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Standard for the Uniform Scheduling of Medicines and Poisons

January 01, 1970

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.

Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023
Department of Health and Aged Care
Citation[1]
Territorial extentAustralia
Enacted22 September 2023
Commenced1 October 2023
Authorizing legislationTherapeutic Goods Act 1989
Repeals
Therapeutic Goods (Poisons Standard—July 2023) Instrument 2023
Status: In force

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 edit

Schedule 1 edit

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

Schedule 2: Pharmacy Medicine edit

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 and
    • do not require medical diagnosis or management.

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 edit

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.

Examples:

Schedule 4: Prescription Only Medicine edit

Schedule 4 (S4) 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.
  • cost of the drug is high, or when there is a risk of dependence

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 edit

Schedule 5 (S5) 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.

Examples:

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

Schedule 6: Poison edit

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.

Examples:

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

Schedule 7: Dangerous Poison edit

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

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 edit

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 edit

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 edit

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:

Unscheduled substances edit

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 edit

New South Wales edit

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 edit

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 edit

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 edit

Recordable S3 products (Schedule G) edit

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 edit

Recordable S3 products (Appendix J) edit

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 edit

Notes edit

  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.

References edit

  • Bullock, S & Manias, E. (2011). Fundamentals of Pharmacology (6th ed). Pearson Australia: Frenchs Forest, NSW

January 01, 1970
standard, uniform, scheduling, medicines, poisons, susmp, also, known, poisons, standard, short, australian, legislative, instrument, produced, therapeutic, goods, administration, before, 2010, known, standard, uniform, scheduling, drugs, poisons, susdp, susmp. 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 update the most recent version is the Therapeutic Goods Poisons Standard October 2023 Instrument 2023 Therapeutic Goods Poisons Standard October 2023 Instrument 2023Department of Health and Aged CareCitation 1 Territorial extentAustraliaEnacted22 September 2023Commenced1 October 2023Authorizing legislationTherapeutic Goods Act 1989RepealsTherapeutic Goods Poisons Standard July 2023 Instrument 2023Status In force 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 Contents 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 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 Schedule 10 Substances of such danger to health as to warrant prohibition of sale supply and use 1 11 Unscheduled substances 2 Interstate variations 2 1 New South Wales 2 1 1 Schedule 3 Recordable 2 1 2 Schedule 4 Appendix D 2 2 South Australia 2 2 1 Recordable S3 products Schedule G 2 3 Western Australia 2 3 1 Recordable S3 products Appendix J 3 See also 4 Notes 5 ReferencesSchedules editSchedule 1 edit Schedule 1 is blank Schedule 1 does not currently contain any medicines or poisons Schedule 2 Pharmacy Medicine edit 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 and do not require medical diagnosis or management Examples 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 Hyoscine used to treat motion sickness postoperative nausea and vomiting Nonsedating antihistamines such as loratadine Nasal sprays containing decongestants or steroids 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 edit 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 Examples Orlistat trade name Xenical Pseudoephedrine marketed in Cold and Flu preparations Salbutamol Ventolin Asmol Rikodeine dihydrocodeine Schedule 4 Prescription Only Medicine edit Schedule 4 S4 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 cost of the drug is high or when there is a risk of dependence 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 Amoxicillin Anabolic steroids Apomorphine Cannabidiol in preparations for therapeutic use containing 2 percent or less of other cannabinoids found in cannabis since June 2015 6 Cisplatin Co codamol preparations comprising codeine and paracetamol Ephedrine Ergotamine Oestradiol Fluticasone Ibogaine Isotretinoin Methoxyflurane Pseudoephedrine in large doses Salmeterol Tramadol Tretinoin Trimethoprim All benzodiazepines except flunitrazepam and alprazolam All SSRIs e g fluoxetine citalopram SNRIs e g duloxetine milnacipran TCAs e g amitriptyline imipramine MAOIs e g selegiline moclobemide Antipsychotic drugs e g aripiprazole quetiapine Schedule 5 Caution edit Schedule 5 S5 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 Examples Ammonia Acetic acid gt 30 Boric acid Chlorinating compounds Clove oil Ivermectin for use in animals Lidocaine Methylated Spirits Petrol Some of the above examples are subject to exceptions dependant on the specific preparation concentration or inclusion in other schedules Schedule 6 Poison edit 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 Examples Arsenic Beryllium Bromethalin Chloroform Cyanamide Safrole Toluene Xylene Ziram Some of the above examples are subject to exceptions dependant on the specific preparation concentration or inclusion in other schedules Schedule 7 Dangerous Poison edit 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 Examples Azo Dyes Benzene Chlorine Demeton Phosphine Vinyl Chloride Some of the above examples are subject to exceptions dependant on the specific preparation concentration or inclusion in other schedules Schedule 8 Controlled Drug edit 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 Alprazolam Amphetamine Barbiturates most Buprenorphine Suboxone Carfentanil Cocaine Codeine single ingredient Dexamfetamine Dronabinol Fentanyl Flunitrazepam GHB Hydrocodone Hydromorphone Ketamine MDMA Methamphetamine Methylphenidate Morphine Nabiximols Opium Oxycodone Pethidine Psilocin Psilocybin Schedule 9 Prohibited Substance edit 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 2C I Benzylpiperazine Bromo DragonFLY Cannabis except when separately specified in other Schedules 7 Coca leaf DMT Harmine Harmaline Heroin Kratom 8 also known as Mitragyna speciosa as well its main alkaloid Mitragynine LSD MDPV Mephedrone Mescaline Methaqualone Methoxypiperamide Salvia divinorum Schedule 10 Substances of such danger to health as to warrant prohibition of sale supply and use edit 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 2 4 Dinitrophenol for human use Borage for therapeutic use except the fixed oil derived from the seeds of Borago officinalis Coal tar for cosmetic use other than in therapeutic goods Juniperus sabina for therapeutic use Oxyphenisatin for therapeutic use Unscheduled substances edit 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 Antacids Alcohol ethanol Caffeine Ephenidine Hydroxymorphinan Ranitidine in small packs larger packs are schedule Paracetamol 500 mg in small packs lt 24 larger packs are schedule 2 Some laxatives e g bulk laxatives Metamucil Lubricant eye drops Nicotine replacement therapy some preparations are schedule 2 Interstate variations editNew South Wales edit 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 edit 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 edit 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 edit Recordable S3 products Schedule G edit 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 edit Recordable S3 products Appendix J edit 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 editRegulation of therapeutic goods Prohibition of drugs Illicit drug use in AustraliaNotes edit Therapeutic Goods Act 1989 Cth s 52D subsection 4A Poisons Standard 2009 Federal Register of Legislation Department of Health 3 August 2009 Explanatory statement Poisons Standard October 2016 Federal Register of Legislation Department of Health 30 October 2016 Contacts for State Territory drugs amp poisons units Therapeutic Goods Administration 7 December 2015 Poisons Standard February 2017 Legislation gov au 28 February 2018 Poisons Standard June 2015 Federal Register of Legislation Department of Health 26 May 2015 Atfield Cameron Remeikis Amy 7 June 2015 Families already using medicinal cannabis on children ahead of trials Brisbane Times 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 References editBullock S amp Manias E 2011 Fundamentals of Pharmacology 6th ed Pearson Australia Frenchs Forest NSW Retrieved from https en wikipedia org w index php title Standard for the Uniform Scheduling of Medicines and Poisons amp oldid 1220855341, wikipedia, wiki, book, books, library,

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