From today, patients 18 years or over can purchase therapeutic vapes from participating pharmacies without a prescription. A consultation with a pharmacist is required, and purchase is subject to certain conditions as well as any state and territory restrictions.
The changes mean there are now two lawful pathways for accessing therapeutic vapes - the pharmacist only model and the prescription model.
- Pharmacist only model, where it is clinically appropriate for the purpose of smoking cessation or the management of nicotine dependence, pharmacists can supply therapeutic vapes containing 20 mg/mL or less of nicotine to patients who are 18 years or older without a prescription, subject to certain conditions.
- Prescription model, patients require a prescription from a medical or nurse practitioner. If patients are under 18 years of age, require a higher nicotine concentration than 20 mg/mL or have complex medical needs and require additional advice and support they will need to obtain a prescription.
Therapeutic vapes can only be dispensed at an Australian registered pharmacy.
Importantly, medical and nurse practitioners are not obliged to prescribe therapeutic vapes, and pharmacists cannot be compelled to stock or supply them, regardless of whether a patient holds a prescription.
Prescribers and pharmacists should also familiarise themselves with the requirements in their state or territory.
Only vaping products included in the TGA's list of notified vapes, or the Australian Register of Therapeutic Goods (ARTG), can be dispensed or supplied, even if a person has a prescription for a product not included in the list.
There are currently no vaping goods for use in smoking cessation or the management of nicotine dependence on the ARTG that have been assessed by the TGA for quality, safety and efficacy. The available vaping goods must still meet certain product standards to be included on the list of notified vapes.
These standards apply to both the e-liquid and device components of vapes, and cover things like permitted and prohibited ingredients, and labelling and packaging requirements. Product sponsors are responsible for notifying the TGA that their goods meet these standards.
The TGA has today published enhanced product standards for vapes which will commence from 1 October 2024 but with transition periods in place until 1 March 2025 (for import and manufacture) and 1 July 2025 (for supply) to allow industry sufficient time to update their products to comply.
The Department of Health and Aged Care, the TGA and a range of stakeholders continue to develop and publish resources to support the Australian community, industry and health practitioners through these changes. Recently published resources include:
- Professional practice guidelines for pharmacists: nicotine dependence support - Pharmaceutical Society of Australia
- Prescribing and dispensing of prescription only therapeutic vaping goods to patients under 18 years of age
- Supporting smoking and vaping cessation: A guide for health professionals - Royal Australian College of General Practitioners
- Pharmacist video series:
Comprehensive information on the broader legislative and regulatory changes is available on the TGA's Vaping hub.
