Legislative requirements for vaping products

​​​​​​​​​​​​​​​​​​​​​​​​​​​ On this page

  1. Access to vaping goods
  2. Information for consumers​
  3. Information for health practitioners
    1. Information for pharmacists
    2. Information for prescribers
  4. Supply of therapeutic​ vaping goods to minors​
  5. ​​Reporting adverse events and faulty vaping goods
  6. Information for wholesalers​
  7. Smoking cessation guidance and vaping resources​

Access to vaping goods

Therapeutic vaping goods are regulated in Australia and may only be supplied for smoking cessation or the management of nicotine dependence.

In NSW, nicotine-containing and nicotine-free vaping goods can only be supplied through pharmacies. It is illegal for tobacconists, vape shops and convenience stores to sell any vaping goods, regardless of nicotine content.

Legal access to therapeutic vaping goods

People aged 18 years and over may be able to obtain certain therapeutic vaping goods from a pharmacy without a prescription, where a pharmacist determines the supply is clinically appropriate.

​A prescription from a medical practitioner or nurse practitioner is required:

  • by people aged under 18 years
  • for vaping goods containing more than 20 mg/mL nicotine.

Therapeutic vaping goods cannot contain nicotine concentrations higher than 50 mg/mL, and are only allowed to have the flavours, mint, tobacco, or menthol. There are also strict requirements on the packaging and labelling of vaping goods.

​Information for consumers

For information about:

  • vaping and health risks
  • support to quit vaping​
  • vaping laws and restrictions
  • resources for parents, carers and schools
  • reporting concerns about vaping

visit the following NSW Health and TGA webpages:

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​Information for health practitioners

The information below outlines legislative requirements for pharmacists, prescribers and wholesalers involved in the supply of therapeutic vaping goods in NSW.​

Information for pharmacists

For detailed information, refer to the TGA guidance document Supplying therapeutic vapes in pharmacies​.

All therapeutic vaping goods, irrespective of the nicotine content, are unapproved products. Pharmacists can only supply or dispense unapproved therapeutic vaping goods via the TGA Authorised Prescriber (AP) scheme or Special Access Scheme (SAS) pathway.

Pharmacists can search the TGA's SAS and AP Online System Information to:

  • verify that a prescription has been issued under the AP scheme or SAS pathway
  • submit a notification under the TGA SAS Category C when issuing a Schedule 3 vaping good, or on behalf of a prescriber when dispensing a Schedule 4 vaping good.

A SAS or AP approval is not required to supply an unapproved therapeutic vaping device. However, these devices can only be supplied for smoking cessation or the management of nicotine dependence.

For more information, see Access an unapproved therapeutic good (health practitioners).

Obtaining vaping goods

Only vaping goods listed on the TGA List of notified vapes can be supplied or dispensed to a person. These vaping goods comply with applicable standards for supply in Australia for smoking cessation or the management of nicotine dependence. For more information on the product standards please visit the TGA’s Product standards: unapproved therapeutic vapes.

Pharmacists are reminded to check current stock of vaping goods regularly and remove non-compliant stock.

Pharmacists may obtain unapproved vaping goods prior to receiving a prescription or request from a patient.

Vaping goods may be obtained:

  • from Australian sponsors holding an Australian licence to supply vaping goods by wholesale,
  • licensed pharmaceutical wholesalers,
  • directly from overseas suppliers. In this case you are likely to be considered the Australian sponsor of these products and you must meet all import requirements and compliance responsibilities.

More information is available on the TGA's Vapes: information for sponsors, importers, and manufacturers.

Only finished products are legally permitted to be dispensed. Pharmacists cannot dispense component ingredients for patients to mix themselves.

Storage of vaping goods

Vaping goods must be stored in a room or enclosure to which the public does not have access, and apart from food. They also must not be used or disposed of in any place or in any manner likely to constitute a risk to the public.

All vaping goods must comply with child-resistant packaging requirements as specified in the Poisons Standard​​. For further information on labelling and packaging requirements of vaping goods refer to the TGA's guidance on Understanding product standards for unapproved therapeutic vapes in Australia.

​Schedule 3 supply

Therapeutic vaping goods can be supplied by a pharmacist as a Schedule 3 medicine when the following requirements are met:

  • supply is for smoking cessation or the management of nicotine dependence
  • supply is to persons aged 18 years and over. Pharmacists are required to request and sight evidence of the patient's identity and age
  • the quantity supplied does not exceed one month supply and is only supplied to the patient once in a month
  • the nicotine concentration of the product does not exceed 20 mg/mL
  • the patient is informed that the product is not a registered or listed good
  • advice is provided on:
    • appropriate dose and frequency depending on age, weight, and the severity of the condition
    • length of treatment, suitable titration, and interactions with other medicines
    • alternative smoking cessation or nicotine dependence supports and therapies
  • the contact details about smoking cessation support services are provided to the patient
  •  a SAS Category C notification is submitted to the TGA within 28 days for each instance of Schedule 3 supply.

Pharmacists should ensure that all other requirements relating to Schedule 3 medicines are met. 

​Schedule 4 supply

On the presentation of a valid prescription, a pharmacist may supply a vaping good as a Schedule 4 medicine, provided the product:

  • has a therapeutic indication for smoking cessation or nicotine dependence
  • does not exceed a nicotine concentration of 50mg/mL
  • is supplied in a quantity appropriate for the intended therapeutic purpose and is consistent with recognised therapeutic standards 
  • is labelled as a dispensed medicine, and a record of the supply is made.

Compounding of vaping goods

A compounded medicine can be prepared only in circumstances when a similar commercially available finished product medicine is unavailable, or clinically unsuitable for that patient.

A therapeutic vaping good may be extemporaneously compounded only when:

  • a prescription has been issued for an individual patient with a TGA approval under AP scheme or SAS pathways.
  • the pharmacist has been granted Section 41RCconsent from the TGA .
  • the compounded product complies with all requirements of the Product standards for therapeutic vapes (TGO110)and the pharmacist maintains records demonstrating that the product conforms to these standards.
  • the pharmacist meets the obligations as a sponsor of the product (a pharmacist will be considered the product sponsor if they extemporaneously compound a product).

All compounding must comply with the Pharmacy Board of Australia Guidelines on compounding of medicines.

Disposal of vaping goods

Vaping goods must be disposed of safely. Where possible, contact product suppliers to arrange the return of non-compliant goods or ensure appropriate disposal.

Do not dispose of vaping devices​ in general waste, recycling bins, or Return Unwanted Medicine (RUM) bins,​ as their batteries can pose a fire or explosion risk. Vaping devices are classified as e-waste and should be disposed of at designated recycling centres or collection points.  If the battery can be safely removed, take it out, wrap the terminals with tape, and place it in a dedicated battery recycling container.

Vaping accessories such as liquids, pods, capsules, or cartridges may be safely disposed of in pharmacy RUM bins.

For additional guidance on safe disposal of vaping goods, visit:

Advertising of therapeutic goods

​Advertising of therapeutic vaping goods to the public is not permitted. However, advertising of smoking cessation services may be permitted in limited circumstances. For more information, see TGA’s Vapes: advertising and promotion​​​.

Pharmacy self-assessment

The Pharmacy self-assessment is designed to help pharmacists assess whether their pharmacy’s practices meet regulatory requirements for the storage and supply of vaping goods. Regular use of the self-assessment tool can help pharmacies identify compliance gaps, strengthen internal processes, and ensure the safe and lawful supply of vaping goods.

​​Information for prescribers

Therapeutic vapes with a nicotine concentration of 20 mg/mL or less may be supplied by pharmacists without a prescription to patients​ aged 18 years and over. In these circumstances, the pharmacist must be satisfied that the supply is clinically appropriate and the conditions for Schedule 3 supply (listed above) are met.

Therapeutic vapes with a nicotine concentration greater than 20 mg/mL, or any supply to patients aged under 18 years, must be prescribed or supplied by a medical practitioner or nurse practitioner. To prescribe to patients aged under 18 years, refer to below on supply of vaping goods to minors.

As with all scheduled medicines, the decision to prescribe or supply is up to the prescriber. Scheduled medicines must not be prescribed merely because a patient requests them, or in a quantity or for a purpose that is inconsistent with recognised therapeutic standards.  

All vaping goods, regardless of nicotine concentration, are unapproved therapeutic goods. To prescribe a therapeutic vaping product, a prescriber must apply to the TGA via the Authorised Prescriber (AP) or Special Access Scheme (SAS) pathways. However, SAS or AP approval is not required to supply an unapproved therapeutic vaping device, provided it is supplied for smoking cessation or the management of nicotine dependence. For more information and access to these pathways, see SAS and AP Online System Information and Prescribe an unapproved therapeutic good (health practitioners).

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Supply of therapeutic vaping goods to minors

Pharmacists can only dispense therapeutic vaping goods to persons aged under 18 years when they are prescribed by a medical practitioner or nurse practitioner and are approved under the AP scheme or SAS pathways.

Prescribers must obtain approval via the following pathways:

  • For patients aged 16 years and over, use the TGA AP or SAS Category B or Category C pathway.
  • For patients aged 15 years and younger, use the TGA AP or SAS Category B pathway.
In all circumstances, the indication must be for smoking cessation or the management of nicotine dependence.

For more information, please refer to the NSW Health Guide to Support Young People to Quit E-Cigarettes.

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​​Reporting adverse events and faulty vaping goods

Adverse events and faulty vaping goods must be reported to the TGA​​ and the​ product sponsor within 15 calendar days of the issue being identified. The report should be made in line with requirements outlined in Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods​​​​​.

​Information for wholesalers

Wholesalers of nicotine vaping goods must hold a licence to supply by wholesale a restricted substance for therapeutic use. See Licences and authorisations.

Wholesalers are required to provide supply records to the Pharmaceutical Services Unit in February and August each year.

​Smoking cessation guidance and vaping resources

​A range of resources are available to support health professionals with smoking cessation and nicotine dependence treatment.

For health professionals:

Current as at: Wednesday 1 July 2026
Contact page owner: Pharmaceutical Services