National Health (Pharmaceutical Benefits) Regulations (Amendment)

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STATUTORY RULES.

1954. No. .

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 twenty-fourth

day of June , 1954.

W. J. Slim

Governor-General.

By His Excellency’s Command,

SGD. EARLE PAGE

Minister of State for Health.

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

Commencement.

1. These Regulations shall be deemed to have come into operation on the first day of June, 1954.

Interpretation.

2. Regulation 2 of the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by omitting from the table in paragraph (b) of sub-regulation the letters and words—

“ BP	British Pharmaceuticals Pty. Ltd.”; and

(b) by omitting from that table the letters and words—

“ OX	Oxo Limited
OP	Oppenheimer, Sons & Co. Ltd.”

and inserting in their stead the letters and words—

“ OP	Oppenheimer. Son & Co. Ltd.
OR	Organon Laboratories Ltd.
OX	Oxo Limited ”.

* Notified in the Commonwealth Gazette on , 1954.

† Statutory Rules 1954, No. 54.

2250.—Price 3d. 10/7.6.1954.

First Schedule.

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

(a) by omitting item 2 and inserting in its stead the following item :—

“ 2	Adrenalin Hydrochloride, Solution of	1 in 1,000................	0.5 cc. amp................	DH, PD	6	1
	Adrenalin Hydrochloride, Solution of	1 in 1,000................	1 cc. amp.................	DH, KL, PD	6	1
		1 in 1,000................	10 cc. vial................	FA, PD	1	1
		1 in 1,000................	1 fl. oz. bottle..............	DH, FA, KL, PD, RT	1
		1 in 1,000................	1 fl. oz. vial...............	DH, RT	1
		1 in 100.................	6 cc. vial.................	PD	1	1
		1 in 100.................	10 cc. vial................	DH, FA	1	. .”;

(b) by omitting item 58 and inserting in its stead the following item :—

“ 58	Ephedrine Sulphate .........	½ gr. pre cc................	1 cc. amp.................	AH	6	1
		5% ....................	1 cc. amp.................	LY	6	1
		3/8 gr..................	capsule ..................	LY	40	1
		¾ gr....................	capsule ..................	LY	40	1
		½ gr....................	hypo. tab.................	FA	20	1
		¼ gr....................	tablet ...................	HY, PD, RT	100	1
i		½ gr	tablet ...................	FS, HY, PD, RY	100	1” .

“ 83	Insulin, Injection of .........	20 U. per cc...............	5 cc. vial.................	AH and BD, BW	3	12
		20 U. per cc...............	10 cc. vial................	AH and BD, BW, GS	3	12
		40 U. per cc...............	5 cc. vial.................	AH and BD, BT, BW	3	12
		40 U. per cc...............	10 cc. vial................	AH and BD, BT. BW, CS	3	12
		60 U. per cc...............	5 cc. vial.................	CS	3	12
		80 U. per cc...............	5 cc. vial.................	AH and BD, BT, BW, CS	3	12
		80 U. per cc...............	10 cc. vial................	AH and BD. BT. BW	3	12
		100 U. per cc...............	5 cc. vial.................	CS	3	12”;

(d) by omitting items 125, 126 and 127 and inserting in their stead the following items :—

“ 125	Penicillin, Injection of ........	5,000 U .................	amp ....................	CS	6
		15,000 U.................	amp....................	CS	6
		100,000 U.................	amp....................	AH, BD, BT, CS, EV, GL, IC, SI	6
		200,000 U.................	amp....................	AH, BD, BT, CS, EV, GL, IC, SI	6

“ 125	Penicillin, Injection of—	500,000 U.................	amp....................	AH, BD, BT, CS, EV, GL, IC, SI	3
contd.	continued.................
		1,000,000 U...............	amp....................	AH, BD, BT, CS, EV, GL, IC, SI	1

		1,500,000 U...............	amp	GL	1
“ 126	Penicillin, Procaine, Aqueous Suspension of	300,000 U.................	amp....................	BT	3
		400,000 U.	vial ....................	FA	3
		600,000 U.................	vial ....................	BT	2
		900,000 U.................	vial ....................	CS, DH, SI	2
		1,000,000 U...............	vial ....................	PA	1
		1,500,000 U...............	vial ....................	CS, GL, SI	1
“ 127	Penicillin, Procaine (Crystalline), Injection of	300,000 U.................	amp....................	AH, BD, BT, BW, CS, DH, EV, IC, MB, SI	3
		400,000 U.................	amp....................	AH, BD, BT, BW, CS, EV, GL, IC, MB, SI	3
		500,000 U.................	amp....................	CS	3
		600,000 U.................	amp....................	DH	2
		667,000 U.................	amp....................	CS	2
		900,000 U.................	amp....................	AH, BD, BT, BW, CS, EV, IC, MB, SI	2
		1,200,000 U...............	amp....................	AH, BD, BT, BW, CS, DH, EV, IC, MB, SI	1
		1,500,000 U...............	amp....................	CS, GL, SI	1
(e) by omitting item 141 and inserting in its stead the following item :—
“ 141	Phthalylsulphathiazole	0.5 G.................	tablet ................	MB, SD	100	. .”;
(f) by omitting item 153 and inserting in its stead the following item :—
“ 153	Pyridoxine Hydrochloride, Injection of	50 mg. per cc............	1 cc. amp...............	AN, BL, CM, DH, PM, KL, PD, RO	6	1
		50 mg. per 2 cc...........	2 cc. amp...............	BD, RO, VM	6	1
		50 mg. per cc............	5 cc. vial ..............	LY	1	1
		50 mg. per cc............	10 co. vial..............	KL	1	. .”
						and

	(g) by omitting item 183 and inserting in its stead the following item :—
“ 183	Theophylline with Ethylene Diamine	0.366 G. per 10 mil.......	10 mil. amp.............	AB	6
	Theophylline with Ethylene Diamine	0.732 G. per 2 mil........	2 mil. amp..............	AB	6
		0.48 G. per 2 mil.........	2 mil. I.M. amp...........	DH, HA	6
		0.5 G. per 2 mil..........	2 mil. I.M. amp...........	AH, BW, CM	6
		0.24G. per 10 mil.........	10 mil. I.V. amp..........	DH. HA	6
		0.25 G. per 10 mil........	10 mil. I.V. amp..........	AH, BW, CM	6
		l½gr.................	tablet ................	BT, BW, CM, DH, EA, HA, HY, KL, RT, SI, SM	100	1
		2.34 gr................	tablet ................	AB	100	l”.

Second Schedule.

4. The Second Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by omitting item 1 and inserting in its stead the following item :—

“ 1

Aureomycin...............

50 mg......

capsule ....

LE ..................

Acute amoebic dysentery

100 mg....

capsule ....

LE ..................

Acute and sub-acute bacterial endocarditis-streptococcus faecalis

250 mg....

capsule ....

LE ..................

100 mg....

Vial.......

LE ..................

Staphylococcal infections that do not respond to penicillin

Pneumonia that has not responded to penicillin or to sulphonamides

Psittacosis

Urinary tract infections due to streptococcus faecalis ”; and

(b) by omitting item 28 and inserting in its stead the following item :—

“ 28

Testosterone, Methyl...............

25 mg.........

tablet .........

AN, BD, BS, BT, CB, HY, KL, OR, SC

Mammary carcinoma Castration”.

50 mg.........

tablet .........

AN, BD, BS, BT, HY, KL, OR, SC

By Authority : L. F. Johnston, Commonwealth Government Printer, Canberra.

Overview

The Statutory Rules of 1954, No. 54, were enacted under the authority of the National Health Act 1953 by the Governor-General, on the advice of the Federal Executive Council. These regulations address the need to update the pharmaceutical benefits provided under the National Health scheme. The enactment body is the Parliament of Australia, with the policy objective being to ensure the availability of essential medications at affordable prices for Australians. The regulations, which came into effect on June 1, 1954, include amendments to the National Health (Pharmaceutical Benefits) Regulations, particularly updating the list of approved pharmaceutical products and their corresponding dosages and pricing. This legislative instrument aims to provide clarity and accessibility to the medications listed under the scheme, ensuring they meet the health needs of the population.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations, as amended by these Regulations, apply to the provision of pharmaceutical benefits under the National Health Act 1953. These Regulations primarily concern the inclusion and exclusion of specific pharmaceutical items that are eligible for subsidies, and the price at which these items can be supplied. The Regulations impact a wide range of entities, including pharmaceutical companies, suppliers, pharmacists, and patients who are eligible for the pharmaceutical benefits scheme. The amendments to the Regulations adjust the list of pharmaceutical items that are subsidised, affecting the availability and cost of certain medications to the public. The Regulations have a national reach, applying across the Commonwealth of Australia. The Regulations do not explicitly state any exclusions or thresholds; however, the amendments to the list of subsidised pharmaceutical items implicitly exclude those not included in the updated schedules. These Regulations can be further extended or restricted through subordinate instruments, which may include additional amendments or specific guidelines issued under the authority of the National Health Act 1953.

Key Provisions

The Regulations under the National Health Act 1953 amend the National Health (Pharmaceutical Benefits) Regulations, effective from 1 June 1954. These amendments primarily concern the list of pharmaceutical products eligible for subsidies under the scheme, updating the names of pharmaceutical companies and the specific pharmaceutical items and their associated dosages and presentations (regs 2 and 3). Additionally, the Regulations modify the indications for which certain pharmaceuticals are eligible for subsidy (regs 4 and 5). Under these Regulations, pharmaceutical companies and suppliers must ensure that their products comply with the updated list of subsidised items. This includes verifying that their products meet the specified dosages and presentations to be eligible for subsidies. They must also ensure that their product labels and marketing materials accurately reflect any changes in eligibility criteria for certain pharmaceuticals (reg 4). Failure to comply with these Regulations may result in administrative penalties. While the Regulations do not explicitly state penalties, non-compliance with health and safety regulations can typically result in fines or other administrative actions under the National Health Act 1953 or other relevant legislation. The severity of the penalty will depend on the nature and extent of the non-compliance. Additionally, inaccurate or misleading information regarding pharmaceutical benefits could lead to actions under consumer protection laws, which may include fines or other civil penalties. The specific penalties for breaches of these Regulations are not detailed in the text but are generally aligned with the penalties prescribed under the overarching National Health Act 1953 and other applicable laws.

Area of Law: Health Law
Instrument: Regulation
Concepts: Commencement Provisions; Reporting & Disclosure Obligations; Regulatory Standards

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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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