Standard for the Uniform Scheduling of Drugs and Poisons
Encyclopedia
The Standard for the Uniform Scheduling of Medicines and Poisons, abbreviated SUSMP, 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 SUSMP 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 SUSMP is only a recommendation to the States, however, and differences still exist in the regulation of drugs and poisons between Australian states.
Examples include:
The location of these medications in the pharmacy varies from state to state.
Some states have subsets of Schedule 3 with additional requirements (see below). Only some Schedule 3 medicines may be advertised to the public.
Examples include:
No drugs under schedule 4 need to be authorised by the health department
Some states have subsets of Schedule 4 with additional requirements (see below). Schedule 4 medicines cannot be advertised directly to the public. The above PBS data is not accurate. The Australian Pharmacuetical Benefits Scheme (PBS), is a list of drugs subsidised by the Australian Federal Government. S4 scripts are almost ALWAYS PBS, with phone authority needed for increased amounts, or multiple repeats. The individual state the drug is in governs that drug i.e. S4, S8 etc, the PBS is about the cost of the medicine and is federal. Again, the individual states legislate independently re drug dangers and harm/abuse issues.
Examples include:
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
.
All drugs that are schedule 8 must be approved by the health department at the time of writing a prescription for that drug; the prescriptions must be written by hand and not printed.
Examples include:
Examples include:
Examples include:
, 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".
s and anabolic steroid
s. A subset of Appendix D are the Appendix B substances, which are subject to similar requirements as S8 drugs.
, 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.
, 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.
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
. It is produced by the National Drugs and Poisons Scheduling Committee (NDPSC), a committee of the Therapeutic Goods Administration
Therapeutic Goods Administration
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...
(TGA). The SUSMP 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 SUSMP is only a recommendation to the States, however, and differences still exist in the regulation of drugs and poisons between Australian states.
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) 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 counseling 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
Examples include:
- DextromethorphanDextromethorphanDextromethorphan is an antitussive drug. It is one of the active ingredients in many over-the-counter cold and cough medicines, such as Robitussin, NyQuil, Dimetapp, Vicks, Coricidin, Delsym, and others, including generic labels. Dextromethorphan has also found other uses in medicine, ranging...
- 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
- 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.
Examples include:
- OrlistatOrlistatOrlistat , also known as tetrahydrolipstatin, is a drug designed to treat obesity. Its primary function is preventing the absorption of fats from the human diet, thereby reducing caloric intake...
- PseudoephedrinePseudoephedrinePseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
- SalbutamolSalbutamolSalbutamol or albuterol is a short-acting β2-adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease. It is marketed as Ventolin among other brand names....
(Ventolin/Asmol)
Schedule 4 prescription only medicine/prescription animal remedy
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
- Your doctor may call the health department to get a drug approved that is not listed on the (P.B.S) so you can get that drug on a (P.B.S)
- Price' not all drugs can be authorised for the (P.B.S)
No drugs under schedule 4 need to be authorised by the health department
Some states have subsets of Schedule 4 with additional requirements (see below). Schedule 4 medicines cannot be advertised directly to the public. The above PBS data is not accurate. The Australian Pharmacuetical Benefits Scheme (PBS), is a list of drugs subsidised by the Australian Federal Government. S4 scripts are almost ALWAYS PBS, with phone authority needed for increased amounts, or multiple repeats. The individual state the drug is in governs that drug i.e. S4, S8 etc, the PBS is about the cost of the medicine and is federal. Again, the individual states legislate independently re drug dangers and harm/abuse issues.
Examples include:
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 (Possession without authority illegal)
Schedule 8 (S8) drugs and poisons, otherwise known as Controlled Drugs, are substances and preparations for therapeutic use which have high potential for abuse
Substance abuse
A substance-related disorder is an umbrella term used to describe several different conditions associated with several different substances .A substance related disorder is a condition in which an individual uses or abuses a...
and addiction
Substance dependence
The section about substance dependence in the Diagnostic and Statistical Manual of Mental Disorders does not use the word addiction at all. It explains:...
.
All drugs that are schedule 8 must be approved by the health department at the time of writing a prescription for that drug; the prescriptions must be written by hand and not printed.
Examples include:
- AmphetamineAmphetamineAmphetamine or amfetamine is a psychostimulant drug of the phenethylamine class which produces increased wakefulness and focus in association with decreased fatigue and appetite.Brand names of medications that contain, or metabolize into, amphetamine include Adderall, Dexedrine, Dextrostat,...
- Barbiturates (most)
- BuprenorphineBuprenorphineBuprenorphine is a semi-synthetic opioid that is used...
- CocaineCocaineCocaine is a crystalline tropane alkaloid that is obtained from the leaves of the coca plant. The name comes from "coca" in addition to the alkaloid suffix -ine, forming cocaine. It is a stimulant of the central nervous system, an appetite suppressant, and a topical anesthetic...
- CodeineCodeineCodeine or 3-methylmorphine is an opiate used for its analgesic, antitussive, and antidiarrheal properties...
(single ingredient) - DextroamphetamineDextroamphetamineDextroamphetamine is a psychostimulant drug which is known to produce increased wakefulness and focus as well as decreased fatigue and decreased appetite....
- Fentanyl
- FlunitrazepamFlunitrazepamFlunitrazepam is marketed as a potent hypnotic, sedative, anticonvulsant, anxiolytic, amnestic, and skeletal muscle relaxant drug most commonly known as Rohypnol...
- HydromorphoneHydromorphoneHydromorphone, a more common synonym for dihydromorphinone, commonly a hydrochloride is a very potent centrally-acting analgesic drug of the opioid class. It is a derivative of morphine, to be specific, a hydrogenated ketone thereof and, therefore, a semi-synthetic drug...
- KetamineKetamineKetamine is a drug used in human and veterinary medicine. Its hydrochloride salt is sold as Ketanest, Ketaset, and Ketalar. Pharmacologically, ketamine is classified as an NMDA receptor antagonist...
- MethadoneMethadoneMethadone is a synthetic opioid, used medically as an analgesic and a maintenance anti-addictive for use in patients with opioid dependency. It was developed in Germany in 1937...
- MethamphetamineMethamphetamineMethamphetamine is a psychostimulant of the phenethylamine and amphetamine class of psychoactive drugs...
- MethylphenidateMethylphenidateMethylphenidate is a psychostimulant drug approved for treatment of attention-deficit hyperactivity disorder, postural orthostatic tachycardia syndrome and narcolepsy. It may also be prescribed for off-label use in treatment-resistant cases of lethargy, depression, neural insult and obesity...
- MorphineMorphineMorphine is a potent opiate analgesic medication and is considered to be the prototypical opioid. It was first isolated in 1804 by Friedrich Sertürner, first distributed by same in 1817, and first commercially sold by Merck in 1827, which at the time was a single small chemists' shop. It was more...
- OxycodoneOxycodoneOxycodone is an opioid analgesic medication synthesized from opium-derived thebaine. It was developed in 1916 in Germany, as one of several new semi-synthetic opioids in an attempt to improve on the existing opioids: morphine, diacetylmorphine , and codeine.Oxycodone oral medications are generally...
- PethidinePethidinePethidine or meperidine Pethidine (INN) or meperidine (USAN) Pethidine (INN) or meperidine (USAN) (commonly referred to as Demerol but also referred to as: isonipecaine; lidol; pethanol; piridosal; Algil; Alodan; Centralgin; Dispadol; Dolantin; Mialgin (in Indonesia); Petidin Dolargan (in Poland);...
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 is strictly prohibited by law.Examples include:
- CannabisCannabisCannabis is a genus of flowering plants that includes three putative species, Cannabis sativa, Cannabis indica, and Cannabis ruderalis. These three taxa are indigenous to Central Asia, and South Asia. Cannabis has long been used for fibre , for seed and seed oils, for medicinal purposes, and as a...
- GHBGamma-Hydroxybutyric acidγ-Hydroxybutyric acid , also known as 4-hydroxybutanoic acid and sodium oxybate when used for medicinal purposes, is a naturally occurring substance found in the central nervous system, wine, beef, small citrus fruits, and almost all animals in small amounts. It is also categorized as an illegal...
- Salvia divinorumSalvia divinorumSalvia divinorum is a psychoactive plant which can induce dissociative effects and is a potent producer of "visions" and other hallucinatory experiences...
- HarmineHarmineHarmine is a fluorescent harmala alkaloid belonging to the beta-carboline family of compounds. It occurs in a number of different plants, most notably the Middle Eastern plant harmal or Syrian rue and the South American vine Banisteriopsis caapi...
/HarmalineHarmalineHarmaline is a fluorescent psychoactive indole alkaloid from the group of harmala alkaloids and beta-carbolines. It is the reduced hydrogenated form of harmine.-Occurrence in nature:... - DMTDimethyltryptamineN,N-Dimethyltryptamine is a naturally occurring psychedelic compound of the tryptamine family. DMT is found in several plants, and also in trace amounts in humans and other mammals, where it is originally derived from the essential amino acid tryptophan, and ultimately produced by the enzyme INMT...
- Heroin
- LSDLSDLysergic acid diethylamide, abbreviated LSD or LSD-25, also known as lysergide and colloquially as acid, is a semisynthetic psychedelic drug of the ergoline family, well known for its psychological effects which can include altered thinking processes, closed and open eye visuals, synaesthesia, an...
- 2C-B2C-B2C-B or 4-bromo-2,5-dimethoxyphenethylamine is a psychedelic drug of the 2C family. It was first synthesized by Alexander Shulgin in 1974. In Shulgin's book PiHKAL, the dosage range is listed as 16–24 mg. 2C-B is sold as a white powder sometimes pressed in tablets or gel caps and is referred...
- MescalineMescalineMescaline or 3,4,5-trimethoxyphenethylamine is a naturally occurring psychedelic alkaloid of the phenethylamine class used mainly as an entheogen....
- MDMA
- PsilocinPsilocinPsilocin , an aromatic compound, sometimes also spelled psilocine, psilocyn, or psilotsin, is a psychedelic mushroom alkaloid. It is found in most psychedelic mushrooms together with its phosphorylated counterpart psilocybin...
- PsilocybinPsilocybinPsilocybin is a naturally occurring psychedelic prodrug, with mind-altering effects similar to those of LSD and mescaline, after it is converted to psilocin. The effects can include altered thinking processes, perceptual distortions, an altered sense of time, and spiritual experiences, as well as...
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.Examples include:
- Antacids
- RanitidineRanitidineRanitidine is a histamine H2-receptor antagonist that inhibits stomach acid production. It is commonly used in treatment of peptic ulcer disease and gastroesophageal reflux disease . Ranitidine is also used alongside fexofenadine and other antihistamines for the treatment of skin conditions...
in small packs (larger packs are schedule 2) - IbuprofenIbuprofenIbuprofen is a nonsteroidal anti-inflammatory drug used for relief of symptoms of arthritis, fever, as an analgesic , especially where there is an inflammatory component, and dysmenorrhea....
200 mg in small packs (<24; larger packs are schedule 2) - ParacetamolParacetamolParacetamol INN , or acetaminophen USAN , is a widely used over-the-counter analgesic and antipyretic . It is commonly used for the relief of headaches and other minor aches and pains and is a major ingredient in numerous cold and flu remedies...
500 mg in small packs (<24; larger packs are schedule 2) - Some laxatives (e.g. bulk laxatives MetamucilMetamucilMetamucil is a bulk-producing laxative and fiber supplement. The Metamucil brand has existed since 1934, and was owned by G.D. Searle & Company until 1985 when Procter & Gamble acquired the brand. The active ingredient is psyllium seed husks. It may also reduce cholesterol when taken daily....
) - Lubricant eye drops
- Nicotine replacement therapy (some preparations are schedule 2)
New South Wales
In New South WalesNew South Wales
New South Wales is a state of :Australia, located in the east of the country. It is bordered by Queensland, Victoria and South Australia to the north, south and west respectively. To the east, the state is bordered by the Tasman Sea, which forms part of the Pacific Ocean. 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 benzodiazepineBenzodiazepine
A benzodiazepine is a psychoactive drug whose core chemical structure is the fusion of a benzene ring and a diazepine ring...
s and anabolic steroid
Anabolic steroid
Anabolic steroids, technically known as anabolic-androgen steroids or colloquially simply as "steroids", are drugs that mimic the effects of testosterone and dihydrotestosterone in the body. They increase protein synthesis within cells, which results in the buildup of cellular tissue ,...
s. 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 AustraliaSouth Australia
South Australia is a state of Australia in the southern central part of the country. It covers some of the most arid parts of the continent; with a total land area of , it is the fourth largest of Australia's six states and two territories.South Australia shares borders with all of the mainland...
, 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
Epinephrine
Epinephrine is a hormone and a neurotransmitter. It increases heart rate, constricts blood vessels, dilates air passages and participates in the fight-or-flight response of the sympathetic nervous system. In chemical terms, adrenaline is one of a group of monoamines called the catecholamines...
(in metered aerosols), dihydrocodeine
Dihydrocodeine
Dihydrocodeine, also called DHC, Drocode, Paracodeine and Parzone and known by the brand names of Synalgos DC, Panlor DC, Panlor SS, Contugesic, New Bron Solution-ACE, Huscode, Drocode, Paracodin, Codidol, Didor Continus, Dicogesic, Codhydrine, Dekacodin, DH-Codeine,...
(in cough preparations), doxylamine
Doxylamine
Doxylamine is one of the many sedating antihistamines used by itself as a short-term sedative, and in combination with other drugs as a night-time cold and allergy relief drug...
(in preparations also containing codeine
Codeine
Codeine or 3-methylmorphine is an opiate used for its analgesic, antitussive, and antidiarrheal properties...
), promethazine
Promethazine
Promethazine is a first-generation antihistamine of the phenothiazine family. The drug has anti-motion sickness, antiemetic, and anticholinergic effects, as well as a strong sedative effect and in some countries is prescribed for insomnia when benzodiazepines are contraindicated...
(in preparations also containing codeine), and pseudoephedrine.
Recordable S3 products (Appendix J)
In Western AustraliaWestern Australia
Western Australia is a state of Australia, occupying the entire western third of the Australian continent. It is bounded by the Indian Ocean to the north and west, the Great Australian Bight and Indian Ocean to the south, the Northern Territory to the north-east and South Australia to the south-east...
, 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
Nicotine
Nicotine is an alkaloid found in the nightshade family of plants that constitutes approximately 0.6–3.0% of the dry weight of tobacco, with biosynthesis taking place in the roots and accumulation occurring in the leaves...
preparations were included in Schedule 3.