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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)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L02128 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Subject: THERAPEUTIC GOODS ORDER NO. 89 Standard for water for injections for parenteral medicines

Section 10, Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (TGO 89) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act).

TGO 89 determines that the matters specified in the instrument constitute the standard for water for injections used in parenteral medicines.

TGO 89 commenced on the day after the day it was registered on the Federal Register of Legislative Instruments.

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.

Section 10 of the Act authorises the Minister, or the Minister's delegate, to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee (TGC), a committee established by the Therapeutic Goods Regulations 1990 (the Regulations) to advise the Minister on matters relating to standards.

Unless consent is granted by the Secretary under section 14 or 14A of the Act, therapeutic goods imported into Australia, supplied in Australia or exported from Australia must comply with any applicable standard.

TGO 89 is a new standard made under section 10 of the Act, and applies to water for injections that is presented as a therapeutic good (e.g. a 10 mL vial alone or as a good in a composite pack) or that is an ingredient or used in the manufacture of another therapeutic good (e.g. the water in an ampoule of sterile saline).

TGO 89 specifies that water for injections complies with the British Pharmacopoeia or the European Pharmacopoeia. There is no difference between the requirements of the British and European Pharmacopoeias.

CONSULTATION

A draft TGO was made available by the TGA for public consultation in September 2009. It was published on the TGA Internet site and key stakeholders were informed. There were three responses.

At its 36th meeting in August 2010, the TGC advised the Minister and the TGA that the draft TGO should be finalised and take effect from the date of its entry onto the Federal Register of Legislative Instruments.

The registered version of TGO 89 is not materially different to the consultation draft.

REGULATION IMPACT STATEMENT

The Office of Best Practice Regulation has agreed that no Regulation Impact Statement is necessary for TGO 89 (OBPR reference number 11770).

REFERENCED DOCUMENTS

Information on the documents referred to in TGO 89 or this Explanatory Statement follows.

The current definition of the British Pharmacopoeia under subsection 3(1) of the Act is the British Pharmacopoeia 2011, as amended by online updates. The British Pharmacopoeia 2011 is a collection of approximately 3375 monographs for pharmaceutical substances and medicinal products for human use. The monograph for water for injections specifies requirements for the method of manufacture by distillation, microbiological monitoring, aluminium, bacterial endotoxins, particulate contamination and sterility, amongst other things. Associated test methods are also included in the British Pharmacopoeia. The British Pharmacopoeia is published by The Stationery Office, on behalf of the Medicines and Healthcare products Regulatory Agency of the UK. It is available for purchase in hard copy or soft copy (compact disc or online edition). The British Pharmacopoeia reproduces all monographs and requirements of the European Pharmacopoeia.
The current definition of the European Pharmacopoeia under subsection 3(1) of the Act is the European Pharmacopoeia 7th edition, including supplements 7.1 and 7.2. It includes more than 2000 specific and general monographs. The monograph for water for injections specifies requirements for the method of manufacture by distillation, microbiological monitoring, aluminium, bacterial endotoxins, particulate contamination and sterility, amongst other things. Associated test methods are also included in the European Pharmacopoeia. The European Pharmacopoeia is published by the Directorate for the Quality of Medicines & HealthCare of the Council of Europe. It is available for purchase in three formats - print, online and USB stick.
The meeting outcomes of the TGC’s 36th meeting referred to in this Explanatory Statement may be viewed and downloaded from the TGA Internet site.

Overview

The Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (TGO 89) was enacted in 2011 by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989. This legislative instrument was introduced to address the need for a nationally consistent standard for water used in parenteral medicines, which are medications administered directly into the body, often through injection. The Act itself establishes a national system to regulate the quality, safety, efficacy, and timely availability of therapeutic goods for human use, with the Therapeutic Goods Administration (TGA) administering the Act. The policy objective behind TGO 89 was to ensure that water for injections meets specific quality standards, thus safeguarding the safety and efficacy of parenteral medicines by aligning with internationally recognised pharmacopoeias.

Scope and Application

Therapeutic Goods Order No. 89, established under section 10 of the Therapeutic Goods Act 1989, sets forth the standard for water used in injections for parenteral medicines. This Order applies to all water for injections presented as therapeutic goods, including individual vials or as part of composite packs, as well as to water used as an ingredient or in the manufacture of other therapeutic goods. The standard is aligned with the British Pharmacopoeia and the European Pharmacopoeia, both of which provide comprehensive specifications for the production of water for injections, including distillation methods, microbiological monitoring, and criteria for contaminants such as aluminium and bacterial endotoxins. This Order is applicable nationally and is enforced to ensure that all imported, supplied, or exported therapeutic goods in Australia comply with the specified standards unless otherwise authorised under sections 14 or 14A of the Act. The Therapeutic Goods Administration is responsible for the oversight and enforcement of this Order.

Key Provisions

Therapeutic Goods Order No. 89 (TGO 89) is a legislative instrument under section 10 of the Therapeutic Goods Act 1989 (the Act), establishing the standard for water for injections used in parenteral medicines. It mandates that water for injections used in therapeutic goods, either as standalone products or as an ingredient in other therapeutic goods, must meet the standards set by the British Pharmacopoeia or the European Pharmacopoeia. These pharmacopoeias specify detailed requirements for the production, quality, and purity of water for injections, including aspects such as distillation methods, microbiological monitoring, and sterility. The Act imposes several obligations on the parties and entities governed by TGO 89. Manufacturers, importers, and suppliers of therapeutic goods that contain or are water for injections must ensure that their products comply with the standards outlined in the British or European Pharmacopoeia. This includes adherence to the prescribed methods of production, stringent microbiological standards, and other quality control measures. Compliance is a prerequisite for the lawful sale and distribution of these products within Australia, unless otherwise specified under sections 14 or 14A of the Act. Failure to comply with TGO 89 can result in several consequences. Under the Act, non-compliance with therapeutic goods standards can lead to regulatory action by the Therapeutic Goods Administration (TGA). This may include product recalls, fines, and legal proceedings against the offending party. The specific penalties for breaches are not detailed in the Explanatory Statement but generally include significant fines and potential imprisonment for individuals found guilty of serious or repeated offences. The exact penalties depend on the severity and intent behind the non-compliance, with the potential for maximum penalties as stipulated by the relevant provisions of the Therapeutic Goods Act 1989.

Area of Law: Medical Law
Instrument: Order
Concepts: Regulatory Standards; Licensing & Registration; Reporting & Disclosure Obligations

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

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