National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02852 Regulations Not in force Legislative Instrument

Legislation content

STATUTORY RULES.

 

1963. No. 34

_______

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1962.*

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 1953-1962.

Dated this twenty-first

day of  April, 1963.

 

 

DE L ‘ISLE

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 May, 1963.

First Schedule.

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

(a) by inserting after the words—

Hexamethonium Tartrate.”

the words—

Hexamethonium Tartrate Injection.”;

(b) by omitting the words—

Pyrimethamine Tablets.”;

and

(c) by omitting the words—

Suxamethonium Chloride Injection.”.

_______________________________________________________________________________________

* Notified in the Commonwealth Gazette on 26th April, 1963.

 

† Statutory Rules 1960, No. 17, as amended by Statutory Rules 1960, Nos. 90 and 102; 1961, Nos 59 and 137; and 1962, Nos. 34, 101 and 114.

2813/63.—Price 5d.  10/8.4.1963.


Second Schedule.

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

(a) by adding at the end of the second column of the item relating to the pharmaceutical benefit “Chloramphenicol B.P.” the words—

Chloramphenicol B.P. with Polymyxin B. Sulphate B.P.”;

(b) by inserting after the item relating to the pharmaceutical benefit “ Cortisone Acetate B.P.” the following item:—

“ Cyclizine Hydrochloride...........

Cyclizine Hydrochloride with Caffeine B.P. and Ergotamine Tartrate B.P.”;

 

(c) by adding at the end of the second column of the item relating to the pharmaceutical benefit “ Ergotamine Tartrate B.P.” the words—

Ergotamine Tartrate B.P. with Caffeine B.P. and Cyclizine Hydrochloride ”;

 and

(d) by adding at the end of the item relating to the pharmaceutical benefit “ Polymyxin B. Sulphate B.P.” the words—

Polymyxin B. Sulphate B.P. with Chloramphenicol B.P.”.

Third Schedule.

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

(a) by inserting after the words—

Acetazolamide Sodium.”

the word—

Acetohexamide.”;

(b) by inserting after the word and letter—

Amphotericin B.

the word—

Ampicillin.”;

(c) by inserting before the word—

Cyclopenthiazide.

the words—

Cyclizine Hydrochloride.”;

(d) by omitting the words and letter—

Desacetyl Lanatoside, C.”

and inserting in their stead the word—

Deslanoside.”;

(e) by inserting after the words—

Diphtheria Toxoid Purified.”

the word—

Dipyridamole.”;

(f) by inserting after the word—

Hydroflumethiazide.

the word—

Hydroxocobalamin.”;


(g) by inserting after the words and letters—

Levorphanol Tartrate, B.P.C.

the word—

Liothyronine.”;

(h) by inserting after the words—

Mecholyl Chloride.

the words—

Medroxyprogesterone Acetate.”;

(i) by inserting before the word—

Methazolamide.

the words—

Metaraminol.

Metformin.”;

(j) by inserting after the word—

Methotrexate.

the words and letters—

Methoxamine Hydrochloride, B.P.C.”;

(k) by inserting after the words and letters—

Methylcellulose Mucilage, A.P.F.”

the word—

Methyldopa.”;

(l) by inserting after the word—

Nandrolone.”

the word—

Niclosamide.”;

(m) by inserting after the word—

Polydimethylsiloxanes.

the word—

Polythiazide.”;

(n) by omitting the word—

Pyrimido-Prymidine.”;

(o) by inserting after the words—

Tripolidine Hydrochloride.”

the word—

Vadrine”;

and

(p) by inserting before the word—

Veriloid.”

the word—

Velactin.”.

Fifth Schedule.

5.  The Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended—

(a) by inserting after the item relating to the pharmaceutical benefit “ Amphotericin B.” the following item:—

“ Ampicillin.....................

Any disease or condition in a patient receiving treatment in or at an approved hospital ”;

 

 

(b) by omitting the item relating to the pharmaceutical benefit “ Calciferol Tablets B.P.” and inserting in its stead the following item:—

“ Calciferol Tablets B.P.............

With the written authority of the Director-General—

Idiopathic hypoparathyroidism

Chronic hypoparathyroid tetany ”;

 

(c) by inserting after the item relating to the pharmaceutical benefit “ Diiodohydroxyquinoline B.P., Vaginal Tablet ” the following item:—

“ Diiodohydroxyquinoline B.P.

Compound Effervescent

Gynaecological Pessary............

Trichomonal and monilial vaginitis ”;

 

(d) by inserting after the item relating to the pharmaceutical benefit “ Diphenhydramine Hydrochloride B.P., Elixir ” the following item:—

“ Dipyridamole Tablets............

Any disease or condition in a patient receiving treatment in or at an approved hospital ”;

 

(e) by inserting after the item relating to the pharmaceutical benefit “ Hydrocortisone Sodium Succinate Injection B.P.” the following items:—

Hydroxocobalamin Injection, 100 microgramme strength 

Established megalocytic anaemia

 

Hydroxocobalamin Injection,  1,000 microgramme strength 

Sub-acute combined degeneration of the cord

Neuroblastoma

(f) by inserting after the item relating to the pharmaceutical benefit “ Levorphanol Tartrate B.P.C.” the following item:—

Liothyronine ..................

 

Any disease or condition in a patient receiving treatment in or at an approved hospital ”;

(g) by inserting before the item relating to the pharmaceutical benefit “ Mepyramine Maleate Elixir ” the following items: —

Mebhydrolin Suspension ...........

 

Any disease or condition in a child under the age of twelve years

Medroxyprogesterone Acetate .........

 

Any disease or condition in a patient receiving treatment in or at an approved hospital ”;

(h) by omitting the item relating to the pharmaceutical benefit “ Methyl Prednisolone Acetate ” and inserting in its stead the following item:—

Methyldopa ..................

 

Any disease or condition in a patient receiving treatment in or at an approved hospital ”;

 


(i) by omitting the item relating to the pharmaceutical benefit “ Polydimethylsiloxanes ” and inserting in its stead the following items:—

Pituitary Posterior Lobe B.P.C., Insufflation

 

Diabetes insipidus

 

Polydimethylsiloxanes ...............

 

Ileostomy or colostomy conditions

 

Polythiazide ......................

 

Any disease or condition in a patient receiving treatment in or at an approved hospital ”;

 

(j) By inserting after the item relating to the pharmaceutical benefit “ Pyridine Aldoxime Methiodide ” the following item:—

Pyridoxine Hydrochloride, Oral Tablet, B.P.C.

Peripheral neuritis due to isoniazid therapy ”;

 

 

and

(k) by omitting the item relating to the pharmaceutical benefit “ Vancomycin Hydrochloride ” and inserting in its stead the following items:—

Vadrine........................

Vancomycin Hydrochloride

 

Any disease or condition in a patient receiving treatment in or at an approved hospital

Velactin .......................

With the written authority of the the Director-General, galactosaemia ”.

 

_____________________

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

Overview

The Statutory Rules of 1963, No. 34, represents amendments to the National Health (Pharmaceutical Benefits) Regulations under the National Health Act 1953-1962. Enacted by the Governor-General in and with the advice of the Federal Executive Council, these regulations were designed to address gaps and update the pharmaceutical benefits list, ensuring that the scheme remains relevant and effective in providing necessary medications to Australians. The policy objective behind these amendments is to expand the range of pharmaceuticals available under the National Health Scheme, thus improving access to essential treatments. These amendments were made to align with the evolving healthcare needs of the population, reflecting advancements in medical science and treatment methodologies. These regulations, which came into operation on the first of May, 1963, introduce new pharmaceutical benefits, remove certain outdated medications, and adjust the criteria for the provision of specific treatments. The changes encompass the addition and removal of various pharmaceutical products, as well as modifications to the conditions under which certain medications can be provided. By implementing these updates, the Australian government aims to enhance the quality and accessibility of healthcare services provided to the public.

Scope and Application

The Statutory Rules of 1963, No. 34, which are regulations made under the National Health Act 1953-1962, provide amendments to the National Health (Pharmaceutical Benefits) Regulations. These regulations apply to the Commonwealth of Australia and govern the pharmaceutical benefits available under the National Health Scheme. They affect various entities, including pharmaceutical manufacturers, suppliers, and healthcare providers, as well as individuals who are beneficiaries of the scheme by making certain medications available at subsidised rates. The regulations pertain to the listing, pricing, and reimbursement of pharmaceutical products that are deemed necessary for the treatment of specified medical conditions. These amendments include additions and deletions to the schedules of the regulations, affecting the inclusion of specific pharmaceutical products and their combinations, as well as the diseases or conditions for which they can be prescribed. The scope of these regulations extends to ensuring that the pharmaceutical benefits provided under the Act are up-to-date and reflective of current medical practices and needs. There are no specific exclusions or thresholds mentioned in these regulations, and their application is not further extended or restricted through subordinate instruments in the provided text.

Key Provisions

The Statutory Rules of 1963, No. 34, under the National Health Act 1953-1962, include amendments to the National Health (Pharmaceutical Benefits) Regulations, which came into operation on 1 May 1963. These amendments primarily affect the lists of pharmaceuticals eligible for benefits under the scheme. Specifically, the First Schedule (2) modifies the list by adding "Hexamethonium Tartrate Injection" and removing "Pyrimethamine Tablets" and "Suxamethonium Chloride Injection". The Second Schedule (3) updates the pharmaceutical benefits list by adding combinations such as "Chloramphenicol B.P. with Polymyxin B. Sulphate B.P." and "Cyclizine Hydrochloride with Caffeine B.P. and Ergotamine Tartrate B.P." while also removing some items. The Third Schedule (4) similarly expands the list of pharmaceuticals covered by inserting new entries such as "Ampicillin" and "Medroxyprogesterone Acetate" and removing others like "Desacetyl Lanatoside, C.". The obligations imposed by these Regulations on the parties, primarily healthcare providers and pharmaceutical companies, include adherence to the updated lists of pharmaceuticals that qualify for benefits. Providers must ensure they are aware of the new inclusions and exclusions to correctly bill for services rendered and to inform patients of their entitlements under the scheme. Pharmaceutical companies, on the other hand, must ensure their products comply with the regulatory requirements to be eligible for the benefits. Breaches of these Regulations can lead to various civil and criminal consequences. While the specific offences and penalties are not detailed in the provided text, generally, non-compliance with health regulations can result in fines, sanctions, and in severe cases, criminal charges. For instance, providing or billing for pharmaceuticals not listed in the approved schedules could be considered fraudulent activity, potentially leading to penalties under the relevant health and consumer protection laws. The exact penalties would depend on the nature and severity of the breach, but they can include significant financial penalties and, in some cases, imprisonment.

Legal classification tags

Area of Law
Health Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Regulatory Standards
Reporting & Disclosure Obligations
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.