COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 27 August 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Pharmacare Laboratories Pty Ltd, gave consent to:
- the supply of Pharmacist Ibuprofen Suspension for Children 200mL bottle [AUST R 92686] that does not conform with the requirements of the British Pharmacopoeia monograph for Ibuprofen Oral Suspension, in that the amount of ibuprofen in the medicine (105.5% of the label claim) is outside the limit specified in the British Pharmacopoeia (95.0 to 105.0% of the stated amount).
The consent is effective from 27 August 2014.
The consent applies to batches B14D116 and B14D117 only.
Overview
The Therapeutic Goods Act 1989, enacted by the Australian Parliament, aims to regulate therapeutic goods, including medicines, medical devices, and other related products to ensure their quality, safety, and efficacy. One of its key provisions allows the Secretary of the Department of Health to give consent for the supply of therapeutic goods that do not fully conform to specified standards, addressing potential gaps in ensuring patient safety while balancing regulatory flexibility. In this context, on 27 August 2014, the delegate of the Secretary provided consent for the supply of Pharmacist Ibuprofen Suspension for Children, which slightly exceeded the specified limit for ibuprofen content, to be used only for specific batches, thereby enabling the provision of necessary medication with minimal risk under controlled conditions.
Scope and Application
The Therapeutic Goods Act 1989, as applied in the context of the notice issued by the delegate of the Secretary of the Department of Health, encompasses entities such as Pharmacare Laboratories Pty Ltd and the therapeutic goods they produce, specifically the Pharmacist Ibuprofen Suspension for Children 200mL bottle. The Act regulates the supply of therapeutic goods within Australia, ensuring that they meet specified standards and criteria for safety, quality, and efficacy. This application pertains to the specific batches B14D116 and B14D117 of the Pharmacist Ibuprofen Suspension for Children, which were found to have an amount of ibuprofen outside the specified British Pharmacopoeia limits. The Act provides the authority for issuing consents that allow for the supply of therapeutic goods that do not fully comply with certain pharmacopoeia standards, under specific conditions and for limited quantities, thereby ensuring that the therapeutic benefit to consumers is not unduly compromised. The consent granted is confined to the Commonwealth jurisdiction and applies to the mentioned batches exclusively, highlighting the Act’s role in balancing regulatory compliance with therapeutic needs.
Key Provisions
The Therapeutic Goods Act 1989, in particular sections 14 and 14A, allows the Secretary of the Department of Health to provide consent for the supply of therapeutic goods that do not fully comply with specified standards. In this case (sections 14 and 14A(1)), the delegate of the Secretary has consented to the supply of Pharmacist Ibuprofen Suspension for Children 200mL bottle [AUST R 92686], manufactured by Pharmacare Laboratories Pty Ltd, which does not conform to the British Pharmacopoeia monograph for Ibuprofen Oral Suspension. Specifically, the amount of ibuprofen in the medicine (105.5% of the label claim) exceeds the acceptable limit of 95.0 to 105.0% as specified in the British Pharmacopoeia. This consent is limited to the specific batches B14D116 and B14D117 and is effective from 27 August 2014.
The Act imposes several obligations on the entities it governs, including the requirement to ensure that therapeutic goods supplied meet the necessary quality and safety standards. In this instance, the consent given by the Secretary acknowledges that the ibuprofen suspension does not meet the pharmacopeial standards but allows for its supply under specific conditions. This highlights the importance of compliance with therapeutic goods regulations, with exceptions being granted only under stringent scrutiny and when certain criteria are met. The Act mandates that any therapeutic goods supplied must still ensure the health and safety of the consumer, and the consent is a recognition that, despite the deviation, the product can still be safely supplied under the specified conditions.
Breach of the Therapeutic Goods Act 1989 can result in various offences and penalties. For example, supplying non-compliant therapeutic goods can be considered an offence under section 25 of the Act, which pertains to the supply of therapeutic goods that do not comply with the standards set by the Therapeutic Goods Regulations. The penalties for such offences can be substantial. For corporations, the maximum penalty can include fines up to $2,100,000 or three times the benefit obtained from the contravention, whichever is the greater (section 33(1)). Additionally, individuals who are responsible for the management of the corporation and whose conduct caused the contravention can face personal penalties, including fines of up to $210,000 or imprisonment for up to five years, or both (section 33(2)). These severe penalties underscore the importance of adherence to the Act's requirements and the potential consequences for non-compliance.