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Rules/Other as amended, taking into account amendments up to Therapeutic Goods (Authorised Supply) Amendment (Medicines and Medical Devices) Rules 2022
Administered by: Health and Aged Care
Registered 21 Feb 2022
Start Date 11 Feb 2022
Date of repeal 24 Dec 2022
Repealed by Therapeutic Goods (Medicines—Authorised Supply) Rules 2022
Table of contents.

Commonwealth Coat of Arms of Australia

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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........................................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Authorisation............................................................................................................................ 1

Schedule 1—Medicines authorised for supply                                                           3

Endnotes                                                                                                                      11

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 www.tga.gov.au.

Therapeutic 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) 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

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