Standard for the Uniform Scheduling of Medicines and Poisons

Last updated

Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023
Coat of Arms of Australia.svg
Department of Health and Aged Care
Citation
Territorial extent Australia
Enacted22 September 2023
Commenced1 October 2023
Authorizing legislation Therapeutic Goods Act 1989
Repeals
Therapeutic Goods (Poisons Standard—July 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] As of 2023, the most recent version is the Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023.

Contents

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]

Schedules

Schedule 1

Schedule 1 is blank. Schedule 1 does not currently contain any medicines or poisons.

Schedule 2: Pharmacy Medicine

Schedule 2 (S2) drugs and poisons, otherwise known as Pharmacy Medicines, are substances and preparations for therapeutic use that –

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 Medicine

Schedule 3 (S3) drugs and poisons, otherwise known as Pharmacist Only Medicines, are substances and preparations for therapeutic use that –

Some states have subsets of Schedule 3 with additional requirements (see below). Only some Schedule 3 medicines may be advertised to the public.

Examples:

Schedule 4: Prescription Only Medicine

Schedule 4 (S4) drugs and poisons, otherwise known as prescription only medicines , are substances and preparations for therapeutic use that –

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:

Schedule 5: Caution

Schedule 5 (S5) drugs and poisons are substances and preparations that must have appropriate packaging and simple warning labels to display that these poisons:

Examples:

Some of the above examples are subject to exceptions dependant on the specific preparation, concentration, or inclusion in other schedules.

Schedule 6: Poison

Must use distinctive packaging and strong warnings to display the potential for:

Examples:

Some of the above examples are subject to exceptions dependant on the specific preparation, concentration, or inclusion in other schedules.

Schedule 7: Dangerous Drug

Substances with a high potential for causing harm at low exposure and which:

Examples:

Some of the above examples are subject to exceptions dependant on the specific preparation, concentration, or inclusion in other schedules.

Schedule 8: Controlled Drug

Schedule 8 (S8) drugs and poisons, otherwise known as Controlled Drugs, are schedule 9 prohibited substances that are appropriate preparations for therapeutic use which have high potential for abuse and addiction. The possession of these medications without authority is the same as carrying a prohibited substance and is illegal.

Like 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:

Schedule 9: Prohibited Substance

Schedule 9 (S9) 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 recognised 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. To clarify, the listed substances are not necessasarily prohibited completely. Rather, it depends on the concentration of the substance and its associated risk for harm. To illustrate, diethylene glycol is prohibited by law, but at a concentration of 0.25% it is allowed to be an ingredient in toothpaste and mouthwash.

Examples are:

As of 15 August 2022, Schedule 10 includes each of the following substances:

a) in liquid or semi-solid food additive preparations, the pH of which is more than 11.5; b) in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 12.5; or c) in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.

a) is in accordance with: i) an approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989, including any conditions specified in the notice of approval; and ii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and iii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or b)is in accordance with the requirements of item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990.

a) in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde; b) in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde; c) in nail hardener cosmetic preparations containing 5 per cent or more of free formaldehyde; or d) in all other cosmetic preparations containing 0.05 per cent or more of free formaldehyde except in preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement: CONTAINS FORMALDEHYDE.

a) in anti-fouling or anti-corrosive paints except in preparations containing 0.1 per cent or less of lead calculated on the non-volatile content of the paint; or b) in paints (other than anti-fouling or anti-corrosive paints), tinters, inks or ink additives except in preparations containing 0.009 per cent or less of lead calculated on the non-volatile content of the paint, tinter, ink or ink additive.

Unscheduled substances

Unscheduled substances do not belong to any of the above schedules. Many of these preparations are also sold in supermarkets in addition to pharmacies. Some may be age-restricted under other laws.

Examples:

Interstate variations

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. Rikodeine cough syrup also falls into category which contains Dihydrocodeine and Sorbitol.[ citation needed ]

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, anabolic steroids, gabapentinoids and opiates. A subset of Appendix D are the Appendix B substances, which are subject to similar requirements as S8 drugs.

South Australia

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.

Western Australia

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.

See also

Notes

  1. Therapeutic Goods Act 1989 (Cth) s 52D, subsection 4A.
  2. "Poisons Standard 2009", Federal Register of Legislation, Department of Health, 3 August 2009.
  3. "Explanatory statement: Poisons Standard October 2016", Federal Register of Legislation, Department of Health, 30 October 2016.
  4. "Contacts for State/Territory drugs & poisons units". Therapeutic Goods Administration. 7 December 2015.
  5. "Poisons Standard, February 2017". Legislation.gov.au. 28 February 2018.
  6. "Poisons Standard June 2015", Federal Register of Legislation, Department of Health, 26 May 2015.
  7. Atfield, Cameron; Remeikis, Amy (7 June 2015). "Families already using medicinal cannabis on children ahead of trials". Brisbane Times .
  8. "National Drugs and Poisons Schedule Committee Record of Reasons, 40th Meeting". 24–26 February 2004. Archived from the original (PDF) on 27 July 2008. Retrieved 19 April 2019 via National Library of Australia.
  9. Care, Health and Aged. "Poisons Standard June 2022". www.legislation.gov.au. Retrieved 15 August 2022.

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References