National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

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Statutory Rules

1976 No. 255

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953.*

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 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 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 thirteenth day of November, 1976.

John R. Kerr

Governor-General.

By His Excellency’s Command,

RALPH J HUNT

Minister of State for Health.

_______

Amendments of The National Health (Pharmaceutical Benefits) Regulations†

Commencement.

1. These Regulations shall come into operation on 1 December 1976.

First Schedule.

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

Second Schedule.

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

Third Schedule.

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

Fifth Schedule.

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

_________________________________________________________________________________

* Notified in the Australian Government Gazette on 1 December 1976.

† Statutory Rules 1960, No. 17 as amended to date. For previous amendments of the National Health (Pharmaceutical Benefits) Regulations see footnote † to Statutory Rules 1976, No. 84 and see also Statutory Rules 1976, Nos. 84, 150 and 195.

16475/76—Recommended retail price 15c 10/11.11.1976

SCHEDULE 1 Regulation 2

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

1. Omit item 47.

2. After item 231 insert the following items:—

“ 231a Ferrous Succinate

231b Ferrous Succinate Capsules ”.

3. After item 345 insert the following item:—

“ 345a Meglumine ”.

4. After item 361 insert the following item:—

“ 361a Mersalyl Injection ”.

5. After item 482 insert the following item:—

“ 482a Potassium Chloride Tablets ”.

6. After item 574 insert the following item:—

“ 574a Sulphacetamide Eye Ointment ”.

_______

SCHEDULE 2 Regulation 3

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

1. After item 10 insert the following items:—

“ 10a	“AMINOFUSIN 5%”.........................................	—
10b	“AMINOFUSIN 10%”........................................	—
10c	“AMINOFUSIN A 5%........................................	—
	WITH ALCOHOL”..........................................	”.

2. Omit item 21.

3. After item 36 insert the following item:—

“ 36a

Cephradine.......................

Purified Water, B.P., with Cephradine ”.

4. Omit item 82.

5. Omit item 84.

6. Omit item 97.

7. Omit item 107 substitute the following item:—

“ 107	Hyoscine Hydrobromide..............	Atropine Sulphate, B.P., with Hyoscyamine Sulphate and Hyoscine Hydrobromide, B.P.
		Papaveretum with Hyoscine Hydrobromide, B.P.”

8. After item 107 insert the following item:—

“ 107a

Hyoscyamine Sulphate...............

Atropine Sulphate, B.P., with Hyoseine Hydrobromide, B.P., and Hyoscyamine Sulphate ”.

9. Omit item 126.

________

SCHEDULE 3 Regulation 4

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

1. After item 22 insert the following items:—

“ 22a	“ AMINOFUSIN 5% ”
22b	“ AMINOFUSIN 10% ”
22c	“ AMINOFUSIN A 5% WITH ALCOHOL ” ”.

2. After item 34 insert the following item:—

“ 34a Azatadine Maleate ”.

3. After item 40 insert the following item:—

“ 40a Betamethasone Dipropionate ”.

4. After item 60 insert the following items:—

“ 60a Cephazolin Sodium

60b Cephradine ”.

Schedule 3—continued

5. After item 74 insert the following item:—

“ 74a Clonazepam”.

6. After item 100 insert the following item:—

“ 100a Diphemanil Methylsulphate ”.

7. Omit item 115.

8. Omit item 130.

9. After item 148 insert the following item:—

“ 148a Hyoscyamine Sulphate ”.

10. After item 159 insert the following item:—

“ 159a Insect Allergen Extract—Mosquito ”.

11. Omit item 163.

12. Omit item 165.

13. After item 255 insert the following item:—

“ 255a Prazosin Hydrochloride ”.

14. After item 321 insert the following item:—

“ 321a Thiabendazole B.P.C.”.

_________

SCHEDULE 4 Regulation 5

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

1. Omit item 17 substitute the following item:—
“ 17	Bisacodyl Suppositories, B.P.	Any disease or condition in a paraplegic or quadriplegic patient
		Patients who are receiving the Supplementary Intensive Nursing Home Care Benefit ”.
2. After item 27 insert the following items:—
“ 27a	Cephazolin Sodium..............		Infections where positive bacteriological evidence confirms that cephazolin sodium is the most appropriate therapeutic agent”.
“27b	(1) Cephradine Capsules ...........		With the written authority of the Director-General—
	(2) Cephradine with Purified Water, B.P.		Infections where positive bacteriological evidence confirms that cephradine is the most appropriate therapeutic agent”.
“ 27c	Cephradine for Injection...........		Infections where positive bacteriological evidence confirms that cephradine is the most appropriate therapeutic agent ”.
3. Omit item 32 substitute the following item:—
“ 32	(1) Chlormethiazole...............		For short-term use in a hospital for alcohol or drug withdrawal therapy
	(2) Chlormethiazole
	Edisylate		Status epilepticus ”.
4. After item 37 insert the following item:—
“ 37a	Clonazepam....................		Epilepsy ”.
5. Omit item 53 substitute the following item:—
“ 53	(1) Dioctyl Sodium Sulphosuccinate		Any disease or condition in a paraplegic or quadriplegic patient
	(2) Dioctyl Sodium Sulphosuccinate with Bisacodyl		Patients who are receiving the Supplementary Intensive Nursing Home Care Benefit ”.
	(3) Dioctyl Sodium Sulphosuccinate with Danthron
6. After item 53 insert the following item:—
“ 53a	Diphemanil Methylsulphate		Amputees
			Any disease or condition in a paraplegic or quadriplegic patient ”.

Schedule 4—continued

7. Omit item 67 substitute the following item:—
“ 67				Glycerol Suppositories, B.P.	Any disease or condition in a paraplegic or quadriplegic patient
					Patients who are receiving the Supplementary Intensive Nursing Home Care Benefit ”.
8. Omit item 124 substitute the following item:—
“ 124		(1) Paraffin Liquid Emulsion				Any disease or condition in a paraplegic or quadriplegic patient
		(2) Paraffin Liquid Emulsion with Phenolphthalein
						Patients who are receiving the Supplementary Intensive Nursing Home Care Benefit ”.
9. After item 133 insert the following item:—
“ 133a			Prazosin Hydrochloride............			Supplementing beta-blockade in the treatment of hypertension ”.
10. Omit item 141 substitute the following item:—
“ 141		(1) Propranolol Tablets, B.P.,				Benign essential tremor (not Parkinsonian tremor)
		10mg and 40mg				Dissecting aneurysm (aortic)
						Hypertension
						Idiopathic hypertrophic subaortic stenosis
						Right ventricular outflow tract obstruction
						Serious arrhythmias
						The treatment of angina in a patient who is frequently disabled by attacks of angina, in whom no evidence of cardiac failure is found
						Thyrotoxicosis
		(2) Propranolol Tablets, B.P., 160mg				With the written authority of the Director-General—
						Hypertension not responding to 160mg or less of propranolol daily
						Frequent disabling angina without evidence of cardiac failure not responding to 160mg or less of propranolol daily ”.
11. After item 148 insert the following item:—
“ 148a	Sodium Nitroprusside for infusion					For use in a hospital ”.

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Overview

The Statutory Rules 1976 No. 255, under the National Health Act 1953, were enacted to amend the National Health (Pharmaceutical Benefits) Regulations and expand the list of drugs and medicinal preparations that can be prescribed as pharmaceutical benefits. These regulations were introduced to address the gap in the provision of certain medications that were not previously covered under the Act, thereby ensuring broader access to essential treatments. Enacted by the Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, the primary policy objective of these regulations is to enhance the availability of pharmaceutical benefits to the public by including additional drugs and medicinal preparations recommended by the Pharmaceutical Benefits Advisory Committee. The regulations aim to improve healthcare outcomes by ensuring that a wider range of treatments are accessible under the national pharmaceutical benefits scheme.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations, as amended by Statutory Rules 1976 No. 255, establish and modify the list of drugs and medicinal preparations eligible for prescription as pharmaceutical benefits under the National Health Act 1953. These regulations apply to all individuals and entities involved in the prescription, supply, and administration of pharmaceuticals within Australia, including doctors, pharmacists, and patients. The regulations define the specific drugs and formulations that can be prescribed and reimbursed under the Pharmaceutical Benefits Scheme (PBS). The regulations are nationally applicable, affecting all states and territories of Australia, and they extend their reach through subordinate instruments that further detail the administration and enforcement of the PBS. These regulations specify the addition and removal of certain pharmaceutical items from the PBS, thereby directly impacting the availability and cost of medications to Australian citizens. The regulations also stipulate conditions and restrictions on the prescription of certain drugs, such as requiring bacteriological evidence for the prescription of specific antibiotics. While the regulations aim to improve access to essential medications, they do not cover all pharmaceuticals, and certain exclusions and exemptions apply, which are defined within the schedules of the regulations themselves.

Key Provisions

The main operative sections of these Regulations amend the National Health (Pharmaceutical Benefits) Regulations, introducing new drugs and medicinal preparations as pharmaceutical benefits. Section 1 establishes that the Regulations will come into effect on 1 December 1976. Section 2 amends the First Schedule, adding new drug items such as Ferrous Succinate, Meglumine, Mersalyl Injection, Potassium Chloride Tablets, and Sulphacetamide Eye Ointment. Section 3 amends the Second Schedule, adding items like Aminofusin 5%, Aminofusin 10%, Cephradine, and omitting others. Section 4 amends the Third Schedule, introducing new drugs like Aminofusin 5%, Aminofusin 10%, Azatadine Maleate, Betamethasone Dipropionate, and others, while omitting certain items. Section 5 amends the Fifth Schedule, adding new therapeutic uses for drugs like Bisacodyl Suppositories, Cephazolin Sodium, Cephradine, Clonazepam, and others, and omitting certain items. These Regulations impose obligations on healthcare providers and pharmacists to adhere to the newly prescribed pharmaceutical benefits, ensuring that the listed drugs and medicinal preparations are available as prescribed under the National Health Act 1953. They also require compliance with the specified conditions for prescribing and dispensing these drugs, ensuring that they are used appropriately and only under the conditions outlined in the amended schedules. Failure to comply with these Regulations may result in civil or criminal penalties. Although the Regulations themselves do not explicitly state the penalties for non-compliance, breaches of the National Health Act 1953 can lead to substantial fines and, in severe cases, imprisonment. The specific penalties would depend on the nature and severity of the breach, as well as any additional legislative provisions governing such offences.

Area of Law: Health Law; Pharmaceutical Law
Instrument: Regulation
Concepts: Definitions & Interpretation; Reporting & Disclosure Obligations; Licensing & Registration; Enforcement Powers

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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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