Supply of fluorescein sodium by Phebra Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for regulating therapeutic goods in Australia, ensuring their safety, quality, and efficacy. This Act aims to address the problem of ensuring that therapeutic goods available to consumers meet the required standards of quality and safety. The Act is administered by the Parliament of Australia and its policy objective is to protect public health by regulating the manufacturing, importation, advertising, and supply of therapeutic goods. In July 2012, a specific notice was issued under sections 14 and 14A of the Act by the delegate of the Secretary of the Department of Health and Ageing, granting consent for the supply of certain fluorescein sodium injection products by Phebra Pty Ltd that do not fully conform to the British Pharmacopoeia pH specifications. This consent is conditional on the products remaining compliant with the BP monograph and no other changes being made to the products, except those already approved.

Scope and Application

The Therapeutic Goods Act 1989, specifically section 14 and 14A, applies to entities such as Phebra Pty Ltd, involved in the supply of therapeutic goods in Australia. This Act governs the regulation and approval processes for therapeutic goods, including medicines, medical devices, and blood and blood components, ensuring they meet safety, quality, and efficacy standards. The Act applies to the aforementioned products which are supplied by Phebra Pty Ltd, a company based in Hunters Hill, NSW, and these products do not conform to the current British Pharmacopoeia monograph for fluorescein sodium drug substance due to differing pH specifications. The geographic reach of this legislation is national, as it applies throughout Australia. The consent granted by the delegate of the Secretary of the Department of Health and Ageing is subject to conditions ensuring the products comply with the BP monograph for fluorescein injection, including specified pH limits, and no other changes have been made to the products except for those approved in a specific submission from the company. This consent extends indefinitely, provided the conditions are met.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") allows for the supply of certain therapeutic goods under specific conditions. In this case, the delegate of the Secretary of the Department of Health and Ageing has given consent for Phebra Pty Ltd to supply three specific fluorescein sodium products (sections 14 and 14A). The products in question are fluorescein sodium (RETINOFLUOR) 10% injection 500 mg/5 mL vial (Aust R 121873), fluorescein sodium (RETINOFLUOR) 10% injection 1 g/10 mL vial (Aust R 23130), and fluorescein sodium (RETINOFLUOR) 25% injection (1.25 g/5 mL) vial (Aust R 23138). These products do not conform to the current British Pharmacopoeia (BP) monograph for fluorescein sodium drug substance, as their pH specifications (8.0 – 10.0) differ from those required by the BP monograph (7.0 – 9.0). The consent granted to Phebra Pty Ltd is subject to specific conditions to ensure the therapeutic goods supplied remain safe and effective. Firstly, the consent applies indefinitely, which means that the supply of the specified products can continue as long as the conditions are met (subsection 15(1)). Secondly, the finished products must remain in compliance with the BP monograph for fluorescein injection, including the specified pH limits. This ensures that the therapeutic goods supplied meet the required safety and quality standards. Lastly, no other changes should be made to the products except for those approved in the submission from Phebra Pty Ltd dated May 4, 2012. Failure to comply with the conditions of the consent may result in legal consequences. The Therapeutic Goods Act 1989 imposes various obligations on the parties it governs. In this case, Phebra Pty Ltd must ensure that the products they supply meet the specified conditions and comply with the Act. Failure to do so may result in the delegate of the Secretary of the Department of Health and Ageing revoking the consent, which could lead to the cessation of the supply of these products. Furthermore, if the products supplied are deemed unsafe or ineffective, it may result in civil or criminal liability under the Act. The penalties for breach of the Act may include fines and imprisonment, with the maximum penalties varying depending on the nature and severity of the offence. In summary, the Therapeutic Goods Act 1989 allows for the supply of specific fluorescein sodium products under certain conditions. The consent granted to Phebra Pty Ltd is subject to conditions that ensure the safety and quality of the products. Failure to comply with the conditions may result in legal consequences, including revocation of consent, civil or criminal liability, and penalties such as fines and imprisonment.