The TGA has advised on codeine stock management following the upcoming reschedule to prescription only
The TGA has updated information for wholesalers, sponsors and retail pharmacies regarding the upscheduling of low-dose codeine products from Schedules 2 to 3 to Schedule 4.
The advice covers both the codeine-containing combination analgesic group and the codeine-containing cough, cold and flu group.
The TGA has advised that when a product is not cancelled on the Australian Register of Therapeutic Goods, all states and territories have agreed that low-dose codeine products in a pharmacy can be dispensed after 1 February 2018 on prescription for a maximum period of nine months.
They can be dispensed until either 31 October 2018 or until the end of the shelf life, whichever is earlier, providing there is a valid prescription, the stock is stored in the dispensary, and any specific State and Territory requirements are adhered to.
However, some products will be cancelled on the ARTG following the 1 February upschedule.
Under the Therapeutic Goods Act 1989, if an ARTG entry for a product is cancelled, that product may continue to be supplied by a retailer if the goods were already available for retail sale at the date of the cancellation from the ARTG.
“However, please note that the regulation of therapeutic goods is a co-regulatory scheme with the States and Territories,” the TGA has advised.
“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.”
Any stock remaining on retail pharmacy shelves of OTC codeine-containing medicines 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 – again, until 31 October 2018 or the end of the product’s shelf life, whichever is earlier.
All States and Territories have again agreed to this.
“It is the responsibility of the pharmacist to ensure that all of the legislative requirements are met,” the TGA advises.
It encourages pharmacists to contain their relevant State or Territory medicines & poisons regulation unit for more information regarding the requirements in their State or Territory.