Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 5
STANDARD FOR THE UNIFORM SCHEDULING OF
MEDICINES AND POISONS
October 2014
The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health or the Secretary’s Delegate in July 2014. The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the TGA website at http://www.tga.gov.au/industry/scheduling-decisions-final.htm.
Further inquiries should be directed to:
The Secretary<br>Chemicals Scheduling Secretariat (MDP88)<br>Office of Chemical Safety<br>Department of Health<br>GPO Box 9848<br>CANBERRA ACT 2601<br> <br>or by email to Chemicals.Scheduling@health.gov.au<br>
The Secretary<br>Medicines Scheduling Secretariat (MD122) Communications and Secretariat Therapeutic Goods Administration PO Box 100 WODEN ACT 2606<br> <br>or by email to Medicines.Scheduling@tga.gov.au<br>
The Poisons Standard 2014, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. Further information on the scheduling amendments and the SPF can be accessed at www.tga.gov.au. Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).
The SUSMP serves two key purposes.
Firstly, the SUSMP contains the decisions of the Secretary of the Department of Health or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation. Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.
Secondly, the SUSMP includes model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Appropriate labelling and container requirements for products, other than therapeutic goods and agricultural and veterinary chemicals, are imposed through adoption of Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. Other government agencies may also impose controls on certain products, for example cosmetics.
The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers. Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation.
Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)]. Note, however that this exemption does not extend to controls on supply of these poisons.
The SUSMP is presented with a view to promoting uniform:
scheduling of poisons throughout Australia;
signal headings on labels for poisons throughout Australia;
labelling and packaging requirements for poisons throughout Australia;
additional controls on the availability and use of poisons in Australia.
The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:
the Agricultural and Veterinary Chemicals Code Act 1994
the Agricultural and Veterinary Chemicals Code Regulations 1995
the Therapeutic Goods Act 1989
Therapeutic Goods Order 69 – General requirements for labels for medicines
Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines
the Required Advisory Statements for Medicine Labels (RASML).
CLASSIFICATION
Poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For the legal definitions, however, it is necessary to check with each relevant State or Territory authority.