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Therapeutic Goods (Authorised Supply of Medicines) Rules 2019
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Administered by
Department of Health and Aged Care
This item is authorised by the following title:
Therapeutic Goods Act 1989
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F2019L01194
13 September 2019
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16 September 2020
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1 Name
2 Commencement
3 Authority
4 Definitions
5 Authorisation
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6 Schedules
Schedule 1—Medicines authorised for supply Note: See section 5. Specified therapeutic goods Column 1 Column 2 Column 3 Column 4 Column 5 Item Active ingredient Dosage form Route of administration Indication 1 allergens—multiple, various (including control solutions) drops intradermal confirmation of suspected allergic reactions 2 allergens – multiple, various (including control solutions) drops skin prick confirmation of suspected allergic reactions 3 amifampridine (3,4-diaminopyridine) tablet oral treatment of Lambert-Eaton Myasthenic Syndrome 4 bifidobacterium bifidum and Lactobacillus acidophilus capsule oral prevention of necrotising enterocolitis 5 betaxolol 0.25% (preservative free) eye drops ophthalmic treatment of elevated intraocular pressure where other treatments are inappropriate 6 bismuth subcitrate tablet oral treatment of resistant Helicobacter Pylori infection 7 buspirone tablet oral treatment of generalised anxiety disorders 8 calcitriol liquid oral prevention of hypophosphatemic rickets in children; treatment of hypoparathyroidism (with severe hypocalcaemia) 9 cholecalciferol capsule oral treatment of severe vitamin D deficiency and prevention of osteoporosis 10 cholecalciferol injection intramuscular treatment of severe vitamin D deficiency and prevention of osteoporosis 11 cinnarizine tablet oral treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere's disease). 12 clobetasol propionate 0.05% cream topical treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed 13 clobetasol propionate 0.05% lotion topical treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed 14 clobetasol propionate 0.05% ointment topical treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed 15 clofazimine capsule oral treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed mycobacterium avium paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum 16 cyclopentolate, 0.2%, and phenylephrine, 1% eye drops ophthalmic production of mydriasis 17 cyclosporin, 0.05% eye drops, emulsion ophthalmic treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca 18 deflazacort tablet oral treatment of Duchenne muscular dystrophy 19 dehydrated ethanol (alcohol) 96% - 100% ampoule topical treatment of progressive keratoconus and intra-operative use in superficial keratectomy (single use per procedure). 20 diazoxide tablet oral treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma 21 diazoxide capsule oral treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma 22 diazoxide suspension oral treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma 23 diflunisal tablet oral treatment of amyloidosis 24 dimethyl sulfoxide (DMSO) solution intravesical symptomatic relief of interstitial cystitis 25 F-18 myocardial perfusion tracer (18F flurpiridaz) injection intravenous myocardial perfusion study 26 F-18 NaF (sodium fluoride) injection intravenous bone study 27 flunarizine tablet oral treatment of vestibular disorders 28 flunarizine capsule oral treatment of vestibular disorders 29 furazolidone tablet oral treatment of resistant Helicobacter Pylori infection 30 Gallium-68 (Ga-68) Galligas aerosol inhalation lung ventilation study 31 Gallium-68 (Ga-68) - MAA injection intravenous lung perfusion study 32 glycopyrronium bromide tablet oral treatment of excessive salivation in patients with neurological conditions 33 hyoscine hydrobromide patch transdermal treatment of excessive salivation 34 hypertonic sodium chloride, 5 % eye ointment ophthalmic temporary relief of corneal oedema (hypertonicity) 35 hypertonic sodium chloride, 5% eye drops ophthalmic temporary relief of corneal oedema (hypertonicity) 36 indigo carmine injection intravenous intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures 37 indocyanine green dye injection intravenous intra-operative diagnostic use 38 insulin neutral-concentrated (Humulin R U-500) solution for injection subcutaneous treatment of diabetes 39 levofloxacin tablet oral treatment of resistant Helicobacter Pylori infection 40 levomepromazine tablet oral treatment of nausea and vomiting or agitation 41 levomepromazine injection subcutaneous treatment of nausea and vomiting or agitation 42 lorazepam injection parenteral treatment of acute severe behavioural episodes in the hospital setting 43 ketotifen tablet oral treatment of allergic conditions 44 melatonin syrup oral treatment of sleep disorders 45 melatonin modified release tablet oral treatment of sleep disorders 46 melatonin capsule oral treatment of sleep disorders 47 melatonin immediate release tablet oral treatment of sleep disorders 48 melatonin lozenge oral treatment of sleep disorders 49 mexiletine tablet oral treatment of ventricular arrhythmia or myotonic disorders 50 mexiletine capsule oral treatment of ventricular arrhythmia or myotonic disorders 51 midodrine tablet oral treatment of severe orthostatic hypotension 52 moxifloxacin 0.5% eye drops ophthalmic treatment of refractory bacterial conjunctivitis 53 nadolol tablet oral treatment of ventricular tachycardia or long QT Syndrome 54 natamycin 5% eye drops ophthalmic treatment of refractory fungal blepharitis, conjunctivitis or keratitis 55 nitazoxanide tablet oral treatment of giardiasis, cryptosporidiosis and blastocystis 56 nitazoxanide suspension oral treatment of giardiasis, cryptosporidiosis and blastocystis 57 paromomycin capsule oral antiprotozoal treatment of the following amoebic infections: (a) blastocystis hominis; (b) dientomoeba fragilis; (c) entamoeba histolytica; (d) parasite infection 58 pimozide tablet oral treatment of schizophrenia, chronic psychosis and Tourette syndrome 59 pristinamycin tablet oral treatment of confirmed methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; treatment of refractory or resistant mycoplasma genitalium infections; treatment of other infections as prescribed by an infectious disease specialist 60 pyrazinamide tablet oral treatment of tuberculosis 61 riboflavin, 0.1% in 20% dextran eye drops ophthalmic intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus 62 riboflavin, 0.1% in sodium chloride eye drops ophthalmic intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus 63 ripasudil 0.4% eye drops ophthalmic treatment of refractory corneal oedema or refractory glaucoma 64 rufinamide tablet oral adjunct treatment of seizures associated with Lennox-Gastaut syndrome in patients over 4 years of age 65 sodium benzoate tablet oral treatment of urea cycle disorders 66 stiripentol capsule oral treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) 67 stiripentol tablet oral treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) 68 stiripentol sachet oral treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) 69 tacrolimus 0.03% ointment topical treatment, or prolongation of flare-free intervals, of moderate to severe atopic dermatitis/eczema in children 70 tacrolimus 0.1% ointment topical treatment, or prolongation of flare-free intervals, of moderate to severe atopic dermatitis/eczema in adults 71 tizanidine capsule oral treatment of spasticity where other treatments have failed 72 tizanidine tablet oral treatment of spasticity where other treatments have failed 73 tetracycline capsule oral treatment of resistant Helicobacter Pylori infection 74 tetracycline tablet oral treatment of resistant Helicobacter Pylori infection 75 tick-borne encephalitis vaccine injection intramuscular prevention of tick-borne encephalitis 76 triamcinolone acetonide suspension for injection ophthalmic treatment of non-infectious uveitis or visualisation during vitrectomy 77 verteporfin powder for injection intravenous infusion photosensitisation for photodynamic therapy 78 yttrium-90 (Y-90) Citrate injection intraarticular radiosynovectomy treatment
Schedule 2—Repeals
Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018