Standard for the Uniform Scheduling of Medicines and Poisons

The Standard for the Uniform Scheduling of Drugs and Poisons, abbreviated SUSDP, is a document used in the regulation of drugs and poisons in Australia. It is produced by the National Drugs and Poisons Scheduling Committee (NDPSC), a committee of the Therapeutic Goods Administration (TGA). The SUSDP contains the decisions of the NDPSC 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 SUSDP is only a recommendation to the States, however, and differences still exist in the regulation of drugs and poisons between Australian states.

Schedules

There are eight schedules included in the SUSDP:

Schedule 1 (Defunct)

This schedule is no longer used. Section 8(2) of the Poisons and Therapeutic Goods Act 1966 (NSW) describes Schedule 1 as, "substances which are of such extreme danger to life as to warrant their being supplied only by medical practitioners, nurse practitioners authorised...pharmacists, dentists, veterinary surgeons or persons licensed..."

Schedule 2 Pharmacy Medicine

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

• which are substantially safe in use but where advice or counselling is available if necessary
• for minor ailments or symptoms which -
  • can be easily recognised by the consumer
  • do not require medical diagnosis or management

Some examples include:

• Dextromethorphan

Schedule 2 substances can be stored in any part of a pharmacy apart from food.

Schedule 3 Pharmacist Only Medicine

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

• which are substantially safe in use but require professional advice or counselling by a pharmacist
• the use of which requires pharmacist advice, management or monitoring
• which MUST be personally handed to the patient by the pharmacist
• which are for ailments or symptoms which -
  • 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

In some states, there are subsets of Schedule 3 with additional requirements (see below). Only some Schedule 3 medicines can be advertised to the public.

Some examples include:

• Orlistat
• Pseudoephedrine
• Salbutamol (Ventolin/Asmol)

Schedule 4 Prescription Only Medicine/Animal Prescription Remedy

Schedule 4 (S4) poisons, otherwise known as Prescription Only Medicines, are substances and preparations for therapeutic use -

• the use of which requires professional medical, dental or veterinary management or monitoring
• which are for ailments or symptoms that require professional medical, dental or veterinary diagnosis or management
• the safety or efficacy of which may require further evaluation
• which are new therapeutic substances

In some states, there are subsets of Schedule 4 with additional requirements (see below). Schedule 4 medicines cannot be advertised directly to the public.

Some examples include:

• Adrenaline
• Co-amoxiclav
• Co-trimoxazole
• All Benzodiazepines except Flunitrazepam(Rohypnol) and Temazepam (Normison)
• Ephedrine
• Ergotamine
• Fluticasone
• Isotretinoin
• Pseudoephedrine in large doses
• Salmeterol
• Tretinoin
• Temazepam (Normison)

Schedule 5 Caution

Schedule 5 (S5) poisons are substances and preparations which -

• have low toxicity or a low concentration
• have a low to moderate hazard
• are capable of causing only minor adverse effects to human being in normal use
• require caution in handling, storage or use

Schedule 6 Poison

Schedule 6 (S6) poisons are substances and preparations -

• with moderate to high toxicity
• which may cause death or severe injury if ingested, inhaled or in contact with the skin or eyes

Schedule 7 Dangerous Poison

Schedule 7 (S7) poisons are substances and preparations -

• with high to extremely high toxicity
• which can cause death or severe injury at low exposures
• which require special precautions in their manufacture, handling or use
• which may require special regulations restricting their availability, possession or use
• which are too hazardous for domestic use or use by untrained persons

Schedule 8 Controlled Drug (Possession without authority illegal)

Schedule 8 (S8) poisons, otherwise known as Controlled Drugs, are substances and preparations for therapeutic use -

• which are dependence producing
• which are likely to be abused or misused

Some examples include:

• Amphetamine
• Most Barbiturates
• Cocaine
• Dexamphetamine
• Flunitrazepam (Hypnodorm)
• Methadone
• Methamphetamine
• Methylphenidate (Ritalin)
• Morphine
• Hydromorphone

Schedule 9 Prohibited Substance

Schedule 9 (S9) poisons are substances and preparations which, by law, may only be used for research purposes. The sale, distribution, use and manufacture of such substances are strictly prohibited under the law.

Some examples include:

• Cannabis (Marijuana)
• GHB
• Heroin
• LSD
• Mescaline
• MDMA (Ecstasy)
• Psilocin
• Psilocybin

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 examples include:

• antacids
• ranitidine in small packs (larger packs are schedule 2)
• ibuprofen 200mg in small packs (larger packs are schedule 2)
• paracetamol 500mg in small packs (larger packs are schedule 2)
• some laxatives (eg. bulk laxatives Metamucil)
• lubricant eye drops
• nicotine replacement therapy (some preparations are schedule 2)

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 which 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 which 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.

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 where included in Schedule 3.