Poisons and Therapeutic Goods Amendment Regulation 2006 (NSW)

2006 No 693

New South Wales

Poisons and Therapeutic Goods

Amendment Regulation 2006

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 (the Regulation) so as to:

(a)	enable the Director-General to approve exemptions to the form of prescriptions so as to allow for changes in technology, and
(b)	enable pharmacists, subject to the approval of the Director-General, to supply restricted medications (including prescribed restricted substances) to nursing homes for emergency use in the nursing homes, and
(c)	provide that the drug buprenorphine is not a type B drug of addiction if it is in the form of transdermal patches, and
(d)	enable locum medical practitioners to prescribe or supply a drug of addiction to certain patients without an authority, and
(e)	remove the substance ketamine from Appendix D.

This Regulation also removes redundant provisions. Section 28 of the Poisons and Therapeutic Goods Act 1966 (the Principal Act) prohibits the prescription of certain drugs of addiction without the proper authority. Clauses 82 and 94 of the Regulation provide that terminally ill cancer patients may be prescribed pain relieving drugs of addiction for extended periods without having to first seek the proper authority. Recent amendments to the Principal Act have resulted in the vast majority of pain relieving drugs prescribed to treat cancer related pain now not requiring any such authority for prescription. Accordingly, the exceptions provided by clauses 82 and 94 are effectively redundant.

This Regulation is made under the Poisons and Therapeutic Goods Act 1966, including sections 17, 24, 28 and 45C (the general regulation-making power).

Published in Gazette No 168 of 1 December 2006, page 10102	Page 1
2006 No 693
Clause 1	Poisons and Therapeutic Goods Amendment Regulation 2006

Poisons and Therapeutic Goods Amendment

Regulation 2006

under the

Poisons and Therapeutic Goods Act 1966

1      Name of Regulation

This Regulation is the Poisons and Therapeutic Goods Amendment
Regulation 2006.

2 Amendment of Poisons and Therapeutic Goods Regulation 2002

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

2006 No 693

Poisons and Therapeutic Goods Amendment Regulation 2006

Amendments	Schedule 1
Schedule 1	Amendments

(Clause 2)

[1]      Clause 17 Schedule 3 substances to be supplied personally by pharmacists

Omit “with” from clause 17 (5) (a). Insert instead “and that deliver”.

[2]      Clause 34 Form of prescription

Insert after clause 34 (4):

(5)	The Director-General may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from any or all of the requirements of this clause.
(6)	Such an exemption may be given unconditionally or subject to conditions.

[3]      Clause 46 Supply by pharmacists to nursing homes of stock for emergency use

Omit “relevant prescribed substance” from clause 46 (1).

Insert instead “restricted substance approved by the Director-General for the purposes of this clause”.

[4]      Clause 46 (2)

Omit “relevant prescribed”. Insert instead “restricted”.

[5]      Clause 46 (3) and (4)

Omit clause 46 (3). Insert instead:

(3)	The Director-General may, by order in writing, either generally or in the case of a particular nursing home or class of nursing homes, approve the supply of a restricted substance (including a prescribed restricted substance) for emergency use in the nursing home or nursing homes.
(4)	An approval under subclause (3) may be given unconditionally or subject to conditions.

2006 No 693	Poisons and Therapeutic Goods Amendment Regulation 2006
Schedule 1	Amendments

[6]      Clause 77 Form of prescription

Insert after clause 77 (4):

(5)	The Director-General may, by order in writing, exempt any person or drug of addiction, or any class of persons or drugs of addiction, from any or all of the requirements of this clause.
(6)	Such an exemption may be given unconditionally or subject to conditions.

[7]      Clause 82 Exceptions to section 28: prescriptions generally

Omit clause 82 (2) and (3).

[8]      Clause 82 (5) (b)

Omit “the same premises as the holder of that authority”.

Insert instead “the same premises that the holder of the authority was practising at when the authority was issued”.

[9]      Clause 94 Exceptions to section 28: supply

Omit clause 94 (2) and (3).

[10]      Clause 94 (5) (b)

Omit “the same premises as the holder of that authority”.

Insert instead “the same premises that the holder of the authority was practising at when the authority was issued”.

[11]      Clause 121A Prescribed type B drugs of addiction

Insert “(other than in transdermal patches)” after “buprenorphine” in clause
121A (b).

[12]      Clause 141 Animals not permitted on premises

Omit “or bird” from clause 141 (1).

[13]      Appendix C Supply by wholesale

Omit “with” from clause 19 (a). Insert instead “and that deliver”.

[14]      Appendix D Prescribed restricted substances

Omit the matter relating to Ketamine from columns 1 and 2.

BY AUTHORITY