THERAPEUTIC GOODS REGULATIONS 1990 - REG 12B Exemptions for certain uses--medicines

Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 12B

Exemptions for certain uses--medicines

(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

(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 (Ga-68) Galligas	aerosol	inhalation	lung ventilation study
35	Gallium-68 (Ga-68) - MAA	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
46	lorazepam	injection	parenteral	treatment of acute severe behavioural episodes in the hospital setting
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
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

(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
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
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	treatment of refractory chronic 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;

(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.

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