Drugs, Poisons and Controlled Substances Amendment (MDMA and Psilocybine) Regulations 2023 (Vic)

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

S.R. No. 61/2023

table of provisions

Regulation  Page

1Objective

2Authorising provisions

3Commencement

4Principal Regulations

5Definitions

6New regulation 9A inserted

7Persons authorised to issue prescriptions

8Issuing prescription for Schedule 4, 8 or 9 poison—registered medical practitioner

9New regulation 17A inserted

10New regulation 36A inserted

11Sale or supply of Schedule 8 poison by pharmacist

12New regulation 78A inserted

13New regulations 98A and 98B inserted

14Administration of Schedule 8 poison by pharmacist

15Schedule 2 amended

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Endnotes

statutory rules 2023

S.R. No. 61/2023

Drugs, Poisons and Controlled Substances Act 1981

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

The Lieutenant-Governor as the Governor's deputy, with the advice of the Executive Council, makes the following Regulations:

Dated: 27 June 2023

Responsible Minister:

MARY-ANNE THOMAS
Minister for Health

ANGELA SMITH

Clerk of the Executive Council

1Objective

The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 2017 with respect to MDMA and psilocybine in Schedule 8 of the Poisons Standard.

2Authorising provisions

These Regulations are made under sections 129 and 132 of the Drugs, Poisons and Controlled Substances Act 1981.

3Commencement

These Regulations come into operation on 1 July 2023.

4Principal Regulations

In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 2017[1] are called the Principal Regulations.

5Definitions

In regulation 5(1) of the Principal Regulations insert the following definitions—

"authorised psychedelic psychiatrist means a registered medical practitioner—

(a)who is registered as a specialist psychiatrist under the Health Practitioner Regulation National Law; and

(b)for whom an authority under section 19(5) of the Therapeutic Goods Act 1989 of the Commonwealth that covers MDMA or psilocybine is in force;

Commonwealth Secretary means the Secretary within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth;

Schedule 8MDMA means N, α ‑DIMETHYL‑3, 4‑(METHYLENEDIOXY)PHENYLETHY LAMINE in Schedule 8 of the Poisons Standard;

Note

MDMA is included in Schedule 8 of the Poisons Standard only for the treatment of post-traumatic stress disorder.

Schedule 8 psilocybine means psilocybine in Schedule 8 of the Poisons Standard;

Note

Psilocybine is included in Schedule 8 of the Poisons Standard only for the treatment of treatment-resistant depression.".

6New regulation 9A inserted

After regulation 9 of the Principal Regulations insert—

"9A   Person must not possess Schedule 8 MDMA or Schedule 8 psilocybine

A person must not possess Schedule 8 MDMA or Schedule 8 psilocybine unless—

(a)the person is an authorised psychedelic psychiatrist; or

(b)the person is a registered medical practitioner, nurse or nurse practitioner who is instructed by an authorised psychedelic psychiatrist to administer the Schedule 8 MDMA or Schedule 8 psilocybine to a person in the authorised psychedelic psychiatrist's care; or

(c)the person is a pharmacist carrying on the lawful practice of the pharmacist's profession; or

(d)the person holds or is the agent of a person who holds a licence or permit under the Act or Regulations that allows that person to possess Schedule 8 MDMA or Schedule 8 psilocybine; or

(e)the person is engaged, or employed by a person who is engaged, to transport Schedule 8 MDMA or Schedule 8 psilocybine at the request of a person referred to in paragraph (d); or

(f)the person is a registered medical practitioner and the Schedule 8 MDMA or Schedule 8 psilocybine is for another person who is a participant in a clinical trial that is—

(i)approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and

(ii)approved by a human research ethics committee; or

(g)the person is a nurse or nurse practitioner who is instructed by a registered medical practitioner to administer the Schedule 8 MDMA or Schedule 8 psilocybine to another person who is a participant in a clinical trial that is—

(A)approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and

(B)approved by a human research ethics committee.

Penalty:100 penalty units.".

7Persons authorised to issue prescriptions

After regulation 16(3) of the Principal Regulations insert—

"(4)A person must not issue a prescription for Schedule 8 MDMA or Schedule 8 psilocybine unless—

(a)the person is an authorised psychedelic psychiatrist; or

(b)the person is a registered medical practitioner and the prescription is for another person who is a participant in a clinical trial that is—

(i)approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and

(ii)approved by a human research ethics committee.

Penalty:100 penalty units.".

8Issuing prescription for Schedule 4, 8 or 9 poison—registered medical practitioner

After regulation 17(d) of the Principal Regulations insert—

"(da)if the poison is Schedule 8 MDMA or Schedule 8 psilocybine, the registered medical practitioner is—

(i)an authorised psychedelic psychiatrist; or

(ii)a registered medical practitioner and the prescription is for another person who is a participant in a clinical trial that is—

(A)approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and

(B)approved by a human research ethics committee; and".

9New regulation 17A inserted

After regulation 17 of the Principal Regulations insert—

"17A   Notice to Secretary of intention to prescribe, authorise administration, or administer Schedule 8 MDMA or Schedule 8 psilocybine

(1)An authorised psychedelic psychiatrist who intends to prescribe, authorise the administration of, or administer, Schedule 8 MDMA or Schedule 8 psilocybine to another person must notify the Secretary in the prescribed form of the psychiatrist's intention to do so not less than 7 days before prescribing, authorising the administration of, or administering, the Schedule 8 MDMA or Schedule 8 psilocybine.

Penalty:100 penalty units.

(2)A registered medical practitioner who intends to prescribe, authorise the administration of, or administer, Schedule 8 MDMA or Schedule 8 psilocybine for or to another person who is a participant in a clinical trial must notify the Secretary in the prescribed form of the medical practitioner's intention to do so not less than 7 days before prescribing, authorising the administration of, or administering the Schedule 8 MDMA or Schedule 8 psilocybine.

Penalty:100 penalty units.

(3)For the purposes of subregulations (1) and (2), the prescribed form is Form 7 in Schedule 2.".

10New regulation 36A inserted

After regulation 36 of the Principal Regulations insert—

"36A   Supply of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners

(1)An authorised psychedelic psychiatrist must not supply Schedule 8 MDMA or Schedule 8 psilocybine unless the supply is to—

(a)a nurse or nurse practitioner for the purpose of administering the Schedule 8 MDMA or Schedule 8 psilocybine under regulation 98B; or

(b)another registered medical practitioner for the purpose of administering Schedule 8 MDMA or Schedule 8 psilocybine to a person under regulation 98A.

Penalty:100 penalty units.

(2)A registered medical practitioner must not supply Schedule 8 MDMA or Schedule 8 psilocybine for another person who is a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and is approved by a human research ethics committee unless the supply is to—

(a)a nurse or nurse practitioner for the purpose of administering the Schedule 8 MDMA or Schedule 8 psilocybine under regulation 98B; or

(b)another registered medical practitioner for the purpose of authorising administration or administering Schedule 8 MDMA or Schedule 8 psilocybine to a person under regulation 78A or 98A.

Penalty:100 penalty units.".

11Sale or supply of Schedule 8 poison by pharmacist

After regulation 48(1)(e) of the Principal Regulations insert—

"(ea)if the poison is Schedule 8 MDMA or Schedule 8 psilocybine, the sale or supply is to—

(i)an authorised psychedelic psychiatrist who has—

(A)issued a prescription for the Schedule 8 MDMA or Schedule 8 psilocybine and the sale or supply is on that original prescription; or

(B)issued a written instruction or given a verbal instruction in respect of the Schedule 8 MDMA or Schedule 8 psilocybine; or

(ii)a registered medical practitioner, nurse practitioner or nurse authorised by an authorised psychedelic psychiatrist referred to in subparagraph (i) to act on the psychiatrist's behalf; or

(iii)a registered medical practitioner who has—

(A)issued a prescription for the Schedule 8 MDMA or the Schedule 8 psilocybine for another person who is a participant in a clinical trial and the clinical trial is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and approved by a human research ethics committee and the sale or supply is on that original prescription; or

(B)issued a written instruction or given a verbal instruction in respect of the Schedule 8 MDMA or Schedule 8 psilocybine for another person who is a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and approved by a human research ethics committee; or

(iv)a registered medical practitioner, nurse practitioner or nurse authorised by a registered medical practitioner referred to in subparagraph (iii) to act on the medical practitioner's behalf; or".

12New regulation 78A inserted

After regulation 78 of the Principal Regulations insert—

"78A   Authorising administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners

(1)An authorised psychedelic psychiatrist must not authorise the administration of Schedule 8 MDMA or Schedule 8 psilocybine unless—

(a)the administration is for the medical treatment of a person other than the psychiatrist; and

(b)that person is under the psychiatrist's care; and

(c)the psychiatrist has taken all reasonable steps to ensure a therapeutic need exists for that poison; and

(d)the administration is authorised not merely for the purpose of supporting the drug dependence of a person; and

(e)the psychiatrist has taken all reasonable steps to ascertain the identity of the person to whom the poison is to be administered; and

(f)the psychiatrist has complied with regulation 17A.

Penalty:100 penalty units.

(2)A registered medical practitioner must not authorise the administration of Schedule 8 MDMA or Schedule 8 psilocybine to a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and approved by a human research ethics committee unless—

(a)the medical practitioner is not the participant in the clinical trial; and

(b)the administration is for the purpose of the clinical trial; and

(c)the participant is under the medical practitioner's care; and

(d)the administration is authorised not merely for the purpose of supporting the drug dependence of the participant; and

(e)the medical practitioner has taken all reasonable steps to ascertain the identity of the participant to whom the poison is to be administered; and

(f)the medical practitioner has complied with regulation 17A.

Penalty:100 penalty units.".

13New regulations 98A and 98B inserted

After regulation 98 of the Principal Regulations insert—

"98A   Administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrists and certain registered medical practitioners

(1)An authorised psychedelic psychiatrist must not administer Schedule 8 MDMA or Schedule 8 psilocybine unless—

(a)the administration is for the medical treatment of a person other than the psychiatrist; and

(b)that person is under the psychiatrist's care; and

(c)the psychiatrist has taken all reasonable steps to ensure a therapeutic need exists for the Schedule 8 MDMA or Schedule 8 psilocybine; and

(d)the administration is not merely for the purpose of supporting the drug dependence of a person; and

(e)the psychiatrist has taken all reasonable steps to ascertain the identity of the person to whom the poison is to be administered; and

(f)the psychiatrist has complied with regulation 17A.

Penalty:100 penalty units.

(2)A registered medical practitioner must not administer Schedule 8 MDMA or Schedule 8 psilocybine—

(a)unless—

(i)the administration is to a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and approved by a human research ethics committee; and

(ii)the medical practitioner is not the participant in the clinical trial; and

(iii)the administration is for the purpose of the clinical trial; and

(iv)the participant is under the medical practitioner's care; and

(v)the administration is not merely for the purpose of supporting the drug dependence of the participant; and

(vi)the medical practitioner has taken all reasonable steps to ascertain the identity of the participant to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered; and

(vii)the medical practitioner has complied with regulation 17A; or

(b)unless—

(i)the medical practitioner is authorised to do so under regulation 78A(1); and

(ii)the Schedule 8 MDMA or Schedule 8 psilocybine is administered for the treatment of another person; and

(iii)the Schedule 8 MDMA or Schedule 8 psilocybine is administered not merely for the purpose of supporting the drug dependence of that person; and

(iv)the medical practitioner has taken all reasonable steps to ascertain the identity of the person to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered.

Penalty:100 penalty units.

98BAdministration of Schedule 8 MDMA or Schedule 8 psilocybine— nurse or nurse practitioner

A nurse or nurse practitioner must not administer Schedule 8 MDMA or Schedule 8 psilocybine—

(a)unless—

(i)the nurse or nurse practitioner is authorised to do so under regulation 78A(1); and

(ii)the Schedule 8 MDMA or Schedule 8 psilocybine is administered for the treatment of another person; and

(iii)the Schedule 8 MDMA or Schedule 8 psilocybine is administered not merely for the purpose of supporting the drug dependence of that person; and

(iv)the nurse or nurse practitioner has taken all reasonable steps to ascertain the identity of the person to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered; or

(b)unless—

(i)the administration is to a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and approved by a human research ethics committee; and

(ii)the nurse or nurse practitioner is authorised to do so under regulation 78A(2); and

(iii)the nurse or nurse practitioner is not the participant in the clinical trial; and

(iv)the administration is for the purpose of the clinical trial; and

(v)the administration is not merely for the purpose of supporting the drug dependence of the participant; and

(vi)the nurse or nurse practitioner has taken all reasonable steps to ascertain the identity of the participant to whom the Schedule 8 MDMA or Schedule 8 psilocybine is to be administered.

Penalty:100 penalty units.".

14Administration of Schedule 8 poison by pharmacist

(1)In regulation 100 of the Principal Regulations, after "Schedule 8 poison" insert "(other than Schedule 8 MDMA or Schedule 8 psilocybine)".

(2)At the end of regulation 100 of the Principal Regulations insert—

"(2)A pharmacist must not administer Schedule 8 MDMA or Schedule 8 psilocybine.

Penalty:100 penalty units.".

15Schedule 2 amended

In Schedule 2 to the Principal Regulations, after Form 6 insert—

"FORM 7

Regulation 17A

Drugs, Poisons and Controlled Substances Regulations 2017

NOTICE OF INTENTION TO PRESCRIBE, AUTHORISE TO ADMINISTER, OR ADMINISTER SCHEDULE 8 MDMA OR SCHEDULE 8 PSILOCYBINE

Section 1: Psychiatrist or medical practitioner's details

First name and surname

Practice address

Qualifications

Health Practitioner Regulation National Law registration number 

TGA Authorised Prescriber approval number (if applicable)

Phone number

Email address

Section 2: Person's details

First name and surname 

Address

Date of birth 

Sex

Name and address of site where the person is receiving treatment 

Substance details

Name of substance 

Proprietary name (if available)

Dose form and strength

Maximum dose and frequency

Anticipated date(s) of administration

Local Australian supplier details

Name and address of local Australian supplier (e.g. pharmacy or wholesaler)

Details of other treatment (if applicable)

Name of Clinical Trial (if applicable)

Clinical Trial Notification ID/Clinical Trial Approval ID (if applicable)

Ethics approval number (if applicable)

Name of Human Research Ethics Committee that granted the ethics approval (if applicable)".

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ENDNOTES

[1] Reg. 4: S.R. No. 29/2017 as amended by S.R. Nos 31/2018, 45/2018, 72/2018, 178/2018, 15/2020, 73/2020, 13/2021, 174/2021, 13/2022, 16/2022, 96/2022, 112/2022, 113/2022 and 20/2023.

——

Penalty Units

These Regulations provide for penalties by reference to penalty units within the meaning of section 110 of the Sentencing Act 1991. The amount of the penalty is to be calculated, in accordance with section 7 of the Monetary Units Act 2004, by multiplying the number of penalty units applicable by the value of a penalty unit.

The value of a penalty unit for the financial year commencing 1 July 2023 is $192.31. The amount of the calculated penalty may be rounded to the nearest dollar.

The value of a penalty unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a penalty unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.