National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02898 Regulations Not in force Legislative Instrument

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Statutory Rules

1977 No. 221

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953*

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 that Committee has recommended to the Minister that the following drugs and medicinal preparations be prescribed as pharmaceutical benefits under section 85 of the National Health Act 1953, namely the drugs and medicinal preparations specified in Schedule 3 to the National Health (Pharmaceutical Benefits) Regulations, as amended by the following Regulations, that had not previously been prescribed as pharmaceutical benefits:

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 this eighteenth day of November 1977.

John R. Kerr

Governor-General

By His Excellency’s Command,

SGD. RALPH J. HUNT

Minister of State for Health

___________

 

AMENDMENTS OF THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS†

Commencement

  1.    These Regulations shall come into operation on 1 December 1977.

____________________________________________________________________________________

* Notified in the Commonwealth of Australia Gazette on 24 November 1977.

† Statutory Rules 1900, No. 17 as amended to date. For previous amendments of the National Health (Pharmaceutical Benefits) Regulations see footnote † to Statutory Rules 1977, No. 39 and see also Statutory Rules 1977, Nos. 39 and 125.

16200/77 Cat. No. —Recommended retail price 20c     12/4.11.1977


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 203 insert the following item:

“ 203a Emetine and Bismuth Iodide Tablets ”.

2.      After item 327 insert the following item:

327a Lincomycin Hydrochloride ”.

3.      After item 465 insert the following item:

465a Phenolphthalein ”.

4.      After item 555 insert the following item:

555a Sodium Calciumedetate Injection ”.

5.      After item 630 insert the following item:

630a Trisodium Edetate Injection ”.

_______________

 

SCHEDULE 2 Regulation 3

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

1. After item 32 insert the following item:

 

32a Betamethasone Valerate.....................

— ”.

2. After item 41 insert the following item:

 

41a Cephalexin.............................

Purified Water, B.P., with Cephalexin ”,

3. Omit item 120.

 

4. After item 133 insert the following item:

 

133a Miconazole Nitrate.......................

— ”.

5. Omit item 163.

 

6. Omit item 187.

 

7. After item 218 insert the following item:

 

218a Triglycerides Oil, Medium Chain

— ”.

_____________

 

SCHEDULE 3 Regulation 4

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

1. After item 208 insert the following items:

208a Metoprolol Tartrate

“ 208b Miconazole Nitrate ”.

2. After item 277 insert the following item:

“ 277a Rabies Immune Globulin, Human ”.

3. Omit item 295.

4. After item 343 insert the following item:

343a Triglycerides Oil, Medium Chain ”.


SCHEDULE 4  Regulation 5

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

1. Omit item 4, substitute the following items:

 

“ 4 Alginic Acid Compound Powder

With the written authority of the Director-General, cardio-oesophageal reflux

“ 4a Alginic Acid Compound Granules

With the written authority of the Director-General, cardio oesophageal reflux not responding to antacid therapy ”.

2. Omit item 19, substitute the following item:

 

“ 19 (1) Calciferol, B.P.

With the written authority of the Director-General—

(2) Calciferol Tablets, Strong, B.P.

Hypocalcaemia

 

Hypoparathyroidism

 

Osteomalacia following gastrectomy, severe steatorrhoea or renal failure

 

Vitamin D-resistant rickets ”.

3. Omit item 23, substitute the following item:

 

“ 23 Carbenicillin Sodium

Any disease or condition in a patient receiving treatment in or at an approved hospital

 

With the written authority of the Director-General—

 

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

 

Septicaemia, suspected or proven ”

4. Omit item 26, substitute the following item:

 

“ 26 Cephaloridine

Endophthalmitis

 

Infections where positive bacteriological evidence conforms that cephaloridine is the most appropriate therapeutic agent ”.

5. Omit item 39, substitute the following item:

 

“ 39 (1) Clindamycin Hydrochloride

Gram-positive coccal infections where the infection cannot be safely and effectively treated with penicillin or a derivative of penicillin ”.

(2) Clindamycin Palmilate Hydrochloride

6. Omit item 47, substitute the following item:

 

“ 47 (1) Cyclophosphamide, B.P.

Any disease or condition in a patient receiving treatment in or at an approved hospital

(2) Cyclophosphamide Tablets, B.P.

 

With the written authority of the Director-General—

 

Anaemia, autoimmune, haemolytic

 

Arthritis, rheumatoid with vasculitis or visceral complications

 

Continuing cyclophosphamide therapy after discharge from an approved hospital

 

Crohn’s disease

 

Dermatomyositis

 

Granulomatosis, Wegener’s

 

Hepatitis, active, chronic

 

Lupus erythematosus, systemic

 

Malignant disease, including leukaemia

 

Nephritis

 

Nephrotic syndrome

 

Pemphigus vulgaris

 

Polyarteritis nodosa

 

Scleroderma

 

Thrombocytopenic purpura

 

Ulcerative colitis ”.

7. Omit item 63, substitute the following item:

 

“ 63 Fluoxymesterone Tablets, B.P.

With the written authority of the Director-General—

 

Aplastic anemias, proven

 

Carcinoma of the beast

 

Hypogonadism

 

Osteoporosis ”.


8. Omit item 70, substitute the following item:

 

“ 70 Gentamicin Injection, B.P.

Any disease or condition in a patient receiving treatment in or at an approved hospital

 

Endophthalmitis

 

With the written authority of the Director-General—

 

Infections where positive bacteriological evidence confirms that gentamicin sulphate is the most appropriate antibiotic

 

Septicaemia including suspected septicaemia ”.

9. Omit item 76, substitute the following item:

 

“ 76 (1) Haloperidol

Any disease or condition in a patient receiving treatment in or at an approved hospital

(2) Haloperidol Tablets, B.P., 1.5 mg

 

Chorea

 

Hyperactive states of organic or toxic delirium

 

Malignant neoplasia (late stage)

 

Radiation sickness

 

Major psychoses including—

 

Major organic psychoses including arteriopathic dementia

 

Manic-depressive psychosis

 

Paranoid states

 

Schizophrenia

 

Senile dementia ”.

10. After item 76 insert the following item:

 

76a Haloperidol Tablets, B.P., 5 mg

For use in a hospital for acute schizophrenia or mania ”.

11. Omit item 88, substitute the following item:

 

“ 88 (1) Levodopa, B.P., with Carbidopa

Treatment of Parkinson’s Disease ”.

(2) Levodopa Capsules, B.P.

 

(3) Levodopa Tablets, B.P.

 

12. Omit item 89.

 

13. Omit item 90.

 

14. Omit item 91.

 

15. Omit item 104, substitute the following item:

 

“ 104 Methicillin Sodium, B.P., for injection

Endophthalmitis

Proven or suspected staphylococcal septicaemia ”.

16. Omit item 107, substitute the following item:

 

“ 107 Methylprednisolone Acetate Injection

For local intra-articular or peri-articular infiltration ”.

17. Omit item 110, substitute the following item:

 

“ 110 (1) Methylteslosterone, B.P.

Carcinoma of the breast

(2) Methyltestosterone Tablets, B.P., 25 mg or 50 mg

Hypogonadism

Klinefelter’s syndrome (seminiferous tubule dysgenesis) ”.

18. After item 111 insert the following items:

 

“ 111a Metoprolol Tartrate

With the written authority of the Director-General, frequent disabling angina without evidence of cardiac failure

“ 111b Miconazole Nitrate

Cutaneous candidiasis

 

Dermatomycosis

 

Pityriasis versicolor ”.

19. Omit item 115, substitute the following item:

 

“ 115 Nandrolone Decanoate Injection, B.P.

With the written authority of the Director-General—

 

Carcinoma of the breast

 

Osteoporosis

 

Patients on long-term treatment with corticosteroids ”.


20.

Omit item 116, substitute the following item:

 

 

“ 116 Nandrolone Phenylpropionate Injection, B.P.

With the written authority of the Director-General—

 

 

Carcinoma of the breast

 

 

Osteoporosis

 

 

Patients on long-term treatment with corticosteroids ”.

21.

Omit item 129.

 

22.

Omit item 132, substitute the following item:

 

 

“ 132 Phenelzine Tablets, B.P.

Depressive illness resistant to treatment with tricyclic antidepressants or electroconvulsive therapy

 

 

Phobic states ”.

23.

Omit item 152.

 

24.

Omit item 155, substitute the following item:

 

 

“ 155 Sodium Nitroprusside

For use in a hospital ”.

25.

Omit item 158, substitute the following item:

 

 

“ 158 Stanolone Tablets, B.P.

With the written authority of the Director-General—

 

 

Carcinoma of the breast

 

 

Osteoporosis

 

 

Patients on long-term treatment with corticosteroids ”.

26.

Omit item 167, substitute the following item:

 

 

“ 167 Thiamine Hydrochloride Tablets, B.P.

Any disease or condition in a pensioner ”.

27.

Omit item 172, substitute the following item:

 

 

“ 172 Tranylcypromine Tablets, B.P.

Depressive illness resistant to treatment with tricyclic anti-depressants or electroconvulsive therapy

 

 

Phobic states ”.

28.

After item 174 insert the following item:

 

 

“ 174a Triglycerides Oil, Medium Chain

With the written authority of the Director-General, patients requiring a ketogenic diet for intractable childhood epilepsy ”.

29.

Omit item 175, substitute the following item:

 

 

“ 175 ‘ TRIGLYDE ’

With the written authority of the Director-General—

 

 

Patients requiring a ketogenic diet for intractable childhood epilepsy

 

 

Proven malabsorption ”.

30.

Omit item 177, substitute the following item:

 

 

“ 177 Vancomycin Hydrochloride

Any disease or condition in a patient receiving treatment in a hospital

 

 

Endophthalmitis ”;

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Printed by Authority by the Acting Commonwealth Government Printer

Overview

The Statutory Rules 1977 No. 221, made under the National Health Act 1953, were introduced to address the need for updating the list of drugs and medicinal preparations that could be prescribed as pharmaceutical benefits. The Pharmaceutical Benefits Advisory Committee recommended these updates, as the existing list was outdated and did not reflect advancements in medical treatments. The National Health Act 1953 empowers the Governor-General, on the advice of the Federal Executive Council, to make regulations regarding the provision of pharmaceutical benefits. The policy objective of these regulations is to ensure that the Pharmaceutical Benefits Scheme remains current and responsive to the evolving healthcare needs of Australians. The regulations, which came into effect on 1 December 1977, amended various schedules of the National Health (Pharmaceutical Benefits) Regulations to include new drugs and medicinal preparations, while removing outdated ones. These amendments aimed to enhance the scope of treatments available under the Pharmaceutical Benefits Scheme, thereby improving access to essential medications for the Australian public. The updates reflect the ongoing commitment to providing affordable and effective healthcare through the Scheme.

Scope and Application

These Regulations, made under the National Health Act 1953, apply to drugs and medicinal preparations that were not previously prescribed as pharmaceutical benefits but have now been recommended by the Pharmaceutical Benefits Advisory Committee for inclusion as such. The Regulations cover a range of pharmaceutical products including tablets, injections, and oils, which are now eligible for prescription as pharmaceutical benefits under the National Health Act. This legislative instrument applies to the Commonwealth of Australia, extending its provisions to all persons and entities within its jurisdiction. Notably, the Regulations specify certain conditions and authorities required for the prescription of some drugs, such as the written authority of the Director-General for particular treatments. There are no stated exclusions or exemptions in these Regulations; however, the application of certain drugs is contingent upon meeting specific criteria and obtaining necessary approvals. The Regulations are supplemented by subordinate instruments, which may further detail the application and scope of the provisions outlined herein.

Key Provisions

The National Health (Pharmaceutical Benefits) Regulations, as amended by these Regulations, establish the list of drugs and medicinal preparations that can be prescribed as pharmaceutical benefits under the National Health Act 1953. The Regulations include specific items in Schedules 1, 2, 3, and 5, detailing which drugs and preparations can be prescribed and the conditions under which they can be administered. These amendments are effective from 1 December 1977. These Regulations impose specific obligations on healthcare providers, patients, and pharmaceutical companies. Healthcare providers must ensure that the drugs prescribed fall within the approved list of pharmaceutical benefits. Patients, in turn, must be informed about which medications are covered under the scheme. Pharmaceutical companies are required to adhere to the recommended retail prices and other stipulations as outlined in the Regulations. Breach of these Regulations can result in both civil and criminal consequences. For instance, prescribing drugs that are not listed in the approved schedules may lead to penalties. The exact penalties are not detailed in these Regulations but can include fines or other sanctions as determined by relevant authorities under the National Health Act 1953. Additionally, any fraudulent claims or misrepresentations in obtaining pharmaceutical benefits could lead to criminal charges, with potential penalties including imprisonment. The severity of the penalties would depend on the nature and extent of the breach.

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