Supply of dexmedetomidine hydrochloride (PRECEDEX) 200 micrograms/2 mL injection vial by Hospira Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the importation, supply, and manufacturing of therapeutic goods in Australia, ensuring they are safe and of high quality. The Act was introduced to address the need for a comprehensive legal framework to protect public health by controlling the therapeutic goods market. This legislation is administered by the Parliament of Australia and its overarching policy objective is to safeguard the health and safety of the Australian public by ensuring that therapeutic goods available in the market are of acceptable quality, safety, and efficacy. In this context, the Act allows the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not fully comply with certain regulations, subject to specific conditions to mitigate any potential risks to public health.

Scope and Application

The Therapeutic Goods Act 1989 (the Act) applies to the regulation and control of therapeutic goods within Australia, including their classification, advertising, and supply. The Act encompasses a broad range of products, including medicines, medical devices, and blood products, and applies to entities such as manufacturers, importers, and suppliers of these goods. The geographic reach of the Act is national, applying across all states and territories of Australia. The Act also extends its reach through subordinate instruments, such as Therapeutic Goods Orders, which provide specific details regarding the regulation of particular classes of therapeutic goods. In the specific case of the notice issued on February 5, 2013, the Act applies to Hospira Pty Ltd in relation to the supply of the product dexmedetomidine hydrochloride (PRECEDEX) 200 micrograms/2 mL injection vial. This consent is limited to certain batches of the product and is subject to specific conditions, such as the use of particular labels, as outlined in the notice.

Key Provisions

Under the Therapeutic Goods Act 1989, Section 14 and 14A Notice, the delegate of the Secretary for the Department of Health and Ageing has granted consent for the supply of dexmedetomidine hydrochloride (PRECEDEX) 200 micrograms/2 mL injection vial by Hospira Pty Ltd. This consent is specific to two batches, numbered 19133DK06 and 19133DK02, which together contain 47,745 vials. The consent is subject to certain conditions, one of which pertains to the labels on the carton and vial. The labels must be identical to those provided by the company in correspondence dated January 18, 2013. This includes addressing the issue where the previous address of the company was listed instead of the current address, which is a non-conformity with the requirements outlined in paragraph 3(2)(l) of Therapeutic Goods Order 69. The obligations imposed by the Act on Hospira Pty Ltd include the adherence to the specified labelling requirements to ensure that all vials are correctly identified. They must ensure that the labels reflect the current address of the company, as per the Therapeutic Goods Order 69, and must use the labels provided in the correspondence dated January 18, 2013. Additionally, they are required to supply the exact batches listed in the consent, without any changes to the product itself. Failure to comply with the conditions set forth in the consent may lead to various legal consequences. Under the Therapeutic Goods Act 1989, non-compliance could result in civil or criminal penalties. Specifically, supplying therapeutic goods that do not meet the required standards can lead to enforcement actions. The maximum penalties for such offences can include substantial fines and, in severe cases, imprisonment. The exact penalties depend on the nature and extent of the non-compliance, but they are designed to ensure that therapeutic goods supplied in Australia meet necessary safety and quality standards.