Codeine Stock Management for Retail Pharmacies

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Supply of codeine-containing medicines after 1 February 2018 when the product is not cancelled in the Australian Register of Therapeutic Goods

All States and Territories have agreed that Schedule 2 and 3 codeine-containing medicines that have been rescheduled to Schedule 4 prescription medicines and are in a retail pharmacy after 1 February 2018 can be dispensed after 1 February 2018 on prescription for a maximum period of 9 months (i.e. until 31 October 2018) or until the end of the shelf life, whichever is earlier, provided:

• the stock is stored in the dispensary;
• there is a valid prescription;
• the stock is labelled with a dispensing label; and
• any specific state or territory requirements are adhered to.

Contact your relevant State or Territory medicines and poisons regulation unit for more information regarding the requirements in your State or Territory.
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Supply of codeine-containing medicines after 1 February 2018 when the product is cancelled in the Australian Register of Therapeutic Goods

Under the Therapeutic Goods Act 1989 (the Act), if an Australian Register of Therapeutic Goods (ARTG) entry for a product is cancelled, that product may continue to be supplied by a retailer (assuming the retailer is not a sponsor or selling wholesaler), if the goods were already available for retail sale at the date of cancellation of those products from the ARTG.

All States and Territories have agreed that any stock remaining on retail pharmacy shelves of OTC codeine-containing medicines (Schedules 2 and 3) that have been cancelled from the ARTG before 1 February 2018 can be dispensed after 1 February 2018 on prescription as a Schedule 4 prescription medicine in a retail pharmacy for a maximum period of 9 months (i.e. until 31 October 2018) or until the end of the shelf life, whichever is earlier, provided:

• the stock is stored in the dispensary;
• there is a valid prescription;
• the stock is labelled with a dispensing label; and
• any specific state or territory requirements are adhered to.

However, please note that the regulation of therapeutic goods is a co-regulatory scheme with the States and Territories.

A person dealing with therapeutic goods must comply with all Commonwealth and state and territory laws.

You should review the relevant state and territory laws carefully as in some states and territories; it is a criminal offence to supply therapeutic goods by retail unless the goods are included in the ARTG.

It is also the responsibility of the pharmacist to ensure that all of the legislative requirements are met.

Contact your relevant State or Territory medicines á poisons regulation unit for more information regarding the requirements in your state or territory.

For more information, visit tga.gov.au.