Standard for the Uniform Scheduling of Medicines and Poisons
The Standard for the Uniform Scheduling of Medicines and Poisons (abbreviated SUSMP) or the Poisons Standard (its legal title), is a legislative instrument used in the regulation of drugs and poisons in Australia. It is produced by the Australian Committee for Chemicals Scheduling (ACCS), a committee of the Therapeutic Goods Administration (TGA). The SUSMP contains the decisions of the ACCS delegate in the aim of standardising the scheduling and packaging/labelling of substances throughout Australia, where such regulation lies within the jurisdiction of the individual state governments. The SUSMP is only a recommendation to the states, however, and differences still exist in the regulation of drugs and poisons between Australian states.
- 1 Schedules
- 1.1 Schedule 1
- 1.2 Schedule 2 Pharmacy Medicine
- 1.3 Schedule 3 Pharmacist Only Medicine
- 1.4 Schedule 4 Prescription Only Medicine (Humans) or Prescription Animal Remedy (Animals)
- 1.5 Schedule 5 Caution
- 1.6 Schedule 6 Poison
- 1.7 Schedule 7 Dangerous Poison
- 1.8 Schedule 8 Controlled Drug
- 1.9 Schedule 9 Prohibited Substance
- 1.10 Unscheduled Substances
- 2 Interstate variations
- 3 Footnotes
- 4 External links
There are eight schedules included in the SUSMP (numbered 2-9).
This schedule level is now defunct and has been set aside for possible future use. Some older printed reference material may have inferred or included traditional or 'herbal' medicines, but these products are now rated as being complementary medicines that require listing only as per the Therapeutic Goods Act 1989.
Schedule 2 Pharmacy Medicine
Schedule 2 (S2) drugs and poisons, otherwise known as Pharmacy Medicines, are substances and preparations for therapeutic use that:
- Are substantially safe in use but where advice or counselling is available if necessary
- Are for minor ailments or symptoms that:
- Can be easily recognised by the consumer
- Do not require medical diagnosis or management
- Dextromethorphan, a cough suppressant
- Simple analgesics such as aspirin, paracetamol and ibuprofen in packs containing more than 24 tablets (packs containing up to 24 tablets of simple analgesics are unscheduled, and can be sold in any shop)
- Nonsedating antihistamines such as loratadine
- Nasal sprays containing decongestants or steroids
The location of these medications in the pharmacy varies from state to state.
Schedule 3 Pharmacist Only Medicine
Schedule 3 (S3) 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
- Do not require medical diagnosis, or only require initial medical diagnosis, and do not require close medical management
Some states have subsets of Schedule 3 with additional requirements (see below). Only some Schedule 3 medicines may be advertised to the public.
- Orlistat (trade name Xenical)
- Pseudoephedrine (marketed in Cold and Flu preparations)
- Salbutamol (Ventolin/Asmol)
Schedule 4 Prescription Only Medicine (Humans) or Prescription Animal Remedy (Animals)
Schedule 4 (S4) drugs and poisons, otherwise known as prescription only medicines, are substances and preparations for therapeutic use that:
- Requires 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
- No drugs under schedule 4 need to be authorised by the health department
- One's doctor may call the health department to get a drug approved that is not listed on the Pharmaceutical Benefits Scheme (PBS) so that the purchase price can be subsidised under the scheme
- Not all drugs can be authorised for the (PBS)
Some states have subsets of Schedule 4 with additional requirements (see below). Schedule 4 medicines cannot be advertised directly to the public.
- Co-codamol preparations comprising 16–30 mg codeine per 500 mg paracetamol
- Pseudoephedrine in large doses
- All benzodiazepines except flunitrazepam and alprazolam
- Antipsychotic drugs (e.g. Aripiprazole, Quetiapine)
Schedule 5 Caution
Schedule 5 (S5) drugs and poisons are substances and preparations that:
- Have low toxicity or a low concentration
- Have a low to moderate hazard
- Can cause only minor adverse effects to human being in normal use
- Require caution in handling, storage, or use.
Schedule 6 Poison
Schedule 6 (S6) drugs and poisons are substances and preparations:
- With moderate to high toxicity
- Which may cause death or severe injury if ingested, inhaled, or in contact with skin or eyes
Schedule 7 Dangerous Poison
Schedule 7 (S7) drugs and poisons are substances and preparations that:
- Have high to extremely high toxicity
- Can cause death or severe injury at low exposures
- Require special precautions in their manufacture, handling, or use
- May require special regulations restricting their availability, possession or use
- Are too hazardous for domestic use, or use by untrained persons
Schedule 8 Controlled Drug
Schedule 8 (S8) 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.
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, dexamphetamine) 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. It is illegal for anyone other than an authorised doctor to issue a prescription for a Schedule 8 CNS stimulant.
Schedule 8 includes, for example:
- Barbiturates (most)
- Buprenorphine / Suboxone
- Codeine (single ingredient)
Schedule 9 Prohibited Substance
Schedule 9 (S9) drugs and poisons are substances and preparations that, by law, may only be used for research purposes (despite Australia being a signatory to various UN conventions stating they must be available for medical use). 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.
- Cannabis - An S9 Drug in all states except NSW, VIC and QLD who are commencing limited clinical trials and have listed it as an S4 drug in their jurisdictions.
Unscheduled substances do not belong to any of the above schedules. Many of these preparations are also sold in supermarkets in addition to pharmacies.
- Ranitidine in small packs (larger packs are schedule)
- Paracetamol 500 mg in small packs (<24; larger packs are schedule 2)
- Some laxatives (e.g. bulk laxatives Metamucil)
- Lubricant eye drops
- Nicotine replacement therapy (some preparations are schedule 2)
New South Wales
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
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.
Schedule 4 Appendix D
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 and anabolic steroids. A subset of Appendix D are the Appendix B substances, which are subject to similar requirements as S8 drugs.
Recordable S3 products (Schedule G)
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.
Recordable S3 products (Appendix J)
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.
- Department of Health, ‘Poison Standard 2015’ (Cth) ii <http://www.comlaw.gov.au/Details/F2015L00128/>
- Department of Health, ‘Poison Standard 2015’ (Cth) iii-iv <http://www.comlaw.gov.au/Details/F2015L00128/>
- Department of Health, ‘Poison Standard 2015’ (Cth) 207-209 <http://www.comlaw.gov.au/Details/F2015L00128/>
- Department of Health, ‘Poison Standard 2015’ (Cth) 210-215 <http://www.comlaw.gov.au/Details/F2015L00128/>
- Bullock, S & Manias, E. (2011). Fundamentals of Pharmacology (6th ed). Pearson Australia: Frenchs Forest, NSW.