Pharmacy Practice Notice
Scheduling of NVPs in Western Australia
Liber has received the following guidance from the Chief Pharmacist, Medicines and Poisons Regulation Branch, WA Department of Health:
From 31 October 2024, all nicotine vaping products will be classified as Schedule 4 (prescription only) items in Western Australia (WA).
Although the national Poisons Standard includes an entry for nicotine vaping products in Schedule 3, the WA Medicines and Poisons Regulations 2016 have been amended to separately schedule nicotine.
Regulation 6A details the scheduling of nicotine in WA. The Regulations are available via the WA Legislation website at: https://www.legislation.wa.gov.au.
The Department has issued a label exemption which ensures a nicotine vaping product labelled as a Schedule 3 item can be supplied as a Schedule 4 item in WA – a copy of the Authorisation is reproduced below.
Please ensure your pharmacy teams are aware of the scheduling change applicable in WA.
AUTHORISATION OF LABEL FOR NICOTINE VAPING PRODUCTS IN WESTERN AUSTRALIA
Issued in accordance with Regulation 84(5)
Background:
From 31 October 2024, all vaping products that contain nicotine are included in Schedule 4 of the Medicines and Poisons Act 2014. Regulation 6A of the Medicines and Poisons Regulations 2016 details the Schedule 4 entry for nicotine that applies in Western Australia.
The Schedule 3 entry for nicotine in the national Poisons Standard, which relates to therapeutic vaping goods, does not apply in Western Australia.
Nicotine replacement therapy (NRT) products on the Australian Register of Therapeutic Goods (ARTG), for oromucosal or transdermal use, remain exempt from scheduling.
Label authorisation and conditions:
In accordance with Regulation 84(5), nicotine vaping products labelled as Schedule 3 (pharmacist only) items can be supplied as Schedule 4 (prescription only) items in Western Australia, even though they are labelled with the Schedule 3 ‘signal heading’.
Despite the Schedule 3 label, these products must be handled as Schedule 4 items at all points of the supply chain within this state.
Licensed wholesalers in Western Australia can only supply these products if they hold a licence for Schedule 4 substances, that include nicotine (such as a licence for supply of all Schedule 4 substances).
Pharmacies and authorised health professionals must store these products in accordance with Regulation 90 and must supply in accordance with the requirements for Schedule 4 medicines.
This authorisation remains in place until amended, suspended or revoked by the CEO of Health or their delegate.
Meeghan Clay
CHIEF PHARMACIST
Delegate of CEO
31 October 2024
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Important links
Therapeutic Goods Administration
Pharmaceutical Society of Australia
References
- PSA Professional Practice Standard 1: https://www.psa.org.au/practice-support-industry/pps/
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