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Nicotine vaping products: Information for pharmacists
- Nicotine vaping product access
- Standard for unapproved and export only nicotine vaping products
- Nicotine vaping products: Frequently Asked Questions
- Authorised Prescribers of unapproved nicotine vaping products
- Guidance for the use of nicotine vaping products for smoking cessation
- Accessing unapproved products
This page provides an overview of what pharmacists need to know in relation to sourcing and dispensing nicotine vaping products in Australia.
Nicotine vaping products are prescription medicines
From 1 October 2021, all nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, will be Schedule 4 (prescription only) medicines. Consumers will require a prescription for all purchases of nicotine vaping products. This includes products purchased both in Australia and from overseas. Further information about the reasons for this change is available on the Nicotine vaping product access page.
Nicotine replacement therapies (NRTs) (including sprays, patches, lozenges, chews and gums) that do not require a prescription will continue to be available from pharmacies and some retail outlets.
Nicotine vaping products are 'unapproved' products
There are currently no nicotine vaping products approved by the Therapeutic Goods Administration (TGA) registered in the Australian Register of Therapeutic Goods (ARTG). Medicines that are not in the ARTG are known as ‘unapproved’ medicines. There are established pathways for consumers to legally access unapproved nicotine vaping products, with a valid medical prescription. The main pathways for Australian pharmacies to dispense unapproved nicotine vaping products are the Authorised Prescriber (AP) scheme and Special Access Scheme Category B (SAS B). Further information about these schemes is provided below.
There are various smoking cessation aids included in the ARTG, including many NRTs and some prescription medicines, which have been assessed by the TGA for safety, quality and efficacy. There are also non-pharmaceutical approaches to smoking cessation.
Product standard for unapproved and export only nicotine vaping products
The TGA has introduced a new standard for unapproved and export only nicotine vaping products, known as the Therapeutic Goods (Standard for Nicotine Vaping Products (TGO 110) Order 2021 (TGO 110), that comes into effect on 1 October 2021. TGO 110 includes minimum safety and quality requirements for unapproved nicotine vaping products.
This does not mean that unapproved nicotine vaping products that comply with TGO 110 have TGA approval. The long-term health risks of unapproved nicotine vaping products, even those that comply with TGO 110, are still unclear and the evidence of their potential efficacy for smoking cessation is currently mixed.
Further information on the requirements of TGO 110 is available in our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) Order 110 2021 (TGO 110) and related matters (Guidance on TGO 110).
Sourcing nicotine vaping products
Pharmacies may obtain unapproved nicotine vaping products prior to receiving, but for the purpose of dispensing, prescriptions issued by an AP or under an SAS approval. You can hold the unapproved nicotine vaping products in your dispensary until you receive a prescription.
Unapproved nicotine vaping products may be sourced:
- from Australian sponsors and/or wholesalers, or
- directly from overseas suppliers.
If you source products from Australian sponsors or wholesalers, you may want to make enquiries of the sponsor or wholesaler about conformance to TGO 110 prior to ordering the products. You should only dispense products that conform to the requirements of TGO 110.
If you source products directly from overseas suppliers, you are likely to be considered the Australian sponsor of those products. Australian sponsors need to make the relevant customs declarations and will have primary responsibility for ensuring that products conform to the requirements in TGO 110. They also need to maintain records demonstrating conformance of their products to TGO 110. The ‘Record-keeping obligations for Australian sponsors’ section of our Guidance on TGO 110 will assist you in determining if you will be considered the Australian sponsor of a product. Further information for Australian sponsors is available on our Information for sponsors, manufacturers and wholesalers page.
Dispensing unapproved nicotine vaping products
If a medical practitioner determines that an unapproved nicotine vaping product is a suitable smoking cessation option for their patient, the medical practitioner can apply to the TGA for authority to prescribe the unapproved product through AP scheme or the SAS B. Depending on state or territory restrictions, other prescribing health practitioners may also be able to apply under the SAS B.
Recent changes to the AP scheme mean that medical practitioners may apply for AP approval to prescribe nicotine vaping products as an aid to stop smoking without ethics committee approval. A simplified nicotine-specific online form is available on the Authorised Prescriber dashboard of the SAS & Authorised Prescriber Online System. For the five year duration of the approval no further applications or permissions are required. These changes do not apply to heat-not-burn tobacco products.
Pharmacists can dispense a prescription for nicotine vaping products with evidence of an AP or SAS B approval, subject to any applicable state or territory restrictions or requirements. See the state and territory restrictions and requirements section below for further information.
The TGA has released a list of APs of unapproved nicotine vaping products who have consented to have their name and consulting location published. There are additional Authorised Prescribers who have not consented to have their name published.
Practical information for prescribers, including to raise awareness of how to prescribe nicotine vaping products in Australia, is available in our Guidance for the use of nicotine vaping products for smoking cessation and may also be relevant for pharmacists.
The Pharmaceutical Society of Australia (PSA) is also preparing guidance for pharmacists about the dispensing of nicotine vaping products (PSA Guidelines).
The flow chart below illustrates the steps leading up to dispensing a prescription for an unapproved nicotine vaping product.
Extemporaneous compounding of nicotine vaping products
Pharmacists can extemporaneously compound a nicotine vaping product for a particular person on prescription. When extemporaneously compounding product, pharmacists must follow all relevant compounding standards and adhere to their professional obligations. The PSA Guidelines are expected to provide further information on these standards and obligations.
Pharmacists will be the Australian sponsor of any unapproved nicotine vaping products they extemporaneously compound. For each product they compound and dispense, pharmacists must:
- ensure that the product conforms to all of the requirements of TGO 110, and
- maintain records demonstrating that the product conforms to all of the requirements of TGO 110.
Further information about the obligations of Australian sponsors and the requirements of TGO 110 is available on our Information for sponsors, manufacturers and wholesalers page and in our Guidance on TGO 110.
Advertising and promotion of nicotine vaping products and related services
The advertising of prescription medicines, including nicotine vaping products, to consumers is generally prohibited in Australia. A number of states and territories also restrict the promotion of vaping devices.
However, a pharmacy may, in specified circumstances, advertise to consumers that they are able to dispense nicotine vaping products on prescription. Some states and territories also allow pharmacists to notify consumers in a specified manner if they supply vaping devices.
In addition, information shared between a doctor, pharmacist or nurse and their patient during consultation or treatment is not subject to the advertising rules for therapeutic goods, including the prohibition on advertising prescription medicines. Presenting factual and balanced information about using nicotine vaping products is also unlikely to be considered advertising, depending on the context in which the information is presented.
Further information on how you can lawfully refer to nicotine vaping products and vaping devices and promote your services is available in our guidance on Advertising nicotine vaping products to the Australian public.
Sourcing and supplying vaping devices
Vaping devices, such as vapes, e-cigarettes and e-cigars, are electronic devices used to heat nicotine vaping products for inhalation. Some nicotine vaping products are supplied in vaping devices (e.g. prefilled, disposable nicotine e-cigarettes and pods). Other vaping devices are supplied separately to the vaping product(s) used with those devices.
Most vaping devices are not medical devices for the purpose of the TGA’s framework. The ‘Vaping devices’ section on our Guidance on TGO 110 provides further information on the types of vaping devices that are and are not regulated by the TGA.
Subject to state and territory restrictions or requirements, pharmacists can hold stock of, and supply, vaping devices (whether or not they are medical devices) for use with nicotine vaping products. No AP, SAS B or clinical trial approval/notification is required to dispense a vaping device alone. If an unapproved nicotine vaping product is supplied in or with a vaping device, the unapproved nicotine vaping product must be accessed under one of the supply pathways for unapproved goods (e.g. under an AP approval), but no separate AP, SAS B or clinical trial approval/notification is required for the vaping device itself.
See the state and territory restrictions and requirements section below for further information.
Additional state and territory restrictions and requirements for nicotine vaping products and vaping devices
In addition to the general requirements applicable to the dispensing of Schedule 4 (prescription only) medicines, each state and territory has tobacco/smoking product or e-cigarette control legislation that may apply to pharmacists seeking to dispense nicotine vaping products or supply vaping devices. Some of the key restrictions and requirements under this legislation are set out below:
- The ACT, South Australia, Northern Territory and Tasmania may require pharmacists to obtain a retail licence for tobacco products/e-cigarettes before they dispense nicotine vaping products or supply vaping devices.
- NSW requires pharmacists to notify NSW Health before they dispense nicotine vaping products or supply vaping devices.
- In WA, products that resemble tobacco products, including vaping devices, cannot be sold. However, pharmacists are permitted to dispense nicotine vaping products that are Schedule 4 (prescription only) medicines.
There are also restrictions and requirements in many jurisdictions relating to advertising, points of sale, and supply to persons under 18 years of age.
Please contact your relevant state or territory health department for further information.
|State / Territory||Contact details||State/Territory guidance materials|
|Australian Capital Territory||Health Protection Service
Phone: 02 6205 2155
|New South Wales||State and Territory contact information||https://www.health.nsw.gov.au/tobacco/Pages/ecig-retailers.aspx https://www.health.nsw.gov.au/tobacco/Pages/tobacco-retailing-laws.aspx|
|Northern Territory||State and Territory contact information|
For smoking productsPrevention Strategy Unit
Preventive Health Branch
Prevention Division, Department of Health
Address: PO Box 2368, FORTITUDE VALLEY BC QLD 4006
For medicines and poisonsState and Territory contact information
For tobacco and e-cigarettes
For medicines and poisons
|Tasmania||State and Territory contact information|
|Victoria||Tobacco Control Section
|Western Australia||State and Territory contact information||https://ww2.health.wa.gov.au/Articles/A_E/Electronic-cigarettes-in-Western-Australia Further guidance will be distributed through established networks|
Report side effects and problems
We strongly encourage consumers and health practitioners to report any suspected side effects related to nicotine vaping products.
The TGA has an important role in monitoring the safety of 'unapproved' products. Reporting side effects and problems helps us to understand the safety of a product. We investigate significant safety concerns as part of ensuring product safety in the Australian community.
Reporting perceived breaches or questionable practices
We encourage you to report any perceived breach of the Therapeutic Goods Act 1989 or questionable practices in relation to the import, manufacture, supply, export or advertising of nicotine vaping products to the TGA. This includes the sale of nicotine vaping products by a retailer other than a pharmacist (e.g. by a vape store).
Nicotine vaping products present a poisoning risk
Accidental ingestion of, or exposure (such as through the skin or eyes) to, nicotine vaping products can have toxic, and sometimes severe, effects. When dispensing nicotine vaping products, you should advise your patient of the risk of accidental child poisoning if the container is left open in the process of refilling/mixing of nicotine vaping products (where relevant) and/or if nicotine vaping products are used in vaping devices without child-resistant safety features (including where a child is able to suck on the vaping device).
Consumers should seek urgent medical attention if they think that they, or anyone else, may have been exposed to or ingested a nicotine vaping product. Emergency services can be contacted by calling 000 and the Poisons Information Centre can be contacted by calling 131 126.