Poisons Amendment Regulations 2004
I, the Lieutenant-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 .
15 November 2004W. J. E. COX
Lieutenant-Governor
By His Excellency's Command,
D. E. LLEWELLYN
Minister for Health and Human Services
These regulations may be cited as the Poisons Amendment Regulations 2004 .
These regulations take effect on the day on which their making is notified in the Gazette.
In these regulations, the Poisons Regulations 2002 are referred to as the Principal Regulations.
4. Regulation 51 amended (Supply of potent substances by pharmaceutical chemists)
Regulation 51 of the Principal Regulations is amended by omitting subregulation (2) and substituting the following subregulation:(2) A pharmaceutical chemist must not supply a Schedule 3 substance that is a specified potent substance, other than salbutamol (S3) supplied for a school firstaid kit in accordance with the written authority of the school principal, unless its container is labelled in accordance with regulation 87(2) and (3) .Penalty: Fine not exceeding 10 penalty units.
5. Regulation 53 rescinded
Regulation 53 of the Principal Regulations is rescinded.
6. Regulation 69 amended (Prescription, &c., of certain substances prohibited, unless authorised by Secretary)
Regulation 69(1) of the Principal Regulations is amended by inserting after paragraph (ab) the following paragraph:(ac) bosentan for human use;
7. Regulation 70 amended (Precautions in prescribing substances capable of producing birth defects)
Regulation 70 of the Principal Regulations is amended as follows:(a) by inserting in subregulation (1) "bosentan," after "bexarotene,";(b) by inserting in subregulation (2)(a) "bosentan," after "bexarotene,";(c) by inserting the following subparagraph after subparagraph (i) in subregulation (2)(b) :(ia) in the case of treatment with bosentan, 3 months after the completion of that treatment; or
8. Regulation 82 amended (Application of provisions of Uniform Standard)
Regulation 82 of the Principal Regulations is amended by inserting after subregulation (4) the following subregulation:(5) A person must comply with paragraph 2 in Part 2 of the Uniform Standard.Penalty: Fine not exceeding 10 penalty units.
9. Regulation 87 amended (Labelling of dispensed medicines)
Regulation 87(3)(e) of the Principal Regulations is amended by inserting "bexarotene, bosentan," after "adapalene,".
10. Regulation 101 amended (Expiry)
Regulation 101 of the Principal Regulations is amended by omitting "1 January 2005" and substituting "31 December 2005".
11. Schedule 5 amended (Substances not to be supplied without approved information sheet)
Schedule 5 to the Principal Regulations is amended by inserting after item 1 the following items:1A. Bexarotene for human use.1B. Bosentan for human use.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 24 November 2004
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 Poisons Regulations 2002 by –(a) increasing restrictions on the prescription of bexarotene and bosentan; and(b) rescinding a provision requiring a pharmaceutical chemist to record certain details in respect of specified potent substances; and(c) prescribing a penalty for failing to comply with paragraph 2 in Part 2 of the Uniform Standard; and(d) postponing their expiry until 31 December 2005.