National Health (Pharmaceutical Benefits—Early Supply) Specification 2026
In ForceCTH
Jurisdiction
Commonwealth
Collection
legislative instrument
Plain English Summary
7/10 complexity
This Specification lists which PBS medicines can be supplied early and, for a subset, allows a larger single‑prescription quantity. It sets the permitted early‑supply period in days and the maximum quantity and number of repeats for each listed drug form.
It affects prescribers, pharmacists and people receiving PBS‑subsidised medicines: the Commonwealth (under the National Health Act) decides the rules; prescribers and approved pharmacists must follow the conditions when authorising or dispensing early supplies, creating additional administrative and compliance checks.
This instrument, the National Health (Pharmaceutical Benefits,Early Supply) Specification 2026 (PB 32 of 2026), sets out which pharmaceutical items and which supply circumstances are specified for the purposes of subsection 84AAA(2) of the National Health Act 1953 (the Act), and it prescribes the period relevant to early supply for those items (see s 1-3 and s 9). In short, it operationalises the Act’s power to permit “early supply” of Pharmaceutical Benefits Scheme (PBS) medicines by identifying particular listed drugs, the formulations (pharmaceutical items), the maximum quantity or number of units and maximum number of repeats that are relevant, and the number of days that are to be used in the Act’s early‑supply calculation. The instrument commences on 1 April 2026 (s 2).
Mechanically, the Specification does three linked things:
It lists hundreds of pharmaceutical items, in two schedules, with columns showing: the listed drug and form, a Period (days), the Maximum quantity or number of units, the Maximum number of repeats and an “Other circumstances (if any)” field (Schedules 1 and 2). Those tables determine whether an item is “specified” for paragraph 84AAA(1)(a) of the Act via the rules in s 6-8 of the Specification (see s 6(1)-(3); Schedules 1 and 2). Schedule 1 is the main list; Schedule 2 is a list of items for which the maximum quantity/units has been increased (see Schedule 2 heading and s 6(3)).
It prescribes the circumstances that must exist for an item listed in Schedule 1 or Schedule 2 to be “specified” for the Act (s 7 and s 8). Those sections require, among other things, that supply be on the basis of a prescription or, for Schedule 1 items, supply may alternatively be made by an “approved pharmacist” under subsection 89A(1) of the Act (s 7(a)(i)-(ii) compared with s 8(a)-(b)). For prescription supplies, the prescription must have been written for the purpose for which the maximum quantity and repeats were determined under paragraph 85A(2) of the Act (s 7(b), s 8(c)). For approved pharmacist supplies of Schedule 1 items, the quantity supplied must be the quantity specified in Schedule 1 (s 7(c)).
Current sections
Direct links to the current provisions in National Health (Pharmaceutical Benefits—Early Supply) Specification 2026.
12
2
Commencement
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
The whole of this instrument 1 April 2026 1 April 2026.
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3
Authority
3 Authority
This instrument is made under subsection 84AAA(2) of the National Health Act 1953.
4
Schedule 3
4 Schedule 3
Each instrument that is specified in Schedule 3 to this instrument is amended or repealed as set out in the applicable items in the Schedule, and any other item in that Schedule has effect according to its terms.
5
Definitions
5 Definitions
(1) In this instrument:
Act means the National Health Act 1953.
determined maximum quantity or number of units, for a pharmaceutical item in a pharmaceutical benefit, means a quantity or number of units determined under paragraph 85A(2)(a) of the Act as the maximum quantity or number of units of the pharmaceutical item that may, in one prescription, be directed to be supplied on any one occasion determined.
Note: A maximum quantity or number of units can be determined in relation to prescriptions directing the supply of the pharmaceutical item for all purposes, or for particular purposes: see paragraph 85A(2)(a) of the Act.
determined maximum number of repeats, for a pharmaceutical benefit, means the number determined under paragraph 85A(2)(b) of the Act as a maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.
Note: A maximum number of repeats can be determined in relation to prescriptions directing the supply of the pharmaceutical benefit for all purposes, or for particular purposes: see paragraph 85A(2)(b) of the Act.
g means gram.
I.U. means international unit.
listed drug has the meaning given by section 84 of the Act.
mg means milligram.
mL means millilitre.
pharmaceutical benefit has the meaning given by section 84 of the Act.
pharmaceutical item has the meaning given by section 84AB of the Act.
prescriber bag provisions has the meaning given by section 84 of the Act.
purposes code has the same meaning as in the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.
relevant previous supply, for a pharmaceutical benefit, means the most recent previous supply to a person of:
(a) the same pharmaceutical benefit; or
(b) another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or
(c) another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit.
relevant purpose, for a pharmaceutical benefit, means a purpose, mentioned in Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 for a purposes code specified in Schedule 1 of that instrument for the pharmaceutical benefit, that includes the phrase “The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient”.
Schedule equivalent has the meaning given by section 84AJ of the Act.
(2) A reference in this instrument to supply on the basis of a prescription includes reference to supply on the basis of a repeat authorisation or deferred supply authorisation.
(3) Unless the contrary intention appears, a reference in this instrument to Schedule 1 or Schedule 2 is taken to be a reference to Schedule 1 to this instrument or Schedule 2 to this instrument, respectively.
6
Specification of pharmaceutical items
6 Specification of pharmaceutical items
(1) A pharmaceutical item in a pharmaceutical benefit is specified for paragraph 84AAA(1)(a) of the Act if subsection (2) or (3) of this section applies in relation to the pharmaceutical item.
(2) This subsection applies in relation to the pharmaceutical item if:
(a) the listed drug and the form of that listed drug in the pharmaceutical item are mentioned in an item in the table in Schedule 1; and
(b) all the circumstances specified in section 7 exist in relation to a pharmaceutical benefit that has that listed drug in that form.
(3) This subsection applies in relation to the pharmaceutical item if:
(a) the listed drug and the form of that listed drug in the pharmaceutical item are mentioned in an item in the table in Schedule 2; and
(b) all the circumstances specified in section 8 exist in relation to a pharmaceutical benefit that has that listed drug in that form.
7
Circumstances relating to specification of pharmaceutical items in Schedule 1
7 Circumstances relating to specification of pharmaceutical items in Schedule 1
For paragraph 6(2)(b), the circumstances in relation to a pharmaceutical benefit are:
(a) the supply of the benefit is made:
(i) on the basis of a prescription; or
(ii) to a person by an approved pharmacist under subsection 89A(1) of the Act; and
(b) if the pharmaceutical benefit is supplied as referred to in subparagraph (a)(i)—the prescription must have been written:
(i) for a purpose for which the maximum quantity or number of units specified in the column headed ‘Maximum quantity or number of units’ in an item in Schedule 1 for the pharmaceutical item was determined under paragraph 85A(2)(a) of the Act; and
(ii) for a purpose for which the maximum number of repeats specified in the column headed ‘Maximum number of repeats’ specified in the same table item in Schedule 1 for the pharmaceutical benefit was determined under paragraph 85A(2)(b) of the Act; and
(c) if the pharmaceutical benefit is supplied as referred to in subparagraph (a)(ii)—the quantity or number of units of the pharmaceutical benefit supplied to the person must be a quantity or number of units specified for the pharmaceutical item in the pharmaceutical benefit in an item in Schedule 1; and
(d) any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table in Schedule 1 for the benefit.
8
Circumstances relating to specification of pharmaceutical items in Schedule 2
8 Circumstances relating to specification of pharmaceutical items in Schedule 2
For paragraph 6(3)(b), the circumstances in relation to a pharmaceutical benefit are:
(a) the supply of the benefit is made on the basis of a prescription; and
(b) the supply was not made under subsection 89A(1) of the Act; and
(c) the prescription must have been written:
(i) for a purpose for which the maximum quantity or number of units specified in the column headed ‘Maximum quantity or number of units’ in an item in Schedule 2 for the pharmaceutical item was determined under paragraph 85A(2)(a) of the Act; and
(ii) for a purpose for which the maximum number of repeats specified in the column headed ‘Maximum number of repeats’ specified in the same table item in Schedule 2 for the pharmaceutical benefit was determined under paragraph 85A(2)(b) of the Act; and
(d) any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table in Schedule 2 for the benefit.
9
Specification of period relating to a pharmaceutical benefit
9 Specification of period relating to a pharmaceutical benefit
(1) This section is made for paragraph 84AAA(1)(b) of the Act.
(2) For a pharmaceutical benefit that has a listed drug mentioned in an item in Schedule 1 in the form mentioned in that item, and the circumstances identified for section 7 apply, the period specified is the number of days mentioned under the heading ‘Period (days)’ for the item in Schedule 1.
(3) For a pharmaceutical benefit that has a listed drug mentioned in an item in Schedule 2 in the form mentioned in that item, and the circumstances identified for section 8 apply:
(a) if:
(i) the relevant previous supply to the person was made on the basis of a prescription; and
(ii) the quantity or number of units of the pharmaceutical benefit directed to be supplied on any one occasion in the prescription was directed for a relevant purpose for the previously supplied pharmaceutical benefit:
the period specified is the number of days mentioned under the heading ‘Period (days)’ for the item in Schedule 2; and
(b) in any other case—the period specified is 20 days.
(4) Despite subsections (2) and (3), if the relevant previous supply of the pharmaceutical benefit was made under a prescriber bag provision, the period specified is zero days.
Sch 1
Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply
Schedule 1—Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply
Listed drug Form Period(days) Circumstances:
Maximum quantity or number of units Maximum number of repeats Other circumstances (if any)
Abatacept Injection 125 mg in 1 mL single dose autoinjector 20 4 5
Abatacept Injection 125 mg in 1 mL single dose pre-filled syringe 20 4 5
Indacaterol Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler) 20 30 5
Indacaterol Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler) 20 30 5
Indacaterol with glycopyrronium Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 50 micrograms (as bromide) (for use in Breezhaler) 20 30 5
Indacaterol with glycopyrronium and mometasone Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 68 micrograms (for use in Breezhaler) 20 30 5
Indacaterol with glycopyrronium and mometasone Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 136 micrograms (for use in Breezhaler) 20 30 5
Relugolix with estradiol and with norethisterone Tablet containing relugolix 40 mg with estradiol (as hemihydrate) 1 mg and with norethisterone acetate 500 micrograms 20 28 5
Ribociclib Tablet 200 mg 20 21 5
Ribociclib Tablet 200 mg 20 42 5
Ribociclib Tablet 200 mg 20 63 5
Rifaximin Tablet 550 mg 20 56 5
Riluzole Tablet 50 mg 20 56 5
Ripretinib Tablet 50 mg 20 90 1
Risankizumab Injection 150 mg in 1 mL pre-filled pen 20 1 1
Risankizumab Injection 150 mg in 1 mL pre-filled pen 20 1 2
Vildagliptin with metformin Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride 20 60 5
Vildagliptin with metformin Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride 20 60 5
Vildagliptin with metformin Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride 20 60 5
Vismodegib Capsule 150 mg 20 28 3
Vosoritide Powder for injection 400 micrograms with diluent 20 30 5
Vosoritide Powder for injection 560 micrograms with diluent 20 30 5
Vosoritide Powder for injection 1.2 mg with diluent 20 30 5
Zanubrutinib Capsule 80 mg 20 120 5
Zonisamide Capsule 25 mg 20 56 5
Zonisamide Capsule 50 mg 20 56 5
Zonisamide Capsule 100 mg 20 112 5
Sch 2
Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply–increased maximum quantity or number of units
Schedule 2—Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply–increased maximum quantity or number of units
Listed drug Form Period(days) Circumstances:
Maximum quantity or number of units Maximum number of repeats Other circumstances (if any)
Acarbose Tablet 50 mg 50 180 5
Acarbose Tablet 100 mg 50 180 5
Aclidinium Powder for oral inhalation in breath actuated device 322 micrograms (as bromide) per dose, 60 doses 50 2 5
Aclidinium with formoterol Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses 50 2 5
Adapalene with benzoyl peroxide Gel 1 mg-25 mg per g, 30 g 50 2 3
Hypromellose with dextran Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL 50 2 5
Indacaterol Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler) 50 60 5
Indacaterol Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler) 50 60 5
Indacaterol with glycopyrronium Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 50 micrograms (as bromide) (for use in Breezhaler) 50 60 5
Indacaterol with glycopyrronium and mometasone Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 68 micrograms (for use in Breezhaler) 50 60 5
Indacaterol with glycopyrronium and mometasone Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 136 micrograms (for use in Breezhaler) 50 60 5
Indacaterol with mometasone Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 62.5 micrograms (for use in Breezhaler) 50 60 5
Indacaterol with mometasone Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 127.5 micrograms (for use in Breezhaler) 50 60 5
Indacaterol with mometasone Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 260 micrograms (for use in Breezhaler) 50 60 5
National Health (Pharmaceutical Benefits—Early Supply) Specification 2026
I, Rebecca Richardson, as delegate for the Minister for Health and Ageing, make the following Specification.
PB 32 of 2026
Dated 26 March 2026
Rebecca Richardson
Assistant Secretary
PBS Listing, Pricing & Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing
Contents
1 Name
2 Commencement
3 Authority
4 Schedule 3
5 Definitions
6 Specification of pharmaceutical items
7 Circumstances relating to specification of pharmaceutical items in Schedule 1
8 Circumstances relating to specification of pharmaceutical items in Schedule 2
9 Specification of period relating to a pharmaceutical benefit
Schedule 1—Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply
Schedule 2—Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply–increased maximum quantity or number of units
Schedule 3—Repeals
1 Name
(1) This instrument is the National Health (Pharmaceutical Benefits—Early Supply) Specification 2026.
(2) This instrument may also be cited as PB 32 of 2026.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
The whole of this instrument 1 April 2026 1 April 2026.
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
It specifies the relevant period to be applied under paragraph 84AAA(1)(b) of the Act for items in Schedule 1 and Schedule 2 (s 9). For Schedule 1 items the period is the number of days given in the Schedule 1 table (s 9(2)). For Schedule 2 items the period is either the number of days listed in Schedule 2 where the relevant previous supply was itself on prescription and for a “relevant purpose” (as defined), or otherwise 20 days (s 9(3)(a)-(b)). It also states that where the relevant previous supply was made under a “prescriber bag provision” the period specified is zero days (s 9(4)).
The Specification is made by a delegate of the Minister (Rebecca Richardson as Assistant Secretary), under subsection 84AAA(2) of the Act (s 3 and the instrument header). Schedule 3 repeals the prior National Health (Pharmaceutical benefits-early supply) Instrument 2015 in its entirety (Schedule 3,Repeals).
This instrument therefore fixes the operational catalogue of early‑supply entitlements and the numerical parameters used in applying s 84AAA of the Act, and it replaces the previous 2015 instrument (see Schedule 3).
Main concepts
Several defined concepts and cross‑references in the Specification determine how to read the tables and apply the rules. The Specification defines or relies on the following legal and technical terms (s 5 and the Schedule headings):
Authority and purpose: the Specification is made under subsection 84AAA(2) of the National Health Act 1953 (s 3). Section 9 is expressly “made for paragraph 84AAA(1)(b) of the Act” (s 9(1)), so the tables and periods function directly to implement the Act’s early‑supply framework.
Pharmaceutical benefit, listed drug, pharmaceutical item: these terms are used with the meanings given in the Act: “listed drug” and “pharmaceutical benefit” are defined by s 84 of the Act; “pharmaceutical item” is defined by s 84AB of the Act (see s 5(1) definitions referencing the Act). The Specification therefore applies to PBS listed items as classified under the Act.
Determined maximum quantity or number of units; determined maximum number of repeats: these are terms defined in the Specification by reference to paragraph 85A(2)(a) and (b) of the Act (s 5(1)). The Specification’s tables show the “Maximum quantity or number of units” and “Maximum number of repeats” for each item; the prescription must be written for the purpose for which those maxima were determined (s 7(b)(i)-(ii), s 8(c)(i)-(ii)).
Relevant previous supply: defined at s 5(1) as the most recent previous supply to a person of (a) the same pharmaceutical benefit; or (b) another benefit that has the same pharmaceutical item; or (c) another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit. That definition controls when the s 9 period is measured from the last supply.
Relevant purpose: defined by reference to Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 for a purposes code specified in Schedule 1 of that instrument, where the relevant purpose includes the phrase “The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient” (s 5(1)). That cross‑reference means the Listing of Pharmaceutical Benefits instrument is essential to determine whether a previous supply counts for the Schedule 2 period calculation (s 9(3)(a)).
Prescriber bag provisions: the Specification uses this term with the meaning given by section 84 of the Act (s 5(1)). Section 9(4) uses the concept to alter the period (to zero) where the relevant previous supply was made under a prescriber bag provision.
Supply basis: the Specification treats “supply on the basis of a prescription” as including supply on the basis of a repeat authorisation or a deferred supply authorisation (s 5(2)). This clarifies that repeat authorisations or deferred supply authorisations are captured by the prescription‑based requirements in s 7 and s 8.
Schedules and table fields: Schedules 1 and 2 are the operative product tables. Schedule 1 contains the main list and the “Period (days)” column; Schedule 2 contains items for which an increased maximum quantity/units is specified (see Schedule 2 heading and s 6(3)). The Specification requires that the listed drug and the form in the pharmaceutical item be mentioned in the applicable table item for the corresponding provision in s 6 to apply (s 6(2)(a), s 6(3)(a)).
The Specification therefore binds the technical terms from the Act and from the Listing Instrument 2024 into a practical matrix: which formulation, what maximum quantity and repeats, what period between supplies, and the precise supply circumstances (prescription vs approved pharmacist) that enable early supply under s 84AAA of the Act.
Who it affects
The Specification imposes practical rules that affect participants in the PBS supply chain and those making prescribing decisions. The instrument text itself identifies the decision‑makers and the actors whose behaviour the rules apply to: the delegate who made the instrument (Rebecca Richardson; instrument header), prescribers (as authors of prescriptions), approved pharmacists (under subsection 89A(1) of the Act), dispensing pharmacists and pharmacies, and persons receiving supplies (patients). More specifically:
Prescribers: they must write prescriptions for the purpose for which the maximum quantity or repeats were determined under paragraph 85A(2) of the Act if the prescription is to be used to access early supply under this Specification (s 7(b)(i)-(ii); s 8(c)(i)-(ii)). Prescribers therefore control eligibility by the purpose stated and the form/quantity they prescribe.
Pharmacists and approved pharmacists: Schedule 1 explicitly contemplates supply by an “approved pharmacist” under s 89A(1) of the Act as an alternative to supply on a prescription (s 7(a)(ii) and s 7(c)). Schedule 2 does not allow approved pharmacist supply (s 8(b) expressly requires that “the supply was not made under subsection 89A(1) of the Act”). Dispensing pharmacists must verify whether the supply circumstances required by s 7 or s 8 are satisfied before treating a supply as an early supply under s 84AAA; they must check the prescription’s stated purpose and the relevant maximum quantity/repeats from the schedule (s 7(b), s 8(c)).
Patients (recipients): the Specification changes which patients can lawfully obtain an early supply of a listed PBS medicine and when, because the period specified (s 9) and the maximum quantity/repeats in the schedule govern eligibility. Patients seeking early supply will be affected by the conditionality on prior supply type (prescription vs prescriber bag provision) and whether the previous supply was for a “relevant purpose” (s 9(3)-(4)).
PBS administrators and the Department: although the Specification does not itself set pricing or subsidy levels, it amends the operational rules governing how early supply operates under the Act. The Department’s PBS Listing, Pricing & Policy Branch is the office associated with the delegate who made the instrument (instrument header). The specification repeals the 2015 instrument (Schedule 3), so administrators must transition to the new lists and periods.
Sponsors, wholesalers and manufacturers: indirectly affected because the Specification changes permitted quantities and timing for dispensing; the Specification lists formulations, some with alternative entries and variable maximums and repeats. That will affect stock flow and dispensing volumes, although the instrument does not itself set commercial terms.
Legal advisers, compliance officers and auditors: required to interpret a large and detailed table, check cross‑references (notably to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 and to provisions of the Act such as paragraphs 85A(2)(a)-(b)), and advise pharmacies and prescribers on operational compliance.
In short, the Specification alters supply eligibility and the operational checks required of prescribers and dispensing pharmacists. It draws clear distinctions between Schedule 1 (where approved pharmacists under s 89A(1) may supply subject to the Schedule 1 quantity) and Schedule 2 (where supply must be on the basis of a prescription and cannot be an approved pharmacist supply), and it conditions periods on the nature and purpose of the prior supply (s 9).
Key duties and rights
The Specification creates a set of positive operational duties for prescribers and pharmacists and sets out rights to supply in particular circumstances. The duties and rights that follow are drawn from the text and the cross‑references that the Specification makes to the Act and the Listing Instrument 2024.
Duties and required checks for prescribers
State the purpose that aligns with the purpose for which the maximum quantity/number of units and maximum number of repeats were determined under paragraph 85A(2) of the Act. Section 7(b) and s 8(c) require that a prescription used for early supply must have been written “for a purpose for which the maximum quantity ... was determined” and “for a purpose for which the maximum number of repeats ... was determined.”
Where a prescriber signs a prescription that is intended to enable early supply, be aware that the Listing Instrument 2024 (Schedule 4) may contain the relevant wording that determines whether a supply counts as a “relevant purpose” for Schedule 2 period calculations (see s 5(1) definition of relevant purpose and s 9(3)(a)).
Duties and required checks for pharmacists (including approved pharmacists)
Identify the pharmaceutical item precisely by listed drug and form and match to an item in Schedule 1 or Schedule 2 before applying early‑supply rules (s 6(2)(a) and s 6(3)(a)). The Specification requires both the listed drug and the form to be mentioned in the table item.
Verify the supply circumstance required for the Schedule entry:
For Schedule 1 items, supply may be made either on the basis of a prescription or by an approved pharmacist under s 89A(1) (s 7(a)). If supplied by an approved pharmacist under s 89A(1), the quantity supplied must be the quantity specified in the Schedule 1 table (s 7(c)). If supplied on the basis of a prescription, the prescription must meet the purpose constraints in s 7(b)(i)-(ii).
For Schedule 2 items, supply must be on the basis of a prescription and must not have been made under s 89A(1) (s 8(a)-(b)). The prescription must meet the purpose constraints in s 8(c).
Compute and apply the correct period under s 9 when deciding whether the person is eligible for early supply (s 9(2)-(3)). For Schedule 1 items use the “Period (days)” in Schedule 1. For Schedule 2 items, if the relevant previous supply was on prescription and for a “relevant purpose” the period is the number of days in Schedule 2; otherwise the period is 20 days. If the previous supply was made under a prescriber bag provision, the period is zero days (s 9(4)).
Recognise that “supply on the basis of a prescription” includes supply via repeat authorisation or deferred supply authorisation (s 5(2)), so repeat authorisations must be treated as prescriptions for these checks.
Rights created or preserved by the Specification
Right to early supply where the statutory and specified conditions are satisfied: where the listed drug/form is in Schedule 1 or 2 and the supply circumstances and period rules are met, the Act’s early‑supply mechanism (as implemented by the Specification) permits early supply of the pharmaceutical benefit (s 6-9 read with subsection 84AAA(2) of the Act).
For approved pharmacists under s 89A(1): a right to supply Schedule 1 items without a new prescription (s 7(a)(ii)), subject to the limit that the quantity supplied must match the Schedule 1 quantity (s 7(c)). Schedule 2 items do not grant that right to approved pharmacists (s 8(b)).
Other operational requirements and implications
The Specification relies on determinations made under paragraph 85A(2) of the Act for the maxima (s 5). Practitioners must therefore cross‑reference the Act and the Listing Instrument 2024 for the matching purposes and the textual form of those purposes.
The “Other circumstances (if any)” column in the schedules is to be taken as noting “any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table in Schedule 1 [or Schedule 2] for the benefit” (s 7(d), s 8(d)). The numbers shown in that column in the tables are therefore operational triggers for further conditions established in the Act or the Listing Instrument; the Specification itself does not expand them in plain text.
In summary, the Specification imposes precise verification duties on prescribers and dispensing pharmacists (including limitations on use of approved pharmacist supply), and it creates rights to early supply when the threshold checks in s 6-9 are satisfied. The decision architecture is largely about matching the item and form, verifying prescribed purpose and prior‑supply type, and applying the correct numeric period and maximums from the schedules.
Penalties and enforcement
The Specification itself contains no express penalty provisions or sanctions (the instrument text lists powers, definitions and tables, but does not create offences or fines). The instrument is made under subsection 84AAA(2) of the National Health Act 1953 and operates within the Act’s enforcement and compliance framework (s 3). Therefore:
Absence of penalties in the Specification: practitioners should note that the Specification does not create administrative fines or criminal sanctions; it performs the statutory function of identifying items and periods relevant to early supply under the Act.
Enforcement will rest with the mechanisms in the Act and the associated regulatory regime: because the Specification references and implements provisions of the Act (notably s 84, s 84AB, s 85A, subsection 84AAA(2), and subsection 89A(1)), any enforcement action, compliance requirement, or sanction for mis‑application will flow from the Act and related instruments (the Specification itself does not add or alter penalty regimes). Users will need to consult the Act for the precise enforcement regime and any disciplinary, civil or criminal consequences of non‑compliance.
Practical compliance risk for pharmacists and prescribers: while not labelled as “penalties,” incorrect application (for example, supplying a Schedule 2 item under an approved pharmacist supply, or failing to ensure the prescription’s stated purpose matches the purpose for which the maximum was determined) risks being treated as non‑compliant with the Act’s PBS requirements. That may trigger regulatory review, claims recovery, or other enforcement actions under the Act or the PBS administrative procedures. The Specification itself requires particular evidentiary checks (s 7 and s 8), so failure to perform them exposes practitioners to the Act’s compliance processes.
Interaction with recordkeeping and audit: the Specification’s reliance on previous supply type (prescription vs prescriber bag provision) and on the purpose stated on the prescription implies a need for recordkeeping that can demonstrate compliance with the Specification’s conditions. Non‑compliance may therefore be uncovered in audits or reconciliations of PBS claims.
In sum, while the Specification creates the operational rules for early supply, it leaves enforcement and penalties to the Act and the broader PBS regulatory framework. Practitioners should therefore consult the National Health Act 1953 and Departmental guidance for detail on sanctions and administrative processes.
How it interacts with other laws
The Specification is heavily cross‑referenced to the National Health Act 1953 and to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024. The instrument’s operation depends on those instruments and their definitions. The principal interactions are as follows:
National Health Act 1953: the Specification is made under subsection 84AAA(2) of the Act and repeatedly references other Act provisions. The definitions of “listed drug”, “pharmaceutical benefit”, “pharmaceutical item” and “prescriber bag provisions” are taken from the Act (s 5(1) and note references). Sections 6-9 of the Specification are framed to implement the early‑supply provisions and the determinations under paragraph 85A(2) of the Act (see s 5 definitions referencing 85A(2)(a) and (b)). The Specification therefore forms part of the statutory machinery for PBS early supply.
National Health (Listing of Pharmaceutical Benefits) Instrument 2024: the Specification defines “purposes code” as having the same meaning as in that Listing Instrument (s 5(1)) and defines “relevant purpose” by direct reference to Schedule 4 of the Listing Instrument 2024 (s 5(1)). Practically, that cross‑reference is necessary because the Listing Instrument contains the text of the clinical purposes for which particular maximum quantities were determined. When s 7(b) and s 8(c) require that a prescription be written for the relevant purpose, determining whether a prescription satisfies that condition requires checking the Listing Instrument 2024.
Subsection 89A(1) of the Act (approved pharmacist supply): the Specification expressly relies upon s 89A(1) by permitting, for Schedule 1 items only, supply to a person by an approved pharmacist under that subsection (s 7(a)(ii)). Schedule 2 supplies are explicitly excluded from being supplied under s 89A(1) (s 8(b)). Consequently, the rules under s 89A(1) will govern who can be an approved pharmacist and the conditions of that supply, and practitioners must apply both instruments together.
Paragraphs 85A(2)(a)-(b) of the Act: these paragraphs are the statutory source for determining maximum quantity/units and maximum number of repeats. The Specification’s tables reproduce specific maxima and repeats and require that the prescription be written for the purpose for which those maxima and repeats were determined (s 7(b); s 8(c)). Therefore, any change under the Act to the determinations under paragraph 85A(2) would affect the application of this Specification.
Prescriber bag provisions and other PBS instruments: the Specification uses the prescriber bag provision term from s 84 of the Act and specifically alters the period when the most recent supply was under such a provision by setting the period to zero days (s 9(4)). Implementing that rule will require knowledge of which supplies were made under prescriber bag provisions and how those are recorded under the Act or other instruments.
Repeal of the 2015 instrument: Schedule 3 repeals the National Health (Pharmaceutical benefits-early supply) Instrument 2015 in its entirety. That repeal means that any transitional arrangements, prior determinations or guidance tied to the 2015 instrument must be revisited and replaced by the 2026 Specification; administrators need to manage the legal transition.
Where the Specification references concepts from the Act and the Listing Instrument 2024 without repeating their text, implementing the Specification requires reading the Act and the Listing Instrument alongside it. The Specification therefore forms an inter‑locking part of the PBS regulatory architecture and cannot be applied in isolation.
Amendment history
The Specification itself contains limited amendment history in the instrument text. Key points recorded by the instrument:
Date and commencement: the instrument is PB 32 of 2026, signed and dated 26 March 2026 by the delegate (Rebecca Richardson) and the whole instrument commences on 1 April 2026 (s 1(1)-(2) and s 2).
Repeal of prior instrument: Schedule 3 expressly repeals the entire National Health (Pharmaceutical benefits-early supply) Instrument 2015 (Schedule 3,Repeals, item 1). The Specification therefore replaces that 2015 instrument from 1 April 2026.
Schedule 3 contains no other amendments to prior instruments beyond the repeal of the 2015 instrument. The body of the Specification does not include transitional provisions other than the repeal. The “Commencement” table (s 2(1)) confirms that the whole instrument commences on 1 April 2026.
The instrument header identifies it as “PB 32 of 2026” and shows the delegate’s office (PBS Listing, Pricing & Policy Branch, Technology Assessment and Access Division, Department of Health, Disability and Ageing). That header provides traceability and indicates which Departmental branch led the drafting.
Beyond the repeal of the 2015 instrument, the Specification does not include a clause listing amendments to earlier regulations (other than Schedule 3’s repeal). Practitioners should therefore assume that the Specification is the primary operative instrument for early supply from 1 April 2026 and that any reliance on the 2015 instrument should be replaced by the new schedules and the rules in ss 6-9.
If users require historical comparisons (for example, to identify what changed between the 2015 instrument and the 2026 Specification), they must read the 2015 instrument (now repealed) against the new Schedule entries and the s 6-9 mechanics. The Specification itself does not annotate where line‑by‑line changes have been made compared to 2015.
Litigation history
The Specification text contains no references to litigation, cases or judicial decisions. It names no court decisions and identifies no pending legal challenges. As an instrument made under the Act, it is a statutory instrument and any litigation that affects its interpretation or operation would be located in cases involving the National Health Act, PBS administration, or disputes about supply under s 84AAA, s 85A or s 89A of the Act.
Given the absence of cases cited or text in the instrument, the following points are relevant for users researching litigation risk or precedent:
No cases are named in the Specification. The instrument does not indicate any judicial interpretation or settled points of construction that must be followed beyond the plain terms of the Act and the Specification.
Potential litigation hotspots are identifiable from the instrument’s logic, though no cases are referenced in the text. For example, disputes could arise about:
Whether a prescription was “written for a purpose for which the maximum quantity ... was determined” under paragraph 85A(2) where that purpose is drawn by cross‑reference to the Listing Instrument 2024 Schedule 4 (see s 7(b), s 8(c) and s 5(1) definition of relevant purpose).
Whether a prior supply counted as a “relevant previous supply” because of Schedule equivalence or because it was supplied under a prescriber bag provision (s 5(1), s 9(4)).
Whether an attempted early supply complied with the requirement that Schedule 2 items must not be supplied under s 89A(1) (s 8(b)).
Any actual litigation will be decided against the text of the Act and these instruments; users should search case law databases for challenges to the operation of subsection 84AAA or to decisions based on the prior 2015 instrument if precedents from before 2026 are sought.
The Specification therefore carries no litigation history within its own text. Parties seeking precedents on contested questions will need to search the broader case law on the National Health Act and PBS administration.
Gotchas
This Specification contains several practical traps for prescribers, pharmacists and administrators. The following list is drawn from the instrument’s text and the way it cross‑references other instruments; each item is linked to the relevant provision in the Specification.
Two different supply‑paths (Schedule 1 vs Schedule 2)
Schedule 1 allows supply either on a prescription or by an approved pharmacist under s 89A(1) of the Act (s 7(a)). Schedule 2 expressly excludes approved pharmacist supply (s 8(b)). Confusing items between the two Schedules can therefore lead to an unlawful supply pathway. Practitioners must check whether the listed drug/form appears in Schedule 1 or Schedule 2 and follow the specific supply path.
The prescription must be for the precise purpose for which the maxima were determined
Both s 7(b) and s 8(c) require that the prescription be written for the purpose for which the maximum quantity and repeats were determined under paragraph 85A(2) of the Act. That purpose is not recited in the Specification; practitioners must cross‑reference the Listing Instrument 2024 to identify the textual purpose. A failure to match the stated prescription purpose to the Listing Instrument’s purpose language will jeopardise the validity of the early supply.
“Relevant purpose” and Schedule 2 period calculation
For Schedule 2 items s 9(3) applies a longer period only where the relevant previous supply was made on prescription and the quantity directed in the previous prescription was for a “relevant purpose” as defined (s 5(1) referencing Listing Instrument 2024 Schedule 4). Determining whether a prior prescription satisfied that phrase is a fact‑sensitive, paper‑heavy check; the result changes the period from the Schedule number to 20 days (s 9(3)(a)-(b)). Pharmacies must be able to determine whether the previous supply’s prescription text maps to the Listing Instrument’s “relevant purpose”.
Prescriber bag provision sets period to zero
Section 9(4) states that if the relevant previous supply was made under a prescriber bag provision the period specified is zero days. That means a previous supply made under a prescriber bag provision alters the period calculation dramatically. Pharmacies must be able to identify whether the previous supply arose under prescriber bag provisions recorded under s 84 of the Act, and must ensure recordkeeping supports that classification.
Multiple table rows for similar formulations and brand‑specific rows
The Schedules list multiple lines for identical (or near‑identical) active substances and strengths in different formulations, packaging sizes, or even with S19A annotations indicating specific suppliers. Mistaking one table line for another (for example, confusing a 20‑day entry in Schedule 1 with a 50‑day entry in Schedule 2 for a different pack size) will change the maximum quantity, repeats and the applicable period, with operational and compliance consequences.
“Other circumstances (if any)” column contains numeric codes but is not explained in the Specification
The Schedules include an “Other circumstances (if any)” column with numeric values (0-11) repeated across items. The Specification does not define these numbers in the instrument text; rather s 7(d) and s 8(d) direct readers to “any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table”. Practitioners must therefore consult the Act and any Departmental guidance to determine what each numeric code means. Treating the numbers as self‑explanatory is a risk.
Repeat authorisations and deferred supply authorisations are “prescriptions” for the Specification but may be recorded differently in practice
Section 5(2) clarifies that “supply on the basis of a prescription includes reference to supply on the basis of a repeat authorisation or deferred supply authorisation.” In practice, different software systems and recordkeeping may treat repeat authorisations differently; pharmacists must ensure their systems show that a supply was authorised by a repeat or deferred authorisation where relevant.
The Specification is silent on price and subsidy consequences
The instrument sets supply and period rules, but does not state whether a given supply will attract the PBS benefit or how dispensing claims are to be handled. Practitioners must consult the Act and PBS claiming procedures to confirm financial and claim consequences. Assuming the Specification alone determines PBS claim entitlement is incorrect.
Transition from the 2015 instrument
Schedule 3 repeals the 2015 instrument. If a practice relied on a transitional arrangement or on a specific 2015‑era interpretation, that may no longer be available. Administrators must reconcile any operational procedures against the new tables and rules.
Complexity for audits and stock management
The combined effect of multiple periods, multiple maxima, and the need to check previous supply type and stated purpose creates a non‑trivial compliance and administrative burden for pharmacies. The Specification requires accurate matching of prior supply records and prescriptions; poor recordkeeping magnifies the risk of non‑compliance.
These “gotchas” are concrete implementation traps that arise directly from the Specification’s structure, the cross‑references it makes to the Act and the Listing Instrument 2024, and the presence of multiple, similar table entries.
How to comply
Complying with the Specification requires a set of concrete operational steps and documentation practices for prescribers, pharmacies and PBS administrators. Below is a practical checklist and recommended processes derived directly from the instrument.
Familiarise with the legal cross‑references
Read the relevant provisions of the National Health Act 1953 (in particular ss 84, 84AB, 84AAA, 85A and 89A) alongside this Specification (s 3 and s 5 cross‑reference those sections). Also consult the National Health (Listing of Pharmaceutical Benefits) Instrument 2024, especially Schedule 4, because the Specification defines “relevant purpose” by reference to that instrument (s 5(1)).
Identify the item precisely before dispensing
Match the listed drug and the form exactly to the item row in Schedule 1 or Schedule 2. The Specification requires both the listed drug and the form to be mentioned in the schedule item for s 6 to apply (s 6(2)(a), s 6(3)(a)). Use the exact formulation, pack size, and manufacturer annotations (including S19A entries) when identifying the item.
Determine which Schedule and supply path applies
If the item is in Schedule 1, check whether the supply will be on prescription or by an approved pharmacist under s 89A(1). For approved pharmacist supply, you must ensure the supply is permitted under s 89A(1) (see s 7(a)(ii)) and supply no more than the quantity mentioned in Schedule 1 for that item (s 7(c)).
If the item is in Schedule 2, ensure the supply is on the basis of a prescription and was not carried out under s 89A(1) (s 8(a)-(b)). Schedule 2 entries specify increased maximum quantity or number of units, so confirm that you are following the stricter requirement of prescription supply.
Check that the prescription states the required purpose
For supplies on prescription, verify that the prescription was written “for a purpose for which the maximum quantity or number of units ... was determined” and “for a purpose for which the maximum number of repeats ... was determined” (s 7(b)(i)-(ii); s 8(c)(i)-(ii)). Because those purposes are determined under paragraph 85A(2) of the Act, practitioners must map the prescription’s purpose to the wording used in the Listing Instrument 2024.
Verify previous supply and apply the period rule
Identify the person’s “relevant previous supply” as defined in s 5(1). Determine whether the previous supply was:
made on the basis of a prescription (including repeat/deferred authorisations, see s 5(2)); and
the quantity directed in that previous prescription was directed for a “relevant purpose” (s 9(3)(a)).
Apply the period from the appropriate Schedule: for Schedule 1, use the Period (days) shown in Schedule 1 (s 9(2)); for Schedule 2, apply the Schedule 2 period if the conditions in s 9(3)(a) are met, otherwise apply 20 days (s 9(3)(b)). If the relevant previous supply was under a prescriber bag provision, set the period to zero days (s 9(4)).
Manage approved pharmacist supply carefully
If acting as an approved pharmacist under s 89A(1) for a Schedule 1 item, confirm that you are an approved pharmacist under the Act, that the conditions of s 89A(1) are met, and that the supply quantity does not exceed the Schedule 1 quantity (s 7(a)(ii) and s 7(c)). Remember that Schedule 2 items cannot be supplied via s 89A(1) (s 8(b)).
Maintain contemporaneous records
Record the following for each early supply decision: the schedule item matched (including pack/formulation), the prescription purpose checked and the Listing Instrument mapping, whether the supply was under s 89A(1) and the authorised pharmacist’s details (if applicable), the date and nature of the relevant previous supply (including whether it was under a prescriber bag provision), and the computed period used to authorise the early supply. The Specification’s reliance on prior‑supply type and purpose means documentary evidence will be required in audits.
Update software and claim processes
Pharmacy dispensing software should be updated to: (a) identify schedule items precisely; (b) capture the prescription’s stated purpose and link it to the Listing Instrument phrases; (c) detect whether the previous supply was under a prescription or prescriber bag provision; and (d) compute the period per s 9. If the software cannot capture these items reliably, pharmacies should implement supplementary manual checks.
Train staff and prescribers
Educate prescribers about the need to state the purpose on the prescription in the wording that maps to the Listing Instrument 2024. Train pharmacists and dispensary staff on the differences between Schedule 1 and Schedule 2, on the s 89A(1) pathway and on the requirement to check previous supply type.
Consult Departmental guidance and the Act for unresolved issues
The Specification contains numeric “Other circumstances” codes without explanation. For meaning, and for enforcement and claim queries, consult Departmental guidance, PBS claiming rules, and the National Health Act. Where doubt exists about interpretation (for example, whether a prior prescription’s wording satisfies a Listing Instrument purpose), seek written Departmental advice or legal advice.
Transitional compliance (repeal of the 2015 instrument)
Replace any reliance on the 2015 instrument with procedures aligned to the 2026 Specification from 1 April 2026. Ensure stock management and claims are reconciled to the new Schedule entries and periods.
Audit readiness
Keep a compliance folder for each early supply event, with copies (or system references) of the prescription, identification of the Schedule row used, calculation of the period, previous supply documentation, and the signature or ID of the authorised pharmacist or prescriber.
Following this checklist will align operational practice with the Specification. Because the Specification is tightly interconnected with the Act and the Listing Instrument 2024, effective compliance requires working across those instruments and ensuring recordkeeping and software capture the precise facts the Specification requires.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 84AAA(2) of the National Health Act 1953.
4 Schedule 3
Each instrument that is specified in Schedule 3 to this instrument is amended or repealed as set out in the applicable items in the Schedule, and any other item in that Schedule has effect according to its terms.
5 Definitions
(1) In this instrument:
Act means the National Health Act 1953.
determined maximum quantity or number of units, for a pharmaceutical item in a pharmaceutical benefit, means a quantity or number of units determined under paragraph 85A(2)(a) of the Act as the maximum quantity or number of units of the pharmaceutical item that may, in one prescription, be directed to be supplied on any one occasion determined.
Note: A maximum quantity or number of units can be determined in relation to prescriptions directing the supply of the pharmaceutical item for all purposes, or for particular purposes: see paragraph 85A(2)(a) of the Act.
determined maximum number of repeats, for a pharmaceutical benefit, means the number determined under paragraph 85A(2)(b) of the Act as a maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.
Note: A maximum number of repeats can be determined in relation to prescriptions directing the supply of the pharmaceutical benefit for all purposes, or for particular purposes: see paragraph 85A(2)(b) of the Act.
g means gram.
I.U. means international unit.
listed drug has the meaning given by section 84 of the Act.
mg means milligram.
mL means millilitre.
pharmaceutical benefit has the meaning given by section 84 of the Act.
pharmaceutical item has the meaning given by section 84AB of the Act.
prescriber bag provisions has the meaning given by section 84 of the Act.
purposes code has the same meaning as in the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.
relevant previous supply, for a pharmaceutical benefit, means the most recent previous supply to a person of:
(a) the same pharmaceutical benefit; or
(b) another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or
(c) another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit.
relevant purpose, for a pharmaceutical benefit, means a purpose, mentioned in Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 for a purposes code specified in Schedule 1 of that instrument for the pharmaceutical benefit, that includes the phrase “The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient”.
Schedule equivalent has the meaning given by section 84AJ of the Act.
(2) A reference in this instrument to supply on the basis of a prescription includes reference to supply on the basis of a repeat authorisation or deferred supply authorisation.
(3) Unless the contrary intention appears, a reference in this instrument to Schedule 1 or Schedule 2 is taken to be a reference to Schedule 1 to this instrument or Schedule 2 to this instrument, respectively.
6 Specification of pharmaceutical items
(1) A pharmaceutical item in a pharmaceutical benefit is specified for paragraph 84AAA(1)(a) of the Act if subsection (2) or (3) of this section applies in relation to the pharmaceutical item.
(2) This subsection applies in relation to the pharmaceutical item if:
(a) the listed drug and the form of that listed drug in the pharmaceutical item are mentioned in an item in the table in Schedule 1; and
(b) all the circumstances specified in section 7 exist in relation to a pharmaceutical benefit that has that listed drug in that form.
(3) This subsection applies in relation to the pharmaceutical item if:
(a) the listed drug and the form of that listed drug in the pharmaceutical item are mentioned in an item in the table in Schedule 2; and
(b) all the circumstances specified in section 8 exist in relation to a pharmaceutical benefit that has that listed drug in that form.
7 Circumstances relating to specification of pharmaceutical items in Schedule 1
For paragraph 6(2)(b), the circumstances in relation to a pharmaceutical benefit are:
(a) the supply of the benefit is made:
(i) on the basis of a prescription; or
(ii) to a person by an approved pharmacist under subsection 89A(1) of the Act; and
(b) if the pharmaceutical benefit is supplied as referred to in subparagraph (a)(i)—the prescription must have been written:
(i) for a purpose for which the maximum quantity or number of units specified in the column headed ‘Maximum quantity or number of units’ in an item in Schedule 1 for the pharmaceutical item was determined under paragraph 85A(2)(a) of the Act; and
(ii) for a purpose for which the maximum number of repeats specified in the column headed ‘Maximum number of repeats’ specified in the same table item in Schedule 1 for the pharmaceutical benefit was determined under paragraph 85A(2)(b) of the Act; and
(c) if the pharmaceutical benefit is supplied as referred to in subparagraph (a)(ii)—the quantity or number of units of the pharmaceutical benefit supplied to the person must be a quantity or number of units specified for the pharmaceutical item in the pharmaceutical benefit in an item in Schedule 1; and
(d) any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table in Schedule 1 for the benefit.
8 Circumstances relating to specification of pharmaceutical items in Schedule 2
For paragraph 6(3)(b), the circumstances in relation to a pharmaceutical benefit are:
(a) the supply of the benefit is made on the basis of a prescription; and
(b) the supply was not made under subsection 89A(1) of the Act; and
(c) the prescription must have been written:
(i) for a purpose for which the maximum quantity or number of units specified in the column headed ‘Maximum quantity or number of units’ in an item in Schedule 2 for the pharmaceutical item was determined under paragraph 85A(2)(a) of the Act; and
(ii) for a purpose for which the maximum number of repeats specified in the column headed ‘Maximum number of repeats’ specified in the same table item in Schedule 2 for the pharmaceutical benefit was determined under paragraph 85A(2)(b) of the Act; and
(d) any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table in Schedule 2 for the benefit.
9 Specification of period relating to a pharmaceutical benefit
(1) This section is made for paragraph 84AAA(1)(b) of the Act.
(2) For a pharmaceutical benefit that has a listed drug mentioned in an item in Schedule 1 in the form mentioned in that item, and the circumstances identified for section 7 apply, the period specified is the number of days mentioned under the heading ‘Period (days)’ for the item in Schedule 1.
(3) For a pharmaceutical benefit that has a listed drug mentioned in an item in Schedule 2 in the form mentioned in that item, and the circumstances identified for section 8 apply:
(a) if:
(i) the relevant previous supply to the person was made on the basis of a prescription; and
(ii) the quantity or number of units of the pharmaceutical benefit directed to be supplied on any one occasion in the prescription was directed for a relevant purpose for the previously supplied pharmaceutical benefit:
the period specified is the number of days mentioned under the heading ‘Period (days)’ for the item in Schedule 2; and
(b) in any other case—the period specified is 20 days.
(4) Despite subsections (2) and (3), if the relevant previous supply of the pharmaceutical benefit was made under a prescriber bag provision, the period specified is zero days.
Schedule 1—Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply
Listed drug Form Period(days) Circumstances:
Maximum quantity or number of units Maximum number of repeats Other circumstances (if any)
Abatacept Injection 125 mg in 1 mL single dose autoinjector 20 4 5
Abatacept Injection 125 mg in 1 mL single dose pre-filled syringe 20 4 5