National Health Act 1953 - Determination under paragraph 98C(1)(b) - conditions (No. PB 52 of 2007)

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Determination — Conditions (PB 52 of 2007)

as amended

made under paragraph 98C(1)(b) of the

National Health Act 1953

This compilation was prepared on 1 July 2008
taking into account amendments up to PB 64 of 2008

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Determination – conditions (PB 52 of 2007)

Commencement [see Note 1]

This instrument commences on 1 August 2007.

Repeal

Instrument No. 34 of 2007 as amended is repealed.

Definitions

“Act” means the National Health Act 1953;

“approved price to pharmacists” has the same meaning as in subsection 98B(3) of the Act;

“Commonwealth price” has the same meaning as in subsection 84(1) of the Act;

“extemporaneously‑prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready‑prepared pharmaceutical benefit;

“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;

“ready‑prepared pharmaceutical benefit” means a listed brand of a pharmaceutical item;

“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act;

“standard formula preparation” means an extemporaneously‑prepared pharmaceutical benefit that is listed in Schedule 5 to this Determination.

Schedules

For the supply of pharmaceutical benefits:

(a) pharmaceutical benefits that involve the admixture of ready‑prepared ingredients are set out in Schedule 1;

(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;

(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;

(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.

Brand identified

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.

Brand not identified

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.

Packs

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.

Variation of medicinal preparation

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.

Election – extemporaneously‑prepared pharmaceutical benefits

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.

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 andWater – 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 mLPowder 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 mLPowder 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 mLGranules for oral suspension 250 mg per 5 mL, 100 mL
Erythromycin with Water – Purified BP	Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mLPowder 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 mLPowder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mLPowder 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


Water For Injections ‑ sterilised BP

Buprenorphine	Transdermal patch 5 mgTransdermal patch 10 mgTransdermal 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 mgOral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mLInjection 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
	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)

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 mLPowder 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 mLEye 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 dosesPowder 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 gCream 50 micrograms (as monohydrate) per g, 30 gScalp 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
	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 mLPowder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
Cephalexin	Granules for oral suspension 125 mg per 5 mL, 100 mLGranules for oral suspension 250 mg per 5 mL, 100 mL
Chloramphenicol	Ear drops (aqueous) 5 mg per mL, 5 mLEye drops 5 mg per mL, 10 mLEye 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
Dipivefrine	Eye drops containing dipivefrine hydrochloride 1 mg per mL, 10 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 dosesPowder 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 mLPowder 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 mLPowder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mLPowder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL
Fluorometholone	Eye drops 1 mg per mL, 5 mLEye 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, 100Sublingual 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 mgPack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre‑filled injection syringe and 28 tablets bicalutamide 50 mgPack 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 mLEye 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 gShampoo 10 mg per g, 100 mLShampoo 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
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, 30Sachets 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 mLSuppositories 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 gOintment containing mometasone furoate 1 mg per g, 15 gLotion 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, 60Tablets 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, 15Vaginal cream 1 mg per g, 15 g
Oestrogens—Conjugated with Medroxyprogesterone	Tablets containing conjugated oestrogens 625 micrograms with medroxyprogesterone acetate 2.5 mg, 28Tablets 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 mLOral liquid 240 mg per 5 mL, 200 mLSuppositories 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
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, 30 mLOral 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, 30Pressurised 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 gCream 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, 30Transdermal patches 12.2 mg, 60Transdermal 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 mLEye 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 mLEar 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

Creams	Salicylic Acid and Sulfur Aqueous APF
Dusting Powders	Zinc, Starch and Talc APF 15Zinc, 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 APFMenthol APFMenthol and Eucalyptus BP 1980
Linctuses containing Codeine Phosphate BP	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	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 16Podophyllin Compound BPSalicylic Acid APF
Pastes containing Cocaine Hydrochloride BP	—
Pastes, Other	Zinc APFZinc Compound (extemporaneous formula) BP
Powders for Internal Use	Magnesium Trisilicate BP
Solutions	—

Notes to the Determination — Conditions (PB 52 of 2007)

Note 1

Note: The Determination — Conditions (PB 52 of 2007) (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.

Note: > Note: Table of Instruments

Title	Date of FRLI Registration	Date ofcommencement	Application, saving ortransitional provisions
PB 52 of 2007	31 July 2007 (see F2007L02396)	1 Aug 2007
PB 77 of 2007	12 Sept 2007 (see F2007L03626)	1 Oct 2007	—
PB 82 of 2007	8 Oct 2007 (see F2007L03946)	1 Nov 2007	—
PB 4 of 2008	23 Nov 2007 (see F2007L04466)	1 Jan 2008	—
PB 11 of 2008	19 Dec 2007 (see F2007L04908)	1 Jan 2008	—
PB 18 of 2008	9 Jan 2008 (see F2008L00039)	1 Feb 2008	—
PB 34 of 2008	11 Mar 2008 (see F2008L00699)	1 Apr 2008	—
PB 45 of 2008	10 Apr 2008 (see F2008L01035)	1 May 2008	—
PB 54 of 2008	12 May 2008 (see F2008L01386)	1 June 2008	—
PB 64 of 2008	10 June 2008 (see F2008L02055)	1 July 2008	—

Note: > Note: Table of Amendments

<table cellspacing="0" cellpadding="0" style="width:448.05pt; margin-right:auto; margin-left:auto; border-collapse:collapse"><thead><tr><td colspan="2" style="width:437.25pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmendHead" style="margin-right:0pt"><span>ad. = added or inserted</span><span> </span><span>am. = amended</span><span> </span><span>rep. = repealed</span><span> </span><span>rs. = repealed and substituted</span></p></td></tr><tr><td style="width:142.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableColHead"><span>Provision affected</span></p></td><td style="width:283.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableColHead"><span>How affected</span></p></td></tr></thead><tbody><tr><td style="width:142.65pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>S. 3</span><span style="width:125.84pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">.......................</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>am. PB 82 of 2007</span></p></td></tr><tr><td style="width:142.65pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span style="font-weight:bold">Schedule 1</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span></span></p></td></tr><tr><td style="width:142.65pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>Schedule 1</span><span style="width:96.81pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">.................</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>am. PB 45 </span><span>and 54 </span><span>of 2008</span></p></td></tr><tr><td style="width:142.65pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span style="font-weight:bold">Schedule 3</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span></span></p></td></tr><tr><td style="width:142.65pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>Schedule 3</span><span style="width:96.81pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">.................</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span>am. PB 34 of 2008</span></p></td></tr><tr><td style="width:142.65pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span style="font-weight:bold">Schedule 4</span></p></td><td style="width:283.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt"><span></span></p></td></tr><tr><td style="width:142.65pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>Schedule 4</span><span style="width:96.81pt; text-indent:0pt; font-family:'Lucida Console', monospace; display:inline-block">.................</span></p></td><td style="width:283.8pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableOfAmend" style="margin-right:0pt; margin-bottom:3pt"><span>am. PB 77 of 2007; PB 4, 11, 18</span><span>, </span><span>34</span><span>, 45</span><span>,</span><span> 54 </span><span>and 64 </span><span>of 2008</span></p></td></tr></tbody></table>

National Health Act 1953 - Determination under paragraph 98C(1)(b) - conditions (No. PB 52 of 2007)

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National Health Act 1953 - Determination under paragraph 98C(1)(b) - conditions (No. PB 52 of 2007)

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1 National Health Act 1953 - Determination under paragraph 98C(1)(b) - conditions (No. PB 52 of 2007)