STATUTORY RULES.
1960. No. 17
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REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1959.*
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 1953-1959.
Dated this 26th
day of February, 1960.
DUNROSSIL
Governor-General.
By His Excellency's Command,
Minister of State for Health.
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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 March, 1960.
Parts.
3. These Regulations arc 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.—Pharmaceutical Benefits under Section 85 of the Act (Regulations 10-14).
Part IV.—Pharmaceutical Benefits under Section 93 of the Act (Regulations 15-18).
Part V.—Prescriptions and Supply (Regulations 19-31).
Part VI.—Miscellaneous (Regulations 32-37).
Repeal and saving.
4.—(1.) The National Health (Pharmaceutical Benefits) Regulations (comprising Statutory Rules 1956, Nos. 54 and 75; 1957, Nos. 25 and 52; 1958, Nos. 23 and 42; and 1959, Nos. 4, 28 and 64) are repealed.
(2.) A prescription or repeat authorization, duly written before the commencement of these Regulations in accordance with the regulations repealed by this regulation shall be deemed, for the purposes of these Regulations, to be duly written in accordance with these Regulations.
(3.) The repeal of the regulations made by sub-regulation (1.) of this regulation does not affect the power of a Committee of Inquiry established under Division 2 of Part VIII. of the Act to inquire into and report, as
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* Notified in the Commonwealth Gazette on 29th February, 1960.
130/60.—Price 1s. 3d. 9/15.2.1960.
provided in regulation 19 of the regulations so repealed, on the prescribing before the commencement of these Regulations by a medical practitioner in the circumstances specified in that regulation and, where a Committee of Inquiry has so reported before the commencement of these Regulations or so reports after the commencement of these Regulations, the medical practitioner is liable to repay to the Commonwealth the amount payable under that regulation as if the repealed regulations were still in force.
Interpretation.
5.—(1.) In these Regulations, unless the contrary intention appears—
"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 top of which appear the letters "N. H.S.";
"the Act" means the National Health Act 1953-1959.
(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 Sixth Schedule.
(2.) Strict compliance with the Forms contained in the Sixth 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 an officer of the Commonwealth Department of Health who is a medical practitioner or 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 shall not, in any way, indicate that he has been, or is, approved to supply pharmaceutical benefits.
Penalty: Fifty pounds.
Part III.—Pharmaceutical Benefits under Section 85 of the Act.
Drugs, &c., that are not pharmaceutical benefits.
10.—(1.) Part VII. of the Act does not apply in relation to such of the drugs and medicinal preparations that are the subject of monographs in the British Pharmacopoeia as are specified in the First Schedule.
(2.) A medicinal preparation containing a drug or medicinal preparation specified in the First Schedule is not a medicinal preparation in relation to which Part VII. of the Act applies unless it is itself the subject of a monograph in the British Pharmacopoeia or is specified in the Third Schedule.
(3.) A medicinal preparation composed of a compound that includes a pharmaceutical benefit specified in the first column of the Second Schedule, other than a compound, if any, specified in the second column of that Schedule opposite to that pharmaceutical benefit, is not a medicinal preparation in relation to which Part VII. of the Act applies.
(4.) Part VII. of the Act does not apply in relation to a medicinal preparation composed of a compound that includes a pharmaceutical benefit (other than Water for Injection or a pharmaceutical benefit specified in the first column of the Second Schedule) which is in the form of a tablet, capsule, injection, pill, pessary, suppository, cachet, sachet or implant or granules or paediatric drops.
Additional pharmaceutical benefits.
11. The drugs and medicinal preparations specified in the Third Schedule are drugs and medicinal preparations in relation to which Part VII. of the Act applies.
Additives.
12. The substances specified in the Fourth Schedule are prescribed additives for the purposes of paragraph (d) of sub-section (2.) of section 85 of the Act.
Variation of determination of maximum number of repeats or maximum number or quantity of units.
13. Where a medical practitioner declares to the Minister that the continuous or extended use of a pharmaceutical benefit is necessary for the medical treatment of a particular person suffering from a chronic complaint or for the purpose of maintaining the life of a particular person, the Minister may, subject to such conditions, if any, as he specifies, issue a numbered authority varying a determination under paragraph (a) of sub-section (5.) of section 85 of the Act so as to authorize the medical practitioner to direct in a prescription in respect of that person that—
(a) such quantity or number of units of the pharmaceutical benefit as the Minister specifics be supplied on any one occasion; or
(b) the supply of the pharmaceutical benefit be repeated on such number of occasions as the Minister specifies.
Pharmaceutical benefits that may be prescribed only for specified persons, diseases, &c.
14.—(1.) A medical practitioner shall not prescribe a pharmaceutical benefit specified in the Fifth Schedule except in accordance with the restrictions and conditions specified in that Schedule.
(2.) Where the prescription of a pharmaceutical benefit specified in the Fifth Schedule is subject to a condition that the written authority of the Director-General is required, a medical practitioner shall not prescribe the pharmaceutical benefit unless he has applied to the Director-General for that authority and he has been notified by the Director-General that his application has been approved.
(3.) The approval of the Director-General of an application under the last preceding sub-regulation shall be recorded on a numbered form and issued by him to the medical practitioner making the application.
Part IV.—Pharmaceutical Benefits under Section 93 of the Act.
Medical practitioners excepted from the authorization conferred by section 93.
15. 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 the purpose of section 93.
16. A medical practitioner shall not obtain a pharmaceutical benefit for the purpose of section 93 of the Act otherwise than by lodging with an approved pharmaceutical chemist an order, in duplicate, signed by the medical practitioner, in accordance with a form authorized by the Director-General.
Supply of pharmaceutical benefits by chemists for the purpose of section 93.
17. 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 those particulars on the back of the order form.
Penalty: Twenty pounds.
Payment for pharmaceutical benefits supplied for the purpose of section 93.
18. 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 prescriptions.
19. (1.)—A prescription is not duly written unless the medical practitioner concerned—
(a) uses an authorized prescription form for the prescription and, unless the Director-General otherwise allows, writes the prescription in ink in his own handwriting;
(b) writes the prescription in duplicate, the duplicate being marked with the word "Duplicate";
(c) specifics on the prescription the date on which the prescription is written and signs the prescription;
(d) states in the prescription the name and address of the person for whom the pharmaceutical benefit is to be supplied;
(e) identifies in the prescription the pharmaceutical benefit by such particulars as are necessary for the complete identification of the pharmaceutical benefit;
(f) if the prescription is for the supply of a pharmaceutical benefit to a pensioner—marks the prescription with the letters "P.M.S." and with the pension number appearing on an entitlement card issued to the pensioner, or to a pensioner of whom that pensioner is a dependant, by the Commonwealth for the purposes of Part IV. and Part VII. of the Act;
(g) if the pharmaceutical benefit to be supplied consists of a single drug—indicates in the prescription the manner in which the pharmaceutical benefit is to be administered;
(h) if the prescription is for the supply of a pharmaceutical benefit specified in the Fifth Schedule and is written by virtue of the fact that it is for a purpose, disease or condition, or that the person for whom it is written is included in a class of persons, specified in that Schedule in relation to the pharmaceutical benefit—marks the prescription in his own handwriting with the words "Specified purpose"; and
(i) if the medical practitioner, in pursuance of regulation 24 of these Regulations, directs in the prescription the supply on the one occasion of a quantity or number of units of a pharmaceutical benefit exceeding the quantity or number of units that could otherwise be prescribed—marks the prescription in his own handwriting with the words "Regulation 24".
(2.) Notwithstanding compliance with the last preceding sub-regulation, a prescription is not duly written by a medical practitioner if the prescription form contains—
(a) two prescriptions for the same pharmaceutical benefit;
(b) prescriptions for pharmaceutical benefits for more than one person;
(c) prescriptions for more than two pharmaceutical benefits;
(d) a prescription 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;
(e) a prescription for a pharmaceutical benefit the prescribing of which is subject, under the Fifth Schedule, to the condition that the written authority of the Director-General is required and also a prescription for another pharmaceutical benefit; or
(f) a prescription for a pharmaceutical benefit that is a dangerous drug and also a prescription for another pharmaceutical benefit, if the prescription directs that one or both of those pharmaceutical benefits is or are to be supplied more than once.
(3.) For the purposes of paragraph (c) of the last preceding sub-regulation, a prescription for the supply of two or more forms, differing only as regards strength, of one of the following pharmaceutical benefits shall be deemed to be a prescription for one pharmaceutical benefit:—
Aurothioglucose Oily;
Calcium Aurothiomalate;
Sodium Aurothiomalate Injection.
(4.) 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 proscribed for persons not entitled or in excessive quantities.
20.—(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 a pharmaceutical benefit, as specified in the report, in contravention of regulation 14 of these Regulations; or
(b) a medical practitioner has prescribed a quantity or number of units of a pharmaceutical benefit that is greater, to an extent specified in the report, than the quantity or number of units of that pharmaceutical benefit that could reasonably have been 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 such amount (if any) as is determined by the Minister, being an amount not exceeding 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 the pharmaceutical benefit supplied upon the prescription; 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 upon 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.
21. An approved pharmaceutical chemist or an approved medical practitioner is not authorized to supply a pharmaceutical benefit upon presentation of a prescription for its supply unless, subject to the next succeeding regulation—
(a) the prescription is surrendered to him;
(b) the prescription is duly written in accordance with these Regulations and is accompanied by a duplicate of the prescription on an authorized prescription form;
(c) the prescription is dated within six months before the date of its presentation;
(d) where the prescription directs that—
(i) a quantity or number of units of the pharmaceutical benefit, greater than the maximum quantity or number of units determined for the pharmaceutical benefit by the Minister under sub-section (5.) of section 85 of the Act, be supplied on the one occasion; or
(ii) the supply of the pharmaceutical benefit be repeated on a number of occasions greater than the maximum number of occasions so determined,
the prescription is accompanied by a numbered authority given by the Minister under regulation 13 of these Regulations authorizing that variation of the determination in relation to the person in respect of whom the prescription was written; and
(e) where, at the time the prescription was written, the authority of the Director-General for the prescription was required under the Fifth Schedule—the prescription is accompanied by a numbered authority given by the Director-General under regulation 14 of these Regulations.
Supply of pharmaceutical benefit before surrender of written prescription.
22.—(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.) A pharmaceutical benefit specified in the Fifth Schedule, the prescribing of which is subject to a condition that the written authority of the Director-General is required, may be supplied before a numbered authority is given by the Director-General under regulation 14 of these Regulations if the medical practitioner informs the approved pharmaceutical chemist or approved medical practitioner that he has been notified by the Director-General, by oral or other means, that his application for such an authority has been approved.
(3.) A medical practitioner who has communicated a prescription under this regulation shall reduce the communicated prescription to writing in accordance with regulation 19 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.) A medical practitioner who has informed an approved pharmaceutical chemist or approved medical practitioner in accordance with sub-regulation (2.) of this regulation shall, within twenty-four hours after receipt of the numbered authority given by the Director-General in respect of the pharmaceutical benefit, despatch it to the approved pharmaceutical chemist or approved medical practitioner who supplied the pharmaceutical benefit.
Penalty: Ten pounds.
(5.) This regulation does not apply to a pharmaceutical benefit 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.
23. 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 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 letter "A" against the first-written pharmaceutical benefit and the letter "B" against the other pharmaceutical benefit; and
(c) in the case of an approved pharmaceutical chemist—he allots to the prescription a number which will identify the prescription and writes that number on the authorized prescription form and on the duplicate.
Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion.
24. A medical practitioner may, in pursuance of sub-section (5.) of section 88 of the Act, instead of directing a repeated supply of a pharmaceutical benefit in accordance with Part VII. of the Act, direct in a prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit allowable under that sub-section if he is satisfied that—
(a) the maximum quantity or number of units applicable in relation to the pharmaceutical benefit under a determination of the Minister under section 85 of the Act is insufficient for the medical treatment of the person for whom the prescription is written;
(b) that person requires the pharmaceutical benefit for the treatment of a chronic illness or is residing in a place remote from the approved pharmaceutical chemist nearest to that person's place of residence; and
(c) that person could not, without great hardship, obtain the required quantity or number of units of the pharmaceutical benefit by means of repeated supplies on separate occasions.
Repeated supplies of pharmaceutical benefit.
25.—(1.) A pharmaceutical benefit shall not be supplied a number of times greater than the number specified in the prescription.
(2.) Where a prescription directs that a pharmaceutical benefit is to be supplied more than once, that pharmaceutical benefit shall not be supplied (whether by the same supplier or by different suppliers) more than once on the same day.
Repeat authorizations.
26.—(1.) An approved pharmaceutical chemist who supplies a pharmaceutical benefit on surrender of a prescription that contains a direction to supply that benefit more than once, or of a duplicate prescription to which is attached 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 to be made—
(a) prepare, in duplicate, a repeat authorization, on and in accordance with a form authorized by the Director-General, in respect of each pharmaceutical benefit the further supply of which is directed;
(b) in the case of the supply of a pharmaceutical benefit on the first occasion—mark on the repeat authorization prepared by him the number of his approval under the Act and the identifying number allotted by him to the prescription;
(c) in the case of the supply of a pharmaceutical benefit on a subsequent occasion—mark on the repeat authorization prepared by him the numbers marked, in pursuance of the last preceding paragraph, on the repeat authorization presented to him;
(d) in case of a pensioner—mark on the repeat authorization prepared by him the pension number marked on the prescription;
(e) where the prescription for the supply of the pharmaceutical benefit is accompanied by a numbered authority issued in respect of the pharmaceutical benefit under regulation 13 or 14 of these Regulations—mark the number of that authority on the repeat authorization prepared by him; and
(f) attach the repeat authorization prepared by him, together with any numbered authority referred to in the last preceding paragraph, to the duplicate of the prescription and issue them to the person to whom the pharmaceutical benefit is supplied.
(2.) An approved pharmaceutical chemist is not authorized to supply a pharmaceutical benefit upon presentation of the duplicate of a prescription unless there are surrendered to him—
(a) that duplicate prescription;
(b) a repeat authorization duly related to the duplicate prescription by a number or numbers and indicating that the pharmaceutical benefit to be supplied has not been supplied for the number of times directed in the prescription; and
(c) any numbered authority for the prescription issued under regulation 13 or 14 of these Regulations.
(3.) An approved pharmaceutical chemist who supplies a pharmaceutical benefit on presentation of a repeat authorization shall write his name on the back of the repeat authorization.
Presentation of prescriptions in trading hours.
27.—(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 the form authorized by the Director-General setting out the normal trading hours during which services for the supply of pharmaceutical benefits are available.
(2.) Subject to the next succeeding regulation, a person is entitled to be supplied with a pharmaceutical benefit from an approved pharmaceutical chemist during normal trading hours only.
Presentation of urgent prescriptions.
28.—(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 payment of any charge lawfully demanded, where a prescription referred to in the last preceding sub-regulation is so presented, the approved pharmaceutical chemist shall not, without reasonable excuse (proof of which lies upon him), refuse or fail to supply the pharmaceutical benefit as soon as practicable.
Penalty: Ten pounds.
Special charges for supply outside trading hours.
29.—(1.) An approved pharmaceutical chemist may make a special charge in respect of the supply of a pharmaceutical benefit outside normal trading hours of an amount not exceeding—
(a) if the pharmaceutical benefit is supplied before eleven o'clock in the evening—Two shillings and sixpence; and
(b) if the pharmaceutical benefit is supplied after eleven o'clock in the evening—Five shillings.
(2.) Where two or more prescriptions are presented to an approved pharmaceutical chemist at the same time, being outside normal trading hours, for the supply of pharmaceutical benefits to the same person, the approved pharmaceutical chemist may make one such special charge only.
Special charge for delivery.
30. 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 may make a special charge equal to the cost of delivery.
Receipts.
31.—(1.) Except in cases to which sub-regulation (3.) of this regulation applies, upon the supply to a person of a pharmaceutical benefit by an approved pharmaceutical chemist or an approved medical practitioner, that person shall sign, on the back of the authorized prescription form or the repeat authorization, as the case may be, a receipt for that pharmaceutical benefit, showing the date of the supply, and, if that person is not the person for whose treatment the prescription was written, showing his address and containing 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 the repeat authorization 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: Ten pounds.
Part VI.—Miscellaneous.
Retention of prescriptions, &c.
32. An approved pharmaceutical chemist or an approved medical practitioner who supplies a pharmaceutical benefit shall, except in the case of the supply of a pharmaceutical benefit that is a dangerous drug within the meaning of regulation 19 of these Regulations, retain in his possession for a period of not less than one year from the date of the supply—
(a) in the case of supply upon a prescription not bearing instructions to supply the pharmaceutical benefit more than once—the duplicate of the prescription;
(b) in the case of supply upon a prescription bearing instructions to supply the pharmaceutical benefit more than once—
(i) the duplicate of the repeat authorization issued in accordance with regulation 26 of these Regulations; or
(ii) where the pharmaceutical benefit is supplied on the last occasion on which supply is authorized—the duplicate of the prescription in respect of which repeat authorizations were issued; and
(c) in the case of supply under section 93 of the Act—the duplicate of the order lodged under regulation 16 of these Regulations.
Penalty: Ten 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 to use 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 medical 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 a form authorized by the Director-General.
Standards of composition and purity of pharmaceutical benefits and additives.
35.—(1.) The standards of composition and purity of—
(a) a pharmaceutical benefit specified in the Third Schedule, not being a controlled therapeutic substance within the meaning of the Therapeutic Substances Act 1953-1959; or
(b) a substance specified in the Fourth Schedule, not being such a controlled therapeutic substance, when used as an additive in a pharmaceutical benefit,
are those specified in the succeeding provisions of this regulation.
(2.) Where the letters "A.P.F." appear after the name of the pharmaceutical benefit or the additive, the standards of composition and purity are those constituted by the description of that pharmaceutical benefit and
its ingredient, or of that additive, as the case may be, in 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 effected by those additions or amendments.
(3.) Where the letters "B.P. 1948" appear after the name of the pharmaceutical benefit or the additive, the standards of composition and purity are those constituted by the description of that pharmaceutical benefit and of its ingredients, or of that additive, as the case may be, in 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.
(4.) Where the letters "B.P. 1953" appear after the name of the pharmaceutical benefit or the additive, the standards of composition and purity are those constituted by the description of that pharmaceutical benefit and of its ingredients, or of that additive, as the case may be, in 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 1953, as affected by the additions or amendments contained in the 1955 Addendum to that book.
(5.) Where the letters "B .P .C. 1949" appear after the name of the pharmaceutical benefit or the additive, the standards of composition and purity are those constituted by the description of that pharmaceutical benefit and of its ingredients, or of that additive, as the case may be, in the edition of the book called the British Pharmaceutical Codex published by direction of the Council of the Pharmaceutical Society of Great Britain in the year 1949.
Samples.
36. When a sample of a substance, drug or medicine (not being a controlled therapeutic substance within the meaning of the Therapeutic Substances Act 1953-1959) 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, just compensation shall be paid by the Commonwealth in respect of the sample.
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 forms that have been supplied to that person by or on behalf of the Commonwealth under or for the purpose of Part VII. of that Act or these Regulations and that are in the possession of the person.
(2.) A person upon whom a notice is served in pursuance of the last preceding sub-regulation shall comply with that notice.
Penalty: Ten pounds.
THE SCHEDULES.
First Schedule. Regulation 10.
DRUGS AND MEDICINAL PREPARATIONS IN THE BRITISH PHARMACOPOEIA THAT ARE NOT TO BE SUPPLIED AS, OR USED IN, PHARMACEUTICAL BENEFITS EXCEPT AS SPECIALLY PROVIDED.
Absorbable Gelatin Sponge._Dextran Sulphate Injection. | |
Acetazolamide. | Dienoestrol. |
Acetomenaphthone. | Diethylcarbamazine Citrate. |
Adrenaline Acid Tartrate. | Dihydrostreptomycin Sulphate. |
Alcohol. | Diiodohydroxyquinoline. |
Aluminium Hydroxide Gel. | Dill Oil. |
Amethocaine Injection. | Dill Water, concentrated. |
Amodiaquine Hydrochloride. | Dimercaprol. |
Amphetamine. | Diodone Injection. |
Amphetamine Sulphate. | Dithranol. |
Amylobarbitone. | Emetine and Bismuth Iodide. |
Anise Oil. | Emetine Hydrochloride. |
Antimony Potassium Tartrate. | Ergometrine Maleate. |
Antimony Sodium Tartrate. | Ergotamine Tartrate. |
Apomorphine Hydrochloride. | Ether Anaesthetic. |
Azovan Blue. | Ether Solvent. |
Bacillus Calmette-Guerin Vaccine. | Ether Vinyl. |
Benzhexol Hydrochloride. | Ethinyloestradiol. |
Bismuth Oxychloride. | Ethisterone. |
Bismuth Sodium. Tartrate. | Ethopropazine Hydrochloride. |
Butobarbitone. | Ethyl Biscoumacetate. |
Calciferol. | Ethyl Chloride. |
Camphor Water. | Ethylenediamine Hydrate. |
Caraway. | Gallamine Triethiodide. |
Carbachol. | Gallamine Injection. |
Carbimazole. | Gentian. |
Carbon Dioxide. | Ginger. |
Cardamom Fruit. | Ginger Syrup. |
Catgut, sterilized surgical. | Hamamelis. |
Cellulose Oxidized. | Helium. |
Chlorcyclizine Hydrochloride. | Heparin. |
Chloroform. | Hexamethonium Tartrate. |
Chloroform Spirit. | Histamine Acid Phosphate. |
Chloroform Water. | Human Blood, whole. |
Chloroquine Phosphate. | Human Red Blood Corpuscles, concentrated |
Chloroquine Sulphate. |
|
Chloroxylenol. | Human Fibrin Foam. |
Chlorpromazine Hydrochloride. | Human Fibrinogen. |
Chlorpromazine Injection. | Human Gamma Globulin. |
Chlorpromazine Tablets. | Human Gamma Globulin Injection. |
Chorionic Gonadotropin. | Human Serum, dried. |
Cinchocaine Hydrochloride. | Human Serum, liquid. |
Cinnamon. | Human Plasma, dried. |
Cinnamon Oil. | Human Thrombin. |
Cinnamon Water, concentrated. | Hydrocortisone. |
Cochineal. | Hydrocortisone Acetate Injection. |
Colchicine. | Hydrocortisone Acetate Ointment. |
Coriander. | Hydrocortisone Ointment. |
Coriander Oil. | Hydrogen Peroxide Solution, strong. |
Corticotrophin. | Hyoscine Eye Ointment. |
Cortisone Acetate. | Hyoscyamus. |
Cresol. | Iodised Oil Injection. |
Cyanocobalamin. | Iodoxyl. |
Cyclobarbitone. | Iopanoic Acid. |
Cyclopropane. | Iopanoic Acid Tablets. |
Dapsone. | Ipecacuanha. |
Dexamphetamine Sulphate. | Ipecacuanha, prepared. |
Dextran Injection. | Isoniazid. |
Dextran Sulphate. | Lead Acetate. |
First Schedule—continued.
Lead Monoxide. | Primidone. |
Lemon Peel, dried. | Procyclidine Hydrochloride. |
Lemon Peel, fresh. | Procaine and Adrenaline Injection. |
Lemon Tincture. | Progesterone. |
Lemon Syrup. | Proguanil Hydrochloride. |
Leptazol. | Propantheline Bromide. |
Lignocaine and Adrenaline Injection. | Propantheline Tablets. |
Lignocaine Hydrochloride. | Propylene Glycol. |
Lignocaine Hydrochloride Injection. | Propyliodone. |
Liquorice Liquid Extract. | Propyliodone Injection. |
Lucanthone Hydrochloride. | Propyliodone Oily Injection. |
Male Fern. | Propyl Thiouracil. |
Maleic Acid. | Pyrimethamine. |
Mannitol. | Pyrimethamine Tablets. |
Mepacrine Hydrochloride. | Quillaia. |
Mephenesin. | Reserpine. |
Mephenesin Injection. | Reserpine Tablets. |
Mercuric Oxide, yellow. | Rosemary Oil. |
Mercury. | Senna Leaf. |
Mersalyl Acid. | Soda Lime. |
Methadone Hydrochloride. | Sodium Antimonylgluconate. |
Methoin. | Sodium Antimonylgluconate Injection. |
Methylated Spirits, industrial. | Sodium Aurothiomalate. |
Methyltestosterone. | Sodium Radio-iodide (131I) Injection. |
Methylamphetamine Hydrochloride. | Sodium Radio-iodide (131I) Solution. |
Methylthiouracil. | Sodium Radiophosphate (32P) Injection. |
Mustine Hydrochloride. | Sodium Radiophosphate (32P) Solution. |
Nalorphine Hydrobromide. | Sodium Stibogluconate. |
Naphazoline Nitrate. | Sodium Stibogluconate Injection. |
Neostigmine Bromide. | Solapsone. |
Neostigmine Methylsulphate. | Solapsone Tablets. |
Nicotinic Acid. | Stibophen. |
Nikethamide. | Sucrose. |
Nitrous Oxide. | Sulphadimidine Sodium. |
Nux Vomica. | Suramin. |
Oestradiol Benzoate. | Suxamethonium Bromide. |
Opium. | Suxamethonium Chloride. |
Opium, powdered. | Suxamethonium Chloride Injection. |
Orange Peel, dried bitter. | Syrup. |
Orange Peel, fresh bitter. | Testosterone. |
Orange Tincture. | Tetrachloroethylene. |
Orange Syrup. | Tetracycline Injection. |
Ouabain. | Thiomersal. |
Oxygen. | Thiopentone Sodium. |
Oxytetracycline Dihydrate. | Thiopentone Injection. |
Paramethadione. | Thyroid. |
Pentamidine Injection. | Thyroxine Sodium. |
Pentamidine Isethionate. | Thyroxine Sodium Tablets. |
Peppermint Oil. | Tolazoline Hydrochloride. |
Peppermint Water, concentrated. | Tolu Syrup. |
Peppermint Spirit. | Trichloroethylene |
Pethidine Tablets. | Troxidone. |
Phenindamine Tartrate. | Tryparsamide. |
Phenindione. | Tuberculin, old. |
Pheniodol. | Tuberculin Purified Protein Derivative. |
Phenolphthalein Tablets. | Tubocurarine Chloride. |
Phenolsulphonphthalein. | Tubocurarine Injection. |
Picrotoxin. | Typhoid-Paratyphoid A and B and Tetanus Vaccine. |
Prednisolone Acetate. | |
Prednisone Acetate. | Vanillin. |
Primaquine Phosphate. | Yellow Fever Vaccine. |
Second Schedule. Regulation 10 (3.)
DRUGS AND MEDICINAL PREPARATIONS THAT ARE PHARMACEUTICAL BENEFITS ONLY WHEN PRESCRIBED FOR USE IN A DETERMINED FORM OR IN ALLOWABLE COMPOUNDS.
Pharmaceutical Benefit._Allowable Compounds (if any). | |
Acetone B.P.C..................... | Zinc Sulphate B.P. with Sulphurated Potash B.P.C., Acetone B.P.C., Glycerin B.P. and Distilled Water B.P. |
| Magenta B.P.C. with Boric Acid B.P., Phenol B.P., Resorcinol B.P., Acetone B.P.C., Industrial Methylated Spirits B.P. and Water |
Dried Aluminium Hydroxide Gel. B.P..... | Prednisolone B.P. with Magnesium Trisilicate B.P. and Dried Aluminium Hydroxide Gel. B.P. |
| Prednisone B.P. with Magnesium Trisilicate B.P. and Dried Aluminium Hydroxide Gel. B.P. |
Aneurine Hydrochloride B.P........... | Vitamin A with Aneurine Hydrochloride B.P., Riboflavine B.P., Nicotinamide B.P., Ascorbic Acid B.P. and Vitamin D |
Ascorbic Acid B.P.................. | Vitamin A with Aneurine Hydrochloride B.P., Riboflavine B.P., Nicotinamide B.P., Ascorbic Acid B.P. and Vitamin D |
Bacitracin B.P..................... | Polymyxin B. Sulphate B.P. with Bacitracin B.P., Neomycin Sulphate B.P. and Paraffin Base |
| Bacitracin B.P. with Ophthalmic Phosphate Buffer Solution |
Bismuth Subnitrate B.P.C............. | Resorcinol B.P. with Bismuth Subnitrate B.P.C., Zinc Oxide B.P., Starch B.P., Cade Oil B.P., Wool Fat B.P., Sodium Metabisulphite, Water, Hard Paraffin B.P. and Yellow Soft Paraffin B.P. |
Carbromal B.P.................... | Pentobarbitone Sodium B.P. with Carbromal B.P. |
Chloramphenicol B.P................ | Chloramphenicol B.P. with Borate Buffer and Sterile Distilled Water |
| Chloramphenicol B.P. with Propylene Glycol B.P. |
Chlortetracycline Calcium............. | — |
Oil of Citronella................... | Dicophane B.P. with Emulsifying Wax B.P., Xylene B.P.C. 1949, Oil of Citronella and Water |
Diphtheria and Pertussis Vaccine B.P..... | Diphtheria, Tetanus and Pertussis Vaccine B.P. |
Diphtheria Vaccine B.P............... | Diphtheria and Pertussis Vaccine B.P. |
| Diphtheria, Tetanus and Pertussis Vaccine B.P. |
| Diphtheria Vaccine B.P. with Tetanus Toxoid, Purified Aluminium Phosphate Adsorbed |
Erythromycin B.P.................. | — |
Hamamelis Dry Extract............... | Hamamelis Dry Extract with Zinc Oxide B.P. and Theobroma Oil B.P. |
Hydrocortisone Acetate B.P............ | Hydrocortisone Acetate B.P. with Neomycin Sulphate B.P., Wool Fat B.P., Liquid Paraffin B.P. and White Soft Paraffin B.P. |
Isoprenaline Hydrochloride............ | — |
Mercuric Oxide Eye Ointment B.P....... | — |
Neomycin Sulphate B.P.............. | Hydrocortisone Acetate B.P. with Neomycin Sulphate B.P., Wool Fat B.P., Liquid Paraffin B.P. and White Soft Paraffin B.P. |
| Polymyxin B. Sulphate B.P. with Bacitracin B.P., Neomycin Sulphate B.P. and Paraffin Base |
Nicotinamide B.P .................. | Vitamin A with Aneurine Hydrochloride B.P., Riboflavine B.P., Nicotinamide B.P., Ascorbic Acid B.P. and Vitamin D |
Oestrone........................ | — |
Second Schedule—continued.
Pharmaceutical Benefit. | Allowable Compounds (if any). |
Oleandomycin..................... | Tetracycline with Oleandomycin |
Oxytetracycline Hydrochloride B.P ...... | — |
Papaveretum B.P.C................. | Papaveretum B.P.C. with Hyoscine Hydrobromide B.P. |
Pancreatin B.P .................... | — |
Benzathine Penicillin B.P ............. | Procaine Penicillin B.P. with Benzylpenicillin B.P. and Benzathine Penicillin B.P. |
Benzylpenicillin B.P................. | Fortified Procaine Penicillin Injection B.P. Benzylpenicillin B.P. with Procaine Penicillin B.P. and Streptomycin Sulphate B.P. Procaine Penicillin B.P. with Benzylpenicillin B.P. and Benzathine Penicillin B.P. |
Pentolinium Tartrate B.P ............. | Pentolinium Tartrate B.P. with Ephedrine B.P. |
Pethidine Hydrochloride B.P ........... | Pethidine Hydrochloride B.P. with Hyoscine Hydrobromide B.P. |
Pertussis Vaccine B.P................ | Diphtheria, Tetanus and Pertussis Vaccine B.P. Diphtheria and Pertussis Vaccine B.P. |
Phenylephrine Hydrochloride B.P ....... | Phenylephrine Hydrochloride B.P. with Benzocaine B.P., Bismuth Subgallate, Zinc Oxide B.P., Hamamclis Dry Extract, Tannic Acid B.P., Menthol B.P., Boric Acid B.P. and Oil of Theobroma B.P. |
Phenoxymethylpenicillin B.P........... | — |
Phenoxymethylpenicillin (Calcium Salt) | — |
Phenoxymethylpenicillin (Potassium Salt) | — |
Phenoxymethylpenicillin (Hydrabamine Salt) | — |
Polymyxin B. Sulphate B.P............ | Polymyxin B. Sulphate B.P. with Mucilage of Methylcellulose and Distilled Water B.P. |
| Polymyxin B. Sulphate B.P. with Bacitracin B.P., Neomycin Sulphate B.P. and Paraffin Base |
| Polymyxin B. Sulphate B.P. with Ophthalmic Phosphate Buffer |
Prednisolone B.P................... | Prednisolone B.P. with Magnesium Trisilicate B.P. and Dried Aluminium Hydroxide Gel. B.P. |
Prednisone B.P .................... | Prednisone B.P. with Magnesium Trisilicate B.P. and Dried Aluminium Hydroxide Gel. B.P. |
Procaine Hydrochloride B.P............ | Procaine Hydrochloride B.P. in Normal Saline. Tetracycline and Procaine Injection B.P. |
Riboflavine B.P.................... | Vitamin A. with Aneurine Hydrochloride B.P., Riboflavine B.P., Nicotinamide B.P., Ascorbic Acid B.P. and Vitamin D |
Sodium Chloride B.P. with Potassium Chloride B.P. and Hydrated Calcium Chloride in Water for Injection B.P. | Sodium Chloride B.P. with Potassium Chloride B.P., Hydrated Calcium Chloride B.P., Water for Injection B.P. and Dextrose B.P. |
Compound Sodium Lactate Injection B.P. | Compound Sodium Lactate Injection B.P. with Dextrose B.P. |
Sodium Lauryl Sulphate B.P........... | Emulsifying Wax B.P. |
Streptomycin Sulphate B.P ............ | Benzylpenicillin B.P. with Procaine Penicillin B.P. and Streptomycin Sulphate B.P. Streptomycin Sulphate B.P. with Normal Saline. |
Sulphadimidine B.P................. | Sulphadiazine B.P. with Sulphamerazine B.P. and Sulphadimidine B.P. |
Sulphamerazine B.P................. | Sulphadiazine B.P. with Sulphamerazine B.P. and Sulphadimidine B.P. |
| Sulphadiazine B.P. with Sulphamerazine B.P. and Sulphathiazole |
Second Schedule—continued.
Pharmaceutical Benefit._Compounds (if any). | |
Sulphamerazine B.P.—continued. | Sulphadiazine B.P. with Sulphamerazine B.P. and Sulphacetamide |
Sulphacetamide.................... | Sulphadiazine B.P. with Sulphamerazine B.P. and Sulphacetamide |
Sulphathiazole.................... | Sulphadiazine B.P. with Sulphamerazine B.P. and Sulphathiazole |
Terpineol B.P..................... | Solution of Chloroxylenol B.P. |
Tetanus Toxoid, Purified Aluminium Phosphate Adsorbed Tetanus Vaccine B.P................ | Diphtheria Vaccine B.P. with Tetanus Toxoid, Purified Aluminium Phosphate Adsorbed Diphtheria, Tetanus and Pertussis Vaccine B.P. |
Tetracycline Hydrochloride B.P......... | Tetracycline Hydrochloride B.P. with Nystatin Tetracycline and Procaine Injection B.P. Tetracycline Hydrochloride B.P. with a buffering agent |
Tetracycline...................... | Tetracycline with Oleandomycin |
Theobroma Prepared B.P.C............ | Calcium Gluconate B.P. with Sucrose B.P., Vanillin B.P. and Theobroma Prepared B.P.C. |
Typhoid Para-Typhoid A and B Vaccine B.P. | Typhoid Para-Typhoid A, B and C Vaccine B.P. |
Tyrothricin....................... | Tyrothricin with a buffering agent |
Concentrated Vitamin A Solution B.P. Concentrated Vitamin D Solution B.P. | Concentrated Vitamins A and D Solution B.P. Concentrated Vitamins A and D Solution B.P. |
Vitamin D....................... | Vitamin A with Aneurine Hydrochloride B.P., Riboflavine B.P., Nicotinamide B.P., Ascorbic Acid B.P. and Vitamin D |
Xylene B.P.C. 1949................. | Dicophane B.P. with Emulsifying Wax B.P., Xylene B.P.C. 1949, Oil of Citronella and Water |
Yellow Mercuric Oxide B.P............ | Mercuric Oxide Eye Ointment B.P. |
__________
Third Schedule.
Regulation 11.
PHARMACEUTICAL BENEFITS ADDITIONAL TO PHARMACEUTICAL BENEFITS IN THE BRITISH PHARMACOPOEIA.
Acetone, B.P.C._ Aromatic Ammonia Spirit, B.P. 1953. | |
Aconite Liniment, B.P.C. | Aurothioglucose. |
Acriflavine, B.P. 1948. | Balsam of Peru, B.P.C. |
Adrenaline Hydrochloride Solution, B.P. 1953. | Beeswax, Yellow, B.P.C. Belladonna Suppository, B.P. 1948. |
Adrenaline in Oil. | Bemegride, A.P.F. 1955. |
Agar, B.P.C. | Benzoinated Lard, B.P.C. |
Aloes Pill, B.P. 1948. | Bismuth Carbonate, B.P. 1953. |
Aloin, B.P. 1953. | Bismuth Glycollylarsanilate. |
Aloxidone. | Bismuth Subgallate, B.P. 1953. |
Aluminium Acetate Solution, B.P.C. | Bismuth Subnitrate, B.P.C. |
Amidopyrin, B.P.C. | Buchu Concentrated Infusion, B.P.C. |
Amiphenazole Hydrochloride, A.P.F. 1955. | Busulphan. Butyl Aminobenzoate, B.P. 1953. |
Ammonium Acetate, Strong Solution, B.P. 1953. | Caffeine Citrate, B.P.C. Cajuput Tincture, B.P.C. |
Ammonium Bicarbonate, B.P. 1953. | Calamine Cream, A.P.F. |
Ammonium Bromide, B.P.C. | Calcium Aurothiomalate. |
Amphotericin B. | Calcium Di-Oxytetracycline. |
Amylobarbitone Sodium, B.P.C. | Calcium Benzoyl Para-Aminosalicylate. |
Aromatic Ammonia Solution, B.P.C. | Calcium Para-Aminosalicylate, B.P.C. |
Third Schedule—continued.
Calcium Phosphate, B.P. 1953. | Heparin Retard. |
Calumba Concentrated Infusion, B.P. 1948. | Hexoestrol. Hydrocortisone Sodium Succinate. |
Calumba Tincture, B.P. 1948. | Hydrocyanic Acid Dilute, B.P.C. |
Capsicum Ointment, B.P.C. | Hypophosphorous Acid Dilute, B.P.C. |
Capsicum Tincture, B.P.C. | Insulin Isophane (N.P.H.). |
Caramiphen Hydrochloride. | Insulin Special P. (Pig). |
Cardamom Aromatic Tincture, B.P.C. | Iodoform, B.P.C. |
Catechu Tincture, B.P.C. | Iodoform Suppository, B.P. 1948. |
Charcoal. | Ipomoca Resin. |
Chiniofon, B.P. 1948. | Iron Carbonate Saccharated, B.P.C. |
Chlorambucil. | Isoprenaline Hydrochloride. |
Chlorazanil. | Lobelia Ethereal Tincture, B.P.C. |
Chlormerodrin. | Magenta, B.P.C. |
Chlorpropamide. Chlortetracycline Calcium. | Magnesium Bicarbonate Solution, B.P. 1948. |
Chlorothiazide. | Mecamylamine. |
Cloves, Concentrated Infusion, B.P.C. | Mecholyl Chloride. |
Codeine, B.P.C. | Mercaptomerin Sodium. |
Cod Liver Oil Emulsion, B.P. 1953. | Mercaptopurine. |
Colchicine Salicylate. | Mercuric Chloride, B.P. 1953. |
Colocynth and Hyoscyamus Pill, B.P.C. | Mercurous Chloride Ointment, B.P. 1948. |
Colocynth, B.P.C. | Mercury Compound Ointment, B.P.C. |
Colocynth Compound Powder Extract, B.P.C. | Methorphinan. Methyl Androstanolone. |
Compound Effervescent Powder B.P., 1953. | Methyl Atropine Nitrate. Myrrh, B.P.C. |
Creosote, B.P. 1953. | Myrrh Tincture, B.P.C. |
Crude Coal Tar. | Nitrofurantoin. |
Darrow’s Solution. | Nitromin. |
Desacetyl-Lanatoside C. | Nux Vomica Extract, Dried, B.P. 1953. |
Dexamethasone. | Nystatin. |
Dextran Iron. | Oestradiol Dipropionate. |
Dextrin Iron. | Oestrone. |
Dextrose in /?/ Normal Saline. | Oleandomycin. |
Diethazine Hydrochloride. Digitoxin, B.P.C. | Orange Peel Infusion Concentrated, B.P. 1948. |
Dihydrochlorothiazide. Dihydroergotamine. | Orange Peel Infusion Concentrated, Compound, B.P.C. |
Dihydromorphinone Hydrochloride, B.P.C. 1949. | Ox-Bile Extract, B.P. 1948. Oxymel, B.P.C. |
Dihydrotachysterol. | Oxymel of Squill, B.P.C. |
Diphtheria Toxoid Purified. | Pancrex 5. |
Disodium Diethylstilboestrol Diphosphate. | Para-Aminosalicylic Acid. |
Effervescent Powder Compound B P 1953. | Paraben Ophthalmic Phosphate Buffer, A.P.F. |
Ephedrine Sulphate, B.P.C. | Paraben Ophthalmic Vehicle, A.P.F. |
Ergot Liquid Extract, B.P.C. | Papaveretum, B.P.C. |
Erythrityltetranitrate, B.P.C. 1949. | Benzylpenicillin in Oil. |
Ether Nitrous Spirit, B.P.C. | Pentaerythritol Tetranitrate. |
Ethoxzolamide. Ethylidene Dicoumarin. | Pertussis Prophylactic (Haemagglutinin Aluminium Phosphate Adsorbed). |
Ferric Chloride Solution, B.P.C. | Phemitone, B.P. 1953. |
Ferrous Phosphate Compound Syrup, B.P.C. | Phenazone, B.P.C. Phenoxymethylpenicillin (Calcium Salt). |
Ferrous Phosphate with Quinine and Strychnine Syrup, B.P.C. | Phenoxymethylpenicillin (Potassium Salt). |
Fluoxymesterone. | Phenoxymethylpenicillin (Hydrabamine Salt). |
Fructose, B.P. 1948. | Phensuximide. |
Gall with Opium Ointment, B.P.C. | Phenylbutazone. |
Gelsemium Tincture, B.P.C. | Phthalysulphacetamide. |
Gentian Violet. | Pholcodine, B.P.C. |
Glucose Liquid, B.P. 1953. | Pholcodine Citrate Syrup, B.P.C. |
Glycerophosphates Compound Syrup, A.P.F. | Pituitary (Posterior Lobe). Potash Sulphurated, B.P.C. |
Hamamelis Dry Extract. | Potassium Chlorate, B.P.C. |
Third Schedule—continued.
Prophenpyridamine Para-Aminosalicylate. | Sulphamethizole. |
Protamine Sulphate. | Sulphathiazole. |
Protoveratrines (A and B). | Sulphapyridine, B.P.C. |
Pyridostigmine Bromide. | Sulphuric Acid Dilute, B.P.C. |
Pyridoxine Hydrochloride, B.P.C. | Sustanon. |
Quassia Tincture. B.P. 1948. | Syntocinon. |
Senega Concentrated Infusion, B.P.C. | Talc Purified, B.P.C. |
Senna Compound Mixture, B.P.C. | Testosterone Oenanthate. |
Senna Leaf Concentrated Infusion, B.P.C. Siberian Fir Oil, B.P.C. 1949. | Tetanus Toxoid, Purified Aluminium Phosphate Adsorbed. |
Silver Picrate, B.P.C. 1949. | Tetracycline. |
Silver Protein Mild, B.P.C. | Theobromine, B.P.C. |
Soap Curd, B.P.C. | Theobroma Prepared, B.P.C. |
Soap Hard, B.P.C. | Thiacetazone. |
Sodium Calcium Edetate. | Thiouracil, B.P. 1948. |
Sodium Carbonate Exsiccated, B.P.C. | Tiger Snake Antivenene. |
Sodium Lactate. | Tolbutamide. |
Sodium Nitrite, B.P.C. | Tretamine. |
Sodium Oleate Acid. | Triethanolamine Trinitrate. |
Sodium Tauroglycocholate. | Trimetaphan Camphorsulphonate. |
Sorbolene, A.P.F. | Trinitrophenol, B.P.C. |
Squill Tincture. | Tyrothrvcin. |
Squill Vinegar, B.P. 1948. | Valerian Ammoniated Tincture. B.P.C. |
Strophanthus Tincture, B.P. 1948. | Vasopressin Tannate in Oil. |
Strychnine, B.P.C. | Veriloid. |
Sulpnacetamide. Sulphadiazine Sodium. | Vitamin A. |
Sulphadimethoxine. | Vitamin D. |
Sulphamethoxypyridazine. | Vitamin K1. |
Sulphafurazole. | Xylene, B.P.C. 1949. |
_________ Fourth Schedule. Regulation 12. ADDITIVES. | |
Alcohol, B.P. | Oil of Lavender, B.P. 1953. |
Anise Oil, B.P. | Oil of Spike Lavender, B.P.C |
Aniseed Water, concentrated, B.P.C. | Orange Syrup, B.P. |
Borate Buffer. | Orange Tincture, B.P. |
Camphor Water, B.P. | Peppermint Oil, B.P. |
Camphor Water, Concentrated, B.P.C. 1949 .. | Peppermint Spirit, B.P. Peppermint Water, concentrated, B.P. |
Carmine Solution, AP.F. | Propylene Glycol, B.P. |
Chloroform, D.P. | Rosemary Oil, B.P. |
Chloroform Spirit, B.P. | Solution of Amaranth, B.P.C. |
Chloroform Water, B.P. | Spirit of Aniseed, B.P .C. 1949. |
Chloroform Water, concentrated, B.P.C. | Spirit of Cajuput, D.P. 1948. |
Cinnamon Oil, D.P. | Spirit of Cinnomon, B.P.C. 1949. |
Cinnamon Water, ·concentrated, B.P. | Stearic Acid, B.P.C. |
Coconut Oil, B.P.C. 1949. | Sucrose, B.P. |
Coriander Oil, B.P. | Syrup, B.P. |
Dill Oil, D.P. | Syrup of Ginger B.P. |
Dill Water, concentrated, B.P. | Syrup of Lemon, neutral, A.P.P. |
Ether Anaesthetic, B.P'. | Syrup, Red. |
Ether Solvent, B.P. | Syrup of Squill, B.P.C. |
Honey Purified, B.P.C. | Syrup of Tolu, B.P. |
Industrial Methylated Spirit, B.P. | Tincture of Cochineal, B.P. 1948. |
Lemon Tincture, B.P. | Tincture of Cudbear, A.P.F. 1947. |
Lemon Syrup, B.P. | Tincture of Quillaia, B.P'.C. |
Liquorice Liquid Extract, D.P. | Triethanolamine, D.P.C. |
Methylcellulose, A.P.F. | Vanillin, B.P. |
Methylcellulose Mucilage, A.P.F. | Volatile Bitter Almond Oil, B.P. 1953. |
Oil of Caraway, B.P.C. | |
Fifth Schedule.
Regulation 14.
PHARMACEUTICAL BENEFITS THE PRESCRIBING OF WHICH IS SUBJECT TO CONDITIONS AND RESTRICTIONS.
Pharmaceutical Benefit._for which, and the Conditions subject to which, the Pharmaceutical Benefit may be prescribed (including any restrictions as to the persons for whose treatment it may be prescribed) for supply under Part VII. of the Act. | |
Amiphenazole Hydrochloride A.P.F. 1955 | As an antidote to barbiturate and other hypnotic poisons |
Amodiaquine Tablets B.P............. | Amoebiasis |
Lupus erythematosus | |
Malaria | |
Any disease or condition in a pensioner | |
Amphotericin B.................... | Systemic fungal infections |
Aneurine Hydrochloride Tablets B.P...... | Any disease or condition in a pensioner |
Ascorbic Acid Tablets B.P............. | Any disease or condition in a pensioner |
Bemegride A.P.F. 1955............... | As an antidote to barbiturate and other hypnotic poisons |
Busulphan....................... | The leukaemias |
Calciferol Tablets B.P................ | Any disease or condition in a pensioner |
Calciferol Solution B.P............... | Any disease or condition in a child under the age of ten years or in a pensioner |
Calcium Para-Aminosalicylate B.P.C...... | Tuberculosis |
Calcium Benzoyl Para-Aminosalicylate | Tuberculosis |
Caramiphen Hydrochloride............ | Parkinsonism |
Chlorambucil..................... | Malignant lymphoma and related conditions |
Chloramphenicol Capsules B.P.......... | Bacillary dysentery that is resistant both to the Sulphonamides and Streptomycin Sulphate |
Bacterium coli meningitis, if other forms of treatment are unsuccessful | |
| Brucellosis |
| Granuloma inguinale |
| Friedlander bacillus infections |
| Haemophilus influenzae infections |
| Laryngo-tracheo-bronchitis, acute |
| Lymphogranuloma venereum |
| Salmonella infections |
| Staphylococcal infections |
| Surgical conditions of the bowel (pre-operative and post-operative) |
| Typhoid fever |
| Typhus and other rickettsial diseases |
| Urinary tract infections duo to gram negative bacilli that are resistant to the Sulphonamides |
| Whooping cough (Haemophilus pertussis) |
| As an alternative to the Penicillins in a person sensitive to the Penicillins |
| Severe gastro-enteritis in a child under the age of sixteen years |
Chloramphenicol B.P., Injection......... | A disease or condition specified in this column in relation to Chloramphenicol Capsules |
Chloramphenicol B.P., Oral Suspension | A disease or condition, specified in this column in relation to Chloramphenical Capsules, in a child under the age of ten years |
|
|
Chloroquine Sulphate Tablets B.P. | Lupus erythematosus |
Chloroquine Phosphate Injection B.P. | Malaria |
Chloroquine Sulphate Injection B.P. | Any disease or condition in a pensioner |
Fifth Schedule—continued.
Pharmaceutical Benefit._Purpose for which, and the Conditions subject to which, the Pharmaceutical Benefit may be prescribed (including any restrictions as to the persons for whose treatment it may be prescribed) for supply under Part VII. of the Act. | |
Chlortetracycline Capsules B........... | As an alternative to the Penicillins in a person sensitive to the Penicillins |
| Actinomycosis |
| Amoebiasis |
| Bacterial endocarditis (Streptococcus faccalis), acute and sub-acute |
| Bacillary dysentery that is resistant both to the Sulphonamides and Streptomycin Sulphate |
| Bronchiectasis |
| Brucellosis |
| Chancroid |
| Fibrocystic disease of the pancreas |
| Granuloma inguinale |
| Friedlander bacillus infections |
| Leptospirosis |
| Lymphogranuloma venereum |
| Mucoviscidosis |
| Pneumonia that is resistant both to the Penicillins and the Sulphonamides |
| Primary atypical pneumonia |
| Psittacosis |
| Puerperal infections |
| Rat-bite fever (Spirillum minus) |
| Staphylococcal infections |
| Trachoma that is resistant to the Sulphonamides |
| Typhus and other rickettsial diseases |
| Urinary tract infections duo to gram negative bacilli that are resistant to the Sulphonamides |
Whooping cough (Haemophilus pertussis) | |
| A disease or condition specified in this column in relation to Chlortetracycline Capsules |
Chlortetracycline Calcium........... | A disease or condition, specified in this column in relation to |
Chlortetracycline B.P., Granules | Chlortetracycline Capsules, in a child under the age of ten years |
Cod Liver Oil Emulsion B.P. 1953....... | Any disease or condition in a child under the age of ten years or in a pensioner |
Corticotrophin Injection B.P........... | With the written authority of the Director-General— |
| Nephritis, type II. |
Status asthmaticus | |
Cortisone Injection B.P............... | With the written authority of the Director-General— |
| Anaemia, acquired haemolytic |
| Addison’s disease and other forms of adrenocortical hypoplasia |
| Adrenalectomy, total |
| Adrenogenital syndrome |
| Cushing’s syndrome, including hyperadrenocorticalism |
| Dermatitis, acute exfoliative, associated with drug therapy |
| Dermatomyositis |
| Hepatitis, progressive or continuing, proven by biopsy or biochemistry |
| The leukaemias |
| Nephritis, type II. |
| Nephrotic syndrome |
| Neuro-myelitis optica |
Fifth Schedule—continued.
Pharmaceutical Benefit._Purpose for which, and the Conditions subject to which, the Pharmaceutical Benefit may be prescribed (including any restrictions as to the persons for whose treatment it may be prescribed) for supply under Part VII. of the Act. | |
Cortisone Injection B.P.—continued. | Optic neuritis following removal of tumor of the brain |
| Panhypopituitarism |
| Pemphigus |
| Periarteritis nodosa |
| Pseudohermaphroditism |
| Purpura, Henoch’s |
| Purpura, thrombocytopenic |
| Rheumatic carditis, acute |
| Sarcoidosis |
| Scleroderma |
| Status asthmaticus |
| Systemic lupus erythematosus |
| Sympathetic ophthalmitis |
| Ulcerative colitis proven by sigmoidoscopy and radiological report |
| Uveitis, posterior |
| Still’s disease in a child under the age of sixteen years |
Cortisone Tablets B.P................ | A disease or condition specified in this column in relation to Cortisone Injection |
Cyanocobalamin Injection B.P. (other than 1,000 microgramme strength) | Established megalocytic anaemias |
Cyanocobalamin Injection B.P., 1,000 microgramme strength | Neuroblastoma |
|
|
Deoxycortone Acetate Injection B.P. | |
Deoxycortone Acetate Implant B.P. | Total adrenalectomy |
Dexamethasone.................... | With the written authority of the Director-General, a disease or condition specified in this column in relation to Cortisone Injection |
| As an alternative to Oral Iron in a person unable to take Oral Iron |
Dextrin Iron .................... | |
Dienoestrol Tablets B.P .............. | Carcinoma of the prostate |
| Mammary carcinoma |
| Any disease or condition in a pensioner |
Dihydrostreptomycin Sulphate Injection B.P. | As an alternative to Streptomycin Sulphate in a person who is being treated for a disease or condition specified in this column in relation to Streptomycin Sulphate and who is allergic to Streptomycin Sulphate |
Dihydrotachysterol.................. | Parathyroid deficiency |
Disodium Diethylstilboestrol Diphosphate | Carcinoma of the prostate |
| Staphylococcal infections that are resistant both to the Tetracyclines and to the Penicillins |
Erythromycin Tablets B.P ............. | |
Erythromycin B.P., Oral Suspension...... | Staphylococcal infections that are resistant both to the Tetracyclines and to the Penicillins in a child under the age of ten years |
Ethinyloestradiol Tablets B.P........... | Turner’s syndrome |
Any disease or condition in a pensioner | |
Ethisterone Tablets B.P............... | Turner’s syndrome |
Any disease or condition in a pensioner | |
Fluoxymesterone .................. | Mammary carcinoma |
| Macrocytic anaemia |
Folic Acid Tablets B.P ............... | Sprue or the sprue-like syndrome |
Hydrocortisone Injection B.P .......... | With the written authority of the Director-General, a disease or condition specified in this column in relation to Cortisone Injection |
Fifth Schedule—continued.
Pharmaceutical Benefit._Purpose for which, and the Conditions subject to which, the Pharmaceutical Benefit may be prescribed (including any restrictions as to the persons for whose treatment it may be prescribed) for supply under Part VII. of the Act. | |
Hydrocortisone Sodium Succinate...... | Acute adrenal failure due to a medical or surgical crisis |
Isoniazid Tablets B.P............... | Leprosy |
Tuberculosis | |
| Any disease or condition in a child under the age of ten years or in a pensioner |
Malt Extract with Cod Liver Oil B.P. | |
Mercaptopurine.................. | The leukaemias |
Methorphinan.................... | Inoperable cancer |
Methyl Androstanolone ............. | Mammary carcinoma |
Mustine Injection B.P .............. | Malignant lymphoma and related conditions |
Nicotinamide Tablets B.P ........... | Any disease or condition in a pensioner |
Nicotinic Acid Tablets B.P ........... | Any disease or condition in a pensioner |
Nitrofurantoin................... | Urinary tract infections |
Nitromin ....................... | Malignant lymphoma and related conditions |
Nystatin ....................... | Proven monilia infections |
| A disease or condition specified in this column in relation to Chlortetracycline Capsules |
Oxytetracycline Injection B.P. | |
Oxytetracycline and Procaine Injection B.P. | |
Calcium Di-Oxytetracycline .......... | A disease or condition, specified in this column in relation to Chlortetracycline Capsules, in a child under the age of ten years |
Pancreatin B.P................... | Fibrocystic disease of the pancreas |
Pancreatico-duodenectomy | |
Pancrex 5 ...................... | Fibrocystic disease of the pancreas |
| Pancreatico-duodenectomy |
Para-Aminosalicylic Acid............ | Tuberculosis |
Benzathine Penicillin Tablets B.P ...... | Chorea |
| Nephritis |
| Rheumatic fever |
| Haemophilia |
| Any disease or condition in a pensioner |
| Any disease or condition in a child under the age of ten years |
Phenoxymethylpenicillin (Calcium Salt), Oral Suspension | |
Phenoxymethylpenicillin (Hydrabamine Salt), Oral Suspension |
|
Phenoxymethylpenicillin (Potassium Salt), Oral Suspension | |
Benzylpenicillin B.P. with Procaine Penicillin B.P. and Streptomycin Sulphate B.P. | Endocarditis due to Streptococcus faecalis or Streptococcus viridans |
Phenylbutazone.................. | Any disease or condition in a pensioner |
| With the written authority of the Director-General, a disease or condition specified in this column in relation to Cortisone Injection |
| |
Prednisone Tablets B.P.............. | With the written authority of the Director-General, a disease or condition specified in this column in relation to Cortisone Injection |
Prednisone B.P. with Magnesium Trisilicate B.P. and Dried Aluminium Hydroxide Gel. B.P. | |
Progesterone Injection B.P........... | Habitual abortion |
Protoveratrines (A and B) ........... | Hypertensive crisis |
| Myasthenia gravis |
Quinine Dihydrochloride B.P. | Malaria |
Quinine Dihydrochloride Injection B.P. | Any disease or condition in a pensioner |
Fifth Schedule—continued.
Pharmaceutical Benefit._for which, and the Conditions subject to which, the Pharmaceutical Benefit may be prescribed (including any restrictions as to the persons for whose treatment it may be prescribed) for supply under Part VII. of the Act. | |
Riboflavine Tablets B.P................. | Any disease or condition in a pensioner |
| Tuberculosis |
Sodium Aminosalicylate Tablets B.P. | |
|
|
Mammary carcinoma | |
Stilboestrol Tablets B.P................ | Any disease or condition in a pensioner |
Streptomycin Sulphate B.P ............... | Bacillary dysentery that is resistant to the Sulphonamides |
| Brucellosis |
| Chancroid |
| Endocarditis due to Streptoccus faecalis or Streptococcus viridans |
| Friedlander bacillus infections |
| Haemophilus influenzae infections |
| Plague |
| Pseudomonas pyocyaneus infections |
| Rat-bite fever (Streptobacillus moniliformis) |
| Salmonella infections |
| Surgical conditions of the bowel (pre-operative and post-operative) |
| Surgical conditions of the thoracic organs |
| Tuberculosis |
| Tularaemia |
| Urinary tract infections that are resistant to the Sulphonamides |
Streptomycin Sulphate Injection B.P......... | A disease or condition specified in this column in relation to Streptomycin Sulphate |
Sustanon........................... |
|
| Mammary carcinoma |
| Castration |
Testosterone Oenanthate................. | |
Testosterone Propionate Injection B.P. | |
Testosterone Propionate B.P. | |
Methyltestosterone Tablets B.P. | Mammary carcinoma |
| A disease or condition, specified in this column in relation to Chlortetracycline Capsules |
Tetracycline Tablets B.P ................. | |
Tetracycline and Procaine Injection B.P. | |
Tetracycline Hydrochloride B.P. with a buffering agent—Capsules Tetracycline with Oleandomycin | |
| |
Tetracycline Hydrochloride B.P. | A disease or condition, specified in this column in relation to Chlortetracycline Capsules, in a child under the age of ten years |
Tetracycline Hydrochloride B.P. with a buffering | |
agent—Oral Suspension | |
Tetracycline Hydrochloride B.P. with a buffering | |
agent—Paediatric Drops | |
Tetracycline with Oleandomycin—Oral Suspension | |
Tetracycline Hydrochloride B.P. with Nystatin | Broad spectrum antibiotic therapy of premature infants, of patients under steroid therapy or of cases complicated by intestinal moniliasis |
| A second or repeated course of broad spectrum antibiotic therapy for a disease or condition specified in this column in relation to Chlortetracycline Capsules |
Tretamine........................... | Malignant lymphoma and related conditions |
Trimetaphan Camphorsulphonate........... | Hypotensive for anaesthesia |
Veriloid............................ | Hypertensive crisis |
Fifth Schedule—continued.
Pharmaceutical Benefit._for which, and the Conditions subject to which, the Pharmaceutical Benefit may be prescribed (including any restrictions as to the persons for whose treatment it may be prescribed) for supply under Part VII. of the Act. | |
Vitamin A Activity with Aneurine Hydrochloride B.P., Riboflavine B.P., Nicotinamide B.P., Ascorbic Acid B.P. and Vitamin D | Any disease or condition in a pensioner |
Concentrated Vitamin A and D Solution B.P. Concentrated Vitamin D Solution | Any disease or condition in a child under the age of ten years or in a pensioner |
Vitamin K1...................... | As an antidote to anticoagulants |
_________
Sixth Schedule.
forms.
Regulation 8.
FORM A.
Commonwealth of Australia.
National Health Act 1953-1959.
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 1953-1959 in respect of pharmaceutical chemists premises situated at
*I/We hereby declare that *I am a/We are pharmaceutical *chemist/chemists registered as such under the law of a *State/Territory of the Commonwealth, namely
*I /We further declare that *I am/We are willing to supply on demand, at or from the premises specified above, pharmaceutical benefits in accordance with Part VII. of the National Health Act 1953-1959.
Dated this day of , 19 .
(Signature of applicant(s).)
To the Director-General of Health,
Commonwealth of Australia.
* Strike out whichever is inapplicable.
Sixth Schedule—continued.
Form B.
Regulation 8.
Commonwealth of Australia.
National Health Act 1953-1959,
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 1953-1959 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 1953-1959.
*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.
_______
Form C.
Regulation 8.
Commonwealth of Australia.
National Health Act 1953-1959.
APPLICATION FOR APPROVAL AS A HOSPITAL AUTHORITY FOR THE PURPOSE OF SUPPLYING PHARMACEUTICAL BENEFITS.
I , of the person authorized to make this application by the *governing body/proprietor of the
Hospital, which is a *private/public hospital, hereby apply under the National Health Act 1953-1959 for approval of that hospital authority for the purpose of supplying 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 1953-1959.
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.
___________________
By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.