Pharmaceutical Benefits Regulations (Amendment)

Legislation au C1954L00020 Regulations Not in force Legislative Instrument

Legislation content

STATUTORY RULES.

1954. No. 20.

 

REGULATIONS UNDER THE PHARMACEUTICAL BENEFITS ACT 1947-1952.*

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 Pharmaceutical Benefits Act 1947-1952.

Dated this fifth day of March, 1954.

W. J. Slim

Governor-General.

By His Excellency’s Command,

Minister of State for Health.

 

Amendments of the Pharmaceutical Benefits Regulations.†

Second Schedule.

1. The Second Schedule to the Pharmaceutical Benefits Regulations is amended in accordance with the First Schedule to these Regulations.

Third Schedule.

2. The Third Schedule to the Pharmaceutical Benefits Regulations is amended in accordance with the Second Schedule to these Regulations.

Amendments of Second Schedule not to apply in certain cases.

3. Notwithstanding the amendments of the Pharmaceutical Benefits Regulations effected by regulation 1 of these Regulations, the provisions of the Pharmaceutical Benefits Regulations as in force immediately before the date of commencement of these Regulations shall, subject to paragraph (b) of the next succeeding regulation, continue to apply in relation to the supply of pharmaceutical benefits upon presentation, whether before or after that date, of prescriptions written before that date.

Application of amendments of Third Schedule.

4. The amendments effected by regulation 2 of these Regulations shall have effect with respect to—

(a) pharmaceutical benefits supplied on presentation of prescriptions written on or after the first day of February, 1954; and

(b) where, in the case of prescriptions written before that date, pharmaceutical benefits are supplied on presentation of those prescriptions for a second or subsequent time on or after that date—pharmaceutical benefits so supplied.

* Notified in the Commonwealth Gazette on , 1954.

† Statutory Rules 1950, No. 48, as amended by Statutory Rules 1950, Nos. 51, 55, 62 and 94; 1951, Nos. 15, 89 and 135; 1952, No. 22; and 1953, Nos. 40, 57, 78 and 100.

265.—Price 5d. 9/26.1.1954.


Amendment of Statutory Rules 1953, No. 78.

5. Regulation 2 of Statutory Rules 1953, No. 78 is amended by omitting the words “clause (c) of sub-paragraph (1.)” and inserting in their stead the words “paragraph (b) of sub-paragraph (1.)”.

 

THE SCHEDULES.

First Schedule.

Regulation 1.

AMENDMENTS OF THE SECOND SCHEDULE TO THE PHARMACEUTICAL BENEFITS REGULATIONS.

1. Insert after item 30 the following item:—

“30a

Chloramphenicol Palmitate

0.125 G. per 4 cc.

60 cc. bottle.....

1

..”.

2. Omit item 40, insert in its stead the following item:—

“40

Dextrose, aqueous injection of

5%...........

1 litre bottle.....

6

1

10%..........

1 litre bottle.....

2

1

20%..........

1 litre bottle.....

2

1

25%..........

1 litre bottle.....

2

1

50%..........

25 cc. amp.......

6

1

50%..........

50 cc. amp.......

6

1”.

3. Insert after item 42 the following item:—

“42a

Dienoestrol...........

.............

5 mg. tab........

100

1

.............

10 mg. tab.......

100

1”.

4. Omit item 46, insert in its stead the following item:—

“46

Digitalis.............

.............

½ gr. tab........

100

1

.............

1 gr. tab........

100

1”.

5. Insert after item 57 the following item:—

“57a

Diphtheria, Pertussis and Tetanus Antigen

.............

1 cc. amp.......

3

..

.............

5 cc. amp.......

1

..

.............

10 cc. vial......

1

..”.

6. Insert after item 59 the following item:—

“59a

Diphtheria Toxoid Purified (diluted for skin test only)

.............

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

1

..”.

7. Omit item 66, insert in its stead the following item:—

“66

Ergometrine Maleate

0.2 mg. per cc.

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

6

..

0.5 mg. per cc.

1 cc. I.M. amp.....

6

..

0.125 mg. per cc.

1 cc. I.V. amp.....

6

..

.............

0.2 mg. tab.......

25

..

.............

0.5 mg. tab.......

25

..”.

8. Omit item 69, insert in its stead the following item:—

“69

Ergotoxine Ethanesulphonate

.............

0.5 mg. tab......

25

..”.

9. Omit item 80, insert in its stead the following items:—

“80

Glyceryl Trinitrate

.............

1/100 gr. hypo. tab..

50

1

.............

1/200 gr. tab......

50

1

.............

1/150 gr. tab......

50

1

.............

1/130 gr. tab......

50

1

.............

1/100 gr. tab......

50

1

.............

1/65 gr. tab.......

50

1

.............

1/50 gr. tab.......

50

1


The Schedules—continued.

“80a

Hartmann’s Solution

.............

1 litre bottle.....

2

1

“80b

Hartmann’s Solution with Dextrose

5%............

1 litre bottle.....

2

1

10%..........

1 litre bottle.....

2

1”.

 

 

 

10. Insert after item 91 the following item:—

“91a

Insulin, Isophane, Injection of

40 U. per cc......

5 cc. vial.......

3

12

40 U. per cc......

10 cc. vial......

3

12

80 U. per cc......

10 cc. vial......

3

12”.

11. Omit item 94, insert in its stead the following item:—

 

 

“94

Isoniazid.......

.............

50 mg. tab.......

100

1”.

12. Omit item 101, insert in its stead the following item:—

“101

Liver Extract, Injection of

2 U.S.P. U. per cc.

1 cc. amp.......

6

1

2 U.S.P. U. per cc.

10 cc. vial......

6

1

5 U.S.P. U. per cc.

2 cc. vial.......

6

1

5 U.S.P. U. per cc.

10 cc. vial......

1

1

5 U.S.P. U. per cc.

20 cc. vial......

1

1

10 U.S.P. U. per cc.

10 cc. vial......

1

1

15 U.S.P. U. per cc.

5 cc. vial.......

1

1”.

13. Omit item 107, insert in its stead the following item:—

“107

Mercuramide with Theophylline, Injection of

.............

1 cc. amp.......

10

..

.............

2 cc. amp.......

10

..”.

14. Insert after item 133 the following item:—

“133a

Pancreatin............

.............

5 gr. tab........

100

..”.

15. Insert after item 136 the following item:—

“136a

Paramethadione........

.............

0.3 G. cap.......

100

2”.

16. Omit items 139, 140 and 141, insert in their stead the following items:—

“139

Penicillin, Injection of

.............

5,000 U. amp.

6

..

.............

15,000 U. amp.

6

..

.............

100,000 U. amp.

6

..

.............

200,000 U. amp.

6

..

.............

500,000 U. amp.

6

..

.............

1,000,000 U. amp.

6

..

.............

2,000,000 U. amp.

6

..

“140

Penicillin, Procaine, Aqueous Suspension of

.............

300,000 U. vial

6

..

.............

400,000 U. vial

6

..

.............

600,000 U. vial

6

..

.............

900,000 U. vial

6

..

.............

1,000,000 U. vial

6

..

.............

3,000,000 U. vial

6

..

400,000 U. per cc.

10 cc. vial.......

6

..


The Schedules—continued.

“141

Penicillin, Procaine (Crystalline), Injection of

.............

300,000 U. amp.

6

..

.............

400,000 U. amp.

6

..

.............

500,000 U. amp.

6

..

.............

600,000 U. amp.

6

..

.............

667,000 U. amp.

6

..

.............

900,000 U. amp.

6

..

.............

1,200,000 U. amp.

6

..

.............

1,500,000 U. amp.

6

..

.............

2,000,000 U. amp.

6

..

.............

3,000,000 U. amp.

6

..

.............

4,000,000 U. amp.

6

..”.

17. Omit item 146, insert in its stead the following item:—

“146

Pertussis Vaccine (Phase 1)

1,000 M. per cc.

1 cc. amp.......

3

1

5,000 M. per cc.

1 cc. amp.......

3

1

5,000 M. per cc.

10 cc. vial......

1

..

10,000 M. per cc.

1 cc. amp.......

3

1

10,000 M. per cc.

10 cc. vial......

1

..

20,000 M. per cc.

1 cc. amp. ......

3

1

20,000 M. per cc.

10 cc. vial......

1

..

50,000 M. per cc.

5 cc. vial.......

1

..

60,000 M. per 1.5 cc.

1.5 cc. vial......

1

..

.............

set of 3 amps. containing 50,000 M. per set

1

..”.

18. Insert after item 152 the following item:—

“152a

Phenylindanedione......

.............

50 mg. tab.......

50

..”.

19. Omit item 155, insert in its stead the following item:—

“155

Phthalylsulphathiazole

.............

0.5 G. tab.......

100

1”.

20. Insert after item 160 the following item:—

“160a

Primidone............

.............

0.25 G. tab......

100

2”.

21. Omit item 162, insert in its stead the following items:—

“161a

Procyclidine Hydrochloride

.............

5 mg. tab.......

100

1

“162

Progesterone, Injection of

.............

5 mg. amp.......

6

..

.............

10 mg. amp......

6

..

.............

20 mg. I.V. amp...

3

..”.

22. Omit item 184, insert in its stead the following item:—

“184

Stilboestrol...........

.............

1 mg. amp.......

6

..

.............

5 mg. amp.......

6

..

.............

1 mg. tab........

100

1

.............

5 mg. tab........

100

1

.............

10 mg. tab.......

100

1”.


The Schedules—continued.

23. Omit items 186, 187, 188 and 189, insert in their stead the following items:—

“186

Succinylsulphathiazole...

.............

0.5 G. tab.......

100

1

“187

Sulphacetamide........

.............

0.5 G. tab.......

50

..

“188

Sulphadiazine.........

.............

0.3 G. tab.......

50

..

.............

0.5 G. tab.......

50

..

“189

Sulphadimidine........

.............

0.25 G. tab.......

50

..

.............

0.5 G. tab.......

50

..”.

24. Omit items 191 and 192, insert in their stead the following items:—

“191

Sulphaguanidine.......

.............

0.5 G. tab.......

100

1

“192

Sulphamerazine........

.............

0.5 G. tab.......

50

..”.

25. Insert after item 193 the following item:—

“193a

Sulphapyridine........

.............

0.125 G. tab......

50

..

.............

0.5 G. tab.......

50

..”.

26. Omit item 195, insert in its stead the following item:—

“195

Sulphathiazole.........

.............

0.3 G. cap.......

50

..

.............

0.5 G. tab.......

50

..”.

27. Insert after item 201 the following items:—

“201a

Terramycin Oral Suspension

0.25 G. per 5 cc.

1 fl. oz. bottle

1

..

“201b

Testosterone..........

.............

100 mg. implant

1

..

.............

150 mg. implant

1

..

.............

200 mg. implant

1

..”.

28. Omit item 203, insert in its stead the following items:—

“202a

Testosterone Oenanthate, Injection of

250 mg. per cc....

1 cc. amp.......

1

..

“202b

Testosterone Phenyl Propionate, Injection of

50 mg. per cc.....

1 cc. amp.......

3

..

50 mg. per cc.....

5 cc. vial.......

1

..

“203

Testosterone Propionate, Injection of

25 mg. per cc.....

1 cc. amp.......

12

..

50 mg. per cc.....

1 cc. amp.......

12

..

50 mg. per cc.....

10 cc. vial......

1

..

100 mg. per 2 mil..

2 mil. amp.......

1

..

..............

100 mg. implant

1

..”.

29. Omit item 215, insert in its stead the following item:—

“215

Vitamin B 12, Injection of

10 γ per cc.......

1 cc. amp.......

12

1

15 γ per cc.......

1 cc. amp.......

12

1

20 γ per cc.......

1 cc. amp.......

12

1

50 γ per cc.......

1 cc. amp.......

6

1

100 γ per cc......

1 cc. amp.......

1

1

1,000 γ per cc.....

1 cc. amp.......

1

..

1,000 γ per cc.....

10 cc. vial.......

1

..”.

30. Omit item 218, insert in its stead the following item:—

“218

Vitamin K (Oral).......

.............

1 mg. cap.......

100

1

.............

4 mg. cap.......

100

1

.............

1 mg. tab.........

100

1

.............

4.8 mg. tab.......

100

1

.............

5 mg. tab........

100

1

.............

10 mg. tab.......

100

1”.


The Schedules—continued.

Second Schedule.

Regulation 2.

AMENDMENTS OF THE THIRD SCHEDULE TO THE PHARMACEUTICAL BENEFITS REGULATIONS.

1. Omit paragraph (c) of sub-paragraph (1.) of paragraph 3, insert in its stead the following paragraph:—

“(c) a dispensing fee of Eighteen pence.”.

2. Insert after paragraph 6 the following paragraph:—

“7. Where an approved pharmaceutical chemist who supplies a pharmaceutical benefit issues a repeat authorization for the further supply of that pharmaceutical benefit under sub-regulation (4.) of regulation 17 of these Regulations, the amount of payment which would otherwise be payable in respect of that pharmaceutical benefit shall be increased by Fourpence.”.

 

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

Overview

The Pharmaceutical Benefits Act 1947-1952 was enacted to provide for the supply of certain pharmaceutical benefits to the public under the control of the Commonwealth. These regulations, introduced by the Governor-General in Council, amend the existing Pharmaceutical Benefits Regulations to reflect changes in the approved list of pharmaceutical benefits. The amendments include additions and substitutions of new pharmaceutical items, updates to dosages and packaging, and adjustments to pricing schedules. The regulations also specify that certain amendments will only apply to prescriptions written after a specific date, ensuring continuity of supply for prescriptions written before the amendment's commencement. This legislative instrument aims to maintain and improve the accessibility and affordability of essential medications under the Pharmaceutical Benefits Scheme.

Scope and Application

The Pharmaceutical Benefits Regulations 1954, under the Pharmaceutical Benefits Act 1947-1952, primarily apply to the supply of pharmaceutical benefits, which include medicines listed on the Pharmaceutical Benefits Scheme (PBS) in Australia. These regulations govern the listing of pharmaceutical products eligible for subsidy, the prices at which these products can be supplied, and the administration of the scheme, including the payment of dispensing fees. The regulations extend to all entities involved in the supply of PBS-listed medicines, including pharmacists, medical practitioners, and suppliers. They have a national jurisdictional reach, applying across the Commonwealth of Australia. Certain amendments to the regulations do not apply retroactively to prescriptions written before the date of the regulations' commencement, ensuring a smooth transition for ongoing treatments. Additionally, the regulations can be further extended or modified through subordinate instruments, allowing for adjustments to the list of PBS-listed items or changes in pricing structures to accommodate new medical evidence or market conditions.

Key Provisions

The main operative sections of the Pharmaceutical Benefits Regulations, as amended by these Regulations, involve the updates to the Second and Third Schedules. Regulation 1 amends the Second Schedule to include new pharmaceutical items, modify existing ones, and omit certain items. This schedule lists the pharmaceutical benefits that are eligible for subsidy under the Pharmaceutical Benefits Scheme, along with their respective costs. Regulation 2 amends the Third Schedule, which pertains to the fees and charges associated with the supply of pharmaceutical benefits. Specifically, it updates the dispensing fee and introduces an additional charge for issuing a repeat authorization for further supply of a pharmaceutical benefit. The Regulations impose several obligations and requirements on the parties involved, particularly on approved pharmaceutical chemists who supply pharmaceutical benefits. They must adhere to the updated schedules regarding the list of eligible pharmaceutical benefits and associated costs. Additionally, they are required to charge the specified dispensing fee and any additional fees for issuing repeat authorizations as outlined in the Third Schedule. Compliance with these updated schedules is critical to ensure that the Pharmaceutical Benefits Scheme operates correctly and that the costs associated with the supply of pharmaceutical benefits are accurately reflected. Failure to comply with these Regulations can result in various consequences. Although the document does not specify the exact penalties or legal consequences for non-compliance, breaches of regulations under the Pharmaceutical Benefits Act 1947-1952 can typically lead to enforcement actions by the relevant authorities. These may include fines, legal proceedings, or other administrative penalties. The precise penalties would depend on the nature and severity of the breach, as well as any relevant legislative provisions that may apply.

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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.