Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017
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 2017 that was registered on 3 July 2017, and make the following Rules.
(Signed by)
These Rules are the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017.
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 | Bismuth subcitrate | Tablet | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
4 | Buspirone | Tablet | Oral | Treatment of generalised anxiety disorders | Medical Practitioner |
5 | Calcitriol | Liquid | Oral | Prevention of hypophosphatemic rickets in children; Treatment of hypoparathyroidism (with severe hypocalcaemia) | Medical Practitioner |
6 | Cholecalciferol | Capsule | Oral | Treatment of severe vitamin D deficiency and prevention of osteoporosis | Medical Practitioner |
7 | Cholecalciferol | Injection | Intramuscular | Treatment of severe vitamin D deficiency and prevention of osteoporosis | Medical Practitioner |
8 | Cinnarizine | Tablet | Oral | Treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere's disease). | Medical Practitioner |
9 | 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 |
10 | Cyclopentolate, 0.2%, & phenylephrine, 1% | Eye drops | Ophthalmic | Production of mydriasis | Medical Practitioner |
11 | Cyclosporin, 0.05% | Eye drops, emulsion | Ophthalmic | Treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca | Medical Practitioner |
12 | Dehydrated ethanol (alcohol) 96% - 100% | Ampoule | Topical | Treatment of progressive keratoconus and intra-operative use in superficial keratectomy (single use per procedure). | Medical Practitioner |
13 | Dexamethasone | Implant | Intravitreal | Treatment of macular oedema, retinal vein occlusion and non-infectious uveitis | Medical Practitioner |
14 | Dexamethasone, 0.1% | Eye drops | Ophthalmic | Treatment of non-infected, steroid responsive, inflammatory conditions of the eye | Medical Practitioner |
15 | Diazoxide | Tablet | Oral | Treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma | Medical Practitioner |
16 | Diazoxide | Capsule | Oral | Treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma | Medical Practitioner |
17 | Diazoxide | Suspension | Oral | Treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma | Medical Practitioner |
18 | Dimethyl sulfoxide (DMSO) | Solution | Intravesical | Symptomatic relief of interstitial cystitis | Medical Practitioner |
19 | Flunarizine | Tablet | Oral | Prophylactic treatment of migraine | Medical Practitioner |
20 | Flunarizine | Capsule | Oral | Prophylactic treatment of migraine | Medical Practitioner |
21 | Fosfomycin | Sachet | Oral | Treatment of uncomplicated urinary tract infections
Treatment of pseudomonas aeruginosa infections in Cystic Fibrosis patients | Medical Practitioner |
22 | Furazolidone | Tablet | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
23 | Glycopyrronium bromide | Tablet | Oral | Treatment of excessive salivation in patients with neurological conditions | Medical Practitioner |
24 | Hyoscine hydrobromide | Patch | Transdermal | Treatment of excessive salivation | Medical Practitioner |
25 | Hypertonic sodium chloride, 5 % | Eye ointment | Ophthalmic | Temporary relief of corneal oedema (hypertonicity) | Medical Practitioner |
26 | Hypertonic sodium chloride, 5% | Eye drops | Ophthalmic | Temporary relief of corneal oedema (hypertonicity) | Medical Practitioner |
27 | Indigo Carmine | Injection | Intravenous | For intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures | Medical Practitioner |
28 | Indocyanine green dye | Injection | Intravenous | For intra-operative diagnostic use | Medical Practitioner |
29 | Ketotifen | Tablet | Oral | Treatment of allergic conditions | Medical Practitioner |
30 | Mannitol | Capsules | Inhalation | Treatment of bronchiectasis
Treatment of cystic fibrosis (adjunct to dornase alpha or for patients intolerant to dornase alpha) | Medical Practitioner |
31 | Melatonin | Syrup | Oral | Treatment of sleep disorders | Medical Practitioner |
32 | Melatonin | Modified release tablet | Oral | Treatment of sleep disorders | Medical Practitioner |
33 | Melatonin | Capsule | Oral | Treatment of sleep disorders | Medical Practitioner |
34 | Melatonin | Immediate Release Tablet | Oral | Treatment of sleep disorders | Medical Practitioner |
35 | Melatonin | Lozenge | Oral | Treatment of sleep disorders | Medical Practitioner |
36 | Midodrine | Tablet | Oral | Treatment of severe orthostatic hypotension | Medical Practitioner |
37 | Nitazoxanide | Tablet | Oral | Treatment of giardiasis, cryptosporidiosis and blastocystis | Medical Practitioner |
38 | Nitazoxanide | Suspension | Oral | Treatment of giardiasis, cryptosporidiosis and blastocystis | Medical Practitioner |
39 | Paromomycin | Capsule | Oral | Antiprotozoal treatment of the following amoebic infections: (a) blastocystis hominis; (b) dientomoeba fragilis; (c) entamoeba histolytica; (d) parasite infection | Medical Practitioner |
40 | Pimozide | Tablet | Oral | Treatment of schizophrenia, chronic psychosis and Tourette syndrome | Medical Practitioner |
41 | 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 |
42 | Pyrazinamide | Tablet | Oral | Treatment of tuberculosis | Medical Practitioner |
43 | 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 |
44 | 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 |
45 | Rufinamide | Tablet | Oral | Adjunct treatment of seizures associated with Lennox-Gastaut syndrome in patients over 4 years of age | Medical Practitioner |
46 | Stiripentol | Capsule | Oral | Treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) | Medical Practitioner |
47 | Stiripentol | Tablet | Oral | Treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) | Medical Practitioner |
48 | Stiripentol | Sachet | Oral | Treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI)) | Medical Practitioner |
49 | Tacrolimus 0.1% | Ointment | Topical | Treatment, or prolongation of flare-free intervals, of moderate to severe atopic dermatitis in adults | Medical Practitioner |
50 | Tetracycline | Capsule | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
51 | Tetracycline | Tablet | Oral | Treatment of resistant Helicobacter Pylori infection | Medical Practitioner |
52 | Tick-borne Encephalitis Vaccine | Injection | Intramuscular | Prevention of tick-borne encephalitis | Medical Practitioner |
53 | Triamcinolone acetonide | Suspension for injection | Ophthalmic | Treatment of inflammatory ocular conditions | Medical Practitioner |
54 | Triamcinolone acetonide | Suspension for injection | Ophthalmic | Visualisation during vitrectomy. | Medical Practitioner |
55 | Verteporfin | Powder for injection | Intravenous infusion | Photosensitisation for photodynamic therapy | Medical Practitioner |
56 | Yttrium-90 (Y-90) Citrate | Injection | Intraarticular | Radiosynovectomy treatment | Medical Practitioner |