Poisons and Therapeutic Goods Act 1966

This Act may be cited as the Poisons and Therapeutic Goods Act 1966.

In this Act, unless the context or subject matter otherwise indicates or requires—

Advisory Committee means the Poisons Advisory Committee constituted by section 6.

Analyst means an analyst appointed or taken to be appointed under section 37A.

Animal means any animal (other than a human being), whether vertebrate or invertebrate, and includes but is not limited to—

mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs, and

the semen, ova or embryo of an animal (other than a human being) or any other substance or thing directly relevant to the reproduction of an animal (other than a human being).

Applied provisions means the Commonwealth therapeutic goods laws that apply as a law of New South Wales because of section 31.

Australian Register of Therapeutic Goods, for Part 3A—see section 19.

Authority means an authority issued and in force for the purposes of this Act or the regulations.

Automatic machine means any machine or mechanical device used or capable of being used for the purpose of supplying goods without the personal manipulation or attention of the supplier or the supplier’s employee or other agent at the time of supply.

commercial quantity, for Part 3A—see section 19.

Commonwealth Act means the Therapeutic Goods Act 1989 of the Commonwealth.

Commonwealth administrative laws means the following Acts and regulations of the Commonwealth—

the Administrative Review Tribunal Act 2024,

(Repealed)

the Freedom of Information Act 1982,

the Ombudsman Act 1976,

the Privacy Act 1988,

the regulations in force under any of those Acts.

Commonwealth Department means the Department of Human Services and Health or such other Department of the Commonwealth as is the relevant Department for the purposes of the Commonwealth therapeutic goods laws.

Commonwealth Minister means the Minister responsible for administering the Commonwealth therapeutic goods laws.

Commonwealth Secretary means the Secretary of the Commonwealth Department.

Commonwealth therapeutic goods laws means—

the Therapeutic Goods Act 1989 of the Commonwealth, and

all regulations, orders and manufacturing principles in force under that Act.

conformity assessment document, for Part 3A—see section 19.

Container, when used in relation to any substance, material, body or thing referred to in this Act, means any vessel, bottle, tube, capsule, tin, box, case, wrapper, cover or other like receptacle or envelope which immediately contains such substance, material, body or thing.

Drug of addiction means any substance specified in Schedule Eight of the Poisons List.

Label includes any tag, brand, mark or statement in writing on or attached to or used in connection with any container or package containing any poison, restricted substance or drug of addiction.

Licence means a licence issued and in force for the purposes of this Act or the regulations.

Listed goods has the same meaning as in the Commonwealth Act.

Manufacturer’s licence means a licence in force under Part 4 of the Commonwealth Act.

Medical Committee means the Medical Committee constituted under section 30.

Package, when used in relation to any substance, material, body or thing referred to in this Act, includes every means by which such substance, material, body or thing may, for transport or for carriage or for storage or for supply, be cased, covered, enclosed, contained or packed.

Poison means any substance specified in Schedule One, Schedule Two, Schedule Three, Schedule Five, Schedule Six, or Schedule Seven of the Poisons List.

Poisons List means the list proclaimed under section 8 as in force for the time being.

Premises includes any structure, building, aircraft, vehicle, vessel or place (whether built upon or not), and any part thereof.

Prescribed means prescribed by this Act or by the regulations.

Public institution means—

any Public Service agency, public hospital, or university within New South Wales, or

any other institution or establishment which the Governor by order published in the Gazette declares to be a public institution for the purposes of this Act.

Registered goods has the same meaning as in the Commonwealth Act.

Regulated goods means—

any substance of a kind specified in a Schedule of the Poisons List, or

therapeutic goods that are not a substance so specified.

Regulations means regulations made under this Act.

Representation means a verbal representation, a written representation or representation by conduct.

Restricted substance means any substance specified in Schedule Four of the Poisons List.

Schedule 9 substance means any substance specified in Schedule 9 of the Poisons List.

Secretary means the Secretary of the Ministry of Health.

section 41R determination, for Part 3A—see section 19.

section 41RC consent, for Part 3A—see section 19.

Sell includes sell whether by wholesale or retail and barter and exchange, and also includes dealing in, agreeing to sell, or offering or exposing for sale, or keeping or having in possession for sale, or sending, forwarding, delivering or receiving for sale or on sale, or authorising, directing, causing, suffering, permitting or attempting any of such acts or things.

sponsor, for Part 3A—see section 19.

Substance includes preparation or admixture and all salts and derivatives of any substance.

Supply includes—

sell, dispense and distribute, and

supply, whether free of charge or otherwise, by way of sample or advertisement, and

supply, whether free of charge or otherwise, in the course of testing for safety or efficacy on persons or animals, and

agree or offer to sell or distribute, and

keep or have in possession for sale, dispensing or distribution, and

send, forward, deliver or receive for sale, dispensing or distribution, and

authorise, direct, cause, suffer, permit or attempt any act mentioned in paragraphs (a)–(f).

Supply by wholesale, in relation to a substance or goods, means—

supply of the substance or goods for the purposes of resupply, or

supply of an ingredient for the purposes of incorporation in the substance or goods,

and includes supply of the substance or goods in wholesale quantities—

for use in a public institution, or

to persons who are authorised by the regulations to be supplied with wholesale quantities of the substance or goods.

Therapeutic device and Therapeutic goods have the same meanings as in the Commonwealth Act.

Therapeutic use has the same meaning as in the Commonwealth Act.

vaping goods, for Part 3A—see section 19.

Veterinary practitioner has the same meaning as in the Veterinary Practice Act 2003.

Note.

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

For the purposes of the Poisons List, a substance may be described—

by reference to any 1 or more of the following—

the common or scientific name of the substance,

any class of substances,

the composition of the substance,

the purpose for which the substance may be used,

the manner in which the substance is packed, or

such other factor or circumstance as may be specified in relation to the substance in the Poisons List or in any such proclamation,

in any other manner so specified.

Nothing in this Act precludes a substance from being both—

a poison, restricted substance or drug of addiction, and

therapeutic goods.

(Repealed)

The Minister may from time to time, by order published in the Gazette, exempt a local council specified in the order or Local Land Services from all of the provisions of this Act or from such of those provisions as may be specified in the order.

The provisions of subsection (1) do not extend to authorising the Minister to grant an exemption from any of the provisions of this Act to the extent that they relate to restricted substances or drugs of addiction.

Nothing in this Act or the regulations under this Act or in the Commonwealth therapeutic goods laws (to the extent they apply as a law of New South Wales) affects any provision of or made under the Hemp Industry Act 2008 or the Poppy Industry Act 2016 or renders unlawful anything done in accordance with any such provision.

There is constituted by this Act a Poisons Advisory Committee consisting of—

6 nominated members, and

10 members appointed by the Governor.

Of the nominated members—

1 is to be a person for the time being nominated by the Minister, being a person employed in the Ministry of Health or an employee of a public health organisation within the meaning of the Health Services Act 1997,

1 shall be the Head of the Department of Pharmacy, University of Sydney, or a person he or she nominates for the time being,

1 shall be a member of the Police Force for the time being nominated by the Commissioner of Police,

1 is to be a person employed in the Department of Primary Industries and Regional Development for the time being nominated by the Minister for Agriculture,

1 shall be a member of staff of the Environment Protection Authority for the time being nominated by the Minister for the Environment, and

1 is to be a person nominated by the Secretary of the Department of Finance, Services and Innovation, being a person who is employed in the part of the Department that is principally involved in the administration of the Work Health and Safety Act 2011.

Of the members appointed by the Governor—

1 shall be a medical practitioner nominated by the Australian Medical Association (NSW) Limited,

1 shall be a pharmacologist nominated by the Minister,

1 shall be a person nominated by the Minister for Agriculture to represent agricultural and pastoral organisations,

1 shall be a representative of the Proprietary Medicines Association of Australia Incorporated,

1 shall be a representative of the Australian Pharmaceutical Manufacturers Association Inc.,

1 shall be a representative of Avcare Limited,

1 shall be a representative of the Pharmacy Guild of Australia (New South Wales Branch),

1 shall be a representative of The Pharmaceutical Society of Australia (New South Wales Branch) Ltd.,

1 is to be a person representing the country members of The Retail Traders’ Association of New South Wales, and

1 shall be a dentist representing The Australian Dental Association, New South Wales Branch.

Schedule 1 has effect with respect to the members of the Advisory Committee.

Schedule 2 has effect with respect to the procedure of the Advisory Committee.

The Advisory Committee may establish subcommittees to assist it in the exercise of its functions.

Subject to the inclusion of at least 1 member of the Advisory Committee, it does not matter that the members of a subcommittee include persons who are not members of the Advisory Committee.

The procedure for the calling of meetings of a subcommittee and for the conduct of business at those meetings shall be as determined by the Advisory Committee or (subject to any determination of the Advisory Committee) by the subcommittee.

The Advisory Committee may delegate to a subcommittee of the Advisory Committee any of its functions other than—

this power of delegation, and

any function required by the regulations to be exercised only by the Advisory Committee.

The Advisory Committee may initiate and refer to the Minister—

recommendations for making, altering or repealing any regulation under this Act,

recommendations for amending the Poisons List.

It is the duty of the Advisory Committee to consider and advise the Minister upon such matters and questions as the Minister may from time to time refer to it relating to—

any proposal, whether or not initiated by the Committee, for making, altering or repealing any regulations under this Act,

any proposal, whether or not initiated by the Committee, for amending the Poisons List.

The proclamation of the Poisons List in force under this section immediately before the commencement of Schedule 2 to the Poisons (Amendment) Act 1987 continues in force at the commencement as the proclamation of the Poisons List for the purposes of this Act.

The Poisons List shall contain 9 Schedules and the substances included in the list shall be classified as follows—

Schedule One

Substances which are of such extreme danger to life as to warrant their being supplied only by medical practitioners, nurse practitioners authorised under section 17A, midwife practitioners authorised under that section, pharmacists, dentists, veterinary practitioners or persons licensed under Part 3.

Schedule Two

Substances which are dangerous to life if misused or carelessly handled, but which should be available to the public for therapeutic use or other purposes without undue restriction.

Schedule Three

Substances which are for therapeutic use and—

about which personal advice may be required by the user in respect of their dosage, frequency of administration and general toxicity,

with which excessive unsupervised medication is unlikely, or

which may be required for use urgently so that their supply only on the prescription of a medical practitioner or veterinary practitioner would be likely to cause hardship.

Schedule Four

Substances which in the public interest should be supplied only upon the written prescription of a medical practitioner, nurse practitioner authorised to prescribe the substance under section 17A, midwife practitioner authorised to prescribe the substance under that section, dentist, optometrist authorised to prescribe the substance under section 17B, podiatrist authorised to prescribe the substance under section 17C or veterinary practitioner.

Schedule Five

Poisonous substances of a dangerous nature commonly used for domestic purposes which should be readily available to the public but which require caution in their handling, use and storage.

Schedule Six

Substances which should be readily available to the public for agricultural, pastoral, horticultural, veterinary, photographic or industrial purposes or for the destruction of pests.

Schedule Seven

Substances of exceptional danger which require special precautions in their manufacture or use.

Schedule Eight

Substances which are addiction producing or potentially addiction producing.

Schedule Nine

Substances which are specified in Schedule 9 of the current Poisons Standard (within the meaning of Part 6-3 of the Commonwealth Act).

Note.

Substances in Schedule 9 are substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with the approval of Commonwealth or State or Territory Health Authorities. The Poisons Standard is available in electronic form, free of cost, at www.comlaw.gov.au.

(Repealed)

The Poisons List may be amended or replaced by proclamation made on the recommendation of the Minister and published on the NSW legislation website.

An amendment of the Poisons List may be made by applying, adopting or incorporating, with or without modification, provisions of the current Poisons Standard (within the meaning of Part 6-3 of the Commonwealth Act) or any other published standard, as in force at a particular time or as in force from time to time.

Editorial note.

See the Poisons and Therapeutic Goods (Poisons List) Proclamation 2016 and the Therapeutic Goods Act 1989 of the Commonwealth.

A person who supplies by wholesale any poison or restricted substance for therapeutic use, except under, and in accordance with the conditions of, a wholesaler’s licence or authority issued under the regulations is guilty of an offence.

Maximum penalty—

20 penalty units or imprisonment for 2 years, or both, if the offence involves a restricted substance of a kind prescribed by the regulations for the purposes of this section, or

15 penalty units or imprisonment for 6 months, or both, in any other case.

A wholesaler’s licence authorises its holder to supply by wholesale poisons and restricted substances for therapeutic use in or on humans or both in or on humans and in or on animals.

A wholesaler’s authority authorises its holder to supply by wholesale poisons and restricted substances for therapeutic use only in or on animals.

This section does not apply to a poison specified in Schedule 5 or 6 of the Poisons List.

For the purposes of this section—

poisons or restricted substances are taken to be for use in or on animals if the poisons or restricted substances bear information that indicates that they are, or are otherwise represented as being, for use only in or on animals, and

poisons or restricted substances are taken to be for use in or on humans if they are not exclusively for use in or on animals.