New South Wales: Medicines, Poisons and Therapeutic Goods Act 2022 (NSW)

Medicines, Poisons and Therapeutic Goods Act 2022 No 73 An Act to regulate activities involving scheduled substances and certain therapeutic goods to protect public health and safety; to repeal the Poisons and Therapeutic Goods Act 1966 and certain instruments under that Act; and to make consequential amendments to other legislation. Chapter 1 Preliminary 1 Name of Act This Act is the Medicines, Poisons and Therapeutic Goods Act 2022. 2 Commencement This Act commences on a day or days to be appointed by proclamation. 3 Objects of Act (1) The objects of this Act are as follows— (a) to regulate activities involving scheduled substances and other prescribed therapeutic goods to protect public health and safety, (b) to use the Commonwealth Poisons Standard as the basis for classifying and regulating certain substances, (c) to complement the Commonwealth laws that regulate therapeutic goods, including by providing for certain Commonwealth laws to apply as a law of New South Wales in relation to the activities of persons who are not corporations, (d) to authorise certain activities involving scheduled substances and other prescribed therapeutic goods, including when the activities are prohibited under another law, (e) to provide for effective administration and enforcement mechanisms in relation to scheduled substances and other prescribed therapeutic goods. (2) In the exercise of functions under this Act, the protection of public health and safety must be the paramount consideration. 4 Definitions (1) The Dictionary in Schedule 3 defines words used in this Act. Note— The Interpretation Act 1987 contains definitions and other provisions affecting the interpretation and application of this Act. (2) A reference in this Act to a substance using "Schedule" with a number is a reference to the substance specified in the Schedule with that number in the NSW Poisons Schedules. Example— A Schedule 7 substance means a substance specified in Schedule 7 of the NSW Poisons Schedules. 5 Meaning of "supply" and "wholesale supply" (1) In this Act, to supply scheduled substances and other prescribed therapeutic goods includes the following— (a) to sell, dispense and distribute, (b) to supply, whether for free or otherwise, as a sample or advertisement, (c) to supply, whether for free or otherwise, for testing for safety or efficacy on humans or animals, (d) to agree or offer to sell or distribute, (e) to keep or possess for sale, dispensing or distribution, (f) to send, forward, deliver or receive for sale, dispensing or distribution, (g) to authorise, direct, cause or allow one or more of the above to be done. (2) In this Act, to supply scheduled substances and other prescribed therapeutic goods does not include the following— (a) to administer scheduled substances or other prescribed therapeutic goods, (b) to supply scheduled substances or other prescribed therapeutic goods to a worker by a person for whom the worker works if— (i) the person is authorised to obtain the substance or goods, and (ii) the worker is authorised to supply, administer or use the substance or goods in connection with the worker's work, (c) to supply scheduled substances or other prescribed therapeutic goods by an authorised practitioner to another authorised practitioner in the same practice for the purposes of supply or administration to patients of the practice, (d) to supply in other prescribed circumstances, whether generally or in relation to prescribed scheduled substances or other prescribed therapeutic goods. (3) In this Act, to wholesale supply scheduled substances and other prescribed therapeutic goods means to supply the substance or goods for the purposes of resupply. (4) In this Act, to wholesale supply scheduled substances and other prescribed therapeutic goods does not include the following— (a) to wholesale supply scheduled substances or other prescribed therapeutic goods to a worker by a person for whom the worker works if— (i) the person is authorised to obtain the substance or goods, and (ii) the worker is authorised to supply, administer or use the substance or goods in connection with the worker's work, (b) to wholesale supply scheduled substances or other prescribed therapeutic goods by an authorised practitioner to another authorised practitioner in the same practice for the purposes of supply or administration to patients of the practice, (c) to wholesale supply scheduled substances or other prescribed therapeutic goods by an authorised practitioner or pharmacist to an agent or carer of a patient or animal for the purposes of supply or administration to the patient or animal, (d) to wholesale supply in other prescribed circumstances, generally or in relation to prescribed scheduled substances or other prescribed therapeutic goods. (5) In this section— worker means a person who does work for another person, whether as an employee, contractor or volunteer. 6 Meaning of "NSW Poisons Schedules" (1) The Schedules to the Commonwealth Poisons Standard, as modified by the regulations— (a) apply for the purposes of this Act, and (b) are referred to in this Act as the NSW Poisons Schedules. (2) For the purposes of determining the Schedule to which a substance belongs, or the meaning of a reference to a scheduled substance in this Act, the following provisions of the Commonwealth Poisons Standard apply, as modified by the regulations— (a) the definitions, (b) other interpretation provisions, (c) the Appendices. (3) The regulations may modify the application of provisions of the Commonwealth Poisons Standard for the purposes of this Act, including by doing the following— (a) adding a substance to or omitting a substance from— (i) a Schedule, or (ii) an Appendix, or (iii) a class or subclass of substances, (b) excluding the following from the NSW Poisons Schedule— (i) a Schedule or part of a Schedule, (ii) an Appendix or part of an Appendix, (iii) a class or subclass of substances or part of a class or subclass of substances, (c) relocating a substance from a Schedule or Appendix to another Schedule or Appendix, (d) relocating a substance from a class or subclass of substances to another class or subclass, whether for the purposes of the same Schedule or Appendix or another Schedule or Appendix, (e) renaming a Schedule, Appendix or class or subclass of substances, (f) adding a Schedule, Appendix or class or subclass of substances, (g) creating a category of substances for a Schedule or Appendix, (h) modifying the interpretative provisions specified in subsection (2). (4) To avoid doubt, the modifications that may be made by the regulations are not limited by the way in which the Commonwealth Poisons Standard does, or does not, classify or otherwise organise substances or classes or subclasses of substances. (5) Without limiting subsections (3) and (4) or the Interpretation Act 1987, section 42, a modification may be limited in its application to— (a) specified provisions of this Act or the regulations, or (b) specified purposes or circumstances. 7 Effect of classification of substances (1) This Act does not prevent a substance from being classified or subclassified as a scheduled substance and as a therapeutic good at the same time. (2) If a substance is classified or subclassified as a scheduled substance or in a subclass of a scheduled substance, by reference to persons prevented, authorised or permitted to do activities involving the substance, the substance's classification or subclassification continues to apply for this Act in relation to activities carried out by other persons. Chapter 2 Regulation of supply, prescriptions and other activities Part 2.1 Introduction 8 Application of Chapter (1) This Chapter makes it an offence to carry out the following activities unless authorised under this Act— (a) wholesale supply of scheduled substances and other prescribed therapeutic goods—see Part 2.2, (b) obtaining wholesale supply of scheduled substances and other prescribed therapeutic goods—see Part 2.3, (c) non-wholesale supply of scheduled substances and other prescribed therapeutic goods—see Part 2.4, (d) the issue of prescriptions for scheduled substances and other prescribed therapeutic goods—see Part 2.5. (2) This Chapter does not limit the circumstances in which an activity that is prohibited under this Chapter may be authorised under another provision of this Act. Note— Activities may also be authorised under the regulations or Chapter 3. 9 Authorisation of activities under other laws (1) An activity referred to in Parts 2.2–2.6 is authorised for the purposes of this Act if the activity is carried out in accordance with a right, entitlement or authority conferred by a relevant law. Example— The Pesticides Act 1999 authorises the possession and use of certain Schedule 7 substances. (2) The regulations may prescribe limitations or restrictions on the carrying out of activities authorised under subsection (1). (3) To avoid doubt, it is not an offence under this Chapter to carry out an activity authorised under subsection (1). 10 Authorisation of activities by regulations (1) The regulations may provide for the following in relation to activities— (a) the persons or classes of persons who are authorised to carry out activities for the purposes of this Act, (b) the circumstances in which activities are authorised for the purposes of this Act, (c) the conditions, limitations, restrictions or other requirements for the carrying out of activities authorised for the purposes of this Act, (d) exemptions from prescribed conditions, limitations, restrictions or other requirements. (2) The regulations may provide for the Health Secretary to do the following, for the purposes of this Act, in relation to activities— (a) authorise persons or classes of persons to carry out the activities, (b) determine the circumstances in which activities are authorised, (c) determine the conditions, limitations, restrictions or other requirements for the carrying out of authorised activities, (d) exempt persons or classes of persons from prescribed conditions, limitations, restrictions or other requirements. (3) Without limiting subsection (1) or (2), the regulations may provide for— (a) the Health Secretary to issue licences to authorise the retail sale of prescribed Schedule 2 and 7 substances, and (b) other matters relating to the licences, including applications for licences, determination of applications, licence conditions and licence fees. (4) The regulations must not provide for the Health Secretary to authorise a person to issue prescriptions for scheduled substances and other therapeutic goods. (5) Regulations may be made under this section in relation to an activity despite other provisions of this Act that regulate the activity. 11 Regulations about application of Parts 2.2–2.6 (1) The regulations may— (a) exclude scheduled substances or other therapeutic goods from the operation of Parts 2.2–2.6, and (b) apply Parts 2.2–2.6 to other scheduled substances or therapeutic goods. (2) The regulations may exclude all or some substances in a NSW Poisons Schedule from the operation of Parts 2.2–2.6. (3) A reference in a provision in Parts 2.2–2.6 to scheduled substances or other prescribed therapeutic goods is a reference to the scheduled substances and other prescribed therapeutic goods to which the provision applies. (4) The regulations may prescribe a penalty, not exceeding a Tier 1 penalty, for the purposes of— (a) paragraph (e) of the penalty provision in sections 14 and 28, and (b) paragraph (d) of the penalty provision in section 36. 12 Regulations may prohibit or restrict authorised activities (1) Despite any other provision of this Act, the regulations may— (a) prohibit a person, or a class of persons, from carrying out an activity, or (b) impose conditions, limitations, restrictions or other requirements on a person, or a class of persons, carrying out an activity. (2) This section applies in relation to the carrying out of an activity by a person, or a class of persons, even if the person, or class of persons, is otherwise authorised to carry out the activity under this Act. Part 2.2 Wholesale supply 13 Application of Part (1) This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations. (2) This Part also applies to other prescribed therapeutic goods. Note— Regulations under section 11 may— (a) exclude scheduled substances or other therapeutic goods from the operation of this Part, and (b) apply this Part to other scheduled substances or therapeutic goods. 14 Offence—unauthorised wholesale supply A person must not wholesale supply, or cause or permit wholesale supply of, scheduled substances or other prescribed therapeutic goods unless— (a) the wholesale supply is authorised under this Act, and (b) the person receiving the substance or goods is authorised to obtain the substance or goods under Part 2.3. Maximum penalty— (a) for a Schedule 10 substance—Tier 1 penalty, or (b) for a Schedule 7 substance—Tier 2 penalty, or (c) for a Schedule 2 or 3 substance—Tier 3 penalty, or (d) for a Schedule 4 substance other than a Schedule 4D substance—Tier 3 penalty, or (e) otherwise—the prescribed penalty. Note— The Drug Misuse and Trafficking Act 1985 also prohibits the supply of prohibited drugs and prohibited scheduled substances. There is an exception for supply authorised under this Act. 15 Wholesale supply by licensed wholesalers (1) Wholesale supply of scheduled substances and other prescribed therapeutic goods is authorised if the substance or goods are wholesale supplied by the holder of a wholesaler licence that authorises the holder to wholesale supply the substance or goods. (2) This section does not apply to a Schedule 7 substance. 16 Wholesale supply of Schedule 7 substances (1) Wholesale supply of Schedule 7 substances, other than prescribed Schedule 7 substances, is authorised if the wholesale supply is for— (a) non-domestic use, or (b) resupply to a person who is authorised to possess or use the substance under the Pesticides Act 1999. (2) Wholesale supply of prescribed Schedule 7 substances is authorised if the substance is— (a) supplied by the holder of a wholesaler licence that authorises the holder to wholesale supply the substance, or (b) resupplied to a person who is authorised to possess or use the substance under the Pesticides Act 1999. 17 Wholesale supply by public health entities (1) Wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by a public health entity to another public health entity is authorised. (2) Wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods for the purposes of the State Vaccine Centre by the Health Secretary, or a person operating the State Vaccine Centre on the Health Secretary's behalf, is authorised. 18 Wholesale supply between pharmacists Wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by a pharmacist from a pharmacy (the supplying pharmacist) to another pharmacist for a pharmacy (the receiving pharmacist) is authorised if— (a) the supplying pharmacist receives a written request in the approved form signed by the receiving pharmacist in the following circumstances— (i) the receiving pharmacist is making the request to satisfy an order of a single customer, (ii) the supplying pharmacist, as far as reasonably practicable, supplies the receiving pharmacist only the minimum amount of the substance or goods necessary to satisfy the order of the customer, or (b) the supplying pharmacist is returning an equivalent amount of the substance or goods to a pharmacist who had previously supplied the same substance or goods in accordance with paragraph (a)(ii). 19 Return of wholesale supply Wholesale supply of scheduled substances and other prescribed therapeutic goods is authorised if— (a) the substance or goods were obtained by wholesale supply that is authorised under this Act, and (b) the substance or goods are being returned to the holder of a wholesaler licence that authorises the holder to wholesale supply the substance or goods. Part 2.3 Obtaining wholesale supply Note— The Drug Misuse and Trafficking Act 1985 also prohibits the possession of prohibited drugs and prohibited scheduled substances. There is an exception for possession authorised under this Act. 20 Application of Part (1) This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations. (2) This Part also applies to other prescribed therapeutic goods. Note— Regulations under section 11 may— (a) exclude scheduled substances or other therapeutic goods from the operation of this Part, and (b) apply this Part to other scheduled substances or therapeutic goods. 21 Obtaining wholesale supply by health practitioners and others (1) Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by the following is authorised— (a) a medical practitioner for medical treatment of a person, (b) a nurse practitioner for treatment of a person, (c) a dentist for dental treatment of a person, (d) a veterinary practitioner for treatment of an animal, (e) a nurse, midwife, podiatrist or optometrist if— (i) the person's registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to possess, use or supply the substance or goods, and (ii) the substance or goods are obtained for a purpose for which the person is qualified, (f) a pharmacist for a pharmacy, (g) a prescribed health practitioner for treatment of a person, (h) a private health facility, (i) the holder of a licence under the Commonwealth Therapeutic Goods Act, Part 3-3 or the Commonwealth Agvet Codes, Part 8. (2) Subsection (1)(h) does not apply in relation to a Schedule 8 substance if the private health facility's licence under the Private Health Facilities Act 2007 prohibits the supply of a Schedule 8 substance. 22 Obtaining wholesale supply by public health entities Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by the following is authorised— (a) a public hospital controlled by the Crown, (b) a recognised establishment, within the meaning of the Health Services Act 1997, of an affiliated health organisation that is a hospital, (c) a local health district, (d) a prescribed statutory health corporation, (e) the Health Secretary, or a person operating the State Vaccine Centre on the Health Secretary's behalf, for the purposes of the State Vaccine Centre, (f) the Health Administration Corporation, (g) another prescribed entity. 23 Obtaining wholesale supply in residential aged care facilities (1) Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by an authorised person for a residential care facility for use in connection with the treatment of residents in the facility is authorised. (2) In this section— authorised person, for a residential care facility, means— (a) the director of nursing for the facility, or (b) if there is no director of nursing for the facility—a manager of the facility nominated by the approved provider, within the meaning of the Aged Care Act 1997 of the Commonwealth, in relation to the facility, or (c) another prescribed person or a person of a prescribed class. 24 Obtaining wholesale supply in correctional centres and detention centres (1) Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by the following is authorised— (a) an authorised person for a managed correctional centre for use in connection with the treatment of inmates in the centre, (b) an authorised person for a detention centre for use in connection with the treatment of detainees in the centre, (c) an authorised person for an immigration detention centre for use in connection with the treatment of detainees in the centre. Note— Subsection (1) does not limit the authority of an authorised person to obtain wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods under another provision of this Division that authorises the person to obtain the substances or therapeutic goods. (2) In this section— authorised person means— (a) for a managed correctional centre— (i) a pharmacist employed or engaged by the management company for the managed correctional centre to receive wholesale supply of scheduled substances and prescribed therapeutic goods on behalf of the company, or (ii) if there is no pharmacist as specified in subparagraph (i)—an authorised practitioner, or a registered nurse in charge of the medical treatment of inmates at the centre, appointed by the management company to receive the supply, and (b) for a detention centre—a medical officer appointed for the detention centre, and (c) for an immigration detention centre— (i) a pharmacist employed or engaged by the centre to receive wholesale supply of scheduled substances and prescribed therapeutic goods on behalf of the centre, or (ii) if there is no pharmacist as specified in subparagraph (i)—an authorised practitioner, or a registered nurse in charge of the medical treatment of detainees at the centre, appointed by the centre to receive the supply. 25 Obtaining wholesale supply by licence holders Obtaining wholesale supply of Schedule 2, 3, 4, 8, 9 and 10 substances and other prescribed therapeutic goods is authorised if the substance or goods are obtained by— (a) the holder of an obtain licence that authorises the holder to obtain the substance or goods, or (b) the holder of a wholesaler licence that authorises the holder to wholesale supply the substance or goods. 26 Obtaining wholesale supply of Schedule 7 substances (1) Obtaining wholesale supply of Schedule 7 substances, other than prescribed Schedule 7 substances, is authorised if the substance is obtained for— (a) non-domestic use, or (b) resupply to a person who is authorised to possess or use the Schedule 7 substance under the Pesticides Act 1999. (2) Obtaining wholesale supply of prescribed Schedule 7 substances is authorised if the substance is obtained— (a) by the holder of an obtain licence that authorises the holder to obtain the substance, or (b) by the holder of a wholesaler licence that authorises the holder to wholesale supply the substance, or (c) for resupply to a person authorised to possess or use the substance under the Pesticides Act 1999. (3) Obtaining wholesale supply of a Schedule 7 substance is authorised if the person obtaining the substance is authorised to possess or use the substance under the Pesticides Act 1999. Part 2.4 Non-wholesale supply 27 Application of Part (1) This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations. (2) This Part also applies to other prescribed therapeutic goods. (3) This Part does not apply in relation to wholesale supply. Note— Regulations under section 11 may— (a) exclude scheduled substances or other therapeutic goods from the operation of this Part, and (b) apply this Part to other scheduled substances or therapeutic goods. 28 Offence—unauthorised non-wholesale supply (1) A person must not supply, or cause or permit the supply of, scheduled substances or other prescribed therapeutic goods unless the supply is authorised under this Act. Maximum penalty— (a) for a Schedule 10 substance—Tier 2 penalty, or (b) for a Schedule 7 substance—Tier 3 penalty, or (c) for a Schedule 2 or 3 substance—Tier 4 penalty, or (d) for a Schedule 4 substance other than a Schedule 4D substance—Tier 4 penalty, or (e) otherwise—the prescribed penalty. (2) It is not an offence under this section to supply, or cause or permit the supply of, a Schedule 7 substance to a person if the person is authorised to possess or use the Schedule 7 substance under the Pesticides Act 1999. Note— The Drug Misuse and Trafficking Act 1985 also prohibits the supply of prohibited drugs and prohibited scheduled substances. There is an exception for supply authorised under this Act. 29 Non-wholesale supply by health practitioners and veterinary practitioners The supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods is authorised if the supply is by the following— (a) a medical practitioner for medical treatment of a person, (b) a nurse practitioner for treatment of a person, (c) a dentist for dental treatment of a person, (d) a veterinary practitioner for treatment of an animal, (e) a nurse, midwife, podiatrist or optometrist if— (i) the person's registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to possess, use, supply or prescribe the substance or goods, and (ii) the substance or goods are obtained for a purpose for which the person is qualified, (f) a prescribed health practitioner for treatment of a person. 30 Non-wholesale supply by pharmacists in pharmacies (1) The supply of Schedule 2 and 3 substances and other prescribed therapeutic goods is authorised if the supply is by a pharmacist in a pharmacy. (2) The supply of Schedule 2 substances is authorised if the supply is by a person employed or engaged by a pharmacy to a customer of the pharmacy. (3) The supply of Schedule 4 and 8 substances and other prescribed therapeutic goods is authorised if the supply is— (a) by a pharmacist in a pharmacy, and (b) on a prescription that was authorised to be issued under section 37. 31 Non-wholesale supply by pharmacists in hospitals (1) The supply of Schedule 2 and 3 substances and other prescribed therapeutic goods is authorised if the supply is by a pharmacist in— (a) a public health entity, or (b) a private health facility. (2) The supply of Schedule 4 and 8 substances and other prescribed therapeutic goods is authorised if the supply is— (a) by a pharmacist in— (i) a public health entity, or (ii) a private health facility, and (b) on one of the following— (i) a prescription that was authorised to be issued under section 37, (ii) the written authorisation of an authorised practitioner, if the authorisation is entered on the patient's medication chart, (iii) the written requisition of an appropriate person. (3) In this section— appropriate person means— (a) an authorised practitioner, or (b) a registered nurse or midwife in charge of the ward in which the substance is supplied. authorised practitioner does not include a veterinary practitioner. 32 Non-wholesale supply by pharmacists in managed correctional centres (1) The supply of Schedule 2, 3, 4 or 8 substances and other prescribed therapeutic goods is authorised if the supply is by a pharmacist employed or engaged by a managed correctional centre for the purposes of treating an inmate at the managed correctional centre. (2) The supply of Schedule 4 or 8 substances and other prescribed therapeutic goods is authorised under subsection (1) only if the supply is— (a) on the written authorisation of an authorised practitioner, if the authorisation is entered on the inmate's medication chart, or (b) on the written requisition of an appropriate person. (3) This section does not affect the supply of a scheduled substance or other prescribed therapeutic goods by a pharmacist employed or engaged by a pharmacy located at a managed correctional centre if the supply is otherwise authorised under this Act. (4) In this section— appropriate person means an authorised practitioner, registered nurse or midwife appointed, by written instrument, by the management company for the managed correctional centre for the purposes of this section. authorised practitioner does not include a veterinary practitioner. 33 Non-wholesale supply by carers The supply of Schedule 2, 3, 4 or 8 substances and other prescribed therapeutic goods by a carer of a person to the person is authorised if the substance or goods have been lawfully supplied to the carer for supply to the person for the person's therapeutic treatment. 34 Non-wholesale supply by State Vaccine Centre The supply of scheduled substances and other prescribed therapeutic goods for the purposes of the State Vaccine Centre by the Health Secretary, or a person operating the State Vaccine Centre on the Health Secretary's behalf, is authorised. Part 2.5 Prescriptions 35 Application of Part (1) This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations. (2) This Part also applies to other prescribed therapeutic goods. Note— Regulations under section 11 may— (a) exclude scheduled substances or other therapeutic goods from the operation of this Part, and (b) apply this Part to other scheduled substances or therapeutic goods. 36 Offence—unauthorised issue of prescription A person must not issue a prescription for a Schedule 2, 3, 4, 7, 8, 9 or 10 substance unless the issue of the prescription is authorised under this Act. Maximum penalty— (a) for a Schedule 8, 9 or 10 substance—Tier 2 penalty, or (b) for a Schedule 4D or 7 substance—Tier 3 penalty, or (c) for a Schedule 2 or 3 substance or other Schedule 4 substance—Tier 4 penalty, or (d) otherwise—the prescribed penalty. Note— The Drug Misuse and Trafficking Act 1985 also prohibits the supply of prohibited drugs and prohibited scheduled substances. There is an exception for supply authorised under this Act. 37 Prescriptions issued by health practitioners and veterinary practitioners (1) This section applies to the issue of a prescription for a Schedule 2, 3, 4 or 8 substance. (2) The issue of a prescription is authorised if it is issued by the following— (a) a medical practitioner for medical treatment of a person, (b) a nurse practitioner for treatment of a person, (c) a dentist for dental treatment of a person, (d) a veterinary practitioner for treatment of an animal, (e) a nurse, midwife, podiatrist or optometrist if— (i) the person's registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to prescribe the substance or goods, and (ii) the prescription is issued for a purpose for which the person is qualified, (f) a prescribed health practitioner for treatment of a person. Part 2.6 Clinical trials 38 Application of Part (1) This Part applies to prescribed Schedule 8 substances and Schedule 9 and 10 substances, subject to the regulations. (2) This Part also applies to other prescribed therapeutic goods. Note— Regulations under section 11 may— (a) exclude scheduled substances or other therapeutic goods from the operation of this Part, and (b) apply this Part to other scheduled substances or therapeutic goods. 39 Authorisation of clinical trials (1) The Health Secretary may authorise a person, or a class of persons, to carry out an activity involving a scheduled substance or other prescribed therapeutic goods for the purposes of a clinical trial. (2) The carrying out of the activity is authorised if it is carried out in accordance with— (a) conditions imposed by the Health Secretary, and (b) the prescribed requirements. Part 2.7 Offences 40 Offence—loss or theft of Schedule 4D or 8 substances (1) A person authorised under this Act to supply a Schedule 4D or 8 substance must notify the Health Secretary immediately after becoming aware that— (a) the person has lost the substance, or (b) the substance has been stolen, or (c) a prescribed event involving the substance has occurred. Maximum penalty—Tier 5 penalty. (2) The regulations may provide for notifications under this section, including the circumstances in which notification is not required. 41 Offence—possessing Schedule 7 substances for domestic use (1) A person must not possess a Schedule 7 substance for domestic use. Maximum penalty—Tier 4 penalty. (2) It is not an offence under this section if the possession or use of the Schedule 7 substance is authorised under the Pesticides Act 1999. 42 Offences—automatic machines for supplying certain therapeutic goods (1) A person must not, in premises under the person's control or in or at another place— (a) install an automatic machine for the supply of scheduled substances or therapeutic goods that do not contain a scheduled substance (applicable goods), or (b) supply applicable goods using an automatic machine. Maximum penalty—Tier 5 penalty. (2) A person who occupies or controls premises is guilty of an offence if— (a) an automatic machine for the supply of applicable goods is installed on the premises, or (b) applicable goods are stored in an automatic machine installed on the premises, or (c) applicable goods are supplied using an automatic machine. Maximum penalty—Tier 5 penalty. (3) Subsections (1) and (2) do not apply to the supply of applicable goods to or by an authorised practitioner for the treatment of a patient. (4) The Health Secretary may, by order published in the Gazette, exempt a person or class of persons, or applicable goods or class of applicable goods, from the operation of subsection (1) or (2). (5) An order under subsection (4) may be made with or without conditions. (6) In this section— automatic machine means a machine or mechanical device used, or capable of being used, for the purposes of supplying goods to members of the public without the personal manipulation or attention of the supplier or the supplier's employee or other agent at the time of supply. 43 Offence—supplying certain therapeutic goods at houses or in public places (1) A person must not— (a) go from house to house supplying scheduled substances or therapeutic goods that do not contain a scheduled substance (applicable goods), or (b) supply applicable goods on a road or at another public place. Maximum penalty—Tier 5 penalty. (2) The Health Secretary may, by order published in the Gazette, exempt a person or class of persons, or applicable goods or class of applicable goods, from the operation of this section. (3) An order under subsection (2) may be made with or without conditions. (4) In this section— house means premises where persons reside, whether or not permanently. road means a road or road related area within the meaning of the Road Transport Act 2013. 44 Offence—administration or non-wholesale supply of unregistered or unlisted therapeutic goods (1) A person must not administer or supply therapeutic goods for use in or on humans unless the goods are— (a) registered goods, or (b) listed goods, or (c) subject to an approval, authority or exemption under the Commonwealth Therapeutic Goods Act, Chapter 3 or 4. Maximum penalty—Tier 5 penalty. (2) This section does not apply to the following— (a) the supply of therapeutic goods that are medical devices, other than medical devices that contain scheduled substances, (b) the administration or supply of therapeutic goods by a person who is a sponsor, (c) the administration or supply of therapeutic goods by a carer of another person to the extent the goods are— (i) a Schedule 2 or 3 substance, or (ii) a Schedule 4 or 8 substance dispensed on a prescription by a pharmacist or supplied by an authorised practitioner for the other person, (d) the self-administration of therapeutic goods by a person, (e) the wholesale supply of therapeutic goods, Note— See the Commonwealth Therapeutic Goods Act, section 21 for an offence relating to wholesale supply of unregistered or unlisted therapeutic goods. (f) the administration or supply of prescribed therapeutic goods in prescribed circumstances, (g) the administration or supply of therapeutic goods if— (i) the registration or listing has been suspended under the Commonwealth Therapeutic Goods Act, and (ii) the Secretary under the Commonwealth Therapeutic Goods Act has not required the therapeutic goods to be recalled under that Act. (3) In this section— listed goods, registered goods and sponsor have the same meaning as in the Commonwealth Therapeutic Goods Act. 45 Offence—supply of expired therapeutic goods (1) A person must not, without reasonable excuse, supply scheduled substances or therapeutic goods that do not contain a scheduled substance (applicable goods) after the expiry date stated on or in relation to the applicable goods in accordance with a standard that applies to the applicable goods. Maximum penalty—Tier 5 penalty. (2) A standard applies to applicable goods for subsection (1) if the standard is— (a) a standard specified in an order under the Commonwealth Therapeutic Goods Act that applies to the goods, or (b) if no order applies to the goods under the Commonwealth Therapeutic Goods Act but there is a relevant monograph about the goods—a standard specified in the relevant monograph. (3) This section applies only to a person who supplies applicable goods in the course of practising the person's profession or employment. (4) In this section— relevant monograph means— (a) for applicable goods for use in or on humans—a monograph in the British, European or United States Pharmacopoeia, or (b) for applicable goods for use in or on animals—a monograph in the British Pharmacopoeia (Veterinary) or United States Pharmacopoeia (Veterinary). 46 Offence—dispensing or compounding scheduled substances on prescription A person must not dispense or compound a scheduled substance on a prescription issued by an authorised practitioner unless the person is a pharmacist. Maximum penalty—Tier 4 penalty. 47 Offence—obtaining scheduled substances by false representation (1) A person must not, by a representation the person knows, or ought reasonably to know, is false or misleading, obtain, or attempt to obtain, a scheduled substance from the following— (a) an authorised practitioner, (b) a pharmacist, (c) a nurse, midwife, podiatrist or optometrist whose registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to possess, use or supply the scheduled substance, (d) the holder of a wholesaler licence or obtain licence, (e) another person authorised under this Act to obtain, supply or administer the scheduled substance. Maximum penalty—Tier 5 penalty. (2) This section does not apply to— (a) a prohibited drug, or (b) a prohibited scheduled substance. 48 Defence for delivering or transporting substances This Act does not make it unlawful for a person to possess, supply or wholesale supply a scheduled substance or other prescribed therapeutic goods if— (a) the person obtained the substance or goods from a person who is lawfully supplying or wholesale supplying the substance or goods (the lawful supplier) to another person who is authorised to obtain the substance or goods (the recipient), and (b) the person is employed or engaged by the lawful supplier to deliver or transport the substance or goods to the recipient, and (c) the possession or supply is only in connection with delivering or transporting the substance or goods to the recipient. Part 2.8 Restriction orders 49 Health Secretary may make restriction orders (1) The Health Secretary may, by written order (a restriction order) given to a person, prohibit or restrict the person from carrying out an activity that the person is authorised to do under this Chapter, including possessing, supplying, wholesale supplying, obtaining wholesale supply, administering, dispensing, using, prescribing, manufacturing, storing or disposing of scheduled substances or other prescribed therapeutic goods. (2) An activity is not authorised under this Act if it is carried out in contravention of a restriction order. (3) A restriction order may, without limitation, prohibit or restrict an activity— (a) by reference to specified therapeutic goods, circumstances, factors or exceptions, or (b) unless it is carried out in a specified way, or (c) generally or by reference to one or more classes or subclasses of activities. (4) A restriction order may be made subject to conditions. (5) A person must not contravene a restriction order applying to the person. Maximum penalty for subsection (5)—Tier 3 penalty. 50 Grounds on which restriction orders may be made (1) A restriction order may be made in relation to a person on one or more of the following grounds— (a) the person has made a written request for the order, (b) the person has been charged or convicted of an offence against— (i) this Act or the regulations, or (ii) the repealed Poisons and Therapeutic Goods Act 1966, or (iii) a relevant law, (c) the Health Secretary considers the person has previously contravened a restriction order, (d) the person is a health practitioner who has given an undertaking under the Health Practitioner Regulation National Law or whose registration is subject to a condition or restriction under that Law, (e) the person is a veterinary practitioner whose registration under the Veterinary Practice Act 2003 is subject to a condition or limitation under that Act, (f) the Health Secretary considers the person is someone who should be restricted or prohibited from carrying out the activity for the purposes of protecting the health or safety of the person or another person, whether or not the other person is identifiable, (g) other prescribed grounds. (2) A restriction order must specify the grounds on which the order is made. 51 Making restriction orders (1) A restriction order must specify the day on which it takes effect. (2) Unless earlier revoked, a restriction order has effect for the period, if any, specified in the order. (3) A restriction order must be published in the Gazette as soon as practicable after the order is made. (4) Failure to comply with subsection (3) does not invalidate the restriction order. 52 Restriction orders for health practitioners (1) As soon as practicable after making a restriction order applying to a health practitioner, the Health Secretary must notify the Council under the Health Practitioner Regulation National Law (NSW) for the person's health profession. (2) Before amending or revoking a restriction order applying to a health practitioner, the Health Secretary must consult with the Council under the Health Practitioner Regulation National Law (NSW) for the person's health profession. (3) Subsection (1) does not apply to a restriction order made under section 50(1)(a). 53 Review of restriction orders (1) A person to whom a restriction order applies may apply to the Health Secretary for a review of the decision to make the restriction order. (2) The Health Secretary may refuse to review a decision to make a restriction order if the Health Secretary— (a) has reviewed the decision within the previous 6 months, and (b) is not satisfied there has been a material change in relevant circumstances. Part 2.9 Miscellaneous 54 Regulations about scheduled substances used for cosmetic purposes (1) The regulations may prescribe requirements about the possession, manufacture, supply, use, prescription, administration, storage and disposal of scheduled substances used for cosmetic purposes. (2) Without limiting subsection (1), the regulations may provide that a prescribed requirement is a category 1 requirement or category 2 requirement. (3) A person must not contravene a category 1 requirement or category 2 requirement. Maximum penalty for subsection (3)— (a) for a category 1 requirement—Tier 2 penalty, or (b) for a category 2 requirement—Tier 4 penalty. 55 Regulations about activities involving certain therapeutic goods and preparations (1) The regulations may provide for prohibiting or otherwise regulating activities in connection with the following— (a) the manufacture, compounding, supply, administration, possession or use of the following (applicable goods)— (i) scheduled substances, (ii) therapeutic goods that are not scheduled substances, (iii) sterile compounded preparations, (b) the issue of prescriptions for applicable goods, (c) the storage, labelling and packaging of applicable goods, (d) the preparation and handling of applicable goods, including the use and condition of the premises used for the preparation and handling, (e) the provision of access to applicable goods, (f) record keeping in relation to applicable goods, including the keeping of registers for applicable goods, (g) the destruction of applicable goods. (2) Despite subsection (1), the regulations cannot prohibit the manufacture or compounding of applicable goods or sterile compounded preparations. (3) The power to make regulations under this section is not limited by other provisions of this Chapter prohibiting or regulating, or authorising regulations to prohibit or regulate, activities of the kind specified in this section. (4) In this section— sterile compounded preparation means a compound of substances, whether or not containing scheduled substances, that is required to be kept sterile, and includes a preparation in— (a) parenteral dosage form, other than an intradermal or subcutaneous injection of an allergen extract, and (b) ophthalmic dosage form. Chapter 3 Licences, approvals and other authorisations Part 3.1 Introduction 56 Application of Chapter (1) This Chapter provides for the following authorisations— (a) wholesaler licences, (b) obtain licences, (c) approvals, (d) OTP registrations, (e) DMT authorities. (2) An activity is authorised under this Act if it is carried out in accordance with— (a) an authorisation, and (b) the terms and conditions, limitations and other restrictions that apply in relation to carrying out the activity. Note— Activities may also be authorised under Chapter 2 or the regulations. (3) An authorisation is not transferable. (4) To avoid doubt, subsection (3) does not prevent a person from carrying out an activity relying on an authorisation granted to another person if another provision of this Act, or a provision of the regulations, authorises the reliance. (5) An authorisation may apply, adopt or incorporate, wholly or in part and with or without modification, a standard, rule, code, specification, method or publication, as in force at a particular time or as in force from time to time, prescribed or published by an authority or body, whether or not it is a New South Wales authority or body. Part 3.2 Licences for wholesale supply and obtaining wholesale supply of certain therapeutic goods Division 1 Granting of wholesaler licences and obtain licences 57 Wholesaler licences and obtain licences (1) The Health Secretary may, on application or the Health Secretary's own initiative, grant a licence (a wholesaler licence) that authorises a person to wholesale supply specified scheduled substances or other prescribed therapeutic goods. (2) The Health Secretary may, on application or the Health Secretary's own initiative, grant a licence (an obtain licence) that authorises a person as follows— (a) to obtain wholesale supply of specified scheduled substances or other prescribed therapeutic goods for use by one or more of the following— (i) a provider under the Opioid Treatment Program, (ii) a corporation that provides paramedical services, (iii) a person providing ambulance transport with the consent of the Health Secretary under the Health Services Act 1997, section 67E, (iv) a person engaged in the administration of a vaccination program for humans, (v) a person on behalf of a university, (vi) a person on behalf of a prescribed research institution, other than a university, (vii) a person on behalf of an analytical or research and development laboratory, (b) to obtain a prescribed Schedule 7 substance, (c) to obtain a prescribed Schedule 10 substance that is not a prohibited drug, (d) to obtain prescribed therapeutic goods for a prescribed purpose. (3) In this Part— licence means a wholesaler licence or an obtain licence. 58 Grounds for granting licence (1) The Health Secretary may grant a licence if satisfied of all the following— (a) the applicant is a fit and proper person to hold the licence, (b) for an application for a licence for a Schedule 9 substance—the licence is intended for— (i) medical or scientific research purposes, or (ii) analysis, teaching or training purposes, or (iii) a prescribed industrial purpose, (c) for an application for a licence for a prescribed Schedule 7 substance—the licence is intended only for supply or obtaining supply for non-domestic use, (d) for an application for a licence for a prescribed Schedule 7 substance marked with an "a" in the NSW Poisons List—the licence is intended only for supply or obtaining supply for an analytical or research purpose, (e) for an application for a licence for a Schedule 9 substance, a prescribed Schedule 7 substance marked with a "p" in the NSW Poisons List or a Schedule 10 substance—the granting of the licence would not pose an unacceptable risk to public health, (f) other prescribed matters, whether generally or for particular kinds of applications. (2) The Health Secretary may grant a licence, even if the Health Secretary is not satisfied of all of the matters specified in subsection (1), if the Health Secretary considers it necessary to grant the licence to deal with urgent, emergency or unforeseen circumstances. (3) To avoid doubt, the Health Secretary may refuse to grant a licence to an applicant even if the Health Secretary is satisfied of all the matters specified in subsection (1). 59 Application for licence (1) A person may apply to the Health Secretary for a licence. (2) An application must— (a) be in an approved form, and (b) be accompanied by the prescribed application fee, if any, and (c) include or be accompanied by information or evidence the Health Secretary reasonably requires to assess the application. Note— The Crimes Act 1900, Part 5A contains offences relating to the making of false or misleading applications or providing false or misleading information or documents. The offences have a maximum penalty of imprisonment for 2 years or a $22,000 fine, or both. (3) The Health Secretary must give the person written notice of a decision to grant or refuse a licence within the prescribed period. (4) If the Health Secretary fails to give notice within the prescribed period, the Health Secretary is taken to have refused to grant the licence. Note— See also section 83, which enables the Health Secretary to require an applicant to provide further information in relation to an application. The Health Secretary may refuse to deal with the application until the information is provided and may reject the application after 6 months. 60 Conditions of licence (1) A licence is subject to any conditions imposed by the Health Secretary— (a) at the time of the grant of the licence, or (b) at another time by variation of the licence. (2) The conditions of a licence may provide that the licence does not take effect until— (a) the end of a specified period, or (b) a specified event happens, or (c) a specified state of affairs occurs. (3) A licence holder must not contravene a condition of the licence. Maximum penalty for subsection (3)—Tier 5 penalty. 61 Variation of licence (1) The Health Secretary may, by written notice to a licence holder, vary the licence, including the conditions of the licence. (2) A variation of a licence includes the following— (a) the imposition of a new licence condition, (b) the substitution of a licence condition, (c) the removal or amendment of a licence condition. (3) The regulations may provide for— (a) applications for variations of licences by licence holders, and (b) the grounds for the variation of licences. 62 Annual fee for licence (1) A licence holder must in each year, on or before 30 September or other date notified in writing by the Health Secretary to the licence holder, pay the prescribed annual fee, if any, to the Health Secretary. (2) An annual fee is not payable for the year during which the licence was granted. (3) The Health Secretary may accept payment of an annual fee up to 3 months after the date required under subsection (1), if an additional late fee of 50% of the annual fee is paid at the same time as the annual fee. Division 2 Suspension or cancellation of wholesaler licences and obtain licences 63 Mandatory grounds for suspension or cancellation of licence The Health Secretary must suspend or cancel a licence— (a) if the licence holder requests or agrees to the suspension or cancellation, or (b) if the licence holder is convicted of an offence against a relevant law that is punishable by imprisonment for 5 years or more, or (c) if the Health Secretary considers the licence holder is no longer a fit and proper person to hold the licence, or (d) on other prescribed grounds. 64 Discretionary grounds for suspension or cancellation of licence The Health Secretary may suspend or cancel a licence on one or more of the following grounds— (a) the licence holder contravenes a condition of the licence, (b) the licence holder is charged with an offence against this Act, the regulations or a relevant law, (c) the licence holder is convicted of an offence against this Act or the regulations, (d) the licence holder is convicted of an offence against a relevant law, other than an offence that is punishable by imprisonment for 5 years or more, (e) an order is made under the Crimes (Sentencing Procedure) Act 1999, section 10(1) relating to the licence holder for an offence against this Act, the regulations or a relevant law, (f) the licence holder has made a representation in connection with the licence, including in connection with an application for the licence, that is false or misleading in a material particular, (g) the prescribed annual fee, if any, and any late fee, for the licence has not been paid in accordance with section 62, (h) other prescribed grounds. 65 Submissions about suspension or cancellation of licence on discretionary grounds (1) Before suspending or cancelling a licence under section 64, the Health Secretary must give written notice to the licence holder of the Health Secretary's intention to suspend or cancel the licence and the proposed grounds for the suspension or cancellation. (2) The notice must specify a period of at least 10 days in which the licence holder may make submissions to the Health Secretary about the proposed suspension or cancellation. (3) Before suspending or cancelling a licence under section 64, the Health Secretary must consider any submissions made within the specified period. (4) The Health Secretary is not required to comply with this section in relation to the suspension or cancellation of a licence if satisfied that— (a) the time required to comply with this section would increase a risk to the health or safety of the public, or (b) the suspension or cancellation is required for urgent or emergency reasons. 66 Notice of suspension or cancellation of licence (1) The Health Secretary must give written notice to a licence holder of the suspension or cancellation of the licence. (2) The notice must specify the following— (a) the date or time from which the suspension or cancellation takes effect, (b) the grounds for the suspension or cancellation, (c) for a suspension—the period of suspension. Part 3.3 Approvals for supply and prescription of certain therapeutic goods by health practitioners 67 Application of Part (1) This Part applies to prescribed Schedule 8 substances and other prescribed therapeutic goods. (2) A reference in a provision in this Part to scheduled substances or therapeutic goods is a reference to the scheduled substances and prescribed therapeutic goods to which the provision applies. 68 Granting of approval (1) The Health Secretary may, subject to the regulations, grant an approval that authorises— (a) the supply or administration of scheduled substances or other prescribed therapeutic goods by a health practitioner or veterinary practitioner, or class of health practitioner or veterinary practitioner, specified in section 29, or (b) the issue of a prescription for scheduled substances or other prescribed therapeutic goods by a health practitioner, or class of health practitioner, specified in section 37. (2) An approval may be granted on application or the Health Secretary's own initiative. (3) An approval may be granted to authorise an activity referred to in subsection (1)(a) or (b) if— (a) the activity is subject to prescribed restrictions, and (b) the regulations require an approval for the activity to be authorised under this Act. (4) The regulations may provide for the circumstances in which an approval, or kind of approval, may or must be granted or refused. (5) An approval may be granted to a particular person or a class of persons. (6) An approval is granted to a class of persons by written notice published on the Ministry of Health's website. (7) The Health Secretary must specify the term of an approval when granting the approval. 69 Offence—supplying or issuing prescriptions for therapeutic goods without approval (1) A health practitioner or veterinary practitioner must not in prescribed circumstances— (a) supply or administer scheduled substances or other therapeutic goods without an approval, or (b) issue a prescription for scheduled substances or other therapeutic goods without an approval. Maximum penalty—Tier 5 penalty. (2) This section does not apply to a health practitioner— (a) acting under the direction of another health practitioner who is authorised under an approval, or (b) carrying out an activity authorised under Part 2.6, or (c) carrying out an activity under an OTP registration. (3) This section does not apply to a veterinary practitioner— (a) acting under the direction of another veterinary practitioner who is authorised under an approval, or (b) carrying out an activity authorised under Part 2.6. 70 Application for approval (1) A person may apply to the Health Secretary for an approval. (2) An application must— (a) be in an approved form, and (b) include or be accompanied by information or evidence the Health Secretary reasonably requires to assess the application. Note— The Crimes Act 1900, Part 5A contains offences relating to the making of false or misleading applications or providing false or misleading information or documents. The offences have a maximum penalty of imprisonment for 2 years or a $22,000 fine, or both. (3) The Health Secretary must give the applicant written notice of a decision to grant or refuse an approval within the prescribed period. (4) If the Health Secretary fails to give notice within the prescribed period, the Health Secretary is taken to have refused the application. Note— Section 83 enables the Health Secretary to require an applicant to provide further information in relation to an application. The Health Secretary may refuse to deal with the application until the information is provided and may reject the application after 6 months. 71 Conditions of approval (1) An approval is subject to conditions imposed by the Health Secretary— (a) at the time of the grant of the approval, or (b) at another time by variation of the approval. (2) The conditions of an approval may provide that the approval does not take effect until— (a) the end of a specified period, or (b) a specified event happens, or (c) a specified state of affairs occurs. (