National Health (Continued Dispensing – Emergency Measures) Determination 2020

The Determination rests on several interlocking legal and operational concepts drawn from the National Health Act and the instrument’s own text.

• Authority and scope: The instrument is a statutory determination made under subsection 89A(3) of the National Health Act 1953 (1.03). It therefore functions as a delegated instrument that implements subsection 89A(1) authorising supply without a current prescription, subject to the conditions it sets (1.05; 2.01(1)).

• Approved pharmacist: The supply power and the duties in the instrument apply to an "approved pharmacist," a term defined in Part VII of the Act and adopted here by reference (1.04(2)). The instrument does not redefine who is an approved pharmacist; that status is determined under the Act.

• PBS prescriber and previous prescription: The mechanism depends on a prior prescription issued by a "PBS prescriber" (1.04(2); 2.01(3)(b)). The pharmacist must be satisfied that the person was previously supplied the pharmaceutical benefit on a PBS prescription and that the PBS prescriber prescribed that supply in at least one of the circumstances determined under paragraph 85(7)(b) of the Act (2.03). The instrument therefore links the permitted continued dispensing to prior prescriber-authorised treatment episodes of a particular legal character under the Act.

• Not practicable: The pharmacist must be satisfied it is "not practicable" for the person to obtain a prescription from a PBS prescriber before the person needs the supply (2.02). The text imposes this as a condition for supply but does not give a formula for "not practicable"; it does require the pharmacist to consider the PSA Guidelines in making that assessment (2.01(2)).

• Stability and prior clinical review: The instrument requires the pharmacist to be satisfied that the patient’s therapy is stable (2.04) and that the patient has been on the medicine regularly for an uninterrupted period and that, during that ongoing period, the PBS prescriber has assessed the person and decided ongoing treatment was required (2.05). These are clinical‑fact inquiries made by the pharmacist based on available information and professional judgment.

• Quantity limits and frequency limits: The supply must replicate the same quantity/number of units previously supplied under the last prescription in line with paragraph 85A(2)(a) of the Act (2.09). The person must not have been supplied the pharmaceutical benefit under s 89A(1) in the 12 months before the requested supply, i.e. once per 12-month period under this pathway (2.07).

• Documentation and notification: The pharmacist must record the information used to support the decision and must prepare and send information to the PBS prescriber (2.10). The information to be recorded and prepared is specified in the instrument (2.10(2)), and the PSA Guidelines provide guidance on timing for sending the information (2.10(1) note).

• Eligible items: The list of eligible pharmaceutical benefits is the set of listed brands of pharmaceutical items in Schedule 1. The supply must be in the form and manner of administration specified for the listed drug in Schedule 1 (3.01(1)-(2)). The instrument treats a Schedule equivalent as a pharmaceutical benefit for specified sections (2.01(3)(c)).

• Interaction with other Act provisions: The instrument cross-references multiple provisions in the National Health Act,Part VII, s 85(7)(b), s 85A(2)(a), s 88A and the prescriber bag provisions,so understanding and applying the Determination requires concurrent reference to those statutory provisions (1.04; 2.03 note; 2.09).

These concepts together form a framework where professional judgement by an approved pharmacist, constrained by specified documentary and clinical prerequisites and by Schedule 1 eligibility, permits a single, limited, recorded supply without a new prescription.

The Determination allocates roles and practical burdens across several actors. The primary actors named in the instrument are the approved pharmacist, the person requesting the supply (the patient), and the PBS prescriber. Agents of the person are also mentioned in a narrow role (2.08). The instrument excludes certain supply mechanisms that are handled elsewhere under the Act (1.06).

• Approved pharmacists (decision-makers): The approved pharmacist bears the primary legal duty to decide whether the statutory conditions are met, to supply the medicine if they are, to record the supporting information, and to prepare and send information to the PBS prescriber (2.01(1)-(2), 2.10(1)). The pharmacist must consider the PSA Guidelines when assessing conditions (2.01(2)). The term "approved pharmacist" is used consistently; its legal status is determined under Part VII of the Act (1.04(2)). Practically, the pharmacist needs access to the patient’s medication history and prior prescription details to satisfy the "previous supply" and "prescription for last supply" conditions (2.03, 2.06).

• Persons requesting supply (patients): A "person" (the patient) is the recipient of the requested supply referenced throughout Part 2 (2.01(3)(a)). The patient must have been previously supplied the pharmaceutical benefit under a PBS prescriber’s prescription and must not have used the continued dispensing mechanism under s 89A(1) in the prior 12 months (2.03; 2.07). The person must sign a declaration acknowledging the supply is being provided without a valid Part VII prescription; alternatively, an agent of the person may sign, but not the approved pharmacist (2.08). The person’s clinical status must also meet the stability and ongoing-treatment conditions (2.04; 2.05).

• PBS prescribers: The PBS prescriber is the clinician who most recently prescribed the medicine to the person (2.01(3)(b)). The instrument requires the pharmacist to send information to the PBS prescriber about the supply (2.10(1)), and it conditions supply on a prior PBS prescriber assessment of ongoing treatment need (2.05). The prescriber is therefore a passive recipient of notification and also an antecedent decision-maker whose prior clinical review determines eligibility.

• Agents: Agents of the person can sign the required declaration (2.08), creating a limited delegated role. The instrument explicitly excludes an approved pharmacist from signing as an agent (2.08).

• Excluded operators: Supply routes that operate under section 100 special arrangements and the prescriber bag provisions under Part VII are outside this Determination’s operation (1.06). Entities relying on those alternative mechanisms are unaffected by the conditions in this Determination, but must continue to comply with their own statutory frameworks.

• Employers and pharmacy owners (indirectly affected): While not named, pharmacy owners and employers will be practically affected because approved pharmacists must create and store records and implement procedures to consider PSA Guidelines and to prepare/send notifications (2.10; 2.01(2)). Workflows, recordkeeping systems and training will therefore be affected.

Who bears the legal compliance burden? The approved pharmacist. Who bears the behavioural change? Patients gain an alternative route for a single supply when they cannot practicably obtain a prescription, but only if they meet the prior‑use, stability and documentation conditions. PBS prescribers receive an information flow and are the prior clinical assessors whose prior judgements determine eligibility. The Determination’s distribution of duties therefore shifts a narrow set of decision and documentation responsibilities from prescribers to pharmacists, while leaving prescribers as the initial gatekeepers of the prior therapeutic decision.

The Determination creates specific duties for approved pharmacists and a limited right for persons to receive a continued supply under the conditions. Many duties hinge on subjective satisfaction by the pharmacist; some duties are documentary and procedural.

Duties placed on approved pharmacists

• Consider PSA Guidelines: Before deciding whether the statutory conditions are satisfied, the pharmacist must consider the PSA Guidelines (2.01(2)). This is a mandatory procedural duty; the text requires the pharmacist to "consider" the Guidelines in both determining and satisfying conditions.

• Assess practicability: The pharmacist must be satisfied that it is not practicable for the person to obtain a prescription from a PBS prescriber before the person needs the supply (2.02). This is a threshold factual assessment that the pharmacist must make in each case.

• Verify previous prescription-based supply: The pharmacist must be satisfied that the person has previously been supplied the pharmaceutical benefit on the basis of a PBS prescriber’s prescription and that the PBS prescriber prescribed that supply in at least one of the circumstances determined under paragraph 85(7)(b) of the Act (2.03).

• Assess stability: The pharmacist must be satisfied that the person’s therapy is stable (2.04). The instrument does not define "stable"; the pharmacist must exercise professional judgment, guided by the PSA Guidelines.

• Confirm prior clinical review and uninterrupted use: The pharmacist must be satisfied that the person has been taking the pharmaceutical benefit regularly for an uninterrupted period, and that since the start of that period the PBS prescriber has assessed the person's condition and decided there was a need for ongoing treatment with the benefit (2.05).

• Verify last prescription validity: The pharmacist must be satisfied that the person had a valid prescription under Part VII of the Act for the last supply before the requested supply (2.06).

• Check frequency limit: The pharmacist must be satisfied that the person has not been supplied the pharmaceutical benefit under s 89A(1) in the prior 12 months (2.07). This duty limits the continued-dispensing route to once per year for any given pharmaceutical benefit.

• Obtain signed declaration: The pharmacist must ensure the person or an agent (but not the pharmacist) signs a declaration acknowledging the supply is without presentation of a valid Part VII prescription (2.08).

• Supply quantity limits: The pharmacist must supply the quantity or number of units that is the same as that previously supplied under the last prescription and that is the quantity determined under paragraph 85A(2)(a) of the Act (2.09). The pharmacist must therefore refer to the last prescription or to the statutory determination of quantity under the Act.

• Record and notify: On supply, the pharmacist must record the information used to support the decision and prepare information to send to the PBS prescriber. The required recorded/prepared information is specified in 2.10(2): a statement that the supply was determined under paragraph 89A(3)(a) of the Act, a statement that the conditions in sections 2.02-2.05 are satisfied, and a statement that the pharmacist is satisfied the medicine needs supplying to facilitate continuity of treatment (2.10(2)(a)-(c)). The PSA Guidelines give guidance about when to send the information (2.10 note).

Rights and constraints for persons (patients)

• Access right (conditional): A person has a conditional right to receive a pharmaceutical benefit without a current Part VII prescription if they meet the statutory eligibility conditions and the approved pharmacist so decides (1.05; 2.01). This is not an absolute right; it is contingent on the pharmacist’s satisfaction of numerous conditions and on the item being included in Schedule 1 (3.01).

• Requirement to declare: The person must sign a declaration acknowledging the lack of a current Part VII prescription (2.08). An agent may sign in their stead, but not the pharmacist.

Other practical rights and constraints

• PBS prescriber: The prescriber’s role is primarily an antecedent one: the prescriber’s earlier decision that ongoing treatment is needed is a condition for supply (2.05). The prescriber receives notification after the continued dispensing event (2.10). The Determination does not create a power for the prescriber to veto a pharmacist’s continued dispensing decision at the time of supply; it relies instead on the prior prescriber assessment and on notification after supply.

• Limits on repeated use: The instrument restricts the continued-dispensing mechanism to medicines listed in Schedule 1 and to one supply under s 89A(1) in any 12‑month period per person per medicine (2.07). The pharmacist must ensure compliance with that limit.

Procedural detail and documentation

• The instrument specifies the minimum content for records/notifications (2.10(2)); the pharmacist must contemporaneously document the bases for satisfying the factual conditions. The requirement to record "the information that the pharmacist used to support his or her decision" (2.10(1)(a)) makes the pharmacist’s clinical and practicability reasoning auditable.

In summary, the Determination imposes a bundle of subjective and objective duties on approved pharmacists,clinical assessment duties, documentation and notification duties, and quantitative limits,while conferring a conditional pathway for patients to receive a single continued supply without a fresh prescription, limited by item eligibility (Schedule 1) and a one-year frequency cap.

The Determination itself does not create express criminal penalties, pecuniary fines, or administrative sanction mechanisms in its text. It sets substantive conditions for lawful supply without a Part VII prescription and prescribes recording and notification obligations, but it does not specify enforcement processes, sanctions or remedies for non-compliance within its own provisions.

• Absence of internal penalties: The instrument contains no clauses imposing penalties, specifying regulatory sanctions, or creating enforcement powers. It focuses on conditions for lawful supply and on recordkeeping and notification duties (Part 2 and 3).

• Regulatory and legal enforcement context: Because the Determination is made under subsection 89A(3) of the National Health Act 1953 (1.03), legal consequences for non-compliance would arise through the Act’s enforcement and sanctioning framework rather than the Determination’s text. The Determination repeatedly refers to provisions of the Act (for example, paragraph 85A(2)(a), paragraph 85(7)(b), and Part VII generally) (1.04; 2.03; 2.09). Any enforcement, liabilities, or administrative consequences for failing to satisfy the conditions will therefore depend on the Act and any regulatory instruments, guidance or administrative practice issued under it. The Determination does not specify that a failure automatically triggers a particular sanction; it simply makes supply lawful only where the conditions are met.

• Evidentiary consequences of documentation requirements: The Determination imposes a duty to record the information used to support supply decisions and to prepare information for the PBS prescriber (2.10(1)-(2)). Those records will be the primary evidentiary materials in any enquiry into compliance. The specified content (2.10(2)(a)-(c)) requires a pharmacist to state the legal basis for the supply and the factual bases for satisfying the conditions. Absence, incompleteness, or inconsistency of those records will therefore have practical consequences in any administrative or disciplinary review, even if the Determination itself does not prescribe a penalty.

• Professional regulation and scope-of-practice consequences: Although not in the Determination, professional regulatory bodies (for example state pharmacy boards) and employer disciplinary regimes may enforce compliance with the Determination via existing professional standards and disciplinary rules. The Determination’s requirement to consider the PSA Guidelines (2.01(2)) also creates a professional governance touchpoint; failure to consider the Guidelines could be relevant in a professional misconduct investigation.

• Operational compliance risk: The Determination sets several subjective satisfactions,"satisfied" appears in multiple sections (2.02-2.07). Regulators reviewing whether supply was lawful will focus on whether the pharmacist had sufficient grounds and documentation to be satisfied as required and whether the PSA Guidelines were considered. The Determination’s documentation provisions (2.10) set out what will be considered in that evaluation.

Practitioners should therefore understand that the instrument delegates compliance and factual decision-making to approved pharmacists and requires them to document their decision-making. While the Determination itself does not list penalties, failure to comply with its conditions will be relevant to enforcement under the Act and to professional regulatory oversight, and the recordkeeping statements required by 2.10 will be central evidence in any enforcement or disciplinary action.

The Determination operates as an instrument under the National Health Act 1953 and makes multiple express cross-references to the Act and to materials outside the instrument that frame its application. It does not operate in isolation.

• Delegated instrument under the Act: The Determination is expressly made under subsection 89A(3) of the National Health Act 1953 (1.03). Its operative authorisation to permit supply without a current prescription therefore depends on the power in the Act. The Determination repeatedly references provisions in Part VII of the Act and particular paragraphs (for instance, paragraphs 85(7)(b), 85A(2)(a), and s 88A) (1.04; 2.03 note; 2.09). Compliance therefore requires consultation of those Act provisions to understand their content and effect.

• Cross-reference to Part VII concepts and definitions: Several terms used in the Determination,"approved pharmacist", "listed brand", "PBS prescriber", "pharmaceutical benefit", "pharmaceutical item", and "Schedule equivalent",are given the same meanings as in Part VII of the Act (1.04(2)). That means the legal definition of those terms is not in the Determination and must be obtained from the Act. The Determination’s practical operation therefore depends on how those terms are defined and interpreted under the Act.

• Interaction with paragraph 85(7)(b) and relevant pharmaceutical benefits: Section 2.03 requires that the PBS prescriber prescribed the supply "in at least one of the circumstances determined for that pharmaceutical benefit under paragraph 85(7)(b) of the Act." The Determination does not include those circumstances: they are contained in the Act. The Determination therefore imposes a dependency on the Act’s separate determinations about which circumstances render a pharmaceutical benefit relevant for continued dispensing.

• Quantity determination under paragraph 85A(2)(a): The allowed quantity is tied to paragraph 85A(2)(a) of the Act by reference in 2.09. The Determination requires the pharmacist to supply the same quantity or number of units that was previously supplied under the last prescription and that is the quantity determined under paragraph 85A(2)(a) of the Act. That external cross-reference means quantity limits under the Act govern permissible supply amounts here.

• Exclusions for s 100 and prescriber bag supplies: The Determination does not apply to supplies under special arrangements pursuant to s 100 of the Act, nor to supplies under the prescriber bag provisions in Part VII, thereby preserving the operation of those other statutory supply routes (1.06). Practitioners must therefore determine whether an intended supply is governed by those other provisions instead of this Determination.

• PSA Guidelines as non-statutory guidance embedded by reference: The Determination requires the pharmacist to consider the PSA Guidelines (2.01(2)). Those Guidelines are not part of the Determination but are elevated to a mandatory consideration. They will therefore shape interpretation of subjective tests such as "not practicable" or "stable." Discrepancies between the PSA Guidelines and statutory text would raise interpretive questions; however, the Determination itself places an explicit duty to consider the Guidelines.

• Schedule 1 dependency: Eligibility of particular medicines is governed by Schedule 1 to the Determination (3.01), which lists the "listed brand of a pharmaceutical item" and prescribes the form and manner of administration. Where a Schedule equivalent exists that meets the definition in Part VII, the Determination may treat it as a pharmaceutical benefit in specified sections (2.01(3)(c)). The Determination therefore interacts with any statutory or policy definitions that determine what a Schedule equivalent is.

In sum, the Determination is tightly integrated with the National Health Act’s Part VII apparatus: its definitions, quantity rules, relevant-benefit circumstances, and other supply mechanisms. Any application requires concurrent reference to the referenced Act provisions and to the PSA Guidelines and Schedule 1. Because many operative constraints are established by reference to the Act (rather than set out in the Determination), practitioners must treat the Determination as a piece in a broader statutory framework rather than as a stand-alone rule.

The Determination text provided contains no internal amendment record, no notation of prior instruments, and no clause reproducing a history of amendments. The instrument identifies itself (1.01) and its making power (1.03), but it does not include any schedule or notation listing amendments, repeal dates, transitional provisions or expiry. There is therefore no amendment history contained within the text that can be cited.

Practical implications of that silence

• Need to consult the legislative register: Because this text does not contain an amendment history, users must consult the formal legislative database or the Federal Register of Legislation to discover whether the Determination has been amended, repealed or replaced since its making. The Determination itself points to the Act for authority but does not report any changes that may subsequently have been made.

• Uncertainty about changes to Schedule 1 or PSA Guidelines: The Determination refers to Schedule 1 for the list of eligible items and to the PSA Guidelines for operational guidance (2.01(2); 3.01). Neither Schedule 1 nor any subsequent variation is reflected here. If Schedule 1 has been updated by later instrument or if the PSA Guidelines have been amended, those changes will not be visible in this text. Practitioners should therefore verify the current content of Schedule 1 and the current PSA Guidelines in the authoritative sources.

• Transitional or sunset arrangements not stated: The Determination text does not include transitional provisions, sunset clauses or expiry dates. If such arrangements were intended or later enacted, they are not recorded here. Users should therefore check the instrument’s entry in official legislative repositories for any notes on commencement, expiry or amending instruments.

• Effect on compliance protocols: Because the Determination requires pharmacists to record and send specific information and to act in accordance with the PSA Guidelines (2.10; 2.01(2)), any amendments to those external instruments or to Schedule 1 would affect compliance practices. The absence of an amendment trace in this text means practitioners cannot rely on it alone to determine the current state of obligations.

In short, the Determination text provided contains no amendment history. That absence imposes a practical obligation on lawyers, compliance officers and pharmacists to consult the official legislative register and the current PSA Guidelines and Schedule 1 to confirm the instrument’s present form and its eligible items before relying on it.

The Determination text supplied does not include any litigation history, judicial citations, or references to cases decided under or about it. No court decisions, administrative reviews, or tribunal matters are mentioned or incorporated. Therefore, within the text of this instrument itself, there is no litigation history to cite.

Practical consequences and how to proceed

• No precedent recorded in the instrument: Because the Determination does not include or summarise any litigation or case law, there is no internal record of how courts or tribunals have interpreted its provisions, nor any description of disputes that may have arisen under it. Practitioners should not assume from this silence that there has been no litigation; the instrument simply does not record such matters.

• Need to research external sources for judicial interpretation: For authoritative interpretations of any contested terms,such as what constitutes being "satisfied", what "not practicable" means in practice, what counts as "stable" therapy, or the ambit of "Schedule equivalent",consultation of relevant case law, administrative decisions, and regulator guidance outside this instrument will be necessary. The Determination’s text leaves those interpretive tasks to external adjudicative sources, yet none are reproduced here.

• Evidentiary reliance and recordkeeping in disputes: The Determination prescribes specific record elements that pharmacists must prepare and record (2.10(1)-(2)). If disputes or reviews occur, those records will be central evidence. Litigation or disciplinary proceedings, should they arise, will likely focus heavily on the quality and completeness of the documentation required by 2.10 and on whether the pharmacist properly considered the PSA Guidelines as required by 2.01(2).

• Administrative review potential: Given the Determination’s reliance on the Act and on professional standards, any enforcement actions or proceedings would likely be processed through administrative or professional channels rather than via new statutory offences contained in the Determination. The absence of litigation history in the text means that practitioners must independently search court databases and administrative tribunal records for any precedent relevant to continued dispensing under s 89A(3).

Summary: This instrument does not record litigation history. Practitioners must therefore perform external searches in legal databases and regulatory records to identify any judicial or disciplinary interpretations that would affect how the Determination’s tests are applied in practice.

Several practical traps and interpretive risks arise from the Determination’s wording and its dependency on external materials. These “gotchas” are matters that lawyers, pharmacists and compliance officers should explicitly consider because the instrument either leaves them unresolved or creates operational friction.

• Schedule 1 is decisive but not reproduced here: The Determination confines supply to "any listed brand of a pharmaceutical item mentioned in Schedule 1" and to the form and manner of administration specified there (3.01). If Schedule 1 is not checked, pharmacists may inadvertently supply an item that is not authorised. The instrument’s operation is therefore contingent on an authoritative, up-to-date Schedule 1. Relying on this text alone without confirming Schedule 1 is a practical risk.

• Subjective satisfaction tests are central and auditable: Multiple conditions hinge on the pharmacist being "satisfied" (2.02-2.06). Those are subjective standards that depend on the pharmacist’s assessment. However, the Determination also mandates recording "the information that the pharmacist used to support his or her decision" (2.10(1)(a)). That makes the pharmacist’s internal reasoning auditable. If the record is thin, disciplinary or administrative review may find the pharmacist did not have adequate grounds to be "satisfied".

• Mandatory consideration of PSA Guidelines: The Requirement to "consider" the PSA Guidelines (2.01(2)) is stronger than mere optional guidance. Failure to document that the Guidelines were considered may be treated as non-compliance. Pharmacists must therefore be able to show in records how the Guidelines informed the decision.

• Frequency cap once per 12 months, per medicine: Section 2.07 prohibits supplying the pharmaceutical benefit under s 89A(1) if the person was supplied the benefit under that subsection in the prior 12 months. This cap is per pharmaceutical benefit and interacts with the need to identify the same listed brand/form under Schedule 1. If a patient receives a supply under this Determination, the pharmacist must have systems to flag this for future 12-month checks.

• Quantity must match previous prescription and statutory determination: 2.09 requires supplying the same quantity or number of units that was previously supplied under the last prescription, and that must be the quantity determined under paragraph 85A(2)(a) of the Act. Practically, this requires the pharmacist to verify the last prescription quantity and to be familiar with the Act’s quantity determinations. Misreading either can lead to oversupply.

• Declaration cannot be signed by the pharmacist: The instrument expressly prevents the pharmacist from signing the declaration as agent; an agent of the person may sign (2.08). Pharmacists must therefore obtain a signature from the patient or their authorised agent; failing to do so creates a procedural defect.

• Exclusions; do not double-count supply streams: The Determination does not apply to s 100 supplies or to prescriber bag provisions (1.06). A pharmacy operating or coordinating multiple supply pathways must ensure the correct legal basis is invoked. Supplying under the wrong mechanism (for example, using continued dispensing when s 100 arrangements apply) may create legal risk.

• PSA Guidelines timing and content left external: 2.10 includes a note that the PSA Guidelines provide guidance about when the information should be sent to the PBS prescriber. The Determination itself does not specify timing. Reliance on the PSA Guidelines therefore becomes necessary to determine timeliness, and any mismatch between practice and Guidelines could raise compliance issues.

• "Relevant pharmaceutical benefits" reference: 2.03(b) requires that the PBS prescriber prescribed the supply in at least one of the circumstances determined under paragraph 85(7)(b) of the Act. The Determination does not reproduce those circumstances; failure to check whether a particular prior prescription meets those criteria could result in reliance on an ineligible prior episode.

• Record content is prescriptive: 2.10(2) spells out the statements that must be recorded and prepared. Omission of any required statement in documentation is a technical non-compliance that could have significant consequences if a subsequent review is commenced.

• Schedule equivalent ambiguity: The Determination treats Schedule equivalents as pharmaceutical benefits for certain sections (2.01(3)(c)). But the Determination does not define in itself what counts as a Schedule equivalent; that definition is in Part VII. Users need to check the Act to ensure that substitutions or equivalents are legally permissible.

Those are the principal operational "gotchas" that arise from the Determination’s text and its reliance on external statutes and materials. Each one presents an identifiable compliance or interpretive risk that should be addressed by policy, training and documentation systems before relying on the continued-dispensing pathway.

To operate within the Determination’s framework, approved pharmacists and pharmacy operators should implement a sequence of checks, documentation steps and system controls aligned to the statutory conditions. Below is a compliance checklist and practical process mapped to the Determination’s sections. Every step references the instrument’s specific provisions.

1. Confirm the medicine is eligible (Schedule 1) and the permitted form/route

   • Check Schedule 1 to ensure the listed brand and the specified form and manner of administration match the requested supply (3.01(1)-(2)).
   • If a Schedule equivalent is being considered, confirm it meets the Part VII definition of Schedule equivalent relevant to this Determination (2.01(3)(c)).

2. Confirm patient identity and prior supply

   • Verify the person requesting supply is the same person who previously had a PBS-prescribed supply (2.01(3)(a); 2.03(a)).
   • Confirm that the last supply was under a valid Part VII prescription (2.06).

3. Confirm the PBS prescriber antecedent requirements

   • Establish that the PBS prescriber who most recently prescribed the medicine did so under at least one of the circumstances determined under paragraph 85(7)(b) of the Act (2.03(b)). Consult the Act to determine the relevant circumstances.

4. Assess practicability of obtaining a new prescription

   • Determine whether it is not practicable for the patient to obtain a prescription before they need the medicine (2.02). Use the PSA Guidelines as required by 2.01(2) to inform this assessment and record the basis for the practicability finding.

5. Assess stability of therapy and prior clinical review

   • Confirm the patient’s therapy is stable (2.04).
   • Confirm the patient has been taking the medicine regularly for an uninterrupted period and that, since the start of that period, the PBS prescriber assessed the patient and decided there was a need for ongoing treatment (2.05).
   • Use available medication history, clinical notes and the PSA Guidelines to support the assessment.

6. Check the 12-month limit for continued dispensing

   • Verify the patient has not been supplied the same pharmaceutical benefit under s 89A(1) within the prior 12 months (2.07). Maintain pharmacy systems to flag prior continued-dispensing events.

7. Confirm quantity to be supplied

   • Determine the quantity or number of units that was supplied under the last prescription and ensure it matches the quantity determined under paragraph 85A(2)(a) of the Act (2.09). Do not exceed that quantity.

8. Obtain the required signed declaration

   • Obtain a signed declaration from the patient or the patient’s agent acknowledging the supply is being made without a current Part VII prescription (2.08). Do not sign the declaration as the pharmacist. Retain the signed declaration with the record.

9. Record the factual basis and prepare notification

   • Record the information used to support the decision to supply (2.10(1)(a)).
   • Prepare the information to send to the PBS prescriber. At a minimum, the record and notification must include the three statements required in 2.10(2): a) that the pharmaceutical benefit supplied is a pharmaceutical benefit determined under paragraph 89A(3)(a) of the Act; b) that the conditions in sections 2.02 to 2.05 are satisfied; and c) that the approved pharmacist is satisfied the pharmaceutical benefit needs to be supplied to the person to facilitate continuity of treatment.
   • Follow the PSA Guidelines for guidance on when to send the notification to the PBS prescriber (2.10 note). Document the timing and manner of sending.

10. Consider PSA Guidelines explicitly and document how they were applied

    • Record that the PSA Guidelines were considered (2.01(2)) and document how they affected the practicability, stability and safety assessments. This demonstration of consideration is part of compliance.

11. Implement internal systems and training

    • Ensure information systems can: • Check and record prior supplies and continued-dispensing events for the 12-month limit (2.07); • Store signed declarations and the required supporting statements (2.08; 2.10); • Produce audit trails showing the pharmacist’s consideration of the PSA Guidelines (2.01(2)); • Identify Schedule 1 items and their permitted forms/administration routes (3.01).
    • Train staff to route requests appropriately and to ensure that only approved pharmacists make the satisfaction determinations (1.04(2); 2.01(1)).

12. Maintain evidentiary files for audits and reviews

    • Retain the contemporaneous record of the pharmacist’s decision-making and the notification that was sent to the PBS prescriber. These records will be central to any administrative review or professional disciplinary inquiry (2.10).

13. Coordinate with prescribers where appropriate

    • Although the Determination depends on a prior PBS prescriber’s assessment, consider establishing arrangements or local protocols with frequent prescribers to streamline notification expectations and to clarify post-supply follow-up by the prescriber (2.05; 2.10).

14. Check external provisions and update compliance

    • Because the Determination references paragraphs and definitions in the National Health Act (e.g. paragraph 85(7)(b), paragraph 85A(2)(a), Part VII definitions), ensure your compliance protocols are consistent with the current text of the Act and with any amendments to Schedule 1 or the PSA Guidelines. The Determination text itself does not include an amendment history (see Amendment history).

15. Avoid using this mechanism for excluded supplies

    • Do not rely on the Determination where s 100 special arrangements apply or where prescriber bag provisions govern the supply; those supply streams are explicitly excluded (1.06).

Adopting this checklist will align day-to-day dispensing practice with the Determination’s requirements. The central compliance priorities are (a) confirming eligibility against Schedule 1 and the Act; (b) documenting the pharmacist’s satisfaction of the practicability, stability and prior review conditions; (c) obtaining the signed declaration; (d) adhering to the quantity and frequency limits; and (e) preparing and sending the required notification to the PBS prescriber in accordance with the PSA Guidelines.