National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017

This Determination is built around a small set of controlling concepts that structure what behaviour is required, permitted, or forbidden. The key concepts are: approved pharmacist; approved premises; dispensing step; approval number; and the scope of application to pharmaceutical benefits.

Approved pharmacist and approved premises: The Determination applies to a person approved as an approved pharmacist and to the premises in respect of which that person is approved. The approval is premise‑specific; many provisions require that actions be performed at the approved premises for the pharmacist. See definitions in s 5 and application in s 5A.

Dispensing step: The instrument defines, in detail, what constitutes a dispensing step in s 5. Dispensing steps include review of the prescription (or repeat/deferred supply authorisation), certain preparation steps (for listed brands when quantity is less than a pack, admixture of ready‑prepared ingredients, or extemporaneous preparation), generation and affixing of a label that must display particular information, preparation of repeat authorisations where required, and recording the dispensing in the dispensing pharmacy’s system. That definition is crucial because s 10 requires that the pharmaceutical benefit be physically at the approved premises whenever each dispensing step is performed and that a registered pharmacist be present or directly supervising those steps. See s 5 (dispensing step) and s 10.

Approval number: Each approved pharmacist has an approval number in respect of particular premises (s 5). The Determination bars use of that approval number in relation to dispensing or purported dispensing at any other premises, and in relation to preparation of repeat authorisations or deferred supply authorisations at other premises. See s 14.

Scope and exclusions: Section 5A defines when the Determination applies. It applies to supplies that are supplies of pharmaceutical benefits under Part VII of the Act (subject to specific exceptions). The Determination does not apply where the drug or preparation is not a pharmaceutical benefit, or where the person presenting requests that the supply not be made as a pharmaceutical benefit under Part VII, among other exceptions. The notes to s 5A give examples drawing on the Act’s provisions (for example s 85(7) and s 88A) and note that entitlement under s 86(1) matters for application. See s 5A and its notes.

Professional standards and continuing education: The instrument requires compliance with legal requirements for pharmacy practice, the PSA Code of Ethics (2017) and Professional Practice Standards (2017), and continuing education in line with the National Competency Standards Framework for Pharmacists in Australia 2016. These standards are incorporated by reference: the Determination mandates compliance rather than creating new standalone professional standards. See s 6 and s 7.

Financial and administrative controls: Section 12 makes it an offence against the Determination to seek advances (subsection 99AB(1) of the Act) or to make claims for payment from the Commonwealth in relation to supplies that are purported at unapproved premises or that contravene ss 10 or 11. The note to s 12 cross‑references s 99 of the Act on payment authorisation.

Commercial prohibitions: Section 15 prohibits entering into an arrangement with the owner or operator of another pharmacy business for the supply of pharmaceutical benefits to persons presenting at that business. This targets the commercial mechanism of using another pharmacy’s customer base or premises to supply benefits under an approved pharmacist’s authority.

Enforcement linkages: The Determination references the Minister’s powers under the Act, including suspension or revocation after investigation by an appropriate Committee of Inquiry, and states that contraventions of conditions specified in s 92A of the Act are deemed to be abuse of approval for s 95 purposes. See s 4 Note 1.

Primary affected parties are approved pharmacists and the premises in respect of which they are approved. The Determination attaches duties to the approved pharmacist in relation to their approved premises and imposes obligations on them to ensure that other registered pharmacists who dispense at those premises but are not themselves approved comply with the Determination. See ss 5, 6, 8.

Registered pharmacists who are not approved for particular premises are affected indirectly: an approved pharmacist must ensure those registered pharmacists comply with the conditions when they dispense at the approved premises. See s 8. That creates an internal compliance responsibility for the approved pharmacist to supervise non‑approved staff performing dispensary duties at the premises.

Pharmacy businesses and owners/operators of pharmacy businesses are affected in several ways. Section 15 prohibits an approved pharmacist from entering into an arrangement with another pharmacy business for supply of pharmaceutical benefits to persons presenting at that other business. That is a direct constraint on business models involving cross‑site arrangements, outsourcing of face‑to‑face supply, or contractual provision of services to physical outlets that are not the approved premises. Owners of pharmacy businesses must therefore heed that approved pharmacists cannot lawfully supply to persons presenting at another pharmacy under an arrangement with the owner/operator of that other business. See s 15.

Pharmacy staff and operations teams are affected because the definition of dispensing step (s 5) and the requirement that the benefit be physically at the approved premises when each dispensing step is performed (s 10(2)) mean that tasks such as labelling, preparation and recording must be carried out at the approved premises. Central‑fill models, off‑site labelling, or partial outsourcing of preparation steps are constrained where those activities would occur away from the approved premises.

Patients and consumers are affected indirectly. The Determination requires pharmacists to comply with the PSA Code of Ethics and Professional Practice Standards and to treat patients with dignity regardless of payment method and other characteristics (s 6(b)-(d)), and it requires pharmacists to provide adequate information to patients as part of the disciplined dispensing procedure (s 6(e)(vi)). The Determination also contemplates patient cooperation where patient medication history access is necessary for individualised care (s 6(d)(i) and Note 1). Patients who prefer to present prescriptions at a non‑approved premises may have their access to supply of pharmaceutical benefits affected by the commercial prohibitions in s 15 and the physical‑presence requirements.

Payers are affected in two practical ways. First, the Determination creates an express bar on seeking advances or making claims for payment for supplies that are purported at unapproved premises or that contravene ss 10 or 11 (s 12). That is a financial enforcement mechanism to prevent payments for non‑compliant supplies. Second, because the Determination links to the Act and the Regulations, decisions about entitlement to receive pharmaceutical benefits (s 86(1) of the Act) and payment authorisation under s 99 of the Act remain relevant; the Determination’s scope is framed by those entitlement and payment rules. See s 5A and note to s 12.

State and Territory regulators are implicated because the Determination acknowledges that dispensing of drugs is also regulated under State and Territory laws (s 4 Note 2). That means operational compliance must align with both the Determination and applicable state pharmacy practice, premises, and medicines handling requirements.

Regulatory decision‑makers and the Minister under the Act are affected because the Determination is an instrument the Minister uses to condition approvals. The Determination also interfaces with the Minister’s powers under s 95 of the Act for suspension, further suspension or revocation of approval after Committee investigation, and treats contraventions of certain conditions as abuse of approval for s 95 purposes. See s 4 Note 1.

Duties imposed by the Determination are mostly expressed as mandatory obligations on an approved pharmacist. The primary duties include:

Standards of practice (s 6)

• Comply with all legal requirements for the practice of pharmacy (s 6(a)).
• Treat patients with dignity irrespective of manner of payment and other listed attributes (s 6(b)).
• Comply with the PSA Code of Ethics for Pharmacists (2017) and the Professional Practice Standards - Version 5 - June 2017 as published, subject to patient co‑operation on access to medication history and other practical items (s 6(c), (d)).
• Maintain a disciplined dispensing procedure with enumerated elements covering product selection accuracy, calculations, preparation techniques, packaging and storage, final product accuracy and provision of adequate information to the patient (s 6(e)).

Continuing education (s 7)

• Maintain currency of pharmaceutical knowledge in accordance with the National Competency Standards Framework for Pharmacists in Australia 2016.

Responsibility for other pharmacists at approved premises (s 8)

• Ensure that registered pharmacists who dispense at the approved premises but are not approved for those premises comply with the conditions in the Determination.

Premises and dispensing obligations (ss 9, 10, 11)

• Not purport to supply pharmaceutical benefits at premises that are not approved premises for the pharmacist, and not purport to supply from premises that are not approved for the pharmacist (s 9(1)‑(2)).
• Ensure the pharmaceutical benefit is physically present at the approved premises when each dispensing step in the dispensing of the benefit is performed (s 10(2)).
• Ensure a registered pharmacist dispenses or directly supervises the dispensing of the benefit, and that the registered pharmacist is physically present at the approved premises when each dispensing step is performed (s 10(3)‑(4)).
• For supplies based on prescriptions other than medication chart prescriptions, ensure the registered pharmacist sees the prescription at the approved premises when the prescription is reviewed as part of the dispensing step process (s 11(1)‑(2)).

Controls on identifiers and authorisations (ss 13, 14)

• Ensure deferred supply authorisations are prepared only at approved premises by or under the direct supervision of a registered pharmacist physically present at those premises (s 13).
• Not use or allow use of the pharmacist’s approval number in respect of premises in relation to dispensing at any other premises, purported supply at any other premises, or the preparation of repeat or deferred supply authorisations at any other premises (s 14).

Commercial prohibition (s 15)

• Not enter into an arrangement with the owner or operator of another pharmacy business for the supply by the approved pharmacist of pharmaceutical benefits to persons presenting at that other pharmacy business.

Financial duty not to claim (s 12)

• Not seek advances under subsection 99AB(1) of the Act, or make claims for payment from the Commonwealth, for supplies that are purported at unapproved premises or for supplies that contravened ss 10 or 11.

Rights and interactions embedded in the Determination

• The Determination does not create a new right to payment; it operates against the background of the Act and the Regulations. The instrument expressly notes that s 99 of the Act does not authorise payment for supplies made by an approved pharmacist at premises in respect of which the pharmacist is not approved (note to s 12). Rights to claim payment therefore remain governed by the Act and the Regulations.
• The Determination requires compliance with external professional documents (PSA Code and Standards and the National Competency Standards). Those documents, as external sources, confer the operational content of professional duties but the Determination makes compliance mandatory for approved pharmacists.

Decision, supervision and delegation

• The Determination draws a line between actions that may be undertaken by non‑registered staff (subject to direct supervision) and those which must be performed or directly supervised by a registered pharmacist physically present at the approved premises. See ss 10(3)‑(4) and s 13.

Transitional protection

• Section 16 provides a temporary saving: pharmacists who were the subject of an inquiry by the Pharmaceutical Services Federal Committee of Inquiry immediately before 1 June 2023 are to be dealt with under the prior form of the Determination during the inquiry period. That preserves existing conditions for the duration of certain administrative reviews. See s 16(1)‑(3).

The Determination uses a combination of administrative enforcement mechanisms and financial controls rather than specifying stand‑alone criminal penalties within the instrument itself. The enforcement structure is primarily:

Financial prohibition and payment denial (s 12)

• Section 12(1) and (2) make it a mandatory condition on approved pharmacists that they must not seek an advance under subsection 99AB(1) of the Act or make a claim for payment from the Commonwealth in relation to (a) purported supplies at unapproved premises as prohibited by s 9, or (b) supplies that contravened the requirements of ss 10 or 11. The note to s 12 explicitly references s 99 of the Act, stating that s 99 does not authorise payment for supply by an approved pharmacist at premises in respect of which the pharmacist is not approved. This creates an administrative financial lever: payment or advances from the Commonwealth are not available where the supply is non‑compliant.

Administrative disciplinary powers under the Act (s 4 Note 1)

• The Determination expressly references the Minister’s power under s 95 of the Act to suspend, further suspend or revoke a pharmacist’s approval after investigation and report by an appropriate Committee of Inquiry if the Minister is satisfied that the pharmacist has been guilty of conduct that is an abuse of that approval. The Determination notes that any conduct that is a contravention of the conditions specified in s 92A of the Act shall be deemed to be conduct that is an abuse of the pharmacist’s approval for the purposes of s 95. That links contraventions of the Determination to the Act’s administrative sanctioning regime. See s 4 Note 1.

Internal compliance responsibility and supervisory liability (s 8)

• An approved pharmacist must ensure that registered pharmacists who are not approved for those premises but who dispense at the premises comply with the Determination. Failure to do so could be treated as part of the conduct that the Minister may consider under s 95 of the Act, given the Determination is operative as conditions of approval under s 92A(1)(f) of the Act per s 4. See s 8 and s 4 Note 1.

Indirect enforcement through operational prohibitions

• The Determination’s operational prohibitions function as enforceable conditions of approval. The text is framed as requirements on an approved pharmacist, and contravention is tied to the Act’s abuse of approval and sanctioning regime via the note in s 4. The immediate practical enforcement effect will often be denial of payment for non‑compliant supplies under s 12, coupled with administrative action under the Act for serious or repeated breaches.

Interaction with State and Territory enforcement

• The Determination notes that dispensing of drugs and medicinal preparations is also regulated under State and Territory laws (s 4 Note 2). State regulators therefore retain their own inspection, licensing and disciplinary powers; this Determination does not supplant state regulatory enforcement.

No express criminal penalty in the Determination itself

• The Determination does not set out criminal offences or pecuniary penalties within its text. Enforcement is effected primarily by making compliance a condition of approval, by withholding Commonwealth payment for non‑compliant supplies, and by referral to the Act’s administrative processes that can result in suspension or revocation of approval following Committee inquiry. See s 4 Note 1 and s 12.

Practical enforcement implications

• Because the Determination ties compliance to Commonwealth payment and to the Act’s approval‑sanctioning powers, enforcement will likely involve administrative review and audit of claims and premises, requests for documentation, and potential Committee inquiries where abuse of approval is alleged. The transitional provision in s 16 preserves prior arrangements for pharmacists the subject of ongoing Committee inquiries as at 1 June 2023, which affects the timing and jurisdictional posture of enforcement in those specific cases.

The Determination is not an isolated instrument. It operates squarely within the statutory architecture of the National Health Act 1953, the Regulations, other National Health instruments, and State and Territory regulatory regimes. Key interaction points are:

The Act (Part VII and related provisions)

• The Determination is made for the purposes of paragraph 92A(1)(f) of the National Health Act 1953 and is expressly tied to the Act’s mechanisms for approval, payment and sanction. The Determination’s conditions are conditions of approval under the Act (s 4). The Determination’s Note 1 connects contraventions to s 95 of the Act, and s 12 references payment provisions in s 99 of the Act. See s 4 Note 1; s 12 note.

The Regulations (National Health (Pharmaceutical Benefits) Regulations 2017)

• The Determination repeatedly cross‑references the Regulations. Definitions in the Regulations (for example paper‑based prescription, electronic prescription, medication chart prescription, deferred supply authorisation and repeat authorisation) feed into the Determination’s definitions and operative requirements. See s 5 notes and references to the Regulations throughout (for example s 5 note 1 and s 5 definitions referencing the Regulations).

Other Commonwealth instruments and listings

• The Determination references other National Health instruments: the National Health (Continued Dispensing) Determination 2022 is cited in the definition of continued dispensing prescription in s 5; the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 is referenced for the definition of extemporaneously‑prepared pharmaceutical benefit; and the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 is mentioned in s 5(c)(i) as an exception for labelling content in certain circumstances. Those cross‑references mean that those instruments will determine the content of certain dispensing steps and the scope of items to which the Determination’s labelling requirement applies. See s 5.

State and Territory laws

• The Determination explicitly notes that the dispensing of drugs and medicinal preparations is also regulated under State and Territory laws (s 4 Note 2). This means that compliance requires attention to both Commonwealth conditions of approval and state licensing, premises, controlled medicines handling, and pharmacy practice law.

The Health Insurance Act 1973 and the National Law

• Section 5 notes that expressions defined for the purposes of the Health Insurance Act 1973 have the meanings they would have in that Act, and that the expression National Law used in this Determination is defined in the Health Insurance Act. This technical cross‑reference should be kept in mind where definitions from the Health Insurance Act feed into interpretation of this Determination. See s 5 Note 2.

Payment and entitlement provisions

• The Determination’s operation on claims and advances references the entitlement and payment framework in the Act. Section 5A sets out when the Determination applies to supplies that are intended to be pharmaceutical benefits under Part VII of the Act and provides examples connected to entitlement provisions (for example s 86(1) of the Act and s 85(7) and s 88A). Section 12’s note cites s 99 of the Act regarding payment authorisation. Practically, whether a supply is a pharmaceutical benefit under the Act determines whether the Determination applies and whether Commonwealth payment may be available. See s 5A and s 12 note.

Regulatory sanctioning mechanisms

• The Determination’s conditions of approval feed into the Act’s administrative sanctioning pathway: the Minister may suspend or revoke approvals under s 95 of the Act following Committee inquiry, and the Determination notes that contraventions of conditions specified in s 92A of the Act can amount to abuse of approval (s 4 Note 1). Thus, contraventions of the Determination can trigger administrative disciplinary processes under the Act.

Operational documents and professional standards

• The Determination incorporates external professional instruments by reference, making compliance with the PSA Code of Ethics 2017, the Professional Practice Standards 2017 and the National Competency Standards Framework 2016 mandatory for approved pharmacists. Those documents will shape professional conduct expectations and may be updated by the PSA; the Determination requires compliance with the texts as published and referenced. See ss 6 and 7.

Transitional and amendment instruments

• Section 16 preserves prior rules for pharmacists subject to Committee inquiries as of 1 June 2023 despite amendments made by the National Health Legislation Amendment (Conditions of Approval for Approved Pharmacists) Instrument 2023. That shows the Determination’s amendments are connected to subsequent instruments and that transitional protections can be provided through express saving provisions. See s 16.

In short, the Determination functions as a condition‑setting instrument within the Part VII architecture of the Act and must be read in tandem with the Act, the Regulations and several related National Health instruments, as well as state and territory pharmacy law.

The Determination itself is dated 2017, but the text supplied includes an express transitional provision that addresses amendments made by a 2023 instrument. The only amendment history recorded inside this text is the 2023 instrument and the transitional saving that follows from it. The relevant provision is s 16.

Section 16 (Application of amendments made by the National Health Legislation Amendment (Conditions of Approval for Approved Pharmacists) Instrument 2023) provides a saving mechanism in three parts:

• Subsection 16(1) states that despite the amendments made by Schedule 1 to the 2023 Instrument, the Determination continues to apply, as if those amendments had not been made, in relation to an approved pharmacist to whom subsection (2) applies during the period mentioned in subsection (3).

• Subsection 16(2) states that the saving applies to an approved pharmacist if immediately before 1 June 2023 the Pharmaceutical Services Federal Committee of Inquiry was inquiring into a matter that concerns the services or conduct of that pharmacist.

• Subsection 16(3) defines the period for the pharmacist as running from 1 June 2023 until the Committee either gives its report to the pharmacist or gives notice in writing that the inquiry has terminated.

This is a specific, limited transitional provision designed to avoid retrospectively applying the 2023 amendments to pharmacists who were subject to an ongoing Committee inquiry on 1 June 2023. The Determination does not include any other amendment history, schedules or earlier saving provisions in the text supplied. Where the Determination references other instruments or standards by year (for example PSA documents published in 2017 and competency standards from 2016), those are not amendments to the Determination itself but external sources that the Determination incorporates by reference.

Practically, the instrument signals that there was a legislative or instrumentary update in 2023 that altered the Determination’s text (Schedule 1 to the 2023 Instrument), but that certain pharmacists subject to ongoing administrative inquiries were to be preserved on the pre‑amendment footing for the inquiry period. The Determination contains no further internal amendment history or amendments record beyond s 16.

The Determination as provided contains no references to litigation and names no cases. The instrument does, however, point to administrative enforcement routes under the Act, particularly through Committee inquiry and Ministerial powers to suspend or revoke an approval (s 4 Note 1). Since the Determination itself is an administrative condition instrument rather than primary legislation establishing offences, disputes about compliance are likely to appear in administrative law contexts, payment recovery proceedings or in actions connected to the Act’s sanctioning mechanisms, rather than as standalone criminal prosecutions derived from the Determination.

Because the text of the Determination supplied does not report or cite any case law, no cases are named in this instrument and there is no litigation history recorded within it. Any litigation or administrative review arising from contraventions of these conditions would therefore be external to the instrument and would arise under the Act, under payment recovery processes, or under State or Territory regulatory frameworks. The Determination’s note on s 95 of the Act suggests that Ministerial decisions following Committee inquiries may be reviewable through judicial review or merits review processes in appropriate forums, but the Determination does not describe those processes or report related litigation.

If a reader requires an authoritative litigation history or case law that interprets the Determination or the Act’s sanctioning provisions, that will require an external search of administrative law decisions, tribunal determinations and court judgments. The instrument itself contains no litigation citations to ground such an inquiry.

This Determination contains a number of operational details that can easily trap an unwary pharmacy operator or pharmacist if not read carefully. The following are concrete compliance pitfalls grounded in the text.

Dispensing step is broader than “handing over the pack”

• The definition of dispensing step in s 5 includes not only review and physical preparation but also generation and affixing of the label and recording the dispensing in the pharmacy’s system. Therefore, any model where labelling or record entry is done off‑site or at a different premises risks a breach of s 10 because those qualify as dispensing steps that must be performed while the benefit is at the approved premises, with a registered pharmacist physically present. See s 5(c) and s 10(2)‑(4).

Physical presence requirement applies to each dispensing step

• Section 10(4) requires the registered pharmacist who is dispensing or directly supervising dispensing to be physically present at the approved premises when each dispensing step is performed. “Direct supervision” without physical presence is insufficient. This can complicate models that depend on remote supervision, centralised clinical review, or telepharmacy unless the registered pharmacist is physically at the approved premises while steps are performed. See s 10(3)‑(4).

Approval number restrictions are strict

• Section 14 forbids using or allowing the use of an approval number in connection with any other premises for dispensing, purported supply, or preparation of repeat/deferred supply authorisations. Labels, repeat authorisations, and deferred supply authorisations must not bear an approval number relating to another premises. This restricts multi‑site labelling or cross‑premises use of an approval number. See s 14 and its explanatory notes.

Arrangements with other pharmacies are prohibited

• Section 15 prohibits an approved pharmacist entering into an arrangement with the owner/operator of another pharmacy business for supply by the approved pharmacist to persons presenting at that other business. That is broader than simply prohibiting staff from moving between sites; it bars contractual and understandings that have that operational effect. The Determination does not define “arrangement” narrowly; s 5 defines arrangement to include oral understandings and arrangements whether or not legally enforceable. See s 15 and s 5.

Deferred supply and repeat authorisation preparation must be on premises

• Section 13 and s 14(d) require deferred supply authorisations and repeat authorisations to be prepared only at approved premises, and only by or under the direct supervision of a registered pharmacist physically present. Off‑site generation or centralised preparation of these authorisations is therefore not permitted. See s 13 and s 14.

Electronic prescriptions do not obviate physical‑presence obligations

• The notes to s 5 state that a prescription may be electronic, and s 11 addresses prescriptions other than medication chart prescriptions. However, s 11(2) requires the registered pharmacist to “see the prescription at the approved premises” when performing the review dispensing step. That means reliance on an electronic prescription system does not necessarily allow the pharmacist to avoid being physically present at the approved premises when undertaking the review step. See s 5 note 1 and s 11(2).

Patient cooperation can be an operational hinge

• Section 6(d)(i) requires compliance with the Professional Practice Standards subject to patient preparedness to ensure the pharmacist has ready access to the patient’s medication history. The Determination anticipates patient cooperation as a precondition to certain aspects of individualising care. Where patients obtain medications from multiple providers and decline to authorise transfer of medication history, the approved pharmacist’s obligations under s 6 will be limited in practice. See s 6(d)(i) and Note 1 to s 6.

Financial exposure if supply is non‑compliant

• Section 12 bars seeking advances and making claims for payment from the Commonwealth for supplies that are purported at unapproved premises or that contravene ss 10 or 11. Non‑compliant supplies may therefore be ineligible for payment and could trigger payment recovery action. See s 12 and its note referencing s 99 of the Act.

Supervisory duty can import vicarious regulatory risk

• An approved pharmacist must ensure that registered pharmacists who are not approved for those premises comply with the Determination (s 8). Failure to enforce compliance at the premises could expose the approved pharmacist to administrative sanction under the Act, because contraventions of conditions are tied to abuse of approval for s 95 purposes per s 4 Note 1.

Transitional quirks

• Section 16 preserves pre‑amendment treatment for pharmacists subject to a Committee inquiry as at 1 June 2023. This means that different pharmacists may be subject to different versions of the conditions depending on inquiry timing. Operationally, that can create inconsistency across approval holders while inquiries are ongoing. See s 16.

Interaction with state laws

• The Determination notes that dispensing is also regulated under State and Territory laws. Compliance with the Determination does not guarantee compliance with all state regulatory or licensing requirements. Operators must align practice with both Commonwealth conditions and state laws. See s 4 Note 2.

Complying with this Determination requires aligning premises operations, staffing, recordkeeping and commercial arrangements to the instrument’s conditions. Below is a practical checklist of concrete steps and system features, tied to the relevant sections of the Determination. This is an operational compliance guidance grounded in the instrument’s requirements.

1. Confirm premises approval and use approval number only at those premises

• Ensure the pharmacist’s approval and approval number are current and mapped to specific premises. Do not affix the approval number or use it in relation to dispensing or purported dispensing at any other premises. See s 14.

2. Ensure each dispensing step is performed at the approved premises

• Map your dispensing workflow to the Determination’s definition of dispensing step in s 5. Identify which tasks qualify as dispensing steps in your operation (review, certain preparations, labelling, repeat authorisation preparation, record entry). Ensure those tasks are performed while the pharmaceutical benefit is physically at the approved premises. See s 5 and s 10(2).

3. Maintain registered pharmacist physical presence for each dispensing step

• Implement staff rosters and shift patterns to guarantee that a registered pharmacist is physically present at the approved premises whenever a dispensing step is performed. Where non‑registered staff undertake tasks, ensure they are under the direct supervision of a registered pharmacist physically present. See s 10(3)‑(4) and s 13.

4. For prescription review, ensure the registered pharmacist sees the prescription at the approved premises

• For prescriptions that are not medication chart prescriptions, ensure the registered pharmacist conducting the review sees the prescription at the approved premises when the review step occurs. Confirm that electronic prescription access methods permit viewing at the approved premises in compliance with s 11. See s 11(1)‑(2) and s 5 note 1.

5. Restrict off‑site labelling, preparation and recording

• Because adverse outcomes can arise from off‑site labelling or central fill where label generation or record entry occurs elsewhere, ensure label generation and affixing, admixture, extemporaneous preparation and final recording are not outsourced to other premises or facilities. See s 5(c) and s 10.

6. Prepare deferred supply and repeat authorisations on‑site under direct supervision

• Prepare deferred supply authorisations and repeat authorisations only at the approved premises, by or under the direct supervision of a registered pharmacist physically present at those premises. Ensure forms are stored and generated only from the approved premises. See s 13 and s 14(c)‑(d).

7. Avoid prohibited arrangements with other pharmacy businesses

• Do not enter into arrangements (broadly defined) with another pharmacy business owner/operator that would have you supply pharmaceutical benefits to persons presenting at that other business. Review contracts, service agreements and commercial understandings to ensure they do not create the prohibited supply relationship under s 15.

8. Implement recordkeeping and audit trail

• Given the condition that recording in the dispensing pharmacy’s system is a dispensing step (s 5(e)), implement secure systems that capture timestamps, user IDs and premises location for dispensing steps. Keep contemporaneous records that show the pharmaceutical benefit was at the approved premises when each dispensing step was performed and that a registered pharmacist was present. These records will support internal audits and responses to payment or compliance inquiries. See s 5(e) and s 10.

9. Train staff on patient dignity and professional standards

• Train staff on s 6 obligations: all legal pharmacy requirements, PSA Code of Ethics (2017), Professional Practice Standards (2017), and the expectation to treat patients with dignity regardless of payment method and other attributes. Document training and maintain evidence of continuing education participation by pharmacists. See ss 6 and 7.

10. Maintain continuing education currency

• Ensure approved pharmacists remain current in pharmaceutical knowledge in accordance with the National Competency Standards Framework for Pharmacists in Australia 2016. Retain certificates and records of CPD activity. See s 7.

11. Control use of approval number on labels and documentation

• Update label templates, dispensing software and procedural checklists to prevent insertion of an approval number that pertains to other premises. Audit labels and repeat/deferred supply forms to verify correct approval numbers are used only for the approved premises. See s 14.

12. Implement policies for patient medication history access

• Put in place procedures to encourage patients to use a single pharmacy or to authorise transfer of medication history as suggested in s 6 Note 1. Where patients refuse, record this and adjust the pharmacist’s counselling and risk assessment accordingly. See s 6(d)(i) and s 6 Note 1.

13. Financial controls and claims validation

• Ensure claims for payment to the Commonwealth and any advance requests under s 99AB(1) of the Act are validated against the Determination’s conditions. Do not submit claims or seek advances for supplies made at unapproved premises or supplies that contravened ss 10 or 11. Implement a claims review step confirming premises, dispensing steps location and supervising pharmacist presence prior to submitting claims. See s 12.

14. Internal supervisory oversight

• If you are an approved pharmacist responsible for premises, establish formal supervisory processes to ensure registered pharmacists who are not approved for your premises comply with the Determination. Maintain documented supervision arrangements and periodic compliance checks as required by s 8.

15. Review contracts and service models

• Revisit central‑fill, telepharmacy, remote labelling, and contractual models with other pharmacy businesses to ensure they do not run afoul of the Determination’s premises, presence and arrangement prohibitions. Where models depend on remote steps, redesign them to perform all dispensing steps at the approved premises or structure them to comply with the Determination’s supervision and presence requirements. See ss 5, 10, 11, 13, 14 and 15.

16. Understand State and Territory law overlay

• Cross‑check state licensing and medicine handling laws against the Determination’s requirements. Ensure that complying with the Determination does not create gaps with state regulatory obligations. See s 4 Note 2.

17. Prepare for audits and potential Committee inquiries

• Put in place processes to produce records and to respond to inquiries from Commonwealth auditors, claim administrators and, where allegations arise, to participate in Committee inquiries under the Act. Be aware of s 16 transitional rules where applicable for ongoing inquiries as at 1 June 2023.

Following the checklist above will align operations to the Determination’s core requirements. Where complex business models are contemplated , for example multi‑site operations, centralised fulfilment, or service arrangements with other pharmacy businesses , bespoke operational design and legal review should be undertaken to ensure no breach of ss 9, 10, 11, 13, 14 or 15, and to avoid the financial exclusion risks under s 12 and administrative sanction risks invoked by s 4 Note 1.