The TGA has published a notice of interim decisions for palmitoylethenolamide (PEA) on their website. The public consultation, closing 17 April, requests stakeholder feedback on the Delegate’s decision to amend the current Poisons Standard in relation to PEA by creating a new Schedule 6 entry that excludes derivatives and preparations for therapeutic use. The interim decision proposing to exclude all preparations for therapeutic use has adopted CMA’s recommendation which previously only included listed medicines.

If the interim decision is confirmed, listed and registered medicines on the ARTG and other therapeutic preparations (such as practitioner compounded medicines) containing PEA will be excluded from the new Schedule 6 entry and will be unaffected. As for all schedule 6 substances, there may be implications for storage, supply and transport of the material under States and Territories.

Please read today’s tech alert for more details.