Information for Pharmacists

Find out what the new federal vaping regulations mean for Pharmacies

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The landscape of vaping regulation in Australia has undergone significant changes, with new federal laws now in place to safeguard public health and ensure the responsible distribution of nicotine vaping products. These regulations impact both pharmacies and wholesalers who supply these products to pharmacies for retail sale. This page provides an overview of the key aspects of these regulations to help you stay compliant and informed.

Dispensing Nicotine Vaping Products -

As of October 1 2024, all e-cigarettes, e-liquids, and nicotine pods become Schedule 3 and available for purchase over the counter.

  • 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.

Submitting a notification in the TGA’s SAS & AP online system -

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.

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.

  • Guidance and Resources for Pharmacists -

    The Pharmaceutical Society of Australia (PSA) is updating its Guidelines for pharmacists providing smoking cessation support- external site (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
    • 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- external site.

    FAQ's

    As asked by you...
    I'm a Pharmacist - what do I need to do when dispensing a vape to a patient?
    What documentation is required to sell nicotine vapes to customers?
    What types of nicotine vapes can I stock in my pharmacy?
    Where is a safe place to source vapes?
    I'm unsure about the effects vapes have on humans - should i still sell them?
    How do we compliantly order from TVC?

    Our Commitment to Compliance and Quality

    At TVC we prioritise compliance with TGO110 to uphold the highest standards of safety and efficacy in our wholesale nicotine vaping products. We work closely with pharmacies across Australia to provide them with products that not only meet regulatory requirements but also exceed expectations in quality and performance.

    By choosing TVC pharmacies can trust that they are offering their customers nicotine vaping products that have undergone rigorous testing and comply with TGA standards. We are dedicated to promoting health and well-being through responsible nicotine vaping solutions that adhere to Australian regulatory requirements.