{"id":"F2021L01118","name":"National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021","slug":"national-health-pharmaceutical-benefits-pharmacist-substitution-of-medicines-without-prescription-du","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102032,"registerId":"commonwealth-F2021L01118-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n (1) This instrument is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021.\n (2) This instrument may also be cited as PB 84 of 2021.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 89A(3) of the National Health Act 1953.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: The expression premises that is used in this instrument is defined in the Act.\n\n In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> listed drug has the same meaning as in Part VII of the Act.\n\n> PBS prescriber has the same meaning as in Part VII of the Act.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Supply of pharmaceutical benefits by approved pharmacist without prescription","content":"#### 5 Supply of pharmaceutical benefits by approved pharmacist without prescription\n\n (1) A pharmaceutical benefit (the substitute benefit) described in column 2 of an item of the table in subsection (8) may be supplied without a prescription to a person by an approved pharmacist, at or from premises in respect of which the pharmacist is approved, if:\n (a) a prescription for a pharmaceutical benefit (the prescribed benefit) described in column 1 of the item is presented to the approved pharmacist; and\n (b) subsections (2), (3), (4), (5), (6) and (7) apply.\n Approved pharmacist cannot supply prescribed benefit\n (2) This subsection applies if the approved pharmacist cannot supply the prescribed benefit.\n Person cannot obtain prescription for substitute benefit in time\n (3) This subsection applies if the approved pharmacist is satisfied that it is not practicable for the person to obtain a prescription for the substitute benefit from a PBS prescriber before the person needs the supply of the prescribed benefit.\n Substitution permitted under Therapeutic Goods Act\n (4) This subsection applies if the substitute benefit may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989.\n Person presenting prescription has been informed of cost implications\n (5) This subsection applies if the approved pharmacist has informed the person presenting the prescription of:\n (a) each substitute benefit that the approved pharmacist can supply instead of the prescribed benefit; and\n (b) for each substitute benefit that the approved pharmacist can supply:\n (i) the amount (which may be a nil amount) that the approved pharmacist would, if the approved pharmacist supplied the substitute benefit to the person for whom the prescribed benefit was prescribed, be permitted by Part VII of the Act to charge that person for that supply; and\n (ii) the amount that the approved pharmacist would, if the approved pharmacist supplied the substitute benefit otherwise than under Part VII of the Act to the person for whom the prescribed benefit was prescribed, charge that person for that supply; and\n (c) the amount (which may be a nil amount) that the approved pharmacist would, if the approved pharmacist supplied the prescribed benefit to the person for whom it was prescribed, be permitted by Part VII of the Act to charge that person for that supply.\n Record of information justifying supply of substitute benefit\n (6) This subsection applies if the approved pharmacist records the information that the approved pharmacist used to support the decision to supply the substitute benefit, including the following statements:\n (a) a statement that the substitute benefit supplied is a pharmaceutical benefit determined under paragraph 89A(3)(a) of the Act;\n (b) a statement that the conditions in this section are satisfied;\n (c) a statement that the approved pharmacist is satisfied that the substitute benefit needs to be supplied because:\n (i) the approved pharmacist cannot supply the prescribed benefit; and\n (ii) it is not practicable for the person to obtain a prescription for the substitute benefit from a PBS prescriber before the person needs the supply of the prescribed benefit.\n Arrangements to inform PBS prescriber of substitution\n (7) This subsection applies if the approved pharmacist has in place arrangements for giving, to the PBS prescriber who wrote the prescription for the prescribed benefit, written notice of the supply of the substitute benefit, within 72 hours after that supply.\n Table of prescribed and substitute pharmaceutical benefits\n (8) For the purposes of subsection (1), the table is as follows.\n\n```html\n

Prescribed and substitute pharmaceutical benefits

Item

Column 1
Prescribed pharmaceutical benefit

Column 2
Substitute pharmaceutical benefit

1.

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 25

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

2.

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 25

3.

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

4.

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 25

5.

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

6.

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

7.

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 25

8.

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

9.

Listed drug: Estradiol

Form: Transdermal patches 1.17 mg, 8

Manner of administration: Transdermal

Brand: Estradot 75

Listed drug: Estradiol

Form: Transdermal patches 585 micrograms, 8

Manner of administration: Transdermal

Brand: any of the following:

(a) Estradot 37.5

(b) Estradiol Transdermal System (Sandoz, USA)

10.

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand: Estradot 100

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 100

11.

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand: Estradot 100

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

12.

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand: Estradot 100

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

13.

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 100

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand: any of the following:

(a) Estradot 100

(b) Estradiol Transdermal System (Sandoz, USA)

14.

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 100

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

15.

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 100

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

16.

Listed drug: Insulin isophane

Form: Injections (human), cartridges, 100 units per mL, 3 mL, 5

Manner of administration: Injection

Brand: Protaphane InnoLet

Listed drug: Insulin isophane

Form: Injections (human), cartridges, 100 units per mL, 3 mL, 5

Manner of administration: Injection

Brand: Protaphane Penfill 3 mL

17.

Listed drug: Nicorandil

Form: Tablets 10 mg, 60

Manner of administration: Oral

Brand: APO‑Nicorandil

Listed drug: Nicorandil

Form: Tablets 20 mg, 60

Manner of administration: Oral

Brand: any of the following:

a) APO‑Nicorandil

b) Ikotab

18.

Listed drug: Nicorandil

Form: Tablets 10 mg, 60

Manner of administration: Oral

Brand: Ikotab

Listed drug: Nicorandil

Form: Tablets 20 mg, 60

Manner of administration: Oral

Brand: any of the following:

a) APO‑Nicorandil

b) Ikotab

19.

Listed drug: Nicorandil

Form: Tablets 20 mg, 60

Manner of administration: Oral

Brand: APO‑Nicorandil

Listed drug: Nicorandil

Form: Tablets 10 mg, 60

Manner of administration: Oral

Brand: any of the following:

a) APO‑Nicorandil

b) Ikotab

20.

Listed drug: Nicorandil

Form: Tablets 20 mg, 60

Manner of administration: Oral

Brand: Ikotab

Listed drug: Nicorandil

Form: Tablets 10 mg, 60

Manner of administration: Oral

Brand: any of the following:

a) APO‑Nicorandil

b) Ikotab

21

Listed drug: Simvastatin

Form: Tablet 5 mg

Manner of administration: Oral

Brand: Zimstat

Listed drug: Simvastatin

Form: Tablet 10 mg

Manner of administration: Oral

Brand: any of the following:

a) APO-Simvastatin

b) SIMVASTATIN-WGR

c) Simvar 10

d) Simvastatin Sandoz

e) Zimstat

22

Listed drug: Clonidine

Form: Tablet containing clonidine hydrochloride 150 micrograms

Manner of administration: Oral

Brand: Catapres

Listed drug: Clonidine

Form: Tablet containing clonidine hydrochloride 100 micrograms

Manner of administration: Oral

Brand: any of the following:

a) APO-Clonidine

b) Catapres 100

c) Clonidine Lupin

\n```","sortOrder":3}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"Yes. The Determination temporarily authorises approved pharmacists to dispense specified substitute PBS medicines without a new prescriber prescription where the prescribed product cannot be supplied and it is not practicable for the patient to obtain a new prescription (s5(1), s5(2)–(3)). It therefore relaxes the usual prescription-only dispensing requirement for the particular listed items (table at s5(8)), subject to conditions including TGA dispensability (s5(4)), patient disclosure (s5(5)), recordkeeping (s5(6)) and prescriber notification within 72 hours (s5(7))."},"complexity_factors":["Multiple cumulative conditions must be satisfied before substitution is allowed (s5(1) and s5(2)–(7)); error risk if any element is missed.","Cross-reference to the Therapeutic Goods Act (s5(4)) creates dependency on external statutory test (s30EL) for dispensability.","Extensive, product-specific table listing interchangeable brands, forms and strengths (s5(8)) increases operational detail and matching burden.","Mandatory patient information and price comparisons required (s5(5)) create communication and billing complexity for pharmacists.","Recordkeeping requirement to state specific justifications and statutory basis (s5(6)) adds administrative compliance burden.","Notification obligation to the PBS prescriber within a 72‑hour window (s5(7)) imposes a tight reporting timeframe.","Requirement that the pharmacist and premises be 'approved' links to approval regimes in Part VII (definitions and s5(1)), limiting who can act.","Subjective practicability test for obtaining a new prescription (s5(3)) and the pharmacist’s satisfaction that prescribed benefit cannot be supplied (s5(2)) introduce discretionary judgement calls.","Scope is narrow (only listed items) but granular (brands, doses, formulations), raising substitutability and stock-management issues at the retail level."],"plain_english_summary":"This Determination lets an approved pharmacist supply a specific listed PBS medicine as a substitute without a new prescription when the prescribed product is unavailable and the patient needs it sooner than a prescriber can be seen. The pharmacist must be working at an approved premises, may only substitute items listed in the table, inform the patient of permitted PBS charges and any alternative charges, keep a record of the decision, and notify the original prescriber within 72 hours. It affects approved pharmacists, PBS prescribers and patients who use the listed medicines."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: enabling pharmacist substitution during medicine shortages. The scope is limited to 22 specific medicine swaps (primarily estradiol patches, insulin, nicorandil, simvastatin, and clonidine) and does not appear to have expanded beyond this targeted shortage-response mechanism."},"complexity_factors":["Multiple cumulative conditions in section 5 (6 separate subsections must all be satisfied)","Cross-reference to external legislation (Therapeutic Goods Act 1989, section 30EL)","Detailed tabular schedule with 22 specific medicine substitutions specifying exact brands, dosages, and forms","Defined terms rely on definitions in Part VII of the National Health Act 1953 (external incorporation)","Record-keeping requirements with specific mandatory statements","Time-bound obligation (72-hour notification to prescriber)"],"plain_english_summary":"This rule lets pharmacists substitute listed PBS medicines for an out‑of‑stock prescribed product without a new prescription, provided strict conditions are met (can't obtain original, patient can't reasonably get a new script, recordkeeping, cost explanation, notify prescriber). It affects patients on the listed therapies, dispensing pharmacists, and prescribers, and ensures continuity of essential treatment during shortages."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-pharmaceutical-benefits-pharmacist-substitution-of-medicines-without-prescription-du","history":"/api/acts/national-health-pharmaceutical-benefits-pharmacist-substitution-of-medicines-without-prescription-du/history","analysis":"/api/acts/national-health-pharmaceutical-benefits-pharmacist-substitution-of-medicines-without-prescription-du/analysis","conflicts":"/api/acts/national-health-pharmaceutical-benefits-pharmacist-substitution-of-medicines-without-prescription-du/conflicts","importantCases":"/api/acts/national-health-pharmaceutical-benefits-pharmacist-substitution-of-medicines-without-prescription-du/important-cases","documents":"/api/acts/national-health-pharmaceutical-benefits-pharmacist-substitution-of-medicines-without-prescription-du/documents"}}