Poisons and Therapeutic Goods Amendment Regulation 2005 (NSW)

2005 No 580

New South Wales

Poisons and Therapeutic Goods

Amendment Regulation 2005

under the

Poisons and Therapeutic Goods Act 1966

Her Excellency the Governor, with the advice of the Executive Council, has made the following Regulation under the Poisons and Therapeutic Goods Act 1966.

JOHN HATZISTERGOS, M.L.C.,

Minister for Health

Explanatory note
The object of this Regulation is to amend the Poisons and Therapeutic Goods Regulation
2002:

(a)	to remove provisions prescribing the form of an application for an authority to prescribe a drug of addiction under section 28 of the Poisons and Therapeutic Goods Act 1966 as a consequence of an amendment to that Act to provide for the application to be in a form approved by the Director-General, and
(b)	to remove a quantity-based exception to the requirement that a medical practitioner, nurse practitioner, dentist or veterinary surgeon who supplies a restricted substance must make and keep certain records of such a supply, and
(c)	to make it clear that the label on a container of a therapeutic substance must contain the approved name of the substance irrespective of whether it is a preparation compounded in accordance with the formula of the dealer supplying the substance.

This Regulation is made under the Poisons and Therapeutic Goods Act 1966, including sections 17, 24 and 45C (the general regulation-making power).

Published in Gazette No 118 of 23 September 2005, page 7543	Page 1
2005 No 580
Clause 1	Poisons and Therapeutic Goods Amendment Regulation 2005

Poisons and Therapeutic Goods Amendment

Regulation 2005

under the

Poisons and Therapeutic Goods Act 1966

1      Name of Regulation

This Regulation is the Poisons and Therapeutic Goods Amendment
Regulation 2005.

2 Amendment of Poisons and Therapeutic Goods Regulation 2002

The Poisons and Therapeutic Goods Regulation 2002 is amended as set out in Schedule 1.

2005 No 580

Poisons and Therapeutic Goods Amendment Regulation 2005

Amendments	Schedule 1
Schedule 1	Amendments

(Clause 2)

[1]      Clause 55 Records to be kept of supply of restricted substances by medical practitioners, nurse practitioners, dentists and veterinary surgeons

Omit “in a quantity exceeding that required for 3 days’ treatment”.

[2]      Clause 176

Omit the clause. Insert instead:

176 Applications for authorities under section 29 (cf cl 157 of P&TG Reg 1994)

Before determining an application referred to in section 29 (1) of the Act, the Director-General may require the applicant to furnish such further information as the Director-General may require in relation to the application.

[3]      Appendix A Labelling of therapeutic substances

Omit clause 1 (3) (b). Insert instead:

(b)	the substance’s approved name,
(b1)	the substance’s proprietary name (unless the substance is a preparation compounded in accordance with the dealer’s own formula),

BY AUTHORITY