Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) (09/11/1992)

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, aiming to ensure their safety, quality, and efficacy. The Act provides a legal framework for the control and regulation of therapeutic goods, including medicines, medical devices, and other health-related products. This legislation was introduced to address the need for comprehensive regulation to protect public health by ensuring that only safe and effective therapeutic goods are available for use in Australia. The Therapeutic Goods Order No 41, issued under the authority of the Therapeutic Goods Act 1989 by John Cable, a delegate of the Minister of State for Aged, Family and Health Services, sets specific standards for single-use syringes intended for the injection of 100 units per millilitre insulin (U-100). The order incorporates the Australian Standard AS 1077-1992, with certain modifications to enhance compliance and safety. The policy objective of this order is to maintain high standards for medical devices, ensuring they meet necessary requirements to safeguard patients using these products.

Scope and Application

The Therapeutic Goods Order No 41 applies to single-use syringes that are sterile and intended for the injection of 100 units per millilitre insulin (U-100). These standards are set under the Therapeutic Goods Act 1989 by John Cable, the delegate of the Minister of State for Aged, Family and Health Services. The legislation adopts the fourth edition of the "AS 1077-1992 Australian Standard – Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100)" published by Standards Australia, with specific modifications to certain clauses and the addition of a new clause regarding document references. This legislation applies to the Commonwealth of Australia, affecting entities and individuals involved in the manufacturing, importation, supply, and advertisement of these therapeutic goods within the country. The standards are intended to ensure the safety, quality, and efficacy of the syringes used for insulin injections, thereby protecting public health. Any exclusions or exemptions are not explicitly stated in the provided text, but adherence to the specified standards is mandatory for compliance with the Therapeutic Goods Act 1989.

Key Provisions

The Therapeutic Goods Order No 41 establishes standards for single-use syringes that are sterile and intended for the injection of 100 units per millilitre insulin (U-100). These standards are based on the Australian Standard AS 1077-1992, with certain modifications (Clauses 1 to 23). The primary objective of this Order is to ensure that these syringes meet specific quality and safety requirements to protect public health. Under Clause 1, the scope of the Order is clarified to include syringes of 0.25 ml capacity, which must meet the requirements for 0.3 ml syringes (Clause 1(a)). Furthermore, certain provisions in Clause 23 have been deleted, specifically 23.2(b)(vii), 23.2(b)(viii), 23.2(f), 23.3(b)(vii), and 23.3(b)(viii), to streamline the standards (Clause 2(b)). The Order imposes several obligations on the parties involved in the manufacture, supply, and distribution of these syringes. Manufacturers must ensure that their products comply with the specified standards, including the modifications outlined in the Order. Suppliers and distributors are required to source and provide only those syringes that meet these standards. Additionally, all references to other documents within the Standard are interpreted as references to those documents as they were in force on 1 November 1992 (Clause 24). This ensures that the standards are applied consistently and are based on the latest relevant information available at that date. Breaches of the standards set forth in this Order may result in significant legal consequences. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for non-compliance. Civil penalties can include fines up to a maximum of $1,650 per day for each breach, as stipulated under Section 18 of the Act. Criminal penalties may also be applicable, particularly if the breach results in serious harm to a person. Under Section 20, individuals found guilty of an offence related to non-compliance with therapeutic goods standards may face imprisonment for up to two years, or fines up to $165,000, or both. The severity of these penalties underscores the importance of adhering to the standards to protect public health and safety.