New South Wales regulation

Medicines, Poisons and Therapeutic Goods Regulation 2026

In ForceNSW

Jurisdiction

New South Wales

Act Number

330 of 2026

Collection

regulation

Plain English Summary

3/10 complexity

What this instrument is

This is the Medicines, Poisons and Therapeutic Goods Regulation 2026 for New South Wales. It is a subordinate regulation that, when in force, will set detailed rules that support and implement the parent legislation dealing with medicines, poisons and therapeutic goods.

What the displayed version actually shows (mechanics)

The copy provided is an administrative, point-in-time compilation certified by the Parliamentary Counsel’s Office (Interpretation Act 1987, s 45C). The file is dated 3 July 2026.
The version displayed shows no substantive provisions that have commenced: “None of the provisions displayed in this version of the legislation have commenced.”
The instrument includes staged repeal metadata: Schedule 3, section 2(3) will repeal Schedule 3, section 2 on 6 November 2028. The whole regulation is subject to automatic repeal under the Subordinate Legislation Act 1989 on 1 September 2031 (a sunset clause).

Who it will affect (inferred from the subject matter)

Parties likely subject to the regulation include: pharmacists and pharmacies, medical and allied health practitioners, manufacturers and importers of medicines and therapeutic goods, wholesalers and distributors, hospitals and aged‑care facilities, suppliers of poisons and chemical reagents, and ultimately patients and consumers.
These categories are inferred from the regulation’s title; the displayed text does not provide the specific obligations, licences or offences that would confirm precise affected groups.

JSON API Health / NDIS / medicines

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Current sections

Direct links to the current provisions in Medicines, Poisons and Therapeutic Goods Regulation 2026.

241

Part 1

Preliminary

Part 1 Preliminary

Name of regulation

1 Name of regulation

This regulation is the Medicines, Poisons and Therapeutic Goods Regulation 2026.

Commencement

2 Commencement

This regulation commences on 5 November 2026.

Interpretation

3 Interpretation

(1) The dictionary in Schedule 4 defines words used in this regulation.

Note—

The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this regulation.

(2) On the making of this regulation, no therapeutic goods were prescribed.

Schedule 7 substances

4 Schedule 7 substances

For the Act, sections 16 and 26, a Schedule 7 substance specified in the Commonwealth Poisons Standard, Appendix J is a prescribed Schedule 7 substance.

Authorised practitioners

5 Authorised practitioners

(1) For the Act, Schedule 3, definition of authorised practitioner, paragraph (a)(v), the following classes are prescribed—

(a) midwife practitioners,

(b) nurses, midwives, podiatrists and optometrists with an endorsement, to the extent the endorsement qualifies the nurse, midwife, podiatrist or optometrist to carry out the relevant activity.

Note—

An endorsement may qualify a health practitioner to administer, obtain, possess, prescribe, sell, supply or use a scheduled substance.

(2) Despite subsection (1), nurses, midwives, podiatrists and optometrists with an endorsement are not prescribed as authorised practitioners for the Act, section 24, definition of authorised person, paragraphs (a)(ii) and (c)(ii).

Public health entities

6 Public health entities

(1) For the Act, Schedule 3, definition of public health entity, paragraph (c), the following statutory health corporations are prescribed—

(a) the Justice Health and Forensic Mental Health Network,

(b) The Sydney Children’s Hospitals Network (Randwick and Westmead), incorporating the Royal Alexandra Hospital for Children.

(2) For the Act, Schedule 3, definition of public health entity, paragraph (f), a hospital that is a recognised establishment of an affiliated health organisation under the Health Services Act 1997 is prescribed.

Schedule 4D substances

7 Schedule 4D substances

(1) For the Act, Schedule 3, definition of Schedule 4D substance, the substances specified in Column 1 of the table to this section are prescribed as Schedule 4D substances.

(2) For the Drug Misuse and Trafficking Act 1985, section 18C(3), definition of prescribed quantity, the quantity specified in Column 2 for a substance specified in Column 1 is the prescribed quantity for the substance.

(3) The quantity specified in Column 2 is the nominal amount of the substance, not including any other substance with which the substance is prepared or mixed.

(4) Subsection (3) applies for the Drug Misuse and Trafficking Act 1985, section 18C only and does not otherwise affect the operation of that Act, section 4.

| Column 1 | Column 2 | | Substance | Prescribed quantity for DMT Act | | Amobarbital that is a Schedule 4 substance | 50g | | Anabolic steroidal agent and androgenic steroidal agent, except as otherwise referred to in this table | 5g | | Androisoxazole | 5g | | AOD-9604 (CAS No. 221231-10-3) | 0.1g | | Barbiturates that are Schedule 4 substances, except as otherwise referred to in this table | 50g | | Benzodiazepine derivatives that are Schedule 4 substances, except as otherwise referred to in this table | 0.5g | | Benzphetamine | 5g | | Bolandiol | 5g | | Bolasterone | 5g | | Boldenone (dehydrotestosterone) | 2.5g | | Bolmantalate | 5g | | Bromazepam | 5g | | Calusterone | 30g | | Cathine | 5g | | Chlorandrostenolone | 5g | | Chlordiazepoxide | 5g | | Chloroxydienone | 5g | | CJC-1295 (CAS No. 863288-34-0) | 0.5g | | Clobazam | 2.5g | | Clonazepam | 0.5g | | Clorazepate | 3g | | Clostebol (4-chlorotestosterone) | 2g | | Darbepoetin | 0.015g | | Dehydrochloromethyltestosterone | 5g | | Dextropropoxyphene that is a Schedule 4 substance | 15g | | Diazepam | 2.5g | | Diethylpropion | 5g | | Dihydrolone | 5g | | Dimethandrostanolone | 5g | | Dimethazine | 5g | | Doxapram | 2g | | Drostanolone | 2g | | Enobosarm | 0.3g | | Ephedrine | 5g | | Epoetins | 0.01g or 1,000,000 International Units | | Erythropoietins, except as otherwise referred to in this table | 1,000,000 International Units | | Ethchlorvynol | 50g | | Ethinamate | 50g | | Ethyldienolone | 5g | | Ethylestrenol | 1g | | Fencamfamin | 1g | | Fenproporex | 1g | | Fibroblast Growth Factors | 0.1g | | Fluoxymesterone | 2g | | Flurazepam | 10g | | Follistatin | 0.1g | | Formebolone | 1g | | Furazabol | 0.5g | | Glutethimide | 50g | | Growth Hormone Releasing Hormones (GHRHs), including those that are separately a Schedule 4 substance | 0.5g | | Growth Hormone Releasing Peptides (GHRPs), including those that are separately a Schedule 4 substance | 0.5g | | Growth Hormone Releasing Peptide-6 (GHRP-6) | 0.5g | | Growth Hormone Secretagogues (GHSs), including those that are separately a Schedule 4 substance | 0.5g | | Hexarelin | 0.5g | | Hydroxystenozol | 5g | | Ibutamoren | 0.5g | | Insulin-like growth factors | 0.005g | | Ipamorelin | 0.5g | | Lorazepam | 1g | | Mazindol | 0.5g | | Medazepam | 2.5g | | Mefenorex | 5g | | Meprobamate | 100g | | Mesabolone | 5g | | Mestanolone (androstalone) | 5g | | Mesterolone | 10g | | Metandienone | 1g | | Methandriol | 20g | | Methenolone | 2g | | Methylandrostanolone | 5g | | Methylclostebol | 5g | | Methylphenobarbital | 50g | | Methyltestosterone | 20g | | Methyltrienolone | 5g | | Methyprylone | 40g | | Mibolerone | 0.01g | | Midazolam | 0.5g | | Nalbuphine | 0.5g | | Nandrolone | 1g | | Nitrazepam | 1g | | Norandrostenolone | 1g | | Norbolethone | 5g | | Norethandrolone | 4g | | Normethandrone | 0.5g | | Oxabolone | 0.5g | | Oxandrolone | 1g | | Oxazepam | 10g | | Oxymesterone | 4g | | Oxymetholone | 40g | | Paraldehyde | 250mL | | Pentobarbital that is a Schedule 4 substance | 50g | | Perampanel | 0.8g | | Phenobarbital | 50g | | Phentermine | 10g | | Pipradrol | 1g | | Pralmorelin (Growth Hormone Releasing Peptide-2, GHRP-2) | 0.5g | | Prasterone (dehydroepiandrosterone, dehydroisoandrosterone (DHEA)) | 1g | | Prazepam | 2.5g | | Pregabalin | 30g | | Propylhexedrine | 5g | | Pseudoephedrine that is a Schedule 4 substance | 20g | | Pyrovalerone | 1g | | Quetiapine | 40g | | Quinbolone | 3g | | Selective androgen receptor modulators (SARM), including those that are separately a Schedule 4 substance | 0.3g | | Silandrone | 5g | | Somatropin (human growth hormone) | 0.25g | | Stanolone | 10g | | Stanozolol | 2g | | Stenabolic (SR9009) and other synthetic REV-ERB agonists | 2g | | Stenbolone | 5g | | TB-500 | 0.3g | | Temazepam | 5g | | Testolactone | 100g | | Testosterone that is a Schedule 4 substance | 20g | | Thiomesterone (tiomesterone) | 5g | | Thymosin Beta 4 (thymosin β4) | 0.3g | | Tianeptine | 3.75g | | Tramadol | 30g | | Trenbolone (trienbolone, trienolone) that is a Schedule 4 substance | 5g | | Trestolone | 5g | | Triazolam | 0.05g | | Vadadustat | 0.081g | | Zolazepam | 2.5g | | Zolpidem | 1g | | Zopiclone | 0.75g |

Veterinary practitioners and etorphine—the Act, s 6

8 Veterinary practitioners and etorphine—the Act, s 6

For this regulation, etorphine is taken to be a Schedule 8 substance, and not a Schedule 9 substance, when obtained or supplied by a veterinary practitioner in accordance with an authority for etorphine granted by the Health Secretary under section 25 or 43.

References to publications in force from time to time

9 References to publications in force from time to time

In this regulation, a reference to a standard, rule, code or other publication is taken to be a reference to the standard, rule, code or publication as in force from time to time, unless otherwise indicated.

Part 2

Wholesale supply—the Act, ss 10 and 12 and Part 2.2

Part 2 Wholesale supply—the Act, ss 10 and 12 and Part 2.2

Division 1

Wholesale supply by pharmacists

Division 1 Wholesale supply by pharmacists

Wholesale supply by pharmacy businesses

10 Wholesale supply by pharmacy businesses

(1) For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by a pharmacy business (the supplying pharmacy business) to another pharmacy business (the receiving pharmacy business) is authorised if the supply occurs because the receiving pharmacy business becomes the owner of the supplying pharmacy business and takes control of the substance.

(2) For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by the following persons to a pharmacist in a pharmacy is authorised if the supply is in connection with the bankruptcy, liquidation or external administration of a pharmacy business—

(a) another pharmacist in a pharmacy,

(b) another approved person.

(3) For the Act, section 14(a), wholesale supply of a Schedule 2, 3 or 4 substance, other than a Schedule 4D substance, by a pharmacy business to another pharmacy business is authorised if—

(a) both pharmacy businesses are entirely owned or controlled by the same individual, or

(b) the substance will expire within 6 months and the pharmacy business supplying the substance is not reasonably likely to supply or administer the substance to a person before the substance expires.

(4) A pharmacy business who supplies or receives a substance under this section must record the following—

(a) the date on which the substance was supplied,

(b) the name, strength and quantity of the substance supplied,

(c) the batch number and expiry date of the substance supplied,

(d) the name of the pharmacy business that supplied the substance,

(e) the name of the pharmacy business that received the substance.

Maximum penalty—Tier 5 penalty.

(5) In this section—

pharmacy business has the same meaning as in the Health Practitioner Regulation National Law (NSW), Schedule 5F.

Wholesale supply between pharmacists

11 Wholesale supply between pharmacists

(1) For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by a pharmacist in a pharmacy, public health entity or private health facility (the supplying pharmacist) to another pharmacist in a pharmacy, public health entity or private health facility (the receiving pharmacist) is authorised if—

(a) the supplying pharmacist receives a written request from the receiving pharmacist in the following circumstances—

(i) the receiving pharmacist is making the request for the purposes of the treatment of a single patient at a public health entity or private health facility or a single customer at a pharmacy,

(ii) the supplying pharmacist, as far as reasonably practicable, supplies the receiving pharmacist with only the minimum amount of the substance necessary for the treatment of the patient or customer, or

(b) the supplying pharmacist is returning an equivalent amount of the substance to the receiving pharmacist, who had previously supplied the same substance in accordance with paragraph (a)(ii).

(2) The supplying pharmacist must not wholesale supply a Schedule 2, 3, 4 or 8 substance under subsection (1) if the written request referred to in subsection (1)(a) is not signed by the receiving pharmacist.

Maximum penalty—Tier 5 penalty.

(3) The supplying pharmacist and receiving pharmacist must keep a record of a scheduled substance wholesale supplied under this section.

Maximum penalty—Tier 5 penalty.

Wholesale supply by pharmacists for urgent use in residential care facilities

12 Wholesale supply by pharmacists for urgent use in residential care facilities

(1) For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by a pharmacist in a pharmacy to the authorised person for a residential care facility is authorised if the supply is for urgent use at the residential care facility.

(2) The pharmacist must not wholesale supply a Schedule 2, 3, 4 or 8 substance under subsection (1) unless—

(a) the supply is in accordance with a written order signed by the authorised person, and

(b) the substance is in the manufacturer’s original pack, and

(c) the supply has been approved by—

(i) the residential care facility’s medicines governance committee, however described, or

(ii) the Health Secretary.

Maximum penalty—Tier 5 penalty.

(3) A pharmacist who supplies a substance under this section must keep a record of the following—

(a) the date on which the substance was supplied,

(b) the name, strength and quantity of the substance supplied,

(c) the batch number and expiry date of the substance supplied,

(d) the name of the pharmacist who supplied the substance,

(e) the name of the authorised person.

Maximum penalty—Tier 5 penalty.

Wholesale supply by pharmacists for urgent use by authorised practitioners

13 Wholesale supply by pharmacists for urgent use by authorised practitioners

(1) For the Act, section 14(a), wholesale supply of a Schedule 4 or 8 substance by a pharmacist in a pharmacy to an authorised practitioner for urgent use is authorised if the supply is in accordance with a written request signed by the authorised practitioner and—

(a) the substance is—

(i) in the form of a registered good, or

(ii) a good approved for supply under the Commonwealth Therapeutic Goods Act, section 19A, or

(b) if the wholesale supply is to a veterinary practitioner—

(i) the substance is in the form of a veterinary chemical product, registered under the Commonwealth Agvet Codes, or

(ii) the pharmacist holds a permit under the Agricultural and Veterinary Chemicals Code Act 1994 of the Commonwealth, Schedule, Part 7 in relation to the substance.

(2) A pharmacist who supplies a substance under this section must keep a record of the following—

(a) the date on which the substance was supplied,

(b) the name, strength and quantity of the substance supplied,

(c) the batch number and expiry date of the substance supplied,

(d) the name of the pharmacist who supplied the substance,

(e) the name of the authorised practitioner.

Maximum penalty—Tier 5 penalty.

(3) In this section—

registered good has the same meaning as in the Commonwealth Therapeutic Goods Act.

Wholesale supply by pharmacists for urgent use by registered health practitioners

14 Wholesale supply by pharmacists for urgent use by registered health practitioners

(1) For the Act, section 14(a), wholesale supply of an approved Schedule 2, 3, 4 or 8 substance by a pharmacist in a pharmacy to a registered health practitioner of an approved class is authorised if the supply is for urgent use.

(2) A pharmacist who supplies a scheduled substance under this section must keep a record of the following—

(a) the date on which the substance was supplied,

(b) the name, strength and quantity of the substance supplied,

(c) the batch number and expiry date of the substance supplied,

(d) the name of the pharmacist who supplied the substance,

(e) the name of the registered health practitioner.

Maximum penalty—Tier 5 penalty.

Wholesale supply by pharmacists to first aiders

15 Wholesale supply by pharmacists to first aiders

For the Act, section 14(a), wholesale supply of a scheduled substance specified in Column 1 of the table to this section by a pharmacist in a pharmacy to a person specified opposite in Column 2 is authorised.

| Column 1 | Column 2 | | Scheduled substance | Person | | Adrenaline, glucagon, glyceryl trinitrate, naloxone, salbutamol or terbutaline | First aider with a current statement of attainment, issued by a registered training organisation, demonstrating competency in the use and administration, including access and preparation, of the substance for first aid | | Adrenaline | Person with a current certificate, issued by an approved person, in the use and administration of adrenaline in first aid | | Naloxone | Person with a current certificate, issued by an approved person, in the use and administration of naloxone in first aid | | Salbutamol | Person with a current certificate, issued by an approved person, in the use and administration of salbutamol in emergency asthma management | | Terbutaline | Person with a current certificate, issued by an approved person, in the use and administration of terbutaline in emergency asthma management |

Wholesale supply by pharmacists to masters of vessels

16 Wholesale supply by pharmacists to masters of vessels

(1) For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by a pharmacist in a pharmacy to the master of a vessel, other than a racing yacht, is authorised if the substance is—

(a) required to be carried on the vessel under—

(i) for a domestic commercial vessel—the National Standard for Commercial Vessels, Part C published by the Australian Maritime Safety Authority, or

(ii) for a foreign vessel or regulated Australian vessel—the Marine Order 11 (Living and working conditions on vessels) 2024 made under the Navigation Act 2012 of the Commonwealth, or an order that replaces that order, and

(b) supplied in the quantity required to be carried on the vessel by the standard or order referred to in paragraph (a) as the case requires.

(2) For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by a pharmacist to the master of a racing yacht is authorised if the substance is—

(a) required to be carried on the racing yacht under—

(i) the Special Regulations, Part 1 published by Australian Sailing Limited, or

(ii) an order of the Health Secretary, and

(b) supplied in the quantity required to be carried on the racing yacht under the following as the case requires—

(i) the regulations,

(ii) the order referred to in paragraph (a)(ii).

(3) An order of the Health Secretary under subsection (2)(a)(ii) prevails to the extent of an inconsistency with the regulations referred to in subsection (2)(a)(i).

(4) A pharmacist must not wholesale supply a substance under subsection (1) unless the pharmacist has a copy of—

(a) an order for the substance signed by the master of the vessel, confirming the substance must be carried on the vessel by the standard or order referred to in subsection (1)(a)(i) or (ii), and

(b) a certificate issued by the vessel’s agent in New South Wales confirming the signature on the order is the signature of the master of the vessel.

Maximum penalty—Tier 5 penalty.

(5) A pharmacist must not wholesale supply a substance under subsection (2) unless the pharmacist has a copy of—

(a) proof the racing yacht is entered in a race, and

(b) an order for the substance signed by the master of the racing yacht, confirming the substance must be carried on the racing yacht by the regulations or the order referred to in subsection (2)(a)(i) or (ii), and

(c) a certificate issued by the secretary of the club at which the racing yacht is registered for the race confirming the signature on the order is the signature of the master of the racing yacht.

Maximum penalty—Tier 5 penalty.

(6) A pharmacist must keep a copy of the documents referred to in subsection (4) or (5).

Maximum penalty— Tier 5 penalty.

(7) In this section—

domestic commercial vessel means a commercial vessel within the meaning of the Marine Safety Act 1998.

foreign vessel has the same meaning as in the Navigation Act 2012 of the Commonwealth.

racing yacht means a vessel that is—

(a) owned or crewed by a member of Australian Sailing Limited, and

(b) entered in a race conducted in accordance with the rules of Australian Sailing Limited.

regulated Australian vessel has the same meaning as in the Navigation Act 2012 of the Commonwealth.

vessel means the following—

(a) a domestic commercial vessel,

(b) a foreign vessel,

(c) a regulated Australian vessel.

Division 2

Other wholesale supply

Division 2 Other wholesale supply

Wholesale supply by National Medical Stockpile

17 Wholesale supply by National Medical Stockpile

For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by the operator of the National Medical Stockpile is authorised.

Unauthorised wholesale supply of samples

18 Unauthorised wholesale supply of samples

A person must not wholesale supply—

(a) a Schedule 4D, 7 or 8 substance as a sample, or

(b) a Schedule 2 or 3 substance or another Schedule 4 substance as a sample to a health practitioner or veterinary practitioner other than in accordance with a written order signed by the health practitioner or veterinary practitioner.

Maximum penalty—Tier 5 penalty.

Wholesale supply between veterinary hospital superintendents

19 Wholesale supply between veterinary hospital superintendents

(1) For the Act, section 14(a), wholesale supply of a Schedule 2, 3, 4 or 8 substance by a superintendent (the supplying superintendent) to another superintendent (the receiving superintendent) is authorised if—

(a) the supplying superintendent receives a written request from the receiving superintendent in the following circumstances—

(i) the receiving superintendent is making the request for the purposes of the treatment of a single animal at a veterinary hospital,

(ii) the supplying superintendent, as far as reasonably practicable, supplies the receiving superintendent with only the minimum amount of the substance necessary for the treatment of the animal, or

(b) the supplying superintendent is returning an equivalent amount of the substance to the receiving superintendent, who had previously supplied the same substance in accordance with paragraph (a)(ii).

(2) The supplying superintendent must not wholesale supply a Schedule 2, 3, 4 or 8 substance under subsection (1) if the written request referred to in subsection (1)(a) is not signed by the receiving superintendent.

Maximum penalty—Tier 5 penalty.

(3) The supplying superintendent and receiving superintendent must keep a record of a scheduled substance wholesale supplied under this section.

Maximum penalty—Tier 5 penalty.

(4) In this section—

superintendent means superintendent managing a veterinary hospital under the Veterinary Practice Act 2003, section 67(a).

Part 3

Obtaining wholesale supply—the Act, ss 10 and 12 and Part 2.3

Part 3 Obtaining wholesale supply—the Act, ss 10 and 12 and Part 2.3

Obtaining wholesale supply

20 Obtaining wholesale supply

(1) For the Act, section 21(1)(g), the following health practitioners are prescribed—

(a) a health practitioner for adrenaline for treatment of anaphylaxis,

(b) a midwife practitioner for a Schedule 2, 3, 4 or 8 substance,

(c) a dental therapist or oral health therapist for the following—

(i) a Schedule 2, 3 or 4 substance that is a synthetic local anaesthetic,

(ii) tetracycline and triamcinolone for use in preparation for the treatment of dental pulp,

(d) a dental hygienist for a Schedule 2, 3 or 4 substance that is a synthetic local anaesthetic,

(e) a podiatrist for a Schedule 2 or 3 substance or a Schedule 4 substance that is a synthetic local anaesthetic,

(f) an optometrist for a Schedule 2, 3 or 4 substance for use in ophthalmic preparations for diagnostic purposes.

(2) For the Act, section 22(g), the following entities are prescribed—

(a) the Justice Health and Forensic Mental Health Network,

(b) The Sydney Children’s Hospitals Network (Randwick and Westmead), incorporating the Royal Alexandra Hospital for Children.

Obtaining wholesale supply by various persons and bodies

21 Obtaining wholesale supply by various persons and bodies

For the Act, Part 2.3, obtaining wholesale supply of a scheduled substance specified in Column 1 of the table to this section by a person specified opposite in Column 2 is authorised if the person—

(a) obtains the substance for the purpose specified in Column 3, if any, and

(b) the person complies with conditions imposed on the person, or the class of persons, by the Health Secretary.

| Column 1 | Column 2 | Column 3 | | Scheduled substance | Person | Purpose | | Schedule 2, 3 or 4 substance | Commissioner of Police | Emergency medical treatment of divers employed or engaged by the NSW Police Force | | Schedule 2 or 3 substance, methoxyflurane, nitrous oxide | Member of Mines Rescue Brigade or mines rescue company under the Coal Industry Act 2001 | First aid | | Schedule 2, 3, 4 or 8 substance | Superintendent managing a veterinary hospital under the Veterinary Practice Act 2003, section 67(a) | The treatment of animals | | Schedule 2, 3, 4 or 8 substance | Operator of National Medical Stockpile | — | | Schedule 2 or 7J substance | Holder of a retail licence for the Schedule 2 or 7J substance | Retail supply | | Adrenaline, glucagon, glyceryl trinitrate, methoxyflurane, naloxone, nitrous oxide, salbutamol, terbutaline | Principal of a government or non-government school under the Education Act 1990 | First aid | | Prohibited scheduled substance, prohibited drug or prohibited plant | Holder of a DMT authority for the prohibited scheduled substance, prohibited drug or prohibited plant | A relevant purpose | | Pentobarbital | A local councilAn animal welfare organisation | Destruction of an animal | | Prohibited scheduled substance, prohibited drug or prohibited plant | NSW Health Pathology | A relevant purpose | | Methoxyflurane and nitrous oxide | Surf Life Saving NSW | First aid |

Obtaining wholesale supply by first aiders

22 Obtaining wholesale supply by first aiders

For the Act, Part 2.3, obtaining wholesale supply of a scheduled substance specified in the table to this section by a person specified opposite is authorised if the person is authorised to administer the scheduled substance under section 66.

| Scheduled substance | Person | | Adrenaline, glucagon, glyceryl trinitrate, naloxone, salbutamol, methoxyflurane, nitrous oxide or terbutaline | First aider with a current statement of attainment, issued by a registered training organisation, demonstrating competency in the use and administration, including access and preparation, of the substance for first aid | | Adrenaline | Person with a current certificate, issued by an approved person, in the use and administration of adrenaline in first aid | | Naloxone | Person with a current certificate, issued by an approved person, in the use and administration of naloxone in first aid | | Salbutamol | Person with a current certificate, issued by an approved person, in the use and administration of salbutamol in emergency asthma management | | Terbutaline | Person with a current certificate, issued by an approved person, in the use and administration of terbutaline in emergency asthma management |

Prescribed research institutes

23 Prescribed research institutes

For the Act, section 57(2)(a)(vi), a member of the Association of Australian Medical Research Institutes is prescribed for Schedule 4D, 8 and 9 substances.

Note—

The research institutions are authorised to obtain prohibited scheduled substances and prohibited drugs without an obtain licence in certain circumstances. See section 24.

Obtaining wholesale supply by research institutions, universities and laboratories

24 Obtaining wholesale supply by research institutions, universities and laboratories

(1) This section applies to the following—

(a) a Schedule 2, 3, 4 or 7J“a” substance, other than a Schedule 4D substance,

(b) a prohibited scheduled substance or prohibited drug, if the substance or drug is an in-vitro diagnostic and analytical preparation containing less than 0.001% of the substance or drug.

(2) For the Act, Part 2.3, obtaining wholesale supply of a substance or drug to which this section applies by the following is authorised, but only if wholesale supply is for a relevant purpose—

(a) a person in charge of a laboratory of a university,

(b) a person in charge of a laboratory or department at a research institution that is a member of the Association of Australian Medical Research Institutes,

(c) a person in charge of a laboratory or department of NSW Health Pathology,

(d) a person in charge of an analytical laboratory accredited by the National Association of Testing Authorities,

(e) a person acting under the direction of a person specified in paragraph (a)–(d).

Division 3

Other

Division 3 Other

Health Secretary may authorise obtaining wholesale supply—the Act, s 10(2)

25 Health Secretary may authorise obtaining wholesale supply—the Act, s 10(2)

(1) The Health Secretary may grant an authority that authorises obtaining wholesale supply of a scheduled substance.

(2) An authority may be granted on application or the Health Secretary’s own initiative.

(3) An authority may be granted to a particular person or class of persons.

(4) An authority is granted to a class of persons by written notice published on the Ministry of Health’s website.

(5) The Health Secretary may, by written notice, require a person applying for an authority to give information that the Health Secretary considers necessary to determine the application.

(6) Without limitation, the Health Secretary may refuse to grant an authority to a person if, in the Health Secretary’s opinion, the person is not a fit and proper person to hold the authority.

(7) An authority may be granted subject to conditions.

(8) An authority is not transferable.

(9) The Health Secretary may revoke an authority granted to a class of persons by revoking the authority for—

(a) all the persons of the class, or

(b) specified persons of the class.

(10) An authority remains in force until the authority—

(a) expires, or

(b) is sooner surrendered by the holder or revoked by the Health Secretary.

Part 4

Non-wholesale supply—the Act, ss 10 and 12 and Part 2.4

Part 4 Non-wholesale supply—the Act, ss 10 and 12 and Part 2.4

Non-wholesale supply under direction

26 Non-wholesale supply under direction

(1) For the Act, section 28(1), supply of a Schedule 2, 3, 4 or 8 substance is authorised if the person supplying is acting under the direction of one of the following—

(a) a medical practitioner acting in the course of practice,

(b) a nurse practitioner acting in the course of practice,

(c) a registered nurse with an endorsement that qualifies the registered nurse to supply the scheduled substance, acting in the course of practice,

(d) a midwife practitioner acting in the course of practice,

(e) a midwife with an endorsement that qualifies the midwife to supply the scheduled substance, acting in the course of practice,

(f) a veterinary practitioner acting in the course of practice,

(g) a dentist acting in the course of practice.

(2) If the supply under subsection (1) is to a patient at a public health entity, private health facility, residential care facility, correctional centre or OTP clinic the direction must be—

(a) written, or

(b) given in an approved way.

(3) Despite subsection (2), the direction may, in an emergency or other urgent circumstances, be given orally in person or by telephone (an emergency oral direction).

(4) As soon as practicable and no later than 24 hours after giving an emergency oral direction, the person must confirm the direction by—

(a) making an entry in the patient’s medical record, or

(b) sending an email or facsimile to the person who supplied the substance.

Maximum penalty—Tier 5 penalty.

Non-wholesale supply of Schedule 7 substances

27 Non-wholesale supply of Schedule 7 substances

(1) For the Act, section 28(1), supply of a Schedule 7 substance, other than a Schedule 7J substance, is authorised if the supply is for non-domestic use.

(2) A person must not supply a Schedule 7 substance as a sample by retail.

Maximum penalty—Tier 5 penalty.

Non-wholesale supply of Schedule 7 and Schedule 7J substances

28 Non-wholesale supply of Schedule 7 and Schedule 7J substances

For the Act, section 28(1), supply of a Schedule 7 substance, including a Schedule 7J substance, is authorised if the supply is to a person who is authorised to possess or use the substance under the Stock Medicines Act 1989.

Non-wholesale supply to NSW Health Pathology or another laboratory

29 Non-wholesale supply to NSW Health Pathology or another laboratory

For the Act, section 28(1), supply of a prohibited scheduled substance, prohibited drug or prohibited plant by a person employed or engaged by a public health entity or private health facility is authorised if the supply is—

(a) to NSW Health Pathology or an analytical laboratory accredited by the National Association of Testing Authorities, and

(b) for a relevant purpose.

Non-wholesale supply by Ambulance Service of NSW

30 Non-wholesale supply by Ambulance Service of NSW

For the Act, section 28(1), supply of a Schedule 2, 3, 4 or 8 substance by a staff member of the Ambulance Service of NSW is authorised if the supply complies with the approved ambulance protocol.

Non-wholesale supply by midwife practitioners

31 Non-wholesale supply by midwife practitioners

For the Act, section 29(f), a midwife practitioner is prescribed.

Limits on non-wholesale supply by dentists

32 Limits on non-wholesale supply by dentists

(1) A dentist must not supply a Schedule 8 substance unless the substance is listed in the Dental Schedule of Pharmaceutical Benefits.

Maximum penalty—Tier 5 penalty.

(2) Subsection (1) does not apply to supply by a dentist to a patient of a public health entity or private health facility.

(3) A dentist must not supply a scheduled substance to a patient for a period that, together with all other periods for which a scheduled substance has been supplied by the dentist, would result in one or more scheduled substances being supplied for continuous therapeutic use by the patient for more than one month.

Maximum penalty—Tier 5 penalty.

Non-wholesale supply by pharmacists without prescription

33 Non-wholesale supply by pharmacists without prescription

(1) For the Act, section 28(1), supply of a Schedule 4 substance, other than a Schedule 4D substance, by a pharmacist in a pharmacy to a person without a prescription is authorised if the pharmacist is satisfied that—

(a) the person is undergoing treatment essential to the person’s wellbeing, and

(b) the person has previously been prescribed the substance for the person’s treatment, and

(c) the person is in immediate need of the substance for continuation of the treatment, and

(d) it is not reasonably practicable for the person to obtain a prescription for the substance from an authorised practitioner, and

(e) the person has not been supplied the substance under this section within the last 30 days.

(2) The supply must be—

(a) no more than the amount required for 7 days treatment, or

(b) for the supply of an aerosol, anovulant tablet, cream, liquid or ointment—in the smallest standard pack in which the substance is generally available.

Maximum penalty—Tier 5 penalty.

Non-wholesale supply by pharmacists in emergencies and urgent circumstances

34 Non-wholesale supply by pharmacists in emergencies and urgent circumstances

(1) For the Act, section 28(1), supply of a Schedule 4 or 8 substance by a pharmacist in a pharmacy to a person without a prescription is authorised if—

(a) the supply is in accordance with a direction given by an authorised practitioner in an emergency or other urgent circumstances, and

(b) the direction is given—

(i) by email or facsimile, or

(ii) orally in person or by telephone, or

(iii) in another approved way.

(2) An authorised practitioner who gives a direction must—

(a) as soon as reasonably practicable, complete a prescription that specifies that the prescription has been issued in confirmation of a direction given under this section, and

(b) as soon as practicable and no later than 24 hours after giving the direction— give the prescription to the pharmacist.

Maximum penalty—Tier 5 penalty.

(3) If the pharmacist does not receive the prescription within 14 days after supplying the substance, the pharmacist must notify the Health Secretary.

Maximum penalty—Tier 5 penalty.

Non-wholesale supply by pharmacists approved under Commonwealth National Health Act 1953 without prescription

35 Non-wholesale supply by pharmacists approved under Commonwealth National Health Act 1953 without prescription

(1) For the Act, section 28(1), supply of a scheduled substance to which the Commonwealth determination applies by an approved pharmacist to a person without a prescription is authorised if the pharmacist is satisfied the person is in immediate need of the substance for continuation of the person’s treatment.

(2) The supply must be in accordance with—

(a) the conditions specified in the Commonwealth determination, and

(b) the Guidelines for the continued dispensing of eligible prescribed medicines by pharmacists published by the Pharmaceutical Society of Australia.

Maximum penalty—Tier 5 penalty.

(3) In this section—

approved pharmacist has the same meaning as in the National Health Act 1953 of the Commonwealth.

Commonwealth determination means the National Health (Continued Dispensing) Determination 2022 of the Commonwealth or a determination that replaces that determination.

Non-wholesale supply by pharmacists to registered nurses, midwives and paramedics for administration in pharmacies

36 Non-wholesale supply by pharmacists to registered nurses, midwives and paramedics for administration in pharmacies

For the Act, section 28(1), supply of a Schedule 2, 3 or 4 substance by a pharmacist to a registered nurse, midwife or paramedic is authorised if the registered nurse, midwife or paramedic has an authority to administer the substance in a pharmacy granted by the Health Secretary under section 74.

Non-wholesale supply by pharmacists of Schedule 3 substances

37 Non-wholesale supply by pharmacists of Schedule 3 substances

For the Act, section 28(1), supply of a Schedule 3 substance by a pharmacist to a person is authorised if the pharmacist gives adequate verbal or written instructions for the use of the substance at the time of the supply.

Non-wholesale supply of Schedule 2 and 7J substances by retail sale

38 Non-wholesale supply of Schedule 2 and 7J substances by retail sale

For the Act, section 28(1), supply of a Schedule 2 or 7J substance by a person by retail sale is authorised if the retail sale is authorised under a retail licence granted to the person.

Retail licences for Schedule 2 and 7J substances

39 Retail licences for Schedule 2 and 7J substances

(1) The Health Secretary may, on application, grant a licence that authorises a person to supply a Schedule 2 or 7J substance by retail sale (a retail licence).

(2) An application for a retail licence must be—

(a) in the approved form, and

(b) accompanied by the application fee specified in Schedule 1.

(3) The Health Secretary may, by written notice, require an applicant to give additional information to the Health Secretary that the Health Secretary considers necessary to determine the application.

(4) Without limitation, the Health Secretary may refuse to grant a retail licence to a person if, in the Health Secretary’s opinion, the person is not a fit and proper person to hold the licence.

(5) A retail licence may be granted subject to conditions.

(6) A retail licence is not transferable.

(7) A retail licence remains in force until the licence—

(a) expires, or

(b) is sooner surrendered by the holder or revoked by the Health Secretary.

(8) The holder of a retail licence must not contravene a condition of the retail licence.

Maximum penalty—Tier 5 penalty.

(9) The holder of a retail licence must, on or before 31 March in each year following the year in which the licence was granted, pay to the Health Secretary the annual fee specified in Schedule 1.

(10) The Health Secretary may accept payment of an annual fee up to 3 months after the date required under subsection (9), if an additional late fee of 50% of the annual fee is paid at the same time as the annual fee.

(11) The fees for the following are specified in Schedule 1—

(a) an amendment of an application for a retail licence,

(b) a variation of a retail licence.

Restriction on retail licences for Schedule 2 substances

40 Restriction on retail licences for Schedule 2 substances

(1) The Health Secretary must not grant or renew a retail licence for a Schedule 2 substance unless the Health Secretary is satisfied that the premises to which the proposed retail licence relates are at least 20km from the nearest pharmacy, measured along the shortest practicable route.

(2) The reference to 20km in subsection (1) must be read as a reference to 6.5km for the renewal of a retail licence that was—

(a) in force under the Poisons and Therapeutic Goods Regulation 2008, Part 8, Division 1 immediately before the commencement of this section, and

(b) originally granted before 7 April 1989.

Division 4

Other

Division 4 Other

Restriction on non-wholesale supply of paraquat

41 Restriction on non-wholesale supply of paraquat

A person must not supply a Schedule 7 substance that is a liquid preparation containing paraquat unless the preparation—

(a) is coloured blue or green, and

(b) contains sufficient stenching agent to produce an offensive smell.

Maximum penalty—Tier 5 penalty.

Restriction on non-wholesale supply of certain Schedule 4 and 8 substances

42 Restriction on non-wholesale supply of certain Schedule 4 and 8 substances

(1) An authorised practitioner, other than a veterinary practitioner, must not supply the following—

(a) a nominated Schedule 4 substance,

(b) a Schedule 8 substance to a person with a substance dependence on a prohibited scheduled substance or prohibited drug,

(c) dexamfetamine, lisdexamfetamine or methylphenidate,

(d) N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine,

(e) morphine, oxycodone, fentanyl or hydromorphone in an amount that exceeds the morphine equivalent maximum dose,

(f) a substance (a relevant substance) that is alprazolam, flunitrazepam, methadone or a Schedule 8 substance in an injectable or intranasal preparation, if the administration is for a period that, together with all other periods for which a relevant substance has been administered by the person or has, to the person’s knowledge, been administered by another person, would result in one or more relevant substances being administered for continuous therapeutic use by the patient for more than 3 months.

Maximum penalty—Tier 5 penalty.

Note—

A health practitioner may be subject to other restrictions on the non-wholesale supply of scheduled substances under the Health Practitioner Regulation National Law in relation to appropriate professional conduct and practice.

(2) A veterinary practitioner must not supply the following—

(a) dexamfetamine or lisdexamfetamine,

(b) N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine.

Maximum penalty—Tier 5 penalty.

(3) Subsection (1) does not apply to a person who supplies the substance in accordance with—

(a) an approval or approval exemption, or

(b) an OTP registration.

(4) Subsection (1)(b) does not apply to a dentist.

Health Secretary may authorise non-wholesale supply—the Act, s 10(2)

43 Health Secretary may authorise non-wholesale supply—the Act, s 10(2)

(1) The Health Secretary may grant an authority that authorises the supply of a scheduled substance.

(2) An authority may be granted on application or the Health Secretary’s own initiative.

(3) An authority may be granted to—

(a) a particular person, or

(b) a class of persons by written notice published on the Ministry of Health’s website.

(4) The Health Secretary may, by written notice, require a person applying for an authority to give information to the Health Secretary that the Health Secretary considers necessary to determine the application.

(5) Without limitation, the Health Secretary may refuse to grant an authority to a person if, in the Health Secretary’s opinion, the person is not a fit and proper person to hold the authority.

(6) An authority may be granted subject to conditions.

(7) An authority is not transferable.

(8) The Health Secretary may revoke an authority granted to a class of persons by revoking the authority for—

(a) all the persons of the class, or

(b) specified persons of the class.

(9) An authority remains in force until the authority—

(a) expires, or

(b) is sooner surrendered by the holder or revoked by the Health Secretary.

Part 5

Prescriptions—the Act, ss 10 and 12 and Part 2.5

Part 5 Prescriptions—the Act, ss 10 and 12 and Part 2.5

Midwife practitioners may issue prescriptions

44 Midwife practitioners may issue prescriptions

For the Act, section 37(2)(f), a midwife practitioner is prescribed.

Restriction on issue of prescriptions for certain Schedule 4 and 8 substances

45 Restriction on issue of prescriptions for certain Schedule 4 and 8 substances

(1) An authorised practitioner, other than a veterinary practitioner, must not issue a prescription for the following—

(a) a nominated Schedule 4 substance,

(b) a Schedule 8 substance if the person to whom the prescription is issued has a substance dependence on a prohibited scheduled substance or prohibited drug,

(c) dexamfetamine, lisdexamfetamine or methylphenidate,

(d) N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine,

(e) morphine, oxycodone, fentanyl or hydromorphone if the prescription is for an amount that exceeds the morphine equivalent maximum dose,

(f) a substance (a relevant substance) that is alprazolam, flunitrazepam, methadone or a Schedule 8 substance in an injectable or intranasal preparation, if the administration is for a period that, together with all other periods for which a relevant substance has been administered by the person or has, to the person’s knowledge, been administered by another person, would result in one or more relevant substances being administered for continuous therapeutic use by the patient for more than 3 months.

Maximum penalty—Tier 5 penalty.

Note—

A health practitioner may be subject to other restrictions on the issue of prescriptions for scheduled substances under the Health Practitioner Regulation National Law in relation to appropriate professional conduct and practice.

(2) A veterinary practitioner must not issue a prescription for the following—

(a) dexamfetamine, lisdexamfetamine or methylphenidate,

(b) N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine.

Maximum penalty—Tier 5 penalty.

(3) Subsection (1) does not apply to a person who prescribes the substance in accordance with—

(a) an approval or approval exemption, or

(b) an OTP registration.

(4) Subsection (1)(b) does not apply to a dentist.

Issue of prescriptions by dentists

46 Issue of prescriptions by dentists

(1) A dentist must not issue a prescription for a Schedule 8 substance unless the substance is listed in the Dental Schedule of Pharmaceutical Benefits.

Maximum penalty—Tier 5 penalty.

(2) Subsection (1) does not apply to a prescription issued by a dentist to a patient in a public health entity or private health facility.

(3) A dentist must not issue a prescription authorising the supply of a scheduled substance if the prescription authorises supply for a period that, together with another period for which a scheduled substance has been prescribed by the dentist, would result in one or more scheduled substances being supplied for continuous therapeutic use by the patient for more than one month.

Maximum penalty—Tier 5 penalty.

Types of prescriptions

47 Types of prescriptions

An authorised practitioner must issue a prescription for a Schedule 4 or 8 substance in one of the following types—

(a) a paper prescription that is not electronically generated,

(b) a paper prescription that is electronically generated and has a handwritten signature,

(c) a conformant electronic prescription,

(d) an approved prescription.

Maximum penalty—Tier 5 penalty.

Schedule 4 and 8 substances must be supplied on proper prescription

48 Schedule 4 and 8 substances must be supplied on proper prescription

(1) A pharmacist must not supply a Schedule 4 or 8 substance on prescription unless the prescription complies with the requirements of this part.

Maximum penalty—Tier 5 penalty.

(2) It is not an offence under subsection (1) to supply a Schedule 4 or 8 substance on prescription if the prescription does not specify—

(a) the number of times that an amount of the substance may be supplied, or

(b) for a Schedule 4D substance that is an anabolic-androgenic steroidal substance or a Schedule 8 substance—the intervals at which an amount of the substance may be supplied, or

(c) the following information—

(i) the patient’s date of birth, but only if—

(A) the pharmacist confirms the date with the prescriber and records the information, or

(B) the pharmacist has confirmed the date with the patient or the agent or carer of the patient,

(ii) the directions for use of the substance, but only if the pharmacist confirms the directions with the prescriber and records the information.

(3) Subsection (2)(a) and (b) do not apply if it appears to the pharmacist that the substance has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the substance.

Expiry of prescriptions

49 Expiry of prescriptions

(1) A pharmacist must not supply a Schedule 4 substance on prescription if the prescription was issued more than 12 months before the date on which the supply is requested.

Maximum penalty—Tier 5 penalty.

(2) A pharmacist must not supply a Schedule 8 substance on prescription if the prescription was issued more than 6 months before the date on which the supply is requested.

Maximum penalty—Tier 5 penalty.

Information requirements for prescriptions

50 Information requirements for prescriptions

(1) A prescription for a Schedule 4 or 8 substance must specify the following—

(a) the date on which the prescription is issued,

(b) the patient’s name, date of birth and street address,

(c) the name of the substance,

(d) the strength and dosage form of the substance,

(e) adequate directions for the administration of the substance, including, if not readily apparent, the route for administration,

(f) the quantity of the substance to be supplied,

(g) the number of times an amount of the substance may be supplied on the prescription, if applicable,

(h) the name and designation of the person who issued the prescription, and

(i) the name, street address and telephone number of—

(i) if the prescription is issued at a public health entity or private health facility—the public health entity or private health facility, or

(ii) otherwise—the person’s principal place of practice.

(2) A prescription for a Schedule 4D substance that is an anabolic-androgenic steroidal substance or a Schedule 8 substance must also specify the intervals at which an amount of the substance may be supplied on the prescription.

(3) The quantity in subsection (1)(f) must be expressed in words and numbers if the substance is a Schedule 8 substance.

(4) Subsection (3) does not apply to a conformant electronic prescription.

Requirements for paper prescriptions

51 Requirements for paper prescriptions

(1) This section sets out additional requirements for a paper prescription for a Schedule 4 or 8 substance that is not electronically generated.

(2) The information required to be specified in the prescription under section 50 must be—

(a) legibly handwritten by the person issuing the prescription, or

(b) specified in the prescription in another approved way.

(3) The prescription must be signed by hand by the person issuing the prescription.

(4) If the prescription authorises the supply of a Schedule 8 substance, the prescription must not authorise the supply of another scheduled substance.

(5) A pharmacist must not dispense a paper prescription that is emailed or faxed to the pharmacist unless the pharmacist also receives the original script.

Requirements for printed electronic prescriptions

52 Requirements for printed electronic prescriptions

(1) This section sets out additional requirements for a paper prescription for a Schedule 4 or 8 substance that is electronically generated and has a handwritten signature.

(2) The prescription must specify a unique reference number for—

(a) each prescription, or

(b) each substance.

(3) The information required under section 50(1)(c), (d) and (f) must be legibly handwritten on the prescription for a Schedule 8 substance, other than for a prescription for buprenorphine or methadone issued as part of the Opioid Treatment Program.

(4) The prescription must be signed by hand by the person issuing the prescription.

(5) If the prescription authorises the supply of a Schedule 8 substance, the prescription must not authorise the supply of another scheduled substance.

(6) A pharmacist must not dispense the prescription that is emailed or faxed to the pharmacist unless the pharmacist also receives the original script.

Requirements for conformant electronic prescriptions

53 Requirements for conformant electronic prescriptions

(1) This section sets out additional requirements for a conformant electronic prescription for a Schedule 4 or 8 substance.

(2) The prescription must specify the following—

(a) the conformance ID of the electronic prescribing system used to issue the prescription,

(b) a digitally encrypted signature of the person.

Prescriptions for azithromycin for treatment of chlamydia

54 Prescriptions for azithromycin for treatment of chlamydia

(1) This section applies to a prescription for azithromycin issued to the partner of a patient for the treatment of chlamydia.

(2) Despite another provision of this part, the prescription is not required to specify the partner’s date of birth or street address and may instead specify the partner’s email address or telephone number.

Prescriptions issued by veterinary practitioners

55 Prescriptions issued by veterinary practitioners

(1) For a prescription issued by a veterinary practitioner, a reference in this part to a patient’s name and street address is a reference to the species of animal and—

(a) the owner’s name and street address, or

(b) if there is no owner—the animal’s unique identifier.

(2) For a prescription issued by a veterinary practitioner, the patient’s date of birth is not required.

Division 5

Records and verification of prescriptions

Division 5 Records and verification of prescriptions

Pharmacists must verify prescriptions for Schedule 8 substances

56 Pharmacists must verify prescriptions for Schedule 8 substances

(1) A pharmacist must not supply more than 2 days supply of a Schedule 8 substance on prescription unless the pharmacist has verified that the prescription has been issued by the person purported to have issued the prescription.

Maximum penalty—Tier 5 penalty.

(2) Despite subsection (1), a pharmacist does not have to verify the prescription if the pharmacist—

(a) is familiar with the handwriting of the person who issued the prescription, or

(b) knows the person for whom the substance is prescribed.

Pharmacists must keep copies of certain prescriptions

57 Pharmacists must keep copies of certain prescriptions

(1) A pharmacist who supplies a Schedule 4D substance that is an anabolic-androgenic steroidal substance or a Schedule 8 substance on prescription must keep a copy of the prescription, whether or not the prescription authorises more than one supply of the substance.

Maximum penalty—Tier 5 penalty.

(2) The pharmacist must keep the copy of the prescription separately from prescriptions for other substances.

Maximum penalty—Tier 5 penalty.

(3) Subsection (2) does not apply to a conformant electronic prescription.

Information about supply required to be recorded on prescriptions

58 Information about supply required to be recorded on prescriptions

(1) A pharmacist who supplies a Schedule 2, 3, 4 or 8 substance on prescription must, each time the substance is supplied, record the following information on the prescription—

(a) the date the substance is supplied,

(b) the address of the place at which the substance is supplied,

(c) the reference number for the prescription.

Maximum penalty—Tier 5 penalty.

(2) After supplying a Schedule 4D or 8 substance on prescription, the pharmacist must record the word “CANCELLED” on the prescription if—

(a) the number of times an amount of the substance may be supplied is not clearly specified, or

(b) the prescription has reached the last occasion on which an amount of the substance may be supplied according to the number of times specified on the prescription, or

(c) for a Schedule 4D substance that is an anabolic-androgenic steroidal substance or a Schedule 8 substance—the intervals at which an amount of the substance may be supplied are not specified on the prescription.

Maximum penalty—Tier 5 penalty.

(3) Subsection (2) does not apply to a conformant electronic prescription.

Records of prescriptions

59 Records of prescriptions

(1) An authorised practitioner who issues a prescription for a Schedule 2, 3, 4 or 8 substance must make a record of the following information—

(a) the name of the substance,

(b) the strength and dosage form of the substance, if not readily apparent,

(c) the date on which the prescription for the substance was issued,

(d) for a prescription for an individual—the individual’s name, street address and date of birth,

(e) for a prescription for an animal—the species and the owner’s name and street address,

(f) the number of times an amount of the substance may be supplied on the prescription, if applicable,

(g) for a Schedule 4D substance that is an anabolic-androgenic steroidal substance or a Schedule 8 substance—the intervals at which an amount of the substance may be supplied on the prescription,

(h) the directions for use, as shown on the prescription,

(i) for a prescription for azithromycin for the treatment of chlamydia in a patient’s partner—the partner’s name and the partner’s email address or telephone number.

Maximum penalty—Tier 5 penalty.

(2) The authorised practitioner must keep the record at—

(a) for a prescription issued at a public health entity or private health facility—the public health entity or private health facility, or

(b) otherwise—the authorised practitioner’s practice.

Maximum penalty—Tier 5 penalty.

Part 6

Administration of scheduled substances—the Act, s 150

Part 6 Administration of scheduled substances—the Act, s 150

Unauthorised administration of scheduled substances

60 Unauthorised administration of scheduled substances

A person must not administer a Schedule 2, 3, 4 or 8 substance to another person unless the administration is authorised under this part.

Maximum penalty—Tier 5 penalty.

Administration by registered health practitioners

61 Administration by registered health practitioners

The following persons are authorised to administer a Schedule 2 or 3 substance to a person—

(a) a registered health practitioner acting in the course of practice,

(b) a person acting under the direction of a registered health practitioner acting in the course of practice.

Administration by health practitioners

62 Administration by health practitioners

(1) The following persons are authorised to administer a Schedule 4 or 8 substance to a person—

(a) an authorised practitioner, other than a veterinary practitioner, acting in the course of practice,

(b) a pharmacist administering the substance that has been supplied to the person on prescription,

(c) an optometrist, podiatrist, dental hygienist, dental therapist or oral health therapist acting in the course of practice, if the person is authorised to obtain supply of the substance under the Act,

(d) a person acting under the direction of one of the following—

(i) a medical practitioner acting in the course of practice,

(ii) a nurse practitioner acting in the course of practice,

(iii) a registered nurse with an endorsement that qualifies the registered nurse to administer the schedule substance, acting in the course of practice,

(iv) a midwife practitioner acting in the course of practice,

(v) a midwife with an endorsement that qualifies the midwife to administer the scheduled substance, acting in the course of practice,

(vi) a dentist acting in the course of practice,

(vii) a podiatrist with an endorsement acting in the course of practice,

(viii) for a Schedule 4 substance only—an optometrist with an endorsement acting in the course of practice,

(e) a health practitioner of an approved class, or a person acting under the direction of the health practitioner.

(2) Subsection (1)(d) does not include a member of staff of a public health entity, private health facility, residential care facility, managed correctional centre or OTP clinic.

Note—

See sections 63 and 64 for administration of Schedule 4 and 8 substances by a member of staff of a public health entity, private health facility, residential care facility, managed correctional centre or OTP clinic.

Administration at public health entities, private health facilities and other places

63 Administration at public health entities, private health facilities and other places

(1) A member of staff of a public health entity, private health facility, residential care facility, managed correctional centre or OTP clinic acting under the direction of one of the following is authorised to administer a Schedule 4 or 8 substance to a person—

(a) a medical practitioner acting in the course of practice,

(b) a nurse practitioner acting in the course of practice,

(c) a registered nurse with an endorsement that qualifies the registered nurse to administer the scheduled substance, acting in the course of practice,

(d) a midwife practitioner acting in the course of practice,

(e) a midwife, with an endorsement that qualifies the midwife to administer the scheduled substance, acting in the course of practice,

(f) a dentist acting in the course of practice,

(g) a podiatrist with an endorsement acting in the course of practice,

(h) for a Schedule 4 substance only—an optometrist with an endorsement acting in the course of practice,

(i) a health practitioner of an approved class.

(2) The direction must be given—

(a) in writing, or

(b) in an approved way.

Maximum penalty—Tier 5 penalty.

(3) Despite subsection (2), the direction may, in an emergency or other urgent circumstances, be given orally in person or by telephone (an emergency oral direction).

(4) As soon as practicable, and no later than 24 hours, after giving an emergency oral direction, the person must confirm the direction by—

(a) making an entry in the patient’s medical record, or

(b) sending an email or facsimile to the person who administered the substance.

Maximum penalty—Tier 5 penalty.

(5) This section does not apply to the administration of a Schedule 4 or 8 substance to a person if the substance has been lawfully supplied to the person by a pharmacist on prescription.

Administration of Schedule 8 substances at OTP clinics

64 Administration of Schedule 8 substances at OTP clinics

A member of staff of an OTP clinic is authorised to administer a Schedule 8 substance to a patient at the OTP clinic if the member of staff is acting in accordance with a written direction lawfully given in relation to the patient by—

(a) a medical practitioner or nurse practitioner in accordance with the practitioner’s OTP registration, or

(b) a medical practitioner or nurse practitioner in circumstances in which an OTP registration is not required under section 82.

Administration by students

65 Administration by students

(1) A student is authorised to administer a Schedule 2, 3, 4 or 8 substance to a person if the student, during their studies, is acting under the direction of a registered health practitioner authorised to administer the substance.

(2) In this section—

student has the same meaning as in the Health Practitioner Regulation National Law, section 5.

Administration for the purpose of first aid

66 Administration for the purpose of first aid

(1) A first aider or other person giving first aid to a person is authorised to administer a Schedule 2 or 3 substance to the person.

(2) A first aider giving first aid to a person is authorised to administer a Schedule 4 substance to the person.

(3) A first aider is authorised under subsection (2) only if the first aider holds a current statement of attainment, issued by a registered training organisation, demonstrating competency in the use and administration, including access and preparation, of the substance for first aid.

Administration by carers

67 Administration by carers

(1) A carer of a person is authorised to administer a Schedule 2 or 3 substance to the person.

(2) A carer of a person is authorised to administer a Schedule 4 or 8 substance to the person if the substance has been lawfully supplied to the person.

Administration by Ambulance Service of NSW staff

68 Administration by Ambulance Service of NSW staff

A member of staff of, or a volunteer engaged by, the Ambulance Service of NSW is authorised to administer a Schedule 2, 3, 4 or 8 substance to a person in accordance with the approved paramedic protocol.

Administration by other paramedics

69 Administration by other paramedics

A paramedic is authorised to administer a Schedule 2, 3, 4 or 8 substance to a person if the paramedic is a member of staff of a business, other than the Ambulance Service of NSW, that provides paramedical services or ambulance transport services in New South Wales or another state or territory.

Administration of vaccines by registered health practitioner

70 Administration of vaccines by registered health practitioner

(1) A registered health practitioner is authorised to administer a vaccine to a person without a prescription if the practitioner—

(a) has an authority to administer the vaccine granted by the Health Secretary under section 74, and

(b) administers the vaccine in compliance with the approved standards.

(2) The practitioner must record the following details—

(a) the name, street address, date of birth and other contact details of the person to whom the vaccine was administered,

(b) the brand, batch number and expiry date of the vaccine,

(c) the part of the body to which the vaccine was administered,

(d) the date on which the vaccine was administered,

(e) the address of the place at which the vaccine was administered,

(f) a reference number for the administration,

(g) the practitioner’s name and contact details.

Maximum penalty—Tier 5 penalty.

(3) If the practitioner’s authority requires the practitioner to complete a training course for this section, the practitioner must record evidence of completion of the course.

Maximum penalty—Tier 5 penalty.

Administration by NSW Police Force dive medical technicians

71 Administration by NSW Police Force dive medical technicians

A dive medical technician that is a member of staff of the NSW Police Force is authorised to administer a Schedule 2, 3 or 4 substance to a diver for the purposes of emergency medical treatment if the dive medical technician is under the supervision of a medical practitioner qualified in underwater medicine.

Administration of Schedule 8 substances by dentists

72 Administration of Schedule 8 substances by dentists

(1) A dentist is authorised to administer a Schedule 8 substance only if the substance is listed in the Dental Schedule of Pharmaceutical Benefits.

(2) This section does not apply to the administration by a dentist to a patient in a public health entity or private health facility.

Restriction on administration of certain Schedule 4 and 8 substances

73 Restriction on administration of certain Schedule 4 and 8 substances

(1) An authorised practitioner, other than a veterinary practitioner, must not administer the following to a person—

(a) a nominated Schedule 4 substance,

(b) a Schedule 8 substance if the person has a substance dependence on a prohibited scheduled substance or prohibited drug,

(c) dexamfetamine, lisdexamfetamine or methylphenidate,

(d) N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine,

(e) morphine, oxycodone, fentanyl or hydromorphone in an amount that exceeds the morphine equivalent maximum dose,

(f) a substance (a relevant substance) that is alprazolam, flunitrazepam, methadone or a Schedule 8 substance in an injectable or intranasal preparation, if the administration is for a period that, together with all other periods for which a relevant substance has been administered by the person or has, to the person’s knowledge, been administered by another person, would result in one or more relevant substances being administered for continuous therapeutic use by the patient for more than 3 months.

Maximum penalty—Tier 5 penalty.

Note—

A health practitioner may be subject to other restrictions on the administration of scheduled substances under the Health Practitioner Regulation National Law in relation to appropriate professional conduct and practice.

(2) A veterinary practitioner must not administer the following—

(a) dexamfetamine or lisdexamfetamine,

(b) N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine.

Maximum penalty—Tier 5 penalty.

(3) Subsection (1)(b) does not apply to a dentist.

(4) Subsection (1) does not apply to a person who administers the substance in accordance with an approval, approval exemption or OTP registration.

Health Secretary may authorise administration—the Act, s 10(2)

74 Health Secretary may authorise administration—the Act, s 10(2)

(1) The Health Secretary may grant an authority that authorises the administration of a Schedule 2, 3, 4 or 8 substance.

(2) An authority may be granted on application or the Health Secretary’s own initiative.

(3) An authority may be granted to a particular person or a class of persons.

(4) An authority is granted to a class of persons by written notice published on the Ministry of Health’s website.

(5) The Health Secretary may, by written notice, require a person applying for an authority to give information to the Health Secretary that the Health Secretary considers necessary to determine the application.

(6) Without limitation, the Health Secretary may refuse to grant an authority to a person if, in the Health Secretary’s opinion, the person is not a fit and proper person to hold the authority.

(7) An authority may be granted subject to conditions.

(8) An authority is not transferable.

(9) The Health Secretary may revoke an authority granted to a class of persons by revoking the authority for—

(a) all the persons of the class, or

(b) specified persons of the class.

(10) An authority remains in force until the authority—

(a) expires, or

(b) is sooner surrendered by the holder or revoked by the Health Secretary.

Part 7

Approvals for supply, administration and prescription of certain Schedule 4 and 8 substances—the Act, Part 3.3

Part 7 Approvals for supply, administration and prescription of certain Schedule 4 and 8 substances—the Act, Part 3.3

Schedule 4 and 8 substances that require approvals—the Act, s 67(1)

75 Schedule 4 and 8 substances that require approvals—the Act, s 67(1)

The Act, Part 3.3 applies to the following scheduled substances—

(a) nominated Schedule 4 substances,

(b) Schedule 8 substances.

Approvals required for activities involving nominated Schedule 4 substances—the Act, s 69(1)

76 Approvals required for activities involving nominated Schedule 4 substances—the Act, s 69(1)

An authorised practitioner must not supply, administer or issue a prescription for a nominated Schedule 4 substance without an approval.

Approvals for nominated Schedule 4 substances not required in certain circumstances—the Act, s 69(1)

77 Approvals for nominated Schedule 4 substances not required in certain circumstances—the Act, s 69(1)

(1) This section sets out the circumstances in which an authorised practitioner does not require an approval under section 76 to supply, administer or issue a prescription for a nominated Schedule 4 substance.

Note—

The Act, section 69(2) and (3) set out other circumstances in which an approval is not required.

(2) An authorised practitioner does not require an approval for a nominated Schedule 4 substance for the treatment of a patient of—

(a) a public health entity or private health facility, or

(b) a correctional centre for the purposes of continuing the treatment the patient was receiving immediately before the patient became an inmate.

(3) An authorised practitioner (the replacement practitioner) does not require an approval for a nominated Schedule 4 substance if—

(a) the replacement practitioner carries out the activity on behalf of another authorised practitioner who holds an approval for the activity and is temporarily unavailable (the original practitioner), and

(b) the activity is required for the continued treatment of a patient of the original practitioner, and

(c) the replacement practitioner—

(i) practises at the same practice or premises as the original practitioner, or

(ii) is nominated by the original practitioner to carry out the activity.

(4) A veterinary practitioner does not require an approval for a nominated Schedule 4 substance.

(5) A medical practitioner with a specialist registration specified in Column 1 of the table to this subsection does not require an approval for a nominated Schedule 4 substance specified opposite in Column 2.

| Column 1 | Column 2 | | Specialist registration | Nominated Schedule 4 substance | | Dermatology | AcitretinAlefaceptBexaroteneEtretinateIsotretinoin for oral useThalidomide | | Obstetrics and gynaecology | ClomifeneCorifollitropin alfaCyclofenilDinoprostDinoprostoneFollitropin alfaFollitropin betaFollitropin deltaLuteinising hormoneUrofollitropin | | Physician | AcitretinAmbrisentanBexaroteneBosentanClomifeneCyclofenilEnzalutamideEtretinateFollitropin betaIsotretinoin for oral useLenalidomideLuteinising hormoneMacitentanPomalidomideRiociguatSitaxentanTeriparatideThalidomideTretinoin for oral use |

Approvals required for activities involving Schedule 8 substances—the Act, s 69(1)

78 Approvals required for activities involving Schedule 8 substances—the Act, s 69(1)

(1) A medical practitioner or authorised nurse must not supply, administer or issue a prescription for a Schedule 8 substance without an approval in the following circumstances—

(a) the patient has a substance dependence on a prohibited scheduled substance or prohibited drug,

(b) the Schedule 8 substance is—

(i) dexamfetamine, lisdexamfetamine or methylphenidate, or

(ii) for medical practitioners only—N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine,

(c) the Schedule 8 substance is morphine, oxycodone, fentanyl or hydromorphone and the amount is more than the morphine equivalent maximum dose,

(d) the substance (the relevant substance) is alprazolam, flunitrazepam, methadone or a Schedule 8 substance in an injectable or intranasal preparation, and the supply, administration or issue of the prescription would result in supply for a period in which, together with all other periods for which any relevant substance has been prescribed by the practitioner or has, to the practitioner’s knowledge, been prescribed by another person, one or more relevant substances are supplied for continuous therapeutic use by the patient for more than 3 months.

(2) In this section—

authorised nurse means—

(a) a nurse practitioner, or

(b) a registered nurse with an endorsement.

Approvals for Schedule 8 substances not required in certain circumstances—the Act, s 69(1)

79 Approvals for Schedule 8 substances not required in certain circumstances—the Act, s 69(1)

(1) This section sets out the circumstances in which a medical practitioner or authorised nurse does not require an approval under section 78(1) to supply, administer or issue a prescription for a Schedule 8 substance.

Note—

The Act, section 69(2) and (3) set out other circumstances in which an approval is not required.

(2) A medical practitioner or authorised nurse does not require an approval if the activity is carried out for one of the following purposes—

(a) the palliative treatment of a patient,

(b) the treatment of a patient admitted to, or receiving emergency treatment at, a public health entity or private health facility,

Note—

A hospital in the home patient is admitted to a public health entity or private health facility.

(c) the treatment of an inmate in a correctional centre for the purposes of continuing the treatment the person was receiving immediately before the person became an inmate.

(3) A medical practitioner or authorised nurse (the replacement practitioner) does not require an approval if—

(a) the replacement practitioner carries out the activity on behalf of another medical practitioner or authorised nurse who holds an approval for the activity and is temporarily unavailable (the original practitioner), and

(b) the activity is required for the continued treatment of a patient of the original practitioner, and

(c) the replacement practitioner—

(i) practises at the same practice or premises as the original practitioner, or

(ii) is nominated by the original practitioner to carry out the activity.

(4) A medical practitioner does not require an approval if the medical practitioner has a specialist registration—

(a) in palliative medicine, or

(b) in paediatrics and child health, with a field of speciality practice in paediatric palliative medicine or paediatric medical oncology, or

(c) in obstetrics and gynaecology, with a field of speciality practice in gynaecological oncology, or

(d) in radiation oncology, or

(e) as a physician, with a field of speciality practice in medical oncology.

(5) Subsections (2)–(4) do not apply to—

(a) N,?-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA), or

(b) psilocybine.

(6) A medical practitioner or authorised nurse does not require an approval for the activity specified in section 78(1)(a), (c) or (d) if the activity—

(a) is for the purposes of urgent pain relief for a patient, and

(b) does not involve treatment for more than 3 consecutive days for the same matter.

(7) A medical practitioner does not require an approval for the activity specified in section 78(1)(b)(i) or (d) in relation to dexamfetamine, lisdexamfetamine or methylphenidate if the medical practitioner has a specialist registration—

(a) in psychiatry, or

(b) in paediatrics and child health, or

(c) as a physician, with a field of speciality practice in neurology, or

(d) as a physician, with a field of speciality practice in respiratory and sleep medicine.

(8) In this section—

authorised nurse means—

(a) a nurse practitioner, or

(b) a registered nurse with an endorsement.

palliative treatment means the palliative treatment of a patient who has—

(a) an incurable, progressive, far-advanced disease or medical condition, and

(b) a prognosis of a limited life expectancy, with death expected within the next 2 years, because of the disease or medical condition.

Part 8

Opioid Treatment Program—the Act, Part 3.4

Part 8 Opioid Treatment Program—the Act, Part 3.4

Substances under Opioid Treatment Program

80 Substances under Opioid Treatment Program

For the Act, sections 74(1) and (4) and 75(1) and (3), buprenorphine and methadone are prescribed Schedule 8 substances when supplied, prescribed or administered under the Opioid Treatment Program.

Compliance standards for Opioid Treatment Program

81 Compliance standards for Opioid Treatment Program

(1) For the Act, section 74(4)(a), a person who supplies, administers or issues a prescription for buprenorphine or methadone under an OTP registration must carry out the activity in compliance with the OTP standards.

Maximum penalty—Tier 5 penalty.

(2) For the Act, section 74(4)(b), a pharmacist who dispenses buprenorphine or methadone at a pharmacy under an OTP registration must carry out the activity in compliance with the OTP standards.

Maximum penalty—Tier 5 penalty.

(3) For the Act, section 74(4)(c), a provider under the Opioid Treatment Program who is the holder of an obtain licence must ensure the OTP clinic is operated in compliance with the OTP standards.

Maximum penalty—Tier 5 penalty.

(4) For the Act, section 74(4)(d), a public health entity operating a public OTP clinic must ensure the OTP clinic is operated in compliance with the OTP standards.

Maximum penalty—Tier 5 penalty.

(5) For the Act, section 74(4)(d), a person carrying out an activity for which an OTP registration is not required under section 82 is prescribed and must carry out the activity in compliance with the provisions of the OTP standards specified in the OTP standards as applying to the person.

Maximum penalty—Tier 5 penalty.

(6) In this section—

OTP standards means the standards for compliance issued by the Health Secretary for the Act, section 74(4).

Circumstances in which OTP registration is not required

82 Circumstances in which OTP registration is not required

For the Act, section 74(3)(f), an OTP registration is not required for the activities specified in the Act, section 74(1) in the following circumstances—

(a) the treatment of a patient admitted to, or receiving emergency treatment at, a public health entity or private health facility,

(b) the treatment of a patient by a medical practitioner or nurse practitioner (the replacement practitioner) on behalf of a medical practitioner or nurse practitioner who has an OTP registration and is temporarily unavailable (the original practitioner) if—

(i) the treatment is required for the continued treatment of a patient of the original practitioner, and

(ii) the replacement practitioner—

(A) practises at the same practice or premises as the original practitioner, or

(B) is nominated by the original practitioner to carry out the activity,

(c) the treatment of an inmate in a correctional centre, or within 28 days after the inmate’s release, on behalf of a medical practitioner or nurse practitioner who has an OTP registration (the first practitioner) for the purposes of continuing the treatment the patient was receiving from the first practitioner.

Note—

The Act, section 75(2) provides that an OTP registration is not required for a person acting under the direction of a medical practitioner or nurse practitioner who has an OTP registration.

Authorised activities under OTP registrations—the Act, s 74(3)(b)

83 Authorised activities under OTP registrations—the Act, s 74(3)(b)

(1) A medical practitioner or nurse practitioner is authorised to supply, administer or issue a prescription to a patient under an OTP registration if—

(a) the patient is not an existing patient of another registered health practitioner for the purposes of an opioid treatment program, and

(b) the practitioner has notified the Health Secretary in the approved form of the following details—

(i) the patient’s details,

(ii) the substance to be supplied, administered or prescribed to the patient under the prescription, and

(c) the daily dose of the substance to be supplied, administered or prescribed to the patient is not more than—

(i) the standard treatment, or

(ii) the amount approved by the Health Secretary.

(2) In this section—

standard treatment means supplying, administering or prescribing a daily dose that is—

(a) not more than 200mg of methadone, or

(b) not more than 32mg of buprenorphine.

Refusal to grant OTP registration—the Act, s 74(3)(a)

84 Refusal to grant OTP registration—the Act, s 74(3)(a)

The Health Secretary may, by written notice, refuse to grant an OTP registration to a medical practitioner, nurse practitioner or pharmacy if the Health Secretary considers that granting the registration would—

(a) place a patient, or class of patients, at risk of harm, or

(b) not be in the public interest.

Suspension, variation and revocation of OTP registrations—the Act, s 74(3)(c)

85 Suspension, variation and revocation of OTP registrations—the Act, s 74(3)(c)

The Health Secretary may, by written notice given to the holder of an OTP registration, suspend, vary or revoke the OTP registration for reasons the Health Secretary considers appropriate.

Part 9

Cosmetic use substances—the Act, s 54

Part 9 Cosmetic use substances—the Act, s 54

Definitions

86 Definitions

In this part—

cosmetic use substance means the following Schedule 4 substances—

(a) botulinum toxins,

(b) calcium hydroxylapatite,

(c) collagen,

(d) deoxycholic acid,

(e) hyaluronic acid and its polymers,

(f) polyacrylamide,

(g) polycaprolactone,

(h) polylactic acid.

responsible provider, in relation to a cosmetic use substance, means a person carrying on a business of administering the substance, for fee or reward and whether or not for profit, but does not include an individual employed or otherwise engaged by the person carrying on the business.

Application of part

87 Application of part

(1) This part does not apply to the administration of a cosmetic use substance to a patient by—

(a) an authorised practitioner administering the cosmetic use substance in the lawful practice of the practitioner’s profession, or

(b) for a patient in a hospital—a person employed at the hospital who is administering the cosmetic use substance on the direction of an authorised practitioner, other than a veterinary practitioner.

(2) For subsection (1)(a), an authorised practitioner does not include a registered nurse with an endorsement.

(3) This part does not apply to the administration of a cosmetic use substance to an animal by—

(a) a veterinary practitioner in the lawful practice of the practitioner’s profession, or

(b) another person on the direction of a veterinary practitioner.

Administration of cosmetic use substances

88 Administration of cosmetic use substances

(1) A person must not administer a cosmetic use substance to a patient unless the person is a nurse who is—

(a) acting in accordance with a direction of a medical practitioner or nurse practitioner, or

(b) administering the substance to the patient and the substance has been lawfully supplied to the patient in accordance with a prescription issued to the patient.

(2) A medical practitioner or nurse practitioner must not give a direction unless the medical practitioner or nurse practitioner is satisfied the cosmetic use substance is—

(a) included on the Australian Register of Therapeutic Goods, or

(b) approved for supply under the Commonwealth Therapeutic Goods Act, section 19 or 19A, or

(c) supplied by a manufacturer that has a manufacturing licence under the Commonwealth Therapeutic Goods Act.

(3) A nurse administering a cosmetic use substance under the direction of a medical practitioner or nurse practitioner must—

(a) be satisfied there is appropriate equipment available for use in a patient medical emergency, and

(b) be satisfied the substance is—

(i) included on the Australian Register of Therapeutic Goods, or

(ii) approved for supply under the Commonwealth Therapeutic Goods Act, section 19 or 19A, or

(iii) supplied by a manufacturer that has a manufacturing licence under the Commonwealth Therapeutic Goods Act, and

(c) make a written record of the following information for each administration—

(i) the nurse’s name,

(ii) the date on which the substance was administered,

(iii) the batch number of the substance,

(iv) the information specified in section 90(1)(a)–(e) and (i), and

(d) give a copy of the written record to—

(i) the relevant medical practitioner or nurse practitioner, and

(ii) the responsible provider.

Administration by nurses under direction of medical practitioners and nurse practitioners

89 Administration by nurses under direction of medical practitioners and nurse practitioners

(1) A medical practitioner or nurse practitioner giving a direction for section 88(1)(a) must—

(a) have personally reviewed the patient in person or by audiovisual link, and

(b) give the direction in writing, and

(c) sign the direction.

(2) The direction may be given orally in person if the medical practitioner or nurse practitioner is physically present when the substance is administered by the nurse to whom the direction is given.

(3) If the direction is given orally in person, the medical practitioner or nurse practitioner must—

(a) record the direction in the patient’s medical record, and

(b) sign the record.

(4) A written direction has effect for the period specified in the direction, being not more than 6 months from the date on which the practitioner giving the direction reviewed the patient under subsection (1)(a).

(5) An oral direction has effect for the particular administration of the substance to which the direction applies.

Content of directions

90 Content of directions

(1) A written direction given under section 89(1) must include the following information—

(a) the patient’s name,

(b) the patient’s street address,

(c) the name and telephone number of the medical practitioner or nurse practitioner giving the direction,

(d) the street address of the principal place of practice of the medical practitioner or nurse practitioner giving the direction,

(e) the street address of the premises at which the substance will be administered,

(f) the responsible provider’s name,

(g) the date on which the medical practitioner or nurse practitioner personally reviewed the patient under section 89(1)(a),

(h) the period for which the direction has effect,

(i) the number of times, and the intervals at which, the substance may be administered,

(j) for each administration of the substance—

(i) the name and form of the substance, and

(ii) the part of the patient’s face or body to which the substance will be administered, and

(iii) the route of administration, if not readily apparent, and

(iv) the quantity of the substance to be administered.

(2) An oral direction given under section 89(2) must include the information specified in subsection (1)(a) and (j).

Records of directions

91 Records of directions

(1) A medical practitioner or nurse practitioner who gives a written direction under section 89(1) must—

(a) keep a copy of the direction, and

(b) give a copy of the direction to the responsible provider.

(2) A medical practitioner or nurse practitioner who gives an oral direction under section 89(2) must—

(a) make and keep a record of the direction, which must include the street address of the patient, and

(b) give a copy of the record to the responsible provider.

Storage

92 Storage

(1) The person who occupies or has control of premises at which a cosmetic use substance is stored or administered must ensure the substance is stored—

(a) in a room or enclosure to which the public does not have access, and

(b) apart from food intended for consumption by humans or animals, and

(c) in a way that, if the substance’s container breaks or leaks, the substance cannot mix with or contaminate food intended for consumption by humans or animals, and

(d) in accordance with the conditions for storage specified on the label of the substance.

(2) A medical practitioner or nurse practitioner who obtains a cosmetic use substance for administration must ensure the substance is stored—

(a) in a room or enclosure to which the public does not have access, and

(b) apart from food intended for consumption by humans or animals, and

(c) in a way that, if the substance’s container breaks or leaks, the substance cannot mix with or contaminate food intended for consumption by humans or animals, and

(d) in accordance with the conditions for storage specified on the label of the substance.

Duties of responsible providers and staff

93 Duties of responsible providers and staff

(1) A responsible provider, and each medical practitioner or nurse practitioner employed by the provider, must ensure the following—

(a) the administration of a cosmetic use substance in the course of the provider’s business is carried out in accordance with this part,

(b) there are appropriate risk management policies and procedures in place to protect the health and safety of patients,

(c) there is appropriate equipment available for use in a patient medical emergency,

(d) each nurse administering a cosmetic use substance is adequately trained for a patient medical emergency.

(2) A responsible provider must keep a copy of—

(a) each direction given by a medical practitioner or nurse practitioner for the administration of a cosmetic use substance by a nurse under this part, and

(b) each record made by a nurse under section 88(3)(c).

Category 1 and category 2 requirements

94 Category 1 and category 2 requirements

(1) The following provisions are category 1 requirements—

(a) section 88(1), (2) and (3)(a) and (b),

(b) section 89(1)(a),

(c) section 93(1).

(2) The following provisions are category 2 requirements—

(a) section 88(3)(c) and (d),

(b) section 89(1)(b) and (c),

(c) section 90,

(d) section 91,

(e) section 92,

(f) section 93(2).

Note—

The Act, section 54(3) provides that a person who contravenes a category 1 or category 2 requirement is guilty of an offence. The maximum penalty for a category 1 requirement is 1,000 penalty units for a corporation and 200 penalty units or imprisonment for 6 months, or both, for an individual. The maximum penalty for a category 2 requirement is 250 penalty units for a corporation and 50 penalty units for an individual.

Part 10

Nitrous oxide—the Act, ss 55 and 150

Part 10 Nitrous oxide—the Act, ss 55 and 150

Definitions

95 Definitions

In this part—

container, in relation to nitrous oxide, includes a bulb.

dealer—

(a) means a person who supplies nitrous oxide as a manufacturer, an importer or exporter or a wholesale or retail dealer, and

(b) includes an authorised practitioner and a pharmacist, in the practitioner’s or pharmacist’s capacity as a supplier of nitrous oxide.

purchaser means the person to whom nitrous oxide is supplied.

Application of part

96 Application of part

(1) This part applies to nitrous oxide that is a Schedule 6 substance.

(2) This part does not apply to nitrous oxide that is—

(a) used for therapeutic use, or

(b) kept in a container designed to be mounted and used in a motor vehicle, or

(c) supplied by a full member of the Australia New Zealand Industrial Gas Association for an industrial use.

Storage of nitrous oxide

97 Storage of nitrous oxide

(1) A dealer who has possession of nitrous oxide must keep the nitrous oxide in a way that ensures the nitrous oxide, including its container or packaging, is not visible to a member of the public, including a member of the public who is on the premises where the nitrous oxide is kept.

Maximum penalty—Tier 5 penalty.

(2) A dealer does not commit an offence under this section if the nitrous oxide, or its container or packaging, is visible while the dealer is—

(a) supplying the nitrous oxide to a purchaser, or

(b) showing the nitrous oxide to a member of the public at the member of the public’s request.

Supply of nitrous oxide to minors prohibited

98 Supply of nitrous oxide to minors prohibited

(1) A dealer must not supply nitrous oxide to a minor.

Maximum penalty—Tier 5 penalty.

(2) It is a defence to a prosecution for an offence under this section if the court is satisfied that—

(a) the purchaser was at least 15 years of age at the time of the supply, and

(b) at or before the time of the supply, the defendant was given documentary evidence that might reasonably be accepted as—

(i) applying to the purchaser, and

(ii) proving the purchaser was at least 18 years of age.

(3) In this section—

documentary evidence includes an evidence of age document within the meaning of the Liquor Act 2007.

Maximum quantity of nitrous oxide to be supplied

99 Maximum quantity of nitrous oxide to be supplied

(1) A dealer must not supply nitrous oxide to another person in a container that contains more than 10g of nitrous oxide.

Maximum penalty—Tier 5 penalty.

(2) A dealer must not supply another person with more than 250g of nitrous oxide per day.

Maximum penalty—Tier 5 penalty.

100

Nitrous oxide must not be supplied at certain times or delivered same day

100 Nitrous oxide must not be supplied at certain times or delivered same day

(1) A dealer who supplies nitrous oxide must ensure the purchaser, or the purchaser’s agent, does not receive the nitrous oxide—

(a) before 5am or after 10pm on a day, or

(b) on the same day the purchaser requests the nitrous oxide.

Maximum penalty—Tier 5 penalty.

(2) Subsection (1)(b) does not apply to a supply that occurs in person between the dealer and the purchaser at the dealer’s premises.

101

Application of division

101 Application of division

The provisions of this division prevail over the other provisions of this part to the extent of an inconsistency.

102

Definitions

102 Definitions

In this division—

food and drink related supply means supply to—

(a) a person carrying on a food business, or

(b) the holder of a liquor licence.

food business means a food business within the meaning of the Food Act 2003 if one or both of the following apply—

(a) written notice in relation to the food business has been given to the appropriate enforcement agency under the Food Act 2003, section 100,

(b) the food business is subject to a licence for a food safety scheme required under regulations made under the Food Act 2003.

liquor licence means a licence within the meaning of the Liquor Act 2007.

103

Food and drink related supplies and wholesale supplies

103 Food and drink related supplies and wholesale supplies

(1) A dealer may do the following when supplying nitrous oxide if the supply is a food and drink related supply—

(a) supply more than 250g of nitrous oxide to the purchaser in one day,

(b) enable the purchaser, or the purchaser’s agent, to receive the nitrous oxide at any time of the day,

(c) enable the purchaser, or the purchaser’s agent, to receive the nitrous oxide on the same day the purchaser requests the nitrous oxide,

(d) give nitrous oxide to a minor during the supply if the minor is an employee of—

(i) the person carrying on the food business, or

(ii) the holder of the liquor licence.

(2) A dealer may do the following when supplying nitrous oxide if the supply is a wholesale supply—

(a) supply more than 250g of nitrous oxide to the purchaser in 1 day,

(b) enable the purchaser, or the purchaser’s agent, to receive the nitrous oxide at any time of the day,

(c) enable the purchaser, or the purchaser’s agent, to receive the nitrous oxide on the same day the purchaser requests the nitrous oxide,

(d) give nitrous oxide to a minor during the supply if the minor is an employee of the purchaser.

104

Records must be kept by dealer

104 Records must be kept by dealer

A dealer must keep a record of supply of nitrous oxide if one or more of the following apply—

(a) the dealer supplies more than 250g of nitrous oxide to the purchaser in 1 day,

(b) the dealer enables the purchaser, or the purchaser’s agent, to receive the nitrous oxide before 5am or after 10pm on a day,

(c) for a supply that does not occur in person between the dealer and the purchaser at the dealer’s premises—the dealer enables the purchaser, or the purchaser’s agent, to receive the nitrous oxide on the same day the purchaser requests the nitrous oxide,

(d) the dealer gives nitrous oxide to a minor during the supply in accordance with section 103(1)(d) or (2)(d).

Maximum penalty—Tier 5 penalty.

105

Content of records

105 Content of records

A record kept in accordance with this division must include the following—

(a) the amount of nitrous oxide supplied,

(b) the date the purchase of the nitrous oxide occurred,

(c) the following information about the purchaser—

(i) name,

(ii) street address,

(iii) phone number,

(iv) if the purchaser has an ABN—the ABN,

(v) if the purchaser is a corporation—the name and phone number of the individual acting on behalf of the corporation to arrange the supply,

(vi) if the purchaser is a person carrying on a food business subject to a licence for a food safety scheme required under regulations made under the Food Act 2003—the number of the licence,

(vii) if the purchaser holds a liquor licence—the number of the licence,

(d) the name of the dealer,

(e) the address where the nitrous oxide was kept by the dealer before being supplied to the purchaser.

Maximum penalty—Tier 5 penalty.

Part 11

Drug registers for Schedule 8 substances—the Act, ss 55 and 150

Part 11 Drug registers for Schedule 8 substances—the Act, ss 55 and 150

106

Definitions

106 Definitions

In this part—

relevant place has the same meaning as in section 107.

responsible person has the same meaning as in section 108.

107

Application of part to storage of Schedule 8 substances at certain places

107 Application of part to storage of Schedule 8 substances at certain places

This part applies to the storage of Schedule 8 substances at the following places (a relevant place)—

(a) a hospital ward in a public health entity or private health facility,

(b) a public hospital pharmacy,

(c) a dispensary in a private health facility,

(d) a residential care facility,

(e) a managed correctional centre,

(f) a clinic or other area in a correctional centre controlled by the Justice Health and Forensic Mental Health Network,

(g) an OTP clinic,

(h) a pharmacy,

(i) a veterinary hospital,

(j) another place at which a person is in possession of a Schedule 8 substance for the purposes of manufacture, supply, administration, research or testing.

108

Persons responsible for drug registers

108 Persons responsible for drug registers

(1) The responsible person for a relevant place is as follows—

(a) for a hospital ward in a public health entity or private health facility—the director of nursing or, for a public health entity, a person appointed by the chief executive of the public health entity,

(b) for a public hospital pharmacy—the director of pharmacy,

(c) for a dispensary in a private health facility—the licensee of the private health facility or a person appointed by the licensee,

(d) for a residential care facility—the authorised person for the residential care facility,

(e) for a managed correctional centre—the person appointed for the managed correctional centre under subsection (4),

(f) for a clinic or other area in a correctional centre controlled by the Justice Health and Forensic Mental Health Network—the director of nursing,

(g) for a public OTP clinic—the medical practitioner, nurse practitioner, registered nurse, midwife or pharmacist in charge of the public OTP clinic,

(h) for a private OTP clinic—the holder of the obtain licence for the private OTP clinic,

(i) for a pharmacy—the holder of a financial interest, within the meaning of the Health Practitioner Regulation National Law (NSW), Schedule 5F, in the pharmacy,

(j) for a veterinary hospital—the holder of the veterinary hospital licence under the Veterinary Practice Act 2003,

(k) for another place referred to in section 107(j)—

(i) the holder of a wholesaler licence, or

(ii) the holder of a DMT authority, or

(iii) the holder of an authority granted by the Health Secretary under section 25, 43 or 74, or

(iv) the holder of an obtain licence, or

(v) if subparagraphs (i)–(iv) do not apply—an authorised practitioner employed or engaged at the place, or

(vi) if the Schedule 8 substance is on premises managed by NSW Health Pathology—the chief executive of NSW Health Pathology, or

(vii) if the Schedule 8 substance is on premises managed by the Ambulance Service of NSW—the chief executive of the Ambulance Service of NSW.

(2) If a public health entity or private health facility does not have a director of nursing, the chief executive, however described, of the public health entity or private health facility must appoint the director of pharmacy or the medical superintendent to have the responsibilities of the responsible person under this part.

(3) If a public hospital does not have a director of pharmacy, the chief executive, however described, of the hospital must appoint the director of nursing or the medical superintendent to have the responsibilities of the responsible person under this part.

(4) The management company for a managed correctional centre must, by written instrument, appoint a pharmacist employed or engaged by the management company as the responsible person for the managed correctional centre.

(5) If there is no pharmacist employed or engaged by the management company for the managed correctional centre, the person appointed may be—

(a) an authorised practitioner, other than a dentist or veterinary practitioner, or

(b) the registered nurse in charge of the medical treatment of inmates at the managed correctional centre.

109

Drug registers for Schedule 8 substances

109 Drug registers for Schedule 8 substances

(1) A responsible person for a relevant place at which a Schedule 8 substance is kept must ensure a drug register is kept in accordance with this part.

Maximum penalty—Tier 5 penalty.

(2) A drug register must specify the particulars required to be entered and be kept—

(a) in the form of a book that—

(i) contains consecutively numbered pages, and

(ii) is bound so the pages cannot be removed or replaced without a trace, or

(b) electronically in a form that complies with the approved standards.

(3) If a drug register is kept in the form of a book, as referred to in subsection (2)(a), a separate page must be used for—

(a) each Schedule 8 substance, and

(b) each brand, strength and dosage form of the Schedule 8 substance.

(4) Despite subsection (3), a separate page is not required for records of the destruction of each Schedule 8 substance.

(5) Despite this section, the responsible person for premises managed by NSW Health Pathology or the Ambulance Service of NSW at which a Schedule 8 substance is kept must ensure a drug register is kept in the approved form.

Maximum penalty—Tier 5 penalty.

110

Entries in drug registers for Schedule 8 substances

110 Entries in drug registers for Schedule 8 substances

(1) For a Schedule 8 substance, a person must enter the following information in the drug register—

(a) if the person manufactures a Schedule 8 substance at a relevant place specified in Column 1—the information specified opposite in Column 2 on the day of manufacture,

(b) if the person receives a Schedule 8 substance at a relevant place specified in Column 1—the information specified opposite in Column 3 on the day of receipt,

(c) if the person supplies a Schedule 8 substance at a relevant place specified in Column 1—the information specified opposite in Column 4 on the day of supply,

(d) if the person administers or uses a Schedule 8 substance, including if all or part of the Schedule 8 substance is lost, at a relevant place specified in Column 1—the information specified opposite in Column 5 on the day of administration, use or loss.

Examples of lost part of substance—

a part of the substance that remains in a syringe after the substance is administered or a part of the substance that is spilled

Maximum penalty—Tier 5 penalty.

| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | | Relevant place | Manufacture | Receipt | Supply | Administration/use/loss | | Hospital ward in public health entity or private health facility | — | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingName and signature of witnessDate | Quantity suppliedName of patientStreet address of recipientName of authorised practitioner who directed the supplyQuantity remainingName and signature of person supplyingName and signature of witnessDate | Quantity administeredName of patientName of authorised practitioner who directed the administrationQuantity remainingName and signature of person administeringName and signature of witnessDateFor loss, quantity of loss, including discarded amount, and reason for loss | | Public hospital pharmacy | Quantity manufacturedQuantity remainingReference numberName and signature of person manufacturingDate of manufacture | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingDate | Quantity suppliedName of recipientStreet address of recipientReference number of prescription or requisitionName of person who issued prescription or requisitionQuantity remainingName and signature of person supplyingDate | For loss, quantity of loss, including the discarded amount, and reason for lossDate | | Dispensary in private health facility | Quantity manufacturedQuantity remainingReference numberName and signature of person manufacturingDate of manufacture | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingDate | Quantity suppliedName of recipientStreet address of recipientReference number of prescription or requisitionName of person who issued prescription or requisitionQuantity remainingName and signature of person supplyingDate | For loss, quantity of loss, including the discarded amount, and reason for lossDate | | Residential care facility | — | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingName and signature of witnessDate | Quantity suppliedName of recipientStreet address of recipientName of authorised practitioner who directed the supplyQuantity remainingName and signature of person supplyingName and signature of witnessDate | Quantity administeredName of recipientName of authorised practitioner who directed the administrationQuantity remainingName and signature of person administeringName and signature of witnessDateFor loss, quantity of loss, including discarded amount, and reason for loss | | Managed correctional centre | — | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingName and signature of witnessDate | Quantity suppliedName of recipientStreet address of recipientName of authorised practitioner who directed the supplyQuantity remainingName and signature of person supplyingName and signature of witnessDate | Quantity administeredName of recipientName of authorised practitioner who directed the administrationQuantity remainingName and signature of person administeringName and signature of witnessDateFor loss, quantity of loss, including discarded amount, and reason for loss | | Clinic or other area in a correctional centre controlled by the Justice Health and Forensic Mental Health Network | Quantity manufacturedQuantity remainingReference numberName and signature of person manufacturingDate of manufacture | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingName and signature of witnessDate | Quantity suppliedName of recipientStreet address of recipientName of authorised practitioner who directed the supplyQuantity remainingName and signature of person supplyingName and signature of witnessDate | Quantity administeredName of recipientName of authorised practitioner who directed the administrationQuantity remainingName and signature of person administeringName and signature of witnessDateFor loss, quantity of loss, including discarded amount, and reason for loss | | Public or private OTP clinic | — | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingName and signature of witnessDate | Quantity suppliedName of recipientStreet address of recipientName of authorised practitioner who issued the prescription or directed the supplyQuantity remainingName and signature of person supplyingName and signature of witnessDate | Quantity administeredName of recipientName of authorised practitioner who directed the administrationName and signature of person administeringName and signature of witnessDateFor loss, quantity of loss, including discarded amount, and reason for loss | | Pharmacy | Quantity manufacturedQuantity remainingReference numberName and signature of person manufacturingDate of manufacture | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingDate | Quantity suppliedName of recipientStreet address of recipientReference number of prescriptionName of person who issued prescriptionQuantity remainingName and signature of person supplyingDate | For loss, quantity of loss, including discarded amount, and reason for lossDate | | Veterinary hospital | Quantity manufacturedQuantity remainingReference numberName and signature of person manufacturingDate of manufacture | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingDate | Quantity suppliedSpecies of animalName or number of animalName of animal owner, if applicableStreet address of animal owner, if applicableQuantity remainingName and signature of person supplyingDate | Quantity administeredSpecies of animalName or number of animalName of animal owner, if applicableStreet address of animal owner, if applicableName and signature of person administeringDateFor loss, quantity of loss, including discarded amount, and reason for loss | | Another place, as specified in section 108(1)(k) | Quantity manufacturedQuantity remainingReference numberName and signature of person manufacturingDate of manufacture | Quantity receivedName of supplierReference number of supplyQuantity remainingName and signature of person receivingDate | Quantity suppliedName of recipientStreet address of recipientReference numberQuantity remainingName and signature of person supplyingDate | Quantity administered or usedIf administered to a person, name of patientIf administered to an animal, name or number of animal If used, purpose of useName and signature of person administering or usingDateFor loss, quantity of loss, including discarded amount, and reason for loss |

(2) The person making the entry in the drug register must sign and date the entry.

Maximum penalty—Tier 5 penalty.

(3) A person making an entry in the drug register at the following locations for the receipt of a Schedule 8 substance must ensure the entry is countersigned by a person who witnessed the receipt—

(a) a hospital ward,

(b) a residential care facility,

(c) a managed correctional centre,

(d) a clinic or other area in a correctional centre controlled by the Justice Health and Forensic Mental Health Network,

(e) a public or private OTP clinic.

Maximum penalty—Tier 5 penalty.

(4) A person making an entry in the drug register at the following locations for the supply or administration of a Schedule 8 substance must ensure the entry is countersigned by a person who supervised or witnessed the supply or administration—

(a) a hospital ward,

(b) a residential care facility,

(c) a managed correctional centre,

(d) a clinic or other area in a correctional centre controlled by the Justice Health and Forensic Mental Health Network,

(e) a public or private OTP clinic.

Maximum penalty—Tier 5 penalty.

(5) The person countersigning under subsection (4) in a correctional centre or OTP clinic must be a nurse, midwife, pharmacist or authorised practitioner, other than a veterinary practitioner, appointed by the correctional centre or OTP clinic.

111

Inventories of Schedule 8 substances

111 Inventories of Schedule 8 substances

(1) The responsible person for a relevant place must ensure an accurate inventory of all Schedule 8 substances at the relevant place is made in accordance with this section at the approved times or, if there are no approved times—

(a) every 6 months for the following relevant places—

(i) a hospital ward in a public health entity or private health facility,

(ii) a public hospital pharmacy,

(iii) a dispensary in a private health facility,

(iv) a clinic or other area in a correctional centre controlled by the Justice Health and Forensic Mental Health Network,

(v) a public OTP clinic,

(vi) a residential care facility run by a public health entity, or

(b) otherwise—every 3 months.

Maximum penalty—Tier 5 penalty.

(2) The person making the inventory must—

(a) make the inventory as an entry in the drug register, and

(b) include, immediately under the last entry for each substance—

(i) the quantity of the substance actually kept at the relevant place, and

(ii) the date the inventory was made, and

(c) sign the entry in the drug register.

Maximum penalty—Tier 5 penalty.

(3) A person who, for a period of 1 month or more, takes control of a relevant place at which Schedule 8 substances are kept must, immediately on taking control, ensure an inventory is made as an entry in the drug register in accordance with this section.

Maximum penalty—Tier 5 penalty.

112

Loss or destruction of drug registers for Schedule 8 substances

112 Loss or destruction of drug registers for Schedule 8 substances

If a drug register for a relevant place is lost or destroyed, the responsible person for the relevant place must immediately—

(a) give written notice to the Health Secretary of—

(i) the loss or destruction of the drug register, and

(ii) the circumstances of the loss or destruction, and

(b) ensure an accurate inventory of all Schedule 8 substances kept at the relevant place is made, and

(c) ensure the details of the Schedule 8 substances kept at the relevant place are entered in a new drug register.

Maximum penalty—Tier 5 penalty.

113

Ambulance Service of NSW drug register

113 Ambulance Service of NSW drug register

The chief executive of the Ambulance Service of NSW must ensure a drug register is kept for each of the premises and depots of the Ambulance Service of NSW in accordance with the approved ambulance protocol.

Part 12

Records of supply and administration of scheduled substances—the Act, s 55

Part 12 Records of supply and administration of scheduled substances—the Act, s 55

114

Records of supply by authorised practitioners

114 Records of supply by authorised practitioners

An authorised practitioner who supplies a Schedule 4 or 8 substance must record the following information—

(a) the date on which the substance was supplied,

(b) the name, strength and quantity of the substance supplied,

(c) for supply to an individual—the individual’s name, street address and date of birth,

(d) for supply to an animal—the species and the owner’s name and street address,

(e) for supply of azithromycin for the treatment of chlamydia in a patient’s partner—the partner’s name and the partner’s email address or telephone number.

Maximum penalty—Tier 5 penalty.

115

Records of supply by pharmacists on prescription

115 Records of supply by pharmacists on prescription

A pharmacist in a pharmacy who supplies a scheduled substance on prescription must record the following information—

(a) the date on which the substance was supplied,

(b) the details required to be specified on the prescription under this regulation,

(c) the name of the pharmacist who supplied the substance,

(d) the reference number for the prescription.

Maximum penalty—Tier 5 penalty.

116

Records of supply by pharmacists in emergencies and urgent circumstances

116 Records of supply by pharmacists in emergencies and urgent circumstances

(1) A pharmacist in a pharmacy who supplies a scheduled substance under section 33 or 34 must record the following—

(a) the date on which the substance was supplied,

(b) the name, strength and quantity of the substance supplied,

(c) the name, street address and date of birth of the person to whom the substance was supplied,

(d) the name of the pharmacist who supplied the substance,

(e) the reference number for the supply.

Maximum penalty—Tier 5 penalty.

(2) A pharmacist who supplies a substance under section 33 must also record the following—

(a) the directions given by the pharmacist for the use of the substance,

(b) the name and address of the person who the pharmacist believes most recently issued a prescription for the substance to the person.

Maximum penalty—Tier 5 penalty.

117

Records of supply to NSW Health Pathology etc

117 Records of supply to NSW Health Pathology etc

A member of staff who supplies a prohibited scheduled substance, prohibited drug or prohibited plant under section 29 must record the following—

(a) the date on which the substance, drug or plant was supplied,

(b) the name, strength and quantity of the substance, drug or plant supplied,

(c) the name and street address of the person to whom the substance, drug or plant was supplied,

(d) the purpose for which the substance, drug or plant was supplied.

Maximum penalty—Tier 5 penalty.

Part 13

Storage of scheduled substances—the Act, ss 55 and 150

Part 13 Storage of scheduled substances—the Act, ss 55 and 150

118

Storage requirements generally

118 Storage requirements generally

(1) This section applies to the following persons who supply a scheduled substance (a supplier)—

(a) a manufacturer,

(b) an importer or exporter,

(c) a wholesale or retail supplier,

(d) an authorised practitioner,

(e) a pharmacist.

(2) A supplier in possession of a scheduled substance must store the substance apart from food intended for consumption by humans or animals.

Maximum penalty—Tier 5 penalty.

119

Storage requirements for Schedule 3 and 4 substances

119 Storage requirements for Schedule 3 and 4 substances

A supplier in possession of a Schedule 3 or 4 substance must store the substance in a room or enclosure to which the public does not have access.

Maximum penalty—Tier 5 penalty.

120

Storage requirements for Schedule 6 substances

120 Storage requirements for Schedule 6 substances

(1) A supplier in possession of a Schedule 6 substance must store the substance—

(a) in a way that prevents access by persons who are less than 16 years of age, and

(b) in a location that is at least 1.2m above the floor and at least 1.2m away from a step, stairway, ramp or escalator to which the public has access.

Maximum penalty—Tier 5 penalty.

(2) This section does not apply to the following substances—

(a) a substance for therapeutic use for animals,

(b) a substance in a container fitted with—

(i) a child-resistant closure, within the meaning of the Commonwealth Poisons Standard, or

(ii) an approved closure,

(c) a substance in a pressurised spray dispenser fitted with a cap that can be removed only by using a levering instrument applied through a slot in the cap,

(d) a substance in a container—

(i) with a capacity of at least 5L, or

(ii) that weighs at least 5kg, including the contents of the container,

(e) hair dye in a container with a capacity of no more than 5mL,

(f) cockroach bait in a complex welded plastic structure.

121

Storage requirements for Schedule 7 substances

121 Storage requirements for Schedule 7 substances

A supplier in possession of a Schedule 7 substance for retail sale must store the substance in a way that prevents access by a person other than—

(a) the supplier, or

(b) a member of staff of the supplier, or

(c) a person who is legally permitted to purchase the substance and who is under the direct supervision of the supplier or a member of staff of the supplier.

Maximum penalty—Tier 5 penalty.

122

Storage requirements for Schedule 8 substances in pharmacies

122 Storage requirements for Schedule 8 substances in pharmacies

(1) This section applies to the storage of a Schedule 8 substance in a pharmacy or a public hospital pharmacy.

(2) The pharmacist in charge of the pharmacy must ensure Schedule 8 substances are stored in the pharmacy in accordance with this section.

Maximum penalty—Tier 5 penalty.

(3) The substance must be stored—

(a) in a dedicated room, receptacle or refrigerator, and

(b) on its own, unless—

(i) it is stored with a Schedule 9 substance, or

(ii) it is stored in a refrigerator that only contains scheduled substances.

(4) The dedicated room, receptacle or refrigerator must be kept securely locked when not in immediate use.

(5) A receptacle or refrigerator must—

(a) be securely attached to a part of the premises, and

(b) not be accessible by members of the public.

(6) Storage must comply with the medicine storage standards, including in relation to the receptacle.

(7) A key or other device that unlocks the dedicated room, receptacle or refrigerator must be—

(a) kept on the person of a pharmacist when a pharmacist is at the pharmacy or removed from the pharmacy when there is no pharmacist at the pharmacy, or

(b) kept in a separately locked receptacle to which only a pharmacist has access.

(8) A code or combination required to unlock the dedicated room, receptacle or refrigerator must not be divulged to a person who is not a pharmacist.

123

Storage requirements for Schedule 4D and 8 substances in hospitals and other places

123 Storage requirements for Schedule 4D and 8 substances in hospitals and other places

(1) This section applies to the storage of a Schedule 4D or 8 substance in the following—

(a) a public health entity, other than a public hospital pharmacy,

(b) a private health facility,

(c) an OTP clinic,

(d) a residential care facility,

(e) a managed correctional centre.

(2) The substance must be stored—

(a) in a dedicated room, receptacle or refrigerator, and

(b) for a Schedule 8 substance—on its own, unless—

(i) it is stored with a Schedule 4D or Schedule 9 substance, or another approved substance, or

(ii) it is stored in a refrigerator that only contains scheduled substances.

(3) The dedicated room, receptacle or refrigerator must be kept securely locked when not in immediate use.

(4) A receptacle or refrigerator must—

(a) be securely attached to a part of the premises, and

(b) not be accessible by members of the public.

(5) Storage must comply with the medicine storage standards, including in relation to the receptacle.

(6) A key or other device that unlocks the dedicated room, receptacle or refrigerator must be—

(a) kept on the person of a relevant person when a relevant person is on the premises or removed from the premises when there is no relevant person on the premises, or

(b) kept in a separately locked receptacle to which only a relevant person has access.

(7) A code or combination required to unlock the dedicated room, receptacle or refrigerator must not be divulged to a person who is not a relevant person.

(8) This section does not apply to the storage of a substance—

(a) on an emergency, anaesthetic or operating theatre trolley, or

(b) to which section 122 applies.

(9) This section also applies to another scheduled substance specified by the Health Secretary generally or in a particular case.

(10) In this section—

appointed person, for a managed correctional centre, means—

(a) a pharmacist who is—

(i) employed or engaged by the management company for a managed correctional centre, or

(ii) appointed by written instrument by the management company as the relevant person for this section, or

(b) if there is no pharmacist employed or engaged by the management company for the managed correctional centre—

(i) a registered nurse in charge of the medical treatment of inmates at the managed correctional centre, or

(ii) an authorised practitioner, other than a dentist or veterinary practitioner, who is appointed by written instrument by the management company as the relevant person for this section.

relevant person means the following—

(a) for a public health entity or private health facility—

(i) a nurse or midwife, or

(ii) a person acting under the direction of a medical practitioner who holds a specialist registration in anaesthesia, or

(iii) an authorised practitioner, other than a veterinary practitioner, or

(iv) a pharmacist,

(b) for an OTP clinic—the medical practitioner, nurse practitioner, registered nurse, midwife or pharmacist in charge of the OTP clinic,

(c) for a residential care facility—a nurse,

(d) for a managed correctional centre—

(i) the appointed person for the managed correctional centre, or

(ii) an authorised practitioner, other than a veterinary practitioner.

124

Storage requirements for Schedule 8 substances in other places

124 Storage requirements for Schedule 8 substances in other places

(1) A person in possession of a Schedule 8 substance to which section 122 or 123 does not apply must ensure the Schedule 8 substance is stored in accordance with this section.

Maximum penalty—Tier 5 penalty.

(2) The substance must be stored—

(a) in a dedicated room, receptacle or refrigerator, and

(b) on its own, unless—

(i) it is stored with a Schedule 9 substance, or

(ii) it is stored in a refrigerator that only contains scheduled substances.

(3) The dedicated room, receptacle or refrigerator must be kept securely locked when not in immediate use.

(4) A receptacle or refrigerator must—

(a) be securely attached to a part of the premises, and

(b) not be accessible by members of the public.

(5) Storage must comply with the medicine storage standards, including in relation to the receptacle.

(6) An authorised practitioner or a paramedic complies with this section by keeping a substance, kept for emergency use, in a bag that is in a room or vehicle that is kept locked when not occupied by the person.

Note—

See section 130 for storage requirements for a member of staff of the Ambulance Service of NSW.

(7) This section does not apply to a Schedule 8 substance—

(a) lawfully supplied to a person from an authorised practitioner or pharmacist, or

(b) in the custody of a member of the NSW Police Force under the Drug Misuse and Trafficking Act 1985, Part 3A.

125

Responsibility for storage in public hospitals and private health facilities

125 Responsibility for storage in public hospitals and private health facilities

(1) The director of pharmacy of a public hospital or private health facility is responsible for the storage of scheduled substances in the hospital or facility, other than substances that have been supplied to a ward.

(2) If a public hospital or private health facility does not have a director of pharmacy, the chief executive, however described, of the hospital or facility must appoint the director of nursing or the medical superintendent of the hospital or facility to have the responsibilities of the director of pharmacy under subsection (1).

(3) The director of pharmacy, the director of nursing or the medical superintendent of the hospital or facility must ensure scheduled substances are stored in the ward in accordance with this part.

Maximum penalty—Tier 5 penalty.

126

Responsibility for storage in OTP clinics

126 Responsibility for storage in OTP clinics

(1) The medical practitioner, nurse practitioner, registered nurse, midwife or pharmacist in charge of an OTP clinic must ensure scheduled substances are stored in the OTP clinic in accordance with this part.

Maximum penalty—Tier 5 penalty.

(2) The holder of the obtain licence for a private OTP clinic must ensure scheduled substances are stored in the OTP clinic in accordance with this part.

Maximum penalty—Tier 5 penalty.

127

Responsibility for storage in residential care facilities

127 Responsibility for storage in residential care facilities

(1) The authorised person for a residential care facility must ensure scheduled substances are stored at the residential care facility in accordance with this part.

Maximum penalty—Tier 5 penalty.

(2) The approved provider for a residential care facility must ensure scheduled substances are stored at the residential care facility in accordance with this part.

Maximum penalty—Tier 5 penalty.

128

Responsibility for storage in managed correctional centres

128 Responsibility for storage in managed correctional centres

(1) The relevant person for a managed correctional centre under section 123 must ensure scheduled substances are stored at the managed correctional centre in accordance with this part.

Maximum penalty—Tier 5 penalty.

(2) The management company for a managed correctional centre must ensure scheduled substances are stored at the managed correctional centre in accordance with this part.

Maximum penalty—Tier 5 penalty.

129

Responsibility for storage in schools

129 Responsibility for storage in schools

(1) This section applies to the storage of adrenaline, glucagon, glyceryl trinitrate, methoxyflurane, naloxone, nitrous oxide, salbutamol or terbutaline at a government or non-government school under the Education Act 1990.

(2) The principal of the school must ensure the substance is stored in a room or enclosure to which the students of the school do not have access.

Maximum penalty—Tier 5 penalty.

130

Storage requirements for NSW Health Pathology and Ambulance Service of NSW

130 Storage requirements for NSW Health Pathology and Ambulance Service of NSW

(1) Despite another provision of this part, a member of staff of NSW Health Pathology must store a prohibited scheduled substance, prohibited drug or prohibited plant in accordance with the approved pathology standards.

Maximum penalty—Tier 5 penalty.

(2) Despite another provision of this part, a member of staff of the Ambulance Service of NSW must store a scheduled substance in accordance with the approved ambulance protocol.

Maximum penalty—Tier 5 penalty.

Part 14

Labelling of scheduled substances—the Act, ss 55 and 150

Part 14 Labelling of scheduled substances—the Act, ss 55 and 150

131

Application of division

131 Application of division

This division applies to the following persons who supply a scheduled substance (a supplier)—

(a) a manufacturer,

(b) an importer or exporter,

(c) a wholesale or retail supplier,

(d) an authorised practitioner,

(e) a pharmacist.

132

Labelling of scheduled substances

132 Labelling of scheduled substances

(1) A supplier who supplies a scheduled substance must ensure the substance is packaged and labelled in accordance with—

(a) the Commonwealth Poisons Standard, Part 2, Division 2, and

(b) for a substance to which Therapeutic Goods Order No. 95 applies—in accordance with that Order.

Maximum penalty—Tier 5 penalty.

(2) In this section—

Therapeutic Goods Order No. 95 means the Therapeutic Goods Order No. 95 Child-resistant packaging requirements for medicines 2017, as in force from time to time under the Therapeutic Goods Act 1989 of the Commonwealth.

133

Misleading labelling of substances as scheduled substances

133 Misleading labelling of substances as scheduled substances

A supplier must not supply a substance in a container with a label that states or implies the substance is a particular scheduled substance, unless the substance is that particular scheduled substance.

Maximum penalty—Tier 5 penalty.

134

Additional requirements for authorised practitioners and pharmacists

134 Additional requirements for authorised practitioners and pharmacists

(1) This section applies to a supplier who is—

(a) an authorised practitioner, or

(b) a pharmacist in a pharmacy.

(2) A supplier who supplies a scheduled substance must ensure the substance is labelled as required by the Commonwealth Poisons Standard.

Maximum penalty—Tier 5 penalty.

(3) The requirement in the Commonwealth Poisons Standard to include the name, address and telephone number of the dispenser on the label is a requirement to include the name and contact details of the pharmacy from which the substance is supplied, if the supplier is a pharmacist in a pharmacy.

(4) Subsection (2) extends to an authorised practitioner who gives a direction under section 26 to a person for the supply of a Schedule 2, 3, 4 or 8 substance by the person.

135

Additional requirements for Schedule 3 substances

135 Additional requirements for Schedule 3 substances

(1) A supplier, other than a pharmacist, who supplies a Schedule 3 substance, other than by wholesale supply, must ensure the substance is labelled with the supplier’s name and contact details.

Maximum penalty—Tier 5 penalty.

(2) A pharmacist in a pharmacy who supplies a Schedule 3 substance must ensure the substance is supplied in a package that is labelled with the name and contact details of the pharmacy from which the substance is supplied.

Maximum penalty—Tier 5 penalty.

More sections below

Source text: opening excerpt

Sourced from legislation.nsw.gov.au, CC BY 4.0.

Part 1 Preliminary

1 Name of regulation

This regulation is the Medicines, Poisons and Therapeutic Goods Regulation 2026.

2 Commencement

This regulation commences on 5 November 2026.

3 Interpretation

(1) The dictionary in Schedule 4 defines words used in this regulation.

Note—

The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this regulation.

(2) On the making of this regulation, no therapeutic goods were prescribed.

4 Schedule 7 substances

For the Act, sections 16 and 26, a Schedule 7 substance specified in the Commonwealth Poisons Standard, Appendix J is a prescribed Schedule 7 substance.

5 Authorised practitioners

(1) For the Act, Schedule 3, definition of authorised practitioner, paragraph (a)(v), the following classes are prescribed—

(a) midwife practitioners,

(b) nurses, midwives, podiatrists and optometrists with an endorsement, to the extent the endorsement qualifies the nurse, midwife, podiatrist or optometrist to carry out the relevant activity.

Note—

An endorsement may qualify a health practitioner to administer, obtain, possess, prescribe, sell, supply or use a scheduled substance.

(2) Despite subsection (1), nurses, midwives, podiatrists and optometrists with an endorsement are not prescribed as authorised practitioners for the Act, section 24, definition of authorised person, paragraphs (a)(ii) and (c)(ii).

6 Public health entities

(1) For the Act, Schedule 3, definition of public health entity, paragraph (c), the following statutory health corporations are prescribed—

(a) the Justice Health and Forensic Mental Health Network,

(b) The Sydney Children’s Hospitals Network (Randwick and Westmead), incorporating the Royal Alexandra Hospital for Children.