National Health (Pharmaceutical Benefits) Regulations (Amendment)

Legislation au C1954L00078 Regulations Not in force Legislative Instrument

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STATUTORY RULES

 

1954. No. .

 

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953.*

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.

Dated this  twenty-fourth

day of  June , 1954.

W. J. Slim

Governor-General.

By His Excellency’s Command,

SGD. EARLE PAGE.

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 July, 1954.

* Notified in the Commonwealth Gazette on , 1954.

† Statutory Rules 1954, No. 54, as amended by Statutory Rules 1954, No.

2797.—Price 3d.

First Schedule.

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

 

(a) by omitting item 13 and inserting in its stead the following item :—

 

 

 

“ 13

Benzhexol. Hydrochloride

2 mg....................

tablet ...................

LB, ST

100

1

 

 

5 mg. ...................

tablet ...................

LE, ST

100

1 ”;

(b) by omitting item 83 and inserting in its stead the following item :—

 

 

“ 83

Insulin, Injection OF...........

20 U. per cc. ..............

5 cc. vial ................

AH and BD, BW

3

12

 

 

20 U. per cc. ..............

10 cc. vial ................

AH and BD, BW, CS

3

12

 

 

40 U. per cc. ..............

5 cc. vial ................

AH and BD, BT, BW

3

12

 

 

40 U. per cc. ..............

10 cc. vial ................

AH and BD, BT, BW, CS

3

12

 

 

60 U. per cc. ..............

5 cc. vial ................

CS

3

12

 

 

80 U. per cc. ..............

5 cc. vial ................

AH and BD, BT, BW, CS

3

12

 

 

80 U. per cc.

10 cc. vial ................

AH and BD, BT, BW, CS

3

12

 

 

100 U. per cc. .............

5 cc. vial ................

CS

3

12 ”;

(c) by omitting item 88 and inserting in its stead the following item :—

 

 

“ 88

Insulin Protamine Zinc, Injection of.

40 U. per cc.

5 cc. vial ................

AH and BD, BT, BW

3

12

 

 

40 U. per cc. ..............

10 cc. vial ................

AH and BD, BT, BW, CS

3

12

 

 

80 U. per cc. ..............

5 cc. vial ................

AH and BD, BT, BW, CS

3

12

 

 

80 U. per cc. ..............

10 cc. vial ................

CS

3

12 ”;

(d) by omitting item 121 and inserting in its stead the following item :—

 

 

“ 121

Papaverine Hydrochloride.......

⅓ gr. per cc. ..............

1 cc. amp. ................

KL

6

..

 

 

1½ gr. per 5 cc. ............

5 cc. amp.................

AN

6

..

 

 

2 gr. per 10 cc. .............

10 cc. amp. ...............

DH, HA, KL

6

..

 

 

¾ gr. ...................

tablet ...................

AN, KL, QE, RT

25

1

 

 

l½ gr. ...................

tablet ...................

AN, DH, FA, HA, KL, QB, RT

25

1 ”;

(e) by omitting items 125, 126 and 127 and inserting in their stead the following items :—

 

“ 125

Penicillin, Injection of..........

5,000 U. .................

amp. ...................

CS

6

..

 

 

15,000 U. ................

amp....................

CS

6

..

 

 

100,000 U. ...............

amp....................

AH, BD, BT, CS, EV, GL, IC, SI

6

..

 

 

200,000 U. ...............

amp. ...................

AH, BD, BT, CS, EV, GL, IC, SI

6

...


“ 125

Penicillin, Injection of

500,000 U. ...............

amp. ...................

AH, BD, BT, CS, DH, BV,

3

..

contd.

continued..................

 

 

GL, IC, SI

 

 

 

 

1,000,000 U. ..............

amp. ...................

AH, BD, BT, CS, DH, BV, GL, IC, SI

1

..

 

 

1,500,000 U. ..............

amp. ...................

GL

1

..

“ 126

Penicillin, Procaine, Aqueous

300,000 U.

amp. ...................

BT

3

..

 

Suspension of..............

400,000 U. ...............

vial ....................

DH, PA

3

..

 

 

600,000 U. ...............

vial ....................

BT, DH

2

..

 

 

900,000 U. ...............

vial ....................

CS, DH, SI

2

..

 

 

1,000,000 U.

vial ....................

DH, PA

1

..

 

 

1,500,000 U. ..............

vial ....................

CS, DH, PA, GL, SI

1

..

“ 127

Penicillin, Procaine (Crystalline), Injection of 

300,000 U. ...............

amp. ...................

AH, BD, BT, BW, CS, DH, EV, IC, MB, SI

3

..

 

 

400,000 U. ...............

amp. ...................

AH, BD, BT, BW, CS, BV, GL, IC, MB, SI

3

..

 

 

500,000 U. ...............

amp. ...................

CS

3

..

 

 

600,000 U. ...............

amp. ...................

DH

2

..

 

 

667,000 U. ...............

amp. ...................

CS

2

..

 

 

900,000 U. ...............

amp. ...................

AH, BD, BT, BW, CS, BV, IC, MB, SI

2

..

 

 

1,200,000 U. ..............

amp. ...................

AH, BD, BT, BW, CS, DH, EV, IC, MB, SI

1

..

 

 

1,500,000 U. ..............

amp. ...................

CS, DH, GL, SI

1

..”;

(f) by omitting item 135 and inserting in its stead the following item :—

 

 

 

“ 135

Phemitone .................

½ gr. ...................

tablet ...................

AS, BA, BT, PA, IC, QE, SI

100

1

 

 

1 gr. ...................

tablet ...................

AS, BA, IC, QE, SI

100

1

 

 

3gr. ....................

tablet ...................

AS, BA, BT, PA, IC, QE, SI

100

1 ”;

 

 

 

 

 

and

(g) by omitting item, 183 and inserting in its stead the following item :—

 

 

“ 183

Theophylline with Ethylene......

0.366 G. per 10 mil...........

10 mil. amp. ..............

AB

6

..

 

diamine.................

0.732 G. per 2 mil...........

2 mil. amp. ...............

AB

6

..

 

 

0.48 G. per 2 mil............

2 mil. I.M. amp. ............

DH, HA

6

..

 

 

0.5 G. per 2 mil.............

2 mil. I.M. amp. ............

AH, BW, CM

6

..

 

 

0.24 G. per 10 mil...........

10 mil. I.V. amp. ...........

DH, HA

6

..


“ 183

Theophylline with ethylene-

0.25 G. per 10 mil...........

10 mil. I.V. amp. ...........

AH, BW, CM

6

..

contd.

Diaminecontinued...........

1½ gr. ..................

tablet ...................

BT, BW, CM, DH, FA, HA, HY, KL, QE, RT, SI, SM

100

1

 

 

2.34 gr. .................

tablet ...................

AB

100

1 ”.

Second Schedule.

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

(a) by omitting item 13 and inserting in its stead the following item :—

“ 13

Isoniazid ..................

50 mg...........

tablet.......

AN, DH, HA, HT, HY, KL, MB, NS, QE, RO, SC, SI

100

1

Tuberculosis ”; and

 

 

100 mg..........

tablet.......

MB, RO

100

1

 

 

(b) by omitting item 33 and inserting in its stead the following item :—

 

 

 

“ 33

Vitamin B12, Injection of.......

10γ per cc........

1 cc. amp.....

BD, DH

12

1

Established megalocytic anaemias ”.

 

 

15γ per cc........

1 cc. amp.....

PD

12

1

 

 

 

 

20γ per cc........

1 cc. amp.....

AH, AN, BD, BL, BT, BW, CK, CM, DH, EV, GL, IC, KL, NS, SI, ST, VM

12

1

 

 

 

50γ per cc........

1 cc. amp.....

AH, BD, BL, BT, BW, CK, DH, EV, GL, IC, NS, VM

6

1

 

 

 

100γ per cc. ......

1 cc. amp.....

AH, AN, BD, BL, BT, BW, CK, CM, DH, EV, GL, IC, KL, PD, SI, VM

1

1

 

 

 

100γ per cc.......

10 cc. vial....

CM

1

..

 

 

 

200γ per cc.......

1 cc. amp.....

BT

1

..

 

 

 

l,000γ per cc.......

1 cc. amp.....

AN, CM, DH, GL, KL

1

..

 

 

 

l,000γ per cc.......

10 cc. vial....

CM

1

..

 

Third schedule.

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

(a) by inserting after item 128 the following items :—

“ 128a

Tabellae Aminophyllinae gr. 1½ cum Phenobarbitoni gr. ½

“ 128b

Tabellae Ephedrinae gr. ½ cum Phenobarbitoni gr. ¼ ”;

(b) by inserting after item 132 the following item :—

“ 132a

Tabellae Potassii Bromidi ”; and

(c) by inserting after item 133 the following item :—

“ 133a

Tabellae Sodii Pentobarbitoni ”.

By Authority : L. F Johnston, Commonwealth Government Printer, Canberra.

Overview

The Statutory Rules 1954 No. 54, which are Regulations under the National Health Act 1953, were enacted to amend the National Health (Pharmaceutical Benefits) Regulations, reflecting the evolving medical needs and treatments available in 1954. These Regulations were made by the Governor-General in Council, acting on the advice of the Federal Executive Council, and came into effect on the first day of July 1954. This legislative instrument aims to update the list of pharmaceutical benefits provided under the Act by including new medications and dosages that were not previously covered, ensuring that the benefits remain relevant and comprehensive. The amendments address the problem of outdated pharmaceutical listings by incorporating the latest therapeutic options available at the time, thereby enhancing the accessibility and effectiveness of healthcare services provided under the National Health Act.

Scope and Application

The Regulations under the National Health Act 1953 primarily apply to pharmaceutical products listed for inclusion in the Pharmaceutical Benefits Scheme (PBS). These Regulations outline specific pharmaceutical items, their forms, strengths, and relevant codes for reimbursement purposes. The scope of these Regulations extends to the inclusion and exclusion of certain drugs from the PBS, impacting healthcare providers and patients who rely on these medications. The geographic reach of these Regulations is national, as they pertain to the Commonwealth of Australia, ensuring consistency in the provision of pharmaceutical benefits across all states and territories. The Regulations do not explicitly state any exclusions, exemptions, or thresholds beyond the listed items and their respective details. The application of these Regulations may be further extended or refined through subordinate instruments, which would provide additional details or modifications to the listed pharmaceutical benefits.

Key Provisions

These Regulations, which come into effect on 1 July 1954, amend the National Health (Pharmaceutical Benefits) Regulations under the National Health Act 1953. Specifically, they revise the First Schedule to update the listings for certain pharmaceutical products, including Benzhexol Hydrochloride, Insulin, Insulin Protamine Zinc, Papaverine Hydrochloride, Penicillin, Penicillin Procaine Aqueous Suspension, Penicillin Procaine (Crystalline), Phemitone, and Theophylline with Ethylene Diamine. Additionally, the Regulations update the Second Schedule to include revised listings for Isoniazid and Vitamin B12. The Third Schedule is also amended to include new items such as Tabellae Aminophyllinae, Tabellae Ephedrinae, Tabellae Potassii Bromidi, and Tabellae Sodii Pentobarbitoni. The Regulations impose obligations on pharmaceutical manufacturers, suppliers, and distributors to ensure that the products they provide are listed in the amended schedules and comply with the specified dosages and formulations. Healthcare providers and pharmacists must adhere to the updated listings when prescribing and dispensing these medications to ensure they are covered under the National Health (Pharmaceutical Benefits) scheme. There are no specific offences, penalties, or civil/criminal consequences outlined in these Regulations for breaches related to the amendments. However, non-compliance with the National Health Act 1953 or any related regulations could potentially lead to enforcement actions, fines, or other penalties as prescribed by the overarching legislation. It is essential for all parties governed by these Regulations to ensure adherence to the updated listings and compliance with the National Health Act to avoid any potential legal repercussions.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Regulation
Concepts
Commencement Provisions
Reporting & Disclosure Obligations
Licensing & Registration
Regulatory Standards
Catchwords
Pharmaceutical Benefits

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