National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

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STATUTORY RULES

1969 No.

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1968.*

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 1953-1968.

Dated this twenty-first day of March, 1969.

CASEY

Governor-General.

By His Excellency's Command,

(SGD.) A. J. FORBES

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 April, 1969.

First schedule.

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

(a) by inserting after item 38 the following item:—

" 38a. Caffeine Hydrate ";

(b) by inserting after item 130 the following item:—

" 130a. Dusting Powder Absorbable ";

(d) by inserting after item 266 the following item:—

" 266a. Oil of Coriander ".

Second Schedule.

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

Third Schedule.

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

Fifth Schedule.

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

* Notified in the Commonwealth Gazette on 1969.

† Statutory Rules 1960, No. 17, as amended to date. For previous amendments of the National Health (Pharmaceutical Benefits) Regulations, see footnote to Statutory Rules 1968, No. 44; and see also Statutory Rules 1968, Nos. 44, 76, 88 and 146.

11928/69—Price 10c 14/11.3.1969

THE SCHEDULES

FIRST SCHEDULE Regulation 4.

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

1. After item 2 insert;—

" 2a. Acetylcholine Chloride ".

2. Omit item 19.

3. After item 48 insert:—

" 48a. Betamethasone Valerate ".

4. After item 49 insert:—

" 49a. Black Snake Antivenene ".

5. After item 67 insert:—

" 67a. Capreomycin Sulphate ".

6. After item 70 insert:—

" 70a. Carbenicillin ".

7. After item 91 insert:—

" 91a. Clioquinol

91b. Clofibrate ".

8. After item 116 insert:—

" 116A. Dihydroergotoxine Mesylate ".

9. After item 149a insert:—

" 149b. Flumethasone Pivalate ".

10. Omit from item 157 " Formula No. 11 " insert " Formula No. 17 ".

11. After item 160 insert:—

" 160a. Gentamicin Sulphate ".

12. Omit item 186.

13. After item 231 insert:—

" 231a. Methysergide Malcate ".

14. After item 237 insert: —

" 237a. Nandrolone Hexoxyphenyl Propionate ".

15. After item 251 insert:—

" 251a. Oxethazaine ".

16. Omit item 261.

17. After item 323 insert:—

" 323a. Snake Bite Antivenene —Polyvalent ".

18. After item 331b insert:—

" 331c. Soyalac ".

19. Omit item 365, insert:—

" 365. Tetracosactrin ".

SECOND SCHEDULE Regulation 5.

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

1. Omit item 1, insert:—_
" 1	Acetylcholine Chloride with Mannitol B.P.	Any disease or condition in a patient receiving treatment in or at an approved hospital
1a	Acetylcysteine ....................	Fibrocystic disease ".

Second Schedule—continued

2. Item 22—

(a) omit "Betamethasone Tablets" (in the second column), insert:—

" (1) Betamethasone Syrup

(2) Betamethasone Tablets ";

(b) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ";

" Dermatitis herpetiformis ";

(d) insert after " Reticulum cell sarcoma " (in the third column)—

" Retroperitoneal fibrosis "; and

(e) add at the end of the item (in the third column)—

" With the written authority of the Director-General, for the treatment, in conjunction with other therapy—

(a) of chronic or recurrent asthma in the case of a patient whose asthma interferes seriously with his normal activities of life; or

(b) of a severe asthmatic whose acute attacks of asthma have been relieved by corticosteroids but who relapses when corticosteroids are withdrawn."

3. After item 24 insert:—

" 24a

Betamethasone Valerate with Clioquinol

For the treatment of diseases of the ear ".

4. After item 29 insert:—

" 29a	Capreomycin Sulphate ...............	Any disease or condition in a patient receiving treatment in or at an approved hospital ".
5. After item 30 insert:—
" 30a	Carbenicillin......................	Any disease or condition in a patient receiving treatment in or at an approved hospital ".
6. After item 32 insert:—
" 32a	Clofibrate .......................	With the written authority of the Director-General, for the treatment of hypercholesterolemia with xanthomata ".

7. Item 46—

(a) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ";

(b) insert after " Dermatitis, acute exfoliative " (in the third column)—

" Dermatitis herpetiformis ";

" Retroperitoneal fibrosis ".

8. Add at the end of item 47 (in the third column)—

" With the written authority of the Director-General, for the treatment, in conjunction with other therapy—

(a) of chronic or recurrent asthma in the case of a patient whose asthma interferes seriously with his normal activities of life; or

(b) of a severe asthmatic whose acute attacks of asthma have been relieved by corticosteroids but who relapses when corticosteroids are withdrawn."

9. Item 56—

(a) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ";

(b) insert after " Cushing’s syndrome including hyperadrenocorticalism " (in the third column)—

" Dermatitis herpetiformis "; and

" Retroperitoneal fibrosis ".

Second Schedule—continued

10. After item 64 insert:—_
“ 64a	Dihydroergotoxine Mesylate ............	For the treatment of patients who have suffered an attack of paralytic poliomyelitis ".
11. After item 79 insert:—
" 79a	Flumethasone Pivalate and Clioquinol	For the treatment of diseases of the ear ".
12. Omit items 82 and 83, insert:—
" 82	Fluphenazine Oenanthate ..............	Any disease or condition in a patient receiving treatment in or at an approved hospital
		The treatment of a mental disorder in a person who has, after treatment for a mental disorder, been discharged from an approved hospital if a medical officer of the hospital gives a certificate certifying that that person received treatment at the hospital and may require further treatment with either or both of the following pharmaceutical benefits:—
		Fluphenazine Oenanthate
		Fluphenazine Hydrochloride
		With the written authority of the Director-General—
		Late-stage malignancy
		Radiation sickness
		Huntington's chorea
		With the written authority of the Director-General, the treatment of a mental disorder in a person who has been discharged from an approved hospital at which he received treatment for a mental disorder and who is living in a place remote from an approved hospital
82a	Fluphenazine Hydrochloride ............	Any disease or condition in a pensioner Any disease or condition in a patient receiving treatment in or at an approved hospital
		The treatment of a mental disorder in a person who has, after treatment for a mental disorder, been discharged from an approved hospital if a medical officer of the hospital gives a certificate certifying that that person received treatment at the hospital and may require further treatment with either or both of the following pharmaceutical benefits:—
		Fluphenazine Oenanthate
		Fluphenazine Hydrochloride
		With the written authority of the Director-General—
		Late-stage malignancy
		Radiation sickness
		Huntington's chorea
		With the written authority of the Director-General, the treatment of a mental disorder in a person who has been discharged from an approved hospital at which he received treatment for a mental disorder and who is living in a place remote from an approved hospital
83	(1) Folic Acid Injection ...............	Macrocytic anaemia
	(2) Folic Acid Tablets, B.P.............	Sprue or the sprue- like syndrome
		Proven folic acid deficiency ".
13. Omit from item 87 " No. 11 " (in the second column), insert " No. 17 ".

Second Schedule—continued

14. After item 88 insert:—_
" 88A	Gentamicin Sulphate ...............	Any disease or condition in a patient receiving treatment in or at an approved hospital ".

15. Item 96—

(a) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ";

(b) insert after " Cushing's syndrome including hyperadrenocorticalism (in the third column)—

" Dermatitis herpetiformis "; and

" Retroperitoneal fibrosis ".

16. After item 106 insert:—
" 106a	Influenza Vaccine ................	For the treatment of pensioners only ".
17. Omit item 112, insert:—
" 112	Lincomycin Hydrochloride ..........	Gram positive coccal infections where these cannot be safely and effectively treated with penicillin
		Osteomyelitis ".

18. Item 128—

(a) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ";

(b) insert after " Cushing's syndrome including hyperadrenocorticalism " (in the third column)—

" Dermatitis herpetiformis ";

" Retroperitoneal fibrosis "; and

(d) add at the end of the item (in the third column)—

" With the written authority of the Director-General, for the treatment, in conjunction with other therapy—

(a) of chronic or recurrent asthma in the case of a patient whose asthma interferes seriously with his normal activities of life; or

(b) of a severe asthmatic whose acute attacks of asthma have been relieved by corticosteroids but who relapses when corticosteroids are withdrawn ".

19. After item 129 insert:—
" 129a	Methysergide Maleate ..............	With the written authority of the Director-General, for the treatment of severe recalcitrant migraine where other treatment has failed ".
20. After item 134 insert:—
" 134a	Nandrolone Hexoxyphenyl Propionate	Mammary carcinoma With the written authority of the Director-General—
		Intermittent use for corticosteroid-induced osteoporosis
		Intermittent use for patients on long term treatment with corticosteroids ".
21. Omit item 136, insert:—
" 136	Nandrolone Decanoate .............	Mammary carcinoma With the written authority of the Director-General—
		Intermittent use for corticosteroid-induced osteoporosis
		Intermittent use for patients on long term treatment with corticosteroids ".
22. Omit from item 143 " in children " (in the third column).

Second Schedule—continued

23. Item 159—

(a) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ",

(b) insert after " Cushing's syndrome including hyperadrenocorticalism " (in the third column)—

" Dermatitis herpetiformis "; and

" Retroperitoneal fibrosis ".

24. Item 173—

(a) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ";

(b) insert after " Cushing's syndrome including hyperadrenocorticalism " (in the third column)—

" Dermatitis herpetiformis ";

" Retroperitoneal fibrosis "; and

(d) add at the end of the item (in the third column)—

" With the written authority of the Director-General, for the treatment, in conjunction with other therapy—

(a) of chronic or recurrent asthma in the case of a patient whose asthma interferes seriously with his normal activities of life; or

(b) of a severe asthmatic whose acute attacks of asthma have been relieved by corticosteroids but who relapses when corticosteroids are withdrawn ".

25. Item 178—

(a) insert after " Agranulocytosis " (in the third column)—

" Angioneurotic oedema ";

(b) insert after " Cushing's syndrome including hyperadrenocorticalism " (in the third column)—

" Dermatitis herpetiformis ";

" Retroperitoneal fibrosis "; and

(d) add at the end of the item (in the third column)—

" With the written authority of the Director-General, for the treatment, in conjunction with other therapy—

(a) of chronic or recurrent asthma in the case of a patient whose asthma interferes seriously with his normal activities of life; or

(b) of a severe asthmatic whose acute attacks of asthma have been relieved by corticosteroids but who relapses when corticosteroids are withdrawn ".

26. Omit from item 181 " Propranolol Hydrochloride " (in the second column), insert—

" (1) Propranolol Hydrochloride, 40 mg. tablets

(2) Propranolol Hydrochloride Injection ".

27. After item 181 insert:—
" 181a	Propranolol Hydrochloride, 10 mg. Tablets	With the written authority of the Director-General, Hypertrophic subaortic stenosis ".
28. Omit item 187, insert:—
" 187	Pyrimethamine Tablets .............	Treatment of—
		Toxoplasmosis
		Malaria ".
29. After item 191 insert:—
" 191a	Soyalac .......................	With the written authority of the Director-General—
		Galactosaemia
		Homocystinuria
		Lactose intolerance
		Milk allergy in children under the age of four years ".

Second Schedule—continued

30. Omit from item 205 (in the second column) " Tetracosactide ", insert:—

" Tetracosactrin ".

31. Insert in item 210, before " Late-stage malignancy " (in the third column)—

" Huntington's chorea ".

32. Insert in item 216, before " Late-stage malignancy " (in the third column)—

" Huntington's chorea ".

Printed for the Government of the Commonwealth by W. G. Murray at the Government Printing Office. Canberra

Overview

The National Health Act 1953-1968, enacted by the Parliament of Australia, was introduced to establish a framework for the provision of healthcare services and the regulation of pharmaceuticals in Australia. This legislation aimed to ensure that essential healthcare services were accessible to all Australians. The 1969 Statutory Rules under the Act further refined the provisions, particularly focusing on the Pharmaceutical Benefits Schedule. These amendments were made to update the list of drugs eligible for subsidy under the National Health (Pharmaceutical Benefits) Regulations. The policy objective behind these amendments was to expand the range of medications available to patients at a reduced cost, thus improving access to necessary treatments. By including new drugs and modifying existing entries, the regulations sought to address emerging health needs and incorporate advancements in medical treatments. The enacting body for these regulations was the Governor-General in Council, acting on advice from the relevant ministers.

Scope and Application

The Statutory Rules 1969 No. 18, Regulations under the National Health Act 1953-1968, pertains to the amendments of the National Health (Pharmaceutical Benefits) Regulations, which came into operation on 1 April 1969. These Regulations apply to the Commonwealth of Australia and are designed to modify existing schedules in the National Health (Pharmaceutical Benefits) Regulations. The amendments primarily involve the addition and removal of pharmaceutical items, which are listed in various schedules of the Regulations. The specific changes include the insertion of new pharmaceutical items such as Caffeine Hydrate, Dusting Powder Absorbable, and Oil of Coriander, as well as the removal of certain items such as item 187. Additionally, the Regulations revise the conditions under which certain pharmaceuticals can be provided, such as Betamethasone Valerate and Clioquinol, which are now listed for the treatment of ear diseases. These changes extend the application of the Act by incorporating new pharmaceuticals into the benefits scheme, thereby broadening the scope of covered treatments and conditions.

Key Provisions

The regulations outlined in this statutory instrument primarily focus on amendments to the National Health (Pharmaceutical Benefits) Regulations under the National Health Act 1953-1968. These regulations came into operation on April 1, 1969, and involve amendments to various schedules of the existing regulations (Regulations 1–5). Specifically, the First Schedule (Regulation 2) introduces new pharmaceutical items such as Caffeine Hydrate, Dusting Powder Absorbable, and Oil of Coriander, while omitting certain items. The Third Schedule (Regulation 4) and Fifth Schedule (Regulation 5) are also amended, as detailed in the respective schedules. These regulations impose several obligations on the parties they govern. Firstly, healthcare providers must ensure that the new pharmaceutical items listed in the schedules are available for prescription and use in treating specified conditions. Additionally, the regulations necessitate that certain treatments require written authority from the Director-General, such as the use of Betamethasone Valerate and Clioquinol for treating ear diseases or the administration of specific medications for chronic or recurrent asthma. This underscores the importance of adhering to prescribed guidelines and obtaining necessary approvals before administering certain treatments. Violations of these regulations may lead to various civil and criminal consequences. Although the specific penalties are not detailed in the text, breaches of pharmaceutical regulations can generally result in fines, sanctions, or even criminal charges depending on the severity and intent of the violation. For instance, unauthorized use of medications that require Director-General approval could be considered fraudulent or negligent practices, potentially leading to severe penalties. Ensuring compliance with these regulations is crucial for maintaining the integrity and efficacy of the national health system.

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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