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Vapes: information for pharmacists

Learn about how vapes for smoking cessation and nicotine dependence are regulated, and the requirements for dispensing and supplying vapes.

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Summary

Vapes for the management of smoking cessation and nicotine dependence can only be sold at participating pharmacies, and not other retail outlets, from 1 July 2024. This applies to all vaping goods, including those that do not contain nicotine.

From 1 October 2024 pharmacists may supply vapes with a nicotine concentration of 20mg/mL or less to people 18 years or over without a prescription subject to certain conditions and state and territory law.

A prescription will continue to be required to dispense a therapeutic vape in some instances.

A prescription from a medical or nurse practitioner will be required for nicotine concentrations greater than 20 mg/mL.

People under 18 years of age will require a prescription to access vapes, where state and territory laws allow.

A prescription may also be required under state and territory legislation, or if the patient is assessed as having more complex medical needs and requires additional advice and support from a medical practitioner.

Pharmacists cannot be compelled to stock or supply therapeutic vapes, regardless of whether a patient holds a prescription.

Cannabis vapes are subject to separate strict regulations (see the Medicinal cannabis hub).

Clinical resources

State and territory requirements

Additional rules relating to vape products vary between states and territories and could affect whether or not vapes can be lawfully prescribed, dispensed and supplied in your state or territory. The PSA has published further information on these requirements on its website - external site.

There are also state and territory restrictions and requirements in many jurisdictions relating to prescribing, dispensing and supply to persons under 18 years of age. See Prescribing and dispensing of prescription only therapeutic vaping goods to patients under 18 years of age.

Pharmacists should check with their relevant state or territory health department for further information to confirm the current requirements in their respective jurisdiction.

Therapeutic vapes are unapproved goods

Therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) are known as unapproved goods.

There are currently no vapes for smoking cessation or the management of nicotine dependence included in the ARTG.

Therefore no vapes have been assessed by the TGA for quality, safety and efficacy or performance.

Unapproved therapeutic vapes must comply with the relevant TGA product standards.

Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme for unapproved goods

There are four pathways for accessing unapproved vapes with a scheduled substance. Learn more about the pathways for accessing unapproved products. 

Authorised Prescriber - Established History of Use pathwayFor medical practitioners for patients over 16 years.*
Authorised Prescriber - Standard pathwayFor medical practitioners for patients under 16 years.*
SAS C notification pathway

For medical practitioners and nurse practitioners for patients over 16 years. *

For pharmacists for patients over 18 years AND for nicotine 20mg/mL or less.

SAS Category B application pathway For medical practitioners and nurse practitioners for patients under 16 years.*

*Please note state and territory restrictions for persons under 18 years of age (see above).

Schedule 3 (pharmacist-only) supply requirements

Pharmacists can supply vapes where it is clinically appropriate to patients who:

  • are 18 years or over
  • require a nicotine concentration of 20mg/mL or less
  • provide informed consent, which includes informing the patient or patient’s carer that the therapeutic good is not a listed good or registered good.

Before supplying a therapeutic vape for smoking cessation or the management of nicotine dependence, a pharmacist must:

  • be satisfied that supply is clinically appropriate for smoking cessation or the management of nicotine dependence
  • request and sight evidence of the patient’s identity and age (cannot be supplied to a third party unless they are the patient's carer)
  • inform the patient that the goods are not included in the ARTG and obtain the patient’s informed consent
  • provide professional advice to the patient in relation to alternative registered (Australian Register of Therapeutic Goods) therapies, appropriate dose and frequency and interactions with other medicines
  • ensure the quantity of goods supplied by the pharmacist to the relevant patient does not exceed one month supply in one month
  • provide contact details about cessation support services to the patient
  • supply the goods in accordance with state and territory legislation and good pharmacy practice.

Rules relating to vape products vary between states and territories and could affect whether or not vapes can be lawfully prescribed, dispensed and supplied in your state or territory.

Other regulatory obligations include:

  • only dispensing up to 1 month supply to the patient per month
  • requesting evidence of patient’s identity and age in accordance with relevant state and territory legislation. However, there is no requirement to report this information to the TGA.
  • providing advice and contact details to the patient on alternative cessation supports and therapies
  • reporting any adverse events to the TGA

Pharmacists supplying unapproved therapeutic vaping goods as Schedule 3 (pharmacist only) medicines must use the TGA SAS-C notification pathway.

SAS-C notification must be:

  • provided by pharmacists for each instance of supply
  • made within 28 days of supply. Best practice is to provide the notification at the time of supply.

Schedule 4 (prescription medicine) dispensing requirements

The supply of prescription only vapes must be accompanied by a valid SAS or AP approval or notification (or reference number) from the prescriber.

Pharmacists who dispense prescriptions for vapes can confirm the validity of the SAS or AP submission by using the TGA online validation tool or by contacting the prescriber.

Using the SAS and AP online system

Pharmacists must use the SAS and Authorised Prescriber Online System to make a SAS-C notification for a Schedule 3 pharmacist only supply of nicotine vaping goods. A notification should be completed for each supply transaction with a patient.

Pharmacists can also validate AP and SAS approvals and notifications through the online validation tool.

First time users will need to register an account: https://compliance.health.gov.au/ - external site

These YouTube videos explain:

Storing, dispensing and supplying

Pharmacists can only dispense and supply vaping products directly to a patient or patient’s carer.

Prescribers and pharmacists must only supply products in their final dosage form (a finished product) to a patient.

Vaping devices that do not contain, and are not packaged with, a vaping substance do not need to be prescribed or supplied under the AP, SAS B or SAS C schemes, and therefore do not require a SAS notification.

However, a pharmacist can only supply a vaping device if satisfied that it will be for use for smoking cessation or the management of nicotine dependence.

Pharmacists must store all vapes - including vaping substances, vaping accessories and vaping devices - behind the counter.

Pharmacists must comply with all legislation relevant to the practice of pharmacy in the jurisdiction where the practice occurs.

Labelling exemption

The TGA has granted a time-limited labelling exemption that applies to vapes containing nicotine where:

  • the vapes are on the notified vape list and contain nicotine as the only active ingredient
  • the vapes are labelled as ‘PRESCRIPTION ONLY MEDICINE’, and
  • at the time of supply by the pharmacist, medical practitioner or nurse practitioner, the vape otherwise complies with the entry for nicotine in Schedule 3 to the Poisons Standard.

This means that – if the labelling exemption is adopted by your state/territory – a product with the signal heading ‘PRESCRIPTION ONLY MEDICINE’ can be supplied as a Schedule 3 pharmacist only product without the signal heading ‘PHARMACIST ONLY MEDICINE’, where these conditions are met.

The exemption is designed to support transition to the updated scheduling of nicotine from 1 October 2024 and allows pharmacists to effectively manage their stock.

The exemption applies until 30 September 2025 unless revoked earlier.

Important. The labelling exemption must be adopted by your state/territory to apply in your jurisdiction. Please contact your state/territory health department for further information.

Product standards and notified vape list

Pharmacies must only source and supply therapeutic vapes for smoking cessation or the management of nicotine dependence that are compliant with the TGA product standards and included on the TGA’s list of notified vapes, or are otherwise included on the Australian Register of Therapeutic Goods.

The vapes on the notified list have not been assessed by the TGA for quality, safety and efficacy or performance, but may be lawfully imported, manufactured and supplied as unapproved therapeutic goods, subject to the regulatory requirements.

Read more about the product standards here.

Compounding

Only finished products are lawful to dispense or supply. Pharmacists cannot dispense or supply component ingredients for consumers to use to mix or dilute their own substances.

Pharmacists can only extemporaneously compound vapes if they have sought and been granted a section 41RC consent from the TGA.

Pharmacists will be the Australian sponsor of any unapproved therapeutic vaping substance that they extemporaneously compound.

For each product they compound and dispense, pharmacists must:

  • ensure that dispensing is done in accordance with the prescriber's intentions
  • must comply with all legislation relevant to the practice of pharmacy in the jurisdiction where the practice occurs
  • meet professional standards that are determined by the Pharmacy Board of Australia
  • ensure that the product conforms to all requirements of product standard TGO 110, and
  • maintain records demonstrating that the product conforms to all requirements of TGO 110.

Further information for Australian sponsors is available on our vapes: information for importers, manufacturers and wholesalers page.

Reporting requirements

ADR reporting

If supplying a pharmacist only vape pharmacists must report adverse events and product defects to the TGA and the sponsor of the therapeutic good.

Read how to report a problem or side effect.

We encourage patients and health practitioners to report any suspected side effects or malfunctions related to vapes.

Report unlawful practices

We encourage you to report any perceived breach of the Therapeutic Goods Act 1989 or questionable practices relating to the importation, manufacture, supply, export or advertising of vapes to the TGA. This includes the supply of vapes by a retailer other than a pharmacist (e.g. by a vape store).

Restrictions on advertising and promotion of vapes

Changes to the Therapeutic Goods Act 1989 from 1 July 2024 prohibit advertising of all vaping goods unless authorised by the TGA. There are significant penalties for advertising vaping goods without authorisation.

Specified health professionals, including pharmacists, can communicate specific information about therapeutic vapes to patients in the context of their treatment.

Read more about advertising and promotion requirements.
 

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