Vapes: information for pharmacists

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.

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

Vaping laws restrict supply to pharmacies

The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commenced on 1 July 2024. This Act, along with other reforms that came into effect between 1 January 2024 and 1 March 2024, have changed the way vapes can be sourced, supplied and advertised. 

From 1 July 2024, new regulations apply to all vapes, including vaping devices, irrespective of nicotine content or therapeutic claims. This means:

• vapes are only available in pharmacies or in pharmacy settings
• it is illegal for retailers such as tobacconists, vape shops and convenience stores to supply any type of vape in any circumstances.

Until 30 September 2024, patients need to speak with a medical or nurse practitioner to:

• get a prescription to buy vapes containing nicotine, and
• access zero-nicotine vapes

From 1 October 2024, therapeutic vapes with a nicotine concentration of 20mg/mL or less will be available in pharmacies to patients 18 years or over without a prescription. A pharmacist will need to be satisfied it is clinically appropriate, and meet several other conditions, to supply a vape to a patient without a prescription. These changes will help facilitate patient access while maintaining appropriate controls and protections. 

See ‘Dispensing therapeutic vapes from 1 October 2024’ for more information.

State and territory regulation of vapes

In addition to the general requirements for dispensing 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. 

This legislation may include the requirement for a retail licence or notification before dispensing therapeutic vapes. There are also state and territory 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.

Pharmacists must comply with all relevant state and territory regulations relating to sourcing and dispensing vapes.

Dispensing vapes

Only vapes included in the TGA’s list of notified vapes can be dispensed, even if a person has a prescription for a product not included in the list. 

Dispensing prescription vapes

All vapes, including vape substances, accessories and devices, are regulated as therapeutic goods, regardless of nicotine content. They can only be lawfully sold by businesses licensed to sell prescription medicines. 

Currently, patients can only purchase therapeutic vapes from a pharmacy with a prescription from an Australian registered medical practitioner or nurse practitioner. 

Therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) are known as unregistered or ‘unapproved’ therapeutic goods. There are no therapeutic vapes for smoking cessation or the management of nicotine dependence included in the ARTG.  

There are established pathways for consumers to lawfully access unapproved goods, but such goods are not assessed by the TGA for quality, safety and efficacy or performance.

The main pathways for Australian pharmacies to dispense unapproved nicotine vapes are the Authorised Prescriber (AP) scheme, Special Access Scheme B (SAS B), and Special Access Scheme C (SAS C). 

Pharmacists are required to validate prescriptions prior to dispensing vapes. Pharmacists can validate a prescription in a number of ways, including contacting the prescriber or using the TGA’s online validation tool. 

An AP approval, a SAS B approval or a notification under SAS C that is submitted to the TGA by practitioners using the online system will generate a reference number. This number should be provided to pharmacists either with the patient’s prescription or by the prescriber directly. 

Pharmacists will be able to use the SAS/AP submission validation search to verify that supply has been made in accordance with applicable pathway. The validation tool provides real time information about SAS or AP prescriptions.

You can view our video: How to use the Special Access Scheme and Authorised Prescriber submission validation tool.

Compounding and component substances

Only finished products are lawful to dispense. Pharmacists cannot dispense component ingredients for consumers to use to mix 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 the product conforms to all requirements of TGO 110, and
• maintain records demonstrating that the product conforms to all requirements of TGO 110. 

Compounded substances must comply with the product standards outlined in TGO 110. Obligations for sponsors would apply, in these circumstances, including, for example, mandatory reporting requirements.  

Dispensing vaping devices and zero-nicotine vapes without a prescription

Vapes that do not contain nicotine (or any other restricted substance) can be sold to consumers without a prescription, but pharmacists must independently verify that they will be used for smoking cessation or managing nicotine dependence. However, zero-nicotine vapes are unapproved therapeutic goods. A pharmacist cannot dispense a zero-nicotine vape unless a medical or nurse practitioner has authorised supply under the AP, SAS B or SAS C schemes. Pharmacists must verify that supply has been made in accordance with an applicable pathway in the same way as for prescription vapes.

Vaping devices that do not contain, and are not packaged with, a vaping substance do not need to be prescribed or authorised for supply under the AP, SAS B or SAS C schemes. However, a pharmacist can only supply a vaping device if satisfied it will be for use for smoking cessation or the management of nicotine dependence. Unless the device is being supplied with a prescribed or authorised vaping substance, a pharmacist will need to discuss intended use with the patient before dispensing. Only vaping devices and zero-nicotine vapes included in the TGA’s list of notified vapes can be dispensed, even if a person has a prescription for a product not included in the list. 

Pharmacists must store all vaping devices and zero-nicotine vapes in the same way as nicotine vapes. They must be kept behind the counter and not available for self-selection.  

Dispensing therapeutic vapes from 1 October 2024

From 1 October 2024, nicotine in therapeutic vapes for smoking cessation and the management of nicotine dependence will be classified as Schedule 3 substances. At this time, the SAS C rules will also be amended to allow pharmacists to supply nicotine and zero-nicotine vaping substances for smoking cessation or the management of nicotine dependence without a prescription from a medical or nurse practitioner in certain circumstances.

Following these changes, patients 18 years or over will no longer require a prescription or SAS/AP authorisation from a medical or nurse practitioner to access therapeutic vaping substances from Australian pharmacies. Instead, the pharmacist will submit the SAS C notification (see below). 

Pharmacies that stock and supply therapeutic vapes will still need to comply with state and territory regulations relating to Schedule 3 substances, including, for example, that the vapes are kept behind the counter and are personally handed to the patient by the pharmacist. See state and territory regulation of vapes above.

Dispensing nicotine vapes without a prescription

The dispensing of vapes containing nicotine or a zero-nicotine vaping substance without a prescription must be in final dosage form for smoking cessation or the management of nicotine dependence.

The pharmacist must ensure:

• supply is to persons aged 18 years or over, including requesting and sighting evidence of the patient’s identity and age
• professional advice is provided to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines
• contact details about smoking cessation support services are provided to the patient
• the quantity of the goods does not exceed 1 month supply and is only supplied to the patient once in a month
• that the nicotine concentration does not exceed 20 mg/mL.

Dispensing of vapes that do not meet these requirements will still require a prescription and SAS/AP authorisation from a doctor or nurse practitioner. This includes, for example, vapes with a nicotine concentration greater than 20mg/mL or patients under 18 years of age, which is also subject to state and territory requirements.

Conditions on supply of vapes without a prescription

Supply to persons without a prescription is conditional on the pharmacist:

• informing the patient, or a parent or a guardian of the patient, that the vaping good is an unapproved therapeutic good 
• obtaining informed consent from the patient, or a parent or a guardian of the patient, before supplying the vape
• supplying the vaping good in accordance with good pharmacy practice
• providing professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines
• providing contact details about smoking cessation support services to the patient.

If the pharmacist becomes aware that:

• the patient has suffered an adverse event in relation to the vaping good, or
• there is a defect in the vaping good, 

the pharmacist must notify the TGA and the sponsor of the therapeutic good about the adverse event or the defect.

A SAS C notification must be made by the pharmacist within 28 days of supplying the vape to the patient. This will generally need to be done at the time of dispensing (see below).

Submitting a notification in the TGA’s SAS & AP online system when supplying vapes without a prescription after 1 October 2024

If a pharmacist determines that a vape can be supplied to a patient for smoking cessation or the management of nicotine dependence, the pharmacist will need to submit a notification under SAS C. The notification must be submitted to the TGA using the SAS & AP Online system.

To make submissions under SAS C, pharmacists must first create a profile in the online system. A notification must be made within 28 days of supplying the vape to the patient. However, unless the pharmacist is keeping separate records relating to the dispensing of therapeutic vapes, it will be necessary to lodge the notification at the time of dispensing to ensure relevant data can be submitted as required.

Advertising and promotion of vapes and related services

The advertising of vaping goods is prohibited except in very limited circumstances.

The Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024 authorises limited advertising of notified therapeutic vaping goods including:

• on the label and packaging of the goods
• advertising directed exclusively to medical practitioners, nurse practitioners pharmacists and their practice managers and purchasing officers
• advertising directed exclusively to businesses involved in the wholesale of notified therapeutic vaping goods
• advertising that is advice or information given directly by a medical practitioner, nurse practitioner or pharmacist to a patient in the course of treatment.

Strict conditions apply to advertising conducted in each of these circumstances, as outlined in the legal instrument. This includes specifying the type of information that can be included in the advertisement, for example:

• the availability and price of the goods
• information on the safe and effective use of the goods
• details on the goods, such as intended purpose, ingredients, and design specifications.

Only therapeutic vaping goods that have been notified to the TGA as complying with the applicable product standards can be advertised in accordance with the permissions listed above.

The term ‘directed exclusively’ is used in the authorisation. This should be interpreted as ‘to the exclusion of others’ ensuring that only the relevant health practitioner or wholesaler receives the advertising content.

The TGA will publish further guidance on the advertising authorisation.

Severe penalties apply for non-compliant advertising or promotion. 

Sourcing vapes

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). Pharmacies can hold unapproved vapes in their dispensary until they receive a prescription.

Pharmacies may only source therapeutic vapes that are included on the TGA’s list of notified vapes. The listed vapes 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. 

Vapes may be sourced from:

• Australian sponsors and/or wholesalers (including non-pharmacy retailers who stopped supply as at 1 July 2024, if they possessed legitimate therapeutic vapes), or
• overseas suppliers directly, subject to the importer holding a licence and permit from the Office of Drug Control.

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 and the requirements for vaping devices prior to ordering therapeutic vapes. You should only dispense therapeutic vapes that conform to the requirements of TGO 110 and applicable device requirements.

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, including the requirement for an import licence and permit, 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 and applicable device requirements. 

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 are required to:

• provide pre-market notifications to the TGA declaring compliance with the relevant product standards (e.g. TGO 110, MDSO), prior to importation, and
• hold an import licence, and permit in relation to the goods, from the Office of Drug Control (ODC).

Vapes are generally only 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 from: 

• Guidance for Sponsor notice – Vaping goods (Notice to import or supply in Australia therapeutic vaping goods) form (TGA), and
• Importing vaping goods into Australia (ODC). 

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

Product standards for unapproved vapes

To be lawfully supplied in Australia, unapproved therapeutic vapes that are used for smoking cessation or the management of nicotine dependence must comply with:  

• the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110) product standards if they are medicines
• either the Essential Principles or the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023 (MDSO) if they are devices.

The requirements in TGO 110 apply to therapeutic vapes 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 vapes (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 TGO 110 requirements is available here: Guidance for Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 and related matters (Guidance on TGO 110).

Vaping devices are electronic devices used to heat therapeutic vaping substances for direct inhalation. Some vaping substances are supplied in, or with, vaping devices (e.g. prefilled). Other vaping devices are supplied separately to the vaping substances used with those devices. 

From 1 March 2024, all vaping devices and accessories (including an unfilled cartridge, capsule, pod or other vessel) for use with a therapeutic vaping substance are covered by the therapeutic goods framework.

Therapeutic vaping devices that were already subject to the therapeutic goods regulatory framework before 1 March 2024 are required to comply with the Essential Principles. Sponsors may apply to the TGA for consent for non-compliance with certain Essential Principles in exceptional circumstances.

The Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023 (MDSO) applies to therapeutic vaping devices and accessories that were excluded from the therapeutic goods regulatory framework prior to 1 March 2024, do not contain a vaping substance, and are not to be imported or supplied in a pack. 

Under the MDSO, requirements for vaping devices include:

• compliance 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.

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 above for further information.

Further information on the updated requirements in TGO 110 is available here: Guidance on TGO 110.

Guidance and resources for pharmacists

The Pharmaceutical Society of Australia (PSA) is updating its Guidelines for pharmacists providing smoking cessation support (PSA Guidelines). The current PSA Guidelines describe 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
• links to additional resources for patients and pharmacists.

The TGA is currently investigating further guidance for pharmacists to support the vaping reforms. Further information will be published shortly. 

The RACGP is currently reviewing its guidelines for smoking cessation. The current RACGP Guidelines can be accessed here Supporting smoking cessation: A guide for health professionals.

There are many methods to quit smoking or vaping. 

• The Quit Centre provides health professionals with the latest clinical information, resources and training on smoking and vaping cessation. 
• Patients can self-refer to the Quitline (13 7848) or can also be directly referred through the Quitline Referral Form. 

Patients can visit quit.org.au for up-to-date information, tools and resources to support their individual quit smoking journey.

Report side effects and problems

The health practitioner is responsible for reporting adverse events or defects arising from the use of ‘unapproved’ therapeutic goods accessed under special access scheme or authorised prescriber pathways to the TGA. 

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

Reporting 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 by a retailer other than a pharmacist (e.g. by a vape store).

Vapes present a poisoning risk

Nicotine poisoning can affect anyone of any age. However, the greatest risk of nicotine poisoning is in children because of their lower body weight – small quantities of the vaping substance (3-10 mL) can be fatal to children without medical intervention. 

Nicotine can enter the body through: 

• absorption through the skin if a vaping substance is spilled on the skin or touched 
• inhalation into the lungs, or 
• ingestion of vaping substances. 

Symptoms of nicotine poisoning include nausea and vomiting, headaches, dizziness, breathing difficulties, seizures and cardiac arrest. 

If the vaping substance is spilled on the skin, flush skin with running water.

If the vaping substance is in the eyes, flush immediately with running water.

Seek immediate medical attention if you think that you, or anyone else, may have been exposed to, or ingested, a vaping substance.

For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor.

Other resources

• RACGP: Supporting smoking cessation: A guide for health professionals
• PSA: Guidelines for pharmacists providing smoking cessation support
• Quit Centre - information, resources and training on smoking and vaping cessation. 
• Quit.org.au - information, advice and tools for individuals wanting to quit smoking or vaping.