A guide to labelling drugs and poisons
Current edition - October 2007
The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) contains certain legal requirements for the labelling of poisons and drugs that are for sale to the public. The labelling system it contains was initially designed to harmonise the requirements of Australia and New Zealand and was phased in over a five year period which commenced on 1 July 1995 and ended on 30 June 2000. In July 2004 the Required Advisory Statements for Medicine Labels (RASML) document was established by the Therapeutic Goods Administration to enable the transfer of all mandatory label advisory statements from the SUSDP and the Therapeutic Goods Regulations to a new document, separate from but linked to TGO 69 - General requirements for labels for medicines (the Labelling Order) <http://www.tga.gov.au/docs/html/tgo/tgo69.htm>. The Labelling Order makes it mandatory for medicine labels to include any label advisory statements specified in Required Advisory Statements for Medicine Labels. The RASML provided a one-year transition period for existing products and took full effect on 1 July 2005. As a consequence the majority of SUSDP medicines advisory labelling requirements were replaced with references to the RASML, effective May 2006.
This Guide has been prepared to assist manufacturers and packers of poisons to draft labels which comply with the SUSDP requirements as they exist on 1 January 2007. The information it contains is not complete nor is it intended to be the sole source of reference. It is essential for users of this Guide to also refer to the SUSDP and Commonwealth, State or Territory legislation which relate to the packaging and labelling of drugs, poisons, therapeutic goods, agricultural chemicals and veterinary chemicals. To assist the reader to refer back to the SUSDP, references to relevant paragraphs and sub-paragraphs have been included in this Guide.
A guide to labelling drugs and poisons (pdf,148kb)
A separate Guide to the Packaging, Labelling and Regulation of Paints, Tinters and Related Products < http://www.tga.gov.au/ndpsc/paintgui.htm> is also available.
The following publications also should be used for guidance, where appropriate, when designing labels for therapeutic goods, agricultural products, veterinary products, paints or dangerous goods:
- Therapeutic Goods Order 69 - General requirements for labels for medicines; <http://www.tga.gov.au/docs/html/tgo/tgo69.htm>
- Therapeutic Goods Order No. 69A - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines; <http://www.tga.gov.au/docs/html/tgo/tgo69a.htm>
- The Required Advisory Statements for Medicine Labels; <http://www.tga.gov.au/meds/rasml.htm>
- Therapeutic Goods Order No. 37 - General Requirements for labels for Therapeutic Devices; <http://www.tga.gov.au/docs/html/tgo/tgo37.htm>
- Labelling Code of Practice: Designing usable non-prescription medicine labels for consumers
- Best practice guideline on prescription medicine labelling; <http://www.tga.gov.au/pmeds/pmbestpractice.htm>
- Veterinary Labelling Code: The Code of Practice for Labelling Veterinary Chemical Products; <http://www.apvma.gov.au/MORAG_vet/vol_5/vet_labelling_code.html>
- Ag Labelling Code; <http://www.apvma.gov.au/MORAG_ag/vol_5/ag_labelling_code.html>
- FAISD Handbook: <http://www.health.gov.au/internet/wcms/publishing.nsf/Content/ocs-faisd-handbook.htm> Handbook of First Aid Instructions, Safety Directions and Warning Statements for Agricultural and Veterinary Chemicals;
- Australian Dangerous Goods Code (ADG) <http://www.dotars.gov.au/transport/australia/dangerous/publications.aspx> (Australian Code for the transport of dangerous goods by road and rail);
- National Code of Practice for the Labelling of Workplace Substances <http://www.ascc.gov.au/ascc/AboutUs/Publications/NationalStandards/IndexofNationalStandardsCodesofPracticeandrelatedGuidanceNotes.htm>; and
- NDPSC Guide to the Packaging, Labelling and Regulation of Paints, Tinters and Related Products <http://www.tga.gov.au/ndpsc/paintgui.htm>.
As poisons labelling is the responsibility of the States and Territories, when further information or assistance is required reference should be made to these contacts, not to the National Drugs and Poisons Schedule Committee (NDPSC). A list of State and Territory contacts is included at the end of this Guide.