Commonwealth legislation

Therapeutic Goods Order No. 29 - Standards for Ethanol (10/04/1986)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

1/10 complexity

What this does: This Order sets the purity and quality standards for ethanol (alcohol) used in making therapeutic goods (medicines and medical products) in Australia.

The two standards:

Fermentation ethanol (95% alcohol): Must meet the specifications in the British Pharmacopoeia 1973 under the monograph for 'Alcohol (95 per cent)'.
Synthetic ethanol (96% alcohol): Must meet the specifications in the British Pharmacopoeia 1980 under the monograph for 'Ethanol (96 per cent)'.

Why it matters: This ensures that any alcohol used in medicines is pure and safe for patients. By adopting the British Pharmacopoeia standards (an internationally recognised authority on pharmaceutical ingredients), Australia ensures its ethanol quality matches global medical benchmarks.

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Current sections

Direct links to the current provisions in Therapeutic Goods Order No. 29 - Standards for Ethanol (10/04/1986).

Therapeutic Goods Order No. 29 - Standards for Ethanol (10/04/1986)

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THERAPEUTIC GOODS ACT 1966

THERAPEUTIC GOODS ORDER NO. 29

STANDARDS FOR ETHANOL

I, NEAL BLEWETT, Minister of State for Health, pursuant to section 11 of the Therapeutic Goods Act 1966, by this Order, DETERMINE –

a) that the standard for Ethanol (95 per cent), when prepared by a fermentation process, shall be as specified in the monograph for Alcohol (95 per cent) of the British Pharmacopoeia, 1973; and

b) that the standard for Ethanol (96 per cent), when prepared by a synthetic process, shall be as specified in the monograph for Ethanol (96 per cent) of the British Pharmacopoeia, 1980.

Dated this tenth day of April 1986

NEAL BLEWETT

Minister of State for Health

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.