Statutory Rules
1977 No. 39
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 Schedule 3 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 Twenty-fourth day of March, 1977.
John R. Kerr
Governor-General.
By His Excellency’s Command,
SGD. 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 April 1977.
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.
____________________________________________________________________________________
* Notified in the Australian Government Gazette on 28 March 1977.
† Statutory Rules 1960, No. 17 as amended by Statutory Rules 1960, Nos. 90 and 102; 1961, Nos. 59 and 137; 1902, Nos, 34, 101 and 114; 1903, 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; 1973, Nos. 15, 57, 139 and 229; 1974, Nos. 37, 126 and 222; 1975, Nos. 50, 148 and 209; and 1976, Nos. 84, 150, 195 and 255.
11158/77 Cat. No. —Recommended retail price 20c 12/4.3.1977
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.
Further amendments of the National Health (Pharmaceutical Benefits) Regulations.
6. The National Health (Pharmaceutical Benefits) Regulations are amended as set out in Schedule 5.
SCHEDULE 1 Regulation 2
Amendments or the First Schedule to the National Health (Pharmaceutical Benefits) Regulations
1. After item 43, insert the following item:—
“ 43a Benzylpenicillin Tablets ”.
2. Omit items 88 and 206.
3. After item 252, insert the following items:—
“ 252a Glutethimide
252b Glutethimide Tablets ”.
4. Omit item 280.
5. After item 363, insert the following item:—
“ 363a Methacycline Hydrochloride ”.
______
SCHEDULE 2 Regulation 3
Amendments or the Second Schedule to the National Health (Pharmaceutical Benefits) Regulations
1. After item 8, insert the following item:—
“ 8a | Amiloride Hydrochloride | Hydrochlorothiazide, B.P., with Amiloride Hydrochloride ”. |
2. Omit item 13, substitute the following item:—
“ 13 | Amphotericin | —”. |
3. Omit item 33.
4. After item 62, insert the following item:—
“ 62a | ‘ DIGESTELACT ’ | —”. |
5. Omit item 72.
6. After item 104, insert the following item:—
“ 104a | Hydrochlorothiazide, B.P. | Amiloride Hydrochloride with Hydrochlorothiazide, B.P.”. |
7. Omit item 128.
_______
SCHEDULE 3 Regulation 4
Amendments of the Third Schedule to the National Health (Pharmaceutical Benefits) Regulations
1. Omit item 53.
2. After item 96, insert the following item:—
“ 96a ‘DIGESTELACT’ ”.
3. After item 118, insert the following item:—
“ 118a Flucytosine ”.
4. Omit item 234, substitute the following item:—
“ 234 Pheniramine Aminosalicylate ”.
5. After item 241, insert the following item:—
“ 241a Pindolol ”.
6. Omit item 260.
SCHEDULE 4 Regulation 5
Amendments of the Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations
1. Omit item 38, substitute the following item:— | ||
“ 38 | (1) Cloxacillin Capsules, B.P. | Any disease or condition in a patient receiving treatment in or at an approved hospital. |
| (2) Cloxacillin Sodium, B.P., with Purified Water. B.P. | |
| With the written authority of the Director-General— | |
|
| Infections due to the presence of penicillin-resistant staphylococci |
|
| Osteomyelitis ”. |
2. After item 49, insert the following item:— | ||
“ 49a | ‘DIGESTELACT’......... | With the written authority of the Director-General, lactose intolerance ”. |
3. After item 56, insert the following item:— | ||
“ 56a | Flucytosine.............. | Invasive or systemic fungal infections such as candidiasis, cryptococcosis and chromoblastomycosis ”. |
4. Omit item 60. |
| |
5. Omit item 66, substitute the following item:— | ||
“ 66 | ‘GLUCOSE | With the written authority of the Director-General— |
NUTRAMIGEN’ | Cows’ milk allergy in children who have not attained the age of 2 years | |
|
| Cystic fibrosis (mucoviscidosis) |
|
| Galactosaemia |
|
| Lactose intolerance ”. |
6. Omit items 68 and 69, substitute the following items:— | ||
“ 68 | Goats’ Milk, Dehydrated..... | With the written authority of the Director-General, cows’ milk allergy in children who have not attained the age of 2 years |
69 | Goats’ Milk, Whole (Sterilized) | With the written authority of the Director-General, cows’ milk allergy in children who have not attained the age of 2 years ”. |
7. After item 71, insert the following item:— | ||
“ 72 | Hydrochlorothiazide, B.P., with Amiloride Hydrochloride | Cardiac failure ”. |
8. Omit items 78, 79, 80, 81 and 82, substitute the following items:— | ||
“ 78 | Influenza Vaccine.......... | For prophylaxis of— |
|
| pensioners |
|
| persons suffering from any severe debilitating disease, chronic heart disease or chronic pulmonary disease |
82 | ‘ISOMIL’............... | With the written authority of the Director-General— |
|
| Cows’ milk allergy in children who have not attained the age of 2 years |
|
| Galactosaemia |
|
| Homocystinuria |
|
| Lactose intolerance ”. |
9. Omit item 86 and substitute the following item:— | ||
“ 86 | (1) Levodopa Capsules, B.P. | Treatment of Parkinson’s Disease ”. |
| (2) Levodopa Tablets, B.P. |
|
10. After item 97, insert the following items:— | ||
“ 97a | (1) Metformin Hydrochloride, B.P. | With the written authority of the Director-General, maturity onset diabetes in patients who have not attained the age of 65 years in whom the risk of lactic acidosis is negligible, where the illness has not been satisfactorily controlled by diet and other drugs |
| (2) Metformin Tablets, B.P. | |
97b | (1) Methadone Injection, B.P. | Disabling pain associated with malignant neoplasia or self-limiting disorders of short duration where the patient has not responded to non-narcotic analgesics ”. |
| (2) Methadone Tablets, B.P. | |
Schedule 4—continued
11. After item 127, insert the following item:— | ||
“ 127a | (1) Phenformin Hydrochloride, B.P. | With the written authority of the Director-General, maturity onset diabetes in patients who have not attained the age of 65 years in whom the risk of lactic acidosis is negligible, where the illness has not been satisfactorily controlled by diet or other drugs”. |
| (2) Phenformin Tablets, B.P. | |
12. After item 128, insert the following items:— | ||
“ 128a | Pindolol Injection............ | Dissecting aneurysm (aortic) |
|
| 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 |
128b | Pindolol Tablets............. | 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 ”. |
13. Omit items 138 and 139. | ||
14. Omit item 142 and substitute the following item:— | ||
“ 142 | ‘PROSOBEE............... | With the written authority of the Director-General— |
|
| Cows’ milk allergy in children who have not attained the age of 2 years |
|
| Galactosaemia |
|
| Homocystinuria |
|
| Lactose intolerance ”. |
15. Omit item 146 and substitute the following item:— | ||
“ 146 | ‘SOBEE................... | With the written authority of the Director-General— |
|
| Cows’ milk allergy in children who have not attained the age of 2 years |
|
| Galactosaemia |
|
| Homocystinuria |
|
| Lactose intolerance ”. |
16. Omit item 149, substitute the following item:— | ||
“ 149 | ‘SOYALAC’............... | With the written authority of the Director-General— |
|
| Cows’ milk allergy in children who have not attained the age of 2 years |
|
| Galactosaemia |
|
| Homocystinuria |
|
| Lactose intolerance ”. |
17. Omit item 156, substitute the following items:— | ||
“ 156 | (1) Testosterone Enanthate | Carcinoma of the breast |
| (2) Testosterone Propionate Injection, B.P. | Hypogonadism |
| Klinefelter’s syndrome (seminiferous tubule dysgenesis) | |
156a | (1) Testosterone Propionate, B.P., with Testosterone Phenylpropionate, B.P. and Testosterone Isocaproate | Carcinoma of the breast |
| Gigantism | |
| Hypogonadism | |
| Klinefelter’s syndrome (seminiferous tubule dysgenesis) ”. | |
| (2) Testosterone Propionate, B.P., with Testosterone Phenylpropionate, B.P., Testosterone Isocaproate and Testosterone Decanoate |
|
SCHEDULE 5 Regulation 6
Provision | Amendment |
Regulation 2................ | Omit “ the first day of March,”, substitute “ 1 March ”. |
Sub-regulation 4 (3)........... | Omit “ of this regulation ”. |
Sub-regulation 5 (1)........... | Omit from the definition of “ the Act ” the figures “ —1959 ” |
Sub-regulation 5 (3)........... | Omit. |
Sub-regulation 6 (1)........... | Omit “ the Sixth Schedule ”, substitute “ Schedule 6 ”. |
Sub-regulation 6 (2)........... | Omit “ the Sixth Schedule ”, substitute “ Schedule 6 ”. |
Sub-regulation 7 (1)........... | Omit “ Director-General ”, substitute “ Permanent Head ”. |
Sub-regulation 7 (3)........... | Omit “ Director-General ”, substitute “ Permanent Head ”. |
Sub-regulation 7 (4)........... | Omit “ Director-General ”, substitute “ Permanent Head ”. |
| Omit. “ Commonwealth Department of Health ”, substitute “ Department ”. |
Regulation 8................ | Omit “ Director-General ”, substitute “ Permanent Head ”. |
Regulation 9................ | Omit “ One hundred dollars ”, substitute “ $100 ”. |
Sub-regulation 10 (1).......... | Omit “ the First Schedule ”, substitute “ Schedule 1 ”. |
Sub-regulation 10 (2).......... | Omit “ the First Schedule ”, substitute “ Schedule 1 ”. |
| Omit “ the Third Schedule ”, substitute “ Schedule 3 ”. |
Sub-regulation 10 (3).......... | Omit “ the second column of the Second Schedule ”, substitute “ column 2 of Schedule 2 ”. |
| Omit “ the third column ”, substitute “ column 3 ”. |
Sub-regulation 10 (4).......... | Omit “ the second column of the Second Schedule ”, substitute “ column 2 of Schedule 2 ”. |
Regulation 11............... | Omit “ the Third Schedule ”, substitute “ Schedule 3 ”. |
Regulation 12............... | Omit “ the Fourth Schedule ”, substitute “ Schedule 4 ”. |
| Omit “ (d) of sub-section (2) of section 85 ”, substitute “ 85 (2) (d) ”. |
Sub-regulation 13 (1).......... | Omit “ (a) of sub-section (5) of section 85 ”, substitute “ 85 (5) (a) ”. |
Sub-regulation 13 (2).......... | Omit “ the last preceding sub-regulation ”, substitute “ sub-regulation (1) ”. |
Sub-regulation 14 (1).......... | Omit “ the Fifth Schedule ”, substitute “ Schedule 5 ”. |
Sub-regulation 14 (2).......... | Omit “ the Fifth Schedule ”, substitute “ Schedule 5 ”. |
| Omit “ Director-General ” (wherever occurring), substitute “ Permanent Head ”. |
Sub-regulation 14 (3).......... | Omit “ Director-General ”, substitute “ Permanent Head ”. |
| Omit “ the last preceding sub-regulation ”, substitute “ sub-regulation (2) ”. |
Sub-regulation 14 (4).......... | Omit “ Director-General ” (wherever occurring), substitute “ Permanent Head ”. |
| Omit “ (a) of sub-section (5) of section 85 ”, substitute “ 85 (5) (a) ”. |
Schedule 5—continued
Provision | Amendment |
Sub-regulation 14 (5).......... | Omit “ two ”, substitute “ 2 ”. |
| Omit “ the second column of the Fifth Schedule ”, substitute “ column 2 of Schedule 5 ”. |
| Omit “ the third column ”, substitute “ column 3 ”. |
Regulation 16............... | Omit “ Director-General ”, substitute “ Permanent Head ”, |
Regulation 17............... | Omit “ the last preceding regulation ”, substitute “ regulation 10 ”. |
| Omit “ Forty dollars ”, substitute “ 340 ”. |
Regulation 18............... | Omit “ of these Regulations ”. |
Sub-regulation 18a (1)......... | Omit “ of these Regulations ”. |
Sub-regulation 18a (2)......... | Omit “ Director-General ” (wherever occurring), substitute “ Permanent Head ”. |
Sub-regulation 18a (3)......... | Omit “ the last preceding sub-regulation ”, substitute “ sub-regulation (2) ”. |
| Omit “ Twenty dollars ”, substitute “ $20 ”. |
Sub-regulation 18a (4)......... | Omit “ of this regulation ”. |
| Omit “ Director-General ” (wherever occurring), substitute “ Permanent Head ”. |
| Omit “ of these Regulations ”. |
Sub-regulation 19 (1).......... | Omit “ of these Regulations ” (wherever occurring). |
| Omit from paragraph (a) “ Director-General ”, substitute “ Permanent Head ”. |
| Omit from paragraph (d) “ the next succeeding regulation ”, substitute “ regulation 20 ”. |
| Omit from paragraph (h) “ the Fifth Schedule ”, substitute “ Schedule 5 ”. |
Sub-regulation 19 (1a)......... | Omit “ of these Regulations ”. |
| Omit “ the last preceding sub-regulation ”, substitute “ sub-regulation (1) ”. |
| Omit “ (b) of that sub-regulation ”, substitute “ (1) (b) ”. |
Sub-regulation 19 (2).......... | Omit “ of this regulation, ”. |
Sub-regulation 20 (1).......... | Omit from paragraph (a) “ of these Regulations ”. |
| Omit from paragraph (c) “ of this sub-regulation ”. |
| Omit from paragraph (d) “ of this sub-regulation ”. |
Sub-regulation 20 (2) ......... | Omit “ the last preceding sub-regulation ”, substitute “ sub-regulation (1) ”. |
Sub-regulation 21 (1).......... | Omit “ of these Regulations ” (wherever occurring). |
| Omit “ the next succeeding regulation ”, substitute “ regulation 22 ”. |
| Omit from paragraph (c) “ six ”, substitute “ 6 ”. |
| Omit from sub-paragraph (i) of paragraph (d) “ (5) of section 85 ”, substitute “ 85 (5) ”. |
| Omit from paragraph (c) “ Director-General ” (wherever occurring), substitute “ Permanent Head ”. |
| Omit from paragraph (c) “ the Fifth Schedule ”, substitute “ Schedule 5 ”. |
Sub-regulation 21 (2).......... | Omit “ of these Regulations ”. |
| Omit from paragraph (e) “ six ”, substitute “ 6 ”. |
Sub-regulation 22 (2).......... | Omit “ the Fifth Schedule ”, substitute “ Schedule 5 ”. |
| Omit “ Director-General ” (wherever occurring), substitute “ Permanent Head ”. |
| Omit “ of these Regulations ”. |
Schedule 5—continued
Provision | Amendment |
Sub-regulation 22 (3).......... | Omit “ of these Regulations ”. |
| Omit “ twenty-four ”, substitute “ 24 ”. |
| Omit “ Twenty dollars ”, substitute “ $20 ”. |
Sub-regulation 22 (4).......... | Omit “ of this regulation ”. |
| Omit “ twenty-four ”, substitute “ 24 ”. |
| Omit “ Director-General ”, substitute “ Permanent Head ”. |
| Omit “ Twenty dollars ”, substitute “ $20 ”. |
Regulation 23............... | Omit “ of these Regulations ”. |
Regulation 24............... | Omit “ (5) of section 88 ”, substitute “ 88 (5) ”. |
Sub-regulation 26 (1).......... | Omit “ of these Regulations ” (wherever occurring). |
| Omit from paragraph (a) “ Director-General ”, substitute “ Permanent Head ”. |
| Omit from paragraph (c) “ the last preceding paragraph ”, substitute “ paragraph (b) ”. |
| Omit from paragraph (f) “ the last preceding paragraph ”, substitute “ paragraph (c) ”. |
| Omit “ Twenty dollars ”, substitute “ $20 ”. |
Sub-regulation 26 (2).......... | Omit from paragraph (c) “ of these Regulations ”. |
| Omit from paragraph (d) “ six ”, substitute “ 6 ”. |
Sub-regulation 27 (1).......... | Omit “ Director-General ”, substitute “ Permanent Head ”. |
Sub-regulation 27 (2).......... | Omit “ the next succeeding regulation ”, substitute “ regulation 28 ”. |
Sub-regulation 28 (2).......... | Omit “ the last preceding sub-regulation ”, substitute “ sub-regulation (1) ”. |
| Omit “ Twenty dollars ”, substitute “ $20 ”. |
Sub-regulation 31 (1).......... | Omit from paragraph (a) “ of these Regulations ”. |
| Omit from paragraph (b) “ of these Regulations ”. |
Sub-regulation 31 (1a)......... | Omit “ of this regulation ”. |
Sub regulation 31 (3).......... | Omit “ Twenty dollars ”, substitute “ $20 ”. |
Sub-regulation 32 (1).......... | Omit “ of these Regulations ” (wherever occurring). |
| Omit “ Twenty dollars ”, substitute “ $20 ”. |
Sub-regulation 32 (2).......... | Omit “ The last preceding sub-regulation ”, substitute “ Sub-regulation (1) ”. |
| Omit “ of these Regulations ”. |
Regulation 33............... | Omit “ Twenty dollars ”, substitute “ $20 ”. |
Regulation 34............... | Omit “ Director-General ”, substitute “ Permanent Head ”. |
Sub-regulation 35 (1).......... | Omit from paragraph (a) “ the Third Schedule ”, substitute “ Schedule 3 ”. |
| Omit from paragraph (a) “ —1959 ”. |
| Omit from paragraph (b) “ the Fourth Schedule ”, substitute “ Schedule 4 ”. |
Sub-regulation 35 (2).......... | Omit “ the next succeeding sub-regulation ”, substitute “ sub-regulation (2a) ”. |
Regulation 36............... | Omit “ —1959 ”. |
| Omit “ the last preceding regulation ”, substitute “ regulation 35 ”. |
Schedule 5—continued
Provision | Amendment |
Sub-regulation 37 (1).......... | Omit “ Director-General ” (wherever occurring), substitute “ Permanent Head ”. |
Sub-regulation 37 (2).......... | Omit “ the last preceding sub-regulation ”, substitute “ sub-regulation (1) ”. |
| Omit “ Twenty dollars ”, substitute “ $20 ”. |
Heading “ THE SCHEDULES ” preceding the First Schedule | Repeal. |
First Schedule............... | Omit “ FIRST SCHEDULE ”, substitute “ SCHEDULE 1 ”, |
Second Schedule............. | Omit “ SECOND SCHEDULE ”, substitute “ SCHEDULE 2 ”. |
| Omit “ First Column ”, substitute “ column 1 ”. |
| Omit “ Second Column ”, substitute “ column 2 ”. |
| Omit “ Third Column ”, substitute “ column 3 ”. |
Third Schedule.............. | Omit “ THIRD SCHEDULE ”, substitute “ SCHEDULE 3 ”. |
Fourth Schedule............. | Omit “ FOURTH SCHEDULE ” substitute “SCHEDULE 4 ”. |
Fifth Schedule.............. | Omit “ FIFTH SCHEDULE ”, substitute “SCHEDULE 5”. |
| Omit “ First Column ”, substitute “ column 1 ”. |
| Omit “ Second Column ”, substitute “ column 2 ”. |
| Omit “ Third Column ”, substitute “ column 3 ”. |
Sixth Schedule.............. | Omit “ SIXTH SCHEDULE ”, substitute “ SCHEDULE 6 ”. |
| Omit from Form A “ —1959 ” (wherever occurring). |
| Omit from Form B “ —1959 ” (wherever occurring). |
| Omit from Form B “ the first day of August, 1945 ”, substitute “ 1 August 1945 ”. |
| Omit from Form C “ —1959 ” (wherever occurring). |
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