National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02903 Regulations Not in force Legislative Instrument

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Statutory Rules

1979 No. 51

REGULATIONS UNDER THE NATIONAL HEALTH ACT 19531

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 twenty-ninth day of March 1979.

 ZELMAN COWEN

 Governor-General

 By His Excellency’s Command,

 

 

RALPH J. HUNT

Minister of State for Health

_______________

AMENDMENTS OF THE NATIONAL HEALTH
PHARMACEUTICAL BENEFITS) REGULATIONS2

1 Commencement

  These Regulations shall come into operation on 1 April 1979.

2 Schedule 1

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

3 Schedule 2

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

4 Schedule 3

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

5 Schedule 4

  Schedule 4 to the National Health (Pharmaceutical Benefits) Regulations is amended by omitting items 18 and 22.

6 Schedule 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. Omit item 7.

 2. After item 268 insert the following item:

 “268A Gelatin”.

 3. After item 367 insert the following item:

 “367A Magnesium Sulphate Dried”.

 4. After item 415 insert the following item:

 “415A Methylprednisolone Acetate”.

 5. After item 416 insert the following item:

 “416A Methyltestosterone”.

 6. After item 467 insert the following item:

 “467A Oxytetracycline Dihydrate”.

 7. Omit item 507.

 8. Omit item 575.

 9. After item 577 insert the following item:

 “577A Quinalbarbitone Sodium”.

_______________

 SCHEDULE 2 Regulation 3

AMENDMENTS OF SCHEDULE 2 OF THE

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

 1. Omit item 7.

 2. After item 28 insert the following items:

 “28A Benzyl Benzoate, B.P......    –”.

 “28B Benzyl Benzoate Application,

  B.P.................    –”.

 3. After item 65 insert the following item:

 “65A ‘DE-LACT  INFANT’....    –”.

 4. After item 84 insert the following item:

 “84A Econazole Nitrate........    –”.

 5. Omit item 90, substitute the following item:

 “90 Ethinyloestradiol........Ethynodiol Diacetate with

   Ethinyloestradiol

   Levonorgestrel with Ethinyloestradiol

   Lynoestrenol with Ethinyloestradiol

   Norethisterone with Ethinyloestradiol

   Norethisterone Acetate with

   Ethinyloestradiol

   Norgestrel with Ethinyloestradiol”.

 6. After item 122 insert the following item:

 “122A Isoprenaline Sulphate, B.P.    –”.

 7. After item 125 insert the following item:

 “125A Levonorgestrel.........Levonorgestrel with Ethinyloestradiol”.

 8. Omit item 138.

 9. Omit item 155, substitute the following item:

 “155 Nystatin..............Gramicidin with Neomycin Sulphate,

 Triamcinolone Acetonide and Nystatin Tetracycline,

 B.P.C., with a buffering agent and

 Nystatin Tetracycline Hydrochloride with Nystatin”.

 10. Omit item 157.

 11. After item 188 insert the following item:

 “188A Pyrimethamine, B.P......Pyrimethamine, B.P., with Sulfadoxine”.

 12. After item 197 insert the following item:

 “197A Sulfadoxine...........Pyrimethamine, B.P., with Sulfadoxine”.

_______________

 SCHEDULE 3  Regulation 4

AMENDMENTS OF SCHEDULE 3 TO THE

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

 1. Omit item 12.

 2. Omit item 81.

 3. After item 103 insert the following item:

 “103A ‘DE-LACT INFANT’ ”.

 4. After item 120 insert the following item:

 120A  Econazole Nitrate”.

 5. Omit item 122.

 6. Omit item 153, substitute the following item:

 “153  Hamamelis Ointment, B.P.C.”.

 7. After item 190 insert the following item:

 “190A  Levonorgestrel”.

 8. After item 194 insert the following item:

 “194A  Mafenide Acetate”.

 9. Omit item 198.

 10. After item 217 insert the following item:

 “217A  Naproxen”.

 11. After item 237 insert the following item:

 “237A  Perhexiline Maleate”.

 12. After item 254 insert the following item:

 “254A  Polyestradiol Phosphate”.

 13 Omit item 256.

 14. After item 258 insert the following item:

 “258A  Potassium Bicarbonate Effervescent Tablets”.

 15. After item 259 insert the following item:

 “259A  Potassium Chloride with Potassium Bicarbonate Effervescent Tablets”.

 16. Omit item 260.

 17. After item 314 insert the following item:

 “314A  Sulfadoxine”.

_______________

 SCHEDULE 4  Regulation 6

AMENDMENTS OF SCHEDULE 5 TO THE

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

 1. Omit item 4.

 2. Omit item 5.

 3. Omit item 41, substitute the following item:

 “41 Cimetidine............With the written authority of the Permanent Head–

 Duodenal ulcer, confirmed by radiology, endoscopy or surgery Gastric ulcer, confirmed by radiology, endoscopy or surgery Zollinger-Ellison syndrome, proven by investigation”.

 4. After item 53 insert the following item:

 “53A 1%, infant’............With the written authority of the Permanent Head, lactose intolerance in infants under the age of 6 months”.

 5. After item 67 insert the following item:

 “67A Econazole Nitrate Cream...Cutaneous candidiasis

  1%, 20 g Dermatomycosis

   Pityriasis versicolor”.

 6. Omit item 77, substitute the following item:

 “77 Gentamicin Injection, B.P..Any disease or condition in a patient receiving treatment in or at an approved hospital

   With the written authority of the Permanent Head–

 Endophthalmitis

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

 Septicaemia including suspected septicaemia”.

 7. After item 90 insert the following item:

 “90A Influenza Vaccine For prophylaxis of–

  (Monovalent)  Pensioners who have not attained the age of 25 years
    Persons who have not attained the age of 25 years and who                                                         are suffering from any severe debilitating disease, chronic                                                         heart disease or chronic pulmonary disease”.

 8. Omit item 91, substitute the following item:

 “91 Influenza Vaccine For prophylaxis of–

  (Trivalent)  Pensioners

    Persons suffering from any severe debilitating disease, chronic heart disease or chronic pulmonary disease”.

 9. Omit item 102, Federal Digest following item:

 “102 Mafenide Acetate With the written authority of the Permanent Head, treatment, in a                                           hospital, of burns”.

 10. Omit item 107, substitute the following item:

 “107 (1) Metformin Maturity onset diabetes not satisfactorily controlled by diet and

   Hydrochloride, B.P. other drugs, where the risk of lactic acidosis is minimised by

  (2) Metformin Tablets, B.P. excluding predisposing factors, especially reduced renal, hepatic

    or cardiovascular function”.

 11. Omit item 113, substitute the following item:

 “113 Methylprednisolone For local intra-articular or peri-articular infiltration”.

  Acetate Injection, B. P.

 12. Omit item 114.

 13. Omit item 116, substitute the following item:

 “116 Methyltestosterone Carcinoma of the breast

  Tablets, B.P., 25 mg  Hypogonadism
  or 50 mg Klinefelter's syndrome (seminiferous tubule dysgenesis)”.

 14. After item 139 insert the following item:

 “139A Perhexiline Maleate With the written authority of the Permanent Head, intractable
   angina not responding to other therapy”.

 15. After item 142 insert the following item:

 “142A Phenoxybenzamine With the written authority of the Permanent Head–

  Capsules, B.P.  Neurogenic urinary retention

    Phaeochromocytoma”.

 16. After item 146 insert the following item:

 “146A Polyestradiol Phosphate....Carcinoma of the breast

   Carcinoma of the prostate”.

 17. Omit item 148.

 18. After item 149 insert the following item:

 “149A Potassium Bicarbonate With the written authority of the Permanent Head, potassium

  Effervescent Tablets deficiency in patients with renal tubular acidosis”.

 19. Omit item 185, substitute the following item:

 “185 Triglycerides Oil, With the written authority of the Permanent Head–

  Medium Chain   Abetalipoproteinaemia, acanthocytosis

    Intestinal lymphangiectasia

    Patients requiring a ketogenic diet for intractable childhood                                                         epilepsy”.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 March 1979.

2. Statutory Rules 1960 No. 17 as amended by Statutory Rules 1960 Nos. 90 and 102; 1961 Nos. 59 and 137; 1962 Nos. 34, 101 and 114; 1963 Nos. 34, 69 and 107; 1964 Nos. 12, 57 and 135; 1965 Nos. 51, 151 and 152; 1966 Nos. 80 and 144; 1967 Nos. 67, 116 and 158; 1968 Nos. 44, 76, 88 and 146; 1969 Nos. 44, 107 and 185; 1970 Nos. 39, 94, 119 and 186; 1971 Nos. 44, 101, 136 and 154; 1972 Nos. 32, 121 and 205; 1973 Nos. 15, 57, 139 and 229; 1974 Nos. 37, 126 and 222; 1975 Nos. 50, 148 and 209; 1976 Nos. 84, 150, 195 and 255; 1977 Nos. 39, 125 and 221; and 1978 Nos. 47, 142, 153 and 245.

Overview

The National Health (Pharmaceutical Benefits) Regulations, 1979, were enacted to amend the National Health (Pharmaceutical Benefits) Regulations under the National Health Act 1953. These regulations were introduced to address the need to update the list of drugs and medicinal preparations that could be prescribed as pharmaceutical benefits. This was achieved by incorporating recommendations from the Pharmaceutical Benefits Advisory Committee to the Minister. The regulations were made by the Governor-General of the Commonwealth of Australia, acting on the advice of the Federal Executive Council, and came into effect on 1 April 1979. The primary objective of these amendments was to expand the scope of drugs available under the Pharmaceutical Benefits Scheme by including additional drugs and medicinal preparations previously not covered, thereby enhancing the accessibility of essential medications for the Australian public.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations 1979, made under the National Health Act 1953, specify the pharmaceutical benefits that are available to the public in Australia, subject to the recommendations of the Pharmaceutical Benefits Advisory Committee. These Regulations apply to the Commonwealth and extend to all states and territories within Australia, governing the prescription and reimbursement of specified drugs and medicinal preparations as pharmaceutical benefits. The Regulations identify specific drugs and medicinal preparations that can be prescribed as pharmaceutical benefits and outline the conditions under which certain drugs may be prescribed with written authority. These Regulations do not cover drugs and medicinal preparations that are not listed in the amended Schedules, which means that other drugs not specified in the Schedules are not eligible for prescription as pharmaceutical benefits unless they are subsequently recommended by the Pharmaceutical Benefits Advisory Committee and added to the Schedules through further amendments. The scope of the Regulations can be extended or restricted by subordinate instruments, which may include additional amendments to the Schedules to include new drugs or modify existing entries.

Key Provisions

The main operative sections of these Regulations involve amendments to various schedules of the National Health (Pharmaceutical Benefits) Regulations, specifically Schedules 1, 2, 3, and 5. Regulation 2 amends Schedule 1 by adding new items, omitting certain existing items, and inserting new items. Regulation 3 amends Schedule 2 in a similar manner, adding, omitting, and substituting items. Regulation 4 amends Schedule 3 by adding new items and omitting existing items. Regulation 5 amends Schedule 5 by omitting certain items and inserting new ones. These amendments reflect the Pharmaceutical Benefits Advisory Committee's recommendations to the Minister to include specific drugs and medicinal preparations as pharmaceutical benefits under the National Health Act 1953. The Regulations impose obligations on various parties involved in the healthcare and pharmaceutical sectors. Pharmaceutical companies must ensure that the drugs and medicinal preparations now listed as pharmaceutical benefits comply with the relevant standards and guidelines. Healthcare providers are required to prescribe these drugs only for the specified conditions and with the necessary approvals where required. Patients must adhere to the prescribed use of these medications as directed by their healthcare providers. Additionally, the Minister and relevant authorities are responsible for monitoring and enforcing compliance with these Regulations. Breaches of these Regulations can result in both civil and criminal consequences. For instance, if a healthcare provider prescribes a drug for an unapproved condition without the necessary authority, they could face disciplinary action or sanctions from the relevant medical board. Pharmaceutical companies found to be in non-compliance with the standards and guidelines for listed drugs could face fines or other penalties. In more severe cases, criminal charges could be brought against individuals or companies for fraudulent activities related to the provision of pharmaceutical benefits. The exact penalties vary depending on the nature and severity of the breach but can include substantial fines and, in some cases, imprisonment.

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Health Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Commencement Provisions
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