National Health Act 1953 Determination under paragraph 98C(1)(b) conditions (No. PB 52 of 2007) (Cth)
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 2008Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, CanberraDetermination – conditions (PB 52 of 2007)
Commencement [see Note 1]
1. This instrument commences on 1 August 2007.
Repeal
2. Instrument No. 34 of 2007 as amended is repealed.
Definitions
3. “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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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 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
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 suspension 250 mg (as magnesium) 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
Water For Injections ‑ sterilised BP
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 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 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 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
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 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 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 suspension 250 mg (as magnesium) 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 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 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 mL
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
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 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 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 —
Notes to the Determination — Conditions (PB 52 of 2007)
Note 1
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.
Table of Instruments
| Title | Date of FRLI Registration | Date of | Application, saving or |
| 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 | — |
Table of Amendments
| ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
| Provision affected | How affected |
| S. 3....................................................... | am. PB 82 of 2007 |
| Schedule 1 | |
| Schedule 1......................................... | am. PB 45 and 54 of 2008 |
| Schedule 3 | |
| Schedule 3......................................... | am. PB 34 of 2008 |
| Schedule 4 | |
| Schedule 4......................................... | am. PB 77 of 2007; PB 4, 11, 18, 34, 45, 54 and 64 of 2008 |
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