Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (50 of 2024)

Schedule 4   Supply of therapeutic vaping goods by pharmacists without prescription

Part 1   Amendments

Therapeutic Goods (Medicines and OTG - Authorised Supply) Rules 2022

11   At the end of section 5A

Add:

Supply by a pharmacist - without prescription

(5) A pharmacist is authorised to supply a therapeutic good to a patient where:

(a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and

(b) the therapeutic good is in the dosage form specified in column 3 of that item; and

(c) the therapeutic good is to be administered by the route specified in column 4 of that item; and

(d) the supply is for the indication specified in column 5 of that item; and

(e) the supply is to a patient who is 18 years of age or over; and

(f) the pharmacist requests and sights evidence of the patient's identity and age; and

(g) the quantity of the goods does not exceed the quantity that is reasonably required for a patient's therapeutic use for 1 month and that quantity is supplied to the patient only once in a month; and

(h) the concentration of nicotine in the goods does not exceed 20 mg/mL; and

(i) the conditions specified in subsections (6) and (7) are satisfied.

(6) The pharmacist must:

(a) inform the patient, or a parent or a guardian of the patient, that the therapeutic good is not a listed good or registered good; and

(b) obtain informed consent from the patient, or a parent or a guardian of the patient, in relation to, and before, the supply of the therapeutic good; and

(c) supply the therapeutic good in accordance with good pharmacy practice; and

(d) provide professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines; and

(e) provide contact details about smoking cessation support services to the patient; and

(f) if the pharmacist becomes aware that the patient has suffered an adverse event in relation to the therapeutic good - notify the Therapeutic Goods Administration and the sponsor of the therapeutic good about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

(g) if the pharmacist becomes aware of a defect in the therapeutic good - notify the Therapeutic Goods Administration and the sponsor of the therapeutic good in accordance with the reporting guidelines set out in the SAS Guidance.

(7) The pharmacist must store the therapeutic good in a part of the pharmacy premises to which the public does not have access.