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Vapes: information for pharmacists
Learn about changes to the regulation of vapes, and what the changes mean for sourcing these products and the requirements for dispensing.
This page provides an overview of what pharmacists need to know in relation to sourcing and dispensing vapes for smoking cessation or the management of nicotine dependence.
Vapes include vaping substances, vaping accessories and vaping devices.
This guidance does not apply to cannabis vapes, which are subject to separate strict regulation. Find out more at the Medicinal cannabis hub.
Consumers currently require a prescription for all purchases of vapes containing nicotine. Vapes containing nicotine can only be supplied in pharmacy settings. It is illegal for Australian retailers such as tobacconists, vape shops and convenience stores, to sell vapes containing nicotine, even with a prescription.
Reforms to the regulation of vapes
New regulations to place stronger controls on the importation, manufacture, and supply of vapes have now been made and are being implemented in stages in 2024. The first stage is the introduction of stricter import controls on vapes from 1 January 2024, with further controls to commence on 1 March 2024.
These reforms will protect Australians, particularly young people, from the harms of vaping and nicotine dependence while ensuring vapes remain available from a pharmacy to patients with a prescription, where clinically appropriate.
From 1 January 2024, the importation of all disposable vapes, irrespective of nicotine content, is banned, subject to very limited exceptions. This means that patients cannot purchase any disposable vapes online from overseas, even with a prescription.
Disposable vapes that were imported into Australia before 1 January 2024 may continue to be lawfully supplied in Australia, subject to the following requirements:
- disposable vapes containing nicotine that meet TGA requirements (including the quality requirements under the existing product standard) may continue to be lawfully supplied in Australia in pharmacy settings to a patient with a prescription in accordance with state and territory laws for prescription medicines
- disposable vapes that do not contain nicotine, or any other medicine, and do not make therapeutic claims, may be supplied by retailers generally, including vape stores, subject to state or territory law.
This allows legitimate retailers of disposable vapes to run down their stocks prior to the Government introducing legislation in early 2024 to prevent the domestic manufacture, advertisement, supply and commercial possession of disposable vapes to ensure comprehensive controls across all levels of the supply chain.
From 1 March 2024, the importation of all other vapes, irrespective of nicotine content or therapeutic claims, will be banned, unless certain conditions are met (see: Vaping reforms: Information for importers, manufacturers and wholesalers).
The importation ban will extend to the importation of vapes not for smoking cessation or the management of nicotine dependence, such as, vitamin, melatonin and tobacco vapes (also known as “heat not burn” tobacco products). Other changes will also commence, including the cessation of the personal importation of all vapes. This means that patients will no longer be able to order vapes from overseas, even if they have a prescription. At the same time, all vaping devices will be brought within the therapeutic goods framework, not simply those that are exclusively for the vaporisation and inhalation of a medicine.
Nicotine replacement therapies (NRTs) that are included in the Australian Register of Therapeutic Goods (including patches, lozenges, chews and gums) that do not require a prescription will continue to be available from pharmacies and some retail outlets.
Vapes are unapproved goods
There are currently no therapeutic vapes for smoking cessation or the management of nicotine dependence that have been evaluated by the TGA and included in the Australian Register of Therapeutic Goods (ARTG). Medicines that are not included in the ARTG are known as unregistered or ‘unapproved’ medicines.
There are established pathways for patients to legally access unapproved vapes, with a valid medical prescription. The main pathways for Australian pharmacies to dispense unapproved nicotine vapes are the Authorised Prescriber (AP) scheme and Special Access Scheme Category B (SAS B), and from 1 January 2024, the Special Access Scheme Category C (SAS C). Further information about these schemes is provided below.
There are various smoking cessation aids that are currently included in the ARTG, including many NRTs and some prescription medicines, which have been evaluated by the TGA for quality, safety and efficacy. There are also non-pharmaceutical approaches to smoking cessation or the management of nicotine dependence.
Product standards for unapproved vapes
The updated standard for therapeutic vaping goods, the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110) commenced on 1 January 2024. It includes minor updates to requirements that applies to goods that are imported or manufactured from 1 March 2024. The standard was previously known as the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021.
The requirements in TGO 110 apply to therapeutic vaping goods that are indicated for smoking cessation or the management of nicotine dependence. The requirements apply to therapeutic vaping substances (including filled pods and cartridges) and packs that contain a combination of vaping goods (including therapeutic vaping devices and unfilled pods and cartridges).
This does not mean that unapproved vapes that comply with TGO 110 are approved by the TGA. The long-term health risks of unapproved vapes, even those that comply with TGO 110, are still unclear and the evidence of their potential efficacy for smoking cessation or the management of nicotine dependence is currently mixed.
Further information on the updated requirements in TGO 110 is available here: Guidance for Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 and related matters (Guidance on TGO 110).
Guidance for pharmacists
The Pharmaceutical Society of Australia (PSA) Guidelines for pharmacists providing smoking cessation support (PSA Guidelines) describes the professional obligations of pharmacists providing services for smoking cessation or the management of nicotine dependence. It includes:
- an overview of the role of pharmacists in providing smoking cessation services
- practical information about supplying approved prescription medicines and vapes for smoking cessation
- a flowchart and guidance on non-prescription medicine treatment for smoking cessation
- a template patient handout on vapes, and
- links to additional resources for patients and pharmacists.
The TGA is currently investigating guidance for pharmacists to support the vaping reforms. Further information will be published shortly.
The RACGP is currently reviewing their guidelines for smoking cessation. The current RACGP Guidelines can be accessed here Supporting smoking cessation: A guide for health professionals.
Pharmacies may take possession of unapproved vapes for the purposes of dispensing, before receiving prescriptions issued under the Authorised Prescriber (AP) scheme or Special Access Schemes (SAS). You can hold unapproved vapes in your dispensary until you receive a prescription.
Unapproved vapes 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 therapeutic vapes. You should only dispense therapeutic vapes that conform to the requirements of TGO 110.
If you source vapes directly from overseas suppliers, you are likely to be considered the Australian sponsor of those products. Australian sponsors are responsible for meeting relevant import requirements and have primary responsibility for ensuring that vapes comply with the relevant product requirements, including the requirements in TGO 110. They also need to maintain records demonstrating conformance of their products to TGO 110.
The 'Record-keeping obligations for sponsors' section of our Guidance on TGO 110 will assist you in determining if you are considered the Australian sponsor of a product.
From 1 March 2024, importers of vapes will be required to:
- provide pre-market notifications to the TGA declaring compliance with the relevant product standards (e.g. TGO 110), prior to importation, and
- hold an import licence, and permit in relation to the goods, from the Office of Drug Control (ODC).
Vapes will generally only be eligible to obtain a permit from ODC if they meet requirements under the Therapeutic Goods Act 1989.
Forms and guidance material for sponsors to notify compliant products and obtain import licences and permits are available on the TGA Guidance for Sponsor notice – Vaping goods (Notice to import or supply in Australia therapeutic vaping goods) form and the ODC Importing vaping goods into Australia websites. This will allow notifications and applications to be made and processed ahead of the changes on 1 March 2024.
Further information about the reforms for Australian sponsors is available on our vapes: information for importers, manufacturers and wholesalers page.
Dispensing unapproved vapes
If a medical practitioner determines that an unapproved therapeutic vape is a suitable option for smoking cessation or the management of nicotine dependence for a patient, the medical practitioner can apply to the TGA for authority to prescribe the unapproved product through the AP scheme or SAS B. Depending on state or territory restrictions, other prescribing health practitioners may also be able to apply for authority or approval to prescribe.
Medical practitioners may apply for AP approval to prescribe vapes containing nicotine for smoking cessation or the management of nicotine dependence without ethics committee approval. A simplified vaping-specific online form is available on the Authorised Prescriber dashboard of the SAS & Authorised Prescriber Online System. No further applications or permissions are required for the duration of the approval but reports are required every six months. This pathway does not apply to heat-not-burn tobacco products.
From 1 January 2024, the Special Access Scheme C (SAS C) pathway is also available to enable medical practitioners and nurse practitioners to prescribe vapes for smoking cessation or the management of nicotine dependence, where clinically appropriate.
Pharmacists may dispense a prescription for therapeutic vapes with evidence of an AP approval, SAS B approval or in accordance with the new SAS C pathway.
Enhancements have been made to the SAS and Authorised Prescriber Online System to streamline the new SAS C notification process for practitioners and to support dispensing by registered pharmacists.
A notification under SAS C that is submitted to the TGA by practitioners in the online system will generate a notification number that will be immediately accessible to registered pharmacists. This means that registered pharmacists will be able to verify that supply has been made in accordance with the new SAS C pathway for smoking cessation or the management of nicotine dependence prior to dispensing a therapeutic vaping substance to a patient.
Dispensing is 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 will publish a list of therapeutic vapes for which the TGA has received a notification from the sponsor declaring compliance with the applicable standards. These products will be suitable for prescribing and dispensing for smoking cessation or the management of nicotine dependence under the new SAS C pathway.
Pharmacists can extemporaneously compound a therapeutic vaping substance for a particular person on prescription. When extemporaneously compounding, pharmacists must follow all relevant compounding standards and adhere to their professional obligations. Pharmacists considering extemporaneously compounding therapeutic vaping substances should familiarise themselves with the information in the PSA Guidelines about the relevant compounding standards and their professional obligations.
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 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.
From 1 March 2024, importers of vapes will be required to provide pre-market notifications to the TGA declaring compliance with the relevant product standards (e.g. TGO 110), prior to the importation of those goods (see above). Importers of liquid nicotine will also be required to provide pre-importation notification to the TGA.
Further information about the changes to obligations of Australian sponsors and the requirements of TGO 110 is available on our vapes: information for importers, manufacturers and wholesalers page. Further information on the updated requirements in TGO 110 is currently being developed and will be available shortly. The current version is available here: Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 and related matters (Guidance on TGO 110).
Advertising and promotion of vapes and related services
The advertising of therapeutic goods, including vapes, is generally prohibited in Australia. Some states and territories also restrict the promotion of vaping devices.
However, some states and territories allow pharmacists to notify patients in a specified manner if they supply vaping devices.
Information shared between a doctor, pharmacist or nurse practitioner 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 vapes is also unlikely to be considered advertising, depending on the context in which the information is presented.
The Government has announced that it will introduce legislation in 2024 to further restrict the advertising of vapes, subject to very limited exceptions.
Sourcing and supplying vaping devices and accessories
Vaping devices are electronic devices used to heat therapeutic vaping substances for direct inhalation. Some vaping substances are supplied in vaping devices (e.g. prefilled). Other vaping devices are supplied separately to the vaping substances used with those devices. Some vaping devices are currently excluded from the therapeutic goods regulatory scheme.
From 1 March 2024, all vaping devices (including an unfilled cartridge, capsule, pod or other vessel) for use with a therapeutic vaping substance will be covered by the therapeutic goods framework. From this time, these devices will be required to comply with any one or more of the following requirements:
- ISO 9001 certification for the manufacture of the device, issued by an IAF accredited body
- ISO 13485 certification for the manufacture of the device, issued by an IAF accredited body;
- certification (or other approval) issued by an overseas regulator of compliance with the overseas regulator’s requirements for:
- consumer grade e-cigarettes, or
- therapeutic vapes.
Therapeutic vaping devices that were already subject to the therapeutic goods regulatory scheme before 1 March 2024 (i.e. those that were previously intended for use exclusively with a medicine for inhalation) will continue to be required to comply with the Essential Principles. The Essential Principles apply to all medical devices, even those not included in the ARTG. Sponsors may apply to the TGA for consent for non-compliance with certain Essential Principles in exceptional circumstances.
Further guidance on the updated vaping device requirements in TGO 110 is currently being developed. The current guidance is available here: Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 and related matters (Guidance on TGO 110).
Subject to state and territory requirements, pharmacists can hold stock and supply vaping devices for use with vaping substances. See the state and territory restrictions and requirements section below for further information.
State and territory regulation of vapes
In addition to the general requirements applicable to the dispensing of prescription medicines, including medicines containing nicotine, each state and territory has tobacco/smoking product or e-cigarette control legislation that may apply to pharmacists seeking to dispense therapeutic vapes.
Some of the key restrictions and requirements under this legislation may include the requirement for a retail licence or notification before dispensing therapeutic vapes. 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 about the requirements in your jurisdiction.
Report side effects and problems
We strongly encourage patients and health practitioners to report any suspected side effects related to vapes.
The TGA has an important role in monitoring the safety of 'unapproved' goods. 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 relating to the importation, manufacture, supply, export or advertising of vapes to the TGA. This includes the supply of vapes containing nicotine by a retailer other than a pharmacist (e.g. by a vape store).
Vapes present a poisoning risk
Accidental ingestion of, or exposure (such as through the skin or eyes) to, vapes can have toxic, and sometimes severe, effects. When dispensing vapes, 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 vapes (where relevant) and/or if vapes 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 vaping product. Emergency services can be contacted by calling 000 and the Poisons Information Centre can be contacted by calling 131 126.