National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02880 Regulations Not in force Legislative Instrument

Legislation content

STATUTORY RULES

1972 No.

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1971.*

WHEREAS it is provided by sub-section (4.) of section 101 of the National Health Act 1953-1971 that a drug or medicinal preparation that was not a pharmaceutical benefit under the National Health Act 1953-1958 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 1953-1971, namely, the drugs and medicinal preparations specified in the Third Schedule 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 ADMINISTRATOR of the Government of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953-1971.

Dated this twenty-seventh day of July, 1972.

Rohan Delacombe

Administrator.

By His Excellency’s Command,

Amendments of the National Health (Pharmaceutical Benefits) Regulations

Commencement.

1. These Regulations shall come into operation on the first day of August, 1972.

First Schedule.

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

Second Schedule.

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

Third Schedule.

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

Fifth Schedule.

5. The Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in the Fourth Schedule to these Regulations.

* Notified in the Commonwealth Gazette on  1972.

† 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; and 1972, No. 32.

16263/72—Recommended retail price 8c  9/6.7.1912


THE SCHEDULES

FIRST SCHEDULE  Regulation 2.

Amendments of the First Schedule to the National Health (Pharmaceutical

Benefits) Regulations

1. After item 59 insert the following item:—

“ 59a. Castor Oil ”.

2. After item 63 insert the following item:—

“ 63a. Chlorcyclizine Hydrochloride ”.

3. After item 136 insert the following item:—

“ 136a. Dichlorophen Tablets ”.

4. After item 174 insert the following item:—

“ 174a. Ethionamide Tablets ”.

5. After item 371 insert the following item:—

“ 371a. Phenylephrine Injection ”.

6. After item 384 insert the following item:—

“ 384a. Prednisolone Pivalate ”.

7. After item 394 insert the following item:—

“ 394a. Progesterone Injection ”.

8. After item 414 insert the following item:—

“ 414a. Senna Fruit ”.

9. After item 475 insert the following item:—

“ 475a. Thiambutosine ”.

SECOND SCHEDULE  Regulation 3.

Amendments of the Second Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. After item 40 insert the following item:—

“ 40a

Clemastine Hydrogen Fumarate

— ”.

2. After item 85 insert the following item:—

“ 85a

Glucose and Ketone Indicator

— ”.

3. Omit from item 94 “ Morphine Sulphate with Hyoscine Hydrobromide ” (in the third column).

4. Omit item 111.

5. Omit from item 122 “ Prednisolone Sodium Phosphate with Neomycin Sulphate ” (in the third, column).

6. After item 150 insert the following item:—

“ 150a

Phenethicillin, Benzathine....

— ”.

7. Omit item 167, insert the following item:—

“ 167

Prednisolone Sodium Phosphate

— ”.

8. Omit item 168.

9. Omit item 177.


THIRD SCHEDULE  Regulation 4

Amendments of the Third Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item 13.

2. After item 26 insert the following item:—

“ 26a. Amiloride Hydrochloride ”.

3. Omit item 46.

4. After item 80 insert the following item:—

“ 80a. Clemastine Hydrogen Fumarate ”.

5. After item 152 insert the following item:—

“ 152a. Glucose and Ketone Indicator ”.

6. Omit item 214.

7. Omit item 246.

8. After item 275 insert the following item:—

“ 275a. Phenethicillin, Benzathine ”.

FOURTH SCHEDULE

Regulation 5.

Amendments of the Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations

1. Omit item 5.

2. Omit item 13, insert the following item:—

“ 13

(1) Ampicillin Capsules, B.P.

(2) Ampicillin Injections, Tablets and Syrups

Infections by organisms sensitive to Ampicillin where the infection cannot be safely and effectively treated with sulphonamides or with any of the following administered orally—

 

 

Benzylpenicillin

 

 

Phenoxymelhylpenicillin

 

 

Phenethicillin

 

 

Urinary tract infections by organisms where sulphonamide treatment has proved ineffective and positive bacteriological evidence confirms that the organisms are sensitive to Ampicillin

 

 

Urinary tract infections where the patient is sensitive to sulphonamides ”.

3. Omit item 58.

4. Omit item 66, insert the following item:—

“ 66

Epicillin Capsules and Syrups

Infections by organisms sensitive to Epicillin where the infection cannot be safely and effectively treated with sulphonamides or with any of the following administered orally—

 

 

Benzylpenicillin

 

 

Phenoxymethylpenicillin

 

 

Phenethicillin

 

 

Urinary tract infections by organisms where sulphonamide treatment has proved ineffective and positive bacteriological evidence confirms that the organisms are sensitive to Epicillin

 

 

Urinary tract infections where the patient is sensitive to sulphonamides ”.

5. Omit from item 94 “ Progesterone deficiency proved by hormonal assay, by lateral wall smear or by endometrial biopsy ” (in the third column).


FOURTH SCHEDULE—continued

6. Omit item 115, insert:—

“ 115

Medroxyprogesterone Acetate

Carcinoma of the endometrium

 

Tablets, 2.5 mg.

Precocious puberty ”.

7. Omit item 118, insert:—

“ 118

Medroxyprogesterone Acetate Injections, 50 mg. in 1 ml. or 250 mg. in 5 ml.

Carcinoma of the endometrium

 

 

Hypernephroma ”.

“ 118a

Medroxyprogesterone Acetate Injections, 150 mg. in 1 ml.

Carcinoma of the endometrium

 

 

Hypernephroma

 

 

Precocious puberty ”.

8. Omit item 132, insert:—

“ 132

Nalidixic Acid ...........

Urinary tract infections by organisms where sulphonamide treatment has proved ineffective and positive bacteriological evidence confirms that the organisms are sensitive to Nalidixic Acid or where the patient is sensitive to sulphonamides ”.

9. Omit item 139, insert:—

“ 139

(1) Nitrofurantoin Tablets, B.P.

Urinary tract infections by organisms where sulphonamide treatment has proved ineffective and positive bacteriological evidence confirms that the organisms are sensitive to Nitrofurantoin or where the patient is sensitive to sulphonamides ”.

 

(2) Nitrofurantoin Oral Suspension

 

10. Omit item 173.

11. Omit item 180, insert:—

“ 180

Pyridoxine Hydrochloride Tablets

Anaemia proved to be responsive to Pyridoxine

 

 

Convulsions responsive to Pyridoxine

 

 

Homocystinuria

 

 

Radiation sickness

 

 

Sideroblastic (refractory) anaemia

 

 

Treatment and prophylaxis of peripheral neuritis caused or likely to be caused by isoniazid therapy

 

 

With the written authority of the Director-General—

Primary hyperoxaluria ”.

12. Omit item 206, insert:—

“ 206

Trimethoprim with Sulphamethoxazole

Infections by organisms sensitive to Trimethoprim with Sulphamethoxazole where the infection cannot be safely and effectively treated with other sulphonamides or with any of the following administered orally—

 

 

Benzylpenicillin

 

 

Phenoxymethylpenicillin

 

 

Phenethicillin

 

 

Urinary tract infections by organisms where other sulphonamide treatment has proved ineffective and positive bacteriological evidence confirms that the organisms are sensitive to Trimethoprim with Sulphamethoxazole

 

 

Ocular surgery ”.

Printed by Authority by the Government Printer of the Commonwealth of Australia

Overview

The National Health (Pharmaceutical Benefits) Regulations 1972 were enacted to amend the National Health (Pharmaceutical Benefits) Regulations under the National Health Act 1953-1971. These Regulations address the need to update the list of pharmaceutical benefits available under the Act, ensuring that new and necessary medications are included for prescription and coverage. The enacting body is the Administrator of the Government of the Commonwealth of Australia, acting with the advice of the Federal Executive Council. The policy objective is to enhance the availability and accessibility of essential medications by including new drugs and medicinal preparations recommended by the Pharmaceutical Benefits Advisory Committee, thereby improving health outcomes for Australians.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations, as amended, pertain to the regulation of pharmaceutical benefits under the National Health Act 1953-1971. The Act applies to individuals and entities within Australia, governing the prescription and provision of pharmaceutical benefits for specific drugs and medicinal preparations. The amendments detailed in these Regulations extend to drugs and preparations listed in the Third Schedule, which had not previously been prescribed as pharmaceutical benefits. The Regulations specify that these drugs and preparations can now be prescribed as pharmaceutical benefits following the recommendation of the Pharmaceutical Benefits Advisory Committee to the Minister. The scope of these Regulations is national, impacting all states and territories within Australia, and they supersede any previously existing provisions for the specified drugs and preparations. The Regulations do not explicitly state any exclusions or exemptions, but their application is contingent on the recommendations of the Advisory Committee and ministerial approval. The Regulations also provide for the amendment of other schedules within the National Health (Pharmaceutical Benefits) Regulations to reflect changes in the pharmaceutical benefits available under the Act.

Key Provisions

These Regulations, made under the National Health Act 1953-1971, specify the drugs and medicinal preparations that are to be prescribed as pharmaceutical benefits. They include the amendments to the National Health (Pharmaceutical Benefits) Regulations which were made by the Third Schedule to these Regulations. The Regulations came into operation on the first day of August, 1972. These amendments include the addition of new drugs and medicinal preparations to the schedules of the Regulations. For instance, Castor Oil and Chlorcyclizine Hydrochloride are added to the First Schedule, Clemastine Hydrogen Fumarate and Phenethicillin, Benzathine are added to the Second Schedule, and Amiloride Hydrochloride and Clemastine Hydrogen Fumarate are added to the Third Schedule. The Fifth Schedule also includes new entries for Ampicillin and Epicillin, among others. The Regulations impose obligations on the parties involved, primarily the Pharmaceutical Benefits Advisory Committee and the Minister for Health. The Committee has the responsibility to recommend to the Minister whether certain drugs and medicinal preparations should be prescribed as pharmaceutical benefits. This recommendation must be based on the criteria that the drug or preparation was not a pharmaceutical benefit immediately before the commencement of the sub-section and that it should be prescribed as such. The Minister, in turn, is required to consider these recommendations and decide accordingly. Additionally, healthcare providers and patients are expected to adhere to the updated list of pharmaceutical benefits as specified in the amended schedules. Breaches of these Regulations may have legal consequences. Although the specific offences, penalties, or civil/criminal consequences are not detailed in these Regulations, it is generally understood that failure to comply with the pharmaceutical benefit prescriptions can lead to legal actions. The penalties for non-compliance can include fines, imprisonment, or other sanctions as prescribed by the relevant laws and regulations. It is crucial for all parties to ensure adherence to these provisions to avoid any potential legal repercussions.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Commencement Provisions
Reporting & Disclosure Obligations
Regulatory Standards
Licensing & Registration

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.