Standard for the Uniform Scheduling of Medicines and Poisons
The Standard for the Uniform Scheduling of Medicines and Poisons is an Australian legislative instrument produced by the Therapeutic Goods Administration. Before 2010, it was known as the Standard for the Uniform Scheduling of Drugs and Poisons. The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public., the most recent version is the Poisons Standard February 2020. 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.
Schedules
Schedule 1
Schedule 1 is blank. Schedule 1 does not currently contain any medicines or poisons.
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." The location of these medications in the pharmacy varies from state to state.
Schedule 3: Pharmacist Only Medicine
Schedule 3 drugs and poisons, otherwise known as Pharmacist Only Medicines, are substances and preparations for therapeutic use that –
are substantially safe in use but require professional advice or counselling by a pharmacist;
require pharmacist advice, management, or monitoring;
are for ailments or symptoms that –
* can be identified by the consumer and verified by a pharmacist;
* don't require medical diagnosis, or only require initial medical diagnosis, and don't require close medical management.
Some states have subsets of Schedule 3 with additional requirements. Only some Schedule 3 medicines may be advertised to the public. Examples:
Schedule 4 drugs and poisons, otherwise known as prescription only medicines, are substances and preparations for therapeutic use that –
require professional medical, dental, or veterinary management or monitoring;
are for ailments or symptoms that require professional medical, dental, or veterinary diagnosis or management;
may require further evaluation for safety or efficacy;
are new therapeutic substances.
The price of many Schedule 4 substances are subsidized by the Australian Government through the Pharmaceutical Benefits Scheme, when prescribed by an authorized 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. Schedule 4 medicines cannot be advertised directly to the public. Examples:
Schedule 5 drugs and poisons are substances and preparations that must have appropriate packaging and simple warning labels to display that these poisons:
have low toxicity or a low concentration;
have a low to moderate hazard;
can cause only minor adverse effects to the human being in normal use;
require caution in handling, storage, or use.
Schedule 6: Poison
Must use distinctive packaging and strong warnings to display the potential for:
moderate to high toxicity;
that may cause death or severe injury if ingested, inhaled, or in contact with the skin or eyes.
Substances with a high potential for causing harm at low exposure and which:
Require special precautions for manufacture, handling or use; or
Only available to specialised and authorised users with appropriate skills
Special regulations regarding their availability, possession, storage or use may apply
Schedule 8: Controlled Drug
Schedule 8 drugs and poisons, otherwise known as Controlled Drugs, are substances and preparations for therapeutic use which have high potential for abuse and addiction. The possession of these medications without authority is an offence. Like schedule 4 substances, the price of many Schedule substances are subsidized through the Pharmaceutical Benefits Scheme, 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 requires authorisation from the NSW Ministry of Health and is generally restricted to specialists, such as paediatricians and psychiatrists. A GP 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:
Schedule 9 drugs and poisons are substances and preparations that, by law, may only be used for research purposes. The sale, distribution, use, and manufacture of such substances without a permit is strictly prohibited by law. Permits for research uses on humans must be approved by a recognized ethics committee on human research. Examples:
Schedule 10: Substances of such danger to health as to warrant prohibition of sale, supply and use
Schedule 10 was known as Appendix C until the introduction of the Poisons Standard 2015. It includes substances of such danger to health as to warrant prohibition of sale, supply and use. Examples:
Unscheduled substances don't belong to any of the above schedules. Many of these preparations are also sold in supermarkets in addition to pharmacies. 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 legislation refers to S2 as "medicinal poisons", S3 as "potent substances", S4 as "restricted substances" and S8 as "drugs of addiction".
Schedule 3 Recordable
Schedule 3 Recordable, 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 . As of January 2006, all pseudoephedrine-containing preparations are S3R.
Schedule 4 Appendix D
Schedule 4, Appendix D refers to Prescription Only Medicines that don't 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 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 Western Australia, supply of certain S3 preparations listed in Appendix J of the Poisons Regulations 1965 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.
