Supply of noradrenline (as titrate)(LEVOPHED 1:1000) 2 mg/mL injection ampoule by Hospira Pty Ltd

Overview

The Therapeutic Goods Act 1989 is the principal Act regulating the supply of therapeutic goods in Australia. It was enacted to ensure that therapeutic goods available in Australia are of acceptable quality, and that their benefits outweigh any risks to health. The Act was introduced to address the need for comprehensive regulation of therapeutic goods to protect public health. The Therapeutic Goods Administration (TGA), an agency of the Australian Government's Department of Health, is responsible for the administration and enforcement of the Act. The policy objective of the Act is to safeguard the health of Australians by ensuring that therapeutic goods are safe, of high quality, and effective. In this context, the Act allows the delegate of the Secretary to provide consent for the supply of certain therapeutic goods under specific conditions, as exemplified by the February 2013 consent for the supply of noradrenline (as tartrate) (LEVOPHED 1:1000) 2 mg/mL injection ampoule by Hospira Pty Ltd, despite a non-conformity with the Therapeutic Goods Order.

Scope and Application

The Therapeutic Goods Act 1989, as modified by Section 14 and 14A Notice issued on February 28, 2013, by the delegate of the Secretary of the Department of Health and Ageing, pertains to the supply of specific therapeutic goods that do not conform to certain regulatory standards. Specifically, the Act applies to the supply of the product noradrenline (as tartrate) (LEVOPHED 1:1000) 2 mg/mL injection ampoule [Aust R 12584] by Hospira Pty Ltd in Melbourne, Victoria. This consent granted under the Act allows the company to supply the product despite it not meeting the requirement of having the current company address on the carton labels, which is stipulated in paragraph 3(2)(1) of Therapeutic Goods Order (TGO) 69. This consent is conditional and valid only until September 30, 2013, and no other changes to the product have been permitted. Additionally, the label used must be identical to the one provided with the application letter from the company dated February 1, 2013, and measures are in place to redirect mail from the old address to the current one until the existing stock is exhausted.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 (the Act) provide the Secretary of the Department of Health and Ageing with the authority to give consent for the supply of therapeutic goods that do not fully comply with the requirements of Therapeutic Goods Orders (TGOs). In this case, the delegate of the Secretary has consented to the supply of the product noradrenline (as tartrate) (LEVOPHED 1:1000) 2 mg/mL injection ampoule [Aust R 12584] by Hospira Pty Ltd Melbourne, VIC (the Company), which does not conform with the requirements of TGO 69 due to the listing of the previous address on the carton labels rather than the current address. This consent is subject to certain conditions (subsection 15(1) of the Act), which include the consent applying only until 30 September 2013, no other changes being made to the product, and the label being identical to that provided with the letter of application from the Company dated 1 February 2013. Additionally, arrangements must be in place to redirect all mail sent to the old address to the current address until all stock bearing the old address has expired. The Act imposes several obligations on the parties or entities it governs, including ensuring compliance with Therapeutic Goods Orders and obtaining necessary consents from the Secretary when required. In this instance, the Company must adhere to the conditions set by the Secretary when supplying the noradrenline product. This includes using the specified label, redirecting mail to the current address, and ensuring the product complies with the Act and relevant orders by the end of the consent period. Failure to comply with these obligations may result in further action being taken against the Company, such as the revocation of the consent or other regulatory measures. There are potential offences, penalties, or civil/criminal consequences for breach of the Therapeutic Goods Act 1989, including fines and imprisonment. However, the specific penalties for breaching the conditions of this consent are not stated in the text. The Act provides for a range of penalties for various offences, including fines of up to $22,200 for individuals and $111,000 for corporations for serious or repeated offences, and imprisonment for up to five years for serious offences. In addition to these penalties, the Secretary may take further regulatory action, such as cancelling or suspending an Australian Therapeutic Goods Registration, if the Company fails to comply with the conditions of the consent or other obligations under the Act.