National Health (Pharmaceutical Benefits) Regulations (Amendment) (Cth)

Statutory Rules

1973 No. 229

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1973.*

WHEREAS it is provided by sub-section 101 (4) of the National Health Act 1953-1973 that a drug or medicinal preparation that was not a pharmaceutical benefit under the National Health Act 1953-1958 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 1953-1973, 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 Australia, acting with the advice of the Executive Council, hereby make the following Regulations under the National Health Act 1953-1973.

Dated this twenty-second day of November, 1973.

PAUL HASLUCK

Governor-General.

By His Excellency’s Command,

D. EVERINGHAM

Minister of State for Health.

Amendments of the National Health (Pharmaceutical Benefits) Regulations 

Commencement.

1. These Regulations shall come into operation on 1 December 1973.

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 by omitting item 178 and substituting the following item:—

“178 Pipenzolate Bromide —”.

* Notified in the AustralianGovernment Gazette on 29 November 1973.

  Statutory Rules 1960, No. 17, as amended by Statutory Rules 1960, Nos. 90 and 102; 1961, Nos. 59 and 137; 1962, Nos. 34, 101 and 114; 1963, Nos. 34, 69 and 107; 1964, Nos. 12, 57 and 135; 1965, Nos. 51, 151 and 152; 1966, Nos. 80 and 144; 1967, Nos. 67, 116 and 158; 1968, Nos. 44, 76, 88 and 146; 1969, Nos. 44, 107 and 185; 1970, Nos. 39, 94, 119 and 186; 1971, Nos. 44, 101, 136 and 154; 1972, Nos. 32, 121 and 205; and 1973. Nos. 15, 57 and 139.

Third Schedule.

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

Fourth Schedule.

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

Fifth Schedule.

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

SCHEDULE 1 Regulation 2

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

1. After item 50 insert the following item:—

“50a. Calcium Aminosalicylate”.

2. Omit item 131.

3. After item 163 insert the following item:—

“163a. Diphenhydramine Injection”.

4. After item 181 insert the following item:—

“181a. Erythromycin Estolate Capsules”.

5. Omit item 204

6. After item 236 insert the following item:—

“236a. Hydroxyprogesterone Injection”.

7. After item 290 insert the following item:—

“290a. Mephentermine Injection”.

8. Omit item 401.

SCHEDULE 2 Regulation 4

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

1. After item 16 insert the following item:—

“16A. Aluminium Aspirin”.

2. After item 57 insert the following item:—

“57a. Calcium Folinate”.

3. Omit item 73.

4. Omit item 75

5. Omit item 129, substitute the following item:—

“129. Erythromycin Gluceptate”.

6. After item 182 insert the following item:—

“182A. Insect Allergen Extract—Bull Ant”.

7. Omit item 206.

8. Omit item 281.

9. Omit item 286, substitute the following item:—

“286. Pipenzolate Bromide”.

10. After item 299 insert the following item:—

“299A. Pralidoxime Iodide”.

11. Omit item 312

SCHEDULE 3 Regulation 5

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

1. Omit item 4.

2. After item 8 insert the following item:—

“8A. Chlorhexidine Acetate”.

SCHEDULE 4 Regulation 6

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

1. Omit from item 8 the word “severe” (in the third column).
2. Omit item 16, substitute the following item:—
“16	Azathioprine.................................	Any disease or condition in a patient receiving treatment in or at an approved hospital
With the written authority of the Director-General—
Anaemia, autoimmune haemolytic
Arthritis, rheumatoid with vasculitis or visceral complications
Continuing azathioprine therapy after discharge from an approved hospital
Crohn’s disease
Dermatomyositis
Granulomatosis, Wegener’s
Hepatitis, active, chronic
Lupus erythematosus, systemic
Nephritis
Nephrotic syndrome
Organ transplant
Polyarteritis nodosa
Scleroderma
Thrombocytopenic purpura
Ulcerative colitis”.
3. Omit item 28.
4. After item 31 insert the following item:—
“31a	Calcium Folinate...........................	Antidote to folic acid antagonists”.
5. Omit item 37, substitute the following item:—
“37	(1) Cephalexin Monohydrate	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Cephalexin Monohydrate with Purified Water, B.P.
	With the written authority of the Director-General, infections where positive bacteriological evidence confirms that cephalexin monohydrate is the most appropriate therapeutic agent”.
6. Omit item 42, substitute the following item:—
“42	Chlorambucil Tablets, B.P..............	Any disease or condition in a patient receiving treatment in or at an approved hospital
With the written authority of the Director-General—
	Anaemia, autoimmune, haemolytic
Arthritis, rheumatoid with vasculitis or visceral complications
Continuing chlorambucil therapy after discharge from an approved hospital
Crohn’s disease
Dermatomyositis
Granulomatosis, Wegener’s
Hepatitis, active, chronic
Lupus erythematosus, systemic
Malignant disease including leukaemia
Nephritis
Nephrotic syndrome
Polyarteritis nodosa
Scleroderma
Thrombocytopenic purpura
Ulcerative colitis”.

Schedule 4—continued

7. Omit item 46, substitute the following item:—
“46	(1) Chlorpromazine Hydrochloride, B.P.	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Chlorpromazine Injection, B.P.	Hereditary chorea (Huntington’s)
(3) Chlorpromazine Tablets, B.P.	Hyperactive states of organic or toxic delirium
Major psychoses including—
Major organic psychoses including arteriopathic dementia
Manic-depressive psychosis
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients who have not attained the age of sixteen years”.
8. Omit from item 49 the word—
“Osteomyelitis” (in the third column).
9. Omit item 51, substitute the following item:—
“51	(1) Cloxacillin Sodium, B.P.	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Cloxacillin Capsules, B.P.
(3) Cloxacillin Sodium, B.P. with Purified Water, B.P.	With the written authority of the Director-General, infections where bacteriological evidence confirms the presence of penicillin-resistant staphylococci
	Osteomyelitis”.
10. Omit item 56, substitute the following item:—
“6	(1) Cyclophosphamide Tablets, B.P.	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Cyclophosphamide, B.P.	With the written authority of the Director-General—
Anaemia, autoimmune, haemolytic
Arthritis, rheumatoid with vasculitis or visceral complications
Continuing cyclophosphamide therapy after discharge from an approved hospital
Crohn’s disease
Dermatomyositis
Granulomatosis, Wegener’s
Hepatitis, active, chronic
Lupus erythematosus, systemic
Malignant disease, including leukaemia
Nephritis
Nephrotic syndrome
Polyarteritis nodosa
Scleroderma
Thrombocytopenic purpura
Ulcerative colitis”.
11. After item 64 insert the following item:—
“64a	Dexamphetamine Tablets, B.P......	With the written authority of the Director-General—
For the treatment of a patient who has not attained the age of twenty-one years and who is hyperkinetic as a result of brain damage
Narcolepsy”.
12. Omit item 80, substitute the following item:—
“80	Ethyloestrenol..............................	With the written authority of the Director General—
Intermittent use for corticosteroid-induced osteoporosis
Intermittent use for patients on long-term treatment with corticosteroids
Intermittent use for the relief of pain due to osteoporosis
Osteomalacia following gastrectomy”.

Schedule 4—continued

13. Omit item 82, substitute the following item:—
“82	Fludrocortisone Tablets, B.P.............	Adrenal cortical hypoplasia including Addison’s disease
Orthostatic hypotension
Salt-losing congenital adrenocortical hyperplasia
Total adrenalectomy”.
14. Omit item 85, substitute the following item:—
“85	(1) Fluphenazine Hydrochloride, B.P.	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Fluphenazine Tablets, B.P.	Hereditary chorea (Huntington’s)
(3) Fluphenazine Enanthate	Hyperactive states of organic or toxic delirium
(4) Fluphenazine Decanoate	Major psychoses including—
Major organic psychoses including arteriopathic dementia
Manic-depressive psychosis
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness”.
15. Omit item 93, substitute the following item:—
“93	Gentamicin Sulphate........................	Any disease or condition in a patient receiving treatment in or at an approved hospital
With the written authority of the Director-General—
Infections where positive bacteriological evidence confirms that gentamicin sulphate is the most appropriate antibiotic
Septicaemia including suspected septicaemia”.
16. Omit from item 95 the word “four” (in the third column), substitute the word “six”.
17. Omit from item 96 the word “four” (in the third column), substitute the word “six”.
18. Omit item 105.
19. After item 109 insert the following item:—
“109a	Insect Allergen Extract—Bull Ant	Severe constitutional reaction to bull ant stings”.
20. Omit item 113, substitute the following item:—
“113	‘ISOMIL’........................................	With the written authority of the Director-General—
Cow’s milk allergy in children under the age of six years
Galactosaemia
Homocystinuria
Lactose intolerance”.
21. Omit item 119.
22. Omit items 121 and 122, substitute the following items:—
“121	Lignocaine Hydrochloride, B. P., Injection	Cardiac arrhythmias
“122	(1) Lincomycin Hydrochloride, B.P.	Anaerobic infections Osteomyelitis”.
(2) Lincomycin Capsules, B.P.
23. Omit item 125, substitute the following item:—
“125	Locasol...........................................	With the written authority of the Director-General—
Hypercalcaemia in children under the age of two years
Osteopetrosis”.

Schedule 4—continued

24. Omit item 134, substitute the following item:—
“134	Megestrol Acetate, B.P. with Ethinyloestradiol, B.P.	Fertility control in females who have severe acne or severe hirsutism which has been aggravated by other oral contraceptives
Sexual infantilism in females
Stein-Leventhal syndrome”.
25. Omit item 138, substitute the following item:—
“138	(1) Methandienone Tablets, B.P.	With the written authority of the Director-General—
(2) Methenolone Acetate
Intermittent use for corticosteroid-induced osteoporosis
Intermittent use for patients on long-term treatment with corticosteroids
Intermittent use for the relief of pain due to osteoporosis”.
26. Omit item 140, substitute the following item:—
“140	(1) Methotrexate Tablets	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Methotrexate Injection
With the written authority of the Director-General—
	Continuing methotrexate therapy after discharge from an approved hospital
Malignant neoplasia
Pemphigus vulgaris
Psoriasis, severe, generalised”.
27. Omit items 150, 151 and 152, substitute the following items:—
“150	Nandrolone Decanoate......................	Carcinoma of the breast
With the written authority of the Director-General—
Intermittent use for corticosteroid-induced osteoporosis
Intermittent use for patients on long-term treatment with corticosteroids
Intermittent use for the relief of pain due to osteoporosis
Severe osteoporosis due to proven pancreatitis
“151	Nandrolone Hexoxyphenyl Propionate	Carcinoma of the breast
With the written authority of the Director-General—
	Intermittent use for corticosteroid-induced osteoporosis
Intermittent use for patients on long-term treatment with corticosteroids
Intermittent use for the relief of pain due to osteoporosis
“152	Nandrolone Phenylpropionate Injection, B.P.	Carcinoma of the breast
		With the written authority of the Director-General—
Intermittent use for corticosteroid-induced osteoporosis
Intermittent use for the relief of pain due to osteoporosis”.

28. Omit from item 160 the word “four” (in the third column), substitute the word “six”.

29. Omit from item 161 the word “severe” (in the third column).

Schedule 4—continued

30. Omit item 170 insert the following item:—
“170	(1) Pericyazine Mesylate	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Pericyazine
Hereditary chorea (Huntington’s)
Hyperactive states of organic or toxic delirium
Major psychoses, including—
Major organic psychoses including arteriopathic dementia
Manic-depressive psychosis
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients who have not attained the age of sixteen years”.
31. Omit from item 188 the word “severe” (in the third column).
32. Omit from item 192 the word “severe” (in the third column).
33. Omit item 194, substitute the following item:—
“194	Prosobee................................................	With the written authority of the Director-General—
Cow’s milk allergy in children under the age of six years
Galactosaemia
Homocystinuria
Lactose intolerance”.
34. Omit item 199, substitute the following item:—
“199	Sobee................................................	With the written authority of the Director-General—
Cow’s milk allergy in children under the age of six years
Galactosaemia
Homocystinuria
Lactose intolerance”.
35. Omit items 201, 202 and 203, substitute the following items:—
“202	(1) Sodium Fusidate	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Diethanolamine Fusidate
With the written authority of the Director-General, for use in combination with another antibiotic in the treatment of serious staphylococcal infections confirmed by bacteriological evidence
“203	Soyalac................................................	With the written authority of the Director-General—
Cow’s milk allergy in children under the age of six years
Galactosaemia
Homocystinuria
Lactose intolerance”.
36. Omit items 205 and 206, substitute the following items:—
“205	Stanolone................................................	Carcinoma of the breast
With the written authority of the Director-General—
Intermittent use for corticosteroid-induced osteoporosis
Intermittent use for patients on long-term treatment with corticosteroids
Intermittent use for the relief of pain due to osteoporosis

Schedule 4—continued

“206	Stanozolol...............................	With the written authority of the Director-General—
Intermittent use for corticosteroid-induced osteoporosis
Intermittent use for patients on long-term treatment with corticosteroids
Intermittent use for the relief of pain due to osteoporosis”.
37. Omit item 214, substitute the following item:—
“214	Tetracosactrin.........................	With the written authority of the Director-General—
Hypsarrhythmia
Multiple sclerosis, acute exacerbation
Severe asthma in children where there is evidence of growth suppression produced by corticosteroids
Status asthmaticus
Treatment of patients who are being withdrawn from long-term corticosteroid therapy”.
38. Omit item 225, substitute the following item:—
“225	(1) Thioridazine	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Thioridazine Tablets, B.P.
Hereditary chorea (Huntington’s)
Hyperactive states of organic or toxic delirium
Major psychoses including—
Major organic psychoses including arteriopathic dementia
Manic-depressive psychosis
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients who have not attained the age of sixteen years”.
39. Omit item 228, substitute the following item: —
“228	(1)Trifluoperazine Hydrochloride, B.P.	Any disease or condition in a patient receiving treatment in or at an approved hospital
(2) Trifluoperazine Tablets, B.P.	Hereditary chorea (Huntington’s)
Hyperactive states of organic or toxic delirium
Major psychoses including—
Major organic psychoses including arteriopathic dementia
Manic-depressive psychosis
Paranoid states
Schizophrenia
Senile dementia
Malignant neoplasia (late stage)
Radiation sickness
Severe conduct disorders in patients who have not attained the age of sixteen years”.