Commonwealth legislation

Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (18/10/2011)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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

2/10 complexity

This law makes the British or European Pharmacopoeia the mandatory quality standard for sterile “water for injections” used in Australia. It applies to pharmaceutical manufacturers, compounding pharmacies, and healthcare providers who prepare or use injectable medicines.

It does not cover water in medicines made in Australia solely for export or in medicines personally imported for an individual. The change reduces the risk of contamination in injections, protecting patients from potentially fatal infections.

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Current sections

Direct links to the current provisions in Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (18/10/2011).

Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (18/10/2011)

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THERAPEUTIC GOODS ACT 1989

Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines

I, Rohan Hammett, delegate of the Minister for Health and Ageing for the purposes of section 10 of the Therapeutic Goods Act 1989 (‘the Act’) and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the Act, HEREBY DETERMINE that matters specified in this Order constitute a standard for water for injections:

for therapeutic use as a parenteral medicine; or
for use as an ingredient or component in the manufacture of a parenteral medicine

other than for:

c. an export only medicine; or

d. a personal import as described under Item 1 of Schedule 5 of the Therapeutic Goods Regulations 1990.

Standard

Water for injections must comply with the monograph for Water for Injections in the British Pharmacopoeia or the European Pharmacopoeia.

Definitions

In this Order:

monograph means the requirements of, and definitions within, an individual or general monograph of the British Pharmacopoeia or the European Pharmacopoeia, read in conjunction with the General Notices contained in the same edition that are applicable to that monograph.

parenteral medicine means a sterile medicine intended for administration by injection, infusion or implantation into the body.

Commencement

This Order commences from the day after the day it is registered on the Federal Register of Legislative Instruments.

Dated this 18th day of October 2011

(signed by)

Rohan Hammett

Delegate of the Minister for Health and Ageing

Source text

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