Controlled Substances (Poisons) Regulations 2011
Part 1Preliminary
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Part 1—Preliminary 1—Short title These regulations may be cited as the Controlled Substances (Poisons) Regulations 2011. 3—Interpretation (1) In these regulations, unless the contrary intention appears— Act means the Controlled Substances Act 1984; address means street address; approved electronic communication means an electronic communication of a kind approved from time to time by the Minister; approved electronic form, in relation to a prescription for a drug, means— (a) a form approved from time to time by the Secretary under the Commonwealth Regulations; or (b) a form approved from time to time by the Minister, for the giving of prescriptions for drugs in electronic form; approved information technology requirements means information technology requirements approved from time to time by the Minister; APVMA means the Australian Pesticides and Veterinary Medicines Authority of the Commonwealth; Australian jurisdiction means the Commonwealth or a State or Territory of the Commonwealth; Chief Executive has the same meaning as in the Health Care Act 2008; Commonwealth Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017 of the Commonwealth; correctional institution has the same meaning as in the Correctional Services Act 1982; council has the same meaning as in the Local Government Act 1999; council subsidiary means a subsidiary of a council established under the Local Government Act 1999; data source entity means any of the following: (a) eRx Script Exchange Pty Ltd; (b) MediSecure Pty Ltd; (c) Medication Knowledge Pty Ltd; (d) a prescription exchange service operating in an Australian jurisdiction; dental hygienist means a person registered under the Health Practitioner Regulation National Law— (b) in the dental hygienists division of that profession; dental therapist means a person registered under the Health Practitioner Regulation National Law— (b) in the dental therapists division of that profession; diesel fuel means a petroleum or shale product used or capable of being used in propelling a diesel engined motor vehicle; dispense means to supply a drug in accordance with a prescription for that drug; domestic partner means a person who is a domestic partner within the meaning of the Family Relationships Act 1975, whether declared as such under that Act or not; drug means a poison designed for human or animal therapeutic use; electronic communication has the same meaning as in the Electronic Communications Act 2000; electronic prescription means a prescription given in an approved electronic form; enrolled nurse means a person registered under the Health Practitioner Regulation National Law— (a) to practise in the nursing and midwifery profession as a nurse (other than as a student); and (b) in the enrolled nurses division of that profession; health service facility means a hospital, nursing home or other facility at which a health service is provided for the public or any section of the public for the purpose of curing, alleviating, diagnosing or preventing the spread of any mental or physical illness, disease, injury, abnormality or disability; information technology requirements has the same meaning as in the Electronic Communications Act 2000; liquefied petroleum gas means a hydrocarbon fluid composed predominantly of any of the following hydrocarbons or mixtures of all or any of them: (a) propane (C3H8); (b) propylene (C3H6); (c) butane (C4H10); (d) butylene (C4H8); medication chart prescription has the same meaning as in the Commonwealth Regulations; Metropolitan Adelaide means Metropolitan Adelaide as defined by the Development Act 1993 immediately before 1 July 2019; monitored drug means any of the following: (a) any S8 poison; (b) any S4 poison that is a benzodiazepine; (c) any S4 poison that contains Codeine; (d) any of the following S4 poisons: (i) Gabapentin; (ii) Pregabalin; (iii) Quetiapine; (iv) Tramadol; (v) Zolpidem; (vi) Zopiclone; monitored drugs database means an electronic database kept by the Department that contains information relating to the sale, supply, prescription, administration and use of monitored drugs; motor spirit means petrol or another petroleum or shale product used or capable of being used in propelling a motor vehicle (other than diesel fuel or liquefied petroleum gas); National Health Act means the National Health Act 1953 of the Commonwealth; National Health (Continued Dispensing) Determination means the determination of that name, as in force from time to time, made under section 89A(3) of the National Health Act; optometrist means a person registered under the Health Practitioner Regulation National Law to practise in the optometry profession (other than as a student); oral health therapist means a person registered under the Health Practitioner Regulation National Law— (b) in the oral health therapists division of that profession; petroleum product means a volatile solvent comprised of— (a) motor spirit; or (b) diesel fuel; or (c) liquefied petroleum gas; pharmaceutical benefit has the same meaning as in Part VII of the National Health Act; podiatrist means a person registered under the Health Practitioner Regulation National Law to practise in the podiatry profession (other than as a student); poison—see regulation 5; prescribed (continued dispensing) pharmaceutical benefit means a pharmaceutical benefit listed in the National Health (Continued Dispensing) Determination as a pharmaceutical benefit that may be supplied under section 89A of the National Health Act by approved pharmacists without a prescription; prescriber means a person who lawfully gives a prescription for a drug; record means— (a) a documentary record; or (b) a record made by an electronic, electromagnetic, photographic or optical process; or (c) any other kind of record; registered nurse means a person registered under the Health Practitioner Regulation National Law— (a) to practise in the nursing and midwifery profession as a nurse (other than as a student); and (b) in the registered nurses division of that profession; scheduled medicine means a medicine that contains a substance included in a schedule of the Uniform Poisons Standard; S4 drug means— (a) an S4 poison; or (b) a substance designed for human or animal therapeutic use that has been approved by— (i) the TGA for inclusion in the Australian Register of Therapeutic Goods; or (ii) APVMA for inclusion in the Public Chemical Registration Information System (PUBCRIS), but has not yet been— (c) listed in some other schedule of the Uniform Poisons Standard; or (d) exempted from listing in the Uniform Poisons Standard; section 22 poison means a poison to which section 22 of the Act applies by virtue of regulation 25; spouse—a person is the spouse of another if they are legally married; TGA means the Therapeutic Goods Administration of the Commonwealth; Uniform Poisons Standard means the current Poisons Standard as defined in the Commonwealth Act and as modified by deleting Sections 54(1) and (2), 57, 58, 59, 60 and 64 and Appendices B, D and J; Vaccine Administration Code means the document of that name published by the Department as in force from time to time. (2) In these regulations, a reference to an S1 poison is a reference to a poison listed in Schedule 1 of the Uniform Poisons Standard, a reference to an S2 poison is a reference to a poison listed in Schedule 2 of the Uniform Poisons Standard, and so on. (3) In these regulations, incorporated hospital and SAAS have the same respective meanings as in the Health Care Act 2008. (4) For the purposes of these regulations— (a) an electronic prescription for a drug is presented when it is accessed electronically for the purpose of dispensing the drug; and (b) a prescription for a drug given to a pharmacist by fax is presented when a faxed copy of the prescription is transmitted to the pharmacy at which the drug is to be dispensed. 4—Application of regulations These regulations do not apply in relation to— (a) a poison when contained in a product that is listed in Appendix A of the Uniform Poisons Standard; or (b) a poison listed in Appendix G of the Uniform Poisons Standard when contained in a preparation in a concentration not exceeding the concentration specified in Appendix G for that poison; or (c) a poison that is listed in any of the Schedules 1 to 6 (but is not listed in Schedule 7 or 8) of the Uniform Poisons Standard when contained in a preparation in a concentration not exceeding 10 milligrams per litre or 10 milligrams per kilogram.