Federal Register of Legislation - Australian Government

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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
Registered 29 Sep 2017
Tabling HistoryDate
Tabled HR16-Oct-2017
Tabled Senate16-Oct-2017
Date of repeal 15 Mar 2018
Repealed by Therapeutic Goods (Authorised Supply of Specified Medicines) Rules March 2018

Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017

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 2017 that was registered on 3 July 2017, and make the following Rules.

Dated 27 September 2017

(Signed by)

 

LARRY KELLY

Delegate of the Minister for Health


1              Name

                These Rules are the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017.

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

Bismuth subcitrate

Tablet

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

4

Buspirone

Tablet

Oral

Treatment of generalised anxiety disorders

Medical Practitioner

5

Calcitriol

Liquid

Oral

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

Medical Practitioner

6

Cholecalciferol

Capsule

Oral

Treatment of severe vitamin D deficiency and prevention of osteoporosis

Medical Practitioner

7

Cholecalciferol

Injection

Intramuscular

Treatment of severe vitamin D deficiency and prevention of osteoporosis

Medical Practitioner

8

Cinnarizine

Tablet

Oral

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

Medical Practitioner

9

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

10

Cyclopentolate, 0.2%, & phenylephrine, 1%

Eye drops

Ophthalmic

Production of mydriasis

Medical Practitioner

11

Cyclosporin, 0.05%

Eye drops, emulsion

Ophthalmic

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

Medical Practitioner

12

Dehydrated ethanol (alcohol) 96% - 100%

Ampoule

Topical

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

Medical Practitioner

13

Dexamethasone

Implant

Intravitreal

Treatment of macular oedema, retinal vein occlusion and non-infectious uveitis

Medical Practitioner

14

Dexamethasone, 0.1%

Eye drops

Ophthalmic

Treatment of non-infected, steroid responsive, inflammatory conditions of the eye

Medical Practitioner

15

Diazoxide

Tablet

Oral

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

Medical Practitioner

16

Diazoxide

Capsule

Oral

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

Medical Practitioner

17

Diazoxide

Suspension

Oral

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

Medical Practitioner

18

Dimethyl sulfoxide (DMSO)

Solution

Intravesical 

Symptomatic relief of interstitial cystitis

Medical Practitioner

19

Flunarizine

Tablet

Oral

Prophylactic treatment of migraine

Medical Practitioner

20

Flunarizine

Capsule

Oral

Prophylactic treatment of migraine

Medical Practitioner

21

Fosfomycin

Sachet

Oral

Treatment of uncomplicated urinary tract infections

 

Treatment of pseudomonas aeruginosa infections in Cystic Fibrosis patients

Medical Practitioner

22

Furazolidone

Tablet

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

23

Glycopyrronium bromide

Tablet

Oral

Treatment of excessive salivation in patients with neurological conditions

Medical Practitioner

24

Hyoscine hydrobromide

Patch

Transdermal

Treatment of excessive salivation

Medical Practitioner

25

Hypertonic sodium chloride, 5 %

Eye ointment

Ophthalmic

Temporary relief of corneal oedema (hypertonicity)

Medical Practitioner

26

Hypertonic sodium chloride, 5%

Eye drops

Ophthalmic

Temporary relief of corneal oedema (hypertonicity)

Medical Practitioner

27

Indigo Carmine

Injection

Intravenous

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

Medical Practitioner

28

Indocyanine green dye

Injection

Intravenous

For intra-operative diagnostic use

Medical Practitioner

29

Ketotifen

Tablet

Oral

Treatment of allergic conditions

Medical Practitioner

30

Mannitol

Capsules

Inhalation

Treatment of bronchiectasis

 

Treatment of cystic fibrosis (adjunct to dornase alpha or for patients intolerant to dornase alpha)

Medical Practitioner

31

Melatonin

Syrup

Oral

Treatment of sleep disorders

Medical Practitioner

32

Melatonin

Modified release tablet

Oral

Treatment of sleep disorders

Medical Practitioner

33

Melatonin

Capsule

Oral

Treatment of sleep disorders

Medical Practitioner

34

Melatonin

Immediate Release Tablet

Oral

Treatment of sleep disorders

Medical Practitioner

35

Melatonin

Lozenge

Oral

Treatment of sleep disorders

Medical Practitioner

36

Midodrine

Tablet

Oral

Treatment of severe orthostatic hypotension

Medical Practitioner

37

Nitazoxanide

Tablet

Oral

Treatment of giardiasis, cryptosporidiosis and blastocystis

Medical Practitioner

38

Nitazoxanide

Suspension

Oral

Treatment of giardiasis, cryptosporidiosis and blastocystis

Medical Practitioner

39

Paromomycin

Capsule

Oral

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

Medical Practitioner

40

Pimozide

Tablet

Oral

Treatment of schizophrenia, chronic psychosis and Tourette syndrome

Medical Practitioner

41

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

42

Pyrazinamide

Tablet

Oral

Treatment of tuberculosis

Medical Practitioner

43

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

44

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

45

Rufinamide

Tablet

Oral

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

Medical Practitioner

46

Stiripentol

Capsule

Oral

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

Medical Practitioner

47

Stiripentol

Tablet

Oral

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

Medical Practitioner

48

Stiripentol

Sachet

Oral

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

Medical Practitioner

49

Tacrolimus 0.1%

Ointment

Topical

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

Medical Practitioner

50

Tetracycline

Capsule

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

51

Tetracycline

Tablet

Oral

Treatment of resistant Helicobacter Pylori infection

Medical Practitioner

52

Tick-borne Encephalitis Vaccine

Injection

Intramuscular

Prevention of tick-borne encephalitis

Medical Practitioner

53

Triamcinolone acetonide

Suspension for injection

Ophthalmic

Treatment of inflammatory ocular conditions

Medical Practitioner

54

Triamcinolone acetonide

Suspension for injection

Ophthalmic

Visualisation during vitrectomy.

Medical Practitioner

55

Verteporfin

Powder for injection

Intravenous infusion

Photosensitisation for photodynamic therapy

Medical Practitioner

56

Yttrium-90 (Y-90) Citrate

Injection

Intraarticular

Radiosynovectomy treatment

Medical Practitioner