Pharmaceutical Benefits Regulations (Amendment)

Legislation au C1950L00094 Regulations Not in force Legislative Instrument

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STATUTORY RULES.

1950. No. 94.

REGULATIONS UNDER THE PHARMACEUTICAL BENEFITS ACT 1947-1949.*

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 1947-1949.

Dated this thirtieth day of November, 1950.

W. J. McKELL

Governor-General.

By His Excellency's Command,

EARLE PAGE

Minister of State for Health.

AMENDMENTS OF THE PHARMACEUTICAL BENEFITS REGULATIONS.†

Supply of benefits upon prescriptions.

1. Regulation 12 of the Pharmaceutical Benefits Regulations is amended—

(a) by omitting from sub-paragraph (ii) of paragraph (c) of sub-regulation (2.) the words "specified, in relation to the pharmaceutical benefit, in column 2 of Table A in the Third Schedule to these Regulations ";

(b) by inserting in sub-regulation (2.), after paragraph (c), the following paragraph :—

 " (ca) the prescription indicates the name and address of the person for whom the pharmaceutical benefit is to be supplied; " ; and

(c) by omitting from sub-regulation (4.) the words " specified, in relation to the pharmaceutical benefit, in column 2 of Table A in the Third Schedule to these Regulations ".

Prescribing of certain drugs restricted.

2. Regulation 14 of the Pharmaceutical Benefits Regulations is amended—

(a) by omitting sub-regulation (1.) and inserting in its stead the following sub regulation : ─

" (1.) A medical practitioner shall not write on an authorized prescription form a prescription for the supply of a pharmaceutical benefit to which this regulation applies unless”—

(a) the Director-General or a delegate of the Director-General has given to him a numbered authority so to write the prescription; and

* Notified in the Commonwealth Gazette on 30th November, 1950.

† Statutory Rules 1950, No. 48, as amended by Statutory Rules 1950, Nos. 51, 55 and 62.

5894.—PRICE 5D.


(b) he refers, on the form, to that authority and its number." ; and

(b) by inserting in sub-regulation (2.), after the word " with ", the words " paragraph (b) of ".

Standards of purity.

3. Regulation 36 of the Pharmaceutical Benefits Regulations is repealed and the following regulation inserted in its stead :—

" 36. —(1.) A pharmaceutical benefit which is included in the British Pharmacopoeia shall conform to the standards of purity thereby required.

" (2.) A pharmaceutical benefit which is not included in the British Pharmacopoeia but is included in the British Pharmaceutical Codex shall conform to the standards of purity required by that Codex.".

Containers.

4. Regulation 37 of the Pharmaceutical Benefits Regulations is amended by omitting from sub-regulation (2.) the word and letter " Table B " and inserting in their stead the word and letter " Table A ".

Second Schedule.

5.—(1.) The Second Schedule to the Pharmaceutical Benefits Regulations is amended—

(a) by inserting after Item 32 the following Item :—

" 32A

DISTILLED WATER (Sterile)

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

2 cc. amp........

6

1

 

 

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

3 cc. amp.......

6

1

 

 

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

5 cc. amp.......

6

1

 

 

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

10 cc. amp......

6

1 " ;

(b) by omitting Item 65 and inserting in its stead the following Item :—

" 65

METHIONINE

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

50 G. bottle .....

1

..

 

 

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

0.25 G. tab.......

100

1

 

 

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

0.5 G. tab.......

100

1 " ;

(c) by inserting after Item 100 the following Item : —

" 100A

PROTOLEX

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

10 cc. amp.......

1

1

(d) by inserting after Item 124 the following Item :—

" 124A

sulphonamides mixed (c)

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

7 ½ gr. tab......

100

1 " ;

 

Sulphadiazine 26 ⅔%

 

 

 

and

 

Sulphamerazine 26 ⅔%

 

 

 

 

 

Sulphanilamide 23 ⅓%

 

 

 

 

 

Sulphathiazole 23 ⅓%

 

 

 

 

(e) in accordance with the Schedule to these Regulations.

(2.) In the Schedule to these Regulations, " words " includes letters, figures and symbols.

Third Schedule.

6. The Third Schedule to the Pharmaceutical Benefits Regulations is amended-—

(a) by omitting paragraph 1 ;

(b) by omitting paragraph 3 and inserting in its stead the following paragraph :—

" 3.—(1.) Subject to this paragraph, the amount of the payment in respect of a pharmaceutical benefit supplied at a place in Zone 1 shall be the sum of the following amounts, as determined by the Director-General :—

(a) the wholesale cost, as at the first day of the month in which the supply took place, of the pharmaceutical benefit in the form and quantity in


which it was supplied and on the basis that it was supplied in or from the standard package, plus one-third of that cost ;

(b) where the number of units of the pharmaceutical benefit, as directed in the prescription to be supplied, was not the number, or a multiple of the number, contained in the standard package an amount, ascertained in the manner agreed on from time to time between the Commonwealth and the Federated Pharmaceutical Service Guild of Australia, as an allowance for wastage resulting from dividing the contents of the standard package and an amount for the supply of a container ascertained in accordance with Table A at the end of this Schedule ; and

(c) a dispensing fee-

(i) in the case of capsules, tablets and pills of fifteen pence ;

(ii) in the case of ampoules, vials and any other forms of fourteen pence.

" (2.) The amount of the payment in respect of a pharmaceutical benefit specified in any of items 58 to 61 (inclusive) in the Second Schedule to these Regulations supplied at a place in Zone 1 shall be the amount determined by the Director-General to be the retail price, as at the first day of the month in which the supply took place, of the pharmaceutical benefit in the form and quantity in which it was supplied.

" (3.) Where the prescription does not identify the form in which the pharmaceutical benefit is to be supplied by reference to a trade mark, brand or name used by a particular manufacturer, the pharmaceutical benefit shall, for the purposes of this paragraph, be deemed to have been supplied in a form in which the pharmaceutical benefit is available in the standard package, being a form in relation to which the wholesale cost of the standard package, as at the first day of the month in which the supply took place, was not higher than the wholesale cost, as at that date, of the standard package of the pharmaceutical benefit in any other form which was available to the supplier from a manufacturer.

" (4.) The amount of a payment under this paragraph shall be adjusted to the nearest penny, any odd half-penny being counted as one penny.

" (5.) In this paragraph, but subject to the next succeeding sub-paragraph, ' the standard package ', in relation to a pharmaceutical benefit, means—

(a) where there is supplied by one or more manufacturers of the pharmaceutical benefit package of the pharmaceutical benefit which


contains a number of units equal to the number specified in column 5 of the Second Schedule to these Regulations in relation to that pharmaceutical benefit a package containing that number of units ; or

(b) where such a package is not supplied by any manufacturer, but one or more manufacturers supply a package or packages containing a greater number of units than the number specified in column 5 of the Second Schedule to these Regulations in relation to the pharmaceutical benefit a package containing the least number of units contained in any of those packages ; and

(c) where the packages of the pharmaceutical benefit supplied by manufacturers all contain a lesser number of units than the number of units specified in relation to the pharmaceutical benefit in column 5 of the Second Schedule to these Regulations a package containing the greatest number of units contained in any of those packages.

" (6.) Where the prescription identifies the pharmaceutical benefit to be supplied by reference to a trade mark, brand or name used by a particular manufacturer, the standard package, for the purposes of this paragraph, shall be ascertained as if the pharmaceutical benefit were not supplied by any other manufacturer." ;

(c) by omitting all the words and figures from the beginning of paragraph 7 to the end of Table A ; and

(d) by omitting the heading " Table B " and inserting in its stead the heading " Table A ".

THE SCHEDULE.

Reg. 5.

AMENDMENTS TO SECOND SCHEDULE OF PRINCIPAL REGULATIONS.

Item No.

Amendments in Columns 3, 4, 5 and 6.

 

 

4

Before line 1 insert ─

 

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

2 min. cap..........

12

3 ”

7

After line 3 insert ─

 

1/100 gr. per cc............

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

1

 .. ”

18

Omit all words, insert ─

 

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

1,000 cc. bottle .....

1

..

 

 

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

500 cc. bottle .......

1

..

 

2 ½% ..................

500 cc. bottle .......

1

.. "

22

Add ─

 

 

8,000 M. per cc............

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

2

 .."

23

After line 3 insert ─

 

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

50 mg. amp ........

1

..

 

 

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

50 mg. crystule......

1

.."


THE SCHEDULEcontinued.

Amendments to second schedule of Principal Regulationscontinued.

Item No.

Amendments in Columns 3, 4, 5 and 6.

24

After line 2 insert—

 

 "

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

1/16 gr. hypo. tab.....

10

.. "

31

Add—

 

 "

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

3 cc. vial ..........

1

1 "

36

After line 1 insert—

 

 "

½ gr. per cc. ...........

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

6

1 "

 

After line 3 insert—

 

 "

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

½ gr. hypo. tab.......

20

1 "

57

After line 3 insert—

 

 "

1/100 gr. per cc. ........

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

1

.. "

64

After line 5 insert—

 

 "

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

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

1

1 "

 

Omit line 7

71

After line 4 insert—

 

 "

½ gr. per cc............

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

1

.. "

84

After line 1 insert—

 

 "

1 gr. per 4 cc...........

4 cc. amp. .........

6

.. "

89

After line 3 insert—

 

 "

10,000 M. per cc........

 5 cc. vial .........

1

..

 

 

20,000 M. per cc.........

 5 cc. vial .........

1

..

 

 

50,000 M. per cc.........

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

1

.. "

91

Omit from column 3 " 0.1 G. per cc. ”, insert " 0.1 G. per 2 cc."

95

After line 2 insert—

 

 "

0.3% ...............

20 cc. bottle .......

1

..

97

Omit all words, insert—

 

 "

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

300,000 U. amp. ....

6

..

 

 

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

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

6

..

 

 

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

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

6

..

 

 

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

900,000 U. amp. ....

6

..

 

 

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

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

6

.. "

98

Omit all words insert—

 

 "

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

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

6

..

 

 

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

1 cc. syrette ........

6

..

 

 

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

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

6

..

 

 

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

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

1

..

 

 

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

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

6

..

 

 

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

1 million U. amp.....

6

..

 

 

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

600,000 U. syrette....

6

..

 

 

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

300,000 U. syringe ...

6

..

 

 

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

600,000 U. syringe ...

6

.. "

107

Omit from column 5 figure " 2 " (wherever occurring), insert " 1 "  

Omit from column 6 figure " 1 " (wherever occurring), insert " 3 "  

 

108

Omit from column 5 figure " 2 " (wherever occurring), insert " 1 "  

 

Omit from column 6 figure " 1 " (wherever occurring), insert " 3 "  

109

After line 3 insert—

 

 "

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

20 cc. amp.........

6

1

 

 

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

50 cc. amp.........

3

1 "

121

Omit all words

 

 "

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

5 gr. enseal  ........

100

1

 

 

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

7½ gr. tab .........

100

1 "

123

After line 1 insert—

 

 "

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

0.33 G. tab.........

100

1 "

124

Omit all words, insert—

 

 "

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

0.25 G. troche ......

100

1

 

 

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

0.3 G. dulcet.......

100

1

 

 

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

0.5 G. tab..........

100

1 "

5894.─2

THE SCHEDULEcontinued.

Amendments to Second Schedule of Principal Regulationscontinued.

Item No.

Amendments in Columns 3, 4, 5 and 6.

 

 

 

 

 

 

128

After line 2 insert—

 

 "

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

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

6

.. "

 

After line 4 insert—

 

 

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

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

6

.. "

 

After line 5 insert—

 

 

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

2.34 gr. Tab. ..........

100

1 "

132

After last line add—

 

 

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

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

100

3 "

137

After line 3 add—

 

 

100 γ per cc...........

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

1

1 "

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

Overview

The Pharmaceutical Benefits Regulations 1950 were enacted to implement the provisions of the Pharmaceutical Benefits Act 1947-1949, which established a scheme to provide financial assistance for the cost of certain prescribed medicines in Australia. The regulations were made under the authority of the Governor-General in Council and were designed to ensure that the scheme operated efficiently and effectively. The policy objective of the regulations was to ensure that the Pharmaceutical Benefits Scheme provided access to affordable and high-quality medicines to all Australians, while also maintaining appropriate standards of safety and efficacy. The regulations covered a range of areas, including the supply of benefits upon prescriptions, the prescribing of certain drugs, standards of purity, and containers. The regulations were amended over time to reflect changes in the availability and use of medicines, as well as changes in the broader healthcare landscape.

Scope and Application

The Pharmaceutical Benefits Regulations 1950, made under the Pharmaceutical Benefits Act 1947-1949, apply to the supply of pharmaceutical benefits within the Commonwealth of Australia. These regulations govern the manner in which pharmaceutical benefits are supplied, prescribed, and the standards that must be met in terms of purity and packaging. They apply to medical practitioners, suppliers of pharmaceutical benefits, and patients who are to receive these benefits. The regulations also determine the geographic reach of the pharmaceutical benefits scheme by specifying how payments for these benefits are calculated and disbursed across different zones within Australia. Notably, these regulations exclude certain pharmaceuticals and procedures not listed in the British Pharmacopoeia or the British Pharmaceutical Codex. The application of these regulations can be further extended or restricted through subordinate instruments, which may include amendments to the schedules or the introduction of new standards and procedures.

Key Provisions

The key provisions of the Pharmaceutical Benefits Regulations 1950, under the Pharmaceutical Benefits Act 1947-1949, introduce significant amendments to the supply, prescription, standards, and payment schedules for pharmaceutical benefits. Regulation 12 has been amended to specify that a prescription must indicate the name and address of the person for whom the pharmaceutical benefit is to be supplied (sub-regulation 2(ca)). Additionally, Regulation 14 now mandates that a medical practitioner must not write a prescription for certain pharmaceutical benefits unless authorised by the Director-General or their delegate (sub-regulation 1). Regulation 36 has been replaced to stipulate that pharmaceutical benefits included in the British Pharmacopoeia must meet the standards of purity required therein, while those in the British Pharmaceutical Codex must conform to the standards of purity required by that Codex (sub-regulation 1). Regulation 37 has been amended to align container standards with Table A instead of Table B (sub-regulation 2). These regulations impose specific obligations on medical practitioners and pharmaceutical suppliers. Medical practitioners are required to obtain a numbered authority from the Director-General before prescribing certain pharmaceuticals, and they must reference this authority on the prescription form. Pharmaceutical suppliers must ensure that the drugs they supply meet the specified purity standards, as outlined in the British Pharmacopoeia or the British Pharmaceutical Codex. Furthermore, prescriptions must accurately identify the patient and the form of the pharmaceutical benefit to be supplied, ensuring traceability and accountability in the supply chain. Failure to comply with these regulations may result in significant legal consequences. While the specific offences and penalties are not detailed in the text, breaches of the Pharmaceutical Benefits Act and its regulations can typically lead to fines, imprisonment, or both. The exact penalties would depend on the severity and nature of the breach, as well as any additional provisions under the Act or related legislation. It is essential for practitioners and entities governed by these regulations to adhere strictly to the stipulated requirements to avoid any legal repercussions.

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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.