National Health (Pharmaceutical Benefits) Regulations (Amendment)

Legislation au C1957L00025 Regulations Not in force Legislative Instrument

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STATUTORY RULES.

1957. No. 25.

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1956.*

I, THE GOVERNOR-GENERAL in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953-1956

Dated this 7th

day of June , 1957.

W. J. Slim

Governor-General.

By His Excellency’s Command,

Minister of State for Immigration, acting for and on behalf of the Minister of State for Health.

Amendments of the National Health (Pharmaceutical Benefits) Regulations.†

Commencement.

1. These Regulations shall come into operation on the first day of July, 1957.

Writing of prescriptions.

2. Regulation 17 of the National Health (Pharmaceutical Benefits) Regulations is amended by inserting in sub-regulation (3.), after the words—

“Calcium Aurothiomalate.”,

the words—

“Cholera Vaccine.”.

First Schedule.

3. The First Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by inserting after item 19 the following item:—

“19a	Chlormerodrin”; and

(b) by inserting after item 120 the following item:—

“120a

Phensuximide”.

* Notified in the Commonwealth Gazette on 7th June, 1957

† Statutory Rules 1956, No. 54, as amended by Statutory Rules No. 75.

2561/57.—Price 5d. 9/30.5.1957.

4. The Second Schedule to the National Health (Pharmaceutical Benefits) Regulations is repealed and the following Schedule inserted in its stead:—

Second Schedule.

Regulation 11.

DRUGS AND MEDICINAL PREPARATIONS THAT MAY BE PRESCRIBED FOR SUPPLY, SUPPLIED AND RECEIVED AS GENERAL PHARMACEUTICAL BENEFITS ONLY FOR THE TREATMENT OF A DISEASE OR PURPOSE.

Item No.	Name or Formula.	Disease or Purpose.
1	Bemegride with Amiphenazole Hydrochloride	Antidote for barbiturate and other hypnotic poisons
2	Busulphan .............	The leukaemias
3	Calcium Para-Aminosalicylate .......	Tuberculosis
4	Calcium Para-Aminosalicylate Granules	Tuberculosis
5	Caramiphen Hydrochloride ..	Parkinsonism
6	Chloramphenicol ........	Acute laryngo-tracheo-bronchitis
		As an alternative to penicillin in the treatment of any disease in a person in whom penicillin sensitivity has been established
		Bacillary dysentery that is resistant both to sulphonamides and streptomycin
		Bacterium coli meningitis if other forms of treatment are unsuccessful
		Brucellosis
		Granuloma inguinale
		Infections due to Friedlander bacillus
		Infections due to haemophilus influenzae
		Lymphogranuloma venereum
		Salmonella infections
		Severe gastro-enteritis in children
		Staphylococcal infections
		Surgical conditions of the bowel (pre-operative and post-operative)
		Typhoid fever
		Typhus and other rickettsial diseases
		Urinary tract infections due to gram negative bacilli that do not respond to sulphonamides
		Whooping cough (haemophilus pertussis)
7	Chloramphenicol Intramuscular	Any disease or purpose specified in this column in relation to chloramphenicol
8	Chloramphenicol Palmitate.	Any disease or purpose specified in this column in relation to chloramphenicol
9	Chlortetracycline .......	Actinomycosis
		Acute and sub-acute bacterial endocarditis-streptococcus faecalis
		Amoebiasis
		As an alternative to penicillin in the treatment of any disease in a person in whom penicillin sensitivity has been established
		Bacillary dysentery that is resistant both to sulphonamides and streptomycin
		Brucellosis
		Chancroid
		Granuloma inguinale
		Infections due to Friedlander bacillus
		Leptospirosis
		Lymphogranuloma venereum
		Pneumonia that does not respond to penicillin or sulphonamides

Second Schedule—continued.

Item No.	Name or Formula.	Disease or Purpose.
9	Chlortetracycline—continued.	Primary atypical pneumonia
9	Chlortetracycline—continued.	Psittacosis
		Puerperal infections
		Rat-bite fever—spirillum minus
		Staphylococcal infections
		Trachoma that does not respond to sulphonamides
		Typhus and other rickettsial diseases
		Urinary tract infections due to gram negative bacilli that do not respond to sulphonamides
		Whooping cough (haemophilus pertussis)
10	Chlortetracycline Granules	Any disease or purpose specified in this column in relation to chlortetracycline
11	Chlortetracycline Suspension	Any disease or purpose specified in this column in relation to chlortetracycline
12	Cortisone Acetate ......	Acquired haemolytic anaemia
		Acute exfoliative dermatitis associated with drug therapy
		Acute rheumatic carditis
		Addison’s disease and other forms of adrenocortical hypoplasia
		Adrenogenital syndrome
		Dermatomyositis
		Panhypopituitarism
		Pemphigus
		Periarteritis nodosa
		Pseudohermaphroditism
		Sarcoidosis
		Scleroderma
		Status asthmaticus
		Systemic lupus erythematosus
		The leukaemias
		Thrombocytopenic purpura
		Total adrenalectomy
13	Cyanocobalamin ......	Established megalocytic anaemias
14	Deoxycortone Acetate Aqueous	Addison’s disease
15	Deoxycortone Acetate Aqueous Suspension	Addison’s disease
16	Deoxycortone Acetate Oily	Addison’s disease
17	Dienoestrol ..........	Carcinoma of the prostate
		Mammary carcinoma
18	Dihydrostreptomycin ...	Any disease or purpose specified in this column in relation to streptomycin, but only if the person being treated for that disease or purpose is allergic to streptomycin
19	Dihydrotachysterol .....	Parathyroid deficiency
20	Erythromycin ........	Staphylococcal infections that are resistant both to the tetracyclines and to penicillin
21	Folic Acid ..........	Sprue or the sprue-like syndrome
		Macrocytic anaemia
22	Hydrocortisone .......	Any disease or purpose specified in this column in relation to cortisone acetate
23	Isoniazid ...........	Leprosy
		Tuberculosis
24	Mercaptopurine .......	The leukaemias
25	Methorphinan ........	Inoperable cancer
26	Nitrofurantoin ........	Urinary tract infections
27	Oxytetracycline Dihydrate	Any disease or purpose specified in this column in relation to chlortetracycline

Second Schedule—continued.

Item No.	Name or Formula.	Disease or Purpose.
28	Oxytetracycline Hydrochloride	Any disease or purpose specified in this column in relation to chlortetracycline
29	Oxytetracycline Suspension .	Any disease or purpose specified in this column in relation to chlortetracycline
30	Pancreatin .............	Fibrocystic disease of the pancreas
30	Pancreatin .............	Pancreatico-duodenectomy
31	Para-Aminosalicylic Acid ..	Tuberculosis
32	Penicillin Tablets ........	For the penicillin treatment of haemophiliacs
		Nephritis in children under the age of 16 years
		Prophylactic use in rheumatic fever or chorea in children under the age of 16 years
33	Phenoxymethyl Penicillin ..	Any disease or purpose specified in this column in relation to penicillin tablets
34	Phenindamine Tartrate ....	Parkinsonism
35	Prednisolone ...........	Any disease or purpose specified in this column in relation to cortisone acetate
36	Prednisone ............	Any disease or purpose specified in this column in relation to cortisone acetate
37	Progesterone ...........	Habitual abortion
38	Progesterone Depot ......	Habitual abortion
39	Pyridostigmine Bromide ...	Myasthenia gravis
40	Quinine Bisulphate .......	Malaria
41	Quinine Dihydrochloride ...	Malaria
42	Quinine Hydrochloride ....	Malaria
43	Quinine Sulphate ........	Malaria
44	Sodium Para-Aminosalicylate	Tuberculosis
45	Stilboestrol ............	Carcinoma of the prostate
45	Stilboestrol ............	Mammary carcinoma
6	Streptomycin ...........	Bacillary dysentery not responding to sulphonamides
		Brucellosis
		Chancroid
		Endocarditis due to streptococcus faecalis
		Endocarditis due to streptococcus viridans
		Infections due to Friedlander bacillus
		Infections due to haemophilus influenzae
		Infections due to pseudomonas pyocyaneus
		Plague
		Rat-bite fever—streptobacillus moniliformis Salmonella infections
		Surgical conditions of the bowel (pre-operative and post-operative)
		Surgical conditions of the thoracic organs
		Tuberculosis
		Tularaemia
		Urinary tract infections which do not respond to sulphonamides
47	Streptomycin Sulphate Intrathecal	Any disease or purpose specified in this column in relation to streptomycin
48	Streptomycin Sulphate Solution	Any disease or purpose specified in this column in relation to streptomycin
49	Suprarenal Cortex Extract ..	Adrenal failure
50	Testosterone ...........	Mammary carcinoma
50	Testosterone ...........	Castration
51	Testosterone Methyl ......	Mammary carcinoma
51	Testosterone Methyl ......	Castration
52	Testosterone Oenanthate ...	Mammary carcinoma
52	Testosterone Oenanthate ...	Castration
53	Testosterone Phenyl Propionate	Mammary carcinoma
53	Testosterone Phenyl Propionate	Castration

Second Schedule—continued.

Item No.	Name or Formula.	Disease or Purpose.
54	Testosterone Propionate .....	Mammary carcinoma
54	Testosterone Propionate .....	Castration
55	Tetracycline .............	Any disease or purpose specified in this column in relation to chlortetracycline
56	Tetracycline Granules .......	Any disease or purpose specified in this column in relation to chlortetracycline
57	Tetracycline Paediatric Drops ..	Any disease or purpose specified in this column in relation to chlortetracycline
58	Tetracycline with Oleandomycin	Any disease or purpose specified in this column in relation to chlortetracycline
59	Tetracycline with Sodium Metaphosphate	Any disease or purpose specified in this column in relation to chlortetracycline
60	Trimetaphan Camphorsulphonate	Hypotensive for anaesthesia
61	Vitamin K1 ..............	Antidote to anticoagulants

By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.

Overview

The Statutory Rules 1957, No. 25, Regulations under the National Health Act 1953-1956, were enacted by the Governor-General in and with the advice of the Federal Executive Council to amend the National Health (Pharmaceutical Benefits) Regulations. These regulations came into effect on the 1st of July, 1957, and primarily aimed to address gaps in the list of drugs and medicinal preparations that could be prescribed for supply, supplied, and received as general pharmaceutical benefits. The enactment sought to expand the range of treatments available under the National Health Act by including additional pharmaceuticals for specific diseases and purposes. This legislative instrument was designed to better align the available pharmaceutical benefits with contemporary medical needs, ensuring that a broader array of treatments could be provided to the public under the national health scheme. The regulations reflect a policy objective to enhance public health by facilitating access to essential medications and treatments.

Scope and Application

The Statutory Rules 1957, No. 25, made under the National Health Act 1953-1956, outlines amendments to the National Health (Pharmaceutical Benefits) Regulations, which govern the supply and prescription of certain pharmaceutical products as part of Australia's national health scheme. These regulations apply to medical practitioners, pharmacists, and patients within the Commonwealth, ensuring that specific drugs are available for the treatment of designated diseases and medical conditions under the Pharmaceutical Benefits Scheme. The regulations specify the inclusion of new drugs, such as Cholera Vaccine and Chlormerodrin, into the list of pharmaceutical benefits, and they detail the diseases or purposes for which these drugs can be prescribed and supplied. The scope of these regulations is national, extending across the Commonwealth to regulate the pharmaceutical industry and ensure that the prescribed drugs are provided to patients in need. There are no stated exclusions, exemptions, or thresholds in these regulations; however, the application of these rules may be further extended or refined through subordinate instruments.

Key Provisions

These Regulations, under the National Health Act 1953-1956, introduce significant amendments to the National Health (Pharmaceutical Benefits) Regulations, effective from July 1, 1957. Section 2 amends Regulation 17 by including 'Cholera Vaccine' in the list of substances that can be prescribed. Furthermore, Section 3 makes modifications to the First Schedule by adding 'Chlormerodrin' after item 19 and 'Phensuximide' after item 120, expanding the list of substances covered under the regulations. The Second Schedule is entirely replaced with a new list of drugs and medicinal preparations that may be prescribed for supply, supplied, and received as general pharmaceutical benefits. These drugs are specifically designated for the treatment of various diseases and purposes, ranging from tuberculosis and leukaemia to bacterial infections and hormonal deficiencies. The amendments impose specific obligations on medical practitioners and patients. Medical practitioners must now adhere to the updated list of drugs and substances that qualify for pharmaceutical benefits under the regulations. This includes ensuring that prescriptions are written for drugs listed in the amended schedules and that these drugs are used for the purposes specified. Patients, on the other hand, must be aware that only those drugs listed in the schedules are eligible for the general pharmaceutical benefits, and their use must align with the specified treatments as outlined in the regulations. Failure to comply with these regulations may result in legal consequences. Although the document does not explicitly detail the penalties for non-compliance, it is implied that breaches could lead to civil or criminal penalties under the broader National Health Act 1953-1956. The specific nature and severity of these penalties would depend on the context and extent of the breach, potentially including fines or other forms of sanctions as deemed appropriate under the Act.

Area of Law: Health Law
Instrument: Regulation
Concepts: Commencement Provisions; Licensing & Registration; Reporting & Disclosure Obligations

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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.

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