Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.
(1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:
(a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and
(b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.
(1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:
(a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and
(b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and
(c) the medicine is in the dosage form specified in column 3 of that item; and
(d) the medicine is to be administered by the route specified in column 4 of that item; and
(e) the supply is for the indication specified in column 5 of that item.
Specified therapeutic goods | ||||
Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
Item | Active ingredient | Dosage form | Route of administration | Indication |
2 | allergens--multiple, various (including control solutions) | drops | intradermal | confirmation of suspected allergic reactions |
3 | allergens - multiple, various (including control solutions) | drops | skin prick | confirmation of suspected allergic reactions |
4 | amiloride | tablet | oral | treatment of hypokalaemia |
4A | argipressin | injection | intravenous | (a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or (b) treatment of uterine fibroids |
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; or treatment of hypoparathyroidism (with severe hypocalcaemia) |
9 | carbidopa | tablet | oral | premedication for F - 18 DOPA imaging |
10 | colecalciferol | capsule | oral | treatment of severe vitamin D deficiency and prevention of osteoporosis |
11 | colecalciferol | injection | intramuscular | treatment of severe vitamin D deficiency and prevention of osteoporosis |
12 | cinnarizine | tablet | oral | treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere's disease). |
13 | clobetasol propionate 0.05% | cream | topical | treatment, or prolongation of flare - free intervals, of dermatitis/eczema where other treatments have failed |
14 | clobetasol propionate 0.05% | lotion | topical | treatment, or prolongation of flare - free intervals, of dermatitis/eczema where other treatments have failed |
15 | clobetasol propionate 0.05% | ointment | topical | treatment, or prolongation of flare - free intervals, of dermatitis/eczema where other treatments have failed |
16 | 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, drug resistant tuberculosis, non - tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist |
17 | cyclopentolate, 0.2%, and phenylephrine, 1% | eye drops | ophthalmic | production of mydriasis |
18 | ciclosporin, 0.05% | eye drops, emulsion | ophthalmic | treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome) |
19 | deflazacort | tablet | oral | treatment of Duchenne muscular dystrophy |
20 | dehydrated ethanol (alcohol) 96% - 100% | ampoule | topical | treatment of progressive keratoconus and intra - operative use in superficial keratectomy (single use per procedure) |
21 | dexamethasone (preservative free) | eye drops | ophthalmic | treatment of inflammatory conditions of the eye that are non - infected and steroid responsive in patients sensitive to preservative - containing formulations |
22 | diazoxide | tablet | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith - Weiderman Syndrome or insulinoma |
23 | diazoxide | capsule | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith - Weiderman Syndrome or insulinoma |
24 | diazoxide | suspension | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith - Weiderman Syndrome or insulinoma |
25 | diflunisal | tablet | oral | treatment of amyloidosis |
26 | dimethyl sulfoxide (DMSO) | solution | intravesical | symptomatic relief of interstitial cystitis |
26A | disulfiram | tablet | oral | deterrent to alcohol consumption |
27 | doxycycline | injection | intralesional | sclerotherapy of lymphatic malformations |
28 | F - 18 DCFPyl (PSMA) | injection | intravenous | prostate cancer imaging study |
29 | F - 18 myocardial perfusion tracer (18F flurpiridaz) | injection | intravenous | myocardial perfusion study |
30 | F - 18 NaF (sodium fluoride) | injection | intravenous | bone study |
30A | famotidine | injection | intravenous | prevention and management of hypersensitivity reactions to chemotherapy |
31 | flunarizine | tablet | oral | treatment of vestibular disorders or prophylactic treatment of migraine |
32 | flunarizine | capsule | oral | treatment of vestibular disorders or prophylactic treatment of migraine |
33 | furazolidone | tablet | oral | treatment of resistant Helicobacter Pylori infection |
34 | Gallium - 68 | aerosol | inhalation | lung ventilation study |
35 | Gallium - 68 | injection | intravenous | lung perfusion study |
36 | Gallium - 68 prostate specific membrane antigen (PSMA) | injection | intravenous | (a) prostate cancer imaging study (b) PET CT gallium - 68 PSMA whole body uptake study |
36A | ganciclovir | gel | ophthalmic | treatment of cytomegalovirus |
37 | glycopyrronium bromide | tablet | oral | treatment of excessive salivation in patients with neurological conditions |
38 | hyoscine hydrobromide | patch | transdermal | treatment of excessive salivation |
39 | hypertonic sodium chloride, 5 % | eye ointment | ophthalmic | temporary relief of corneal oedema (hypertonicity) |
40 | hypertonic sodium chloride, 5% | eye drops | ophthalmic | temporary relief of corneal oedema (hypertonicity) |
40A | iloprost | injection | intravenous infusion | (a) treatment of patients with severe disabling Raynaud's phenomenon; or (b) treatment of peripheral ischaemia |
41 | indigo carmine | injection | intravenous | intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures |
42 | indocyanine green dye | injection | intravenous | intra - operative diagnostic use |
42AA | interferon alpha - 2b | eye drops | ophthalmic | treatment of ocular surface squamous neoplasia |
42A | ketotifen | tablet | oral | treatment of allergic conditions |
43 | levofloxacin | tablet | oral | treatment of resistant Helicobacter Pylori infection or drug resistant tuberculosis |
44 | levomepromazine | tablet | oral | treatment of nausea and vomiting or agitation |
45 | levomepromazine | injection | subcutaneous | treatment of nausea and vomiting or agitation |
45A | lifitegrast | eye drops | ophthalmic | treatment of dry eye disease |
46A | lutetium - 177 (Lu 177) dotatate | injection | intravenous | treatment of somatostatin receptor - positive gastroenteropancreatic neuroendocrine tumors (GEP - NETs) |
46B | lutetium - 177 (Lu 177) prostate specific membrane antigen (PSMA) | injection | intravenous | treatment of metastatic castration - resistant prostate cancer |
48 | melatonin | syrup | oral | treatment of sleep disorders |
49 | melatonin | capsule | oral | treatment of sleep disorders |
50 | melatonin | immediate release tablet | oral | treatment of sleep disorders |
51 | melatonin | lozenge | oral | treatment of sleep disorders |
51A | metolazone | tablet | oral | treatment of fluid overload |
52 | mexiletine | tablet | oral | treatment of ventricular arrhythmia or myotonic disorders |
53 | mexiletine | capsule | oral | treatment of ventricular arrhythmia or myotonic disorders |
54 | moxifloxacin 0.5% | eye drops | ophthalmic | treatment of refractory bacterial conjunctivitis |
55 | nadolol | tablet | oral | treatment of ventricular tachycardia or long QT Syndrome |
56 | natamycin 5% | eye drops | ophthalmic | treatment of refractory fungal blepharitis, conjunctivitis or keratitis |
57 | neomycin | tablet | oral | sepsis prevention for colorectal operation |
58 | nicotine in solution, salt or base form | liquid or solid | inhalation | smoking cessation or management of nicotine dependence |
58A | nifedipine | immediate release tablet | oral | (a) treatment of preterm labour; or (b) treatment of pre - eclampsia |
58B | nifedipine | capsule | oral | (a) treatment of preterm labour; or (b) treatment of pre - eclampsia |
59 | nitazoxanide | tablet | oral | treatment of giardiasis, cryptosporidiosis or blastocystis |
60 | nitazoxanide | suspension | oral | treatment of giardiasis, cryptosporidiosis or blastocystis |
61 | paromomycin | capsule | oral | antiprotozoal treatment of any of the following amoebic infections: (a) blastocystis hominis ; (b) dientomoeba fragilis ; (c) entamoeba histolytica ; (d) parasite infection |
62 | pimozide | tablet | oral | treatment of schizophrenia, chronic psychosis or Tourette syndrome |
63 | pristinamycin | tablet | oral | treatment of confirmed methicillin - resistant Staphylococcus aureus or vancomycin - resistant enterococci infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or treatment of refractory or resistant mycoplasma genitalium infections; or treatment of other infections as prescribed by an infectious disease specialist |
63A | progesterone | injection | subcutaneous | treatment of progesterone deficiency |
63B | progesterone in oil | injection | intramuscular | treatment of progesterone deficiency |
64 | pyrazinamide | tablet | oral | treatment of tuberculosis |
65 | riboflavin, 0.1% in 20% dextran | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
66 | riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC) | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
67 | riboflavin, 0.1% in sodium chloride | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
68 | riboflavin, 0.22% in sodium chloride | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
69 | ripasudil 0.4% | eye drops | ophthalmic | treatment of refractory corneal oedema or refractory glaucoma |
70 | sodium benzoate | tablet | oral | treatment of urea cycle disorders |
71 | tacrolimus 0.03% | ointment | topical | treatment, or prolongation of flare - free intervals, of moderate to severe atopic dermatitis/eczema in children |
72 | tacrolimus 0.1% | ointment | topical | treatment, or prolongation of flare - free intervals, of moderate to severe atopic dermatitis/eczema in adults |
72A | Technetium - 99m (99m Tc) prostate specific membrane antigen (PSMA) - I&S | injection | intravenous | prostate cancer imaging study |
75 | tetracycline | capsule | oral | treatment of resistant Helicobacter Pylori infection |
76 | tetracycline | tablet | oral | treatment of resistant Helicobacter Pylori infection |
77 | tick - borne encephalitis vaccine | injection | intramuscular | prevention of tick - borne encephalitis |
78 | tinidazole | tablet | oral | treatment of trichomonas vaginalis infections of the genito - urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or prevention of infection of the surgical site |
78A | tizanidine | capsule | oral | treatment of spasticity where other treatments have failed |
78B | tizanidine | tablet | oral | treatment of spasticity where other treatments have failed |
79 | triamcinolone acetonide | suspension for injection | ophthalmic | treatment of non - infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post - operative macular oedema (cataract surgery) |
80 | verteporfin | powder for injection | intravenous infusion | photosensitisation for photodynamic therapy |
81 | yttrium - 90 (Y - 90) Citrate | injection | intraarticular | radiosynovectomy treatment |
(1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:
(a) the circumstances specified in column 2 of an item in the following table exist in relation to the medicine; and
(b) the medicine is in the dosage form specified in column 3 of that item; and
(c) the medicine is to be administered by the route specified in column 4 of that item; and
(d) the supply is for the indication specified in column 5 of that item.
Specified therapeutic goods | ||||
Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
Item | Circumstances | Dosage form | Route of administration | Indication |
1 | (a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and (b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | liquid | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients; or (c) treatment of refractory sleep disorders in adult patients; or (d) treatment of autism spectrum disorder in adult patients; or (e) treatment and management of refractory cancer pain in adult patients |
1A | (a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and (b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | spray | oral | treatment of refractory chronic pain in adult patients |
2 | (a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and (b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | capsule | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients |
3 | (a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | liquid | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients; or (c) treatment of refractory sleep disorders in adult patients; or (d) treatment and management of refractory cancer pain in adult patients |
4 | (a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | capsule | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients |
5 | (a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | liquid | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory sleep disorders in adult patients; or (c) treatment and management of refractory cancer pain in adult patients |
6 | (a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | capsule | oral | treatment of refractory chronic pain in adult patients |
(2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life - threatening, or otherwise serious, illness or condition.
(3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.
(5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.
(6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:
(a) the person's initials, date of birth and gender;
(b) each medical condition in relation to which the medicine was supplied;
(c) each indication of the medicine in relation to which the medicine was supplied;
(d) each active ingredient of the medicine;
(e) the dosage form of the medicine;
(f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine--information about the release mechanism;
(g) if the route of administration of the medicine was clinically relevant to the supply of the medicine--information about the route of administration;
(h) the practitioner's name, AHPRA number and contact details;
(i) the health profession in which the practitioner is registered or licensed to practise;
(j) the address of the practitioner's principal place of
practice.