Controlled Substances (Poisons) (Serious Shortage Medicine Substitution) Variation Regulations 2021 (SA)

South Australia

Controlled Substances (Poisons) (Serious Shortage Medicine Substitution) Variation Regulations 2021

under the Controlled Substances Act 1984

Contents

Part 1—Preliminary

1            Short title

2            Commencement

3            Variation provisions

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

4            Insertion of regulation 35B

35B         Dispensing prescriptions—S4 drugs in serious shortage

Part 1—Preliminary

1—Short title

These regulations may be cited as the Controlled Substances (Poisons) (Serious Shortage Medicine Substitution) Variation Regulations 2021.

2—Commencement

These regulations come into operation on the day on which they are made.

3—Variation provisions

In these regulations, a provision under a heading referring to the variation of specified regulations varies the regulations so specified.

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

4—Insertion of regulation 35B

After regulation 35A insert:

35B—Dispensing prescriptions—S4 drugs in serious shortage

(1)If—

(a)a prescription for an S4 drug is presented to a pharmacist for dispensing; and

(b)the drug to which the prescription relates is a medicine in respect of which a Serious Shortage Medicine Substitution Notice issued by the TGA under the Commonwealth Act is in force; and

(c)the pharmacist is unable to dispense the prescription because the pharmacist does not have, and cannot obtain, the drug to which the prescription relates in the strength, release form or dose form specified in the prescription; and

(d)the person for whom the prescription has been given consents to receiving the drug in a strength, release form or dose form specified in the Notice instead; and

(e)the pharmacist is of the opinion that it is appropriate to supply the person with the drug in a strength, release form or dose form specified in the Notice,

the pharmacist may supply the person with the drug in a strength, release form or dose form specified in the Notice in accordance with the conditions stated in the Notice.

(2)If a pharmacist supplies a drug as authorised by subregulation (1), the pharmacist must, as soon as practicable, give the prescriber of the drug notice in writing of the strength, release form and dose form in which the drug was supplied.

Maximum penalty: $3 000.

(3)For the purposes of these regulations, if a pharmacist supplies a drug as authorised by subregulation (1), the pharmacist will be taken to have dispensed the prescription for the drug presented to the pharmacist.

Note—

As required by section 10AA(2) of the Subordinate Legislation 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 27 January 2021

No 3 of 2021