The National Drugs and Poisons Schedule Committee (NDPSC), at its June 2009 meeting made the following resolution:
RESOLUTION 2009/56-8
The Committee decided:
* that the current scheduling of codeine combinations for coughs and colds remained appropriate
* that OTC combination analgesics containing codeine (CACC) be removed from Schedule 2
* to limit the duration of treatment for OTC CACC to no more than 5 days
* to limit the maximum unit dose of codeine in OTC CACC to no more than 12 mg
* to limit undivided OTC CACC preparations to no more than 5 days supply at a maximum daily dose of 100 mg and at a concentration of no more than 0.25 per cent
* to limit the maximum daily dose of codeine in OTC CACC to no more than 100 mg
* not to include codeine in OTC CACC in Appendix H, and
* to defer implementation of this resolution until 1 May 2010.
Information on the background and reasons for this resolution appear on the TGA website at: NDPSC record of reasons, 56th meeting 16-17 June 2009 <http://www.tga.gov.au/ndpsc/record/rr200906.htm>.
In October 2009, the NDPSC varied this resolution to the following:
RESOLUTION 2009/57-14 (variation to Resolution 2009/56-8)
The Committee confirmed the June 2009 resolution (2009/56-8) regarding a Schedule 3 entry for all OTC combination analgesics containing codeine. However, the Committee agreed to vary the June 2009 resolution (2009/56-8) regarding the Schedule 2 entry for codeine combinations for coughs and colds by increasing the pack size limit to not more than 6 days (rather than 5) of supply as the maximum dose recommended on the label.
Schedule 2 – Amendment
CODEINE – Amend entry to read:
CODEINE in preparations for the treatment of coughs and colds when:
1. not combined with any other opiate substance
2. compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance
1. in divided preparations containing 10 mg or less of codeine per dosage unit, or
2. in undivided preparations containing 0.25 per cent or less of codeine
3. labeled with a recommended daily dose not exceeding 60mg of codeine, and
4. in packs containing not more than 6 days of supply at the maximum dose recommended on the label.
Information on the background and reasons for the revised resolution appear on the TGA website at: NDPSC record of reasons, 57th meeting, 20-21 October 2009 <http://www.tga.gov.au/ndpsc/record/rr200910.htm>
These two resolutions have the effect of removing all Over-The-Counter (OTC) combination analgesics containing codeine (CACC) (other than phenylephrine-containing combinations for the treatment of coughs and colds) from Schedule 2 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), from 1 May 2010.
Based on these resolutions:
* those CACC products (with the stated maximum units and daily dosage) in packs containing up to 5 days' supply (and which are not Schedule 2 ('S2') medicines) will be transferred to Schedule 3 ('S3' - Pharmacist Only) of the SUSDP, and
* all packs containing more than 5 days' supply (and that are not S2 medicines) will be reclassified as Schedule 4 ('S4' - Prescription Only) medicines.
It is a regulatory requirement that all medicines included in Schedules 3 and 4 of the SUSDP have product information (PI) and consumer medicine information (CMI) documents. Given the timeframe for implementation of the changes and the numbers of products affected, the TGA has made the following arrangements, in consultation with the Australian Self-Medication Industry (ASMI) (including developing core PI and CMI – see below), to assist sponsors in making required changes for their products. The TGA has also written to all sponsors of OTC CACC medicines explaining these arrangements.
source:
http://www.tga.gov.au/npmeds/codeine.htm