Therapeutic Goods (Medicines—Authorised Supply) Rules 2020 (Cth)
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 ( 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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........................................................................................................................................ 1
3 Authority.................................................................................................................................. 1
4 Definitions................................................................................................................................ 1
5 Authorisation............................................................................................................................ 1
Schedule 1—Medicines authorised for supply 3
Endnotes11
Endnote 1—About the endnotes 11
Endnote 2—Abbreviation key 12
Endnote 3—Legislation history 13
Endnote 4—Amendment history 14
1 Name
This instrument is the Therapeutic Goods (Medicines—Authorised Supply) Rules 2020.
3 Authority
This instrument is made under subsection 19(7A) of the Therapeutic Goods Act 1989.
4 Definitions
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 Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.
5 Authorisation
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
(Ga‑68) Galligasaerosol inhalation lung ventilation study 35 Gallium‑68
(Ga‑68) ‑ MAAinjection 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 Endnotes
Endnote 1—About the endnotes
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.
Endnote 2—Abbreviation key
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
Endnote 3—Legislation history
| Name | Registration | Commencement | Application, saving and transitional provisions |
| Therapeutic Goods (Medicines—Authorised Supply) Rules 2020 | 16 Sep 2020 (F2020L01170) | 17 Sep 2020 | ¾ |
| Therapeutic Goods (Authorised Supply) Amendment (Medicines and Medical Devices) Rules 2022 | 10 Feb 2022 (F2022L00123) | 11 Feb 2022 | ¾ |
Endnote 4—Amendment history
| 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 |
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