Controlled Substances (Poisons) (Psilocybine and MDMA) Amendment Regulations 2023 (SA)

South Australia

Controlled Substances (Poisons) (Psilocybine and MDMA) Amendment Regulations 2023

under the Controlled Substances Act 1984

Contents

Part 1—Preliminary

1            Short title

2            Commencement

Part 2—Amendment of Controlled Substances (Poisons) Regulations 2011

3            Insertion of regulation 20

20          Regulation of prescription drugs—prescription of certain S8 poisons by medical practitioners (section 18(2) of Act)

4            Insertion of regulation 44A

44A         Special provisions relating to the supply and administration of certain drugs of dependence

Part 1—Preliminary

1—Short title

These regulations may be cited as the Controlled Substances (Poisons) (Psilocybine and MDMA) Amendment Regulations 2023.

2—Commencement

These regulations come into operation on 1 July 2023.

Part 2—Amendment of Controlled Substances (Poisons) Regulations 2011

3—Insertion of regulation 20

After regulation 19 insert:

20—Regulation of prescription drugs—prescription of certain S8 poisons by medical practitioners (section 18(2) of Act)

(1)For the purposes of section 18(2) of the Act—

(a)each of the S8 poisons listed in column 1 of the table below, when used for the purpose set out in column 2, is a prescribed prescription drug; and

(b)the qualifications and requirements specified in that table alongside a drug in column 3 are prescribed qualifications and requirements.

Prescription drug	Use	Qualifications and requirements
1	N,α‑dimethyl‑3,4‑(methylenedioxy)phenylethylamine (MDMA)	Human use, for the treatment of post-traumatic stress disorder	A medical practitioner—     (a)    who is registered in the specialty of psychiatry; and     (b)    for whom an authority under section 19(5) of the Commonwealth Act that covers MDMA is in force.
2	Psilocybine (Psilocybin)	Human use, for the treatment of treatment-resistant depression.	A medical practitioner—     (a)    who is registered in the specialty of psychiatry; and     (b)    for whom an authority under section 19(5) of the Commonwealth Act that covers psilocybine is in force.

(2)A medical practitioner who prescribes an S8 poison listed in the table in subregulation (1) must, within 1 business day of prescribing the poison and for the purposes of the Chief Psychiatrist performing the Chief Psychiatrist's functions under the Mental Health Act 2009, give notice to the Chief Psychiatrist—

(a)in a form determined by the Chief Psychiatrist; and

(b)containing such information as the Chief Psychiatrist may determine.

4—Insertion of regulation 44A

After regulation 44 insert:

44A—Special provisions relating to the supply and administration of certain drugs of dependence

(1)A drug of dependence to which this regulation applies may only be supplied or administered to a person for whom it has been prescribed—

(a)by the medical practitioner who prescribed the drug of dependence for the person; and

(b)at a prescribed health service facility; and

(c)in accordance with an approved treatment protocol.

(2)A person who supplies or administers a drug in contravention of subregulation (1) commits an offence.

Maximum penalty: $5 000.

(3)This regulation applies in relation to the following drugs of dependence:

(a)N,α‑dimethyl‑3,4‑(methylenedioxy)phenylethylamine (MDMA);

(b)Psilocybine (Psilocybin).

(4)In this regulation—

approved treatment protocol means a treatment protocol which has been approved by an ethics committee;

ethics committee has the same meaning as in the Commonwealth Act;

prescribed health service facility means—

(a)an approved treatment centre or authorised community mental health facility (both within the meaning of the Mental Health Act 2009); or

(b)any other health service facility, or health service facility of a class, determined by the Minister by notice in the Gazette to be a prescribed health service facility for the purposes of this regulation.

Editorial note—

As required by section 10AA(2) of the Legislative Instruments Act 1978, the Minister has certified that, in the Minister's opinion, it is necessary or appropriate that these regulations come into operation as set out in these regulations.

Made by the Governor

after consultation by the Minister with the Controlled Substances Advisory Council and with the advice and consent of the Executive Council

on 29 June 2023

No 62 of 2023