Poisons Amendment Regulations 1998
I, the Governor in and over the State of Tasmania and its Dependencies in the Commonwealth of Australia, acting with the advice of the Executive Council, make the following regulations under the Poisons Act 1971 .30 November 1998
G. S. M. GREEN
Governor
By His Excellency’s Command,
JUDY JACKSON
Minister for Health and Human Services
1Short titleThese regulations may be cited as the Poisons Amendment Regulations 1998 . 2CommencementThese regulations take effect on the day on which their making is notified in the Gazette. 3Principal RegulationsIn these regulations, the Poisons Regulations 1975 are referred to as the Principal Regulations. 4Regulation 2 amended (Interpretation)Regulation 2 of the Principal Regulations is amended as follows: (a) by inserting after the definition of "dispensary" the following definition: drug means a poison intended for human therapeutic use or animal therapeutic use; (b) by omitting the definition of Uniform Standard and substituting the following definition: Uniform Standard means the Standard for the Uniform Scheduling of Drugs and Poisons of the Australian Health Ministers Advisory Council published by the Australian Government Publishing Service, as amended from time to time. 5Regulation 13 rescindedRegulation 13 of the Principal Regulations is rescinded. 6Regulation 15 amended (Prescribing and supply of narcotic substances)Regulation 15 of the Principal Regulations is amended by inserting after subregulation (1) the following subregulation: (1A) A medical practitioner, veterinary surgeon or dentist, subject to this regulation, is authorised to write or issue a prescription for a narcotic substance. 7Regulation 16 amended (Prescription for certain narcotic substances to be issued only on authority of Secretary)Regulation 16(1) of the Principal Regulations is amended by inserting after paragraph (b) the following paragraph: (ba) dextromoramide; 8Regulation 32 amended (Prescriptions for restricted substances)Regulation 32 of the Principal Regulations is amended as follows: (a) by inserting after subregulation (1) the following subregulation: (1A) A medical practitioner, dentist or veterinary surgeon, subject to this regulation, is authorised to issue a prescription for any restricted substance. (b) by omitting from subregulation (2) "may issue a prescription for any restricted substance if he or she complies" and substituting "on issuing a prescription must comply". 9Regulation 34 amended (Dispensing prescriptions for restricted substances)Regulation 34 of the Principal Regulations is amended by inserting after subregulation (3) the following subregulation: (3A) A pharmaceutical chemist or an assistant under the direct personal supervision of a pharmaceutical chemist, subject to this regulation, is authorised to dispense a prescription for a restricted substance. 10Regulation 34C substitutedRegulation 34C of the Principal Regulations is rescinded and the following regulation is substituted: 34CAdvertising of Schedule 3 substances A person must not advertise a Schedule 3 substance except – (a) in a publication circulating generally only among persons lawfully engaged in – (i) medical, dental, veterinary or pharmaceutical practice; or (ii) the manufacture or supply of Schedule 3 substances; or (b) in accordance with the Uniform Standard. 11Regulation 41 amended (Prescription, &c., of certain substances prohibited, unless authorised by Secretary)Regulation 41 of the Principal Regulations is amended by inserting after paragraph (e) the following paragraphs: (ea) follitropin alpha (recombinant human follicle-stimulating hormone) for human use; (eb) follitropin beta (recombinant human follicle-stimulating hormone) for human use; 12Regulation 56 amended (Labelling of dispensed medicines)Regulation 56 of the Principal Regulations is amended by inserting after subregulation (4) the following subregulation: (5) The Secretary may approve a variation to the labelling requirements set out in this regulation subject to any conditions he or she considers appropriate. 13Regulation 61B insertedAfter regulation 61A of the Principal Regulations the following regulation is inserted: 61BReturns to be provided (1) Except as otherwise approved by the Secretary – (a) a pharmaceutical chemist or dispensing medical practitioner is to provide the Secretary within 3 days after the end of each month with a return, in a form approved by the Secretary, giving details of all acquisitions and disposals of relevant substances during that month; and (b) a licensed manufacturing chemist or licensed wholesale chemist is to provide the Secretary within 3 days after the end of each week with a return in duplicate, in a form approved by the Secretary, giving details of all acquisitions and disposals of relevant substances during that week. (2) If a person to whom subregulation (1) applies does not make any acquisitions or disposals of relevant substances during any period for which the person is required to provide the Secretary with a return, the person is to provide a "nil" return. (3) For the purposes of this regulation – (a) a week begins at midnight on Saturday and ends at midnight on the following Saturday; and (b) a "relevant substance" "means a substance in relation to which the Secretary determines a return is to be provided. 14Schedule V amended (Specified psychotropic substances)Schedule V to the Principal Regulations is amended as follows: (a) by inserting after item 18 the following item: 18A. Clonazepam. (b) by inserting after item 21 the following item: 21A. Dextropropoxyphene. (c) by inserting after item 22 the following item: 22A. Diethylpropion. (d) by omitting item 28; (e) by inserting after item 43 the following item: 43A. Midazolam. (f) by inserting after item 52 the following items: 52A. Phentermine. 52B. Prasterone. 15Schedule X amended (Substances not to be put to human therapeutic use)Schedule X to the Principal Regulations is amended as follows: (a) by inserting after item 1 the following item: 1A. Acorus calamus (calamus) (b) by omitting item 10. Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 9 December 1998
These regulations are administered in the Department of Health and Human Services.
EXPLANATORY NOTE
(This note is not part of the regulation) These regulations amend the
(a) conferring certain rights on medical practitioners, veterinary surgeons, dentists, and pharmaceutical chemists and their assistants, for the purpose of section 92 of the Poisons Act 1971 ; and (b) inserting a definition of "drug" and updating the definition of "Uniform Standard"; and (c) amending the list of substances that are not to be prescribed, sold or supplied without the Secretary’s authorisation; and (d) requiring returns to be provided to the Secretary in relation to the acquisition and disposal of certain substances; and (e) amending the list of specified psychotropic substances.