Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2026

The statutory architecture centres on three main concepts: (1) declaration of serious scarcity, (2) authorised substitution by pharmacists, and (3) layered permitted-circumstances tests combining item-specific and general conditions.

1. Declaration of serious scarcity. Section 5 effects a formal declaration under paragraph 30EK(1)(a) of the Therapeutic Goods Act 1989 that a serious scarcity exists across Australia in respect of the medicines listed in Schedule 1. The declaration is product‑specific: it names PRESOLOL 200 (labetalol hydrochloride 200 mg tablet bottle, reg. no. 56476) and PRESOLOL 100 (labetalol hydrochloride 100 mg tablet bottle, reg. no. 56475) in Schedule 1 column 2. The declaration is bounded in time by the instrument’s period in force (s 7).

2. Authorised substitution. Section 6, premised on paragraph 30EK(1)(b) of the Act, authorises pharmacists to dispense the substitutable medicine identified in Schedule 1 column 3 in substitution for the scarce medicine in column 2. The substitutable medicine is defined as either a registered medicine or a medicine that is the subject of an approval under section 19A of the Act, with the required active ingredient strength and manufactured in tablet form (Schedule 1 column 3). Substitution is expressly conditional: it is permitted only where both the item-specific circumstances in Schedule 1 column 5 and the general permitted circumstances in Schedule 2 are satisfied (s 6 and note).

3. Dose unit equivalence and administration detail. Schedule 1 column 4 sets out dose unit equivalences for the two items: for the 200 mg scarce product, two tablets of a 100 mg substitutable medicine are equivalent to one 200 mg tablet; for the 100 mg scarce product, half a 200 mg tablet is equivalent to one 100 mg tablet. Schedule 1 column 5 requires the pharmacist to advise the patient (or person acting on their behalf) of the number of dose units needed to achieve equivalence, to provide suitable instructions where cutting of a tablet is required, to explain differences between the scarce and substitutable medicines, and to provide or arrange suitable instructions for administering the substitutable medicine or to obtain those instructions from the prescriber or a general practitioner.

Complementary definitions are relevant. The instrument imports several terms from subsection 3(1) of the Act (medicine, pharmacist, registration number) and defines “prescriber” as a person authorised under state or territory law who prescribed the scarce medicine for the patient (s 4). It also adopts the TGO 101 meaning of “tablet” by reference (s 4).

Operational constraints are also central. The substitution is temporary (tied to the instrument period), product‑specific, dose‑equivalent by unit as specified, and procedurally constrained (patient advice, consent, record, prescriber notification, professional judgement). The general permitted circumstances require that the pharmacist does not have access to the scarce medicine and that the amount dispensed achieves an equivalent dosage regimen and duration (Schedule 2 items 2 and 5). The prescriber’s contemporary instruction that substitution is not permitted on the prescription operates as a veto (Schedule 2 item 3).

The instrument affects three cohorts directly and others indirectly.

Pharmacists (direct). The instrument places specific permissions and obligations on pharmacists. Under s 6 a pharmacist is the authorised actor permitted to dispense the substitutable medicine in substitution for the scarce medicine, but only where both the item‑specific and general permitted circumstances are satisfied. Schedule 2 explicitly requires the pharmacist to exercise professional judgement in determining patient suitability (item 4), to make a contemporaneous record when dispensing substitutable medicine in substitution (item 7), and to have an established procedure to notify the prescriber at the time of or as soon as practicable after dispensing (item 8). Schedule 1 column 5 further requires the pharmacist to advise the patient or their agent about dose-unit equivalence, tablet‑cutting instructions where relevant, differences between medicines, and administration instructions (Schedule 1 column 5(a)-(d)). Pharmacists are thus the decision-makers at point of sale and the primary compliance actors responsible for meeting the instrument’s procedural conditions.

Patients and persons acting on behalf of patients (direct). Patients are the recipients of substituted products and must provide consent for substitution (Schedule 2 item 6). The instrument also explicitly contemplates persons acting on behalf of the patient (Schedule 1 column 5 and Schedule 2 item 1) for the purposes of receiving advice, demonstrating evidence of a valid prescription, and consenting. Patients are entitled to be informed about the number of dose units, swallowing and cutting instructions where necessary, differences between the products, and the availability of administration instructions from the prescriber or general practitioner (Schedule 1 column 5).

Prescribers (direct). The instrument recognises the prescriber both in definition (s 4) and in the general permitted circumstances. A prescriber may indicate on the prescription that substitution is not permitted; the Schedule 2 framework treats such an indication as excluding substitution (item 3). The instrument also requires the pharmacist to notify the prescriber of any substitution made (Schedule 2 item 8). The prescriber’s legal authorisation is governed by state or territory law; the instrument does not change that authorisation but relies on it for the definition of who qualifies as a prescriber (s 4).

Manufacturers and suppliers (indirect). The scarcity declaration is product-specific and will affect supply‑chain participants who manufacture, import or distribute the named PRESOLOL products (Schedule 1 column 2). The instrument also authorises substitution with certain medicines that are either registered or subject to an approval under s 19A, which may bring into scope medicines temporarily approved under the Act’s approval mechanisms (Schedule 1 column 3); manufacturers or sponsors of such products may therefore see changes in dispensing volume and demand.

Payers and funders (indirect). The instrument does not address pricing, reimbursement or funding arrangements. Any financial impacts arising from substitution (cost differences, co-payments, or insurer reimbursement rules) are not set out in the instrument itself; these remain governed by existing pharmaceutical benefits, private insurer arrangements, or retail pricing practices outside the text of the instrument.

Regulators and enforcement agencies (indirect). The instrument is made under the Therapeutic Goods Act and therefore operates within the regulatory architecture that administers that Act. While the instrument prescribes specific duties, it does not itself create or specify enforcement mechanisms or penalties, leaving enforcement to whatever powers and remedies exist under the Act and other applicable laws.

Other health professionals (indirect). General practitioners and other prescribers may be asked to provide administration instructions for substituted medicines if the pharmacist does not supply them directly (Schedule 1 column 5(d)(ii)). Hospitals and emergency services might also be indirectly affected if their dispensing or stocking practices interact with the scarcity declaration.

Geographic scope and temporal limits. The declaration is "across the whole of Australia" (s 5). The authorisation applies only during the instrument’s life, from commencement on 28 January 2026 to 31 May 2026 (s 2(1), s 7). After that date the substitution authorisation ceases (s 8).

The instrument allocates specific duties and recognises certain rights for pharmacists, prescribers and patients. The requirements are concrete and largely procedural; compliance is achieved by meeting both the specific item requirements (Schedule 1 column 5) and the general permitted circumstances (Schedule 2).

Duties placed on pharmacists

• Verify evidence of prescription. Schedule 2 item 1 requires that the patient or person acting on their behalf has evidence of a valid prescription for the scarce medicine, unless some other law permits otherwise.
• Confirm lack of access to scarce medicine. Schedule 2 item 2 requires that substitution only occurs where the pharmacist does not have access to the scarce medicine.
• Check prescriber instructions. Schedule 2 item 3 requires the pharmacist to ensure the prescriber has not indicated on the prescription that substitution is not permitted; such an indication prevents substitution.
• Exercise professional judgement. Schedule 2 item 4 places an affirmative requirement on the pharmacist to determine whether the patient is suitable to receive the substitutable medicine.
• Ensure dosage equivalence. Schedule 2 item 5 requires that the amount of substitutable medicine dispensed results in an equivalent dosage regimen and duration to that prescribed for the scarce medicine; Schedule 1 column 4 supplies specific unit equivalences for the two listed items.
• Obtain patient consent. Schedule 2 item 6 requires the patient or their agent to consent to receiving the substitutable medicine.
• Recordkeeping. Schedule 2 item 7 requires the pharmacist to make a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing.
• Notification procedure. Schedule 2 item 8 requires the pharmacist to have an established procedure to notify the prescriber at the time of, or as soon as practicable after, dispensing the substitutable medicine.
• Provide information to patient. Schedule 1 column 5 imposes an obligation to advise the patient or person acting on their behalf about the number of dose units required to substitute, to give suitable instructions for cutting a tablet if necessary, to inform the patient of differences between scarce and substitutable medicines, and to provide suitable administration instructions or seek them from the prescriber or a general practitioner (Schedule 1 column 5(a)-(d)).

Rights and constraints of prescribers

• Veto on substitution. Schedule 2 item 3 recognises the prescriber’s ability to indicate on the prescription that substitution is not permitted; where that indication exists, substitution must not occur under the instrument. The instrument defines "prescriber" as someone authorised under state or territory law to prescribe and who prescribed the scarce medicine (s 4).

Patient rights and position

• Consent. Patients or their authorised agents must consent to substitution (Schedule 2 item 6).
• Information. Patients have the right to receive the specified information about dose-unit equivalence, cutting instructions if needed, product differences, and administration instructions (Schedule 1 column 5).

Pharmacist discretion and professional judgement

• The pharmacist holds decision-making authority at the point of dispensing. Schedule 2 item 4 requires the pharmacist to exercise their professional judgment on patient suitability; Schedule 2 item 7 and 8 further entrench professional procedures (record and notification). The instrument therefore channels discretion to pharmacists while requiring contemporaneous procedural steps and communications.

Limits on substitution

• Substitution is authorised only in the narrow circumstances set out: both the specific item requirements and general permitted circumstances must be met (s 6 and the Schedule 1 note). The dose‑equivalence rules in Schedule 1 column 4 construe acceptable forms of substitution (two 100 mg tablets for one 200 mg tablet; half a 200 mg tablet for one 100 mg tablet). Cutting of tablets is contemplated but only after provision of suitable instructions (Schedule 1 column 5(b)).

Temporal and product scope

• The authorisation applies to the listed PRESOLOL products at the specified registration numbers and to substitutable medicines meeting the Schedule 1 column 3 definition (Schedule 1 columns 2-3). It is time-limited to the instrument’s period (s 7).

Record and notification obligations

• The pharmacist must make a contemporaneous record of substitution (Schedule 2 item 7) and have a procedure to notify the prescriber (Schedule 2 item 8). These duties are explicit and operational.

The instrument does not specify payment, reimbursement or pricing duties, nor does it create new offences or civil penalties within its text. It prescribes actions and conditions and leaves enforcement and sanctioning to the broader legal framework of the Act and other applicable laws.

The instrument does not itself create specified criminal offences or administrative penalties. Its text prescribes permitted conduct (substitution in defined circumstances) and prescribes procedural duties for pharmacists (information to patient, recordkeeping and notification), but it contains no express enforcement provisions, fines or sanctioning clauses within the instrument.

Legal basis and enforcement context

• The instrument is made under section 30EK of the Therapeutic Goods Act 1989 (s 3). That provision authorises the Minister to declare serious scarcity and to permit substitution by pharmacists under specified conditions; the instrument implements those powers. Any enforcement or regulatory action for non-compliance with duties imposed by this instrument will therefore depend on the broader enforcement mechanisms available under the Therapeutic Goods Act and potentially on state and territory laws regulating pharmacists and prescribers. The instrument itself does not specify which authority enforces compliance or what penalties may attach to contraventions of the instrument’s requirements.

Operational compliance triggers

• The instrument creates clear, contemporaneous duties that are capable of being audited or reviewed: the pharmacist must make a record at the time of dispensing (Schedule 2 item 7), have an established procedure to notify the prescriber (Schedule 2 item 8), and provide specified information to the patient (Schedule 1 column 5). These documentary and procedural requirements are the principal means by which compliance would be demonstrated or assessed.

Risk of professional accountability

• While the instrument does not create internal penalties, non-compliance could engage existing professional or regulatory accountability mechanisms external to the instrument. Pharmacists are required to exercise professional judgement (Schedule 2 item 4) and to meet the specified duties; failure to do so could, depending on other legal or regulatory frameworks, expose a pharmacist to professional discipline, civil liability, or regulatory action under the general powers of the Therapeutic Goods Act or under state/territory pharmacy regulation. The instrument itself does not list or quantify these outcomes.

Absence of criminal or civil enforcement detail

• Because the instrument is silent about penalties, it does not prescribe whether breaches amount to offences under the Act, nor does it provide an administrative penalty regime. Enforcement therefore depends on the residual or express powers available elsewhere in the Act or other applicable laws; the instrument provides statutory authorisation for substitution but not an enforcement schedule.

Temporal enforcement window

• Enforcement and compliance obligations are relevant only during the instrument’s life, which runs from commencement on 28 January 2026 until 31 May 2026 (s 2(1) and s 7). After the instrument is repealed at the start of 1 June 2026 (s 8), the special substitution permissions and the instrument’s procedural duties cease to operate.

Practical consequences for enforcement

• The instrument’s most readily enforceable obligations are documentary: the contemporaneous record (Schedule 2 item 7) and any retained evidence that the pharmacist notified the prescriber pursuant to an established procedure (Schedule 2 item 8). Those items create an auditable trail a regulator could inspect if they sought to determine whether substitution had been carried out lawfully under this instrument.

This instrument sits within the statutory architecture of the Therapeutic Goods Act 1989 and interacts by reference with other statutory provisions and state/territory authorisations.

Therapeutic Goods Act 1989

• Source authority. The instrument is made under section 30EK of the Therapeutic Goods Act 1989 (s 3). Section 5 explicitly declares a serious scarcity for purposes of paragraph 30EK(1)(a), and section 6 implements paragraph 30EK(1)(b) by specifying the authorised substitutions and conditions.
• Section 19A approvals. Schedule 1 column 3 allows the substitutable medicine to be either a registered medicine or a medicine that is the subject of an approval under section 19A of the Act. That explicit cross-reference allows medicines not yet registered but then approved under s 19A to be used as substitutes under this instrument; the instrument therefore leverages the Act’s separate approval mechanisms.

State and territory prescribing laws

• Definition of prescriber. The instrument defines “prescriber” as a person authorised under a law of a State or Territory to prescribe medicine and who prescribed the scarce medicine for the patient (s 4). That definition embeds state and territory regulatory boundaries into the instrument: who counts as a prescriber is governed by state/territory law. The instrument therefore interfaces with state/territory professional licencing and scope-of-practice rules.

Other Commonwealth legislative instruments

• TGO 101. The instrument adopts the term “tablet” using the meaning in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 (s 4 note and s 4). That tie-in means that technical requirements or definitions in TGO 101 , for example, what counts as a tablet , will feed into the interpretation of what products qualify as substitutable medicines.

Prescription law and dispensing rules

• Evidence of a valid prescription. Schedule 2 item 1 requires evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law. That carve-out recognises that other laws or arrangements may permit supply without the standard prescription requirement; the instrument does not displace those laws.

Professional regulation

• Professional judgement. Schedule 2 item 4 requires pharmacists to exercise professional judgement when determining suitability for substitution; this links the instrument to the professional standards and regulatory obligations that govern pharmacists. Any professional misconduct or negligence issues that arise in relation to substitution will be examined against those broader professional standards and regulatory frameworks, not the instrument alone.

Funding and reimbursement frameworks

• The instrument is silent on funding and pricing. It does not alter Pharmaceutical Benefits Scheme (PBS) listings, co-payment rules, insurer reimbursements or other funding arrangements. Those interactions will be governed by the relevant existing schemes and are outside this instrument’s text.

Criminal, civil and administrative liability frameworks

• The instrument does not create criminal offences or administrative penalties within its text. Any liability consequences for acting outside the instrument’s permissions will depend on the broader enforcement provisions of the Therapeutic Goods Act, the law governing registered health professionals in states and territories, or applicable civil law doctrines.

Temporal interaction

• Time-limited effect. The substitution authorisation operates only while the instrument is in force, from 28 January 2026 to 31 May 2026 (s 2(1), s 7). Post-repeal, the Act and other laws will continue to regulate supply and substitution outside this temporary authorisation.

Interpretive cross-references

• Because the instrument repeatedly cross-references the Act and TGO 101 and imports definitions from subsection 3(1) of the Act (s 4 note), any interpretation of the instrument will take those sources into account. The instrument both relies on and is subordinate to the Act and to other legislative instruments and state/territory laws it references.

This instrument, as published in the text provided, appears to be an original, time-limited instrument with no amendments recorded within the instrument itself. The instrument contains a commencement table stating that the whole instrument commenced on 28 January 2026 (s 2(1)). It further provides that it remains in force until 31 May 2026 (s 7) and is repealed at the start of 1 June 2026 unless repealed earlier (s 8).

Specific amendment-history features in the instrument

• Commencement note. Section 2 contains a commencement table and a note that the table relates only to the provisions as originally made and will not be amended to deal with later amendments. This indicates the instrument was intended as an original instrument rather than an amending instrument.
• Temporal limit and automatic repeal. Sections 7 and 8 impose a defined end-date and automatic repeal at the start of 1 June 2026, marking the instrument as temporary and self-terminating.
• No recorded amendments within the instrument. The text does not include any later amendment entries, schedules or notes indicating subsequent variation, revocation or replacement.

Practical consequence for tracking amendments

• Because the instrument itself states the commencement and the automatic repeal dates, any amendments or replacement instruments would need to be separately made and published. The instrument’s s 2 note emphasises that the commencement table will not be updated to reflect later amendments of the instrument, indicating that amendment history for this instrument, if any, would be recorded outside the original instrument text (for example, in the Federal Register of Legislation where legislative instruments are published).

What the instrument does not show

• There is no explicit amendment record, no history of earlier versions, and no in-text note of any prior instruments varied or repealed by this instrument. The Schedule 1 "Note: See sections 5 and 6" and Schedule 2 "Note: See section 6" indicate internal cross-references only. The instrument therefore presents as a single, self-contained, time-limited instrument created and commenced on 28 January 2026.

The instrument text contains no reference to litigation, judicial decisions, or administrative determinations concerning its validity, application or interpretation. There are no cases, disputes, or litigation outcomes recorded within the instrument itself.

Consequences of absence of litigation history in the instrument

• Because the instrument does not record any judicial or tribunal proceedings, there is no source-provided jurisprudence that interprets contested points such as the scope of pharmacist discretion, the meaning of “evidence of a valid prescription” in particular operational settings, or the interplay with state prescription laws. Any future disputes about the instrument’s operation would be resolved under general administrative and judicial processes, but the instrument contains no guidance or prior case law.

How to approach potential disputes

• In the absence of instrument-specific litigation history, interpretation and enforcement questions would be resolved by reference to the instrument’s text, the Therapeutic Goods Act 1989 (including the provisions under which the instrument was made), any relevant secondary approvals (such as section 19A approvals), and applicable state or territory professional regulation. The instrument’s clear procedural duties (contemporaneous record, notification, patient advice, consent, professional judgement) create discrete factual questions that an adjudicator would likely evaluate on documentary and evidentiary records.

Limitations on using the instrument as precedent

• Because it is a time-limited, product-specific instrument with no recorded litigation history, the instrument is primarily an operational authorisation rather than a source of legal doctrine developed through litigation. Any binding legal interpretations will arise only if and when a court or tribunal considers the instrument in the context of a dispute.

The instrument is tightly drafted and administratively specific. Several practical and legal friction points arise from the instrument’s structure and the duties it imposes.

Dual-condition requirement

• Substitution is only permitted where both the specific permitted circumstances for the Schedule 1 item and the general permitted circumstances in Schedule 2 exist (s 6 and Schedule 1 note). Failure to satisfy either set of conditions invalidates the authorisation. In practice this requires parallel checks: item‑specific counselling steps plus the general predicates such as lack of access to the scarce medicine, valid prescription evidence, prescriber not vetoing substitution, patient consent, equivalent regimen, recordmaking and prescriber notification.

Dose-unit handling and tablet cutting

• Schedule 1 sets dose equivalences that require either doubling tablets (two 100 mg tablets for one 200 mg tablet) or halving tablets (half of a 200 mg tablet for one 100 mg tablet). Where cutting is necessary, Schedule 1 column 5(b) obliges the pharmacist to provide “suitable instructions for cutting a tablet of the substitutable medicine.” Practical complications arise where a substitutable tablet is not scored or where tablet formulation makes accurate halving impractical. The instrument contemplates cutting but places the duty on the pharmacist to provide suitable instructions; it does not specify technical standards for accuracy or stability of half-tablet dosing.

Prescriber’s on-prescription veto

• Schedule 2 item 3 treats a prescriber’s notation that substitution is not permitted on the prescription as a bar to substitution. In practice, pharmacists must inspect prescriptions carefully and be alert to such notations. Ambiguities on the prescription (e.g., unclear handwriting) could create a compliance risk if a pharmacist misinterprets the prescriber’s intention. The instrument requires that substitution not occur in that case, so the pharmacist must resolve ambiguity before substitution.

Definition of prescriber tied to state/territory law

• The instrument defines “prescriber” by reference to state/territory authorisation (s 4). That means an individual who is a prescriber in one jurisdiction but not in another may not be a prescriber for the instrument’s purposes. In multi-jurisdictional contexts (telehealth prescribing across borders, or prescriptions issued by prescribers licensed in different states), pharmacists must ensure the prescriber meets the instrument’s definition.

Evidence of valid prescription caveat

• Schedule 2 item 1 requires evidence of a valid prescription “unless otherwise permitted by law.” That carve-out recognises other legal provisions may permit supply without the same evidence. Pharmacists must therefore be aware of other applicable legal permissions, but the instrument does not specify what those are; reliance on any other law must be informed by separate legal advice or policy guidance outside the instrument.

Recordkeeping, notification and audit trail

• The instrument requires contemporaneous recordmaking (Schedule 2 item 7) and a procedure to notify the prescriber (Schedule 2 item 8). Absent standard templates or prescribed form, pharmacies must implement internal procedures to meet these requirements. Failure to make contemporaneous records or to notify may expose the pharmacist to scrutiny under the broader regulatory framework.

No price, reimbursement or supply‑chain direction

• The instrument does not address pricing, reimbursement or PBS status. Substitution may change patient costs or insurer payments, but the instrument is silent. Pharmacists and patients must resolve any cost implications through normal pricing and reimbursement mechanisms; the instrument imposes no obligation to subsidise price differences.

Temporal limit and stock management

• The instrument is only in force until 31 May 2026 (s 7). Pharmacists and supply chain managers should track the instrument period and plan for the reversion to normal regulatory conditions after repeal on 1 June 2026 (s 8). Inventory, dispensing protocols, and communication to prescribers and patients must account for the time-limited nature of the authorisation.

Ambiguity about what counts as “not having access”

• Schedule 2 item 2 requires substitution only where the pharmacist “does not have access to the scarce medicine.” The instrument does not define “access” (e.g., on-shelf stock at the pharmacy, availability from a supplier within a certain time window, or access via home delivery). Pharmacists must form and document a reasonable operational interpretation consistent with their professional judgement.

Substitutable medicine scope

• Schedule 1 column 3 permits the substitutable medicine to be either a registered medicine or a medicine subject to an approval under s 19A of the Act. Pharmacists must verify that the specific alternative product satisfies that description; this may require checking registration details or approvals. The Schedule lists registration numbers for the scarce products (56476 and 56475) but not for the substitutable alternatives, so verification falls to the pharmacist or sponsor.

Prescriber instruction for administration

• Schedule 1 column 5(d) allows the pharmacist either to provide suitable instructions for administering the substitutable medicine or to obtain those instructions from the prescriber or a general practitioner. If the pharmacist chooses to seek instructions, there may be practical delays or inability to contact the prescriber in a timely manner. The instrument requires either that the pharmacist supply suitable instructions or that they obtain them from a prescriber or GP; operational readiness and workflows must reflect this contingency.

This section spells out practical steps a dispensing pharmacist or a pharmacy operator should follow to comply with the instrument. The compliance pathway is sequential and must satisfy both the item-specific conditions in Schedule 1 column 5 and the general permitted circumstances in Schedule 2 items 1-8.

1. Confirm instrument applicability and time window

• Verify the instrument is in force: confirm the date (commencement 28 January 2026; in force until 31 May 2026, s 2(1) and s 7). Do not rely on substitution authorisation after 31 May 2026.

2. Identify scarce medicine and appropriate substitutable medicine

• Check whether the prescription is for one of the Schedule 1 scarce medicines: PRESOLOL 200 labetalol hydrochloride 200 mg tablet bottle (reg. no. 56476) or PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottle (reg. no. 56475) (Schedule 1 column 2).
• Confirm the substitutable medicine meets Schedule 1 column 3 criteria: it must be either a registered medicine or a medicine that is the subject of an approval under section 19A of the Act, containing the specified labetalol strength as the only active ingredient and manufactured as a tablet. Verify product registration or approval status before dispensing.

3. Ensure the general permitted circumstances are present (Schedule 2 items 1-8)

• Evidence of valid prescription. Obtain and retain evidence of a valid prescription for the scarce medicine unless another law permits substitution without such evidence (Schedule 2 item 1).
• Confirm lack of access. Establish and document that the pharmacy “does not have access to the scarce medicine” (Schedule 2 item 2). Adopt an internal definition of “does not have access” (for example, no on-hand stock and no immediate supplier availability) and record the factual basis.
• Check for prescriber prohibition. Examine the prescription to ensure the prescriber has not indicated that substitution is not permitted (Schedule 2 item 3). If the prescriber has indicated substitution is not permitted, do not substitute.
• Exercise professional judgement. Apply professional clinical judgement to determine whether the patient is suitable to receive the substitutable medicine (Schedule 2 item 4). Consider patient history, allergies, concomitant medication and clinical context.
• Confirm dosage equivalence. Ensure the amount of substitutable medicine dispensed would result in an equivalent dosage regimen and duration to that prescribed (Schedule 2 item 5). Use Schedule 1 column 4 dose-unit equivalences: for substituting a 200 mg scarce product with 100 mg tablets, dispense two 100 mg tablets per prescribed 200 mg dose; where substituting a 100 mg scarce product with 200 mg tablets, supply a half tablet per 100 mg dose.
• Obtain patient consent. Secure the patient’s or authorised person’s consent to receive the substitutable medicine and document that consent (Schedule 2 item 6).

4. Comply with item-specific advice duties (Schedule 1 column 5)

• Advise the patient or person acting on their behalf of the number of dose units required to substitute for the prescribed dose of the scarce medicine, explicitly referencing the dose unit equivalence in Schedule 1 column 4.
• Provide suitable instructions for cutting a tablet where half‑tablet dosing is required. If tablets are to be halved, ensure the patient is given clear, practical instructions about tablet cutting and any limitations of the tablet design (Schedule 1 column 5(b)).
• Explain differences between the scarce and substitutable medicines, including strength format (number of tablets or half-tablet), possible formulation differences, and any counselling points relevant to the substitutable product (Schedule 1 column 5(c)).
• Provide suitable instructions for administering the substitutable medicine, or, if the pharmacist cannot provide such instructions, obtain them from the prescriber or a general practitioner (Schedule 1 column 5(d)).

5. Make and retain contemporaneous records (Schedule 2 item 7)

• At the time of dispensing, make a record that the substitutable medicine was dispensed in substitution for the scarce medicine. The instrument does not prescribe a form, but the record should minimally identify the patient, the scarce medicine prescribed, the substitutable medicine supplied (including batch or registration/approval identifier where available), the dose equivalence applied, the date and time of dispensing, and confirmation that the patient consented and received the required information.

6. Notify the prescriber (Schedule 2 item 8)

• Use the pharmacy’s established procedure to notify the prescriber at the time of, or as soon as practicable after, dispensing the substitutable medicine. Ensure the procedure documents who is notified, the information conveyed (including dose equivalence and the reason for substitution), and the timestamp of the notification.

7. Establish and document pharmacy procedures

• Implement a written internal protocol for substitution under this instrument that addresses: verification of product registration/approval status; criteria for "no access" to scarce medicine; screening of prescriptions for prescriber prohibition; clinical suitability checklist; script for patient counselling (including cutting instructions); consent recording; contemporaneous record template; prescriber notification template and workflow; and storage/retention requirements for documentation.

8. Training and operational readiness

• Train pharmacists and pharmacy staff on the instrument’s requirements: the specific Schedule 1 dose equivalences (two 100 mg tablets for one 200 mg tablet; half a 200 mg tablet for one 100 mg tablet), the patient-information obligations, recordkeeping and notification practices, and how to exercise and document professional judgement. Ensure staff know how to verify medicine registration or s 19A approval status.

9. Stock and supply considerations

• Track inventory and supplier availability of both scarce and substitutable medicines. Because substitution is authorised only where the pharmacist lacks access to the scarce medicine (Schedule 2 item 2), pharmacies should document current stock status and supplier enquiries as part of their “no access” determination.

10. Contingency planning

• If unable to contact the prescriber to obtain administration instructions when required by Schedule 1 column 5(d)(ii), the pharmacist should either (a) provide suitable administration instructions themselves if competent to do so, or (b) delay substitution until instructions are obtained, mindful of the patient’s clinical needs and the requirement that substitution only occur where the pharmacist exercises professional judgement that the patient is suitable (Schedule 2 item 4).

11. Privacy and record retention

• Ensure records created at dispensing comply with privacy and record retention obligations under applicable laws. The instrument requires contemporaneous recordmaking but does not specify retention periods; pharmacies should align retention with broader legal and professional requirements.

12. End-of-instrument actions

• Update protocols for cessation of substitution after the instrument’s repeal on 1 June 2026 (s 8). Cease substitution authorisations once the instrument is no longer in force and communicate the change to staff, prescribers and patients as necessary.

Summary checklist (operational)

• Confirm instrument is in force and item applies.
• Verify prescriber status and check prescription for “do not substitute” notation.
• Confirm pharmacy lacks access to scarce medicine.
• Confirm substitutable product is registered or s 19A-approved and matches tablet form and active ingredient criteria.
• Apply dose equivalence (Schedule 1 column 4) and determine whether cutting is necessary.
• Provide patient information (dose units, cutting instructions where relevant, differences, administration instructions).
• Obtain and document patient consent.
• Make contemporaneous record of substitution.
• Notify prescriber per established procedure.
• Retain records and follow internal audit and training procedures.

Following these steps aligns with the instrument’s text and creates the evidentiary trail necessary to demonstrate lawful substitution under the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2026.