Supply of irbesartan/hydrochorothiazide 300mg/12.5 mg (KSART HCT 300/12.5) tablet blister pack by Spirit Pharmaceuticals Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia meet appropriate standards of quality, safety, efficacy, and performance. The Act was introduced to address the need for regulation and oversight of therapeutic goods, including medicines, medical devices, and other health-related products, to protect public health. The Therapeutic Goods Act 1989 is administered by the Therapeutic Goods Administration (TGA), an agency of the Australian Government Department of Health. The primary policy objective of the Act is to safeguard the health and safety of the Australian public by regulating the supply, advertising, and approval of therapeutic goods. In February 2013, the delegate of the Secretary of the Department of Health and Ageing granted consent for the supply of a specific batch of the product irbesartan/hydrochorothiazide 300 mg/12.5 mg (KSART HCT 300/12.5) tablet blister pack, subject to certain conditions to address a compliance issue with the Therapeutic Goods Order (TGO) 69 concerning the presentation of the expiry date on the packaging.

Scope and Application

The Therapeutic Goods Act 1989, as referenced in the gazette C2013G00467, pertains to the regulation of therapeutic goods in Australia. Specifically, this act governs the supply, advertising, and manufacturing of therapeutic goods, which include medicines, medical devices, blood, and tissues. This legislation applies to entities and individuals involved in the supply and manufacture of these goods, extending to all states and territories within Australia. The Act allows the delegate of the Secretary of the Department of Health and Ageing to issue consent for the supply of therapeutic goods that do not conform to specific standards, subject to certain conditions. In this particular instance, the Act facilitates the supply of a specific batch of irbesartan/hydrochorothiazide 300 mg/12.5 mg tablets, which does not meet the expiry date formatting requirements set out in Therapeutic Goods Order (TGO) 69. The consent provided is limited to batch number 005 and requires the inclusion of a "Dear Pharmacist" letter to ensure patient safety. This consent does not alter the existing regulatory framework or exempt the product from other compliance requirements under the Act or subordinate instruments.

Key Provisions

The Therapeutic Goods Act 1989 (section 14) outlines the process by which a delegate of the Secretary can consent to certain activities that would otherwise breach the regulations. In this instance, section 14A specifically allows the delegate to permit the supply of a therapeutic good that does not meet the standards set out in a Therapeutic Goods Order (section 14A(1)). Section 15(1) of the Act details the conditions under which such consent may be granted. In this case, the delegate has consented to the supply of the product irbesartan/hydrochorothiazide 300 mg/12.5 mg (KSART HCT 300/12.5) tablet blister pack [AUST R 186254] by Spirit Pharmaceuticals Pty Ltd, subject to specific conditions. The obligations imposed on the parties by this consent include that the consent applies only to batch number 005, and no other changes have been made to the product. The foil label must be identical to those provided with the letter from the company dated January 25, 2013, despite the missing expiry date prefix, the expiry date itself must still be present. Additionally, a ‘Dear Pharmacist’ letter, provided with the email from the company dated February 26, 2013, must be supplied with the affected batch, reminding patients to keep the blister strips within the carton. This ensures that patients are informed of the minor defect while still receiving the necessary medication. The Therapeutic Goods Act 1989 stipulates that breaches of the provisions can result in both civil and criminal consequences. Section 33DA outlines the potential penalties for supplying non-compliant therapeutic goods, which can include substantial fines. The maximum penalty for individuals can be up to $330,000 or imprisonment for up to five years, or both. For bodies corporate, the maximum penalty is $1.65 million. The Act also allows for the issuance of infringement notices for less serious breaches, with fines that can vary depending on the severity of the breach. This underscores the importance of compliance with the terms of the consent and the conditions specified by the delegate.