A new Poisons Standard is in force and has been published on the Federal Register of Legislation, available here. The Poisons Standard February 2021 incorporates changes to the Poisons Standard October 2020 and also incorporates amendments to the Poisons Standard February 2021, outlined in the Poisons Standard Amendment (Boric Acid and Picramic Acid) Instrument 2021.
Changes to the Poisons Standard of interest to the complementary medicines sector include:
- The addition of cannabidiol (CBD) to Schedule 3 of the Poisons Standard (Pharmacist Only).
Important points include that oral cannabidiol medicines may only be sold to a consumer by a Pharmacist. Guidance on what constitutes supply by a Pharmacist is available from State and Territory bodies, for example, NSW. The allowable maximum recommended daily dose of 150mg is higher than the 60mg initially proposed in the Scheduling consultation. However, it must first be evaluated and approved as a Registered medicine and included on the ARTG. This means it must have evidence suitable for a registered medicine. Information on applying for registered complementary medicines is available here and further information relating to over-the-counter access to low dose cannabidiol can be found here. Please also refer to CMA's 15 December member alert for the full list of Schedule 3 requirements.
Boron has new requirements in Schedule 5 for warning statements that apply to the following classes of products: cosmetic hand cleaning preparations, cosmetic talc preparations, cosmetic oral hygiene preparations, and in other cosmetic preparations.
Important Note: Boron in the 26BB Permissible Ingredients Determination- transition ending
While the Poisons Standard hasn’t implemented warning statements for boron for oral or dermal preparations for human therapeutic use, please be reminded that boron warning statements were introduced into the 26BB Permissible Ingredients Determination, and that these changes apply to medicines that were listed in the Register on or after 2 March 2020; or released for supply after 2 March 2021. Please refer to the Determination if you have any oral or dermal preparations with ingredients containing boron listed onto the ARTG to ensure all the warning statements are present or being implemented on batches that will be released for supply after 2 March 2021.