Poisons and Therapeutic Goods Regulation 2008
Part 1 Preliminary
1 Name of Regulation
This Regulation is the Poisons and Therapeutic Goods Regulation 2008.
This Regulation commences on 1 September 2008.
(1) In this Regulation:Ambulance Service of NSW has the same meaning as it has in the Health Services Act 1997.means:charitable organisation means an organisation or association that holds an authority under the Charitable Fundraising Act 1991 or that is referred to in section 7 of that Act as an organisation or association to which that Act (section 48 excepted) does not apply.Commonwealth Department of Health means the Commonwealth Department of Health and Ageing.confer a function includes impose a duty.current Poisons Standard has the same meaning as it has in the Therapeutic Goods Act 1989 of the Commonwealth.dealer, in relation to a substance, means a person who supplies the substance as a manufacturer, an importer or exporter or a wholesale or retail dealer, and includes an authorised practitioner or pharmacist in his or her capacity as a supplier of the substance.exercise a function includes perform a duty.function includes a power, authority and duty.hospital means a public hospital, public institution, private health facility or nursing home.inspector means a person authorised by the Director-General to exercise the powers conferred by section 43 of the Act.medication chart means a document, in a form that complies with the National Health (Residential Medication Chart) Determination 2012 of the Commonwealth, that contains detailed information about an individual patient and the medication orders, administration record and other health care information related to that patient’s care.medication chart prescription means a prescription included in a medication chart kept at a residential care facility in relation to a resident of that facility.nabiximols means a botanical extract of Cannabis sativa in a buccal spray for human therapeutic use:(a) that includes the following cannabinoids:(i) tetrahydrocannabinol,(ii) cannabidiol,(iii) cannabinol,(iv) cannabigerol,(v) cannabichromene,(vi) cannabidiolic acid,(vii) tetrahydrocannabinolic acid,(viii) tetrahydrocannabivarol,(ix) cannabidivarol, and(b) in which tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content.nursing home has the same meaning as in the Public Health Act 1991.practitioner of alternative medicine means a herbalist, nutritionist, naturopath, practitioner of Chinese medicine or homoeopathic practitioner.prescribed restricted substance—see clause 61.prescription reference number means the unique reference number for the prescription recorded under clause 55 or 114.private health facility means a private health facility licensed under the Private Health Facilities Act 2007.public hospital means a public hospital within the meaning of the Health Services Act 1997.residential care facility means a residential facility at which a person is provided with residential care, within the meaning of the Aged Care Act 1997 of the Commonwealth, and includes a nursing home.retail dealer, in relation to a substance, means a person who supplies the substance as a retailer, and not as a manufacturer, importer, exporter or wholesaler, and not as an authorised practitioner or pharmacist in his or her capacity as a supplier of the substance.retail pharmacist means a pharmacist who is employed in a retail pharmacy.retail pharmacy means premises included in the Register of Pharmacies kept under Schedule 5F of the Health Practitioner Regulation National Law (NSW).scientifically qualified person means:(a) a medical practitioner, dentist, veterinary practitioner or pharmacist, or(b) a person who holds a degree or diploma approved for the time being by the Director-General, or(c) a person approved for the time being by the Director-General.seized goods means regulated goods that have been seized under section 43 of the Act.special restricted substance means a substance included in Appendix B to this Regulation.the Act means the Poisons and Therapeutic Goods Act 1966.Therapeutic Goods Order No. 80 means the order of that number called Child-Resistant Packaging Requirements for Medicines, as in force from time to time under section 10 of the Therapeutic Goods Act 1989 of the Commonwealth.therapeutic substances means substances that are therapeutic goods.ward of a hospital includes any theatre, laboratory or department of the hospital, other than the pharmacy department.Note.The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this Regulation.(2) In this Regulation:(a) expressions that are defined in the current Poisons Standard have the meanings given to them by that Standard, and(b) expressions that are defined in the current Poisons Standard and that are also defined in the Act or in this Regulation have the meanings given to them by the Act or this Regulation, respectively, and(c) a reference to a Schedule 1, 2, 3, 4, 5, 6, 7, 8 or 9 substance is a reference to a substance included in the correspondingly numbered Schedule of the Poisons List.(3) Notes included in this Regulation do not form part of this Regulation.