— (a) if the licence is for a program conducted at a hospital operated by the Territory—obtained on a requisition that complies with section 55 (General requirements for written requisitions) and section 56 (Particulars for requisitions); or

First-aid kit licence authorisations Division 9.5.2 (b) in any other case—purchased on a complying purchase order. Division 9.5.2 First-aid kit licence authorisations Note For other provisions about first-aid kit licences, see pt 14.3.

450 Authorisations under first-aid kit licences—Act, s 20 (1) (a) authorised medicine, for a first-aid kit, means— (a) a medicine stated in the first-aid kit licence for the kit; and (b) a pharmacy medicine or pharmacist only medicine for the kit. (2) A first-aid kit licence authorises— (i) issue a purchase order for an authorised medicine for the first-aid kit; and (ii) obtain on a purchase order an authorised medicine for the first-aid kit; and (b) the licence-holder, and anyone else authorised to deal with a medicine by the licence, to— (i) possess an authorised medicine as part of the first-aid kit for the emergency treatment of a person’s medical condition; and (ii) supply an authorised medicine to someone else who is authorised under the licence to administer the medicine; and

(iii) administer an authorised medicine in the first-aid kit if the person believes on reasonable grounds that the administration of the medicine is necessary for the emergency treatment of a person’s medical condition.

451 Authorisation condition for first-aid kit licences—Act, A licence-holder’s authorisation to obtain a medicine under a first-aid kit licence is subject to the condition that the medicine is purchased on a complying purchase order. Note For other provisions about wholesalers licences, see pt 14.4.

460 Authorisations under medicines wholesalers licences— Act, s 20 (1) (a) (1) A medicines wholesalers licence authorises the licence-holder to do any of the following in relation to a medicine (the licensed medicine) stated in the licence at the premises (the licensed premises) stated in the licence: (a) issue a purchase order for a licensed medicine; (b) obtain a licensed medicine on a purchase order for sale by wholesale from the licensed premises; (c) possess a licensed medicine for sale by wholesale from the licensed premises; (d) sell a licensed medicine by wholesale (whether or not for resale) from the licensed premises to— (i) a person authorised to issue a purchase order for the

Wholesalers licence authorisations Division 9.5.3 (ii) someone in another State who may obtain the medicine by wholesale under the law of the other State; or medicine by wholesale in the other country; Note The medicines must be sold on a purchase order in accordance with s 140 (see s 461). (e) unless the licensed medicine is a controlled medicine—supply the medicine in accordance with the medicines Australia code of conduct provisions for product starter packs. Note Medicines Australia code of conduct—see the dictionary. (3) Also, subsection (1) (d) (iii) does not apply in relation to a licensed medicine that is a prohibited export under the Customs Act 1901 (Cwlth).

461 Authorisation conditions for medicines wholesalers licences—Act, s 44 (1) (b) and (2) (b) A licence-holder’s authorisation under a medicines wholesalers licence is subject to the following conditions: (a) the dealings with a medicine authorised by the licence will be carried out under the supervision of an individual approved under section 616 (1) (Restrictions on issuing of medicines wholesalers licences—Act, s 85 (1) (a)); (b) the licence-holder must comply with, and the licence-holder must ensure that the licence-holder’s agents and employees comply with— (i) the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8; and

Division 9.5.4 Opioid dependency treatment licence authorisations (ii) the medicines Australia code of conduct; Note Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 and medicines Australia code of conduct— see the dictionary. (c) a medicine obtained under the licence is purchased on a complying purchase order; (d) a medicine sold under the licence is sold on a complying purchase order in accordance with section 141 (Supplying medicines on purchase orders). Division 9.5.4 Opioid dependency treatment licence Note For other provisions about opioid dependency treatment licences, see pt 14.5.

470 Authorisations under opioid dependency treatment (1) An opioid dependency treatment licence issued to a pharmacist authorises the licence-holder, and any other pharmacist at the community pharmacy (the licensed pharmacy) to which the licence relates, to do any of the following for the purpose of treating a person’s drug-dependency: (a) issue a purchase order for buprenorphine or methadone; (b) obtain buprenorphine or methadone on a purchase order for administration at the licensed pharmacy; (c) possess buprenorphine and methadone; (d) dispense buprenorphine and methadone in accordance with a

Opioid dependency treatment licence authorisations Division 9.5.4 (e) supply buprenorphine and methadone to a nurse at the licensed pharmacy for administration at the pharmacy under the supervision of a pharmacist; (f) administer buprenorphine and methadone at the licensed pharmacy in accordance with a prescription (including the prescription as changed by a pharmacist at the oral direction of the prescriber). (2) An opioid dependency treatment licence issued to a pharmacist authorises a nurse to administer buprenorphine and methadone at the licensed pharmacy under the supervision of a pharmacist and in accordance with a prescription (including the prescription as changed by a pharmacist at the oral direction of the prescriber). Note 1 Nurse does not include an enrolled nurse (see Legislation Act, dict, pt 1). (3) To remove any doubt, an authorisation under this section does not, by implication, limit a pharmacist’s or nurse’s authorisations under schedule 1 (Medicines—health-related occupations authorisations) in relation to other dealings with buprenorphine and methadone.

471 Authorisation condition for opioid dependency treatment licences—Act, s 44 (1) (b) and (2) (b) (1) A licence-holder’s authorisation under an opioid dependency treatment licence is subject to the following conditions: (a) the licence-holder must ensure that a person to whom buprenorphine or methadone is administered under the licence signs a written acknowledgment in accordance with subsection (2) that the medicine has been administered to the person;

(b) a purchase order issued by the licence-holder to obtain buprenorphine or methadone under the licence is a complying purchase order. Note 1 Written includes in electronic form (see Act, dict). Note 2 For licence conditions, see the Act, s 89. (2) For subsection (1) (a), the acknowledgment must include the (a) the approved name or brand name of the medicine administered; (b) the form, strength and quantity of the medicine administered; (c) the date the medicine is administered. Division 9.5.5 Pharmacy medicines rural communities licences Note For other provisions about pharmacy medicines rural communities licences, see pt 14.6.

480 Authorisations under pharmacy medicines rural communities licences—Act, s 20 (1) (a) A pharmacy medicines rural communities licence authorises— (i) issue a purchase order for a pharmacy medicine (the licensed medicine) stated in the licence for retail sale from the premises (the licensed premises) stated in the (ii) obtain the licensed medicine on a purchase order for retail sale from the licensed premises; and (iii) possess the licensed medicine at the licensed premises for retail sale from the licensed premises; and

Pharmacy medicines rural communities licences Division 9.5.5 (iv) sell the licensed medicine by retail from the licensed premises to customers attending in person at the licensed premises; and (b) an employee of the licence-holder to— (i) possess the medicine at the licensed premises for retail sale from the licensed premises; and (ii) sell the medicine by retail from the licensed premises to customers attending in person at the licensed premises. Examples—sales to which par (a) (iv) and par (b) (ii) do not apply sales over the internet or by mail Note For other requirements in relation to medicines sold under rural communities licences—see s 500 (3), s 502 (4) and s 522.

481 Authorisation conditions for pharmacy medicines rural communities licences—Act, s 44 (1) (b) and (2) (b) A licence-holder’s authorisation under a pharmacy medicines rural communities licence is subject to the following conditions: (a) a pharmacy medicine obtained under the licence is purchased on a complying purchase order; (b) the pharmacy medicines to which the licence relates are sold in the manufacturer’s packs; (c) the packs are labelled in accordance with— (i) section 502 (Labelling of supplied manufacturer’s packs of medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)); or

(d) the pharmacy medicines to which the licence relates are sold from the premises stated in the licence to customers attending in

Medicines authorisations for health practitioners Part 9.6 Part 9.6 Medicines authorisations for health practitioners

490 Authorisations for endorsed health practitioners—Act, s 20 (1) (d) (1) This section applies to a health practitioner whose registration is endorsed under the Health Practitioner Regulation National Law (ACT), division 8 (Endorsement of registration) if the endorsement provides for dealing with a medicine (an endorsed health practitioner). (2) The endorsed health practitioner is authorised to deal with the medicine in accordance with the endorsement. (3) If there is an inconsistency between the endorsement and this regulation, the endorsement prevails to the extent of the inconsistency.

490A Authorisations for health practitioners to deal with medicines with CHO approval—Act, s 20 (1) (c) (1) A health practitioner is authorised to deal with a medicine if the health practitioner is approved under this section to deal with the medicine. (2) The chief health officer may approve a health practitioner, or a class of health practitioners, to deal with a medicine if the chief health officer is satisfied that the approval is appropriate in the circumstances. (3) The approval must be in writing and include the following (a) the health practitioner or the class of health practitioners to whom the approval relates; (b) the dealing to which the approval relates;

Part 9.6 Medicines authorisations for health practitioners (c) the medicine to which the approval relates; (d) any conditions to which the approval is subject; (e) a unique identifying number for the approval; (f) the date the approval starts; (g) if the approval applies for a stated period—the stated period. (4) An approval is a notifiable instrument.

Packaging and labelling of medicines generally Chapter 10

Chapter 10 Packaging and labelling of medicines generally

500 When pharmacy medicines and pharmacist only medicines to be supplied in manufacturer’s packs—Act, health practitioner does not include— (a) a pharmacist, or intern pharmacist, at a hospital; or (b) a prescriber who supplies a medicine during a consultation. supply does not include dispense. (2) A health practitioner or employee acting under the direction of a health practitioner, must supply a pharmacy medicine or pharmacist only medicine in a whole manufacturer’s pack of the medicine. (3) A pharmacy medicines rural communities licence-holder, or an employee acting under the direction of the licence-holder, must sell a pharmacy medicine stated in the licence in a whole manufacturer’s pack of the medicine.

501 Packaging of supplied manufacturer’s packs of medicines—Act, s 59 (1) (c) (i) and (2) (c) (i) A manufacturer’s pack of a medicine supplied must be packaged— (b) in a container in which the medicine may be sold under a corresponding law. Note A manufacturer’s pack of a medicine supplied may also be packaged in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 59 (1) (c) (ii) and (2) (c) (ii)).

Chapter 10 Packaging and labelling of medicines generally

502 Labelling of supplied manufacturer’s packs of medicines—Act, s 60 (1) (c) (i) and (2) (c) (i) supply, a medicine, does not include— (a) dispense the medicine; or (b) supply the medicine on a requisition or standing order. (2) A manufacturer’s pack of a supplied medicine must be labelled in accordance with— (b) a corresponding law. Note A manufacturer’s pack of a medicine supplied may also be labelled in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 60 (1) (c) (ii) and (2) (c) (ii)). (3) A manufacturer’s pack of a pharmacist only medicine sold by retail at a community pharmacy must be labelled with the pharmacy’s name, business address and telephone number. (4) A manufacturer’s pack of a pharmacy medicine sold at premises licensed under a pharmacy medicines rural communities licence must be labelled with the licence-holder’s name, business address and telephone number.

Preliminary Part 11.1

510 Meaning of prescribed person—ch 11 For this chapter, each of the following is a prescribed person: practitioner or veterinary practitioner; Note 1 Dentist and doctor does not include an intern or trainee (see defs of these terms in dict). Note 2 Medical radiation practitioner does not include a person holding student, limited or provisional registration to practise in the profession (see dict). (b) a pharmacist responsible for the management of a community pharmacy; (c) the chief pharmacist at an institution; (d) a medicines wholesalers licence-holder; (e) a pharmacy medicines rural communities licence-holder; (f) an approved analyst; Note Approved analyst—see the dictionary. (g) a medicines and poisons inspector (including a police officer); (h) a controlled medicines research and education program licence-holder; (i) a person in charge of any of the following: (i) an ambulance service (whether or not operated by the Commonwealth, the Territory or a State); (ii) a correctional centre;

(iii) a CYP detention place; (iv) a health centre operated by the Territory; (v) a residential aged care facility without a pharmacy; (vi) a residential disability care facility without a pharmacy; (vii) a ward (including an opioid dependency treatment centre operated by the Territory). Note 2 Residential aged care facility and residential disability care facility— see the Act, dictionary.

511 Meaning of key—ch 11 key includes an electronic swipe card or electronic proximity device.

Storage requirements for medicines generally Part 11.2

Part 11.2 Storage requirements for medicines generally

515 Storage of medicines generally—Act, s 61 (b) and (c) (1) A prescribed person must ensure that a medicine in the person’s possession is stored— (a) within the manufacturer’s recommended storage temperature range; and (b) in any other environmental condition that is necessary to preserve the medicine’s stability and therapeutic quality. (2) To remove any doubt, this section does not apply to a prescribed

Part 11.3 Additional storage requirements for medicines other than controlled Part 11.3 Additional storage requirements for medicines other than 520 Storage of medicines other than controlled medicines in community pharmacies—Act, s 61 (b) and (c) (1) The pharmacist responsible for the management of a community pharmacy must ensure that each pharmacy medicine at the pharmacy is stored— (a) if the medicine is for retail sale—within 4m of, and in sight of, the pharmacy’s dispensary; and (b) in any other case—so that public access to the medicine is restricted. (2) The pharmacist responsible for the management of a community pharmacy must ensure that each pharmacist only medicine and prescription only medicine at the pharmacy is stored— (a) in a part of the premises to which the public does not have access; and (b) so that only a pharmacist, or a person under the direct supervision of a pharmacist, has access to the medicine.

521 Storage of medicines other than controlled medicines by other people—Act, s 61 (b) and (c) prescribed person does not include a pharmacist responsible for the management of a community pharmacy.

Additional storage requirements for medicines other than controlled Part 11.3 (2) A prescribed person must ensure that a medicine (other than a controlled medicine) in the person’s possession is stored so that public access to it is restricted. (3) To remove any doubt, this section does not apply to a prescribed

522 Storage of pharmacy medicines by pharmacy medicines rural communities licence-holders—Act, s 61 (b) and (c) A pharmacy medicines rural communities licence-holder must store a pharmacy medicine for retail sale so that public access to the medicine is restricted.

Part 11.4 Additional storage requirements for controlled medicines

530 Meaning of personal custody—pt 11.4 personal custody, of a key by a person, includes keeping the key in a combination-operated key safe, the combination of which the person keeps confidential.

531 Storage of controlled medicines by wholesalers licence-holders—Act, s 61 (b) and (c) (1) A wholesalers licence-holder must store a controlled medicine in the person’s possession (other than a controlled medicine required for immediate supply) in a vault that— (a) complies with, or is more secure than a vault that complies with, the requirements for a vault in schedule 5, section 5.8 (Requirements for vaults); and (b) is fitted with an alarm system. (2) However, if the chief health officer is satisfied that the total amount of controlled medicine held by the licence-holder at any time is not large enough to need to be stored in a vault, the chief health officer may approve, in writing, the storage of the controlled medicine in a safe or strong room. (3) If the chief health officer gives an approval under subsection (2)— (a) if the approval is for a safe—the safe must comply with, or be more secure than a safe that complies with, the requirements for a safe in schedule 5, section 5.6 (Requirements for safes); and

(b) if the approval is for a strong room—the strong room must comply with, or be more secure than a strong room that complies with, the requirements for a strong room in schedule 5, section 5.7 (Requirements for strong rooms); and (c) the safe or strong room must be fitted with an alarm system.

532 Storage of controlled medicines for certain health-related occupations—Act, s 61 (b) and (c) designated person means— practitioner or veterinary practitioner (other than 1 of those health practitioners at an institution); or (b) an ambulance officer or paramedic employed by the (c) a first-aid kit licence-holder; or (d) a controlled medicines research and education program Note 1 Dentist and doctor does not include an intern or trainee (see defs of these Note 2 Medical radiation practitioner and paramedic does not include a person holding student, limited or provisional registration to practise in the profession (see defs of these terms in dict).

(2) A designated person who possesses a controlled medicine must store the controlled medicine as follows: (a) the person must ensure that the controlled medicine is stored in— (i) a locked container that prevents ready access to the container’s contents and is securely attached to a building; or (ii) a locked drawer, cupboard, room or vehicle; or (iii) if the controlled medicine is required to be stored in a refrigerator—a locked refrigerator; (b) if the controlled medicine is kept in a container or refrigerator that is unlocked by a combination lock—the person must keep the combination confidential; (c) if the controlled medicine is kept in a container or refrigerator that is unlocked by a key—the person must keep personal custody of the key; (d) if the controlled medicine is kept in a drawer, cupboard, room or vehicle—the person must keep personal custody of the key to the drawer, cupboard, room or vehicle; (e) if the controlled medicine is required to be stored in a refrigerator—the person must ensure that the refrigerator in which the medicine is kept is used only to store medicines requiring refrigeration. (3) However, subsection (2) does not apply to a controlled medicine if— (a) the controlled medicine is being carried by a designated person in— (i) a locked first-aid kit; or

(ii) an unlocked first-aid kit that is in immediate use; and (b) the person keeps personal custody of the key to the first-aid kit.

533 Storage of controlled medicines by certain other prescribed people—Act, s 61 (b) and (c) excluded person means— practitioner or veterinary practitioner at an institution; or (b) the person in charge of an ambulance service (whether or not operated by the Commonwealth, the Territory or a State); or (c) the person in charge of a residential aged care facility or residential disability care facility in relation to a controlled medicine dispensed in a dose administration aid for a patient at the facility; or (d) the person in charge of a correctional centre in relation to a controlled medicine dispensed for a detainee in a dose administration aid; or (e) the person in charge of a CYP detention place in relation to a controlled medicine dispensed for a young detainee in a dose administration aid. Note 2 Correctional centre—see the Legislation Act, dictionary, pt 1. Note 3 Detainee—see the Corrections Management Act 2007, s 6. Note 4 Young detainee—see the Children and Young People Act 2008, s 95. Note 5 State includes the Northern Territory (see Legislation Act, dict, pt 1).

(2) This section applies to a prescribed person, other than an excluded person, in relation to a controlled medicine in the person’s possession if the medicine is not for immediate administration. (3) The person must ensure that— (a) the controlled medicine is stored in a medicines cabinet, safe, strong room or vault (a storage receptacle) that complies with, or is more secure than a storage receptacle that complies with, the requirements for the receptacle in schedule 5 (Requirements for storage receptacles); and (b) the storage receptacle is kept securely locked when not in immediate use; and (c) if the storage receptacle is unlocked by a combination lock—the person keeps the combination confidential; and (d) if the storage receptacle is unlocked by a key—the person keeps personal custody of the key; and (e) if the prescribed person is the chief pharmacist at an institution—the storage receptacle is fitted with an alarm system. (4) However, if the controlled medicine is required to be stored in a refrigerator, the prescribed person must ensure— (a) if the refrigerator has a lock—the refrigerator is kept securely locked when not under the supervision of the prescribed person; and (b) if the refrigerator does not have a lock—the room or enclosure where the refrigerator is located is kept securely locked when the room or enclosure is not under the supervision of the prescribed person; and

(c) if the refrigerator, or the room or enclosure where the refrigerator is located, is unlocked by a combination lock—the prescribed person keeps the combination confidential; and (d) if the refrigerator, or the room or enclosure where the refrigerator is located, is unlocked by a key—the prescribed person keeps personal custody of the key; and (e) the refrigerator is used only to store medicines requiring refrigeration. (5) If a controlled medicine is stored in a refrigerator, the prescribed person may leave the refrigerator, or the room or enclosure where the refrigerator is located, unlocked if— (a) the refrigerator, room or enclosure is under the supervision of the prescribed person; and (b) the controlled medicine is kept in a metal container that prevents ready access to the container’s contents and is securely fixed inside the refrigerator; and (c) the metal container is kept securely locked when not in immediate use; and (d) if the metal container is unlocked by a combination lock—the prescribed person keeps the combination confidential; and (e) if the metal container is unlocked by a key—the prescribed person keeps personal custody of the key. (6) To remove any doubt, this section does not apply to a prescribed

533A Storage of buprenorphine or methadone by opioid dependency treatment licence-holders etc—Act, s 61 (b) and (c) (1) This section applies to a pharmacist authorised under an opioid dependency treatment licence to possess buprenorphine or methadone. (2) Despite section 533, the pharmacist may, during the business hours for the pharmacy to which the opioid dependency treatment licence relates, store buprenorphine or methadone that is not for immediate administration in a medicines cupboard or drawer if— (a) the medicines cupboard or drawer is securely fixed to a wall or floor (or both); and (b) the medicines cupboard or drawer is kept securely locked when not in immediate use; and (c) the medicines cupboard or drawer is under the direct supervision of the pharmacist at all times the medicines cupboard or drawer contains buprenorphine or methadone; and (d) for a medicines cupboard or drawer that is unlocked by a combination lock—the pharmacist keeps the combination confidential; and (e) for a medicines cupboard or drawer that is unlocked by a key— the pharmacist keeps personal custody of the key; and (f) the door of the medicines cupboard or drawer is not in direct view of a member of the public attending the pharmacy.

540 Keeping of controlled medicines registers by certain people—Act, s 48 (a) and s 50 (1) (b) and (2) (b) (1) A person mentioned in table 540, column 2 who possesses a controlled medicine must keep a controlled medicines register. Note Also, a pharmacist responsible for the management of a community pharmacy must keep a controlled medicines register for controlled medicines kept at the pharmacy (see Act, s 48). (2) However, subsection (1) does not apply to the person in relation to— (a) a controlled medicine in a first-aid kit kept by the person; or (b) if the person is the person in charge of a residential aged care facility or residential disability care facility—a controlled medicine dispensed for the patient in a dose administration aid; or (c) if the person is the person in charge of a correctional centre—a controlled medicine dispensed for a detainee in a dose administration aid; or (d) if the person is the person in charge of a CYP detention place— a controlled medicine dispensed for a young detainee in a dose administration aid. Note 2 Correctional centre—see the Legislation Act, dictionary, pt 1. Note 3 Detainee—see the Corrections Management Act 2007, s 6. Note 4 Young detainee—see the Children and Young People Act 2008, s 95. Note 5 For keeping controlled medicines in a first-aid kit, see s 541. (3) A person to whom subsection (1) applies must keep a controlled medicines register for a controlled medicine at the place prescribed in table 540, column 3 for the person.

(4) A pharmacist responsible for the management of a community pharmacy at which controlled medicines are kept must keep the controlled medicines register for the controlled medicines at the pharmacy. Note For the requirement for a controlled medicine register to be kept for a community pharmacy, see the Act, s 48. Table 540 Keeping controlled medicines registers item 1 person in charge of ambulance service the premises where the controlled medicine is kept 2 approved analyst the analyst’s laboratory 3 person in charge of correctional centre the correctional centre 4 person in charge of CYP detention place the detention place 5 dentist the dentist’s surgery 6 doctor the doctor’s surgery 7 medicines wholesalers licence-holder the licensed premises under s 460 8 medicines and poisons inspector (other the place directed in writing by the chief health officer 9 person in charge of residential aged care the facility 10 person in charge of residential disability care facility without pharmacy the facility 11 supervisor of program under controlled medicines research and education program licence the premises where program is being conducted 12 veterinary practitioner the practitioner’s registered veterinary premises

item 13 person in charge of ward (including an opioid dependency treatment centre operated by the Territory) the ward 14 endorsed health practitioner the endorsed health practitioner’s place of practice 15 medical radiation practitioner the medical radiation practitioner’s place of practice

541 Keeping of controlled medicines registers by first-aid kit holders—Act, s 48 (a) and s 50 (1) (b) and (2) (b) designated person means— (a) a dentist, doctor, endorsed health practitioner or veterinary (b) an ambulance officer or paramedic employed by the (c) a first-aid kit licence-holder. Note 1 Dentist and doctor does not include an intern or trainee (see defs of these Note 2 Paramedic does not include a person holding student, limited or provisional registration to practise in the profession (see dict). (2) A designated person who possesses a first-aid kit containing a controlled medicine must keep the controlled medicines register for the controlled medicine with the first-aid kit.

542 Form of controlled medicines registers—Act, s 49 (1) (b) (1) Each page in a controlled medicines register must relate to a single form and strength of a controlled medicine. (2) If a controlled medicines register is kept electronically, a separate record must be used for each form and strength of controlled medicine kept.

543 Making entries in controlled medicines registers—Act, (1) The following details for a dealing with a controlled medicine are medicine, dealt with; (d) if the dealing is receiving the medicine—the name and address of the supplier; (e) if the dealing is supplying the medicine—the name and address of the person to whom it is supplied; (f) if the medicine is supplied on a prescription—the prescriber’s name and suburb and the prescription’s number under section 123 (i) (Labelling dispensed medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)); (g) if the medicine is supplied on a requisition—the requisition’s number under section 132 (e) (Labelling medicines supplied on requisition—Act, s 60 (1) (c) (i) and (2) (c) (i)); (h) if the medicine is supplied on a purchase order—the date of the purchase order;

(i) if the Act, section 53 (Registers—witnessing administration of medicines) applies to the dealing—the name of the person to whom the medicine is administered; (j) the quantity of the medicine held after the dealing. (2) However, subsection (1) (i) does not apply in relation to a controlled medicine dispensed in a dose administration aid for— (a) a patient at a residential aged care facility or residential disability care facility; or (b) a detainee at a correctional centre; or (c) a young detainee at a CYP detention place. (3) A dealing with a controlled medicine must be entered in— (a) if the dealing happens in a pharmacy at an institution—the controlled medicines register kept at the pharmacy; or (b) if the dealing happens in a ward at an institution—the controlled medicines register kept at the ward; or (c) if the person must keep both a controlled medicines register for a first-aid kit and another controlled medicines register— (i) for a dealing with a controlled medicine to which the first-aid kit relates—the controlled medicines register for the kit; or (ii) for any other dealing by the person—the other controlled medicines register; or (d) in any other case—the controlled medicines register the person must keep.

544 Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b) administration of a controlled medicine: (a) if the medicine is administered by an intern doctor— (i) an ambulance officer or paramedic employed by the (ii) a dentist; or (iii) a doctor; or (iv) a medical radiation practitioner; or (v) a midwife; or (vi) a nurse; or (vii) a pharmacist; Note 1 Dentist, doctor and pharmacist does not include an intern or trainee (see defs of these terms in dict). Note 2 Medical radiation practitioner and paramedic does not include a person holding student, limited or provisional registration to practise in the profession (see defs of these terms in dict). Note 3 Nurse does not include an enrolled nurse (see Legislation Act, dict, Note 4 State includes the Northern Territory (see Legislation Act, dict, (b) if the medicine is administered by a person who is not an intern doctor— (i) a person prescribed under paragraph (a); or (ii) an intern doctor or enrolled nurse.

(2) However, a person mentioned in subsection (1) is not prescribed as a witness to the administration of a controlled medicine if the person is— (a) related to, a close friend of or employed by the person administering the medicine; or (b) the supervisor of the person administering the medicine; or (c) supervised by the person administering the medicine.

545 Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a) and (b) discarding of a controlled medicine: (a) an ambulance officer or paramedic employed by the Commonwealth, the Territory or a State; (b) an approved analyst; (c) a dentist; (d) a doctor; (e) a medical radiation practitioner; (f) a medicines and poisons inspector; (g) a midwife; (h) a nurse; (i) a nurse practitioner; (j) a pharmacist; (k) a veterinary practitioner. Note 1 Approved analyst—see the dictionary. Note 2 Dentist and doctor does not include an intern or trainee (see defs of these

Note 3 Medical radiation practitioner and paramedic does not include a person holding student, limited or provisional registration to practise in the profession (see defs of these terms in dict). Note 4 Nurse does not include an enrolled nurse (see Legislation Act, dict, pt 1). Note 5 See s 390 for the discarding of the residue of a controlled medicine left after administration. (2) However, a person mentioned in subsection (1) is not prescribed as a witness to the discarding of a controlled medicine if the person is— the medicine; or (b) the supervisor of the person discarding the medicine; or (c) supervised by the person discarding the medicine.

546 Changes etc to entries in controlled medicines registers—Act, s 55 (2) (b) (1) An entry in a paper-based controlled medicines register may be (b) if the entry relates to administering a controlled medicine— (i) the amendment being witnessed by a person prescribed under section 544 (Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)); and (ii) the witness signing the amendment as witness; and (c) if the entry relates to the discarding of a controlled medicine— (i) the amendment being witnessed by a person prescribed under section 545 (Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a) and (b)); and

(2) An entry in an electronic controlled medicines register may be amended by the person who made the entry by the person attaching or linking, by electronic means, a document that includes— (b) if the entry relates to administering a controlled medicine—the signature as witness of a person prescribed under section 544; and (c) if the entry relates to the discarding of a controlled medicine— the signature as witness of a person prescribed under section 545.

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Chapter 13 Controlled medicines and appendix D medicines approvals for human use Note It is a condition of an authorisation to prescribe a controlled medicine for human use that the prescriber has an approval under this part (see s 31 (1) (d)).

550 Meaning of controlled medicines approval controlled medicines approval means an approval to prescribe a controlled medicine under— (a) division 13.1.2 (Standing controlled medicines approvals); or (b) division 13.1.3 (Chief health officer controlled medicines approvals).

551 Meaning of designated prescriber—pt 13.1 designated prescriber means the following: (a) a prescriber (other than a veterinary practitioner) in relation to whom prescribing a controlled medicine is included in schedule 1, column 3;

use Standing controlled medicines approvals Division 13.1.2 (b) an endorsed health practitioner if prescribing a controlled medicine is— (i) in accordance with the endorsement of their registration; and (ii) if not inconsistent with the endorsement of their registration—allowed under this regulation.

Division 13.1.2 Standing controlled medicines

554 Standing CHO approvals to prescribe controlled medicines in certain circumstances—Act, s 20 (1) (c) (1) A designated prescriber is approved to prescribe a controlled medicine for a patient of the prescriber if the prescriber— (a) is a member of a class of designated prescribers approved under this section to prescribe the controlled medicine; and (b) believes on reasonable grounds that the patient is not a drug-dependant person in relation to a controlled medicine or prohibited substance. (2) The chief health officer may approve a class of designated prescribers to prescribe a controlled medicine, or category of controlled medicine, if the chief health officer is satisfied that the approval is appropriate in the circumstances. (3) The approval must be in writing and include the following (a) the class of designated prescribers to whom the approval relates; (b) the controlled medicine, or category of controlled medicine, to which the approval relates;

use (c) if the approval is for a particular form of the controlled medicine—the form of the medicine; (d) if the approval is for a particular strength of the controlled medicine—the strength of the medicine; (e) if the approval is for a maximum daily dose of the controlled medicine—the maximum daily dose of the medicine; (f) any condition to which the approval is subject; (g) a unique identifying number for the approval; (h) the date the approval starts; (i) if the approval applies for a stated period—the stated period. (4) An approval is a notifiable instrument.

555 Standing approval to prescribe controlled medicines for hospital in-patient or patient discharge A designated prescriber is approved to prescribe a controlled medicine for a patient of the prescriber if— (a) the patient is an in-patient at a hospital; or (b) the prescription is issued— (i) as part of the patient’s discharge from a hospital; and (ii) for the patient’s use of the controlled medicine for a period of not more than 7 days. Note A hospice is a hospital (see Macquarie Dictionary, 8th ed, def hospice).

use Standing controlled medicines approvals Division 13.1.2

556 Standing approval to prescribe controlled medicines for short-term treatment (1) A designated prescriber is approved to prescribe a controlled medicine for a patient of the prescriber during a short-term treatment period if— (a) the prescriber believes on reasonable grounds that the patient— (i) is not a drug-dependant person in relation to a controlled medicine or prohibited substance; and (ii) has not been prescribed the same controlled medicine by another prescriber in the 2-month period immediately before the day the prescriber prescribes the controlled (b) the prescriber has not prescribed the same controlled medicine to the patient in the 2-month period immediately before the short-term treatment period; and (c) the prescriber prescribes the controlled medicine for the patient’s use during the short-term treatment period only. Note For prescribing controlled medicines for more than a short-term treatment period, see division 13.1.3. short-term treatment period, for a patient to be prescribed a controlled medicine, means a consecutive 2-month period beginning on the day the prescriber first prescribes the controlled medicine for the period.

556A Controlled medicines to which standing approvals do not apply (1) The chief health officer may declare a controlled medicine to which approvals under section 555 and section 556 do not apply. (2) A declaration is a notifiable instrument.

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557 Standing interim approval to prescribe buprenorphine and methadone for patients of certain institutions designated prescriber includes an intern doctor only if the intern doctor is acting under the direct supervision of a doctor. (2) A designated prescriber is approved (the interim approval) to prescribe buprenorphine or methadone if— (a) the designated prescriber— (i) is working at a hospital and prescribes the medicine for an outpatient at the hospital; or (ii) is working at any of the following institutions and prescribes the medicine for a patient of the institution: (A) a correctional centre; (B) a CYP detention place; (C) an opioid dependency treatment centre operated by the Territory; or Note Institution includes a correctional centre and a CYP detention place (see s 652). (iii) prescribes the medicine for a person in police custody; and (b) the buprenorphine or methadone is prescribed in accordance with the opioid dependency treatment guidelines; and Note Opioid dependency treatment guidelines—see the dictionary. (c) the designated prescriber makes an application under section 560 to prescribe the medicine not later than 72 hours after the designated prescriber first prescribes buprenorphine or methadone for the patient.

use (3) The interim approval ends— (a) if the chief health officer approves the application under division 13.1.3—when the designated prescriber is given notice of the approval; or (b) if the application under section 560 is withdrawn—on the withdrawal of the application; or (c) if the chief health officer refuses to approve the application and the 7-day period mentioned in section 565 (2) (Applications for review of unfavourable CHO decisions for approvals) ends without an application for review being made—at the end of the 7-day period; or (d) if the chief health officer refers the application to the medicines advisory committee or an application is made to the committee under section 565—when the designated prescriber is given notice of the chief health officer’s decision under section 573 (Medicines advisory committee—recommendations to CHO). Division 13.1.3 Chief health officer controlled medicines approvals

559 Application—div 13.1.3—standing CHO approvals to prescribe controlled medicines in certain circumstances This division does not apply in relation to a controlled medicines approval by the chief health officer under section 554.

560 Applications for CHO controlled medicines approvals (1) A designated prescriber may apply to the chief health officer for approval to prescribe a controlled medicine. (2) An application under subsection (1) must— (a) be for approval to prescribe a controlled medicine for a single individual; and

use (b) be made in a way determined by the chief health officer. Examples telephone, email and fax (3) An application under subsection (1) may be made— (a) on the applicant’s own behalf; or (b) on the applicant’s own behalf and on behalf of 1 or more other named designated prescribers; or (c) on behalf of a group of designated prescribers that includes the applicant and who practise at the same premises. the doctors practising at a suburban medical practice so that if a person’s usual doctor is unavailable another doctor at the practice can, under the approval, prescribe the controlled medicine (4) A determination under subsection (2) (b) is a notifiable instrument.

561 Requirements for CHO controlled medicines approval applications (1) An application by a designated prescriber for an approval to prescribe a controlled medicine for a patient must include the following: (a) the designated prescriber’s name and address; (b) if the application is made on behalf of a group of designated prescribers—the names of the designated prescribers or a description of the group; (c) the medicine, and either— (i) the form, strength and maximum daily dose of the Note Other forms and strengths of the medicine, and a daily dose less than the maximum daily dose, may be prescribed in accordance with s 32.

use (ii) for an approval authorised under a category approval under section 575—details of the approval sought; (d) the patient’s name and home address; (e) the condition from which the patient is suffering that, in the designated prescriber’s opinion, requires treatment with the medicine; (f) whether, in the designated prescriber’s opinion, based on reasonable grounds, the patient is a drug-dependent person in relation to a controlled medicine or prohibited substance. (2) To remove any doubt, the application may include any other information the designated prescriber considers relevant. (3) The chief health officer may ask the designated prescriber for any other information reasonably required to decide the application, including, for example, further information about the patient’s

562 CHO decision on applications to prescribe controlled (1) On application under section 560, the chief health officer must— (a) approve the application in the terms applied for; or (b) approve the application in terms different from those applied for; or (c) refuse to approve the application; or (d) refer the application to the medicines advisory committee. Note 1 An approval may include conditions (see s 570). Note 2 For the form of a controlled medicines approval by the chief health officer, see s 571.

use (2) However, the chief health officer need not decide the application if the chief health officer has asked for information under section 561 (3) and the information has not been given. (3) The chief health officer must give the applicant written notice of the chief health officer’s decision not later than 7 days after the day the decision is made. (4) If the decision is made under subsection (1) (b) or (c), the notice must include information about the applicant’s right to seek review of the decision under section 565 (Applications for review of unfavourable CHO decisions for approvals).

563 Restrictions on CHO power to approve applications for designated prescriber does not include an intern doctor. (2) In making a decision under section 562, the chief health officer— (a) must comply with any guidelines approved under section 574 (Guidelines for CHO decisions on applications); and (b) must comply with any standards determined under section 575 (Controlled medicines prescribing standards); and (c) must not approve an application to prescribe buprenorphine or methadone to treat a drug-dependent person’s drug-dependency unless the applicant is— (i) a designated prescriber who is working at a hospital, or an institution mentioned in section 557 (2) (a) (ii) (Standing interim approval to prescribe buprenorphine and methadone for patients of certain institutions); or

use (ii) an intern doctor who is working at a hospital, or an institution mentioned in section 557 (2) (a) (ii), and who is acting under the direct supervision of a doctor at the hospital or institution; or (iii) a designated prescriber who is treating a person held in police custody; or (iv) a designated prescriber who holds an endorsement under section 582 (CHO decisions on applications for endorsement to treat drug-dependency); or (v) a designated prescriber who is prescribing continuing opioid dependency treatment for up to 5 drug-dependent people if— (A) the people have already undergone opioid dependency treatment for at least 14 consecutive days (the initial treatment); and (B) the initial treatment was prescribed by a designated prescriber holding an endorsement under section 582. (3) However, the decision of the chief health officer under section 562 need not comply with a controlled medicines prescribing standard if the decision— (a) is in accordance with a recommendation of the medicines advisory committee that the prescribing standard not apply in the particular circumstances; or (b) is in accordance with an entry for a controlled medicine listed in the Australian Register of Therapeutic Goods; or (c) is necessary for the continuation of the patient’s treatment in the particular circumstances.

use Australian Register of Therapeutic Goods means the register maintained under the Therapeutic Goods Act 1989 (Cwlth). Note The Australian Register of Therapeutic Goods can be accessed at www.tga.gov.au.

564 Term of CHO controlled medicines approvals A controlled medicines approval under this division is for the period stated in the approval.

565 Applications for review of unfavourable CHO decisions for approvals (1) This section applies if, under section 562, the chief health officer— (a) approves an application for a controlled medicines approval in terms different from those applied for; or (b) refuses to approve the application for an approval. (2) The applicant for the approval may, not later than 7 days after the day the person receives written notice of the decision, apply to the medicines advisory committee for review of the decision. (a) must be in writing signed by the applicant; and (c) may include any information that the applicant considers appropriate for the review.

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566 Medicines advisory committee—referred applications and review of unfavourable CHO decisions (1) This section applies to an application— (a) for approval to prescribe a controlled medicine referred to the medicines advisory committee under section 562 (1) (d); or (b) under section 565 for review of a decision of the chief health officer on an application for a controlled medicines approval. (2) The medicines advisory committee may, in writing, ask the applicant to give the committee further information about the treatment of the person to whom the application relates not later than a stated reasonable time. (3) After considering the application and any further information provided in accordance with a notice under subsection (2), the medicines advisory committee must— (a) for an application for review of a decision by the chief health officer— (i) recommend that the chief health officer confirm the decision made; or (ii) do both of the following: (A) recommend that the chief health officer revoke the decision made; (B) make a recommendation under paragraph (b) (i), (ii) or (iii); or (b) recommend that the chief health officer— (i) approve the application to prescribe a controlled medicine in the terms applied for; or (ii) approve the application in terms different from those applied for; or

use (iii) refuse to approve the application. Note 1 The medicines advisory committee may recommend that the chief health officer include conditions in the approval (see s 570 (2)). Note 2 The chief health officer must consider the committee’s recommendation (4) A recommendation must be in writing.

567 Amendment and revocation of controlled medicines (1) The chief health officer may amend or revoke a controlled medicines approval on the chief health officer’s own initiative and without consulting the medicines advisory committee. (2) The medicines advisory committee may recommend that the chief health officer amend or revoke a controlled medicines approval, whether or not the approval was given on the recommendation of the (3) A recommendation must be in writing. (4) The chief health officer must send the approval-holder written notice of the chief health officer’s decision not later than 7 days after the day the decision is made. (5) If the decision is to amend or revoke a controlled medicines approval under subsection (1), the notice must include information about the approval-holder’s right to seek review of the decision under section 568. (6) In this section: amend, a controlled medicines approval, includes imposing a condition on, or changing a condition of, the approval.

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568 Application for review of amendment and revocation on CHO initiative (1) This section applies if the chief health officer amends or revokes a controlled medicines approval under section 567 (1). (2) The person to whom the approval was given may, not later than 7 days after the day the person is given written notice of the amendment or revocation, apply to the medicines advisory committee for review of the decision. (a) must be in writing signed by the applicant; and (c) may include any information that the applicant considers appropriate for the review. (4) To remove any doubt, the decision to which the application relates continues to operate despite the making of the application until the day the chief health officer’s decision following a recommendation under section 569 (3) takes effect.

569 Medicines advisory committee—review of amendment or revocation on CHO initiative (1) This section applies if an application is made to the medicines advisory committee under section 568 to review a decision (the original decision) of the chief health officer to amend or revoke a controlled medicines approval. (2) The medicines advisory committee may, in writing, ask the designated prescriber to give the committee further information about the treatment of the person to whom the application relates not later than a stated reasonable time.

use (3) After considering the application for review and any further information provided in accordance with a notice under subsection (2), the medicines advisory committee must recommend that the chief health officer— (a) confirm the original decision; or (b) revoke the original decision; or (c) revoke the original decision and approve the application as recommended by the committee. Note 1 The medicines advisory committee may recommend that the chief health officer include conditions in the approval (see s 570 (2)). Note 2 The chief health officer must consider the committee’s recommendation (4) A recommendation must be in writing.