Supply of zinc chloride (ZINC CHLORIDE) 10.6 mg/2 mL injection vial by Phebra Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring that such goods are of acceptable quality, safety and efficacy. The Act aims to protect public health by controlling the import, manufacture, supply and advertising of therapeutic goods. The Therapeutic Goods Administration, operating under the auspices of the Australian Government Department of Health, is responsible for enforcing the Act. In this context, the 2013 notice regarding the supply of zinc chloride injection vials by Phebra Pty Ltd, highlights the Act's role in maintaining stringent standards for therapeutic products, even when they do not fully conform to international benchmarks such as the United States Pharmacopoeia. The notice demonstrates the Act's flexibility in allowing for temporary supply of non-compliant products, provided that appropriate measures are taken to rectify the non-compliance and protect public health.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, encompassing a broad range of products including medicines, medical devices, and blood. Under section 14 and 14A of the Act, the delegate of the Secretary of the Department of Health and Ageing has the authority to consent to the supply of therapeutic goods that do not fully comply with certain standards, subject to specific conditions. In this instance, the Act allows for the temporary supply of a product that does not meet the specified pH range as outlined in the United States Pharmacopoeia (USP) 36 monograph for Zinc Chloride Injections. This consent is specifically for the zinc chloride 10.6 mg/2 mL injection vial supplied by Phebra Pty Ltd, and it is subject to conditions including the pH range of the product being 3.0-5.0, the requirement for the company to reformulate the product to meet the USP standards, and the stipulation that no other changes should be made to the product. The consent granted is effective until May 31, 2015, and is limited to the specific product and supplier involved, thereby applying to the particular pharmaceutical product and the company responsible for its supply.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) sections 14 and 14A pertain to the regulation of therapeutic goods in Australia. Under section 14, the delegate of the Secretary of the Department of Health and Ageing has the authority to give consent for the supply of therapeutic goods that do not conform with certain standards, such as the United States Pharmacopoeia (USP) monograph. In this case, section (a) of the notice indicates that consent has been given for the supply of zinc chloride (ZINC CHLORIDE) 10.6 mg/2 mL injection vial [Aust R 22876] by Phebra Pty Ltd, Hunters Hill, NSW. The product does not conform with the USP 36 monograph for Zinc Chloride Injections because the pH of the product is outside the specified range of 1.5-2.5. The Act imposes specific obligations and requirements on the parties involved. Phebra Pty Ltd, the supplier of the zinc chloride injection, must ensure that the product supplied meets the conditions set out in the consent given by the delegate of the Secretary. This includes taking appropriate regulatory action to reformulate the product and update the finished product specifications to comply with the USP monograph for Zinc Chloride Injections. Additionally, the company must not make any other changes to the product beyond those specified in the consent. Failure to comply with the conditions of the consent or the requirements of the Act may result in civil or criminal consequences. The Therapeutic Goods Act 1989 contains provisions for offences and penalties, though the exact nature of these penalties is not detailed in the notice provided. Generally, breaches of the Act can result in substantial fines and, in severe cases, imprisonment. The specific penalties would depend on the nature and extent of the breach, as outlined in the relevant sections of the Act. The consent given by the delegate of the Secretary is effective until May 31, 2015. During this period, the pH of the zinc chloride injection must remain within the range of 3.0-5.0 as specified in the notice. Any deviation from these conditions without proper authorisation could lead to the revocation of the consent and potential enforcement actions against Phebra Pty Ltd. It is crucial for the company to adhere to the conditions to avoid legal repercussions and ensure the safety and efficacy of the therapeutic product supplied.