Poisons and Therapeutic Goods Amendment (Drugs of Addiction) Regulation 2020 (NSW)

New South Wales

Poisons and Therapeutic Goods Amendment

(Drugs of Addiction) Regulation 2020

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.

BRAD HAZZARD, MP

Minister for Health and Medical Research

Explanatory note

The object of this Regulation is to amend the Poisons and Therapeutic Goods Regulation 2008 (the

Regulation) as follows—

(a)	to permit prescriptions for and the supply of methadone or buprenorphine in any form to inmates at correctional centres by a medical practitioner or nurse practitioner without an authority under section 29 of the Poisons and Therapeutic Goods Act 1966 (the Act),
(b)	to permit prescriptions for methadone or buprenorphine in any form to former inmates within 21 days of release of the person from a correctional centre by a medical practitioner or nurse practitioner without an authority under section 29 of the Act,
(c)	to exclude cannabis medicines that are intended for administration by injection, inhalation, spray or application to mucous membranes from the prescribed category of type B drugs of addiction,
(d)	to make it clear that a medical practitioner must not supply specified unregistered drugs of addiction for the purposes of a clinical trial unless the medical practitioner holds an authority under Part 8 of the Regulation that authorises the supply of the drugs for that purpose.

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

Poisons and Therapeutic Goods Amendment (Drugs of Addiction) Regulation 2020 [NSW]

Poisons and Therapeutic Goods Amendment (Drugs of

Addiction) Regulation 2020

under the

Poisons and Therapeutic Goods Act 1966

1      Name of Regulation

This Regulation is the Poisons and Therapeutic Goods Amendment (Drugs of

Addiction) Regulation 2020.

2      Commencement

This Regulation commences on the day on which it is published on the NSW legislation website.

Poisons and Therapeutic Goods Amendment (Drugs of Addiction) Regulation 2020 [NSW]

Schedule 1 Amendment of Poisons and Therapeutic Goods Regulation 2008

Schedule 1 Amendment of Poisons and Therapeutic Goods
Regulation 2008

[1]      Clause 83 Exceptions to section 28—prescriptions generally

Omit “in oral dosage form” from clause 83(2)(c).

[2]      Clause 84A Authority required for prescriptions for clinical trials

Insert before clause 84A(a)—

(aa) the prescription is for the purposes of a clinical trial, and

[3]      Clause 94 Exceptions to section 28—supply

Omit “in oral dosage form” from clause 94(2)(c).

[4]      Clause 94AA Authority required for supply for clinical trials

Insert before clause 94AA(a)—

(aa) the prescription is for the purposes of a clinical trial, and

[5]      Clause 123 Prescribed type B drugs of addiction

Omit paragraph (a). Insert instead—

(a)

a drug of addiction that—

(i)	does not contain cannabis or tetrahydrocannabinols (when included in Schedule 8 of the Poisons List) or nabiximols, and
(ii)	is packaged and labelled in a manner that is consistent with the drug being intended for administration by injection, inhalation, spray or application to mucous membranes,