In recent amendments to the National Health Act 1953 (Cth) (‘the Act’), the Secretary of the Department of Health and Aged Care (‘the Secretary’) now has a wider scope of power to cancel the approval of approved pharmacists.[1] Prior to the amendments, the Secretary was only able to cancel approvals if they were satisfied that:
- an approved pharmacist was not carrying on a business as a pharmacist at premises in respect of which the pharmacist was approved; or
- the premises were not accessible by members of the public for the purpose of receiving pharmaceutical benefits at reasonable times.[2]
Under the amendments, the Secretary may now cancel an approval if it is satisfied that the approved pharmacist has breached any conditions to which their approval is subject.[3] This represents a material shift, as the Secretary’s discretionary powers now extend beyond operational issues to encompass compliance with all approval conditions. The practical impact of this expanded cancellation power becomes more apparent when viewed against the statutory framework that defines the scope and content of an approved pharmacist’s obligations.
The National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017 (‘the Determination’) plays a critical role in defining those obligations, as it prescribes a wide‑ranging and detailed set of conditions that are attached to approval.[4] These conditions transcend clinical dispensing standards and encompass governance, record‑keeping, professional conduct, supervision of staff, cooperation with audits, and compliance with broader PBS administrative requirements.[5]
It is also a requirement for approved pharmacists to ensure that other pharmacists at approved premises apply with the conditions of approval.[6] The breadth of the Determination significantly expands the compliance landscape, meaning that breaches may arise not only from deliberate misconduct but also from systemic administrative failures, inadequate oversight, or misunderstandings of technical obligations. When read together with the expanded cancellation powers under the Act, the Determination effectively elevates routine compliance matters into potential grounds for approval cancellation, increasing regulatory exposure for both individual pharmacists and pharmacy businesses as a whole.
Conditions imposed on a pharmacist’s approval are subject to s 92A of the Act, as well as restrictions imposed by the Minister by legislative instrument pursuant to section 92A(1A) of the Act.[7] The addition of s 98(3)(g) rovides another pathway for the Department of Health and Aged Care (‘the Department’) to pursue breaches of approval conditions without having to refer the matter to the Pharmaceutical Services Federal Committee of Inquiry (‘the Committee’) which is often a timely and costly process for both parties.[8]
It is critical for approved pharmacists to be aware of all conditions that their approval is subject to as the Secretary is only required to provide notice in writing before cancelling approval. The process of challenging such a notice will impose substantial administrative and financial burdens, disrupt business operations, and create significant professional uncertainty. A clear understanding of approval conditions – and early legal advice where non‑compliance is suspected – can therefore help mitigate risk and prevent issues from escalating into a cancellation notice.
Responding to alleged breaches often requires diverting substantial resources toward preparing documentation, obtaining legal advice, and engaging in correspondence with the Department – costs that can escalate quickly, even where the underlying issue is minor.
When a pharmacist’s approval has been cancelled or suspended, they are no longer eligible to receive Pharmaceutical Benefits Scheme (PBS) payments, causing even greater financial distress. As a consequence, urgent legal representation needs to be sought to apply for a stay of the cancellation or suspension to prevent greater financial penalties.
These changes to the Secretary’s scope of powers reflect an increased regulatory focus on compliance with approval conditions and reinforce the importance of ongoing adherence to the PBS framework. While these amendments currently remain untested, they signal a clear intention by the Department to take a more assertive approach to enforcing approval obligations. Pharmacists may therefore see a shift toward earlier intervention, greater scrutiny of compliance records, and a lower threshold for initiating cancellation action where conditions are breached. Until the new provisions are considered in judicial settings, their practical reach – and the extent of the Secretary’s discretion – will remain uncertain. In the interim, approved pharmacists should adopt a cautious approach by proactively reviewing approval conditions, strengthening internal compliance systems, and seeking legal advice promptly where a potential breach is identified.
Contact Andrew Lambros, Managing Director, for advice on responding to a complaint or notification.
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This publication covers legal and technical issues in a general way. It is not designed to express opinions on specific circumstances It is intended for information purposes only and should not be regarded as legal advice. Further professional advice should be obtained before taking action on any issue dealt with in this publication.
[1] Regulatory Reform Omnibus Bill 2025 No.48, 2025, 58.
[2] National Health Act 1953 (Cth) s 98(3).
[3] Ibid s 98(3)(g).
[4]The National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017 pt 2.
[5] Ibid.
[6] Ibid s 8.
[7] Explanatory Memorandum, Regulatory Reform Omnibus Bill 2025 (Cth) p. 59.s
[8] Ibid.