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Rules/Other as made
This instrument repeals the Therapeutic Goods (Authorised Supply of Medicines) Rules 2019 and authorises the supply of specified medicines by specified health practitioners provided specified conditions are met.
Administered by: Health
Registered 16 Sep 2020
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Medicines—Authorised Supply) Rules 2020

I, Jane Cook, as delegate of the Minister for Health, make the following rules.

Dated 15 September 2020

Dr Jane Cook

First Assistant Secretary

Medicines Regulation Division

Health Products Regulation Group

Department of Health

 

 

 

 

 

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

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

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

5  Authorisation............................................................................................................................ 2

6  Repeals..................................................................................................................................... 3

Schedule 1—Medicines authorised for supply                                                           4

Schedule 2—Repeals                                                                                                   11

Therapeutic Goods (Authorised Supply of Medicines) Rules 2019                                           11

 

 


1  Name

                   This instrument is the Therapeutic Goods (Medicines—Authorised Supply) Rules 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

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.

Repeals

                   Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

 


 

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

1

aciclovir

eye

ointment

ophthalmic

treatment of herpes simplex keratitis

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

10

cholecalciferol

capsule

oral

treatment of severe vitamin D deficiency and prevention of osteoporosis

11

cholecalciferol

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

cyclosporin, 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

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

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)

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

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

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

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

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

 


 

Schedule 2—Repeals

Note:       See section 6.

Therapeutic Goods (Authorised Supply of Medicines) Rules 2019

1  The whole of the instrument

Repeal the instrument.