See also— Health Legislation Amendment (Miscellaneous) Bill 2023
(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.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.Commonwealth Act means theof the Commonwealth. Therapeutic Goods Act 1989 Commonwealth administrative laws means the following Acts and regulations of the Commonwealth:
(a) the , Administrative Appeals Tribunal Act 1975 (b) (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 of the Commonwealth, and Therapeutic Goods Act 1989 (b) all regulations, orders and manufacturing principles in force under that Act. 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.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.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 andTherapeutic goods have the same meanings as in the Commonwealth Act.Therapeutic use has the same meaning as in the Commonwealth Act.Veterinary practitioner has the same meaning as in the. Veterinary Practice Act 2003 Note— The contains definitions and other provisions that affect the interpretation and application of this Act. Interpretation Act 1987
(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.
(1) The proclamation of the Poisons List in force under this section immediately before the commencement of Schedule 2 to the continues in force at the commencement as the proclamation of the Poisons List for the purposes of this Act. Poisons (Amendment) Act 1987 (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.
(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.
(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.
(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.
(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 or the regulations made under that Act, or an order has been made against the person under section 10 (1) of the Drug Misuse and Trafficking Act 1985 in respect of such an offence, Crimes (Sentencing Procedure) Act 1999 (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).
(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 licence, inspection, permit, or authority made or issued under the regulations, (g) providing for the forfeiture of any such drug unlawfully in the possession of any person, (h) providing that any specified breach of the regulations shall be regarded as “misconduct in a professional respect” within the meaning of any Act, (h1) prohibiting or regulating the administering, otherwise than on the order of a medical practitioner, nurse practitioner, midwife practitioner or dentist, of any drug of addiction, and (i) generally, regulating and controlling the manufacture, possession and supply of drugs of addiction. (j)
(1) Every person guilty of an offence against this Division shall in respect of each offence be liable to a fine not exceeding 20 penalty units or to imprisonment for a term not exceeding 2 years, or to both such fine and imprisonment, and the court convicting any such person may order that any article in respect of which the offence was committed shall be forfeited to Her Majesty. (2) The court before which the offender was convicted of an offence against this Division may order any forfeited articles to be destroyed or otherwise disposed of as the court thinks fit.
(1) A medical practitioner or nurse practitioner must not, without the proper authority, prescribe for or supply to any person a type A drug of addiction. (2) A medical practitioner or nurse practitioner must not, without the proper authority, prescribe or supply a type B drug of addiction:
(a) for continuous therapeutic use by a person for a period exceeding 2 months, or (b) for a period that, together with any other period for which that drug or any other type B drug of addiction has been prescribed or supplied by the medical practitioner or nurse practitioner or has, to the medical practitioner’s or nurse practitioner’s knowledge, been prescribed or supplied by any other medical practitioner or nurse practitioner, would result in that drug, or that drug together with any other such drug, being prescribed or supplied for continuous therapeutic use for a period exceeding 2 months.
(1) The Secretary may, on the recommendation of the Medical Committee, approve a medical practitioner as a prescriber of drugs of addiction. (2) Application for such an approval must be made to the Secretary in writing and must be referred by the Secretary to the Medical Committee for its recommendation. (3) An applicant must provide the Secretary:
(a) in the application, and (b) before approval of the application, with such information relevant to the application as the Secretary requires. (4) The Secretary may give an unconditional approval or an approval subject to specified conditions.
(1) An application for the authority of the Secretary referred to in section 28 is to be in a form approved by the Secretary. (2) Any such application may be referred by the Secretary to the Medical Committee. (3) The Secretary may give an authority for the medical practitioner or nurse practitioner by whom any such application is made to prescribe for or supply to the person to whom the application relates any drug of addiction specified in that authority for the purpose of the treatment of that person.
(1) The Minister shall constitute a Medical Committee for the purposes of this Division.
(1) This section applies if:
(a) under section 28A (8) or 29 (8) the Secretary refers an approval or an authority to the Medical Committee for review, and (b) the review of the approval or authority is with respect to a possible contravention of this Act or the regulations, or a failure to comply with any conditions to which the approval or authority is subject. (2) For the purposes of conducting the review and preparing its report and the recommendation, the Medical Committee may require the Health Care Complaints Commission, the Medical Council of New South Wales, the Medical Board of Australia, the Nursing and Midwifery Council of New South Wales or the Nursing and Midwifery Board of Australia to provide the Medical Committee with any information in the Commission’s, Council’s or Board’s possession that is relevant to the Medical Committee’s review.
(1) The Commonwealth administrative laws apply as laws of New South Wales to any matter arising in relation to the applied provisions as if those provisions were a law of the Commonwealth and not a law of New South Wales.
(1) A person who:
(a) goes from house to house supplying regulated goods, or (b) while in a public street or other public place, supplies regulated goods, is guilty of an offence. Maximum penalty: 20 penalty units.
(1) The Secretary may, by notice served on a person who manufactures in, imports into or supplies in New South Wales any regulated goods, require the person to give to the Secretary, or to such other person as may be identified in the notice, such information about the substance or goods as is specified in the notice. Such a notice may specify a period of not less than 14 days within which the requirement of the notice is to be complied with.
(1) A person who, whether in premises under the person’s control or elsewhere:
(a) installs an automatic machine for the supply of regulated goods, or (b) supplies regulated goods by means of an automatic machine, is guilty of an offence. Maximum penalty: 20 penalty units.
(1) The Minister may appoint particular persons or a class of persons to be analysts for the purposes of this Act.
(1) An inspector may submit for analysis under this section any substance or goods seized under this Act.
(1) The Secretary may, in writing, appoint a person to be an inspector for the purposes of this Act. (2) An appointment under this section may authorise the exercise of all the functions of an inspector under this Act or only specified functions and may authorise the exercise of functions generally or in a particular case.
(1) This section applies to:
(a) regulated goods that are for supply or are (whether or not the goods are to be the subject of further manufacture) intended for supply, or (b) goods that an inspector reasonably believes to be regulated goods referred to in paragraph (a). (2) For the purpose of ascertaining whether the provisions of this Act or the regulations, or any condition of an approval, authority or licence given or issued for the purposes of this Act or the regulations, are being complied with, an inspector may do any of the following:
(a) enter any premises that the inspector reasonably believes to be used in or in connection with the manufacture, distribution, conveyance, storage, handling or supply of goods to which this section applies, (b) search those premises, (c) require the production of stocks of any such goods that are kept on those premises and any record relating to the keeping of, or dealings with, those stocks, (d) inspect stocks, and inspect and make copies of a record, or part of a record, produced in accordance with such a requirement or found on the premises, (e) open and examine any receptacle, container or package that the inspector reasonably believes may contain any such goods, (f) examine any such goods, (g) seize and remove for analysis portions or samples of any such goods, (h) seize and detain any things found on those premises if the inspector reasonably believes that a contravention of this Act or the regulations, or a condition of an approval, authority or licence given or issued for the purposes of this Act or the regulations, has been committed with respect to those things, (i) examine any records (including prescriptions), that may be relevant to investigating or auditing compliance with an approval given, or authority or licence issued, for the purposes of Part 4 or with respect to a prescribed restricted substance, (j) remove any records referred to in paragraph (i). (3) The power conferred by subsection (2) (g) or (h) to seize goods or things includes a power to remove the goods or things from the premises where they were seized.
(1) In this section: authorised officer has the same meaning as it has in the. Law Enforcement (Powers and Responsibilities) Act 2002
(1) In this section: police vessel means a vessel ordinarily used by members of the police force in the execution of their duty.prescribed restricted substance means a restricted substance prescribed for the purposes of section 16.
(1) The Governor may make regulations, not inconsistent with this Act, for or with respect to any matter that by this Act is required or permitted to be prescribed or that is necessary or convenient to be prescribed for carrying out or giving effect to this Act. (1A) In particular, the regulations may make provision for or with respect to any of the following:
(a) providing for the issue, renewal, suspension and cancellation of licences for the purposes of section 36C and the conditions subject to which such licences may be issued or renewed for those purposes, (b) prohibiting or regulating the advertising of therapeutic goods by persons engaged in the supply of those goods, including the form and content of advertisements and the manner in which advertisements may be published or displayed, (c) providing for labelling, sampling, examining, testing and analysing therapeutic goods, (d) prescribing conditions to be complied with when preparing, supplying, storing, packing, handling, carrying and delivering therapeutic goods, (e) prohibiting or regulating the supply of therapeutic goods of a specified class, (f) prescribing fees that are to be paid for matters arising under this Part (including fees for the issue and renewal of licences referred to in paragraph (a)), (g) requiring persons of a specified class to keep records for the purposes of this Part, (h) prohibiting the supply of therapeutic goods by self-service methods specified in the regulations.
(Section 6)
(Section 6)