| Short Title: | Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024 |
| Legislature: | Department of Health and Aged Care |
| Citation: | https://www.legislation.gov.au/Details/F2024L00095 |
| Territorial Extent: | Australia |
| Date Enacted: | 23 January 2024 |
| Date Commenced: | 1 February 2024 |
| Authorizing Legislation: | Therapeutic Goods Act 1989 |
| Repeals: | Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023 |
| Status: | in force |
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), also known as the Poisons Standard for short, is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA).[1] Before 2010, it was known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).[2] The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public.[3], the most recent version is the Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024.
The Schedules are referred to under State and Territory legislation for regulatory purposes. Although each State and Territory has its own laws, the vast majority of medicines and poisons are classified according to the SUSMP to achieve uniform national regulation.[4]
Examples:
The SUSMP March 2018 defines a Schedule 2 substance as "Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person."[5]
The location of these medications in the pharmacy varies from state to state.
Schedule 3: Pharmacist Only MedicineSome states have subsets of Schedule 3 with additional requirements (see below). Only some Schedule 3 medicines may be advertised to the public.
Examples:
The price of many Schedule 4 substances are subsidized by the Australian Government through the Pharmaceutical Benefits Scheme (PBS), when prescribed by an authorised prescriber. Certain medications may require an authority from the PBS. Situations that may require an authority include where the drug may only have benefit in limited conditions, the true cost of the drug is high, or when there is a risk of dependence. Some states have subsets of Schedule 4 with additional requirements (see below). Schedule 4 medicines cannot be advertised directly to the public.
Examples:
Examples:
Some of the above examples are subject to exceptions dependant on the specific preparation, concentration, or inclusion in other schedules.
Schedule 6: PoisonExamples:
Some of the above examples are subject to exceptions dependant on the specific preparation, concentration, or inclusion in other schedules.
Schedule 7: Dangerous PoisonExamples:
Some of the above examples are subject to exceptions dependant on the specific preparation, concentration, or inclusion in other schedules.
Schedule 8: Controlled DrugLike schedule 4 substances, the price of many Schedule substances are subsidized through the Pharmaceutical Benefits Scheme (PBS), some of which may require an authority. In addition, in some states, all drugs on schedule 8 require a doctor to have an S8 permit before prescribing treatment. For example, in NSW the prescribing of Schedule 8 CNS stimulant medication (e.g., methylphenidate, dexamfetamine) requires authorisation from the NSW Ministry of Health (Pharmaceutical Services) and is generally restricted to specialists, such as paediatricians and psychiatrists. A GP (General Practitioner) cannot initiate the treatment, although they can prescribe in very limited circumstances, e.g. co-prescribing on behalf of the specialist; and in rural areas, if the patient has been diagnosed with ADHD, a GP may apply for the authority to prescribe. Patients who may require Schedule 8 CNS stimulant medication should be referred to a specialist for assessment.
Examples:
Examples:
Examples are:
Unscheduled substances do not belong to any of the above schedules. Many of these preparations are also sold in supermarkets in addition to pharmacies. All ages are allowed to have these.
Examples:
In New South Wales, poisons are proclaimed in the Poisons List by the Poisons Advisory Committee, under the authority of the Poisons and Therapeutic Goods Act 1966 (NSW). NSW legislation refers to S2 as "medicinal poisons", S3 as "potent substances", S4 as "restricted substances" and S8 as "drugs of addiction".
Schedule 3 Recordable (S3R), or "recordable potent substances", refers to Pharmacist Only Medicines where supply is recorded as for Schedule 4 drugs. S3R drugs are those that may have an increased risk of illegal diversion or abuse. These are specified in Clause 23 of the Poisons and Therapeutic Goods Regulation 2002 (NSW). As of January 2006, all pseudoephedrine-containing preparations are S3R. Rikodeine cough syrup also falls into category which contains Dihydrocodeine and Sorbitol.
Schedule 4, Appendix D (S4D) refers to Prescription Only Medicines that do not have sufficient addictiveness or risk of abuse to be classified as S8, but for which a significant addiction/abuse risk exists. As such, S4D drugs are subject to additional prescription and recording requirements over S4. These drugs are referred to as "prescribed restricted substances" under the Poisons and Therapeutic Goods Regulation 2002 (NSW) and are listed in Appendix D of the Regulation. Drugs included in Appendix D include benzodiazepines, anabolic steroids, gabapentinoids and opiates. A subset of Appendix D are the Appendix B substances, which are subject to similar requirements as S8 drugs.
In South Australia, supply of certain S3 preparations listed in Schedule G of the Controlled Substances (Poisons) Regulations 1996 (SA) are recordable under Regulation 14(2). As of 2006, Schedule G products specified are: adrenaline (in metered aerosols), dihydrocodeine (in cough preparations), doxylamine (in preparations also containing codeine), promethazine (in preparations also containing codeine), and pseudoephedrine.
In Western Australia, supply of certain S3 preparations listed in Appendix J of the Poisons Regulations 1965 (WA) are recordable under Regulation 35A. As of 2006, Appendix J products specified are: hydrocortisone, hydrocortisone acetate, pseudoephedrine, and nicotine preparations were included in Schedule 3.