Supplying therapeutic vapes in pharmacies

• Vapes for smoking cessation and the management of nicotine dependence are ‘unapproved’ therapeutic goods.
  • ‘Unapproved’ therapeutic goods refer to therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG).
  • Generally, therapeutic goods must be included in the ARTG before they can be lawfully imported, supplied, or exported from Australia.
  • Under vaping law reforms, there is legal access to therapeutic vapes in pharmacies through regulatory pathways for unapproved therapeutic goods.
• Only supply vaping goods that are included in our notified vape list.
  • Product sponsors have notified us that these vaping goods meet our applicable product standards.
• Therapeutic vapes are not first-line treatment for smoking cessation or the management of nicotine dependence.
  • First-line treatments include behavioural support and approved pharmacotherapies.
• Clinical guidelines are available on the use of therapeutic vapes for smoking cessation and the management of nicotine dependence, including:
  • Royal Australian College of General Practitioners (RACGP) Guidelines
  • Pharmaceutical Society of Australia (PSA) Guidelines
• Pharmacists may supply Schedule 3 (S3) therapeutic vapes that have a nicotine concentration of 20 mg/mL or less (where permitted under applicable state and territory law):
  • only to people aged 18 years and over, and subject to conditions including those set out in state and territory law.
• A prescription is required from a medical or nurse practitioner to supply a Schedule 4 (S4) therapeutic vape, that has a nicotine concentration greater than 20 mg/mL (or for all therapeutic vapes in a state or territory that does not permit S3 supply).
• A prescription is required for supply of a vape to persons under 18 years of age.
  • Note, some state and territory laws do not allow supply of vapes to anyone under 18 years of age, even with a prescription.
  • To learn more about the requirements for people under 18 years of age see Prescribing and dispensing of prescription only therapeutic vaping goods to patients under 18 years of age.
• Vapes with a nicotine concentration of more than 50 mg/mL are not permitted.
• Vapes should only be supplied in person by the pharmacist to the patient or their carer.
• Vaping devices (i.e. which do not contain a vaping substance) may be supplied by a pharmacist without a prescription provided that:
  • pharmacists are satisfied that the intended use of the vaping device is to support smoking cessation or the management of nicotine dependence; and
  • subject to any additional restrictions or limitations under state or territory law.
• Pharmacists are not compelled to stock therapeutic vapes.
• There is more information online about the vaping reforms on our TGA Vaping hub.
• This guidance is not for medicinal cannabis vaping devices - for information about these go to our TGA Medicinal cannabis hub.

Access to therapeutic vapes is only through Australian pharmacies for the purpose of helping people to quit smoking and manage nicotine dependence, where clinically appropriate.

Therapeutic vapes are classified as Prescription Only (S4) medicines, or Pharmacist Only (S3) medicines depending on their nicotine concentration.

Therapeutic vapes that contain zero-nicotine, while not included in S3 or S4, are still considered to be vaping goods. As such, access to zero-nicotine vapes is also restricted to pharmacies.

Pharmacists must store all vaping goods - including vaping substances, vaping accessories and vaping devices - behind the counter and out of line of sight of the public.

States and territories may impose additional controls on access to vapes. Pharmacists should contact their state or territory health department for further information. 

To find contacts for State/Territory medicines and poisons regulation units go to Contacts for State/Territory medicines & poisons regulation units.

As vaping substances are unapproved therapeutic goods, their lawful supply is via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways.

For more information about the SAS and AP online system see SAS and AP Online System Information.

Pharmacists must consult with the patient to assess their clinical needs and the suitability of a vaping product, taking account of first-line treatment options.

All instances of supply by a pharmacist without a prescription must comply with the Authorised Supply Rules, including that pharmacists must:

• ensure the goods are on our notified vape list
• ensure that supply is for the indication of smoking cessation and/or the management of nicotine dependence
• verify that the patient is 18 years of age or older by requesting and sighting evidence of identity and age
• ensure that the quantity supplied does not exceed what would reasonably be required for a patient’s therapeutic use for 1 month and that quantity is supplied to the patient only once in a month
• ensure that the concentration of nicotine in the product does not exceed 20 mg/mL
• inform the patient that the product is not a registered or listed good
• obtain informed consent from the patient
• supply in accordance with good pharmacy practice
• provide professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency, length of treatment, suitable titration, and interactions with other medicines
• provide contact details about smoking cessation support services to the patient
• report adverse events and product defects to us and the product sponsor in line with SAS guidance.

Note

You can read the Authorised Supply rules in full at Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022.

Pharmacists should use the SAS and Authorised Prescriber Online System to make a SAS Category C notification.

To lawfully supply S4 vapes: 

• a valid prescription from a medical practitioner or nurse practitioner is required,

and either:

• the prescription is accompanied by a SAS B approval or AP authorisation (or a reference number); or
• supply is under SAS C (notification pathway).

Pharmacists can confirm the SAS B approval or AP authorisation using the TGA online validation tool or by contacting the prescriber.

Supply by a pharmacist with a prescription under SAS C (notification pathway) must comply with the Authorised Supply Rules, including that:

• the goods are on our notified vape list
• supply is for the indication of smoking cessation and/or the management of nicotine dependence
• supply is to a patient at least 16 years of age (subject to age restrictions in some states and territories)
• the pharmacist reports adverse events and product defects to us and the sponsor in line with SAS guidance.

Note

Pharmacists may only supply vapes to patients under 16 years of age where the supply is approved under SAS B or AP – and when permitted under state and territory law.

RACGP Guidelines recommend that prescriptions be limited to a maximum of 3 months’ supply.

Staged supply of medicines is a structured pharmacist service where medications are dispensed in periodic instalments rather than all at once. Staged supply is permissible for vaping goods and may be requested by the prescriber, patient or carer; for example, to support safe use.

Pharmacists should note that staged supply of S3 vapes requires a SAS C notification for each supply (i.e. every time a vaping good is provided to the patient).

Pharmacies must only stock and supply therapeutic vapes that comply with our relevant product standards. The following standards apply to vaping goods:

• For therapeutic vaping substances, substance accessories, kits and goods in a pack: Therapeutic Goods (Standard for Therapeutic Vaping Products) (TGO 110)
• For therapeutic vaping devices and device accessories: Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order (MDSO)

Permitted ingredients for vapes are only:

• Nicotine (max 50 mg/mL)
• Propylene glycol
• Glycerol
• Water
• Mint, menthol or tobacco flavour.

Packaging: must be plain packaging and include information leaflets. Name restrictions apply.

Labelling: there must be labelling and usage instructions for devices and accessories.

Design: only plain design (no branding or decorative elements) for devices and accessories is permitted.

Technical standards: devices and accessories must meet stricter standards for:

• medical device quality
• risk management
• battery and electrical safety
• specific design and construction
• toxicological risk assessment.

Product sponsors are responsible for ensuring compliance with all applicable standards.

Note

More information on product standards for vaping goods is available at Product standards: unapproved therapeutic vapes.

It is important to remember that the TGA has not evaluated any vaping product for inclusion in the ARTG. Therapeutic vapes remain unapproved goods.

We publish the notified vape list online. This specifies therapeutic vaping goods that can legally be supplied in Australia, for use in smoking cessation and the management of nicotine dependence. The notified vape list includes:

• vaping substances
• devices
• kits
• packs
• accessories.

Sponsors have declared that these goods comply with our product standards.

It is important to remember that notified vaping goods are not included on the ARTG, and have not been assessed by us for quality, safety and efficacy or performance.

We also publish a list of vaping goods that the sponsor has voluntarily withdrawn, or that we have ceased after determining that the product should no longer be supplied.

Note

More information on product standards for vaping goods is available a Product standards: unapproved therapeutic vapes.

It is important to remember that the TGA has not evaluated any vaping product for inclusion in the ARTG. Therapeutic vapes remain unapproved goods.

We publish the Withdrawn or cased sponsor notices on our website.

Vaping devices (including replacement batteries or mouthpieces supplied separate to a vape) that do not contain (and are not packaged with a vaping substance) do not require a prescription, or SAS or AP approval or notification. However, pharmacists must be satisfied that the vaping device will be used by the intended person for purposes of smoking cessation or the management of nicotine dependence.

Pharmacists must only supply a vaping substance (whether supplied alone or with a vaping device) in its final dosage form. Vaping substances cannot be supplied in a form that requires change or modification prior to administration (other than the process of vaporisation).

Pharmacists are not permitted to compound vapes without individual consent from us for the manufacture of the goods.

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

For more information about the manufacture of vaping goods see Vapes: information for sponsors, importers and manufacturers.

If a pharmacist becomes aware that a patient has suffered an adverse event following the use of a therapeutic vaping good, they must notify us and the product sponsor within 15 calendar days after being made aware of this.

This notification should be in accordance with the Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods.

Patients and health practitioners are encouraged to report any suspected side effects or malfunctions related to vaping goods.

For more information about how to report an adverse event, including side effects and problems with vaping devices see Report an adverse event or safety problem.

TGA product standards require sponsors to provide an information leaflet to support the safe and proper use of therapeutic vapes.

Advertising or promoting therapeutic vaping goods to the public is prohibited, unless specifically authorised by us. Serious offences and civil penalty contraventions apply to the unlawful advertising of vaping goods.

However, certain information shared between a health practitioner and their patient about therapeutic vaping goods during consultation or treatment is exempt from advertising restrictions. Pharmacists are permitted to provide advice to patients to support the safe use of therapeutic vapes. Advice can include information about the availability and price of therapeutic vapes, details necessary for proper use, and product specific information.

To find out more about the restrictions around advertising and promotion that apply to vapes see Vapes: advertising and promotion.

Note

Pharmacists may provide direct advice or information to their patients about vaping products, where clinically appropriate. This forms part of patient counselling for smoking cessation or the management of nicotine dependence.

Audiovisual displays, stalls, electronic or hardcopy advertising, banners, pamphlets or samples of vapes must not used to promote vapes to patients.

Testimonials or endorsements about the vaping goods are not permitted.

When advertising a health service to the public that involves supporting smoking cessation or the management of nicotine dependence, pharmacists must ensure that all material does not promote the use or supply of vaping goods, either directly or indirectly.

Pharmacists must:

• focus on the health services and not therapeutic goods when advertising cessation support
• not promote vaping products, including vapes listed in S3, or using substitute terms
• ensure that any educational content produced is non-promotional and does not include references to vapes
• review social media platforms to ensure compliance.

For further guidance on advertising services that involve therapeutic goods see Advertising a health service.

• Clinical guidance for health professionals at Supporting smoking cessation on the RACGP website.
• Clinical guidance for pharmacists on the Pharmaceutical Society of Australia (PSA) Resource Hub.