THE Therapeutic Goods Administration yesterday issued new guidance on the phase-out of OTC codeine products once they become prescription-only on 01 Feb, including clarification that reclassified items can continue to be sold as long as they are stored in pharmacy dispensaries.
The TGA website details the update for pharmaceutical wholesalers and retail pharmacies, following agreement by all states and territories.
Community pharmacies may still supply products containing codeine that were originally S2 or S3 that from 01 Feb are classified S4 prescription, but only under very strict conditions.
The products may be dispensed for up to nine months or until the end of shelf life, whichever comes first, after 01 Feb, provided the stock is stored in the dispensary only, there is a valid prescription, the stock is labelled with a dispensing label and any specific state or territory requirements are adhered to.
This applies even if the product has been cancelled, but for wholesalers, while they can supply remaining stock of non-ARTG-cancelled S2 and S3 products containing codeine to retailers with current packaging for up to nine months after Jan, they may not supply any ARTG-cancelled products from 01 Feb.
Go to tga.gov.au for details.
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