New South Wales: Poisons and Therapeutic Goods Act 1966 (NSW)

Poisons and Therapeutic Goods Act 1966 No 31 An Act relating to the regulation, control and prohibition of the supply and use of poisons, restricted substances, drugs of addiction, certain dangerous drugs and certain therapeutic goods; to establish a Poisons Advisory Committee and to define its powers, authorities, duties and functions; to repeal the Poisons Act 1952 and certain other Acts; to amend the Police Offences (Amendment) Act 1908, the Crimes Act 1900, the Motor Traffic Act 1909 and certain other Acts; and for purposes connected therewith. Part 1 Preliminary 1 Name of Act This Act may be cited as the Poisons and Therapeutic Goods Act 1966. 2, 3 (Repealed) 4 Interpretation (1) In this Act, unless the context or subject matter otherwise indicates or requires— Advisory Committee means the Poisons Advisory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— (a) mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs, and (b) 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means the following Acts and regulations of the Commonwealth— (a) the Administrative Appeals Tribunal Act 1975, (b) (Repealed) (c) the Freedom of Information Act 1982, (d) the Ombudsman Act 1976, (e) the Privacy Act 1988, (f) the regulations in force under any of those Acts.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— (a) the Therapeutic Goods Act 1989 of the Commonwealth, and (b) 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— (a) any Public Service agency, public hospital, or university within New South Wales, or (b) 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— (a) any substance of a kind specified in a Schedule of the Poisons List, or (b) 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— (a) sell, dispense and distribute, and (b) supply, whether free of charge or otherwise, by way of sample or advertisement, and (c) supply, whether free of charge or otherwise, in the course of testing for safety or efficacy on persons or animals, and (d) agree or offer to sell or distribute, and (e) keep or have in possession for sale, dispensing or distribution, and (f) send, forward, deliver or receive for sale, dispensing or distribution, and (g) 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— (a) supply of the substance or goods for the purposes of resupply, or (b) 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— (c) for use in a public institution, or (d) 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. (2) For the purposes of the Poisons List, a substance may be described— (a) by reference to any 1 or more of the following— (i) the common or scientific name of the substance, (ii) any class of substances, (iii) the composition of the substance, (iv) the purpose for which the substance may be used, (v) the manner in which the substance is packed, or (vi) such other factor or circumstance as may be specified in relation to the substance in the Poisons List or in any such proclamation, (b) in any other manner so specified. (3) Nothing in this Act precludes a substance from being both— (a) a poison, restricted substance or drug of addiction, and (b) therapeutic goods. (4) (Repealed) 5 Exemption from operation of Act (1) The Minister may from time to time, by order published in the Gazette, exempt a council within the meaning of the Local Government Act 1993 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. (2) 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. 5A Relationship with Hemp Industry Act 2008 and Poppy Industry Act 2016 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. Part 2 Poisons Advisory Committee and Poisons List Division 1 Poisons Advisory Committee 6 Poisons Advisory Committee (1) There is constituted by this Act a Poisons Advisory Committee consisting of— (a) 6 nominated members, and (b) 10 members appointed by the Governor. (2) Of the nominated members— (a) 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, (b) 1 shall be the Head of the Department of Pharmacy, University of Sydney, or a person he or she nominates for the time being, (c) 1 shall be a member of the Police Force for the time being nominated by the Commissioner of Police, (d) 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, (e) 1 shall be a member of staff of the Environment Protection Authority for the time being nominated by the Minister for the Environment, and (f) 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. (3) Of the members appointed by the Governor— (a) 1 shall be a medical practitioner nominated by the Australian Medical Association (NSW) Limited, (b) 1 shall be a pharmacologist nominated by the Minister, (c) 1 shall be a person nominated by the Minister for Agriculture to represent agricultural and pastoral organisations, (d) 1 shall be a representative of the Proprietary Medicines Association of Australia Incorporated, (e) 1 shall be a representative of the Australian Pharmaceutical Manufacturers Association Inc., (f) 1 shall be a representative of Avcare Limited, (g) 1 shall be a representative of the Pharmacy Guild of Australia (New South Wales Branch), (h) 1 shall be a representative of The Pharmaceutical Society of Australia (New South Wales Branch) Ltd., (i) 1 is to be a person representing the country members of The Retail Traders' Association of New South Wales, and (j) 1 shall be a dentist representing The Australian Dental Association, New South Wales Branch. (4) Schedule 1 has effect with respect to the members of the Advisory Committee. (5) Schedule 2 has effect with respect to the procedure of the Advisory Committee. 6A Subcommittees (1) The Advisory Committee may establish subcommittees to assist it in the exercise of its functions. (2) 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. (3) 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. 6B Delegation The Advisory Committee may delegate to a subcommittee of the Advisory Committee any of its functions other than— (a) this power of delegation, and (b) any function required by the regulations to be exercised only by the Advisory Committee. 7 Functions of Advisory Committee (1) The Advisory Committee may initiate and refer to the Minister— (a) recommendations for making, altering or repealing any regulation under this Act, (b) recommendations for amending the Poisons List. (2) 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— (a) any proposal, whether or not initiated by the Committee, for making, altering or repealing any regulations under this Act, (b) any proposal, whether or not initiated by the Committee, for amending the Poisons List. Division 2 Poisons List 8 Poisons List (1) 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. (2) 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— (i) about which personal advice may be required by the user in respect of their dosage, frequency of administration and general toxicity, (ii) with which excessive unsupervised medication is unlikely, or (iii) 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. (3)–(5) (Repealed) (6) The Poisons List may be amended or replaced by proclamation made on the recommendation of the Minister and published on the NSW legislation website. (7) 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. Part 3 Poisons and restricted substances Division 1 Restrictions on supply, possession, etc, of poisons and restricted substances 9 Prohibition on wholesale supply of certain substances for therapeutic use (1) 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— (a) 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 (b) 15 penalty units or imprisonment for 6 months, or both, in any other case. (2) 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. (3) A wholesaler's authority authorises its holder to supply by wholesale poisons and restricted substances for therapeutic use only in or on animals. (4) This section does not apply to a poison specified in Schedule 5 or 6 of the Poisons List. (5) For the purposes of this section— (a) 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 (b) 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. 9A (Repealed) 10 Prohibition on supply of certain substances otherwise than by wholesale (1) A person who supplies otherwise than by wholesale any substance specified in Schedule 1, 2 or 3 of the Poisons List except under, and in accordance with the conditions of, a general supplier's licence or a general supplier's authority issued under the regulations is guilty of an offence. Maximum penalty—15 penalty units or imprisonment for 6 months, or both. (2) Subsection (1) does not apply to a supply— (a) by a medical practitioner, dentist, veterinary practitioner or pharmacist in the lawful practice of his or her profession, or (a1) by a nurse practitioner, who is authorised under section 17A to supply the substance, in the lawful practice of his or her profession as such, or (a2) by an optometrist, who is authorised under section 17B to supply the substance, in the lawful practice of his or her profession as such, or (a3) by a midwife practitioner who is authorised under section 17A to supply the substance in the lawful practice of his or her profession as such, or (a4) by a podiatrist, who is authorised under section 17C to supply the substance, in the lawful practice of his or her profession as such, or (b) by any other person, or person of a class, licensed or authorised by or under this Act to supply the substance. (3) A person who supplies a restricted substance otherwise than by wholesale is guilty of an offence. Maximum penalty— (a) 20 penalty units or imprisonment for 2 years, or both, if the restricted substance involved in the offence is of a kind prescribed by the regulations for the purposes of this section, or (b) 15 penalty units or imprisonment for 6 months, or both, in any other case. (4) Subsection (3) does not apply to a supply of a restricted substance— (a) by a medical practitioner, dentist or veterinary practitioner in the lawful practice of his or her profession, or (a1) by a nurse practitioner, who is authorised under section 17A to supply the substance, in the lawful practice of his or her profession as such, or (a2) by an optometrist, who is authorised under section 17B to supply the substance, in the lawful practice of his or her profession as such, or (a3) by a midwife practitioner who is authorised under section 17A to supply the substance in the lawful practice of his or her profession as such, or (a4) by a podiatrist, who is authorised under section 17C to supply the substance, in the lawful practice of his or her profession as such, or (b) by a pharmacist in accordance with the prescription of a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, podiatrist or veterinary practitioner, or (c) to a patient of a designated hospital, or an inmate of a designated institution, by a person authorised to supply the substance to patients or inmates of the hospital or institution in accordance with the prescription of a medical practitioner, nurse practitioner, midwife practitioner or a dentist, or (c1) by a person who has the care of, or is assisting in the care of, another person (for or to whom the supply of the substance has been authorised by the prescription of a medical practitioner, nurse practitioner, midwife practitioner or dentist) and who administers the restricted substance to the other person in accordance with that prescription, or (d) by any other person, or person of a class, licensed or authorised by or under this Act to supply the substance. (5) The Secretary may at any time revoke an authorisation or designation given for the purposes of subsection (4) (c) for any reason that the Secretary considers appropriate. (6) As soon as practicable after revoking such an authorisation or designation, the Secretary must notify the revocation in writing to the person, hospital or institution concerned. The notice must specify the reason for the revocation. (7) In this section— authorised means authorised by the Secretary, either specifically or as a member of a class. designated hospital means a hospital, or a hospital of a class, designated in writing by the Secretary. designated institution means an institution, or an institution of a class, designated in writing by the Secretary. 11 Restriction on wholesale supply of certain substances (1) A holder of a wholesaler's licence or a wholesaler's authority who supplies to a person other than an authorised person— (a) a substance specified in Schedule 1, 2, 3 or 7 of the Poisons List, or (b) a restricted substance, is guilty of an offence. Maximum penalty— (a) 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 (b) 15 penalty units or imprisonment for 6 months, or both, in any other case. (2) In this section, authorised person means— (a) a medical practitioner, dentist, veterinary practitioner or pharmacist, or (a1) a nurse practitioner authorised under section 17A to supply or use, or have possession of, the substance concerned, or (a2) an optometrist authorised under section 17B to supply or use, or have possession of, the substance concerned, or (a3) a midwife practitioner authorised under section 17A to supply or use, or have possession of, the substance concerned, or (a4) a podiatrist authorised under section 17C to supply or use, or have possession of, the substance concerned, or (b) a holder of a manufacturer's licence, a wholesaler's licence or a wholesaler's authority, or (c) a holder of a general supplier's licence or a general supplier's authority, or (d) any other person licensed or authorised by or under this Act to supply or use, or have possession of, the substance concerned. 12 Obtaining substances by false representation (1) A person who, by a representation that the person knows, or ought reasonably to know, is false or misleading in a material respect, obtains, or attempts to obtain, from an authorised person— (a) a substance specified in Schedule 1, 2, 3 or 7 of the Poisons List, or (b) a restricted substance, is guilty of an offence. Maximum penalty—10 penalty units or imprisonment for 6 months, or both. (2) In this section, authorised person means— (a) a medical practitioner, dentist, veterinary practitioner or pharmacist, or (a1) a nurse practitioner authorised under section 17A to supply or use, or have possession of, the substance concerned, or (a2) an optometrist authorised under section 17B to supply or use, or have possession of, the substance concerned, or (a3) a midwife practitioner authorised under section 17A to supply or use, or have possession, of, the substance concerned, or (a4) a podiatrist authorised under section 17C to supply or use, or have possession of, the substance concerned, or (b) a holder of a manufacturer's licence, a wholesaler's licence or a wholesaler's authority, or (c) a holder of a general supplier's licence or a general supplier's authority, or (d) any other person licensed or authorised by or under this Act to supply or use, or have possession of, the substance concerned. 13–15 (Repealed) 16 Offences relating to prescribed restricted substances (1) A person shall not have in his or her possession or attempt to obtain possession of a prescribed restricted substance unless— (a) the person is a medical practitioner, pharmacist, dentist or veterinary practitioner, and the person obtains possession or attempts to obtain possession of it in the lawful practice of the person's profession as such, (a1) the person is a nurse practitioner who is authorised under section 17A to possess the substance and the person obtains possession or attempts to obtain possession of it in the lawful practice of his or her profession, (a2) the person is an optometrist who is authorised under section 17B to possess the substance and the person obtains possession or attempts to obtain possession of it in the lawful practice of his or her profession, (a3) the person is a midwife practitioner who is authorised under section 17A to possess the substance and the person obtains possession or attempts to obtain possession of it in the lawful practice of his or her profession, (a4) the person is a podiatrist who is authorised under section 17C to possess the substance and the person obtains possession or attempts to obtain possession of it in the lawful practice of his or her profession, (b) the person obtains possession or attempts to obtain possession of it on and in accordance with the prescription of a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, podiatrist or veterinary practitioner for its supply to the person, (c) the person is a person or belongs to a class of persons authorised by the Secretary for the purposes of section 10 (4) (c), (d) the person is a person authorised in writing by the Secretary to obtain possession of the prescribed restricted substance for the purposes of the person's profession or employment and obtains, or attempts to obtain, as the case may be, possession of the prescribed restricted substance in accordance with any conditions subject to which the person is so authorised, (d1) the person is a person who has the care of, or is assisting in the care of, another person (for or to whom the supply of the substance has been authorised by the prescription of a medical practitioner, nurse practitioner, midwife practitioner, optometrist, podiatrist or dentist) and has the prescribed restricted substance in his or her possession for the sole purpose of administering, or assisting in the self-administration of, the substance to the other person in accordance with that prescription, or (e) the person is licensed or otherwise authorised by this Act or the regulations to obtain possession of the substance for the purposes of his or her profession or employment. Maximum penalty— (a) for an offence relating to a prescribed restricted substance that is an anabolic or androgenic steroidal agent, 20 penalty units or imprisonment for 2 years, or both, and (b) for an offence relating to a prescribed restricted substance other than an anabolic or androgenic steroidal agent, 20 penalty units or imprisonment for 6 months, or both. (2) A person shall not forge or fraudulently alter, or utter, knowing it to be forged or fraudulently altered, any prescription of a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, podiatrist or veterinary practitioner including any prescribed restricted substance. Maximum penalty—20 penalty units or imprisonment for 6 months, or both. (3) A person who— (a) by a representation that the person knows, or ought reasonably to know, is false or misleading— (i) obtains, or attempts to obtain, from a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, podiatrist or veterinary practitioner a prescription that includes a restricted substance of a kind prescribed by the regulations for the purposes of this section, or (ii) induces, or attempts to induce, a pharmacist to dispense a prescription that includes such a substance, knowing the prescription to be forged or fraudulently altered, or (iii) induces, or attempts to induce, a pharmacist to dispense a prescription that includes such a substance, knowing the prescription to have been obtained as referred to in subparagraph (i), or (b) is in actual possession of a prescription that includes such a substance, knowing the prescription to be forged or fraudulently altered, or (c) is in actual possession of a prescription obtained as referred to in paragraph (a) (i), knowing the prescription to be so obtained, is guilty of an offence. Maximum penalty—20 penalty units or imprisonment for 6 months, or both. (4) Any prescribed restricted substance in the order or disposition of a person shall, for the purposes of subsection (1), be deemed to be in the person's possession. (5) A person shall not be guilty of an offence against subsection (1) by virtue of the person having in his or her possession, or attempting to obtain possession of, a prescribed restricted substance if the person proves that he or she had possession, or attempted to obtain possession, of the substance only for the purpose of delivering it— (a) to a medical practitioner, nurse practitioner, midwife practitioner, pharmacist, dentist, optometrist, podiatrist or veterinary practitioner, or (b) to a person to whom its supply has been authorised by the prescription of a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, podiatrist or veterinary practitioner. 17 Regulations under Part 3 (1) Without limiting the generality of section 45C, the Governor may make regulations under this Part for or with respect to— (a) the issue, renewal, refusal to issue or renew, suspension and cancellation of licences and authorities for the purposes of this Part and the conditions subject to which licences or authorities may be issued or renewed for those purposes, (a1) fixing the fees to be paid in respect of any licence issued or renewed under this Part, (b) the colouring of any poisons and restricted substances, (c) the conditions under which poisons and restricted substances shall be supplied, disposed of, obtained, stored, kept or used, (d) the shape, size, colour and materials of, and method of sealing, the container or package in which any poison or restricted substance shall or shall not be supplied, (e) requiring the container or package in which any prescribed poison or restricted substance is cased, covered, enclosed, contained or packed for supply to have printed thereon or on the label affixed or attached thereto such particulars as may be prescribed, (f) the conditions under which any proprietary preparation for use as a sheep or cattle dip, or for agricultural, pastoral, veterinary, piscicultural or horticultural purposes or as a vermicide shall be exempt from the operation of the provisions of this Part or any regulations made under this Part, (g) requiring persons engaged in the supply of any poison or restricted substance to keep records and furnish to any prescribed person information (whether in writing or otherwise), (h) the issue of prescriptions or orders for any poison or restricted substance, the dispensing of such prescriptions and the supply of poisons and any such substance on such a prescription or order, (i) prohibiting or regulating the free distribution of any poison or restricted substance, (j) (Repealed) (j1) prohibiting or regulating the administering, otherwise than on the order of a medical practitioner, nurse practitioner, midwife practitioner, optometrist, podiatrist or dentist, of any restricted substance prescribed for the purposes of section 16. (k) (Repealed) (2) A regulation made under this Part may apply— (a) to all poisons and restricted substances, to any poison or restricted substance specified in the regulation or to all poisons and restricted substances other than those so specified, and (b) to all persons, to persons or classes of persons specified in the regulation, or to all persons other than persons or classes of persons so specified. 17A Authorisation of possession, use, supply or prescription of substances by nurses and midwives (1) A nurse is authorised to possess, use, supply or prescribe a poison, restricted substance or drug of addiction for the purposes of the practice of nursing, if— (a) the nurse's registration has an endorsement of a kind referred to in section 94 of the Health Practitioner Regulation National Law (NSW) that qualifies the nurse to possess, use, supply or prescribe that poison, restricted substance or drug of addiction, or (b) the nurse is a nurse practitioner who is authorised in writing by the Secretary to possess, use, supply or prescribe that poison, restricted substance or drug of addiction. (2) A midwife is authorised to possess, use, supply or prescribe a poison, restricted substance or drug of addiction for the purposes of the practice of midwifery, if— (a) the midwife's registration has an endorsement of a kind referred to in section 94 of the Health Practitioner Regulation National Law (NSW) that qualifies the midwife to possess, use, supply or prescribe that poison, restricted substance or drug of addiction, or (b) the midwife is a midwife practitioner who is authorised in writing by the Secretary to possess, use, supply or prescribe that poison, restricted substance or drug of addiction. 17B Authorisation of possession, use, supply or prescription of substances by optometrists An optometrist whose registration has an endorsement of a kind referred to in section 94 of the Health Practitioner Regulation National Law (NSW) that qualifies the optometrist to possess, use, supply or prescribe a poison or restricted substance is authorised to possess, use, supply or prescribe that poison or restricted substance for the purposes of the practice of optometry. 17C Authorisation of possession, use, supply or prescription of substances by podiatrists A podiatrist whose registration has an endorsement of a kind referred to in section 94 of the Health Practitioner Regulation National Law (NSW) that qualifies the podiatrist to possess, use, supply or prescribe a poison or restricted substance is authorised to possess, use, supply or prescribe that poison or restricted substance for the purposes of the practice of podiatry. 17D Authorisation of use etc of Schedule 9 substances for research and similar purposes (1) The Secretary may, by order in writing, authorise a specified person or class of persons to manufacture, possess, use or supply a specified Schedule 9 substance (not being a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985) for medical or scientific research, analytical, teaching or training purposes or for industrial or commercial purposes. (2) The authorisation may be given unconditionally or subject to conditions. 18 Offence to fail to comply with condition of licence or authority A person who fails to comply with a condition of a licence or authority issued for the purposes of this Part is guilty of an offence. Maximum penalty— (a) 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 (b) 15 penalty units or imprisonment for 6 months, or both, in any other case. 18AA Secretary may restrict possession or supply (1) In this section, relevant person means a medical practitioner, a nurse, a midwife, a dentist, an optometrist, a pharmacist, a podiatrist or a veterinary practitioner. (2) The Secretary may, by order in writing served on a relevant person, prohibit or restrict the person from possessing, supplying or prescribing a substance specified in Schedule 2, 3 or 4 of the Poisons List that the person— (a) possesses, supplies or prescribes in the practice of the person's profession as a relevant person, or (b) is licensed or authorised by or under this Act to possess, supply or prescribe. (3) Such an order may be made for any one or more of the following reasons— (a) the person has requested or agreed in writing to the making of the order, (b) the person is convicted of an offence against this Act or the regulations made under this Act, or of an offence against the Drug Misuse and Trafficking Act 1985 or the regulations made under that Act, or an order has been made against the person under section 10 (1) of the Crimes (Sentencing Procedure) Act 1999 in respect of such an offence, (c) the person has, in the opinion of the Secretary, failed to comply with any prohibition, restriction or condition imposed on the person by an order under this section, (d) the person is, in the opinion of the Secretary, a person who should be restricted or prohibited from possessing, supplying or prescribing such a substance for the purpose of protecting the life, or the physical or mental health, of that or any other person (whether or not any other such person is identifiable). (4) An order that restricts a person as referred to in subsection (2)— (a) may be made unconditionally or subject to conditions, and (b) may apply generally or be limited in its application by reference to specified exceptions or factors, and (c) may apply differently according to different factors of a specified kind. (5) An order under this section must specify the grounds on which it is made. (6) An order under this section takes effect— (a) in the case of an order made on the grounds referred to in subsection (3) (d), when the order is served on the person against whom it is made, or (b) in any other case, on the date specified in the order in that regard. (7) Except in the case of an order that is made on the ground referred to in subsection (3) (a), the date referred to in subsection (6) (b) must be a date occurring not less than 14 days after the date on which the order is served on the person against whom it is made. (8) A person must not contravene any order in force under this section. Maximum penalty—20 penalty units. 18A Evidentiary provisions (1) A person who has actual possession of a quantity of a prescribed restricted substance exceeding the quantity prescribed for the purposes of this subsection is, for the purposes of any proceedings for an offence involving the supply of a quantity of that substance, taken to have possession of the substance for the purposes of supply unless the person— (a) proves the contrary, or (b) proves that the possession of the substance was obtained in accordance with the prescription of a medical practitioner, nurse practitioner, midwife practitioner, optometrist, podiatrist, dentist or veterinary practitioner. (2) A substance that, for the purpose of being supplied, is represented as being a particular prescribed restricted substance is taken to be that particular restricted substance for the purposes of any proceedings for an offence involving the supply of a prescribed restricted substance. (3) In this section, prescribed restricted substance means a restricted substance prescribed by the regulations for the purposes of section 16. Division 1A Substances and goods used for cosmetic and other purposes 18B Object of Division The object of this Division is to prescribe requirements in respect of certain substances and goods that may be used for cosmetic and other purposes. 18C Substances and goods to which Division applies This Division applies to the following— (a) botulinum toxins for human use, (b) hyaluronic acid and its polymers in preparations for injection or implantation, (c) any other substance specified in Schedule 2, Schedule 3, Schedule 4 or Schedule 8 of the Poisons List that is prescribed by the regulations, (d) any therapeutic goods prescribed by the regulations. 18D Regulation of substances and goods to which Division applies (1) The regulations may prescribe requirements in respect of the possession, manufacture, supply, use, prescription, administration, storage and disposal of any substance or goods to which this Division applies. (2) A person who contravenes a requirement prescribed for the purposes of this section and identified in the regulations as a category 1 requirement or a category 2 requirement is guilty of an offence. Maximum penalty— (a) in the case of a requirement identified in the regulations as a category 1 requirement—1,000 penalty units in the case of a body corporate or 200 penalty units or imprisonment for 6 months (or both) in the case of an individual, or (b) in the case of a requirement identified in the regulations as a category 2 requirement—250 penalty units in the case of a body corporate or 50 penalty units in any other case. Division 2 (Repealed) Part 3A Vaping goods Division 1 Preliminary 19 Definitions In this part— Australian Register of Therapeutic Goods means the Australian Register of Therapeutic Goods kept under the Commonwealth therapeutic goods laws. commercial quantity, of a kind of vaping goods, has the same meaning as in the Commonwealth Act. conformity assessment document has the same meaning as in the Commonwealth Act. section 41R determination means a determination made by the Commonwealth Minister under the Commonwealth Act, section 41R authorising the supply or possession of vaping goods. section 41RC consent means a consent given by the Commonwealth Secretary under the Commonwealth Act, section 41RC(1) to manufacture, supply or possess vaping goods. sponsor, in relation to therapeutic goods, has the same meaning as in the Commonwealth Act. vaping goods has the same meaning as in the Commonwealth Act. Division 2 Regulation of supply and possession of vaping goods 20 Prohibition on supplying vaping goods (1) A person who supplies vaping goods in New South Wales is guilty of an offence. Maximum penalty—7 years imprisonment or 14,000 penalty units, or both. (2) A person who supplies vaping goods in New South Wales is guilty of a strict liability offence. Maximum penalty—560 penalty units. (3) Subsections (1) and (2) do not apply if— (a) subsections (4)–(6) apply in relation to the supply of the vaping goods by the person, or Note— Subsections (4)–(6) together apply in relation to wholesale supply of vaping goods. (b) subsections (4), (7) and (8) apply in relation to the supply of the vaping goods by the person. Note— Subsections (4), (7) and (8) together apply in relation to retail supply of vaping goods. (4) This subsection applies in relation to the supply of vaping goods by the person if— (a) the vaping goods are therapeutic goods included in the Australian Register of Therapeutic Goods, or (b) both of the following apply— (i) the vaping goods are therapeutic goods— (A) that are exempt goods under regulations made under the Commonwealth Act, section 18(1) or an exempt device under regulations made under the Commonwealth Act, section 41HA(1), and (B) in relation to which the sponsor has given the Commonwealth Secretary a notice in compliance with the exemption, (ii) the vaping goods are not the subject of a determination by the Commonwealth Secretary, published on the Commonwealth Department's website, that the supply of the goods be stopped or should be stopped because the Commonwealth Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods, or (c) the vaping goods are covered by a section 41R determination. (5) This subsection applies in relation to the supply of the vaping goods by the person if— (a) the person is— (i) the holder of a licence or permission, granted under regulations made under the Customs Act 1901 of the Commonwealth, section 50 to import the vaping goods, or (ii) otherwise approved under those regulations to import the vaping goods, or (b) the person is the holder of a licence under the Commonwealth Act, Part 3-3 that— (i) is in force, and (ii) authorises a step in the manufacture of the vaping goods, or (c) the person is the holder of a conformity assessment document that applies to the vaping goods, or (d) both of the following apply— (i) the person is a wholesaler who is the holder of a licence or authority, or is otherwise authorised, under this Act to supply one or more substances included in the Poisons List, Schedule 3, (ii) the supply is in accordance with the licence or authority, or (e) both of the following apply— (i) the person has been given a section 41RC consent to supply the vaping goods, (ii) the supply is in accordance with the consent, or (f) if the vaping goods are covered by a section 41R determination— (i) the person is specified in the determination, or is included in a class of persons specified in the determination, in relation to the vaping goods, and (ii) the supply is in accordance with the determination. (6) This subsection applies in relation to the supply of the vaping goods by the person if— (a) the person (the recipient) to whom the vaping goods are supplied is the holder of a licence under the Commonwealth Act, Part 3-3 that— (i) is in force, and (ii) authorises a step in the manufacture of the vaping goods, or (b) the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in the Poisons List, Schedule 3 under a law of the State or Territory in which the recipient carries on a business, practises or is employed, or (c) the recipient has been given a section 41RC consent to supply the vaping goods, or (d) if the vaping goods are covered by a section 41R determination—the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to the vaping goods. (7) This subsection applies in relation to the supply of the vaping goods by the person if the person is a pharmacist, medical practitioner or nurse practitioner. (8) This subsection applies in relation to the supply of the vaping goods by the person if— (a) the supply is— (i) to another person for use by the other person for smoking cessation, management of nicotine dependence or another indication determined by the Commonwealth Minister under the Commonwealth Act, section 41RA, or (ii) to another person, who is the carer of a third person, for use by the third person for smoking cessation, management of nicotine dependence or another indication determined by the Commonwealth Minister under the Commonwealth Act, section 41RA, and (b) if the vaping goods are, or contain, a vaping substance—the vaping substance is in final dosage form, and (c) the supply is— (i) apart from this section, otherwise in accordance with this Act, and (ii) consistent with the person's authority to supply the vaping goods under a law of New South Wales. (9) For the purposes of paragraph (8)(b), a vaping substance is in final dosage form if the vaping substance is in a form that can be administered to a person without any change or modification other than vaporisation. 21 Prohibition on possession of vaping goods—commercial quantities (1) A person is guilty of an offence if— (a) the person possesses a quantity of a kind of vaping goods in New South Wales, and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of the kind of vaping goods. Maximum penalty—2 years imprisonment or 2,800 penalty units, or both. (2) A person is guilty of a strict liability offence if— (a) the person possesses a quantity of a kind of vaping goods in New South Wales, and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of the kind of vaping goods. Maximum penalty—330 penalty units. (3) A person is guilty of an offence if— (a) the person possesses a quantity of a kind of vaping goods in New South Wales, and (b) the quantity is at least 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of the kind of vaping goods. Maximum penalty—4 years imprisonment or 8,400 penalty units, or both. (4) A person is guilty of a strict liability offence if— (a) the person possesses a quantity of a kind of vaping goods in New South Wales, and (b) the quantity is at least 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of the kind of vaping goods. Maximum penalty—670 penalty units. (5) A person is guilty of an offence if— (a) the person possesses a quantity of a kind of vaping goods in New South Wales, and (b) the quantity is at least 1,000 times the commercial quantity of the kind of vaping goods. Maximum penalty—7 years imprisonment or 14,000 penalty units, or both. (6) A person is guilty of a strict liability offence if— (a) the person possesses a quantity of a kind of vaping goods in New South Wales, and (b) the quantity is at least 1,000 times the commercial quantity of the kind of vaping goods. Maximum penalty—1,170 penalty units. (7) Subsections (1) and (2) do not apply in relation to the possession of the vaping goods by the person if— (a) the vaping goods have been lawfully supplied to the person, and (b) the vaping goods are for use by the person personally, and (c) the quantity of the vaping goods is less than 5 times the commercial quantity of the kind of vaping goods. (8) Subsections (1)–(6) do not apply if subsections (9) and (10) apply in relation to the possession of the vaping goods by the person. (9) This subsection applies in relation to the possession of the vaping goods by the person if— (a) the vaping goods are therapeutic goods included in the Australian Register of Therapeutic Goods, or (b) both of the following apply— (i) the vaping goods are therapeutic goods— (A) that are exempt goods under regulations made under the Commonwealth Act, section 18(1) or an exempt device under regulations made under the Commonwealth Act, section 41HA(1), and (B) in relation to which the sponsor has given the Commonwealth Secretary a notice in compliance with the exemption, (ii) the vaping goods are not the subject of a determination by the Commonwealth Secretary, published on the Commonwealth Department's website, that the supply of the goods be stopped or should be stopped because the Commonwealth Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods, or (c) the vaping goods are covered by a section 41R determination. (10) This subsection applies in relation to the possession of the vaping goods by the person if— (a) the person— (i) is the holder of a licence or permission, granted under regulations made under the Customs Act 1901 of the Commonwealth, section 50, to import the vaping goods, or (ii) is otherwise approved under those regulations to import the vaping goods, or (b) the person is the holder of a licence under the Commonwealth Act, Part 3-3 that— (i) is in force, and (ii) authorises a step in the manufacture of the vaping goods, or (c) the person is the holder of a conformity assessment document that applies to the vaping goods, or (d) both of the following apply— (i) the person is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, under this Act to supply one or more substances included in the Poisons List, Schedule 3, (ii) the possession of the vaping goods is in accordance with the licence or authority, or (e) both of the following apply— (i) the person has been given a section 41RC consent to possess the vaping goods, (ii) the possession of the vaping goods is in accordance with the consent, or (f) if the vaping goods are covered by a section 41R determination— (i) the person is specified in the determination, or is included in a class of persons specified in the determination, in relation to the vaping goods, and (ii) the possession of the vaping goods is in accordance with the determination. 22 Prohibition on possession of vaping goods—less than commercial quantities (1) A person is guilty of an offence if— (a) the person is a retailer in relation to retail premises in New South Wales, and (b) the person possesses a quantity of a kind of vaping goods at the retail premises, and (c) the quantity is less than the commercial quantity of the kind of vaping goods. Maximum penalty—12 months imprisonment or 1,400 penalty units, or both. (2) A person is guilty of a strict liability offence if— (a) the person is a retailer in relation to retail premises in New South Wales, and (b) the person possesses a quantity of a kind of vaping goods at the retail premises, and (c) the quantity is less than the commercial quantity of the kind of vaping goods. Maximum penalty—160 penalty units. (3) Subsections (1) and (2) do not apply if subsections (4) and (5) apply in relation to the possession of the vaping goods by the person. (4) This subsection applies in relation to the possession of the vaping goods by the person if— (a) the vaping goods are therapeutic goods included in the Australian Register of Therapeutic Goods, or (b) both of the following apply— (i) the vaping goods are therapeutic goods— (A) that are exempt goods under regulations made under the Commonwealth Act, section 18(1) or an exempt device under regulations made under the Commonwealth Act, section 41HA(1), and (B) in relation to which the sponsor has given the Commonwealth Secretary a notice in compliance with the exemption, (ii) the vaping goods are not the subject of a determination by the Commonwealth Secretary, published on the Commonwealth Department's website, that the supply of the goods be stopped or should be stopped because the Commonwealth Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods, or (c) the vaping goods are covered by a section 41R determination. (5) This subsection applies in relation to the possession of the vaping goods by the person if— (a) both of the following apply— (i) the person is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, under this Act to supply one or more substances included in the Poisons List, Schedule 3, (ii) the possession of the vaping goods is in accordance with the licence or authority, or (b) both of the following apply— (i) the person has been given a section 41RC consent to possess the vaping goods, (ii) the possession of the vaping goods is in accordance with the consent, or (c) if the vaping goods are covered by a section 41R determination— (i) the person is specified in the determination, or is included in a class of persons specified in the determination, in relation to the vaping goods, and (ii) the possession of the vaping goods is in accordance with the determination. (6) Subsections (1) and (2) do not apply in relation to the possession of the vaping goods by the person if— (a) the vaping goods are for use by the person personally, and (b) the quantity of the vaping goods is not more than the permitted quantity of the kind of vaping goods. (7) In this section— permitted quantity, of a kind of vaping goods, has the same meaning as in the Commonwealth Act, section 41QD(10). retail premises means either of the following types of premises, whether or not the premises are used wholly or predominantly for the relevant purpose— (a) premises from which goods or services are available for supply, or are supplied, to a consumer, or (b) premises that are used in connection with the supply of goods or services to a consumer. retailer, in relation to retail premises in New South Wales, means the following— (a) an owner, lessee or occupier of the retail premises, (b) a person conducting a business or undertaking at, or in connection or association with, the retail premises, (c) a director, officer or agent of a person referred to in paragraph (a) or (b), (d) a person performing work in any capacity, including an employee or a contractor, for, or on behalf of, a person referred to in paragraph (a), (b) or (c) at or in connection with the retail premises. Part 4 Drugs of addiction Division 1 Restrictions on possession, manufacture, supply, etc, of drugs of addiction 23 Possession and supply of drugs of addiction by carers Despite any other provision of or made under this or any other Act, a person who has the care of, or is assisting in the care of, another person (for or to whom the supply of a drug of addiction has been authorised by the prescription of a medical practitioner, nurse practitioner, midwife practitioner or dentist) is not guilty of an offence in relation to the possession or supply of the drug if the person is in possession of the drug for the sole purpose of administering, or assisting in the self-administration of, the drug to the other person and does so in accordance with that prescription. 24 Regulations under Division 1 of Part 4 (1) Without limiting the generality of section 45C, the Governor may, for the purpose of preventing the improper use of drugs of addiction, make regulations under this Division for or with respect to— (a) prohibiting the manufacture of any drug of addiction except on premises licensed for the purpose and subject to the conditions specified in the licence, (b) prohibiting the manufacture or supply of any such drug except by persons licensed or otherwise authorised under the regulations and subject to any conditions specified in the licence or authority, (c) prohibiting the issue by persons other than medical practitioners, nurse practitioners, midwife practitioners, dentists or veterinary practitioners of prescriptions containing any such drug, (d) prohibiting or regulating the issue by medical practitioners, nurse practitioners, midwife practitioners, dentists or veterinary practitioners of prescriptions containing any such drug, the dispensing of such prescriptions, and the supply of any such drugs thereunder, (e) requiring persons engaged in the manufacture or supply of any such drug to keep such books and furnish such information either in writing or otherwise to such persons as may be prescribed, and making provision for the inspection of such books and records by prescribed persons, (f) fixing the fees to be paid in respect of any