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Commonwealth act
This Act has been repealed and is no longer in force. It is retained for historical reference.
This Act sets quality and labelling standards for therapeutic substances — things like medicines, drugs, surgical stitches (sutures), and wound dressings — and controls how they can be imported, traded between States, and supplied to the Commonwealth Government or as taxpayer-funded medicines (called "pharmaceutical benefits").
Defines "controlled therapeutic substance": This covers medicines listed in two authoritative British reference books — the British Pharmacopoeia and the British Pharmaceutical Codex (official scientific catalogues of medicines and their required standards) — as well as any substances added by government regulations.
Sets labelling rules: Goods containing therapeutic substances must clearly show:
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Direct links to the current provisions in Therapeutic Substances Act 1953.
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View on official registerSourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
Bans non-compliant imports: Medicines that don't meet labelling or quality standards cannot be legally imported into Australia. Goods that breach this rule become "prohibited imports" under customs law.
Regulates interstate trade: You can't send therapeutic substances across State lines unless they meet the same labelling and quality rules — unless the Minister gives written approval.
Protects government medicine programs: If a medicine is supplied as a government-funded "pharmaceutical benefit," it must meet the required quality standard. If it doesn't, it's legally treated as though it was never supplied at all.
Covers government supply contracts: Anyone supplying medicines directly to the Commonwealth or a Territory government must also meet the quality standards.
Allows testing and inspection: Regulations can authorise people to take samples, enter premises, and test goods to check they meet the standards. Certificates from laboratories can be used as evidence in court.
Emergency powers: If a therapeutic substance is causing (or is likely to cause) a serious disease outbreak or poses a danger to people or animals, the Governor-General can declare a quarantine emergency. The Minister can then order people to destroy stock, stop selling it, or stop making it altogether.
Ministerial exemptions: The Minister can grant exemptions — for example, for scientific researchers or where public interest demands it — allowing non-compliant goods to be imported or traded. Breaching the conditions of an exemption is treated as an offence.
Penalties: Breaches can result in fines or imprisonment. Summary conviction (less serious court process) carries up to £100 fine or 6 months' jail. Indictable conviction (more serious court process) carries up to £500 fine or 12 months' jail. Courts can also order goods to be forfeited.
Repeals old law: This Act replaced two earlier versions of the same law from 1937 and 1938.
This law is an early piece of consumer protection and public health legislation. Before laws like this, medicines could be sold with misleading labels, unknown ingredients, or dangerous quality. This Act ensures that if something is sold as a medicine, it actually is that medicine — made to a known standard, properly labelled, and safe to use. It also gives the government emergency powers to pull dangerous substances off the market quickly.