National Health (Pharmaceutical Benefits) Regulations (Amendment)

Legislation au C1954L00128 Regulations Not in force Legislative Instrument

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STATUTORY RULES.

1954. No. 128.

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953.*

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.

Dated this fifteenth day of December, 1954.

W.J. Slim

Governor-General.

By His Excellency's Command,

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 January, 1955.

Certain requirements to be met after cancellation, &c., of approval.

2. Regulation 7 of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting the word "approved" (second occurring).

General pharmaceutical benefits.

3. Regulation 8 of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting sub-regulation (4.).

* Notified in the Commonwealth Gazette on , 1954

† Statutory Rules 1954, No. 54, as amended by Statutory Rules 1954, Nos. 77, 78, 93 and 95.

5223.—Price 3d. 9/2.12.1954.

Writing of prescriptions.

4. Regulation 19 of the National Health (Pharmaceutical Benefits) Regulations is amended by inserting in paragraph (g) of sub-regulation (1.), after the words "Second Schedule", the words "other than a prescription for the supply to a pensioner of a drug referred to in sub-regulation (3.) of regulation 8 of these Regulations".

Supply of pharmaceutical benefits on prescriptions.

5. Regulation 23 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by omitting from sub-regulation (1.) the words ", an approved medical practitioner or an approved hospital authority (being the proprietor of a private hospital)" and inserting in their stead the words "or an approved medical practitioner"; and

(b) by omitting from sub-regulation (2.) the words ",an approved hospital authority".

Supply of pharmaceutical benefit before surrender of written prescription.

6. Regulation 24 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by omitting from sub-regulation (1.) the words "or an approved hospital authority";

(b) by omitting from that sub-regulation the words "or approved hospital authority";

(d) by omitting sub-regulation (4.).

Supply of pharmaceutical benefit on first presentation of prescription.

7. Regulation 25 of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting the words ",approved medical practitioner or approved hospital authority (being the proprietor of a private hospital)" and inserting in their stead the words "or an approved medical practitioner".

Supply of brand of general pharmaceutical benefit specified in a prescription.

8. Regulation 29 of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting the words ",approved hospital authority" (wherever occurring).

Retention of prescriptions, &.c.

9. Regulation 35 of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting the words ",approved medical practitioner or approved hospital authority (being the proprietor of a private hospital) who or which supplies pharmaceutical benefits shall retain in his or its" and inserting in their stead the words "or an approved medical practitioner who supplies pharmaceutical benefits shall retain in his".

First Schedule.

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

(a) by omitting item 17 and inserting in its stead the following item:—

“17	Bismuth Salicylate, Oily Injection of	..........................	1 cc. amp....................	12	..
		..........................	10 cc. amp....................	6	..
		..........................	25 cc. bottle ....................	1	..
		..........................	60 cc. bottle ..................	1	..
		..........................	2 fl. oz. bottle .................	1	..";

(b) by omitting item 26 and inserting in its stead the following item:—

"26	Chiniofon ...................	0.25 G. .....................	pill ........................	25	1
		0.25 G. .....................	tablet ......................	25	1";

"38	Digifortis....................	½gr. .......................	tablet ......................	100	1
		1 gr	tablet ......................	100	1";

(d) by omitting item 40 and inserting in its stead the following item:—

"40	Digitoxin....................	0.1 mg. ...................	tablet .......................	100	1
		0.2 mg...................	tablet ......................	100	1
		0.25 mg. ..................	tablet ......................	100	1"

(e) by omitting item 72 and inserting in its stead the following item:—

"72	Glyceryl Trinitrate .............	1/100 gr. ....................	hypo. tab. ...................	100	1
		1/200 gr.....................	tablet .......................	100	1
		1/150 gr.....................	tablet ......................	100	1
		1/130 gr.....................	tablet ......................	100	1
		1/100 gr.....................	tablet ......................	100	1
		1/65 gr.....................	tablet ......................	100	1
		1/50 gr.....................	tablet ......................	100	1";

(f) by omitting item 82 and inserting in its stead the following item:—

"82	Hyoscine Hydrobromide..........	1/150 gr. ....................	amp. .......................	6	..
		1/100 gr.....................	amp. .......................	6	..
		1/75 gr.....................	amp. .......................	6	1
		1/200 gr.....................	hypo. Tab...................	100	1
		1/150 gr.....................	hypo. Tab...................	100	1
		1/100 gr.....................	hypo. tab. ...................	100	1
		1/100 gr. per cc................	10 cc. vial ...................	1	..";

(g) by omitting item 97;

(h) by omitting item 119 and inserting in its stead the following item:—

"119

Pamaquin ...................

0.01 G. .....................

tablet ......................

..";

(i) by omitting item 135 and inserting in its stead the following item:—

"135	Phemitone ...................	1/2 gr. ......................	tablet ......................	200	1
		1 gr. .......................	tablet .......................	200	1
		3 gr. .......................	tablet ......................	200	1";

(j) by omitting item 139 and inserting in its stead the following item:—

"139	Phenytoin Sodium .............	0.03 G......................	capsule .....................	200	1
		0.1 G ......................	capsule .....................	200	1
		0.1 G.......................	tablet ......................	200	1";

(k) by omitting item 161 and inserting in its stead the following item:—

"161	Sodium Chloride Physiological	..........................	2 cc.. amp. ...................	6	1
	Solution for Injection	..........................	5 cc. amp. ...................	6	1
		..........................	10 cc. amp...................	6	1
		..........................	10 cc.. vial ...................	2	1"

(l) by omitting item 181 and inserting in its stead the following item:—

"181	Tetanus Antitoxin ..............	500 I.U. ....................	amp. .......................	6	1
		1,000 I.U. ...................	amp. .......................	6	1
		1,500 I.U....................	amp. .......................	6	1
		10,000 I.U. ..................	amp. .......................	6	1"

(m) by omitting item 189 and inserting in its stead the following item:—

"189

Triethanolamine Trinitrate.........

1 mg. ....................

tablet ....................

100

1"; and

(n) by omitting item 195 and inserting in its stead the following item:—

"195	Water for Injection .............	..........................	2 cc. amp....................	6	3
		..........................	5 cc. amp....................	6	3
		..........................	10 cc. amp. ..................	6	3".

Second Schedule.

11. The Second Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by omitting item 25 and inserting in its stead the following item:—

"25	Streptomycin Sulphate Solution for Injection	250,000 U. per mil............... per mil.	4 mil. vial................... .. ..	5	3	Any disease or purpose specified in this column in relation to streptomycin".
		500,000 U. per mil..............r mil.	2 mil. vial. .. ...................	5	3

12. The Third Schedule to the National Health (Pharmaceutical Third Schedule Benefits) Regulations is amended—

(a) by inserting after item 134 the following item:—

"134a | Tabellae Amphetaminae Sulphatis B.P.C.";

(b) by inserting after item 141 the following item:—

"141a | Tabellae Saccharini B.F.C."; and

"143a | Tabellae Sodii Salicylatis (Enteric Coated)".

Fourth Schedule.

13. The Fourth Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by inserting after the words and figures—

"Tablets of phenobarbitone sodium ..............................

100"

the words and figures—

"Tablets of saccharin ......................................	200
Tablets of theobromine sodium salicylate .........................	100".

Printed for the Government of the Commonwealth by A. J. Arthur

at the Government Printing Office, Canberra.

Overview

The Statutory Rules 1954, No. 128, made under the National Health Act 1953, were enacted by the Governor-General, acting on the advice of the Federal Executive Council, to amend the National Health (Pharmaceutical Benefits) Regulations. These regulations address issues related to the supply of pharmaceutical benefits, the writing of prescriptions, and the retention of prescriptions by medical practitioners. The amendments aim to streamline the process of supplying pharmaceutical benefits by removing certain requirements and updating the lists of approved drugs and their dosages, while ensuring that the necessary regulatory framework remains in place to manage the distribution and use of pharmaceuticals within Australia. The regulations came into effect on 1 January 1955, providing clarity and updating the regulatory environment to better serve public health needs.

Scope and Application

The Statutory Rules 1954, No. 128, Regulations under the National Health Act 1953, primarily concern the amendments to the National Health (Pharmaceutical Benefits) Regulations. These Regulations are designed to modify certain aspects of the pharmaceutical benefits scheme, such as the requirements for the supply of pharmaceutical benefits, the writing of prescriptions, and the retention of prescriptions. They apply to approved medical practitioners who supply pharmaceutical benefits, thereby excluding approved hospital authorities as entities eligible for certain provisions. The Regulations come into effect from 1 January 1955 and amend specific regulations to streamline the process of supplying and prescribing pharmaceuticals under the Act. The amendments also include updates to the First, Second, Third, and Fourth Schedules, detailing the quantities and specifications of certain pharmaceutical products covered by the regulations.

Key Provisions

These Regulations, made under the National Health Act 1953, primarily amend the National Health (Pharmaceutical Benefits) Regulations. They come into effect on the first day of January 1955 (Section 1). The regulations revise certain pharmaceutical benefits and their provisions, including the cancellation of approvals and the writing of prescriptions. For instance, Regulation 7 is amended by removing the word "approved" in a specific instance (Section 2). Regulation 8 is also amended to clarify general pharmaceutical benefits, particularly concerning the supply of drugs to pensioners (Section 3). Additionally, prescriptions for pharmaceutical benefits are updated to exclude specific instances where an approved hospital authority is not required (Sections 4 to 8). The Regulations impose various obligations on parties involved in the supply and provision of pharmaceutical benefits. Approved medical practitioners and entities supplying pharmaceutical benefits must adhere to the updated requirements, including retaining relevant prescriptions and supplying specified pharmaceutical benefits as outlined (Sections 4 to 9). The Regulations also detail specific amendments to the schedules, ensuring that the list of pharmaceutical benefits, their quantities, and prices are accurately reflected (Sections 10 to 13). Violations of these Regulations can lead to both civil and criminal consequences. While the specific offences and penalties are not detailed within the Regulations themselves, breaches of the National Health Act 1953 or its subsidiary legislation can result in substantial penalties. Generally, under the National Health Act, penalties for non-compliance can include fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as outlined in the primary Act and any relevant case law or further legislative instruments.

Area of Law: Health Law
Instrument: Regulation
Concepts: Commencement Provisions; Regulatory Standards; 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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