Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025

The instrument revolves around several discrete legal and practical concepts, each defined or invoked in the instrument text.

Declaration of serious scarcity (s 5 and Schedule 1)

• A statutory scarcity is declared for one specific registered medicine: CATAPRES 150 (clonidine hydrochloride 150 microgram tablet blister pack), registration number 78376 (Schedule 1, column 2). The scarcity is declared "across the whole of Australia" (s 5).

Permitted substitution (s 6 and Schedule 1)

• For the scarce medicine, the instrument identifies specific substitutable medicines by product name and registration number (Schedule 1, column 3). The substitution permitted is not open-ended; it is limited to those listed products.
• Dose unit equivalence is set out in Schedule 1, column 4: one and a half tablets of the 100 microgram substitutable products equals one tablet of the scarce 150 microgram product. That numerical equivalence is the dosing bridge that enables substitution.

Conditions for substitution (Schedule 1 column 5 and Schedule 2)

• The instrument sets two concurrent layers of conditions: specific permitted circumstances (Schedule 1, column 5) and general permitted circumstances (Schedule 2). Both must be satisfied for substitution to be lawful (note to s 6).
• Specific permitted circumstances require particular patient-facing counselling elements: advising the patient or their agent of the number of dose units to take, providing suitable cutting instructions where necessary, and informing the patient of differences between the medicines (Schedule 1, column 5(a)-(c)).
• General permitted circumstances enumerate eight procedural and professional prerequisites: valid prescription (unless law permits otherwise), lack of access to the scarce medicine, no prescriber prohibition on substitution, pharmacist professional judgement regarding suitability, dispensed quantity that yields equivalent dosage regimen and duration, patient consent, contemporaneous record of substitution, and an established procedure to notify the prescriber at or soon after dispensing (Schedule 2, items 1-8).

Scope and temporal limits (s 5, s 7, s 8)

• The geographical scope is national (s 5).
• The instrument is time-limited: it commences on 22 December 2025 (s 2) and remains in force until 28 April 2026 (s 7), with repeal at the start of 29 April 2026 (s 8).

Authority and definitions (s 3, s 4)

• The instrument is made under s 30EK of the Therapeutic Goods Act 1989 (s 3).
• Key terms are defined by reference to the Act (s 4), including "medicine", "pharmacist", and "registration number", and the instrument defines "prescriber", "scarce medicine", "substitutable medicine", and adopts the TGO 101 definition of "tablet" (s 4).

Process emphasis rather than substance change

• The instrument does not change the registered therapeutic indications or the regulatory status of any product. It allows temporary substitution under described conditions; it does not alter registration numbers, labelling or manufacturing approvals in this instrument text.

Directly affected persons and entities

• Pharmacists: The instrument vests the operational decision to substitute in the pharmacist, contingent on meeting defined conditions (s 6; Schedule 2 items 2, 4, 7, 8). Pharmacists must exercise professional judgement that the patient is suitable to receive the substitutable medicine (Schedule 2, item 4) and must make contemporaneous records when dispensing in substitution (Schedule 2, item 7). They must also have an established procedure to notify the prescriber at the time of, or as soon as practical after, dispensing (Schedule 2, item 8). The specific permitted circumstances require pharmacists to advise patients on dose units, cutting instructions and differences between products (Schedule 1, column 5).
• Prescribers: The instrument recognises the prescriber’s authority: a "prescriber" is someone authorised under State or Territory law to prescribe (s 4). A prescriber retains the right to indicate on a prescription that substitution is not permitted; where the prescriber has indicated substitution is not permitted, substitution is not allowed under the instrument (Schedule 2, item 3). The instrument also requires pharmacists to notify prescribers when they substitute (Schedule 2, item 8).
• Patients and persons acting on their behalf: Substitution is conditional on patient consent (Schedule 2, item 6), and the pharmacist must provide specified information to the patient or their agent (Schedule 1, column 5). Patients are required to have evidence of a valid prescription for the scarce medicine, unless another law permits otherwise (Schedule 2, item 1).
• Sponsors/manufacturers: The instrument names both the scarce product and permitted substitutes by registration number and product name (Schedule 1, columns 2-3). While the instrument does not directly regulate sponsors’ behaviour, it may affect dispensing patterns for the sponsors of the substitutable medicines (Schedule 1, column 3) and could have commercial effects during the declaration period.

Indirectly affected parties and systems

• State and Territory regulators and pharmacy boards: The instrument assumes prescribers authorised under State or Territory laws (s 4) and co-exists with other legal regimes, for example where other laws may permit dispensing without a prescription (Schedule 2, item 1). State pharmacy practice rules, professional standards, and indemnity arrangements may govern how pharmacists satisfy the professional-judgement and counselling obligations noted in Schedule 2 and Schedule 1.
• Health services and dispensing software providers: Pharmacists are required to make a record at the time of dispensing (Schedule 2, item 7) and to notify prescribers (Schedule 2, item 8); existing dispensing software and practice workflows will need to operationalise these steps.
• Patients reliant on dosing convenience or specific formulations: The dose unit equivalence set in Schedule 1, column 4 (one and a half 100 microgram tablets equivalent to one 150 microgram tablet) changes the unit-based dosing for patients. This can affect pill burden, the need to cut tablets, and counselling requirements.

What the instrument does not directly affect

• Registration status and regulatory approvals: The instrument does not change registrations or labelling directly; it permits substitution between already registered products identified by registration number (Schedule 1, columns 2-3).
• Pricing and reimbursement: The instrument is silent about pricing, pharmacy remuneration or subsidy arrangements. It does not specify how costs are to be allocated between patient, insurer, or government.

Geographical and temporal boundary

• The declaration is national (s 5) and temporary (s 7-8). Any effects, including increased dispensing of listed substitutes, are constrained to the instrument’s active period between 22 December 2025 and 28 April 2026 inclusive (s 2, s 7, s 8).

Duties placed on pharmacists

• Confirm evidence of valid prescription: The pharmacist must ensure the patient, or the person acting on the patient’s behalf, has evidence of a valid prescription for the scarce medicine, "unless otherwise permitted by law" (Schedule 2, item 1). The instrument therefore requires a prescription evidencing the prescriber’s original intention for the scarce product except where another law provides for dispensing without such evidence.
• Ensure lack of stock of scarce medicine: Substitution is only permitted where the pharmacist "does not have access to the scarce medicine" (Schedule 2, item 2). This embeds an availability gate on substitution.
• Observe prescriber’s prohibition: The pharmacist must check that the prescriber has not indicated on the prescription that substitution is not permitted; substitution is disallowed if the prescriber has so indicated (Schedule 2, item 3).
• Exercise professional judgement: The pharmacist must make a contemporaneous professional suitability assessment determining that the patient is suitable to receive the substitutable medicine (Schedule 2, item 4).
• Dispense an equivalent quantity: The pharmacist must ensure the amount of substitutable medicine dispensed results in an "equivalent dosage regimen and duration" to that prescribed for the scarce medicine (Schedule 2, item 5). The instrument gives a specific unit conversion (Schedule 1, column 4) to assist this calculation.
• Obtain patient consent: The patient, or their agent, must consent to receiving the substitutable medicine (Schedule 2, item 6).
• Make a record at time of dispensing: The pharmacist must make a record of dispensing the substitutable medicine in substitution for the scarce medicine at the time of dispensing (Schedule 2, item 7).
• Notify prescriber: The pharmacist must have an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing (Schedule 2, item 8).
• Provide patient information: Under the specific permitted circumstances in Schedule 1, column 5, the pharmacist must advise the patient (or their agent) of: the number of dose units to take in substitution (Schedule 1, column 5(a)); suitable instructions for cutting a tablet where required to obtain correct dose (Schedule 1, column 5(b)); and the differences between the scarce and substitutable medicines (Schedule 1, column 5(c)).

Rights and constraints of prescribers

• Right to prohibit substitution: The prescriber may indicate on the prescription that substitution is not permitted and the pharmacist must respect that direction (Schedule 2, item 3).
• Right to receive notification: The instrument requires pharmacists to notify the prescriber of substitution at or soon after the time of dispensing (Schedule 2, item 8), which supports prescriber continuity of care.

Patient rights and obligations

• Consent: Substitution requires patient consent (Schedule 2, item 6).
• Information: Patients must be informed of dose conversion, cutting instructions where necessary, and differences between medicines (Schedule 1, column 5).
• Evidence of prescription: Patients are expected to present evidence of a valid prescription for the scarce medicine unless other law permits alternative arrangements (Schedule 2, item 1).

Administrative and definitional duties

• Use of prescribed definitions: The instrument relies on Act definitions for "medicine", "pharmacist" and "registration number" (s 4), so compliance requires interpreting those terms in accordance with the Act.
• Use of TGO 101 for "tablet": The instrument adopts TGO 101’s definition of "tablet" (s 4), which is relevant to cutting/splitting obligations and any technical issues about tablet form.

Constraints and limits

• Substitution only where both sets of circumstances exist: The instrument unambiguously conditions substitution on both the specific and general permitted circumstances being satisfied (note to s 6). If either layer is unmet, substitution is not permitted.

Duties not specified in the instrument

• The instrument does not specify disciplinary sanctions, criminal penalties, or civil liability frameworks for failure to comply. It also does not specify record retention periods, notification content, or the precise form of cutting instructions. These matters remain matters for professional regulation, institutional policy, or other law to the extent they apply.

Instrument text on penalties and enforcement

• The instrument contains no express penalties, infringement notices, or enforcement provisions within its own text. It does not prescribe fines, suspension mechanisms, or administrative sanctions for non-compliance. The instrument is made under section 30EK of the Therapeutic Goods Act 1989 (s 3), but the instrument itself does not set out enforcement processes or penalties.

Implications of silence

• Because the instrument is silent about penalties, enforcement and remediation fall to the general legal and regulatory environment that governs pharmacists and therapeutic goods. The instrument imposes procedural and professional duties (Schedule 1 and Schedule 2), but any consequences for failing to meet those duties will depend on:
  • The enforcement mechanisms available under the Therapeutic Goods Act 1989 (not reproduced in this instrument text), including any powers the Act gives to regulators in relation to instruments made under s 30EK.
  • Professional standards and disciplinary regimes administered by State and Territory pharmacy boards or similar regulators, which govern professional conduct, record keeping and counselling obligations for pharmacists.
  • Civil liability law where a claim might arise out of negligent dispensing, failure to advise correctly, or incorrect dosing being provided, subject to the ordinary operation of tort and contract law (these legal regimes are not modified by the instrument text).

Practical enforcement mechanisms implied by the instrument’s requirements

• Record making at the time of dispensing (Schedule 2, item 7) and the requirement to notify prescribers (Schedule 2, item 8) create documentary trails that can be used by regulators or in any dispute about compliance. The contemporaneous record obligation increases detectability of substitutions.
• The professional-judgement requirement (Schedule 2, item 4) embeds an expectation that pharmacists will follow professional standards and supports oversight by professional regulators. Non-compliance with these duties could therefore attract professional discipline even though the instrument itself does not specify such penalties.

No express immunity or indemnity

• The instrument does not grant pharmacists immunity from liability for substitution, nor does it provide an indemnity on behalf of pharmacists. It does not alter product registrations or labelling nor does it purport to change statutory liability regimes within the text.

Time-limited nature and enforcement window

• The instrument’s temporary duration (s 7-8) confines any enforcement interest to the active period. After repeal, the specific substitution authority ends; however, records and actions taken while the instrument was in force could still be relevant to subsequent regulatory or civil proceedings.

Statutory anchoring and cross-references

• Authority: The instrument is made under section 30EK of the Therapeutic Goods Act 1989 (s 3). It therefore sits within the framework of the Therapeutic Goods Act and is subordinate to that Act.
• Definitions: Several expressions used in the instrument are defined by subsection 3(1) of the Act (s 4). The instrument also adopts the definition of "tablet" from the Therapeutic Goods (Standards for Tablets, Capsules and Pills) (TGO 101) Order 2019 (s 4). Compliance therefore requires reading the instrument together with definitions and possibly other operative provisions from the Act and TGO 101.

Interaction with State and Territory prescribing and pharmacy law

• The instrument defines "prescriber" as someone authorised under a law of a State or Territory to prescribe (s 4). The instrument therefore relies on State and Territory regimes to identify who qualifies to prescribe.
• Schedule 2, item 1 conditions substitution on the patient having evidence of a valid prescription "unless otherwise permitted by law". That phrase expressly recognises that other statutory or regulatory rules (State, Territory or Commonwealth) may permit dispensing without a prescription or permit different evidentiary standards. The instrument therefore does not purport to displace other laws on these evidentiary matters.

Professional regulation and standards

• The pharmacist duties in Schedule 2 (exercise of professional judgement, record-making and notification) overlap with the regulatory and disciplinary remit of State and Territory pharmacy boards. The instrument does not specify disciplinary procedures but creates procedural expectations that are likely to be enforced through professional regulation rather than by this instrument itself.

Regulatory scope over products

• The instrument permits substitution between specific registered medicines identified by registration number (Schedule 1, columns 2-3). It does not change registration numbers or product approvals. Any issue concerning product labelling, manufacturing compliance, or variations to registration remains governed by the usual regulatory pathways under the Therapeutic Goods Act and associated instruments, not by this instrument.

Gaps and delegation

• The instrument prescribes what pharmacists must do but leaves technical and operational detail to other regulatory instruments, professional codes and practice. For example, it requires cutting instructions where cutting is required (Schedule 1, column 5(b)) but does not say who must devise the cutting instructions or how detailed they must be. That gap means the content and standard of such instructions will be influenced by professional guidance, State law and entity-level procedures rather than by the instrument itself.

Interaction with Commonwealth subsidy and pricing arrangements

• The instrument is silent on pricing, subsidies, or reimbursement. Any interaction with Pharmaceutical Benefits Scheme arrangements, private insurance or consumer payments is not addressed in the instrument and would remain governed by those schemes and contracts.

Temporal interaction

• The instrument is temporary (s 7-8). After repeal, its substitution permissions lapse. Parties relying on this authority must therefore be mindful of the instrument’s start and end dates (s 2, s 7-8). Any ongoing authorities or exceptions needed beyond the repeal date would require further instruments, legislative change, or other legal pathways.

Original instrument and commencement

• The instrument as presented is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025, dated 18 December 2025 and signed by the delegate (text header and signature). It commenced on 22 December 2025 (s 2). The instrument text includes a commencement table that lists "The whole of this instrument" as commencing 22 December 2025 (section 2).

No amendments recorded in the instrument text

• The instrument does not contain any textual amendments or schedules indicating prior amendments. Section 2 contains the standard note that the commencement table relates only to the instrument "as originally made" and will not be amended to deal with later amendments. The instrument does not include any subsequent amending provisions or consolidated amendments.

Temporal limitation and automatic repeal

• The instrument contains a built-in expiry: it remains in force until 28 April 2026 (s 7) and is repealed at the start of 29 April 2026 unless earlier repealed (s 8). That built-in expiry is an express part of the instrument’s lifecycle.

How to track amendments outside the instrument text

• The instrument’s text does not list amendments or historical versions beyond the original. Any future or past amendments would be recorded on the Federal Register of Legislation or in later instruments. The instrument itself warns that the commencement table "relates only to the provisions of this instrument as originally made" and that published versions may edit or insert information in column 3 of that table (s 2(2)). The instrument therefore anticipates external publication mechanics for version control, but contains no internal amendment history.

Implication for practitioners

• As of the instrument text provided, there is a single original instrument with no amendments. Practitioners needing to know whether a later instrument has modified these provisions must consult the official legislative register or subsequent instruments made under section 30EK of the Act.

Instrument text on litigation

• The instrument contains no references to litigation, court challenges, or judicial determinations. It is a statutory instrument in itself and does not record any case law or disputes.

No recorded cases or judicial interpretation in the instrument

• There are no cases named, cited or summarised in the instrument text. The instrument does not contain a litigation history or references to prior judicial treatment.

Practical relevance of absence of litigation

• The absence of litigation references in the instrument means there is no legal precedent recorded within this instrument to guide interpretation of its specifics such as the meaning of "suitable", "as soon as practical", or the sufficiency of cutting instructions. Those interpretive issues, if litigated, would be resolved by courts or tribunals applying the instrument together with the Therapeutic Goods Act and general principles of statutory interpretation and professional regulation, none of which are reproduced in this instrument text.

What to do if disputing scope or compliance

• Because the instrument contains prescriptive duties and procedural requirements but no internal enforcement regime, disputes over compliance or interpretation will look to the broader legal framework: the Therapeutic Goods Act, State or Territory professional regulation, and general administrative and civil law. The instrument itself provides no litigation guidance and no memorandum of reasoning or explanatory material within its text.

Narrow product list and strict registration identification

• The instrument permits substitution only for the scarce medicine specified in Schedule 1, column 2 and only to the substitutable medicines listed by product name and registration number in Schedule 1, column 3. Substituting to any other formulation, strength or unlisted product is not authorised by this instrument. Practitioners must check registration numbers carefully (Schedule 1 columns 2-3).

Dose unit equivalence is not an intuitive integer

• The equivalence is one and a half substitutable tablets equals one scarce tablet (Schedule 1, column 4). That non-integer conversion introduces a practical requirement to instruct patients on how to take 1.5 tablets, and in many cases to cut tablets to obtain the correct dose (Schedule 1, column 5(b)). This raises practical issues about tablet splitting and correct dosing that the instrument requires the pharmacist to address but does not specify technically how to address.

Cutting instructions are required but not standardised

• The instrument requires "suitable instructions for cutting a tablet" where cutting is required (Schedule 1, column 5(b)). The instrument does not define "suitable" or prescribe a method, spacing, stability considerations, or labelling. Pharmacists must therefore determine and document their own acceptable instructions consistent with professional standards.

Two-tiered conditions must both be satisfied

• Substitution is permitted only where both the specific permitted circumstances in Schedule 1 and the general permitted circumstances in Schedule 2 exist (note to s 6). A failure to satisfy any one item in either schedule destroys the authority to substitute. For example, even if the pharmacist has no access to the scarce medicine (Schedule 2, item 2) and the patient consents (item 6), substitution is still unlawful if the pharmacist has not given the information required under Schedule 1, column 5.

Prescriber veto

• A prescriber can prohibit substitution by indicating on the prescription that substitution is not permitted (Schedule 2, item 3). Pharmacists must check each prescription for such a notation or instruction.

Recordkeeping expectations not quantified

• The instrument requires that the pharmacist "makes a record" at the time of dispensing (Schedule 2, item 7) but does not specify record content, format, or retention period. Practitioners must therefore decide how to satisfy this obligation in a way that will stand up to external scrutiny given that the instrument offers no prescriptive standard.

Notification timing is flexible

• The pharmacist must have an established procedure to notify the prescriber "at the time of, or as soon as practical after, dispensing" (Schedule 2, item 8). The instrument leaves the meaning of "as soon as practical" to professional judgment, which may create ambiguity in time-sensitive contexts.

Evidence of valid prescription caveat

• Schedule 2, item 1 requires evidence of a valid prescription "unless otherwise permitted by law." This wording acknowledges there may be other legal pathways (for example temporary emergency supply rules) that permit dispensing without standard prescription evidence. Pharmacists must be aware of and reconcile applicable State or Commonwealth exceptions.

No express treatment of labelling or packaging

• The instrument does not require relabelling instructions on the substitute pack, nor does it mandate an insert or sticker explaining the substitution to the patient. The instrument requires verbal or other advice but is silent about packaging or documentation handed to patients.

Temporary window

• The authority is time-limited (s 7-8). Any systems, stock planning or patient instructions put in place must be time-aware: substitution authority ceases at the instrument’s repeal, and pharmacists must revert to normal dispensing practice thereafter.

Silence on price and reimbursement

• The instrument is silent on whether the substitutable medicine must be charged differently or whether public subsidy arrangements apply. Practitioners need to verify payer and subsidy arrangements separately because the instrument does not control them.

No express liability protection

• The instrument does not state whether pharmacists are legally protected from liability for substitution, and it does not confer an explicit indemnity or immunity. Pharmacists remain subject to general civil liability and professional discipline regimes.

Checklist approach for pharmacists (operative provisions cited)

1. Confirm the instrument is in force

   • Verify the date: the instrument is in force from 22 December 2025 until 28 April 2026 (s 2, s 7). Substitution is lawful only during this period.

2. Confirm the scarce and substitutable products

   • Scarce medicine: CATAPRES 150 clonidine hydrochloride 150 microgram tablet blister pack, reg no. 78376 (Schedule 1, column 2).
   • Substitutable medicines (only these products permitted): CATAPRES 100 (reg no. 17921), APO-CLONIDINE 100 micrograms (reg no. 265776), CLONIDINE Lupin 100 micrograms (reg no. 265778) (Schedule 1, column 3).

3. Confirm the patient has evidence of a valid prescription (unless other law applies)

   • Ensure the patient or their agent presents evidence of a valid prescription for the scarce medicine, unless some other law permits dispensing without such evidence (Schedule 2, item 1).

4. Confirm lack of access to scarce medicine

   • Ensure the pharmacy does not have access to the scarce product (Schedule 2, item 2).

5. Check prescriber directions on substitution

   • Confirm the prescriber has not indicated on the prescription that substitution is not permitted; substitution is not allowed if prohibited (Schedule 2, item 3).

6. Assess suitability using professional judgement

   • Exercise professional judgement to determine whether the patient is suitable to receive the substitutable medicine (Schedule 2, item 4). Consider factors including dosing complexity from the 1.5 tablet equivalence (Schedule 1, column 4) and the patient’s capacity to follow cutting instructions if required (Schedule 1, column 5(b)).

7. Calculate dispensing quantity for equivalent regimen and duration

   • Ensure the amount dispensed will result in an equivalent dosage regimen and duration as prescribed for the scarce medicine, applying the dose unit equivalence in Schedule 1, column 4 (Schedule 2, item 5).

8. Obtain informed consent

   • Obtain the patient’s or agent’s consent to receiving the substitutable medicine (Schedule 2, item 6).

9. Provide required patient information (specific permitted circumstances)

   • Advise the patient or agent of: a) the number of dose units that must be taken to substitute the prescribed dose, based on the dose unit equivalence (Schedule 1, column 5(a)); b) suitable instructions for cutting a tablet where cutting is required to obtain the correct dose (Schedule 1, column 5(b)); c) the differences between the scarce medicine and the substitutable medicine (Schedule 1, column 5(c)).

10. Make a contemporaneous record

    • Make a record at the time of dispensing that notes the substitution (Schedule 2, item 7). Because the instrument does not prescribe format or retention period, maintain records consistent with professional standards and local regulatory recordkeeping requirements.

11. Notify the prescriber

    • Use an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing (Schedule 2, item 8). Document the notification in the record.

12. Operational and policy steps for pharmacy owners and managers

    • Update standard operating procedures to include:
      • Verification steps for checking prescriber prohibition and prescription validity (Schedule 2, items 1 and 3).
      • Stock checks and documentation that scarce product is not accessible (Schedule 2, item 2).
      • A clear template for the contemporaneous record and notification protocol for prescribers (Schedule 2, items 7 and 8).
      • Counselling scripts and written guidance covering dose conversion, tablet cutting instructions and differences between products (Schedule 1, column 5).
      • Staff training on the temporary nature of the authority and the exact product registration numbers to avoid mis-substitution.

13. Liaise with payers and sponsors where necessary

    • Because the instrument is silent on pricing and subsidy arrangements, confirm with payers (government schemes, insurers) and sponsors whether any special billing or substitution recording is required.

14. Reassess at end of instrument period

    • Cease substitution authority when the instrument expires at the start of 29 April 2026 (s 7-8) unless a further instrument or other legal authority is in place. Notify patients and prescribers that substitution authority is time-limited and re-evaluate supply and stock planning.

Compliance considerations of particular note

• Cutting instructions and dosing accuracy: Provide clear, documented cutting instructions where a patient must take 1.5 tablets to match a 150 microgram dose (Schedule 1, column 5(b)), and consider written confirmation for patients with dexterity or cognitive issues.
• Documentation sufficiency: Given the instrument does not specify record formats or retention, adopt best-practice records compatible with pharmacy board expectations and be prepared to produce them in case of regulatory scrutiny (Schedule 2, item 7).
• Prescriber communications: Because notification timing is flexible ("as soon as practical"), adopt a protocol that balances timely clinical communication with operational realities; document notification attempts and outcomes (Schedule 2, item 8).
• Interaction with other laws and schemes: Verify whether State or Territory law creates exceptions to prescription evidence or imposes additional constraints (Schedule 2, item 1; s 4).