Codeine stock management for wholesalers, sponsors and retail pharmacies

Related information

13 September 2017

Disclaimer

The information on this website is presented by the Therapeutic Goods Administration (TGA) for the purpose of disseminating information free of charge for the benefit of the public.

While the Commonwealth has exercised due care in ensuring the accuracy, currency and completeness of the information provided, it is not legislative in nature and should not be taken to be statements of any law, policy or regulation.

This document relates to the up-scheduling of codeine-containing medicines only.

Introduction

On 20 December 2016 the Department of Health, through the Therapeutic Goods Administration (TGA), announced that over-the-counter (OTC) medicines containing low dose codeine will become prescription-only medicines from 1 February 2018. All medicines that contain low-dose codeine will be up-scheduled from Schedules 2 and 3 to Schedule 4 (Prescription Only Medicines).

The following codeine-containing medicines will no longer be available without a prescription:

  • Codeine-containing combination analgesics; and
  • Codeine-containing cough, cold and flu medicines.

Retail pharmacies

Supply of codeine-containing medicines after 1 February 2018 when the product is not cancelled on 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 there is:

  • A valid prescription;
  • The stock is stored in the dispensary; and
  • Any specific State or Territory requirements are adhered to.

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

Supply of codeine-containing medicines after 1 February 2018 when the product is cancelled on 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.

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 laws. You should review the relevant State laws carefully as in some States it is a criminal offence to supply therapeutic goods by retail unless the goods are included in 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 are cancelled from the ARTG before 1 February 2018 can be dispensed after 1 February 2018 on prescription as a Schedule 4 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.

It is 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 wholesalers and sponsors

It is an offence under the Act for a sponsor to import, export, manufacture or supply a product that is a therapeutic good in Australia unless the product is included in the ARTG or is otherwise exempt from the requirement to be included in the ARTG, or is the subject of an approval or authority under the Act.

It is also an offence under the Act for a person to supply therapeutic goods by wholesale if the goods are not included in the ARTG (unless they are exempt goods).

Therefore once an ARTG entry is cancelled, any future export or introduction of the product into the market (via import, or manufacture and supply) by that product's sponsor or wholesaler may be a breach of the Act.

For more information visit Selling and advertising of cancelled listed medicines: Questions and answers.