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SR 1982 No. 334 Regulations as made
These Regulations amend the National Health (Pharmaceutical Benefits) Regulations.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled Senate07-Dec-1982
Tabled HR08-Dec-1982
Gazetted 30 Nov 1982
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Statutory Rules 1982 No. 3341

__________

National Health (Pharmaceutical Benefits) Regulations2 (Amendment)

WHEREAS it is provided by sub-section 101 (4) of the National Health Act 1953 that a drug or medicinal preparation that was not a pharmaceutical benefit under that Act immediately before the commencement of that sub-section shall not be prescribed as a pharmaceutical benefit in accordance with section 85 of that Act unless the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that it be so prescribed:

            AND WHEREAS the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that each of the following drugs or medicinal preparations be prescribed as a pharmaceutical benefit under section 85 of that Act, namely—

                (a)    ‘‘INFASOY’’;

               (b)    Nifedipine; and

                (c)    Ticarcillin Disodium:

            AND WHEREAS it is desirable, amongst other things, to prescribe each of those drugs or medicinal preparations as a pharmaceutical benefit under that section:

            NOW THEREFORE I, the Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953.

            Dated 23 November 1982.

                                                                                                             N. M. STEPHEN

                                                                                                            Governor-General

     By His Excellency’s Command,

J. J. CARLTON

Minister of State for Health

__________

Commencement

          1.    These Regulations shall come into operation on 1 December 1982.

Schedule 1

          2.    Schedule 1 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 1.

Schedule 2

          3.    Schedule 2 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 2.

Schedule 3

          4.    Schedule 3 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 3.

Schedule 5

          5.    Schedule 5 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 4.

                                   SCHEDULE 1                      Regulation 2

AMENDMENTS OF SCHEDULE 1 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

 

1.

After item 300 insert the following item:

 

“300A  Dichlorphenamide Tablets”.

2.

After item 303 insert the following item:

 

“303A  Dienoestrol Tablets”.

3.

After item 457 insert the following item:

 

“457A  Glycerol Suppositories”.

4.

Omit item 651.

5.

Omit item 670.

6.

Omit item 1079.

__________

 

                                 SCHEDULE 2                       Regulation 3

AMENDMENTS OF SCHEDULE 2 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

 

1.

Omit item 66.

 

2.

Omit item 91.

 

3.

Omit item 137, substitute the following item:

 

 

“137 Hydrocortisone, B.P.

Polymyxin B Sulphate, B.P., with Neomycin Sulphate, B.P., and Hydrocortisone, B.P.”.

4.

After item 146 insert the following item:

 

 

“146A  ‘INFASOY’

—”.

5.

Omit item 147, substitute the following item:

 

 

“147 Insulin Injection, Neutral, B.P.

Insulin Injection, Isophane, B.P., and Insulin Injection, Neutral, B.P.”.

6.

Omit item 148, substitute the following item:

 

 

“148 Insulin Injection, Isophane, B.P.

Insulin Injection, Neutral, B.P., and Insulin Injection, Isophane, B.P.”.

7.

After item 167 insert the following item:

 

 

“167A  Metoclopramide Hydrochloride, B.P.

—”.

8.

Omit item 172, substitute the following item:

 

 

“172 Natamycin

—”.

9.

Omit item 173, substitute the following item:

 

 

“173 Neomycin Sulphate, B.P.

Bacitracin with Polymyxin B Sulphate, B.P., and Neomycin Sulphate, B.P.

Colistin Sulphate, B.P., with Neomycin Sulphate, B.P.

Gramicidin with Nystatin, B.P., Triamcinolone Acetonide, B.P., and Neomycin Sulphate B.P.

Hydrocortisone Acetate, B.P., with Neomycin Sulphate, B.P.

Polymyxin B Sulphate, B.P., with Bacitracin Zinc, B.P., and Neomycin Sulphate, B.P.

Polymyxin B Sulphate, B.P., with Gramicidin, and Neomycin Sulphate, B.P.

Polymyxin B Sulphate, B.P., with Hydrocortisone, B.P., and Neomycin Sulphate, B.P.”.

10.

Omit item 219.

 

__________

                                   SCHEDULE 3                      Regulation 4

AMENDMENTS OF SCHEDULE 3 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

 

1.

Omit item 62.

2.

Omit item 89.

3.

After item 128 insert the following item:

 

“128A  ‘INFASOY’ ”.

4.

Omit item 136.

5.

Omit item 137.

6.

Omit item 138.

7.

Omit item 139.

8.

Omit item 140.

9.

Omit item 141.

10.

After item 180 insert the following item:

 

“180A  Nifedipine”.

11.

Omit item 244.

12.

After item 265 insert the following item:

 

“265A  Ticarcillin Disodium”.

__________

                                   SCHEDULE 4                      Regulation 5

AMENDMENTS OF SCHEDULE 5 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

 

1.

After item 5 insert the following item:

 

 

“5A  Amoxycillin Trihydrate, B.P., Dispersible Tablets

Infection of the lower urinary tract”.

2.

Omit item 6, substitute the following item:

 

 

   “6  Ascorbic Acid Tablets, B.P.

Any disease or condition in a pensioner or a dependant of a pensioner”.

3.

Omit item 8, substitute the following item:

 

 

   “8  Azathioprine Tablets, B.P.

With the written authority of the Permanent Head—

Anaemia, autoimmune haemolytic

Continuing azathioprine therapy initiated in a hospital

Dermatomyositis

Granulomatosis, Wegener’s

Hepatitis, active, chronic

Lupus erythematosus, systemic

Nephrotic syndrome

Organ transplant

Polyarteritis nodosa

Pyoderma gangrenosum

Scleroderma

Thrombocytopenic purpura”.

4.

After item 10 insert the following item:

 

 

“10A Beclomethasone Dipropionate, B.P., Capsules, 100 micrograms

With the written authority of the Permanent Head—

Chronic intractable asthma requiring maintenance corticosteroids in children under the age of eight (8) years who are unable to use a metered aerosol spray”.

5.

Omit item 15, substitute the following item:

 

 

“15  Bleomycin Sulphate

Germ cell neoplasms

Lymphoma

Squamous cell carcinoma”.

6.

Omit item 20, substitute the following item:

 

 

“20  Calciferol Tablets, High-Strength, B.P. Hypocalcaemia

Hypoparathyroidism

Osteomalacia following gastrectomy, severe steatorrhoea or renal failure

Vitamin D-resistant rickets”.

7.

Omit item 21, substitute the following item:

 

 

“21  Calcitriol

With the written authority of the Permanent Head—

Hypocalcaemia due to renal disease

Hypoparathyroidism”.

8.

Omit item 24, substitute the following items:

 

 

“24  Calcium Folinate, Injection

“24A Calcium Folinate, Tablets, 15 mg

Antidote to folic acid antagonists

With the written authority of the Permanent Head—

Antidote to folic acid antagonists”.

9.

Omit item 34, substitute the following item:

 

 

“34  Chlorambucil Tablets, B.P.

With the written authority of the Permanent Head—

Anaemia, autoimmune, haemolytic

Continuing chlorambucil therapy initiated in a hospital

Granulomatosis, Wegener’s

Leukaemia, chronic lymphatic

Lupus erythematosus, systemic

Lymphoma

Myeloproliferative disorders

Polyarteritis nodosa

Scleroderma

Thrombocytopenic purpura”.

10.

Omit item 47, substitute the following item:

 

 

“47  Codeine Phosphate, B.P., with Aspirin, B.P., Soluble Tablets

Any disease or condition in a pensioner or a dependant of a pensioner”.

11.

Omit item 48, substitute the following item:

 

 

“48  Codeine Phosphate, B.P., with Aspirin, B.P., Tablets, 30mg-325mg

With the written authority of the Permanent Head—

Malignant neoplasia”.

12.

Omit item 49, substitute the following item:

 

 

“49  Codeine Phosphate, B.P., with Paracetamol, B.P., Tablets, 8mg-500mg

Any disease or condition in a pensioner or a dependant of a pensioner”.

13.

Omit item 53, substitute the following item:

 

 

“53  (1) Cyclophosphamide, B.P.

        (2)   Cyclophosphamide Tablets, B.P.

With the written authority of the Permanent Head—

Anaemia, autoimmune haemolytic

Continuing cyclophosphamide thereapy initiated in a hospital

Dermatomyositis

Granulomatosis, Wegener’s

Hepatitis, active, chronic

Lupus erythematosus, systemic

Malignant disease including leukaemia

Nephritis

Nephrotic syndrome

Polyarteritis nodosa

Scleroderma

Thrombocytopenic purpura”.

14.

After item 55 insert the following item:

 

 

“55A Daunorubicin

With the written authority of the Permanent Head—

Acute leukaemia”.

15.

Omit item 66.

 

16.

After item 68 insert the following item:

 

 

“68A Doxepin Hydrochloride, B.P. Tablet, 50mg (base)

With the written authority of the Permanent Head—

Endogenous depression where there is an inadequate response to not less than 100mg of doxepin daily”.

17.

Omit item 72, substitute the following item:

 

 

“72  Ergocalciferol, B.P.

Hypocalcaemia

Hypoparathyroidism

Osteomalacia following gastrectomy, severe steatorrhoea or renal failure

Vitamin D-resistant rickets”.

18.

Omit item 84, substitute the following item:

 

 

“84  Glycerol, B.P., Suppositories

Any disease or condition in a paraplegic or quadriplegic patient

For use by patients who are receiving long-term intensive nursing care in hospitals or nursing homes

For use by patients for whose care a Commonwealth Domiciliary Nursing Care Benefit is approved”.

19.

After item 89 insert the following item:

 

 

“89A ‘INFASOY’

With the written authority of the Permanent Head—

Cows’ milk allergy in children under the age of two (2) years

Galactosaemia

Homocystinuria

Lactose intolerance”.

20.

Omit item 91.

 

21.

Omit item 95, substitute the following item:

 

 

“95  Labetalol Hydrochloride

Tablets Hyertension which fails to respond adequately to multiple antihypertensive drug therapy”

22.

Omit item 100, substitute the following item:

 

 

   “100  (1)   Medroxyprogesterone Acetate, B.P., Injection,
50 mg in 1 ml

             (2)   Medroxyprogesterone Acetate B.P., Tablets
100 mg

Breast cancer

Endometrial cancer

Renal cell cancer”.

23.

Omit item 101, substitute the following item:

 

 

“101 Medroxyprogesterone Acetate, B.P., Injection, 150 mg in 1 ml

Breast cancer

Endometrial cancer

Precocious puberty

Renal cell cancer”.

24.

Omit item 103, substitute the following item:

 

 

“103 Medroxyprogesterone Acetate, B.P., Tablets, 10 mg

Breast cancer

Dysfunctional uterine bleeding

Endometrial cancer

Precocious puberty

Renal cell cancer

Turner’s syndrome”.

25.

Omit item 104.

 

26.

Omit item 109, substitute the following items:

 

 

   “109  (1)   Methotrexate,  B.P., 5 mg Injection

             (2)   Methotrexate Injection, B.P., 5 mg

             (3)   Methotrexate Tablets, B.P.

With the written authority of the Permanent Head—

Acute leukaemia

Breast cancer

Chorioadenoma destruens

Continuing methotrexate therapy initiated in a hospital

Gestational choriocarcinoma

Head and neck epidermoid cell carcinoma

Hydatidiform mole

Lung cancer

Lymphoma

Osteogenic sarcoma

Severe intractable or extensive psoriasis

 

   “109A  (1)   Methotrexate, B.P., 50 mg Injection

             (2)   Methotrexate Injection, B.P., 50 mg

With the written authority of the Permanent Head—

Head and neck epidermoid cell carcinoma

Lymphoma

Osteogenic sarcoma”.

27.

After item 114 insert the following item:

 

 

   “114A Metoclopramide Hydrochloride, B.P.

With the written authority of the Permanent Head—

Gastric retention after gastric surgery

Malignant neoplasia (late stage)”.

28.

Omit item 124, substitute the following items:

 

 

“124 Nicotinic Acid Tablets, B.P.

Any disease or condition in a pensioner or a dependant of a pensioner

 

“124A  Nifedipine, Capsules, 10 mg

With the written authority of the Permanent Head—

Intractable angina not responding to other therapy”.

 

29.

After item 133 insert the following item:

 

 

“133A  Papaveretum, Tablets 10 mg

Disabling pain associated with proven malignant neoplasia

Disabling pain of short duration not responding to non-narcotic analgesics, the maximum duration of treatment being two weeks”.

30.

Omit item 134, substitute the following item:

 

 

    “134 (1)     Penicillamine, B.P.,

             (2)     Penicillamine Capsules, B.P.

             (3)     Penicillamine Tablets, B.P.

With the written authority of the Permanent Head—

Acute heavy metal intoxication

Cystinosis

Cystinuria with calculus formation

For the continuing treatment of rheumatoid arthritis where penicillamine therapy was initiated in a hospital

Haemoglobinuria, paroxysmal cold

Patients with rheumatoid arthritis who are already receiving long-term (greater than 6 months) therapy with penicillamine

Wilson’s disease (hepatolenticular degeneration)”.

31.

After item 153 insert the following item:

 

 

    “153A Procarbazine Hydrochloride

With the written authority of the Permanent Head—

Lymphoma

Small cell carcinoma of the lung”.

32.

Omit item 160, substitute the following items:

 

 

   “160      Riboflavine, B.P., Tablets

Any disease or condition in a pensioner or a dependant of a pensioner

 

   “160A    Salbutamol Sulphate, B.P., Capsules, 200 micrograms

With the written authority of the Permanent Head—

Bronchial asthma in children under the age of eight (8) years who are unable to use a metered aerosol spray”.

33.

Omit item 168.

 

34.

Omit item 178, substitute the following item:

 

 

   “178  Thiamine Hydrochloride Tablets, B.P.

Any disease or condition in a pensioner or a dependant of a pensioner”.

35.

Omit item 181, substitute the following item:

 

 

    “181 Ticarcillin Disodium Injection

With the written authority of the Permanent Head—

Infections where positive bacteriological evidence confirms that ticarcillin disodium is the most appropriate therapeutic agent

Septicaemia, suspected or proven”.

36.

After item 188 insert the following item:

 

 

   “188A    Trimethoprim, B.P.

Acute urinary tract infections”.

 

NOTES

1.       Notified in the Commonwealth of Australia Gazette on 30 November 1982.

2.       Statutory Rules 1960 No. 17 as amended to date. For previous amendments see Note 2 to Statutory Rules 1982 No. 69 and see also Statutory Rules 1982 Nos. 69, 76 and 179.