Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018
Therapeutic Goods Act 1989
I, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 19(7A) of the Therapeutic Goods Act 1989, revoke the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017 that was registered on 29 September 2017, and make the following Rules.
(Signed by)
These Rules are the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018.
These Rules commence the day after they are registered.
3 Authority
These Rules are made under subsection 19(7A) of the Therapeutic Goods Act 1989.
4 Authorisation to supply medicines
(1) A health practitioner of the class specified in column 5 in an item in table 1 is authorised to supply a medicine that:
(a) contains only the active ingredient or ingredients, in the strength or concentration (if any), specified in column 1 in the item; and
(b) is in the dosage form specified in column 2 in the item;
to a person if:
(c) the person is a patient of the health practitioner; and
(d) the medicine is to be administered through the route of administration specified in column 3 in the item; and
(e) the supply is for an indication specified in column 4 in the item; and
(f) the following conditions are satisfied:
(i) the health practitioner must inform the patient, or a parent or guardian of the patient, that the medicine is not registered or listed;
(ii) the health practitioner must ensure that the medicine is supplied only after receiving informed consent from the patient, or a parent or guardian of the patient;
(iii) the health practitioner must ensure that the medicine is supplied in accordance with good medical practice;
(iv) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the adverse event, in accordance with subsection (3);
(v) if the health practitioner becomes aware of any defect in the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the defect, in accordance with subsection (3).
(2) A health practitioner is authorised to supply a medicine that:
(a) contains only the active ingredient or ingredients, in the strength or concentration (if any), specified in column 1 in an item in table 1; and
(b) is in the dosage form specified in column 2 in the item;
to a person if:
(c) the person is a patient of another health practitioner (the treating practitioner); and
(d) the treating practitioner is a health practitioner of the class specified in column 5 in the item; and
(e) the supply is requested by the treating practitioner; and
(f) the medicine is to be administered through the route of administration specified in column 3 in the item; and
(g) the supply is for an indication specified in column 4 in the item; and
(h) the following conditions are satisfied:
(i) if the health practitioner supplying the medicine becomes aware that the patient has suffered an adverse event in relation to the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the adverse event, in accordance with subsection (3);
(ii) if the health practitioner supplying the medicine becomes aware of any defect in the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the defect, in accordance with subsection (3).
(3) For the purposes of subparagraphs (1)(f)(iv) and (v) and (2)(h)(i) and (ii), notification must be in accordance with the reporting guidelines set out in the document titled Special Access Scheme Guidance for health practitioners and sponsors, version 1.1, published by the Therapeutic Goods Administration in September 2017.
Table 1: Authorised supply of medicines
Item | Column 1 Active ingredient(s) and strength or concentration | Column 2 Dosage form | Column 3 Route of administration | Column 4 Indication(s) | Column 5 Authorised health practitioner |
1 | Allergens – multiple, various (including control solutions) | Drops | Intradermal | Confirmation of suspected allergic reactions | Medical Practitioner |
2 | Allergens – multiple, various (including control solutions) | Drops | Skin prick | Confirmation of suspected allergic reactions | Medical Practitioner |
3 | Amifampridine (3,4-diaminopyridine) | Tablet | Oral | Treatment of Lambert-Eaton Myasthenic Syndrome | Medical Practitioner |
4 | Bifidobacterium bifidum & Lactobacillus acidophilus | Capsule | Oral | Prevention of necrotising enterocolitis | Medical Practitioner |
5 | Betaxolol 0.25% (preservative free) | Eye drops | Ophthalmic | Treatment of elevated intraocular pressure where other treatments are inappropriate | Medical Practitioner |
6 | Bismuth subcitrate | Tablet | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
7 | Buspirone | Tablet | Oral | Treatment of generalised anxiety disorders | Medical Practitioner |
8 | Calcitriol | Liquid | Oral | Prevention of hypophosphatemic rickets in children; Treatment of hypoparathyroidism (with severe hypocalcaemia) | Medical Practitioner |
9 | Cholecalciferol | Capsule | Oral | Treatment of severe vitamin D deficiency and prevention of osteoporosis | Medical Practitioner |
10 | Cholecalciferol | Injection | Intramuscular | Treatment of severe vitamin D deficiency and prevention of osteoporosis | Medical Practitioner |
11 | Cinnarizine | Tablet | Oral | Treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere's disease). | Medical Practitioner |
12 | Clobetasol propionate 0.05% | Cream | Topical | Treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed | Medical Practitioner |
13 | Clobetasol propionate 0.05% | Lotion | Topical | Treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed | Medical Practitioner |
14 | Clobetasol propionate 0.05% | Ointment | Topical | Treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed | Medical Practitioner |
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 | Medical Practitioner |
16 | Cyclopentolate, 0.2%, & phenylephrine, 1% | Eye drops | Ophthalmic | Production of mydriasis | Medical Practitioner |
17 | Cyclosporin, 0.05% | Eye drops, emulsion | Ophthalmic | Treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca | Medical Practitioner |
18 | Deflazacort | Tablet | Oral | Treatment of Duchenne muscular dystrophy | Medical Practitioner |
19 | Dehydrated ethanol (alcohol) 96% - 100% | Ampoule | Topical | Treatment of progressive keratoconus and intra-operative use in superficial keratectomy (single use per procedure). | Medical Practitioner |
20 | Diazoxide | Tablet | Oral | Treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma | Medical Practitioner |
21 | Diazoxide | Capsule | Oral | Treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma | Medical Practitioner |
22 | Diazoxide | Suspension | Oral | Treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma | Medical Practitioner |
23 | Diflunisal | Tablet | Oral | Treatment of amyloidosis | Medical Practitioner |
24 | Dimethyl sulfoxide (DMSO) | Solution | Intravesical | Symptomatic relief of interstitial cystitis | Medical Practitioner |
25 | Flunarizine | Tablet | Oral | Treatment of vestibular disorders | Medical Practitioner |
26 | Flunarizine | Capsule | Oral | Treatment of vestibular disorders | Medical Practitioner |
27 | Furazolidone | Tablet | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
28 | Glycopyrronium bromide | Tablet | Oral | Treatment of excessive salivation in patients with neurological conditions | Medical Practitioner |
29 | Hyoscine hydrobromide | Patch | Transdermal | Treatment of excessive salivation | Medical Practitioner |
30 | Hypertonic sodium chloride, 5 % | Eye ointment | Ophthalmic | Temporary relief of corneal oedema (hypertonicity) | Medical Practitioner |
31 | Hypertonic sodium chloride, 5% | Eye drops | Ophthalmic | Temporary relief of corneal oedema (hypertonicity) | Medical Practitioner |
32 | Indigo Carmine | Injection | Intravenous | For intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures | Medical Practitioner |
33 | Indocyanine green dye | Injection | Intravenous | For intra-operative diagnostic use | Medical Practitioner |
34 | Insulin Neutral-concentrated (Humulin R U-500) | Solution for injection | Subcutaneous | Treatment of diabetes | Medical Practitioner |
35 | Levofloxacin | Tablet | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
36 | Levomepromazine | Tablet | Oral | Treatment of nausea and vomiting or agitation | Medical Practitioner |
37 | Levomepromazine | Injection | Subcutaneous | Treatment of nausea and vomiting or agitation | Medical Practitioner |
38 | Lorazepam | Injection | Parenteral | Treatment of acute severe behavioural episodes in the hospital setting | Medical Practitioner |
39 | Ketotifen | Tablet | Oral | Treatment of allergic conditions | Medical Practitioner |
40 | Melatonin | Syrup | Oral | Treatment of sleep disorders | Medical Practitioner |
41 | Melatonin | Modified release tablet | Oral | Treatment of sleep disorders | Medical Practitioner |
42 | Melatonin | Capsule | Oral | Treatment of sleep disorders | Medical Practitioner |
43 | Melatonin | Immediate Release Tablet | Oral | Treatment of sleep disorders | Medical Practitioner |
44 | Melatonin | Lozenge | Oral | Treatment of sleep disorders | Medical Practitioner |
45 | Mexiletine | Tablet | Oral | Treatment of ventricular arrhythmia or myotonic disorders | Medical Practitioner |
46 | Mexiletine | Capsule | Oral | Treatment of ventricular arrhythmia or myotonic disorders | Medical Practitioner |
47 | Midodrine | Tablet | Oral | Treatment of severe orthostatic hypotension | Medical Practitioner |
48 | Moxifloxacin 0.5% | Eye drops | Ophthalmic | Treatment of refractory bacterial conjunctivitis | Medical Practitioner |
49 | Nadolol | Tablet | Oral | Treatment of ventricular tachycardia or long QT Syndrome | Medical Practitioner |
50 | Natamycin 5% | Eye drops | Ophthalmic | Treatment of refractory fungal blepharitis, conjunctivitis or keratitis | Medical Practitioner |
51 | Nitazoxanide | Tablet | Oral | Treatment of giardiasis, cryptosporidiosis and blastocystis | Medical Practitioner |
52 | Nitazoxanide | Suspension | Oral | Treatment of giardiasis, cryptosporidiosis and blastocystis | Medical Practitioner |
53 | Paromomycin | Capsule | Oral | Antiprotozoal treatment of the following amoebic infections: (a) blastocystis hominis; (b) dientomoeba fragilis; (c) entamoeba histolytica; (d) parasite infection | Medical Practitioner |
54 | Pimozide | Tablet | Oral | Treatment of schizophrenia, chronic psychosis and Tourette syndrome | Medical Practitioner |
55 | 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 | Medical Practitioner |
56 | Pyrazinamide | Tablet | Oral | Treatment of tuberculosis | Medical Practitioner |
57 | Riboflavin, 0.1% in 20% dextran | Eye drops | Ophthalmic | Intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus. | Medical Practitioner |
58 | Riboflavin, 0.1% in sodium chloride | Eye drops | Ophthalmic | Intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus. | Medical Practitioner |
59 | Ripasudil 0.4% | Eye drops | Ophthalmic | Treatment of refractory corneal oedema or refractory glaucoma | Medical Practitioner |
60 | Rufinamide | Tablet | Oral | Adjunct treatment of seizures associated with Lennox-Gastaut syndrome in patients over 4 years of age | Medical Practitioner |
61 | Sodium benzoate | Tablet | Oral | Treatment of urea cycle disorders | Medical Practitioner |
62 | Stiripentol | Capsule | Oral | Treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) | Medical Practitioner |
63 | Stiripentol | Tablet | Oral | Treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) | Medical Practitioner |
64 | Stiripentol | Sachet | Oral | Treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) | Medical Practitioner |
65 | Tacrolimus 0.03% | Ointment | Topical | Treatment, or prolongation of flare-free intervals, of moderate to severe atopic dermatitis/eczema in children | Medical Practitioner |
66 | Tacrolimus 0.1% | Ointment | Topical | Treatment, or prolongation of flare-free intervals, of moderate to severe atopic dermatitis/eczema in adults | Medical Practitioner |
67 | Tizanidine | Capsule | Oral | Treatment of spasticity where other treatments have failed | Medical Practitioner |
68 | Tizanidine | Tablet | Oral | Treatment of spasticity where other treatments have failed | Medical Practitioner |
69 | Tetracycline | Capsule | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
70 | Tetracycline | Tablet | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
71 | Tick-borne Encephalitis Vaccine | Injection | Intramuscular | Prevention of tick-borne encephalitis | Medical Practitioner |
72 | Triamcinolone acetonide | Suspension for injection | Ophthalmic | Treatment of non-infectious uveitis or visualisation during vitrectomy | Medical Practitioner |
73 | Verteporfin | Powder for injection | Intravenous infusion | Photosensitisation for photodynamic therapy | Medical Practitioner |
74 | Yttrium-90 (Y-90) Citrate | Injection | Intraarticular | Radiosynovectomy treatment | Medical Practitioner |