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Rules/Other as made
This instrument authorises the supply of specified medicines by specified health practitioners to specified recipients in specified circumstances provided specified conditions are met.
Administered by: Health
Registered 13 Sep 2019
Tabling HistoryDate
Tabled HR16-Sep-2019
Tabled Senate17-Sep-2019
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Authorised Supply of Medicines) Rules 2019

I, Adrian Bootes, as delegate of the Minister for Health, make the following rules.

Dated   13 September 2019

Adrian Bootes

Acting 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

5  Schedules................................................................................................................................. 3

Schedule 1—Medicines authorised for supply                                                           4

Schedule 2—Repeals                                                                                                   11

Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018            11

 

 


1  Name

                   This instrument is the Therapeutic Goods (Authorised Supply of Medicines) Rules 2019.

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)    medicine;

(c)    Register; and

(d)    supply.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

listed means included in the part of the Register for goods known as listed goods.

medical practitioner has the same meaning as in section 19 of the Act.

registered means included in the part of the Register for goods known as registered goods or provisionally registered goods.

Regulations means the Therapeutic Goods Regulations 1990.

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 immediately before 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 Regulations.

5  Authorisation

                   Supply by, or to a patient of, a medical practitioner

             (1)  A medical practitioner is authorised to supply a medicine that contains an active ingredient specified in column 2 of an item in the table in Schedule 1, to a patient of that practitioner, in circumstances where:

                     (a)  the medicine only contains the active ingredient in the strength and concentration specified (if any) in column 2 of that item; and

                     (b)  the medicine is in the dosage form specified in column 3 of that item; and

                     (c)  the medicine is administered by the route specified in column 4 of that item; and

                     (d)  the supply is for the indication specified in column 5 of that item; and

                     (e)  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 registered or listed; 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.

             (3)  A health practitioner is authorised to supply a medicine that contains an active ingredient specified in column 2 of an item in the table in Schedule 1, to a patient of a medical practitioner (the treating practitioner), in circumstances where:

                     (a)  the medicine only contains the active ingredient in the strength and concentration specified (if any) in column 2 of that item; and

                     (b)  the supply is requested by the treating practitioner; and

                     (c)  the medicine is in the dosage form specified in column 3 of that item; and

                     (d)  the medicine is 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 (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.

6  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 


 

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

allergens—multiple, various (including control solutions)

drops

intradermal

confirmation of suspected allergic reactions

2

allergens – multiple, various (including control solutions)

drops

skin prick

confirmation of suspected allergic reactions

3

amifampridine (3,4-diaminopyridine)

tablet

oral

treatment of Lambert-Eaton Myasthenic Syndrome

4

bifidobacterium bifidum and Lactobacillus acidophilus

capsule

oral

prevention of necrotising enterocolitis

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;

 

treatment of hypoparathyroidism (with severe hypocalcaemia)

9

cholecalciferol

capsule

oral

treatment of severe vitamin D deficiency and prevention of osteoporosis

10

cholecalciferol

injection

intramuscular

treatment of severe vitamin D deficiency and prevention of osteoporosis

11

cinnarizine

tablet

oral

treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere's disease).

12

clobetasol propionate 0.05%

cream

topical

treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed

13

clobetasol propionate 0.05%

lotion

topical

treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed

14

clobetasol propionate 0.05%

ointment

topical

treatment, or prolongation of flare-free intervals, of dermatitis/eczema where other treatments have failed

15

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

16

cyclopentolate, 0.2%, and phenylephrine, 1%

eye drops

ophthalmic

production of mydriasis

17

cyclosporin, 0.05%

eye drops, emulsion

ophthalmic

treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca

18

deflazacort

tablet

oral

treatment of Duchenne muscular dystrophy

19

dehydrated ethanol (alcohol) 96% - 100%

ampoule

topical

treatment of progressive keratoconus and intra-operative use in superficial keratectomy (single use per procedure).

20

diazoxide

tablet

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma

21

diazoxide

capsule

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma

22

diazoxide

suspension

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith-Weiderman Syndrome and insulinoma

23

diflunisal

tablet

oral

treatment of amyloidosis

24

dimethyl sulfoxide (DMSO)

solution

intravesical 

symptomatic relief of interstitial cystitis

25

F-18 myocardial perfusion tracer (18F flurpiridaz)

injection

intravenous

myocardial perfusion study

26

F-18 NaF (sodium fluoride)

injection

intravenous

bone study

27

flunarizine

tablet

oral

treatment of vestibular disorders

28

flunarizine

capsule

oral

treatment of vestibular disorders

29

furazolidone

tablet

oral

treatment of resistant Helicobacter Pylori infection

30

Gallium-68
(Ga-68) Galligas

aerosol

inhalation

lung ventilation study

31

Gallium-68
(Ga-68) - MAA

injection

intravenous

lung perfusion study

32

glycopyrronium bromide

tablet

oral

treatment of excessive salivation in patients with neurological conditions

33

hyoscine hydrobromide

patch

transdermal

treatment of excessive salivation

34

hypertonic sodium chloride, 5 %

eye ointment

ophthalmic

temporary relief of corneal oedema (hypertonicity)

35

hypertonic sodium chloride, 5%

eye drops

ophthalmic

temporary relief of corneal oedema (hypertonicity)

36

indigo carmine

injection

intravenous

intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures

37

indocyanine green dye

injection

intravenous

intra-operative diagnostic use

38

insulin neutral-concentrated (Humulin R U-500)

solution for injection

subcutaneous

treatment of diabetes

39

levofloxacin

tablet

oral

treatment of resistant Helicobacter Pylori infection

40

levomepromazine

tablet

oral

treatment of nausea and vomiting or agitation

41

levomepromazine

injection

subcutaneous

treatment of nausea and vomiting or agitation

42

lorazepam

injection

parenteral

treatment of acute severe behavioural episodes in the hospital setting

43

ketotifen

tablet

oral

treatment of allergic conditions

44

melatonin

syrup

oral

treatment of sleep disorders

45

melatonin

modified release tablet

oral

treatment of sleep disorders

46

melatonin

capsule

oral

treatment of sleep disorders

47

melatonin

immediate release tablet

oral

treatment of sleep disorders

48

melatonin

lozenge

oral

treatment of sleep disorders

49

mexiletine

tablet

oral

treatment of ventricular arrhythmia or myotonic disorders

50

mexiletine

capsule

oral

treatment of ventricular arrhythmia or myotonic disorders

51

midodrine

tablet

oral

treatment of severe orthostatic hypotension

52

moxifloxacin 0.5%

eye drops

ophthalmic

treatment of refractory bacterial conjunctivitis

53

nadolol

tablet

oral

treatment of ventricular tachycardia or long QT Syndrome

54

natamycin 5%

eye drops

ophthalmic

treatment of refractory fungal blepharitis, conjunctivitis or keratitis

55

nitazoxanide

tablet

oral

treatment of giardiasis, cryptosporidiosis and blastocystis

56

nitazoxanide

suspension

oral

treatment of giardiasis, cryptosporidiosis and blastocystis

57

paromomycin

capsule

oral

antiprotozoal treatment of the following amoebic infections:

(a)   blastocystis hominis;

(b)   dientomoeba fragilis;

(c)   entamoeba histolytica;

(d)   parasite infection

58

pimozide

tablet

oral

treatment of schizophrenia, chronic psychosis and Tourette syndrome

59

pristinamycin

tablet

oral

treatment of confirmed methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis;

 

treatment of refractory or resistant mycoplasma genitalium infections;

 

treatment of other infections as prescribed by an infectious disease specialist

60

pyrazinamide

tablet

oral

treatment of tuberculosis

61

riboflavin, 0.1% in 20% dextran

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

62

riboflavin, 0.1% in sodium chloride

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

63

ripasudil 0.4%

eye drops

ophthalmic

treatment of refractory corneal oedema or refractory glaucoma

64

rufinamide

tablet

oral

adjunct treatment of seizures associated with Lennox-Gastaut syndrome in patients over 4 years of age

65

sodium benzoate

tablet

oral

treatment of urea cycle disorders

66

stiripentol

capsule

oral

treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI))

67

stiripentol

tablet

oral

treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI))

68

stiripentol

sachet

oral

treatment of intractable epilepsy and Dravet syndrome (severe myoclonic epilepsy of infancy (SMEI))

69

tacrolimus 0.03%

ointment

topical

treatment, or prolongation of flare-free intervals, of moderate to severe atopic dermatitis/eczema in children

70

tacrolimus 0.1%

ointment

topical

treatment, or prolongation of flare-free intervals, of moderate to severe atopic dermatitis/eczema in adults

71

tizanidine

capsule

oral

treatment of spasticity where other treatments have failed

72

tizanidine

tablet

oral

treatment of spasticity where other treatments have failed

73

tetracycline

capsule

oral

treatment of resistant Helicobacter Pylori infection

74

tetracycline

tablet

oral

treatment of resistant Helicobacter Pylori infection

75

tick-borne encephalitis vaccine

injection

intramuscular

prevention of tick-borne encephalitis

76

triamcinolone acetonide

suspension for injection

ophthalmic

treatment of non-infectious uveitis or visualisation during vitrectomy

77

verteporfin

powder for injection

intravenous infusion

photosensitisation for photodynamic therapy

78

yttrium-90 (Y-90) Citrate

injection

intraarticular

radiosynovectomy treatment

 

 

 


 

 

Schedule 2—Repeals

Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018

1  The whole of the instrument

Repeal the instrument