Pharmaceutical Benefits Regulations (Amendment)

Legislation au C1951L00089 Regulations Not in force Legislative Instrument

Legislation content

Statutory Rules 1951, No. 89.(g)

Supply of benefits upon prescriptions.

1. Regulation 12 of the Pharmaceutical Benefits Regulations is amended by omitting paragraphs (e) and (f) of sub-regulation (2.) and inserting in their stead the following paragraphs:—

“(e) the prescription does not prescribe more than two pharmaceutical benefits;

(f) the prescription does not prescribe anything which is not a pharmaceutical benefit; and

(g) the person obtaining the pharmaceutical benefit signs and dates a receipt for it on the back of the prescription form.”.

2. After regulation 12a of the Pharmaceutical Benefits Regulations the following regulation is inserted:—

Prescribing of certain benefits.

“12aa.—(1.) Where a prescription prescribes a pharmaceutical benefit to which this regulation applies in one form but in two or more different strengths—

(a) for the purpose of paragraph (db) of sub-regulation (2.) of regulation 12 of these Regulations, that pharmaceutical benefit shall be deemed to be prescribed once only; and

(b) for the purpose of paragraph (e) of that sub-regulation, one pharmaceutical benefit only shall be deemed to be so prescribed.

(a) Made under the Pharmaceutical Benefit Act 1947-1950 on 31st August, 1951; notified in Gazette on 31st August, 1951.


“(2.) This regulation applies to pharmaceutical benefits being—

Aurothioglucose (Oily),

Calcium Aurothiomalate,

Pertussis Vaccine,

Sodium Aurothiomalate (Aqueous),

Sodium Aurothiomalate (Oily).”.

Prescriptions for dangerous drugs.

3. Regulation 12b of the Pharmaceutical Benefits Regulations is amended by omitting from sub-regulation (1.) the words “take possession of” and inserting in their stead the word “cancel”.

Repeal.

4. Regulation 13 of the Pharmaceutical Benefits Regulations is repealed.

5. Regulation 14 of the Pharmaceutical Benefits Regulations is repealed and the following regulations are inserted in its stead:—

Prescribing of certain drugs restricted.

“14.—(1.) The Minister may, by notice published in the Gazette, declare that a pharmaceutical benefit specified in the notice is a restricted pharmaceutical benefit.

“(2.) Subject to this regulation, a medical practitioner shall not write on an authorized prescription form a prescription for the supply of a restricted pharmaceutical benefit unless he writes on the prescription form, in relation to the prescription, the words ‘I certify that in my opinion there is no other drug available which would he equally effective in this case’.

“(3.) The Minister may, by notice published in the Gazette, declare that, in his opinion, it is necessary that the provisions of the next succeeding sub-regulation should apply in relation to a pharmaceutical benefit specified in the notice, being a restricted pharmaceutical benefit.

“(4.) While a notice under the last preceding sub-regulation is in force in relation to a pharmaceutical benefit—

(a) the provisions of sub-regulation (2.) of this regulation do not apply in relation to that pharmaceutical benefit; and

(b) a medical practitioner shall not write on an authorized prescription form a prescription for the supply of that pharmaceutical benefit unless—

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

(ii) he refers, on the form, to that authority and its number.

“(5.) A person is not entitled to receive, on presentation of a prescription, a pharmaceutical benefit which was a restricted pharmaceutical benefit on the date on which the prescription was written unless the medical practitioner has, in writing the prescription, complied with sub-regulation (2.) or sub-regulation (4.) of this regulation, whichever is applicable.

“(6.) A notice under this regulation takes effect from the date upon which it is published in the Gazette or such later date as is specified in the notice.


“(7.) In this regulation, ‘restricted pharmaceutical benefit’ means a pharmaceutical benefit in respect of which a notice under sub-regulation (1.) of this regulation is in force.

Restrictions on use of certain drugs.

“14a.—(1.) The Minister may, by notice published in the Gazette, declare that a pharmaceutical benefit specified in the notice may be prescribed only for the treatment of a disease specified in the notice.

“(2.) While a notice under this regulation is in force in relation to a pharmaceutical benefit a medical practitioner shall not write on an authorized prescription form a prescription for the supply of that pharmaceutical benefit unless—

(a) that pharmaceutical benefit is required for the treatment of the disease specified in relation to that pharmaceutical benefit in the notice; and

(b) he writes on the prescription form, in relation to the prescription, the words ‘Written in accordance with regulation 14a’.

“(3.) A person is not entitled to receive, on presentation of a prescription, a pharmaceutical benefit in respect of which a notice under this regulation was in force on the date on which the prescription was written unless the medical practitioner has, in writing the prescription, complied with this regulation.

“(4.) A notice under this regulation takes effect from the date upon which it is published in the Gazette or such later date as is specified in the notice.”.

Second Schedule.

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

(a) by inserting after Item 11 the following Item:—

11a

Aurothioglucose

(Oily)

...........

0.01 G. amp............

1

3

 

...........

0.025 G. amp...........

1

3

 

...........

0.05 G. amp............

1

3

 

...........

0.1 G. amp.............

1

3

 

0.01 G. per cc.

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

1

..

 

0.1 G per cc.

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

1

..

(b) by omitting Item 80 and inserting in its stead the following Item:—

80

Kinaden

..........

set containing—3 amps. each of 10 units and 3 amps. of solvent

1

1

(c) by inserting after Item 131 the following Item:—

131a

Procaine Penicillin  (Aqueous)

...........

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

6

..

 

...........

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

6

..

 

...........

3,000,000 U. vial........

6

..

(d) by inserting after Item 167 the following Item:—

167a

Suprarenal Cortex Extract

200 γ per cc.

10 cc. bottle..........

3

1

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

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


Third Schedule.

7.—(1.) The Third Schedule to the Pharmaceutical Benefits Regulations is amended—

(a) by omitting from paragraph (c) of sub-paragraph (1.) of paragraph 3 the words “fifteen” and “fourteen” and inserting in their stead the words “eighteen” and “seventeen” respectively;

(b) by omitting the table from paragraph 4 and inserting in its stead the following table:—

State.

Amount in pence.

Zone 2.

Zone 3.

Zone 4.

Zone 5.

New South Wales.....................

0.40

0.81

1.04

1.20

Victoria............................

0.27

0.44

0.56

..

Queensland.........................

0.51

0.95

1.34

1.76

South Australia.......................

0.40

0.69

0.98

..

Western Australia.....................

0.60

0.87

1.29

1.59

Tasmania...........................

0.36

0.61

..

..

(c) by omitting the table from paragraph 5 and inserting in its stead the following table:—

Place.

Amount in pence.

 

Place.

Amount in pence.

New South Wales.

 

Queensland—continued.

 

Lord Howe Island..............

0.75

Muttaburra....................

2.53

Queensland.

 

Proserpine....................

1.83

Alpha......................

1.90

Quilpie......................

1.83

Aramac....................

2.17

Ravenshoe....................

2.98

Atherton....................

2.91

Rockhampton..................

0.83

Ayr.......................

2.01

Springsure....................

1.83

Babinda....................

2.70

Tambo.......................

2.32

Barcaldine..................

2.07

Townsville....................

0.96

Blackall....................

2.11

Tully........................

2.25

Bowen.....................

0.92

Winton......................

2.44

Bundaberg..................

0.78

South Australia.

 

Cairns.....................

1.00

Ceduna......................

1.06

Charters Towers...............

2.16

Cleve.......................

0.61

Clermont...................

1.83

Cowell.......................

0.57

Cloncurry...................

3.11

Cummins.....................

1.11

Cooktown...................

2.98

Elliston......................

1.09

Cunnamulla..................

1.83

Kimba.......................

0.55

Gladstone...................

0.79

Kingscote.....................

0.78

Gordonvale..................

2.74

Port Lincoln...................

0.85

Herberton...................

2.94

Streaky Bay...................

1.00

Home Hill...................

2.01

Tumby Bay...................

0.91

Hughenden..................

2.79

Whyalla......................

0.50

Ingham.....................

2.16

Wudinna.....................

1.39

Innisfail....................

1.00

 

 

Longreach...................

2.21

Victoria.

 

Mackay....................

0.90

Corryong.....................

0.59

Malanda....................

2.94

Edenhope.....................

0.58

Mareeba....................

2.86

Omeo.......................

0.66

Maryborough.................

0.75

 

 

Mossman...................

2.95

Western Australia.

 

Mount Isa...................

3.14

Carnarvon....................

1.73

Mourilyan...................

1.31

Wiluna......................

1.82


(2.) The amendments effected by this regulation shall have effect with respect to—

(a) pharmaceutical benefits supplied on presentation of prescriptions written on or after the first day of April, 1951; 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 a subsequent time on or after that date—pharmaceutical benefits so supplied.

Amendments not to apply to certain cases.

8.—(1.) Notwithstanding the amendments of the Pharmaceutical Benefits Regulations effected by regulations 1 to 6 (inclusive) of these Regulations, the provisions of the Pharmaceutical Benefits Regulations, as in force immediately before the date of commencement of these Regulations shall 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.

(2.) Nothing in this regulation shall be deemed to affect the operation of sub-regulation (2.) of regulation 7 of these Regulations.

THE SCHEDULE. Reg. 6.

AMENDMENTS OF SECOND SCHEDULE TO PRINCIPAL REGULATIONS.

Item No.

Amendments in Columns 3, 4, 5 and 6.

4

After line 2 insert—

 

“

1 in 1,000...........

25 cc. bottle...........

1

..”

 

Add—

 

“

1 in 100.............

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

1

1”

5

After line 3 insert—

 

“

10 mg. per cc 

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

1

..”

31

Omit from column 5 line 1 the figure “2”, insert “6”

51

Before line 1 insert—

 

“

0.2 mg. per cc.........

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

6

..”

 

After line 3 insert—

 

“

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

0.2 mg. tab............

25

..”

52

After line 1 insert—

 

“

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

2½ gr. tab.............

25

1”

108

Insert, in column 6 line 1, “3”

 

After line 1 insert—

 

“

2.5 mg. per cc.........

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

1

1”

116

Omit all words, insert—

 

“

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

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

6

..

 

 

1/3 gr. per cc..........

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

6

..

 

 

2 gr. in 10 cc..........

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

6

..

 

 

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

3/4 gr. tab............

25

1

 

 

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

11/2 gr. tab............

25

1”

121

After line 2 insert—

 

“

5,000 M. per cc........

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

1

..”

 

After line 4 insert—

 

“

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

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

1

..”

 

After line 6 insert—

 

“

60,000 M. per 1.5 cc.....

1.5 cc. vial...........

1

..”

125

Omit lines 1 and 2, insert—

 

“

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

0.03 G. cap...........

100

1

 

 

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

0.1 G. cap............

100

1 ”

133

Add—

 

“

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

1 million U. syringe.....

6

..”

136

Before line 1 insert—

 

“

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

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

6

1”

144

Omit from column 5 figure “2” insert “4”

151

Before line 1 insert—

 

“

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

1.5 G. cachet..........

200

1”


THE SCHEDULE—continued.

Amendments of Second Schedule to Principal Regulations—continued.

Item No.

Amendments in Columns 3, 4, 5 and 6.

 

181

After line 3 insert—

 

“

50 γ per cc............

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

3

1 “

182

Omit all words, insert—

 

“

1 mg. per cc..........

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

6

1

 

 

5 mg. per cc...........

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

6

1

 

 

10 mg. per cc..........

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

6

1

 

 

75 mg. per cc..........

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

6

1

 

 

60 mg. per 10 cc........

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

l

1

 

 

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

2 mg. amp............

6

1

 

 

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

4 mg. amp............

6

1

 

 

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

72 mg. amp..........

1

1”

183

Omit all words, insert—

 

 

“

5 mg. per cc...........

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

6

1

 

 

10 mg. per cc..........

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

6

1”

 

Overview

The Statutory Rules 1951, No. 89, made under the Pharmaceutical Benefits Act 1947-1950, address the regulation of pharmaceutical benefits and their prescriptions. These rules were introduced to ensure that the supply of pharmaceutical benefits aligns with the Act's objectives, particularly in terms of controlling costs and ensuring proper use of prescribed medications. The rules modify existing regulations, including those concerning the number of benefits that can be prescribed, the conditions for prescribing certain medications, and the requirements for prescriptions to be valid. The enactment body was the Australian Parliament, and the policy objective is to regulate the supply of pharmaceutical benefits effectively and efficiently. The rules also introduce new regulations for the prescription of certain drugs, including those that may only be prescribed for specific diseases or require special authorisation. Furthermore, they make amendments to the Pharmaceutical Benefits Regulations to update pricing and availability details for various pharmaceutical benefits. These changes ensure that the supply of pharmaceuticals remains within the framework of the Act, maintaining its objectives of providing affordable and accessible healthcare to the public.

Scope and Application

The Statutory Rules 1951, No. 89, made under the Pharmaceutical Benefits Act 1947-1950, primarily amend the Pharmaceutical Benefits Regulations to refine the administration and regulation of the supply of pharmaceutical benefits. These amendments apply to medical practitioners and pharmacies that provide pharmaceutical benefits to individuals in Australia. The regulations impact the prescribing practices of medical practitioners and the dispensing process at pharmacies, particularly concerning the quantities and types of pharmaceutical benefits that can be prescribed and supplied. Geographic reach of these regulations is national, applying uniformly across all states and territories within Australia. The amendments do not exclude any particular entities or classes of individuals, but rather extend uniformly to all who engage in the prescription and supply of pharmaceutical benefits. However, certain exceptions apply to prescriptions written before the date of commencement of these regulations, which continue to be governed by the previous regulations. The Minister has the authority to declare certain pharmaceutical benefits as restricted, which may require additional certification from medical practitioners before a prescription can be written. Additionally, the Minister can limit the use of certain drugs to specific diseases, further regulating the prescription and supply of pharmaceutical benefits.

Key Provisions

The key provisions of this statutory instrument (Statutory Rules 1951, No. 89) involve amendments to the Pharmaceutical Benefits Regulations, which are made under the Pharmaceutical Benefits Act 1947-1950. Firstly, Regulation 12 is amended to allow a prescription to cover only two pharmaceutical benefits (Regulation 12(2)(e)) and ensure that only pharmaceutical benefits are prescribed (Regulation 12(2)(f)). Additionally, the person receiving the pharmaceutical benefit must sign and date a receipt on the back of the prescription form (Regulation 12(2)(g)). A new Regulation 12aa is introduced to address the prescribing of pharmaceutical benefits in different strengths, deeming such a prescription as prescribing only one benefit (Regulation 12aa(1)(b)). The regulation applies to specific benefits, including Aurothioglucose (Oily), Calcium Aurothiomalate, Pertussis Vaccine, Sodium Aurothiomalate (Aqueous), and Sodium Aurothiomalate (Oily) (Regulation 12aa(2)). Regulation 12b is also amended to change the requirement for prescriptions of dangerous drugs from taking possession to cancelling them (Regulation 12b(1)). Furthermore, Regulation 13 and Regulation 14 are repealed and replaced with new regulations concerning restricted pharmaceutical benefits and restrictions on the use of certain drugs (Regulations 14 and 14a). These amendments impose obligations on medical practitioners to adhere to the new rules when prescribing pharmaceutical benefits. For example, a medical practitioner must certify that no other drug would be equally effective when prescribing a restricted pharmaceutical benefit (Regulation 14(2)). They must also obtain a numbered authority from the Director-General or a delegate if a notice is in force, and refer to that authority and its number on the prescription form (Regulation 14(4)). Similarly, when prescribing a pharmaceutical benefit for a specific disease, the practitioner must state that the prescription is written in accordance with Regulation 14a (Regulation 14a(2)). Failure to comply with these requirements disqualifies the person from receiving the pharmaceutical benefit (Regulations 14(5) and 14a(3)). Breach of the provisions of this statutory instrument may result in civil or criminal consequences. However, the specific offences, penalties, or consequences are not detailed within the text. The penalties for breaches of the Pharmaceutical Benefits Act 1947-1950, under which this statutory instrument is made, generally depend on the severity of the offence. For instance, in the case of false claims or fraudulent activities, the maximum penalty can be imprisonment for up to five years or a fine of up to 5,000 Australian pounds, or both. Other offences may incur lesser penalties, such as fines or other civil sanctions. It is important to note that the specific penalties for breaches of this statutory instrument would be determined by the courts, taking into account the particular circumstances of each case.

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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.