Federal Register of Legislation - Australian Government

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Rules/Other as made
These rules authorise the supply of specified therapeutic goods by specified classes of health practitioners.
Administered by: Health
Made 28 Jun 2017
Registered 03 Jul 2017
Tabled HR 08 Aug 2017
Tabled Senate 08 Aug 2017
Date of repeal 30 Sep 2017
Repealed by Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017

Therapeutic Goods (Authorised Supply of Specified Medicines) Rules 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, make the following Rules.

Dated 28 June 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 2017.

2              Commencement

                These Rules commence on 3 July 2017.

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 1.0, published by the Therapeutic Goods Administration in June 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

Triamcinolone acetonide

Suspension for injection

Ophthalmic

Treatment of inflammatory ocular conditions

Medical practitioner

2

Triamcinolone acetonide

Suspension for injection

Ophthalmic

Visualization during vitrectomy.

Medical practitioner

3

Melatonin

Syrup

Oral

Treatment of sleep disorders

Medical practitioner

4

Melatonin

Modified release tablet

Oral

Treatment of sleep disorders

Medical practitioner

5

Melatonin

Capsule

Oral

Treatment of sleep disorders

Medical practitioner

6

Melatonin

Tablet

Oral

Treatment of sleep disorders

Medical practitioner

7

Bismuth subcitrate

Tablet

Oral

Treatment of resistant H.Pylori infection

Medical practitioner

8

Tetracycline

Capsule

Oral

Treatment of resistant H.Pylori infection

Medical practitioner

9

Riboflavin, 0.1% in 20% dextran

Eye drops

Ophthalmic

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

Medical practitioner

10

Riboflavin, 0.1% in sodium chloride (hypotonic)

Eye drops

Ophthalmic

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

Medical practitioner

11

Flunarizine

Tablet

Oral

Prophylactic treatment of migraine

Medical practitioner

12

Cyclosporin, 0.05%

Eye drops, emulsion

Ophthalmic

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

Medical practitioner

13

Cinnarizine

Tablet

Oral

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

Medical practitioner

14

Hypertonic sodium chloride, 5%

Eye drops

Ophthalmic

Temporary relief of corneal oedema (hypertonicity)

Medical practitioner

15

Hypertonic sodium chloride

Eye ointment

Ophthalmic

Temporary relief of corneal oedema (hypertonicity)

Medical practitioner

16

Dexamethasone, 0.1%

Eye drops

Ophthalmic

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

Medical practitioner

17

Buspirone

Tablet

Oral

Treatment of generalised anxiety disorders

Medical practitioner

18

Paromomycin

Capsule

Oral

Antiprotozoal treatment of the following amoebic infections:

(a) blastocystis hominis;

(b) dientomoeba fragilis;

(c) entamoeba histolytica;

(d) parasite infection

Medical practitioner

19

Allergens – multiple, various

Skin prick test

Intradermal

Confirmation of suspected allergic reactions

Medical practitioner

20

Cyclopentolate, 0.2%, & phenylephrine, 1%

Eye drops

Ophthalmic

Production of mydriasis.

Medical practitioner

21

Verteporfin

Powder for injection

Intravenous infusion

Photosensitisation for photodynamic therapy

Medical practitioner

22

Pyrazinamide

Tablet

Oral

Treatment of resistant tuberculosis

Medical practitioner

23

Furazolidone

Tablet

Oral

Treatment of resistant H.Pylori infection

Medical practitioner

24

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 other infections as prescribed by an infectious disease specialist

Medical practitioner

25

Glycopyrronium bromide

Tablet

Oral

Treatment of excessive salivation in patients with neurological conditions

Medical practitioner

26

Cholecalciferol

Capsule

Oral

Treatment of severe vitamin D deficiency and prevention of osteoporosis

Medical practitioner

27

Cholecalciferol

Injection

Intramuscular

Treatment of severe vitamin D deficiency and prevention of osteoporosis

Medical practitioner