{"id":"F2008L02618","name":"National Health Act 1953 - Determination under paragraph 98C(1)(b) - conditions (No. PB 79 of 2008)","slug":"national-health-act-1953-determination-under-paragraph-98c-1-b-conditions-no-pb-79-of-2008","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":74639,"registerId":"commonwealth-F2008L02618-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health Act 1953 - Determination under paragraph 98C(1)(b) - conditions (No. PB 79 of 2008)","content":"![](image.001.png)\n\nDetermination — Conditions (PB 79 of 2008)\n\nas amended\n\nmade under paragraph 98C(1)(b) of the\n\nNational Health Act 1953\n\nThis compilation was prepared on 30 November 2008 \ntaking into account amendments up to PB 111 of 2008\n\nPrepared by the Office of Legislative Drafting and Publishing, \nAttorney‑General’s Department, Canberra\n\nDetermination – conditions (PB 79 of 2008)\n\nCommencement\n\n1. This instrument commences on 1 August 2008.\n\nRepeal\n\n2. Instrument number PB 52 of 2007 is repealed.\n\nDefinitions\n\n3. “Act” means the National Health Act 1953;\n\n“approved price to pharmacists” has the same meaning as in subsection 98B(3) of the Act;\n\n“Commonwealth price” has the same meaning as in subsection 84(1) of the Act;\n\n“extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit;\n\n“prescription” includes a prescription written on an authority prescription made under regulation 13 of the Regulations, a prescription required to be submitted to the Chief Executive Officer of Medicare Australia for the purposes of a determination made under subsection 85(2A) or subsection 85A(2) of the Act, a repeat authorisation, or a deferred supply authorisation;\n\n“ready-prepared pharmaceutical benefit” means a listed brand of a pharmaceutical item;\n\n“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act;\n\n“standard formula preparation” means an extemporaneously-prepared pharmaceutical benefit that is listed in Schedule 5 to this Determination.\n\nSchedules\n\n4. For the supply of pharmaceutical benefits:\n\n(a) pharmaceutical benefits that involve the admixture of ready-prepared ingredients are set out in Schedule 1;\n\n(b) drugs that are used in the preparation of extemporaneously-prepared pharmaceutical benefits and that are unstable or packed sterile and unused quantities of which are unsuitable for future use are set out in Schedule 2 ;\n\n(c) pharmaceutical benefits that are classified as dangerous drugs for the purpose of payment of a dangerous drug fee are pharmaceutical benefits that have the pharmaceutical items which have the listed drug in the form set out in Schedule 3 to this Determination;\n\n(d) pharmaceutical benefits the complete pack of which shall be supplied regardless of any lesser quantity ordered are pharmaceutical benefits that have the pharmaceutical items which have the listed drug in the form set out in Schedule 4.\n\nBrand identified\n\n5. Where a prescription identifies the ready-prepared pharmaceutical benefit to be supplied by reference to a particular brand, the amount payable shall be based on the approved price to pharmacists for that brand.\n\nBrand not identified\n\n6. Where a prescription does not identify the ready-prepared pharmaceutical benefit to be supplied by reference to a particular brand, the amount payable shall be based on the approved price to pharmacists of the brand of that benefit, being a brand which is available from a wholesale source in the capital city of the State in which the benefit is supplied, for which the Commonwealth price for the supply of the benefit is lowest.\n\nPacks\n\n7. Where a prescription calls for a quantity of one of the pharmaceutical benefits that have the pharmaceutical items which have the form of the listed drug set out in Schedule 4 that is less than the quantity contained in the size of unit included in the particulars specified in the column headed 'Form' in that Schedule in relation to that benefit, the complete pack shall be supplied.\n\nVariation of medicinal preparation\n\n8. A medicinal preparation that is a variation of a standard formula preparation, due to the addition or deletion of an ingredient or to variation of the dose, or that is a combination of standard formula preparations, shall be deemed not to be a standard formula preparation.\n\nElection – extemporaneously-prepared pharmaceutical benefits\n\n9. An election made pursuant to paragraph 38 of the determination made under subsection 98B(1) of the Act shall be made in writing to the Chief Executive Officer of Medicare Australia and shall remain in force for a period of not less than 3 months from and including the date of election, but may be revoked in writing at any time after the expiration of that period; and while the election remains in force, the amount payable to the approved pharmacist or approved medical practitioner, in respect of the supply of an extemporaneously-prepared pharmaceutical benefit that is not a standard formula preparation, shall be the amount calculated in accordance with paragraph 21 of the determination made under subsection 98B(1) of the Act.\n\n```html\n

SCHEDULE 1 – PHARMACEUTICAL BENEFITS THAT INVOLVE THE ADMIXTURE OF READY
PREPARED INGREDIENTS

Listed Drug

Form (strength, type, size, etc.)

Amoxycillin with Water – Purified BP

Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Amoxycillin with Clavulanic Acid and Water – Purified BP

Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

Azithromycin with Water – Purified BP

Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL

Cefaclor with Water – Purified BP

Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

Cephalexin with Water – Purified BP

Granules for oral suspension 125 mg per 5 mL, 100 mL

Granules for oral suspension 250 mg per 5 mL, 100 mL

Clarithromycin with Water – Purified BP

Powder for oral liquid 250 mg per 5 mL, 50 mL

Erythromycin with Water – Purified BP

Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL

Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL

Flucloxacillin with Water – Purified BP

Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL

Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL

Mycophenolic Acid with Water – Purified BP

Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

\n```\n\n```html\n

SCHEDULE 2 – DRUGS THAT ARE USED IN THE PREPARATION OF EXTEMPORANEOUSLY-PREPARED PHARMACEUTICAL BENEFITS AND THAT ARE UNSTABLE OR PACKED STERILE AND UNUSED QUANTITIES OF WHICH ARE UNSUITABLE FOR FUTURE USE

Listed Drug

Form (strength, type, size, etc.)

Water For Injections—sterilised BP

\n```\n\n```html\n

SCHEDULE 3 – PHARMACEUTICAL BENEFITS THAT ARE CLASSIFIED AS DANGEROUS DRUGS FOR THE PURPOSE OF PAYMENT OF A DANGEROUS DRUG FEE

Listed Drug

Form (strength, type, size, etc.)

Buprenorphine

Transdermal patch 5 mg

Transdermal patch 10 mg

Transdermal patch 20 mg

Codeine

Tablet containing codeine phosphate 30 mg

Dexamphetamine

Tablet containing dexamphetamine sulfate 5 mg

Fentanyl

Lozenges 200 micrograms (as citrate), 3

Lozenges 400 micrograms (as citrate), 3

Lozenges 600 micrograms (as citrate), 3

Lozenges 800 micrograms (as citrate), 3

Lozenges 1200 micrograms (as citrate), 3

Lozenges 1600 micrograms (as citrate), 3

Transdermal patch 2.1 mg

Transdermal patch 4.2 mg

Transdermal patch 8.4 mg

Transdermal patch 12.6 mg

Transdermal patch 16.8 mg

Hydromorphone

Tablet containing hydromorphone hydrochloride 2 mg

Tablet containing hydromorphone hydrochloride 4 mg

Tablet containing hydromorphone hydrochloride 8 mg

Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL

Injection containing hydromorphone hydrochloride 2 mg in 1 mL

Injection containing hydromorphone hydrochloride 10 mg in 1 mL

Injection containing hydromorphone hydrochloride 50 mg in 5 mL

Injection containing hydromorphone hydrochloride 500 mg in 50 mL

Methadone

Tablet containing methadone hydrochloride 10 mg

Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL

Injection containing methadone hydrochloride 10 mg in 1 mL

Methylphenidate

Tablet containing methylphenidate hydrochloride 10 mg

Tablet containing methylphenidate hydrochloride 18 mg (extended release)

Tablet containing methylphenidate hydrochloride 27 mg (extended release)

Tablet containing methylphenidate hydrochloride 36 mg (extended release)

Tablet containing methylphenidate hydrochloride 54 mg (extended release)

Capsule containing methylphenidate hydrochloride 20 mg (modified release)

Capsule containing methylphenidate hydrochloride 30 mg (modified release)

Capsule containing methylphenidate hydrochloride 40 mg (modified release)

Morphine

Tablet containing morphine sulfate 10 mg

Tablet containing morphine sulfate 20 mg

Tablet containing morphine sulfate 30 mg

Tablet containing morphine sulfate 5 mg (controlled release)

Tablet containing morphine sulfate 10 mg (controlled release)

Tablet containing morphine sulfate 15 mg (controlled release)

Tablet containing morphine sulfate 30 mg (controlled release)

Tablet containing morphine sulfate 60 mg (controlled release)

Tablet containing morphine sulfate 100 mg (controlled release)

Tablet containing morphine sulfate 200 mg (controlled release)

Capsule containing morphine sulfate 10 mg (containing sustained release pellets)

Capsule containing morphine sulfate 20 mg (containing sustained release pellets)

Capsule containing morphine sulfate 30 mg (controlled release)

Capsule containing morphine sulfate 50 mg (containing sustained release pellets)

Capsule containing morphine sulfate 60 mg (controlled release)

Capsule containing morphine sulfate 90 mg (controlled release)

Capsule containing morphine sulfate 100 mg (containing sustained release pellets)

Capsule containing morphine sulfate 120 mg (controlled release)

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet

\n```\n\n```html\n

SCHEDULE 3 – PHARMACEUTICAL BENEFITS THAT ARE CLASSIFIED AS DANGEROUS DRUGS FOR THE PURPOSE OF PAYMENT OF A DANGEROUS DRUG FEE — continued

Listed Drug

Form (strength, type, size, etc.)

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet

Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet

Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL

Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL

Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL

Injection containing morphine sulfate 10 mg in 1 mL

Injection containing morphine tartrate 120 mg in 1.5 mL

Injection containing morphine sulfate 15 mg in 1 mL

Injection containing morphine sulfate 30 mg in 1 mL

Oxycodone

Tablet containing oxycodone hydrochloride 5 mg

Capsule containing oxycodone hydrochloride 5 mg

Capsule containing oxycodone hydrochloride 10 mg

Capsule containing oxycodone hydrochloride 20 mg

Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL

Tablet containing oxycodone hydrochloride 5 mg (controlled release)

Tablet containing oxycodone hydrochloride 10 mg (controlled release)

Tablet containing oxycodone hydrochloride 20 mg (controlled release)

Tablet containing oxycodone hydrochloride 40 mg (controlled release)

Tablet containing oxycodone hydrochloride 80 mg (controlled release)

Suppository 30 mg (as pectinate)

\n```\n\n```html\n

SCHEDULE 4 – PHARMACEUTICAL BENEFITS THE COMPLETE PACK OF WHICH SHALL BE SUPPLIED REGARDLESS OF ANY LESSER QUANTITY ORDERED

Listed Drug

Form (strength, type, size, etc.)

Aciclovir

Eye ointment 30 mg per g, 4.5 g

Amoxycillin

Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Amoxycillin with Clavulanic Acid

Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

Apraclonidine

Eye drops 5 mg (as hydrochloride) per mL, 10 mL

Aprepitant

Pack containing 1 capsule 125 mg and 2 capsules 80 mg

Atovaquone

Oral suspension 750 mg per 5 mL, 210 mL

Atropine

Eye drops containing atropine sulfate 10 mg per mL, 15 mL

Azithromycin

Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL

Beclomethasone

Pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation)

Pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)

Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation)

Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)

Benzydamine

Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL

Betamethasone

Cream 500 micrograms (as dipropionate) per g, 15 g

Ointment 500 micrograms (as dipropionate) per g, 15 g

Cream 500 micrograms (as valerate) per g, 15 g

Ointment 500 micrograms (as valerate) per g, 15 g

Betaxolol

Eye drops, suspension, 2.5 mg (as hydrochloride) per mL, 5 mL

Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Bisacodyl

Enemas 10 mg in 5 mL, 25

Brimonidine

Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

Brimonidine with Timolol

Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL

Brinzolamide

Eye drops 10 mg per mL, 5 mL

Budesonide

Nebuliser suspension 500 micrograms in 2 mL single dose units, 30

Nebuliser suspension 1 mg in 2 mL single dose units, 30

Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses

Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses

Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses

Budesonide with Eformoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Calcipotriol

Ointment 50 micrograms per g, 30 g

Cream 50 micrograms (as monohydrate) per g, 30 g

Scalp solution 50 micrograms (as monohydrate) per mL, 30 mL

Captopril

Oral solution 5 mg per mL, 95 mL

Carbamazepine

Oral suspension 100 mg per 5 mL, 300 mL

Carbomer 980

Ocular lubricating gel 2 mg per g, 10 g

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 15 mL

Eye drops containing carmellose sodium 10 mg per mL, 15 mL

\n```\n\n \n\n```html\n

SCHEDULE 4 – PHARMACEUTICAL BENEFITS THE COMPLETE PACK OF WHICH SHALL BE SUPPLIED REGARDLESS OF ANY LESSER QUANTITY ORDERED — continued

Listed Drug

Form (strength, type, size, etc.)

Mouth spray containing carmellose sodium 10 mg per mL, 25 mL

Mouth spray containing carmellose sodium 10 mg per mL, 100 mL

Carmustine

Implants 7.7 mg, 8

Cefaclor

Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

Cephalexin

Granules for oral suspension 125 mg per 5 mL, 100 mL

Granules for oral suspension 250 mg per 5 mL, 100 mL

Clarithromycin

Powder for oral liquid 250 mg per 5 mL, 50 mL

Chloramphenicol

Ear drops (aqueous) 5 mg per mL, 5 mL

Eye drops 5 mg per mL, 10 mL

Eye ointment 10 mg per g, 4 g

Chlorpromazine

Oral solution containing chlorpromazine hydrochloride 25 mg per 5 mL, 100 mL

Cholestyramine

Sachets containing 9.4 g oral powder (equivalent to 8 g cholestyramine), 50

Ciclesonide

Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation)

Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation)

Ciprofloxacin

Ear drops 3 mg (as hydrochloride) per mL, 5 mL

Clonazepam

Oral liquid 2.5 mg per mL, 10 mL

Coal Tar - Prepared

Gel 10 mg per g, 100 mL

Colestipol

Oral powder, sachets containing colestipol hydrochloride 5 g, 120

Cromoglycic Acid

Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses

Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC-free formulation)

Pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC-free formulation)

Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL

Desmopressin

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL

Dexamethasone

Eye drops 1 mg per mL, 5 mL

Dexamethasone with Framycetin and Gramicidin

Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL

Dorzolamide

Eye drops 20 mg (as hydrochloride) per mL, 5 mL

Dorzolamide with Timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Eformoterol

Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 6 micrograms per dose, 60 doses

Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Electrolyte Replacement, Oral

Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10

Erythromycin

Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL

Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL

Escitalopram

Oral solution 10 mg (as oxalate) per mL, 28 mL

Esomeprazole and Clarithromycin and Amoxycillin

Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)

Ethosuximide

Oral solution 250 mg per 5 mL, 200 mL

Etidronic Acid and Calcium

Pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium 500 mg (as carbonate)

Ferrous Sulfate

Oral liquid 30 mg per mL, 250 mL

Flucloxacillin

Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL

Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL

Fluorometholone

Eye drops 1 mg per mL, 5 mL

Eye drops containing fluorometholone acetate 1 mg per mL, 5 mL

Fluticasone

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses

Fluticasone with Salmeterol

Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Framycetin

Eye or ear drops containing framycetin sulfate 5 mg per mL, 8 mL

Frusemide

Oral solution 10 mg per mL, 30 mL

Gentamicin

Eye drops 3 mg (as sulfate) per mL, 5 mL

Glucose Indicator—Blood

Electrode strips, 100 (FreeStyle Lite)

Electrode strips, 100 (Optium glucose)

Electrode strips, 100 (Precision Plus)

Electrode strips, 100 (SofTact)

Electrode strips, 100 (TrueSense)

Glyceryl Trinitrate

Tablets 600 micrograms, 100

Sublingual spray (pump pack) 400 micrograms per dose, 200 doses

Goserelin and Bicalutamide

Pack containing 1 subcutaneous implant containing goserelin 3.6 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg

Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg

Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 84 tablets bicalutamide 50 mg

Haloperidol

Oral solution 2 mg per mL, 100 mL

Homatropine

Eye drops containing homatropine hydrobromide 20 mg per mL, 15 mL

Hydrocortisone

Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g

Eye ointment containing hydrocortisone acetate 10 mg per g, 5 g

Cream 10 mg per g, 50 g

Cream containing hydrocortisone acetate 10 mg per g, 30 g

Cream containing hydrocortisone acetate 10 mg per g, 50 g

Ointment containing hydrocortisone acetate 10 mg per g, 30 g

Ointment containing hydrocortisone acetate 10 mg per g, 50 g

Hypromellose

Eye drops 3 mg per mL, 15 mL

Eye drops 5 mg per mL, 15 mL

Hypromellose with Carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Hypromellose with Dextran

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

Ketoconazole

Cream 20 mg per g, 30 g

Shampoo 10 mg per g, 100 mL

Shampoo 20 mg per g, 60 mL

Lactulose

Solution BP 3.34 g per 5 mL, 500 mL

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Latanoprost with Timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Leflunomide

Pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Levobunolol

Eye drops containing levobunolol hydrochloride 2.5 mg per mL, 5 mL

Macrogol 3350

Sachets containing powder for oral solution 6.563 g with electrolytes, 30

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Memantine

Oral drops containing memantine hydrochloride 10 mg per g, 50 g

Mesalazine

Suppositories 1 g, 28

Methylprednisolone

Cream containing methylprednisolone aceponate 1 mg per g, 15 g

Ointment containing methylprednisolone aceponate 1 mg per g, 15 g

Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g

Lotion containing methylprednisolone aceponate 1 mg per g, 20 g

Metoprolol succinate

Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release)

Metronidazole

Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL

Suppositories 500 mg, 10

Miconazole

Cream containing miconazole nitrate 20 mg per g, 30 g

Cream containing miconazole nitrate 20 mg per g, 70 g

Powder containing miconazole nitrate 20 mg per g, 30 g

Tincture 20 mg per mL, 30 mL

Lotion containing miconazole nitrate 20 mg per mL, 30 g

Mineral mixture

Oral powder 250 g (Metabolic Mineral Mixture)

Mometasone

Cream containing mometasone furoate 1 mg per g, 15 g

Ointment containing mometasone furoate 1 mg per g, 15 g

Lotion containing mometasone furoate 1 mg per g, 30 mL

Mycophenolic Acid

Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

Nafarelin

Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses

Naproxen

Oral suspension 125 mg per 5 mL, 474 mL

Nedocromil

Pressurised inhalation containing nedocromil sodium 2 mg per dose, 112 doses (CFC-free formulation)

Neomycin with Bacitracin

Ear ointment 3.5 mg neomycin (as undecenoate) with bacitracin zinc 400 units per g, 10 g

Nicorandil

Tablets 10 mg, 60

Tablets 20 mg, 60

Nystatin

Oral suspension 100,000 units per mL, 24 mL

Oestradiol

Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28

Transdermal patches 390 micrograms, 8

Transdermal patches 750 micrograms (as hemihydrate), 8

Transdermal patches 2 mg, 4

Transdermal patches 2 mg, 8

Transdermal patches 585 micrograms, 8

Transdermal patches 1.5 mg (as hemihydrate), 8

Transdermal patches 3.8 mg, 4

Transdermal patches 4 mg, 8

Transdermal patches 780 micrograms, 8

Transdermal patches 5.7 mg, 4

Transdermal patches 1.17 mg, 8

Transdermal patches 3 mg (as hemihydrate), 8

Transdermal patches 7.6 mg, 4

Transdermal patches 8 mg, 8

Transdermal patches 1.56 mg, 8

Vaginal tablets 25 micrograms, 15

Oestradiol and Oestradiol with Dydrogesterone

Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg

Oestradiol and Oestradiol with Norethisterone

Pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg

Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate

Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate

Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg

Oestradiol with Norethisterone

Tablets containing 1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28

Tablets containing 2 mg oestradiol (as hemihydrate) with 1 mg norethisterone acetate, 28

Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8

Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8

Oestriol

Pessaries 500 micrograms, 15

Vaginal cream 1 mg per g, 15 g

Oestrogens—Conjugated with Medroxyprogesterone

Tablets containing conjugated oestrogens 625 micrograms with medroxyprogesterone acetate 2.5 mg, 28

Tablets containing conjugated oestrogens 625 micrograms with medroxyprogesterone acetate 5 mg, 28

Omeprazole and Clarithromycin and Amoxycillin

Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)

Ondansetron

Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

Paracetamol

Oral liquid 120 mg per 5 mL, 100 mL

Oral liquid 240 mg per 5 mL, 200 mL

Suppositories 500 mg, 24

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Permethrin

Cream 50 mg per g, 30 g

Phenoxybenzamine

Capsules containing phenoxybenzamine hydrochloride 10 mg, 100

Phenytoin

Oral suspension 30 mg per 5 mL, 500 mL

Pilocarpine

Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL

Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL

Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL

Eye drops containing pilocarpine hydrochloride 60 mg per mL, 15 mL

Pimecrolimus

Cream 10 mg per g, 15 g

Polyethylene Glycol 400 with Propylene Glycol

Eye drops 4 mg-3 mg per mL, 15 mL

Polyvinyl Alcohol

Eye drops 14 mg per mL, 15 mL

Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)

Eye drops 30 mg per mL, 15 mL

Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)

Prednisolone

Oral solution 5 mg (as sodium phosphate) per mL, 30 mL

Prednisolone with Phenylephrine

Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL

Prochlorperazine

Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5

Promethazine

Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL

Quinagolide

Pack containing 3 tablets quinagolide 25 micrograms (as hydrochloride) and 3 tablets quinagolide 50 micrograms (as hydrochloride)

Ramipril

Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg

Reteplase

Pack containing 2 vials powder for injection 10 units, 2 single use pre-filled syringes with solvent, 2 reconstitution spikes and 2 needles

Rifampicin

Syrup 100 mg per 5 mL, 60 mL

Risedronic Acid and Calcium

Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)

Risedronic acid and calcium with colecalciferol

Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms

Risperidone

Oral solution 1 mg per mL, 100 mL

Rivastigmine

Oral solution 2 mg (as hydrogen tartrate) per mL, 120 mL

Salbutamol

Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30

Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

Salmeterol

Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses

Silver Sulfadiazine with Chlorhexidine

Cream containing silver sulfadiazine 10 mg with chlorhexidine gluconate 2 mg per g, 50 g

Cream containing silver sulfadiazine 10 mg with chlorhexidine gluconate 2 mg per g, 100 g

Sirolimus

Oral solution 1 mg per mL, 60 mL

Sterculia with Frangula Bark

Granules 620 mg-80 mg per g, 500 g

Sulfacetamide

Eye drops containing sulfacetamide sodium 100 mg per mL, 15 mL

Terbutaline

Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses

Testosterone

Transdermal gel 50 mg in 5 g sachet, 30

Transdermal patches 12.2 mg, 60

Transdermal patches 24.3 mg, 30

Theophylline

Oral solution 133.3 mg per 25 mL, 500 mL

Timolol

Eye gel 1 mg (as maleate) per g, 5 g

Eye drops 2.5 mg (as maleate) per mL, 5 mL

Eye drops 5 mg (as maleate) per mL, 5 mL

Eye drops (gellan gum solution) 2.5 mg (as maleate) per mL, 2.5 mL

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL

Tobramycin

Eye drops 3 mg per mL, 5 mL

Eye ointment 3 mg per g, 3.5 g

Tramadol

Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL

Travoprost

Eye drops 40 micrograms per mL, 2.5 mL

Travoprost with Timolol

Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Triamcinolone with Neomycin, Gramicidin and Nystatin

Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL

Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g

Trimethoprim with Sulfamethoxazole

Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL

Varenicline

Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack

\n```\n\n```html\n

SCHEDULE 5 – LIST OF STANDARD FORMULA PREPARATIONS

Form of pharmaceutical benefit

Standard formula preparations

Creams

Salicylic Acid and Sulfur Aqueous APF

Dusting Powders

Zinc, Starch and Talc APF 15

Zinc, Starch and Talc BPC 1973

Ear Drops

Aluminium Acetate APF

Aluminium Acetate BP

Sodium Bicarbonate APF

Sodium Bicarbonate BP

Spirit APF

Eye Drops containing Cocaine Hydrochloride BP

—

Eye Drops, Other

—

Eye Lotions

—

Inhalations

Benzoin and Menthol APF

Menthol APF

Menthol and Eucalyptus BP 1980

Linctuses containing Codeine Phosphate

Codeine APF

Linctuses, Other

—

Lotions

Aluminium Acetate Aqueous APF

Mixtures containing Codeine Phosphate

—

Mixtures, Other

Gentian Alkaline APF

Kaolin BPC 1968

Kaolin and Opium APF 14

Magnesium Trisilicate BPC 1968

Magnesium Trisilicate and Belladonna BPC 1968

Mixtures for Children containing Codeine Phosphate BP

—

Mixtures for Children, Other

—

Mouth Washes

Thymol Compound APF 15

Nasal Instillations

—

Ointments, Waxes

Benzoic Acid Compound APF

Benzoic Acid Compound (extemporaneous formula) BP

Boric Acid, Olive Oil and Zinc Oxide QHF

Salicylic Acid APF

Salicylic Acid (extemporaneous formula) BP

Paints

Podophyllin Compound APF 16

Podophyllin Compound BP

Salicylic Acid APF

Pastes containing Cocaine Hydrochloride BP

—

Pastes, Other

Zinc APF

Zinc Compound (extemporaneous formula) BP

Powders for Internal Use

Magnesium Trisilicate BP

Solutions

—

\n```\n\n> Notes to the Determination — Conditions (PB 79 of 2008)\n\n> Note 1\n\n> Note: The Determination — Conditions (PB 79 of 2008) (in force under paragraph 98C(1)(b) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.\n\n> Note: > Note: Table of Instruments\n\n| Title | Date of FRLI Registration | Date ofcommencement | Application, saving ortransitional provisions |\n| -------------- | ------------------------------ | ------------------- | --------------------------------------------- |\n| PB 79 of 2008 | 28 July 2008 (see F2008L02618) | 1 Aug 2008 | |\n| PB 89 of 2008 | 13 Aug 2008 (see F2008L03062) | 1 Sept 2008 | — |\n| PB 105 of 2008 | 13 Oct 2008 (see F2008L03781) | 14 Oct 2008 | — |\n| PB 111 of 2008 | 11 Nov 2008 (see F2008L04303) | (a) | — |\n\n> Note: (a) Section 1 of PB 109 of 2008 provides as follows:\n\n> Note: 1. Commencement\n\n> Note: This instrument commences at 11.59 pm on 30 November 2008.\n\n> Note: > Note: Table of Amendments\n\n```html\n

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

Provision affected

How affected

Schedule 1

Schedule 1.................

am. PB 89 of 2008

Schedule 4

Schedule 4.................

am. PB 89, 105 and 111 of 2008

\n```","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":3041},"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This determination replaces a previous instrument (PB 52 of 2007) and operates within the established scope of setting supply conditions for pharmaceutical benefits. The content consists of updated drug listings and standard operational rules consistent with the original legislative intent for PBS administration."},"complexity_factors":["Seven defined terms incorporating concepts from the parent Act and Regulations","Five schedules listing specific drug formulations with precise chemical strengths and pack sizes","Cross-references to sections 84, 85, 98B and 98C of the National Health Act 1953","Conditional logic for brand selection based on prescription identification and wholesale availability","Technical pharmaceutical classifications distinguishing ready-prepared from extemporaneously-prepared benefits"],"plain_english_summary":"This determination sets the rules pharmacists must follow when supplying subsidised PBS medicines: which products must be mixed or supplied as complete packs, which controlled drugs attract extra safety fees, when the prescriber's brand must be honored versus cheaper substitutes, and how pharmacists are paid for custom (extemporaneous) preparations. It affects patients, prescribers and pharmacists by ensuring safe preparation, consistent pricing and secure handling of high‑risk medicines."},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"The Determination updates and replaces the previous instrument (PB 52 of 2007) and amends the lists and conditions that implement paragraph 98C(1)(b) of the National Health Act. It does not create new statutory powers or extend the classes of persons covered; it narrows to operational rules (pricing, pack supply, elections and enumerated items) and records later amendments (PB 89, PB 105, PB 111 of 2008)."},"complexity_factors":["Extensive, technical drug lists across five schedules (many individual formulations and pack sizes)","Multiple cross-references to the National Health Act and Regulations and to defined pricing terms (eg, 'approved price to pharmacists', 'Commonwealth price')","Two-tier pricing rule that depends on whether a prescription names a brand (brand-identified vs brand-not-identified) with an algorithm for choosing the lowest Commonwealth price","Different treatment of extemporaneously-prepared benefits (standard formula vs variations) and an election procedure with a 3-month minimum term","Operational rules that impose supply constraints (complete-pack requirement in Schedule 4) creating inventory and dispensing implications","Amendment and repeal history (repeals PB 52 of 2007; amended by PB 89, PB 105, PB 111 of 2008) requiring users to track versions and commencement dates","Administrative obligations involving written notices to the Chief Executive Officer of Medicare Australia and potential compliance burdens for pharmacists and prescribers"],"plain_english_summary":"This Determination sets the conditions for supplying and paying for pharmaceutical benefits under the National Health Act. It defines key terms, fixes how payment is calculated (different rules when a brand is named or not), requires whole-pack supply for listed items, and lists drugs and preparation types (including dangerous drugs and standard extemporaneous formulas).\n\nIt affects approved pharmacists, approved medical practitioners, prescribers and Medicare Australia: prescribing and supply choices determine how much the Commonwealth pays and what pharmacists receive, and certain written elections and notices to the CEO of Medicare Australia are required."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-act-1953-determination-under-paragraph-98c-1-b-conditions-no-pb-79-of-2008","history":"/api/acts/national-health-act-1953-determination-under-paragraph-98c-1-b-conditions-no-pb-79-of-2008/history","analysis":"/api/acts/national-health-act-1953-determination-under-paragraph-98c-1-b-conditions-no-pb-79-of-2008/analysis","conflicts":"/api/acts/national-health-act-1953-determination-under-paragraph-98c-1-b-conditions-no-pb-79-of-2008/conflicts","importantCases":"/api/acts/national-health-act-1953-determination-under-paragraph-98c-1-b-conditions-no-pb-79-of-2008/important-cases","documents":"/api/acts/national-health-act-1953-determination-under-paragraph-98c-1-b-conditions-no-pb-79-of-2008/documents"}}