EXPLANATORY STATEMENT
THERAPEUTIC GOODS ORDER NUMBER 54B
DISINFECTANTS AND STERILANTS
(Section 10, Therapeutic Goods Act 1989)
The Therapeutic Goods Act 1989 (the Act), regulates the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods which are used in humans. The Act came into effect on 15 February 1991.
Part 2 of the Act, in sections 10-15, contains provisions dealing with how and what standards may be made in relation to therapeutic goods.
Subsection 10(1) of the Act provides: "The Minister may, by order published in the Gazette, determine that matters specified in the order constitute a standard for therapeutic goods or a class of therapeutic goods identified in the order (whether or not those goods are the subject of a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary)".
The Therapeutic Goods Committee (TGC), which is the committee that advises the Minister on matters relating to standards for therapeutic goods, agreed that the document Standard For Disinfectants And Sterilants should be adopted as the standard for disinfectants and sterilants. The Therapeutic Goods Order (TGO 54) adopting the standard was signed by the delegate of the Minister on 25 October 1996.
The Senate Standing Committee for Regulations and Ordinances recommended changes to TGO 54 to remove what were considered to be technical legislative flaws. These changes together with two minor modifications to TGO 54 that were requested by industry were effected by TGO 54A on 26 March 1997.
The present Order, “No. 54B ‑ Amendment to the standard for disinfectants and sterilants”, was made on 23 September 1999 after the Senate Standing Committee for Regulations and Ordinances noted cross referencing errors between TGO 54 and TGO 54A. TGO 54B corrects those errors. It also clarifies the requirements for embossing of batch and expiry particulars on labels by deleting subclause 5(14) and replacing it with a simpler subclause 5(13).
Overview
The Therapeutic Goods Act 1989 was enacted to establish and maintain a national system of controls aimed at ensuring the quality, safety, and efficacy of therapeutic goods used in humans. This legislation, which came into effect on 15 February 1991, is overseen by the Australian Parliament and aims to safeguard public health by regulating the therapeutic goods market. Part 2 of the Act, in particular, sets out provisions for establishing standards for therapeutic goods, allowing the Minister to determine these standards through published orders. One such order, Therapeutic Goods Order No. 54B, pertains specifically to disinfectants and sterilants, and was introduced to correct cross-referencing errors and clarify labelling requirements identified in previous orders. The enactment of this order reflects the ongoing commitment to refining the regulatory framework to address emerging issues and ensure the highest standards in therapeutic goods.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods used in humans, establishing a national system of controls to ensure quality, safety, and efficacy. This legislation encompasses a broad range of entities, including manufacturers, importers, sponsors, and distributors of therapeutic goods, as well as their activities and transactions related to these products. The Act operates on a national level, governing practices across all states and territories in Australia. The Therapeutic Goods Order No. 54B, which amends the standard for disinfectants and sterilants, applies specifically to the standards and requirements for these products, ensuring they meet specific quality and safety criteria. This Order, as an extension of the Act, corrects previous cross-referencing errors and simplifies certain labelling requirements. Notably, the Act does not specify particular exclusions, but its broad application is subject to the conditions and modifications set out in various Orders under the Act, which can further refine or expand the scope of its provisions.
Key Provisions
The main operative sections of the Therapeutic Goods Order No. 54B, Disinfectants and Sterilant (TGO 54B) (subsection 10(1)) establish the standards for disinfectants and sterilants in Australia, ensuring these products meet certain quality, safety, and efficacy criteria. This order amends the previous TGO 54, addressing technical legislative flaws and cross-referencing errors identified by the Senate Standing Committee for Regulations and Ordinances. It adopts the Standard for Disinfectants and Sterilants as agreed upon by the Therapeutic Goods Committee (TGC) and ensures that these products adhere to the specified standards.
The obligations and requirements imposed by TGO 54B on parties or entities it governs include ensuring that disinfectants and sterilants meet the established standards as per the adopted Standard for Disinfectants and Sterilants. Manufacturers, importers, and suppliers of these products must ensure that they comply with the specifications outlined in TGO 54B. This includes maintaining records of compliance, ensuring product labels contain necessary information such as batch and expiry details, and ensuring that the products are manufactured, packaged, and stored under conditions that maintain their quality and efficacy. The Therapeutic Goods Administration (TGA) may conduct inspections and audits to verify compliance with these requirements.
Failure to comply with TGO 54B may result in various civil or criminal consequences. The Therapeutic Goods Act 1989 provides for penalties for breaches of the Act and its associated orders. For example, a person who contravenes a provision of the Act or an order made under the Act may be subject to a civil penalty of up to $1,110,000 for a corporation and up to $222,000 for an individual, or imprisonment for up to five years, or both. Additionally, the TGA may take action to recall non-compliant products, issue warnings, or take legal action against entities that fail to comply with the standards set forth in TGO 54B. These penalties underscore the importance of adhering to the established standards for disinfectants and sterilants in Australia.