National Health (Pharmaceutical Benefits) Regulations (Cth)

STATUTORY RULES.

1956. No. 54.

REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1955.*

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 1953-1955.

Dated this twenty-eighth day of June, 1956.

W.J. SLIM

Governor-General.

By His Excellency's Command,

(Sgd.) Donald A. Cameron

Minister of State for Health.

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS.

PART I.—PRELIMINARY.

Citation.

1. These Regulations may be cited as the National Health (Pharmaceutical Benefits) Regulations.

Commencement.

2. These Regulations shall come into operation on the first day of July, 1956.

Repeal.

3. The National Health (Pharmaceutical Benefits) Regulations (comprising Statutory Rules 1954, Nos. 54, 77, 78, 93, 95 and 128; and Statutory Rules 1955, No. 40) are repealed.

Parts.

4. These Regulations are divided into Parts as follows:—

Part I.—Preliminary (Regulations 1-7).

Part II.—Approvals of Chemists and Hospitals under Part VII. of the Act (Regulations 8-9).

Part III.—General Pharmaceutical Benefits (Regulations 10-11).

Part IV.—Pharmaceutical Benefits under Section 93 of the Act (Regulations 12-16).

Part V.—Prescriptions and Supply (Regulations 17-31).

Part VI.—Miscellaneous (Regulations 32-36).

Interpretation.

5.—(1.) In these Regulations, unless the contrary intention appears—

“authorized form” means a form authorized by the Director-General;

“authorized prescription form” means a paper, not less than five or more than six inches in length and not less than three or more than four inches in breadth, on which appear the name and address of a medical practitioner and at the

* Notified in the Commonwealth Gazette on , 1956.

3014/56.—PRICE 1S. 9/5.6.1956.

top of which appear the letters “N.H.S.” and, in the case of a prescription written for a pensioner pharmaceutical benefit, the words “Pensioner Benefit”;

“controlled therapeutic substance” has the same meaning as in the Therapeutic Substances Act 1953;

“pension number”, in relation to a pensioner, means his pension number appearing on an entitlement card issued to him by the Commonwealth for the purposes of Part IV. and Part VII. of the Act;

“pensioner pharmaceutical benefit” means a pharmaceutical benefit in relation to a pensioner under paragraph (b)of sub-section (1.) of section 85 of the Act as affected by a determination of the Minister under that paragraph;

“the Act” means the National Health Act 1953-1955;

“the Australian Pharmaceutical Formulary” means the latest edition for the time being of the book called the Australian Pharmaceutical Formulary published by the Pharmaceutical Association of Australia or, if that edition has been added to or amended, that edition as affected by those additions or amendments;

“the British Pharmacopoeia (1948)” means the edition of the book called the British Pharmacopoeia published under the direction of the General Medical Council of the United Kingdom in the year 1948 as affected by the additions or amendments contained in the 1951 Addendum to that book;

“trading hours”, in relation to an approved pharmaceutical chemist, means his trading hours established by or under the law of the State or Territory in which his premises are situated.

(2.) In these Regulations, unless the contrary intention appears, a reference to prescribing or to the writing of a prescription shall be read as a reference to the writing of a prescription for the supply of a pharmaceutical benefit under Part VII. of the Act.

(3.) In these Regulations, a reference to a Schedule by number shall be read as a reference to the Schedule to these Regulations so numbered.

Forms.

6.—(1.) A reference to a Form by letter shall be read as a reference to the Form so lettered in the Third Schedule.

(2.) Strict compliance with the Forms contained in the Third Schedule is not necessary and substantial compliance is sufficient.

Delegation.

7.—(1.) The Minister or the Director-General may, in relation to a matter or class of matters, or to a State or part of the Commonwealth, by writing under his hand, delegate any of his powers and functions under these Regulations (except this power of delegation).

(2.) A power or function so delegated may be exercised or performed by the delegate with respect to the matter or to the matters included in the class of matters, or with respect to the State or part of the Commonwealth, specified in the instrument of delegation.

(3.) A delegation under this regulation is revocable at will and does not prevent the exercise of a power or the performance of a function by the Minister or the Director-General, as the case may be.

(4.) The Director-General shall not delegate any of his powers and functions under these Regulations except to a Commonwealth Director of Health for a State or for the Northern Territory or to an officer of the Commonwealth Department of Health who is a pharmacist.

PART II.—APPROVALS OF CHEMISTS AND HOSPITALS UNDER PART VII. OF THE ACT.

Application for approval by a pharmaceutical chemist or hospital authority.

8. The Director-General may refuse to entertain an application by a pharmaceutical chemist or a hospital authority for approval under Part VII. of the Act unless the application for approval is on and in accordance with Form A, Form B or Form C, whichever is appropriate.

Certain requirements to be met after cancellation, &c., of approval.

9. Where the approval of an approved pharmaceutical chemist is suspended, revoked or cancelled, the pharmaceutical chemist—

(a) shall, if the Director-General so requests, deliver up to the Director-General all documents and forms supplied to him by the Commonwealth with respect to the provision of pharmaceutical benefits other than documents or forms that he has parted with in accordance with Part VII. of the Act and the Regulations for the time being in force under the Act or the Regulations repealed by that Part; and

(b)shall not, in any way, indicate that he has been, or is, approved to supply pharmaceutical benefits.

Penalty: Fifty pounds.

PART III.—GENERAL PHARMACEUTICAL BENEFITS.

General pharmaceutical benefits.

10. The names or formulae of drugs and medicinal preparations that may be prescribed for supply and received as general pharmaceutical benefits are those specified in the First Schedule and the Second Schedule.

Pharmaceutical benefits that may be prescribed only for specified diseases or purposes.

11.—(1.) Except as provided by the next succeeding sub-regulation, a general pharmaceutical benefit the name or formula of which is specified in the Second Schedule may be prescribed by a medical practitioner for the purpose of Part VII. of the Act only for the treatment of a disease, or for a purpose, specified in that Schedule in relation to the general pharmaceutical benefit.

(2.) A medical practitioner may, in respect of a pensioner, prescribe the following general pharmaceutical benefits for the treatment of any disease from which the pensioner is suffering:—

Dienoestrol,

Penicillin Tablets.

Quinine Bisulphate.

Quinine Dihydrochloride.

Quinine Hydrochloride.

Quinine Sulphate.

Stilboestrol.

PART IV.—PHARMACEUTICAL BENEFITS UNDER SECTION 93 OF THE ACT.

Medical practitioners excepted from the authorization conferred by section 93.

12. A medical practitioner who is an approved medical practitioner and a medical practitioner who is practising his profession on a ship are not authorized to supply pharmaceutical benefits under section 93 of the Act.

Obtaining of benefits by medical practitioners for purposes of section 93.

13.—(1.) A medical practitioner shall not obtain a pharmaceutical benefit for the purpose of section 93 of the Act by any means other than by signing and lodging with an approved pharmaceutical chemist an order, in duplicate, on and in accordance with the authorized form.

(2.) Where a medical practitioner has obtained a pharmaceutical benefit for the purpose of section 93 of the Act, he is not entitled to obtain a further supply of that pharmaceutical benefit while he has in his possession a quantity or number of units of that pharmaceutical benefit equal to or greater than the maximum quantity or number of units determined by the Minister under that section.

Supply of pharmaceutical benefits by chemists for purpose of section 93.

14. An approved pharmaceutical chemist shall not supply a pharmaceutical benefit on an order given under the last preceding regulation unless the medical practitioner whose signature appears on the order is known to him or, if the medical practitioner is not known to him, he obtains from the person who presents the order particulars of the full name, address and medical registration number of the medical practitioner and endorses these particulars on the back of the order form.

Penalty: Twenty pounds.

Obtaining a particular brand for purpose of section 93.

15. Where a medical practitioner specifies in an order given under regulation 13 of these Regulations a particular brand of a pharmaceutical benefit that may be obtained for the purpose of section 93 of the Act, an approved pharmaceutical chemist shall supply to the medical practitioner that brand of the pharmaceutical benefit.

Penalty: Fifty pounds.

Payment for pharmaceutical benefits supplied for the purpose of section 93.

16. An approved pharmaceutical chemist who has supplied a pharmaceutical benefit to a medical practitioner for the purpose of section 93 of the Act in accordance with these Regulations is entitled to payment from the Commonwealth in respect of the supply of that pharmaceutical benefit at such rate and subject to such conditions as are determined by the Minister and applicable at the time of the supply.

PART V.—PRESCRIPTIONS AND SUPPLY.

Writing of prescription.

17.—(1.) A prescription is not duly written unless the medical practitioner who writes the prescription—

(a) writes the prescription in ink in his own handwriting, unless the Director-General otherwise allows, on an authorized prescription form;

(b) writes the prescription in duplicate and marks that duplicate with the word “Duplicate”;

(c) dates and signs the prescription;

(d) states the name and address of the person for whom the pharmaceutical benefit is to be supplied;

(c) where the prescription is for the supply of a general pharmaceutical benefit—identifies that benefit by its name or formula as specified in the First Schedule or the Second Schedule, or by a brand of that benefit, and by such other particulars as are necessary for the complete identification of that benefit;

(f) where the prescription is for the supply of a pensioner pharmaceutical benefit—

 (i) states the pension number of the pensioner to whom the pensioner pharmaceutical benefit is to be supplied; and

(ii) if the benefit to be supplied consists of a single drug, indicates the mode in which the benefit is to be used; and

(g)where the prescription is for the supply of a general pharmaceutical benefit the name or formula of which is specified in the Second Schedule, other than a prescription for the supply to a pensioner of a pharmaceutical benefit referred to in sub-regulation (2.) of regulation 11 of these Regulations—endorses the prescription in his own handwriting with the words "For a specified disease".

(2.) A prescription is not duly written if the prescription—

(a)prescribes a general pharmaceutical benefit and a pensioner pharmaceutical benefit;

(b)includes two prescriptions for the same pharmaceutical benefit;

(c) prescribes pharmaceutical benefits for more than one person;

(d)prescribes more than two general pharmaceutical benefits or more than two pensioner pharmaceutical benefits;

(e) prescribes a pensioner pharmaceutical benefit by reference to a brand or in any other manner that indicates a brand; or

(f) prescribes for the supply to a person of a pharmaceutical benefit for the supply of which to the same person another prescription has been written by the same medical practitioner on the same day.

(3.) For the purposes of paragraph (d)of the last preceding sub-regulation, a prescription for the supply of two or more strengths of a form of one of the following general pharmaceutical benefits as specified in a determination of the Minister under paragraph (a)of sub-section (1.) of section 85 of the Act shall be deemed to prescribe one general pharmaceutical benefit:—

Aurothioglucose Oily.

Calcium Aurothiomalate.

Pertussis Vaccine (Phase 1).

Sodium Aurothiomalate Aqueous.

(4.) A prescription for the general pharmaceutical benefit Cortisone Acetate shall be deemed not to be duly written—

(a)unless the medical practitioner who writes the prescription has applied to the Director-General in accordance with Form D for authority to write such a prescription and that authority is given on a form issued and numbered by the Director-General; or

(b)if he writes another prescription on the same authorized prescription form as that on which be prescribes Cortisone Acetate.

Prescription of dangerous drugs.

18.—(1.) A prescription for the supply of a dangerous drug as a pharmaceutical benefit is not duly written if the medical practitioner who writes the prescription writes a prescription for another pharmaceutical benefit on the same authorized prescription form as that on which he prescribes the dangerous drug and he directs that one of those pharmaceutical benefits is to be supplied more than once.

(2.) In this regulation, “dangerous drug” means a drug or medicinal preparation in respect of which the law of the State or Territory in which the prescription is written provides that a pharmaceutical chemist who dispenses that drug or medicinal preparation or who dispenses it on the last of a number of occasions of supply indicated in a prescription for its supply shall take possession of the prescription and cancel it or deliver it to the authority administering that law.

Recovery of cost of pharmaceutical benefits prescribed for persons not entitled or in excessive quantities.

19.—(1.) If a Committee of Inquiry established under Division 2 of Part VIII. of the Act reports that, in its opinion—

(a) a medical practitioner has prescribed, as a pharmaceutical benefit, a drug or medicinal preparation, which may be prescribed as a pharmaceutical benefit only for the treatment of a disease specified in the Second Schedule in relation to the name or formula of that pharmaceutical benefit, for the treatment of a person who was not suffering from that disease when the prescription was written; or

(b)a medical practitioner has prescribed a quantity, or number of units of a pharmaceutical benefit that is greater than the quantity or number of units of that pharmaceutical benefit that could reasonably be necessary for the proper medical treatment of the person in respect of whose medical treatment the prescription was written,

the medical practitioner is liable to repay to the Commonwealth an amount equal to the cost to the Commonwealth of—

(c)in the circumstances specified in paragraph (a) of this sub-regulation—the quantity or number of units of that drug or medicinal preparation supplied on the prescription as the Pharmaceutical benefit; or

(d) in the circumstances specified in paragraph (b)of this sub-regulation—the excess quantity or number of units of the pharmaceutical benefit supplied on the prescription.

(2.) An amount that a medical practitioner is liable to repay under the last preceding sub-regulation is recoverable as a debt due to the Commonwealth in a court of competent jurisdiction.

Supply of pharmaceutical benefits on prescriptions.

20.—(1.) An approved pharmaceutical chemist or an approved medical practitioner is not authorized to supply a drug or medicinal preparation as a pharmaceutical benefit unless—

(a) subject to the next succeeding regulation, the prescription for its supply is surrendered to him;

(b)the prescription for its supply is duly written in accordance with these Regulations and is accompanied by a duplicate of the prescription on an authorized prescription form; and

(c) the prescription for its supply is dated within six months before the date of its presentation.

(2.) Subject to the next succeeding regulation, an approved pharmaceutical chemist or an approved medical practitioner is not authorized to supply Cortisone Acetate/as a pharmaceutical benefit unless the prescription for its supply is accompanied by a numbered authority given under sub-regulation (4.) of regulation 17 of these Regulations.

Supply of pharmaceutical benefit before surrender of written prescription.

21.—(1.) Subject to this regulation, a pharmaceutical benefit may be supplied by an approved pharmaceutical chemist before the prescription for that pharmaceutical benefit is surrendered to him where, in a case of urgency, a medical practitioner, by oral or other means, communicates the prescription to the approved pharmaceutical chemist.

(2.) The pharmaceutical benefit Cortisone Acetate may be supplied under the last preceding sub-regulation before a numbered authority is given on an application under paragraph (a) of sub-regulation (4.) of regulation 17 of these Regulations if the medical practitioner, before communicating the prescription, has been notified by the Director-General, by oral or other means, that his application will be approved.

(3.) A medical practitioner who has communicated a prescription under this regulation shall reduce the communicated prescription to writing in accordance with regulation 17 of these Regulations and, within twenty-four hours of the communication, despatch the prescription so written to the approved pharmaceutical chemist who supplied the pharmaceutical benefit.

Penalty: Ten pounds.

(4.) For the purposes of the last preceding sub-regulation, a medical practitioner who has communicated a prescription for Cortisone Acetate as a pharmaceutical benefit in accordance with sub-regulations (1.) and (2.) of this regulation shall, notwithstanding paragraph (a) of sub-regulation (4.) of regulation 17 of these Regulations, be deemed to write the prescription in accordance with regulation 17 of these Regulations if—

(a) he reduces the communication to writing in accordance with the other provisions of that last-mentioned regulation; and

(b)upon receipt of the numbered authority given under that paragraph, he despatches it within twenty-four hours to the approved pharmaceutical chemist who supplied the Cortisone Acetate.

(5.) This regulation does not apply to a pharmaceutical benefit that is a drug or medicinal preparation the prescription for which is required to be in writing by or under a law of the State or Territory of the Commonwealth in which the premises of the approved pharmaceutical chemist are situated.

Supply of pharmaceutical benefit on first presentation of prescription.

22. An approved pharmaceutical chemist or an approved medical practitioner is not authorized to supply a pharmaceutical benefit on the first presentation of a prescription unless—

(a) he writes on the back of the authorized prescription form and on the back of the duplicate his name and the number of his approval (if any) under the Act;

(b)if two pharmaceutical benefits have been prescribed on the authorized prescription form—he marks on that form and on the duplicate the first-written pharmaceutical benefit with the letter “A” and the other pharmaceutical benefit with the letter “B”; and

(c)in the case of an approved pharmaceutical chemist—he allots a serial number to the prescription and writes that serial number on the authorized prescription form and on the duplicate.

Repeat prescriptions.

23.—(1.) Subject to these Regulations, a medical practitioner may, in a prescription, direct that the supply of a pharmaceutical benefit be repeated a specified number of times not exceeding such number of times as is determined by the Minister in relation to the pharmaceutical benefit.

(2.) The last preceding sub-regulation does not entitle a medical practitioner to direct the supply of a repeat of a pharmaceutical benefit unless the quantity or number of units that he directs to be supplied on the first occasion is the maximum quantity or number of units determined by the Minister under section 85 of the Act in relation to the pharmaceutical benefit.

(3.) In special circumstances, the Minister may, subject to such conditions as he specifies, authorize a medical practitioner to direct in a prescription that—

(a) a pharmaceutical benefit, the supply of which the medical practitioner is not otherwise entitled to direct be repeated, be repeated in those circumstances such number of times as the Minister specifies; or

(b)a pharmaceutical benefit, the supply of which the medical practitioner is entitled to direct be repeated in a prescription a number of times not exceeding the number determined by the Minister under sub-regulation (1.) of this regulation, be repeated in those circumstances a number of times, specified by the Minister, greater than the number of times otherwise allowed in the determination.

Supply of repeats.

24.—(1.) A pharmaceutical benefit shall not be supplied a number of times greater than the number specified, in accordance with the last preceding regulation, in the prescription.

(2.) Where a prescription directs that a pharmaceutical benefit is to be supplied more than once, that benefit shall not be supplied (whether by the same supplier or by different suppliers) more than once on the same day.

Penalty: Ten pounds.

Repeat authorizations.

25.—(1.) An approved pharmaceutical chemist who supplies a pharmaceutical benefit on surrender of—

(a) a prescription that contains a direction to supply that benefit more than once; or

(b)a repeat authorization issued in accordance with this regulation,

shall, unless no further supply of the pharmaceutical benefit (after the supply that he is making) is authorized—

(c) issue, to the person presenting the prescription or repeat authorization, a repeat authorization, on and in accordance with an authorized form, in respect of each benefit the further supply of which is authorized;

(d)write the repeat authorization in duplicate;

(e) attach the repeat authorization to the duplicate of the prescription;

(f) in the case of the supply of a pharmaceutical benefit on the first occasion—mark on the repeat authorization the number of his approval under the Act and the serial number allotted by him to the prescription; and

(g)in the case of the supply of a pharmaceutical benefit on a subsequent occasion—mark on the repeat authorization which he issues the numbers marked, in pursuance of the last preceding paragraph, on the repeat authorization presented to him.

(2.) A pharmaceutical benefit shall not be supplied upon surrender of the duplicate of a prescription unless—

(a)there is attached to that duplicate a repeat authorization—

(i) duly related to the duplicate prescription by a number or numbers;

(ii) where the prescription refers to two pharmaceutical benefits—referring to the first-written pharmaceutical benefit by the letter “A” and the second-written pharmaceutical benefit by the letter “B”; and

(iii) indicating that the pharmaceutical benefit to be supplied has not been supplied for the number of times directed in the prescription; and

(b) the person obtaining the pharmaceutical benefit surrenders the repeat authorization to the person supplying the pharmaceutical benefit.

(3.) An approved pharmaceutical chemist who supplies a benefit on presentation of a repeat authorization shall write his name on the back of the repeat authorization.

Penalty: Ten pounds.

Supply of brand of general pharmaceutical benefits specified in a prescription.

26. Where a prescription for the supply of a general pharmaceutical benefit, presented to an approved pharmaceutical chemist or an approved medical practitioner, indicates a brand of that general pharmaceutical benefit, the approved pharmaceutical chemist or approved medical practitioner, as the case may be, shall not supply any other brand of that general pharmaceutical benefit unless the Minister otherwise allows.

Penalty: Fifty pounds.

Receipts

27.—(1.) Subject to this regulation, upon the supply to a person of a pharmaceutical benefit by an approved pharmaceutical chemist or an approved medical practitioner, that person shall sign and date a receipt for that pharmaceutical benefit and, if that person is not the person for whose treatment the prescription was written, that person shall write on the back of the authorized prescription form or repeat authorization form, as the case may be, his address and a statement that he is obtaining the benefit for and on behalf of the person for whose treatment the prescription was written.

(2.) An approved pharmaceutical chemist or an approved medical practitioner shall not demand a receipt for the supply of a pharmaceutical benefit to a person unless the approved pharmaceutical chemist or approved medical practitioner has supplied that pharmaceutical benefit to that person.

(3.) Where a pharmaceutical benefit is supplied by an approved pharmaceutical chemist or an approved medical practitioner through the post or by rail or other means of transport and it is impracticable for him to obtain a receipt in accordance with the preceding provisions of this regulation, the approved pharmaceutical chemist or approved medical practitioner shall certify on the back of the authorized prescription form or repeat authorization form that he has supplied the pharmaceutical benefit, stating the date on which the supply was made and also particulars of the means by which the pharmaceutical benefit was supplied.

Penalty: Twenty pounds.

Presentation of prescriptions in trading hours.

28.—(1.) An approved pharmaceutical chemist shall, at all times, keep prominently displayed at each of the premises in respect of which he is approved, so as to be readily visible to persons who enter the premises, a notice in an authorized form setting out the trading hours during which services for the supply of pharmaceutical benefits are available.

(2.) Subject to the next succeeding regulation, a person is entitled on demand to be supplied with a pharmaceutical benefit from an approved pharmaceutical chemist during trading hours only.

Presentation of urgent prescriptions.

29.—(1.) A prescription for the supply of a pharmaceutical benefit marked “Urgent”, that marking being initialled by the medical practitioner writing the prescription, may be presented at any time to an approved pharmaceutical chemist at the premises in respect of which he is approved.

(2.) Subject to the next succeeding sub-regulation, where a prescription referred to in the last preceding sub-regulation is so presented, the approved pharmaceutical chemist shall, as soon as practicable, supply the pharmaceutical benefit.

Penalty: Ten pounds.

(3.) An approved pharmaceutical chemist may refuse to supply a pharmaceutical benefit outside trading hours unless a special charge is paid in accordance with the next succeeding regulation.

Special charges for supply outside trading hours.

30.—(1.) An approved pharmaceutical chemist is entitled to make a special charge of such amount as is determined by the Director-General in respect of the supply of a pharmaceutical benefit outside trading hours.

(2.) Where two or more prescriptions are presented to an approved pharmaceutical chemist at the same time, being outside trading hours, for the supply of pharmaceutical benefits to the same person, the approved pharmaceutical chemist is entitled to make one special charge only.

Special charge for delivery.

31. When a pharmaceutical benefit is supplied by delivery at or to a place other than premises in respect of which the approved pharmaceutical chemist is approved or the premises at which an approved medical practitioner carries on his practice, as the case may be, the pharmaceutical chemist or medical practitioner is entitled to make a special charge equal to the cost of delivery and to refuse to deliver the pharmaceutical benefit unless the special charge is paid by or on behalf of the person to whom the pharmaceutical benefit is to be supplied.

PART VI.—MISCELLANEOUS.

Retention of prescriptions, &c.

32. Subject to regulation 18 of these Regulations, an approved pharmaceutical chemist or an approved medical practitioner who supplies pharmaceutical benefits shall retain in his possession for a period of not less than three years from the respective dates on which the pharmaceutical benefits were supplied—

(a) in the case of prescriptions that do not bear instructions to supply the pharmaceutical benefits more than once— the duplicates of those prescriptions;

(b)in the case of prescriptions that bear instructions to supply the pharmaceutical benefits more than once—the duplicates of repeat authorizations issued in accordance with regulation 25 of these Regulations;

(c) where the pharmaceutical benefits are supplied on the last occasion on which supply is authorized—the duplicates of the prescriptions in respect of which repeat authorization were issued; and

(d)the duplicates of order forms lodged under regulation 13 of these Regulations.

Penalty: Fifty pounds.

Proper stocks to be kept.

33. An approved pharmaceutical chemist shall, as far as practicable, keep in stock an adequate supply of all drugs and medicinal preparations that he may reasonably be expected to be called upon to supply as pharmaceutical benefits or as ingredients of pharmaceutical benefits.

Penalty: Ten pounds.

Forms suspected forged, &c.

34. Where an approved pharmaceutical chemist suspects that a prescription has not been signed by a medicinal practitioner or has been forged or fraudulently obtained, he is entitled, before supplying the pharmaceutical benefit specified in the prescription, to require that there be furnished to him a statement in accordance with an authorized form.

Standards of composition and purity of pharmaceutical benefits.

35.—(1.) The standard of composition and purity of a drug or medicinal preparation which is not a controlled therapeutic substance but which may be supplied as a pharmaceutical benefit or may be an ingredient of a pharmaceutical benefit is as prescribed by this regulation.

(2.) A drug or medicinal preparation that is a general pharmaceutical benefit the name or formula of which is specified in the First Schedule or the Second Schedule but is not a controlled therapeutic substance shall conform to such standards of composition and purity as are specified in relation to that drug or medicinal preparation in the Australian Pharmaceutical Formulary.

(3.) A drug or medicinal preparation that is a pensioner pharmaceutical benefit specified in a determination of the Minister under sub-paragraph (ii) of paragraph (b)of sub-section (1.) of section 85 of the Act but is not a controlled therapeutic substance shall conform to such standards of composition and purity as are specified in relation to that drug or medicinal preparation in the Australian Pharmaceutical Formulary or in the British Pharmacopoeia (1948), as the case may be.

Samples.

36. When a sample of a substance, drug or medicine (not being a controlled therapeutic substance) that may be supplied as, or may be an ingredient of, a pharmaceutical benefit is taken in pursuance of the power conferred upon an authorized person by section 104 of the Act and that sample conforms to the standards of composition and purity prescribed by the last preceding regulation, payment shall be made by the Commonwealth as if the quantity of the substance, drug or medicine taken as a sample had been supplied as a pharmaceutical benefit.

Surrender of forms.

37.—(1.) The Director-General may, by notice in writing served on a person, require that person to surrender to the Director-General or to a person specified in the notice, within a time specified in the

notice, any unused forms that have been supplied to that person by or on behalf of the Commonwealth under or for the purposes of the Act or these Regulations and that are in the possession of the person.

(2.) A person upon whom a notice given in pursuance of the last preceding sub-regulation is served shall comply with that notice.

Penalty: Ten pounds.

 

THE SCHEDULE.

FIRST SCHEDULE.

Regulation 10.

DRUGS AND MEDICINAL PREPARATIONS THAT MAY BE PRESCRIBED FOR SUPPLY, SUPPLIED AND RECEIVED AS GENERAL PHARMACEUTICAL BENEFITS.

Item No.	Name or Formula.
1	Acetarsol Soluble
2	Acetazoleamide
3	Adrenalin in Oil
4	Adrenalin Tartrate Solution
5	Aloxidone
6	Amidone
7	Amodiaquine
8	Amyl Nitrite
9	Antazoline
10	Atropine Sulphate
11	Aurothioglucose Oily
12	Benzathine Penicillin with Procaine Penicillin and Potassium Penicillin
13	Benzhexol Hydrochloride
14	Calcium Aurothiomalate
15	Calf Lymph
16	Carbachol
17	Carbarsone
18	Carbimazole
19	Chiniofon
20	Chloroquine
21	Cholera Vaccine
22	Dapsone
23	Darrow’s Solution
24	Desacetyl-Lanatoside C
25	Dextrose Aqueous
26	Dextrose in 1/5 Normal Saline
27	Dextrose in Ringer’s Solution
28	Diasone
29	Diethazine Hydrochloride
30	Diethylcarbamazine
31	Digitalis
32	Digitoxin
33	Digoxin
34	Dihydroergotamine
35	Dihydromorphinone
36	Diiodohydroxyquinoline
37	Dimercaprol
38	Diphenhydramine Hydrochloride
39	Diphtheria and Tetanus Toxoids Combined
40	Diphtheria Antitoxin
41	Diphtheria Pertussis Antigen
42	Diphtheria Pertussis and Tetanus Antigen
43	Diphtheria Prophylactic (Formalinized Toxoid)

FIRST SCHEDULE—continued.

Item No.	Name or Formula.
44	Diphtheria Prophylactic (Purified Toxoid Aluminium Phosphate)
45	Diphtheria Toxoid Purified (diluted for skin test only)
46	Emetine Hydrochloride
47	Emetine Bismuth Iodide
48	Entero-Vioform
49	Ephedrine Hydrochloride
50	Ephedrine Sulphate
51	Ergometrine Maleate
52	Ergotamine Tartrate
53	Ethopropazine Hydrochloride
54	Ethyl Biscoumacetate
55	Ethylidene Dicoumarin
56	Gas Gangrene Antitoxin (Oedematiens)
57	Gas Gangrene Antitoxin (Perfringens)
58	Gas Gangrene Antitoxin (Polyvalent)
59	Gas Gangrene Antitoxin (Septique)
60	Glyceryl Trinitrate
61	Hartmann’s Solution
62	Hartmann’s Solution with Dextrose
63	Heparin
64	Heparin Retard
65	Hexamethonium Bromide
66	Hexamethonium Bromide with Ephedrine
67	Hexamethonium Tartrate
68	Hyaluronidase
69	Hyoscine Hydrobromide
70	Insulin
71	Insulin Globin Zinc
72	Insulin Isophane
73	Insulin (Special P)
74	Insulin Protamine Zinc
75	Insulin Zinc Suspension
76	Insulin Zinc Suspension (Amorphous)
77	Insulin Zinc Suspension (Crystalline)
78	Isoprenaline Hydrochloride
79	Isoprenaline Sulphate
80	Leptazol
81	Mecholyl Chloride
82	Mepacrine Hydrochloride
83	Meprochol
84	Mepyramine Maleate
85	Mercaptomerin Sodium
86	Mercuramide with Theophylline
87	Mersalyl
88	Methoin
89	Methyl Atropine Nitrate
90	Methylergometrine Tartrate
91	Morphine Sulphate
92	Morphine with Atropine
93	Morphine with Hyoscine
94	Nalorphine Hydrobromide
95	Neoarsphenamine
96	Neostigmine Bromide
97	Neostigmine Methylsulphate
98	Nikethamide
99	Noradrenaline
100	Nucleotides
101	Ouabain
. 102	Oxophenarsine Hydrochloride
103	Oxytocin
104	Pamaquin

FIRST SCHEDULE—continued.

Item No.	Name or Formula.
105	Papaveretum
106	Papaveretum with Hyoscine Hydrobromide
107	Papaverine Hydrochloride
108	Paramethadione
109	Penicillin, Injection of
110	Penicillin, Procaine Aqueous Suspension
111	Penicillin, Procaine (Crystalline)
112	Pentaerythritol Tetranitrate
113	Pentolinium Tartrate
114	Pentolinium Tartrate with Ephedrine
115	Pertussis Prophylactic (Hemagglutinin Aluminium Phosphate Adsorbed)
116	Pertussis Vaccine (Phase 1)
117	Pethidine Hydrochloride
118	Pethidine Scopolamine
119	Phemitone
120	Phenobarbitone Sodium
121	Phenylindanedione
122	Phenytoin Sodium
123	Phthalylsulphacetamide
124	Phthalylsulphathiazole
125	Physostigmine Sulphate
126	Picrotoxin
127	Pitressin Tannate in Oil
128	Primaquine
129	Primidone
130	Procaine Amide Hydrochloride
131	Procaine Hydrochloride in Normal Saline
132	Procyclidine Hydrochloride
133	Proguanil Hydrochloride
134	Promethazine Hydrochloride
135	Prophenpyridamine Para Aminosalicylate
136	Protamine Sulphate
137	Pyridoxine Hydrochloride
138	Quinidine Sulphate
139	Ringer’s Solution
140	Sodium Aurothiomalate Aqueous
141	Sodium Chloride Hypertonic Solution
142	Sodium Chloride Physiological Solution
143	Sodium Chloride Physiological Solution (with Dextrose)
144	Sodium Lactate Solution
145	Sodium Sulphate Solution
146	Solapsone
147	Succinylsulphathiazole
148	Sulphadiazine
149	Sulphadimidine
150	Sulphafurazole
151	Sulphaguanidine
152	Sulphamerazine
153	Sulphamethizole
154	Sulphapyridine
155	Sulpharsphenamine
156	Sulphathiazole
157	Sulphonamides, Mixed (A): Two Sulphonamides
158	Sulphonamides, Mixed (B): Three Sulphonamides
159	Sulphonamides, Mixed (C): Four Sulphonamides
160	Suprarenal Cortex Extract
161	T.A.B. Vaccine (Anti-Typhoid-Para-Typhoid)
162	Tetanus Antitoxin
163	Tetanus Toxoid (Formalinized)
164	Tetanus Toxoid (Purified Aluminium Phosphate Adsorbed)
165	Theophylline with Ethylenediamine

FIRST SCHEDULE—continued.

Item No.	Name or Formula.
166	Thiacetazone
167	Thiouracil, Methyl
168	Thiouracil, Propyl
169	Thyroid
170	Tiger Snake Anti-Venene
171	Triethanolamine Trinitrate
172	Troxidone
173	Vasopressin
174	Vitamin K Aqueous
175	Vitamin K Oily
176	Vitamin K Oral
177	Water for Injection

  

SECOND SCHEDULE

Regulation 11.

DRUGS AND MEDICINAL PREPARATIONS THAT MAY BE PRESCRIBED FOR SUPPLY, SUPPLIED AND RECEIVED AS GENERAL PHARMACEUTICAL BENEFITS ONLY FOR THE TREATMENT OF A DISEASE OR PURPOSE.

Item No.	Name or Formula.	Disease or Purpose.
1	Aureomycin ...................................	Acute amoebic dysentery
		Acute and sub-acute bacterial endocarditis-streptococcus faecalis
		Leptospirosis
		Pneumonia that has not responded to penicillin or sulphonamides
		Psittacosis
		Scrub typhus
		Staphylococcal infections that do not respond to penicillin
		Urinary tract infections due to streptococcus faecalis
		Shigella sonnei which is resistant both to sulphonamides and streptomycin
2	Aureomycin Granules .....................	Any disease or purpose specified in this column in relation to aureomycin
3	Aureomycin Suspension .................	Any disease or purpose specified in this column in relation to aureomycin
4	Bemegride with Amiphenazole Hydrochloride	Antidote for barbiturate and other hypnotic poisons
5	Calcium Para-Aminosalicylate	Tuberculosis
6	Calcium Para-Aminosalicylate Granules	Tuberculosis
7	Caramiphen Hydrochloride .............	Parkinsonism
8	Chloramphenicol ............................	Typhoid fever
		Brucellosis
		Typhus and other rickettsial diseases
		Scrub typhus
		Influenzal meningitis
		Granuloma inguinale
		Lymphogranuloma venereum
		Whooping cough (haemophilus pertussis)

Second 'Schedule—continued.

Item No.	Name or Formula.	Disease or Purpose.
Infections due to haemophilus influenza
Acute laryngo-tracheo-bronchitis
Salmonella infections
Severe gastro-enteritis in children
Staphylococcal infections that do not respond to either penicillin or aureomycin
Urinary tract infections due to gram negative bacilli that do not respond to sulphonamides
Meningitis due to bacterium coli if other forms of treatment are unsuccessful
Shigella sonnei which is resistant both to sulphonamides and streptomycin
9	Chloramphenicol Palmitate .............	Any disease or purpose specified in this column in relation to chloramphenicol
10	Cortisone Acetate ...........................	Acquired haemolytic anaemia
		Acute exfoliative dermatitis associated with drug therapy
		Acute rheumatic carditis
		Addison’s disease and other forms of adrenocortical hypoplasia
		Adrenogenital syndrome
		Panhypopituitarism
		Status asthmaticus
		Systematic lupus erythematosus or allied conditions
		Thrombocytopenic purpura
		Total adrenalectomy
		Pseudo-hermaphroditism
11	Cyanocobalamin ............................	Established megalocytic anaemias
12	Deoxycortone Acetate Aqueous	Addison’s disease
13	Deoxycortone Acetate Aqueous Suspension	Addison’s disease
14	Deoxycortone Acetate Oily	Addison’s disease
15	Dienoestrol ....................................	Carcinoma of the prostate
		Mammary carcinoma
16	Dihydrostreptomycin ......................	Any disease or purpose specified in this column in relation to streptomycin, but only if the person being treated for that disease or purpose is allergic to streptomycin
17	Dihydrotachysterol .........................	Parathyroid deficiency
18	Folic Acid ......................................	Sprue or the sprue-like syndrome
19	Isoniazid ........................................	Tuberculosis
		Leprosy
20	Methorphinan ................................	Inoperable cancer
21	Oxytetracycline Dihydrate ..............	Acute amoebic dysentery
		Acute and sub-acute bacterial endocarditis-streptococcus faecalis

Staphylococcal infections that do not respond to penicillin

Pneumonia that has not responded to penicillin or sulphonamides

Psittacosis

Urinary tract infections due to Streptococcus faecalis

Scrub typhus

Leptospirosis

Shigella sonnei which is resistant both to sulphonamides and streptomycin

SECOND SCHEDULE—continued.

Item No,	Name or Formula.	Disease or Purpose.
22	Oxytetracycline Hydrochloride	Any disease or purpose specified in this column in relation to oxytetracycline dihydrate
23	Oxytetracycline Suspension.............	Any disease or purpose specified in this column in relation to oxytetracycline dihydrate
24	Pancreatin ......................................	Fibrocystic disease of the pancreas
		Pancreatico-duodenectomy
25	Para-Aminosalicylic Acid ...............	Tuberculosis
26	Penicillin Tablets ...........................	Prophylactic use in rheumatic fever or chorea in children under the age of 16 years
27	Phenindamine Tartrate ....................	Parkinsonism
28	Progesterone ..................................	Habitual abortion
29	Quinine Bisulphate .........................	Malaria
30	Quinine Dihydrochloride ................	Malaria
31	Quinine Hydrochloride ...................	Malaria
32	Quinine Sulphate ............................	Malaria
33	Sodium Para-Aminosalicylate	Tuberculosis
34	Stilboestrol ....................................	Carcinoma of the prostate
		Mammary carcinoma
35	Streptomycin .................................	Infections due to haemophilus influenza
		Chancroid
		Pneumonia due to bacillus Friedlander
		Acute tuberculosis
		Acute exacerbations in chronic tuberculosis
		Salmonella infections
		Bacillary dysentery not responding to sulphonamides
		Surgical conditions of the bowel and of the thoracic organs
		Tularaemia
		Infections due to pseudomonas pyocyaneus
		Shigella sonnei which is resistant to sulphonamides
36	Streptomycin Sulphate Intrathecal	Tuberculous meningitis
37	Streptomycin Sulphate Solution	Any disease of purpose specified in this column in relation to streptomycin
38	Testosterone	Mammary carcinoma
		Castration
39	Testosterone Methyl	Mammary carcinoma
		Castration
40	Testosterone Oenanthate .................	Mammary carcinoma
		Castration
41	Testosterone Phenyl Propionate	Mammary carcinoma
		Castration
42	Testosterone Propionate ..................	Mammary carcinoma
		Castration
43	Tetracycline ...................................	Any disease or purpose specified in this column in relation to aureomycin
44	Tetracycline Granules .....................	Any disease or purpose specified in this column in relation to aureomycin
45	Tetracycline Paediatric Drops	Any disease or purpose specified in this column in relation to aureomycin
46	Vitamin K1 .....................................	Antidote to anticoagulants

THIRD SCHEDULE.

FORM A.

Regulation 8.

COMMONWEALTH OF AUSTRALIA.

National Health Act 1953-1955.

APPLICATION FOR APPROVAL AS A PHARMACEUTICAL CHEMIST.

(By a Registered Pharmaceutical Chemist.)

*I,	of
We,

trading as , hereby apply for approval as a pharmaceutical chemist under the National Health Act 1953-1955 in respect of premises situated at

*I,	hereby declare that	*I, am a	pharmaceutical	*chemist chemists	registered as such
We,		we are,
under the law of the		*State of
		*Territory

 

*I,	further declare that	*I, am	willing to supply on demand, at or from the premises
We,		we are,

specified above, pharmaceutical benefits in accordance with Part VII. of the National Health Act 1953-1955.

Dated this day of , 19  .

(Signature of Applicant.)

To the Director-General of Health, Commonwealth of Australia.

* Strike out whichever is inapplicable.

 

FORM B.

Regulation 8.

Commonwealth of Australia.

National Health Act 1953-1955.

APPLICATION FOR APPROVAL AS A PHARMACEUTICAL CHEMIST.

(By a Friendly Society, &c.)

I, of

the person authorized to make this application by

 , which is a Friendly Society or body carrying on business for the benefit of members of a friendly society or friendly societies, hereby apply for approval of that Friendly Society or body as a pharmaceutical chemist under the National Health Act 1953-1955 in respect of premises situated at

The Friendly Society or body is prepared to supply on demand, at or from its premises specified above, pharmaceutical benefits in accordance with Part VII. of the National Health Act 1953-1955.

*I declare that the Friendly Society or body was carrying on the business of a pharmaceutical chemist on the first day of August, 1945.

Dated this day of , 19  .

(Signature of person authorized to make application.)

To the Director-General of Health, Commonwealth of Australia.

* Strike out if inapplicable.

THIRD SCHEDULE—continued.

FORM C.

Regulation 8.

COMMONWEALTH OF AUSTRALIA.

National Health Act 1953-1955.

APPLICATION FOR APPROVAL AS A HOSPITAL AUTHORITY.

I, of
the person authorized to make this application by		*governing body	of
		proprietor
the Hospital, which is a
*private	hospital, hereby apply under the National Health Act 1953-1955 for
public

approval of that hospital authority for the purpose of supplying general pharmaceutical benefits to patients receiving treatment in or at that hospital.

The hospital authority is prepared to supply pharmaceutical benefits in accordance with Part VII. of the National Health Act 1953-1955.

The dispensing of drugs and medicinal preparations at the hospital is performed by or under the direct

supervision of who is a	*medical practitioner.
	pharmaceutical chemist.

Dated this day of , 19  .

(Signature of person authorized to make application.)

To the Director-General of Health, Commonwealth of Australia.

* Strike out whichever is inapplicable.

FORM D.

Regulation 17 (4.).

COMMONWEALTH OF AUSTRALIA.

National Health Act 1953-1955.

APPLICATION FOR AUTHORITY TO PRESCRIBE CORTISONE ACETATE.

(By a Medical Practitioner.)

I, of  hereby apply under sub-regulation (4.) of regulation 17 of the National Health (Pharmaceutical Benefits) Regulations for authority to write a prescription for the general pharmaceutical benefit Cortisone Acetate in the following strength, form of unit, brand and quantity or number of units:—

I certify that the pharmaceutical benefit is required for the treatment of

of  , who is suffering from  , being a disease or purpose specified in the Second Schedule to those Regulations in relation to that pharmaceutical benefit, and that in my opinion there is no other drug available that would be equally effective in this case.

Dated this day of , 19  .

(Signature of Medical Practitioner.)

To the Director-General of Health, Commonwealth of Australia.

By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.