Therapeutic Goods (Medicines—Authorised Supply) Rules 2020
made under subsection 19(7A) of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 11 February 2022
Includes amendments up to: F2022L00123
Therapeutic Goods (Medicines—Authorised Supply) Rules 2020
made under subsection 19(7A) of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 11 February 2022
Includes amendments up to: F2022L00123
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Medicines—Authorised Supply) Rules 2020 that shows the text of the law as amended and in force on 11 February 2022 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
1 Name
3 Authority
4 Definitions
5 Authorisation
Schedule 1—Medicines authorised for supply
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
This instrument is the Therapeutic Goods (Medicines—Authorised Supply) Rules 2020.
This instrument is made under subsection 19(7A) of the Therapeutic Goods Act 1989.
Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a) health practitioner;
(b) listed goods;
(c) medicine;
(d) Register;
(e) registered goods;
(f) sponsor; and
(g) supply.
In this instrument:
Act means the Therapeutic Goods Act 1989.
SAS Guidance means the document titled Special Access Scheme Guidance for health practitioners and sponsors (Version 1.1, September 2017) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.
Note: The SAS Guidance is published at www.tga.gov.au.
Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.
Supply by a medical practitioner
(1) A health practitioner who is a medical practitioner is authorised to supply a medicine to a patient of that practitioner where:
(a) the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 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; and
(f) the conditions specified in subsection (2) are satisfied.
(2) The medical practitioner must:
(a) inform the patient, or a parent or guardian of the patient, that the medicine is not a listed good or registered good; and
(b) obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the medicine; and
(c) supply the medicine in accordance with good medical practice; and
(d) if the medical practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and
(e) if the medical practitioner becomes aware of a defect in the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine in accordance with the reporting guidelines set out in the SAS Guidance.
Supply to a patient of a medical practitioner
(3) A health practitioner is authorised to supply a medicine to a patient of a medical practitioner (the treating practitioner) where:
(a) the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 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 supply is requested by the treating practitioner; and
(d) the medicine is in the dosage form specified in column 3 of that item; and
(e) the medicine is to be administered by the route specified in column 4 of that item; and
(f) the supply is for the indication specified in column 5 of that item; and
(g) the conditions specified in subsection (4) are satisfied.
(4) The health practitioner supplying the medicine must:
(a) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and
(b) if the health practitioner becomes aware of a defect in the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine in accordance with the reporting guidelines set out in the SAS Guidance.
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 |
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 | amifampridine (3,4‑diaminopyridine) | tablet | oral | treatment of Lambert‑Eaton Myasthenic Syndrome |
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 |
11A | ciclosporin, 0.05% | eye drops, emulsion | ophthalmic | treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome) |
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 |
16A | colecalciferol | capsule | oral | treatment of severe vitamin D deficiency and prevention of osteoporosis |
16B | colecalciferol | injection | intramuscular | treatment of severe vitamin D deficiency and prevention of osteoporosis |
17 | cyclopentolate, 0.2%, and phenylephrine, 1% | eye drops | ophthalmic | production of mydriasis |
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 | capsule | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma |
23 | diazoxide | suspension | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma |
24 | diazoxide | tablet | 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 |
31 | flunarizine | capsule | oral | treatment of vestibular disorders or prophylactic treatment of migraine |
32 | flunarizine | tablet | 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 | prostate cancer imaging study |
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 drops | ophthalmic | temporary relief of corneal oedema (hypertonicity) |
40 | hypertonic sodium chloride, 5% | eye ointment | ophthalmic | temporary relief of corneal oedema (hypertonicity) |
40A | iloprost | injection | intravenous infusion | treatment of patients with severe disabling Raynaud’s phenomenon; or 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 |
42A | interferon alpha-2b | eye drops | ophthalmic | treatment of ocular surface squamous neoplasia |
43 | ketotifen | tablet | oral | treatment of allergic conditions |
44 | levofloxacin | tablet | oral | treatment of resistant Helicobacter Pylori infection or drug resistant tuberculosis |
45 | levomepromazine | injection | subcutaneous | treatment of nausea and vomiting or agitation |
46 | levomepromazine | tablet | oral | treatment of nausea and vomiting or agitation |
46A | lifitegrast | eye drops | ophthalmic | treatment of dry eye disease |
47 | lorazepam | injection | parenteral | treatment of acute severe behavioural episodes in the hospital setting |
48 | melatonin | capsule | oral | treatment of sleep disorders |
49 | melatonin | immediate release tablet | oral | treatment of sleep disorders |
50 | melatonin | lozenge | oral | treatment of sleep disorders |
51 | melatonin | syrup | oral | treatment of sleep disorders |
52 | mexiletine | capsule | oral | treatment of ventricular arrhythmia or myotonic disorders |
53 | mexiletine | tablet | 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 | nitazoxanide | suspension | oral | treatment of giardiasis, cryptosporidiosis or blastocystis |
59 | nitazoxanide | tablet | oral | treatment of giardiasis, cryptosporidiosis or blastocystis |
60 | paromomycin | capsule | oral | antiprotozoal treatment of any of the following amoebic infections: (a) blastocystis hominis; (b) dientomoeba fragilis; (c) entamoeba histolytica; (d) parasite infection |
61 | pimozide | tablet | oral | treatment of schizophrenia, chronic psychosis or Tourette syndrome |
62 | 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 |
62A | progesterone | injection | subcutaneous | treatment of progesterone deficiency |
62B | progesterone in oil | injection | intramuscular | treatment of progesterone deficiency |
63 | pyrazinamide | tablet | oral | treatment of tuberculosis |
64 | 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 |
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 sodium chloride | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
67 | riboflavin, 0.22% in sodium chloride | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
68 | ripasudil 0.4% | eye drops | ophthalmic | treatment of refractory corneal oedema or refractory glaucoma |
69 | sodium benzoate | tablet | oral | treatment of urea cycle disorders |
70 | tacrolimus 0.03% | ointment | topical | treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in children |
71 | tacrolimus 0.1% | ointment | topical | treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in adults |
71A | Technetium-99m (99m Tc) prostate specific membrane antigen (PSMA)-I&S | injection | intravenous | prostate cancer imaging study |
72 | tetracycline | capsule | oral | treatment of resistant Helicobacter Pylori infection |
73 | tetracycline | tablet | oral | treatment of resistant Helicobacter Pylori infection |
74 | tick‑borne encephalitis vaccine | injection | intramuscular | prevention of tick‑borne encephalitis |
75 | 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 |
76 | tizanidine | capsule | oral | treatment of spasticity where other treatments have failed |
77 | tizanidine | tablet | oral | treatment of spasticity where other treatments have failed |
78 | 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) |
79 | verteporfin | powder for injection | intravenous infusion | photosensitisation for photodynamic therapy |
80 | yttrium‑90 (Y‑90) Citrate | injection | intraarticular | radiosynovectomy treatment |
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
ad = added or inserted | o = order(s) |
am = amended | Ord = Ordinance |
amdt = amendment | orig = original |
c = clause(s) | par = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
Ch = Chapter(s) | pres = present |
def = definition(s) | prev = previous |
Dict = Dictionary | (prev…) = previously |
disallowed = disallowed by Parliament | Pt = Part(s) |
Div = Division(s) | r = regulation(s)/rule(s) |
exp = expires/expired or ceases/ceased to have | reloc = relocated |
effect | renum = renumbered |
F = Federal Register of Legislation | rep = repealed |
gaz = gazette | rs = repealed and substituted |
LA = Legislation Act 2003 | s = section(s)/subsection(s) |
LIA = Legislative Instruments Act 2003 | Sch = Schedule(s) |
(md) = misdescribed amendment can be given | Sdiv = Subdivision(s) |
effect | SLI = Select Legislative Instrument |
(md not incorp) = misdescribed amendment | SR = Statutory Rules |
cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |
mod = modified/modification | SubPt = Subpart(s) |
No. = Number(s) | underlining = whole or part not |
| commenced or to be commenced |
Name | Registration | Commencement | Application, saving and transitional provisions |
Therapeutic Goods (Medicines—Authorised Supply) Rules 2020 | 16 Sep 2020 (F2020L01170) | 17 Sep 2020 | |
Therapeutic Goods (Authorised Supply) Amendment (Medicines and Medical Devices) Rules 2022 | 10 Feb 2022 (F2022L00123) | 11 Feb 2022 | |
Provision affected | How affected |
s 2..................... | rep LA s 48D |
s 6..................... | rep LA s 48C |
Sch 1................... | am F2022L00123 |
Sch 2................... | rep LA s 48C |