Scheduling of Medicines

In Australia, scheduling is a national classification system that controls how medicines and poisons are made available to the public. Federal responsibility for this is undertaken by the National Drugs and Poisons Schedule Committee, a branch of the Therapeutic Goods Administration (TGA). The committee classifies medicines and poisons are into different ‘Schedules’ according to the level of regulatory control over the availability of the medicine and poison needed to protect public health and safety.

The legislation under which the scheduling framework operates is the Therapeutic Goods Act of 1989 and Therapeutic Goods Regulations of 1990.

The Schedules are
Schedule 1: Not currently in use:

Schedule 2: Pharmacy Medicine:
S2 substances and preparations for therapeutic use that are generally safe in use but where some advice is available if necessary and are for what could be considered minor disorders or symptoms that can be easily recognized by the consumer and do not require medical diagnosis or management. They can be considered as being dangerous if misused or handled carelessly. The policy is that S2 drugs should be available to the public for therapeutic use without undue restriction. There is some variation in state law as where in the pharmacy they have to be located.
Examples include: dextromethorphan (cough suppressant); simple analgesics (eg ibuprofen in packs containing more than 24 tablets); hyoscine (for motion sickness, vomiting); topical terbinafine and amoralfine.

Schedule 3: Pharmacist Only Medicine:
S3 substances and preparations for therapeutic use that could be considered as being substantially safe in use but require professional advice or counseling by a pharmacist. The advice needed concerns the dosage, frequency of administration and the risk for general toxicity. They are for disorders or symptoms that could be identified by the consumer and verified by a pharmacist and do not require medical diagnosis or they only require initial medical diagnosis and do need close ongoing medical management. Some states have additional requirements for some S3 drugs.
Examples: orlistat; pseudoephedrine; salbutamol

Schedule 4: Prescription Only Medicine OR Prescription Animal Remedy:
S4 drugs and medicines are substances and preparations for therapeutic use that require health professional management or monitoring and are for disorders or symptoms that require professional diagnosis or management. S4 drugs can only be available on a prescription. Medicines are also included in the S4 if they require further evaluation for safety or efficacy; or are new therapeutic substances; or the cost of the drug is high or when there is a risk of becoming dependent.
Many S4 medicines are subsidized by the Australian Government through the Pharmaceutical Benefits Scheme (PBS), when prescribed by an authorized prescriber.
Examples: amoxicillin; ephedrine; ergotamine; isotretinoin; pseudoephedrine (large doses); salmeterol; benzodiazepines (except for flunitrazepam and alprazolam); SSRIs (e.g. fluoxetine, citalopram)

Schedule 5: Caution:
S5 drugs and poisons are substances and preparations commonly used for domestic purposes. They 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 and can cause only minor adverse effects with normal use.
Examples: methylated spirits; kerosene; bleaches

Schedule 6: Poison:
S6 poisons are generally used for agricultural, horticultural, veterinary, photographic or other industrial processes. They must use distinctive packaging and have strong warnings as to the potential for moderate to high toxicity and that they may cause death or severe injury if ingested, inhaled, or in contact with the skin or eyes.

Schedule 7: Dangerous Poison:
S7 substances have a high potential for causing harm at low exposure. They require special precautions in their
manufacture and use.
Examples: arsenic; strychnine

Schedule 8: Controlled Drug:
S8 drugs and poisons are substances and preparations for therapeutic use which have high potential for abuse and addiction. Possessing of these medications without authority is a criminal offense.
Examples: alprazolam; amphetamine; barbiturates; codeine; fentanyl; hydrocodone; ketamine; oxycodone; pethidine

Schedule 9: Prohibited Substance:
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 S9 substances without a permit is strictly prohibited by law.
Examples: heroin; LSD

Schedule 10: Substances of such danger to health as to warrant prohibition of sale, supply and use:
S10 substances are banned.
Examples: Coal tar for cosmetic use

‘Not scheduled’:
Substances here are the ones that where it is not considered necessary to control access to these medicines. They can still cause harm if not used in the way that is intended.
Examples: antacids; ephenidine; paracetamol (500 mg <24 packs)

Podiatrists Prescribing of Scheduled Medicines:
The National podiatry scheduled medicines list does specify which Schedule 2, 3, 4 and 8 medicines that podiatrists and podiatric surgeons whose registration has been endorsed for scheduled medicines by the Podiatry Board of Australia are qualified to administer, obtain, possess, prescribe, sell, supply or use for the treatment of podiatric conditions.

Medicine Schedules in Other Countries:

USAAustraliaCanadaNew ZealandUnited Kingdom
South Africa

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