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Rules/Other as made
These rules authorise the supply of specified medicines by specified classes of health practitioners.
Administered by: Health
Made 12 Mar 2018
Registered 14 Mar 2018
Tabled HR 26 Mar 2018
Tabled Senate 19 Mar 2018

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

Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 19(7A) of the Therapeutic Goods Act 1989, revoke the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017 that was registered on 29 September 2017, and make the following Rules.

Dated  12        March 2018

(Signed by)

 

LARRY KELLY

Delegate of the Minister for Health


1              Name

                These Rules are the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018.

2              Commencement

                These Rules commence the day after they are registered.

3              Authority

                These Rules are made under subsection 19(7A) of the Therapeutic Goods Act 1989.

4              Authorisation to supply medicines

         (1)   A health practitioner of the class specified in column 5 in an item in table 1 is authorised to supply a medicine that:

(a)     contains only the active ingredient or ingredients, in the strength or concentration (if any), specified in column 1 in the item; and

(b)     is in the dosage form specified in column 2 in the item;

                to a person if:

(c)     the person is a patient of the health practitioner; and

(d)     the medicine is to be administered through the route of administration specified in column 3 in the item; and

(e)     the supply is for an indication specified in column 4 in the item; and

(f)      the following conditions are satisfied:

(i)      the health practitioner must inform the patient, or a parent or guardian of the patient, that the medicine is not registered or listed;

(ii)     the health practitioner must ensure that the medicine is supplied only after receiving informed consent from the patient, or a parent or guardian of the patient;

(iii)    the health practitioner must ensure that the medicine is supplied in accordance with good medical practice;

(iv)    if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the adverse event, in accordance with subsection (3);

(v)     if the health practitioner becomes aware of any defect in the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the defect, in accordance with subsection (3).

         (2)   A health practitioner is authorised to supply a medicine that:

(a)     contains only the active ingredient or ingredients, in the strength or concentration (if any), specified in column 1 in an item in table 1; and

(b)     is in the dosage form specified in column 2 in the item;

                to a person if:

(c)     the person is a patient of another health practitioner (the treating practitioner); and

(d)     the treating practitioner is a health practitioner of the class specified in column 5 in the item; and

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

(f)      the medicine is to be administered through the route of administration specified in column 3 in the item; and

(g)     the supply is for an indication specified in column 4 in the item; and

(h)     the following conditions are satisfied:

(i)      if the health practitioner supplying the medicine becomes aware that the patient has suffered an adverse event in relation to the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the adverse event, in accordance with subsection (3);

(ii)     if the health practitioner supplying the medicine becomes aware of any defect in the medicine, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the medicine, about the defect, in accordance with subsection (3).

(3)   For the purposes of subparagraphs (1)(f)(iv) and (v) and (2)(h)(i) and (ii), notification must be in accordance with the reporting guidelines set out in the document titled Special Access Scheme Guidance for health practitioners and sponsors, version 1.1, published by the Therapeutic Goods Administration in September 2017.


Table 1:    Authorised supply of medicines

 

 

Item

Column 1

Active ingredient(s) and strength or concentration

Column 2

Dosage form

Column 3

Route of administration

Column 4

Indication(s)

Column 5

Authorised health practitioner

1

Allergens – multiple, various (including control solutions)

Drops

Intradermal

Confirmation of suspected allergic reactions

Medical Practitioner

2

Allergens – multiple, various (including control solutions)

Drops

Skin prick

Confirmation of suspected allergic reactions

Medical Practitioner

3

Amifampridine (3,4-diaminopyridine)

Tablet

Oral

Treatment of Lambert-Eaton Myasthenic Syndrome

Medical Practitioner

4

Bifidobacterium bifidum & Lactobacillus acidophilus

Capsule

Oral

Prevention of necrotising enterocolitis

Medical Practitioner

5

Betaxolol 0.25% (preservative free)

Eye drops

Ophthalmic

Treatment of elevated intraocular pressure where other treatments are inappropriate

Medical Practitioner

6

Bismuth subcitrate

Tablet

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

7

Buspirone

Tablet

Oral

Treatment of generalised anxiety disorders

Medical Practitioner

8

Calcitriol

Liquid

Oral

Prevention of hypophosphatemic rickets in children; Treatment of hypoparathyroidism (with severe hypocalcaemia)

Medical Practitioner

9

Cholecalciferol

Capsule

Oral

Treatment of severe vitamin D deficiency and prevention of osteoporosis

Medical Practitioner

10

Cholecalciferol

Injection

Intramuscular

Treatment of severe vitamin D deficiency and prevention of osteoporosis

Medical Practitioner

11

Cinnarizine

Tablet

Oral

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

Medical Practitioner

12

Clobetasol propionate 0.05%

Cream

Topical

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

Medical Practitioner

13

Clobetasol propionate 0.05%

Lotion

Topical

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

Medical Practitioner

14

Clobetasol propionate 0.05%

Ointment

Topical

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

Medical Practitioner

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

Medical Practitioner

16

Cyclopentolate, 0.2%, & phenylephrine, 1%

Eye drops

Ophthalmic

Production of mydriasis

Medical Practitioner

17

Cyclosporin, 0.05%

Eye drops, emulsion

Ophthalmic

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

Medical Practitioner

18

Deflazacort

Tablet

Oral

Treatment of Duchenne muscular dystrophy

Medical Practitioner

19

Dehydrated ethanol (alcohol) 96% - 100%

Ampoule

Topical

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

Medical Practitioner

20

Diazoxide

Tablet

Oral

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

Medical Practitioner

21

Diazoxide

Capsule

Oral

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

Medical Practitioner

22

Diazoxide

Suspension

Oral

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

Medical Practitioner

23

Diflunisal

Tablet

Oral

Treatment of amyloidosis

Medical Practitioner

24

Dimethyl sulfoxide (DMSO)

Solution

Intravesical 

Symptomatic relief of interstitial cystitis

Medical Practitioner

25

Flunarizine

Tablet

Oral

Treatment of vestibular disorders

Medical Practitioner

26

Flunarizine

Capsule

Oral

Treatment of vestibular disorders

Medical Practitioner

27

Furazolidone

Tablet

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

28

Glycopyrronium bromide

Tablet

Oral

Treatment of excessive salivation in patients with neurological conditions

Medical Practitioner

29

Hyoscine hydrobromide

Patch

Transdermal

Treatment of excessive salivation

Medical Practitioner

30

Hypertonic sodium chloride, 5 %

Eye ointment

Ophthalmic

Temporary relief of corneal oedema (hypertonicity)

Medical Practitioner

31

Hypertonic sodium chloride, 5%

Eye drops

Ophthalmic

Temporary relief of corneal oedema (hypertonicity)

Medical Practitioner

32

Indigo Carmine

Injection

Intravenous

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

Medical Practitioner

33

Indocyanine green dye

Injection

Intravenous

For intra-operative diagnostic use

Medical Practitioner

34

Insulin Neutral-concentrated (Humulin R U-500)

Solution for injection

Subcutaneous

Treatment of diabetes

Medical Practitioner

35

Levofloxacin

Tablet

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

36

Levomepromazine

Tablet

Oral

Treatment of nausea and vomiting or agitation

Medical Practitioner

37

Levomepromazine

Injection

Subcutaneous

Treatment of nausea and vomiting or agitation

Medical Practitioner

38

Lorazepam

Injection

Parenteral

Treatment of acute severe behavioural episodes in the hospital setting

Medical Practitioner

39

Ketotifen

Tablet

Oral

Treatment of allergic conditions

Medical Practitioner

40

Melatonin

Syrup

Oral

Treatment of sleep disorders

Medical Practitioner

41

Melatonin

Modified release tablet

Oral

Treatment of sleep disorders

Medical Practitioner

42

Melatonin

Capsule

Oral

Treatment of sleep disorders

Medical Practitioner

43

Melatonin

Immediate Release Tablet

Oral

Treatment of sleep disorders

Medical Practitioner

44

Melatonin

Lozenge

Oral

Treatment of sleep disorders

Medical Practitioner

45

Mexiletine

Tablet

Oral

Treatment of ventricular arrhythmia or myotonic disorders

Medical Practitioner

46

Mexiletine

Capsule

Oral

Treatment of ventricular arrhythmia or myotonic disorders

Medical Practitioner

47

Midodrine

Tablet

Oral

Treatment of severe orthostatic hypotension

Medical Practitioner

48

Moxifloxacin 0.5%

Eye drops

Ophthalmic

Treatment of refractory bacterial conjunctivitis

Medical Practitioner

49

Nadolol

Tablet

Oral

Treatment of ventricular tachycardia or long QT Syndrome

Medical Practitioner

50

Natamycin 5%

Eye drops

Ophthalmic

Treatment of refractory fungal blepharitis, conjunctivitis or keratitis

Medical Practitioner

51

Nitazoxanide

Tablet

Oral

Treatment of giardiasis, cryptosporidiosis and blastocystis

Medical Practitioner

52

Nitazoxanide

Suspension

Oral

Treatment of giardiasis, cryptosporidiosis and blastocystis

Medical Practitioner

53

Paromomycin

Capsule

Oral

Antiprotozoal treatment of the following amoebic infections: (a) blastocystis hominis; (b) dientomoeba fragilis; (c) entamoeba histolytica; (d) parasite infection

Medical Practitioner

54

Pimozide

Tablet

Oral

Treatment of schizophrenia, chronic psychosis and Tourette syndrome

Medical Practitioner

55

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

Medical Practitioner

56

Pyrazinamide

Tablet

Oral

Treatment of tuberculosis

Medical Practitioner

57

Riboflavin, 0.1% in 20% dextran

Eye drops

Ophthalmic

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

Medical Practitioner

58

Riboflavin, 0.1% in sodium chloride

Eye drops

Ophthalmic

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

Medical Practitioner

59

Ripasudil 0.4%

Eye drops

Ophthalmic

Treatment of refractory corneal oedema or refractory glaucoma

Medical Practitioner

60

Rufinamide

Tablet

Oral

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

Medical Practitioner

61

Sodium benzoate

Tablet

Oral

Treatment of urea cycle disorders

Medical Practitioner

62

Stiripentol

Capsule

Oral

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

Medical Practitioner

63

Stiripentol

Tablet

Oral

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

Medical Practitioner

64

Stiripentol

Sachet

Oral

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

Medical Practitioner

65

Tacrolimus 0.03%

Ointment

Topical

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

Medical Practitioner

66

Tacrolimus 0.1%

Ointment

Topical

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

Medical Practitioner

67

Tizanidine

Capsule

Oral

Treatment of spasticity where other treatments have failed

Medical Practitioner

68

Tizanidine

Tablet

Oral

Treatment of spasticity where other treatments have failed

Medical Practitioner

69

Tetracycline

Capsule

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

70

Tetracycline

Tablet

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

71

Tick-borne Encephalitis Vaccine

Injection

Intramuscular

Prevention of tick-borne encephalitis

Medical Practitioner

72

Triamcinolone acetonide

Suspension for injection

Ophthalmic

Treatment of non-infectious uveitis or visualisation during vitrectomy

Medical Practitioner

73

Verteporfin

Powder for injection

Intravenous infusion

Photosensitisation for photodynamic therapy

Medical Practitioner

74

Yttrium-90 (Y-90) Citrate

Injection

Intraarticular

Radiosynovectomy treatment

Medical Practitioner