{"id":"C1956L00054","name":"National Health (Pharmaceutical Benefits) Regulations","slug":"c1956l00054","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":"54 of 1956","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":320700,"registerId":"commonwealth-C1956L00054-current","compilationNumber":null,"startDate":"2026-04-08","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health (Pharmaceutical Benefits) Regulations","content":"STATUTORY RULES.\n\n![](image.001.png)1956\\. No. 54.\n\nREGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1955.\\*\n\nI, 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.\n\nDated this twenty-eighth day of June, 1956.\n\nW.J. SLIM\n\nGovernor-General.\n\nBy His Excellency's Command,\n\n(Sgd.) Donald A. Cameron\n\n![](image.001.png)Minister of State for Health.\n\nNATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS.\n\nPART I.—PRELIMINARY.\n\nCitation.\n\n1. These Regulations may be cited as the National Health (Pharmaceutical Benefits) Regulations.\n\nCommencement.\n\n2. These Regulations shall come into operation on the first day of July, 1956.\n\nRepeal.\n\n3\\. 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Regulations (comprising Statutory Rules 1954, Nos. 54, 77, 78, 93, 95 and 128; and Statutory Rules 1955, No. 40) are repealed.\n\nParts.\n\n4. These Regulations are divided into Parts as follows:—\n\nPart I.—Preliminary (Regulations 1-7).\n\nPart II.—Approvals of Chemists and Hospitals under Part VII. of the Act (Regulations 8-9).\n\nPart III.—General Pharmaceutical Benefits (Regulations 10-11).\n\nPart IV.—Pharmaceutical Benefits under Section 93 of the Act (Regulations 12-16).\n\nPart V.—Prescriptions and Supply (Regulations 17-31).\n\nPart VI.—Miscellaneous (Regulations 32-36).\n\nInterpretation.\n\n5.—(1.) In these Regulations, unless the contrary intention appears—\n\n“authorized form” means a form authorized by the Director-General;\n\n![](image.002.png)“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\n\n\\* Notified in the Commonwealth Gazette on , 1956.\n\n3014/56.—PRICE 1S. 9/5.6.1956.\n\n \ntop 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”;\n\n“controlled therapeutic substance” has the same meaning as in the Therapeutic Substances Act 1953;\n\n“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;\n\n“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;\n\n“the Act” means the National Health Act 1953-1955;\n\n“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;\n\n“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;\n\n“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.\n\n(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.\n\n(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.\n\nForms.\n\n6.—(1.) A reference to a Form by letter shall be read as a reference to the Form so lettered in the Third Schedule.\n\n(2.) Strict compliance with the Forms contained in the Third Schedule is not necessary and substantial compliance is sufficient.\n\nDelegation.\n\n7.—(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).\n\n(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.\n\n \n\n(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.\n\n(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.\n\nPART II.—APPROVALS OF CHEMISTS AND HOSPITALS UNDER PART VII. OF THE ACT.\n\nApplication for approval by a pharmaceutical chemist or hospital authority.\n\n8\\. 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.\n\nCertain requirements to be met after cancellation, &c., of approval.\n\n9. Where the approval of an approved pharmaceutical chemist is suspended, revoked or cancelled, the pharmaceutical chemist—\n\n(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\n\n(b) shall not, in any way, indicate that he has been, or is, approved to supply pharmaceutical benefits.\n\nPenalty: Fifty pounds.\n\nPART III.—GENERAL PHARMACEUTICAL BENEFITS.\n\nGeneral pharmaceutical benefits.\n\n10. 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.\n\nPharmaceutical benefits that may be prescribed only for specified diseases or purposes.\n\n11.—(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.\n\n(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:—\n\nDienoestrol,\n\nPenicillin Tablets.\n\nQuinine Bisulphate.\n\nQuinine Dihydrochloride.\n\nQuinine Hydrochloride.\n\nQuinine Sulphate.\n\nStilboestrol.\n\n \nPART IV.—PHARMACEUTICAL BENEFITS UNDER SECTION 93 OF THE ACT.\n\nMedical practitioners excepted from the authorization conferred by section 93.\n\n12. 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.\n\nObtaining of benefits by medical practitioners for purposes of section 93.\n\n13.—(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.\n\n(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.\n\nSupply of pharmaceutical benefits by chemists for purpose of section 93.\n\n14. 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.\n\nPenalty: Twenty pounds.\n\nObtaining a particular brand for purpose of section 93.\n\n15. 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.\n\nPenalty: Fifty pounds.\n\nPayment for pharmaceutical benefits supplied for the purpose of section 93.\n\n16. 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.\n\nPART V.—PRESCRIPTIONS AND SUPPLY.\n\nWriting of prescription.\n\n17.—(1.) A prescription is not duly written unless the medical practitioner who writes the prescription—\n\n(a) writes the prescription in ink in his own handwriting, unless the Director-General otherwise allows, on an authorized prescription form;\n\n(b) writes the prescription in duplicate and marks that duplicate with the word “Duplicate”;\n\n(c) dates and signs the prescription;\n\n \n\n(d) states the name and address of the person for whom the pharmaceutical benefit is to be supplied;\n\n(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;\n\n(f) where the prescription is for the supply of a pensioner pharmaceutical benefit—\n\n(i) states the pension number of the pensioner to whom the pensioner pharmaceutical benefit is to be supplied; and\n\n(ii) if the benefit to be supplied consists of a single drug, indicates the mode in which the benefit is to be used; and\n\n(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\".\n\n(2.) A prescription is not duly written if the prescription—\n\n(a) prescribes a general pharmaceutical benefit and a pensioner pharmaceutical benefit;\n\n(b) includes two prescriptions for the same pharmaceutical benefit;\n\n(c) prescribes pharmaceutical benefits for more than one person;\n\n(d) prescribes more than two general pharmaceutical benefits or more than two pensioner pharmaceutical benefits;\n\n(e) prescribes a pensioner pharmaceutical benefit by reference to a brand or in any other manner that indicates a brand; or\n\n(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.\n\n(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:—\n\nAurothioglucose Oily.\n\nCalcium Aurothiomalate.\n\nPertussis Vaccine (Phase 1).\n\nSodium Aurothiomalate Aqueous.\n\n \n\n(4.) A prescription for the general pharmaceutical benefit Cortisone Acetate shall be deemed not to be duly written—\n\n(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\n\n(b) if he writes another prescription on the same authorized prescription form as that on which be prescribes Cortisone Acetate.\n\nPrescription of dangerous drugs.\n\n18.—(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.\n\n(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.\n\nRecovery of cost of pharmaceutical benefits prescribed for persons not entitled or in excessive quantities.\n\n19.—(1.) If a Committee of Inquiry established under Division 2 of Part VIII. of the Act reports that, in its opinion—\n\n(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\n\n(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,\n\nthe medical practitioner is liable to repay to the Commonwealth an amount equal to the cost to the Commonwealth of—\n\n(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\n\n(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.\n\n \n\n(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.\n\nSupply of pharmaceutical benefits on prescriptions.\n\n20.—(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—\n\n(a) subject to the next succeeding regulation, the prescription for its supply is surrendered to him;\n\n(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\n\n(c) the prescription for its supply is dated within six months before the date of its presentation.\n\n(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.\n\nSupply of pharmaceutical benefit before surrender of written prescription.\n\n21.—(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.\n\n(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.\n\n(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.\n\nPenalty: Ten pounds.\n\n(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—\n\n(a) he reduces the communication to writing in accordance with the other provisions of that last-mentioned regulation; and\n\n \n\n(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.\n\n(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.\n\nSupply of pharmaceutical benefit on first presentation of prescription.\n\n22. 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—\n\n(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;\n\n(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\n\n(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.\n\nRepeat prescriptions.\n\n23.—(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.\n\n(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.\n\n(3.) In special circumstances, the Minister may, subject to such conditions as he specifies, authorize a medical practitioner to direct in a prescription that—\n\n(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\n\n(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.\n\n \nSupply of repeats.\n\n24.—(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.\n\n(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.\n\nPenalty: Ten pounds.\n\nRepeat authorizations.\n\n25.—(1.) An approved pharmaceutical chemist who supplies a pharmaceutical benefit on surrender of—\n\n(a) a prescription that contains a direction to supply that benefit more than once; or\n\n(b) a repeat authorization issued in accordance with this regulation,\n\nshall, unless no further supply of the pharmaceutical benefit (after the supply that he is making) is authorized—\n\n(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;\n\n(d) write the repeat authorization in duplicate;\n\n(e) attach the repeat authorization to the duplicate of the prescription;\n\n(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\n\n(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.\n\n(2.) A pharmaceutical benefit shall not be supplied upon surrender of the duplicate of a prescription unless—\n\n(a) there is attached to that duplicate a repeat authorization—\n\n(i) duly related to the duplicate prescription by a number or numbers;\n\n(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\n\n(iii) indicating that the pharmaceutical benefit to be supplied has not been supplied for the number of times directed in the prescription; and\n\n \n\n(b) the person obtaining the pharmaceutical benefit surrenders the repeat authorization to the person supplying the pharmaceutical benefit.\n\n(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.\n\nPenalty: Ten pounds.\n\nSupply of brand of general pharmaceutical benefits specified in a prescription.\n\n26. 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.\n\nPenalty: Fifty pounds.\n\nReceipts\n\n27.—(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.\n\n(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.\n\n(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.\n\nPenalty: Twenty pounds.\n\nPresentation of prescriptions in trading hours.\n\n28.—(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.\n\n(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.\n\n \nPresentation of urgent prescriptions.\n\n29.—(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.\n\n(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.\n\nPenalty: Ten pounds.\n\n(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.\n\nSpecial charges for supply outside trading hours.\n\n30.—(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.\n\n(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.\n\nSpecial charge for delivery.\n\n31. 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.\n\nPART VI.—MISCELLANEOUS.\n\nRetention of prescriptions, &c.\n\n32. 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—\n\n(a) in the case of prescriptions that do not bear instructions to supply the pharmaceutical benefits more than once— the duplicates of those prescriptions;\n\n(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;\n\n \n\n(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\n\n(d) the duplicates of order forms lodged under regulation 13 of these Regulations.\n\nPenalty: Fifty pounds.\n\nProper stocks to be kept.\n\n33. 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.\n\nPenalty: Ten pounds.\n\nForms suspected forged, &c.\n\n34. 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.\n\nStandards of composition and purity of pharmaceutical benefits.\n\n35.—(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.\n\n(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.\n\n(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.\n\nSamples.\n\n36. 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.\n\nSurrender of forms.\n\n37.—(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\n\n \nnotice, 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.\n\n(2.) A person upon whom a notice given in pursuance of the last preceding sub-regulation is served shall comply with that notice.\n\nPenalty: Ten pounds.\n\n![](image.003.png)\n\nTHE SCHEDULE.\n\nFIRST SCHEDULE.\n\nRegulation 10.\n\nDRUGS AND MEDICINAL PREPARATIONS THAT MAY BE PRESCRIBED FOR SUPPLY, SUPPLIED AND RECEIVED AS GENERAL PHARMACEUTICAL BENEFITS.\n\n| Item No. | Name or Formula. |\n| -------- | ----------------------------------------------------------------------- |\n| 1 | Acetarsol Soluble |\n| 2 | Acetazoleamide |\n| 3 | Adrenalin in Oil |\n| 4 | Adrenalin Tartrate Solution |\n| 5 | Aloxidone |\n| 6 | Amidone |\n| 7 | Amodiaquine |\n| 8 | Amyl Nitrite |\n| 9 | Antazoline |\n| 10 | Atropine Sulphate |\n| 11 | Aurothioglucose Oily |\n| 12 | Benzathine Penicillin with Procaine Penicillin and Potassium Penicillin |\n| 13 | Benzhexol Hydrochloride |\n| 14 | Calcium Aurothiomalate |\n| 15 | Calf Lymph |\n| 16 | Carbachol |\n| 17 | Carbarsone |\n| 18 | Carbimazole |\n| 19 | Chiniofon |\n| 20 | Chloroquine |\n| 21 | Cholera Vaccine |\n| 22 | Dapsone |\n| 23 | Darrow’s Solution |\n| 24 | Desacetyl-Lanatoside C |\n| 25 | Dextrose Aqueous |\n| 26 | Dextrose in 1/5 Normal Saline |\n| 27 | Dextrose in Ringer’s Solution |\n| 28 | Diasone |\n| 29 | Diethazine Hydrochloride |\n| 30 | Diethylcarbamazine |\n| 31 | Digitalis |\n| 32 | Digitoxin |\n| 33 | Digoxin |\n| 34 | Dihydroergotamine |\n| 35 | Dihydromorphinone |\n| 36 | Diiodohydroxyquinoline |\n| 37 | Dimercaprol |\n| 38 | Diphenhydramine Hydrochloride |\n| 39 | Diphtheria and Tetanus Toxoids Combined |\n| 40 | Diphtheria Antitoxin |\n| 41 | Diphtheria Pertussis Antigen |\n| 42 | Diphtheria Pertussis and Tetanus Antigen |\n| 43 | Diphtheria Prophylactic (Formalinized Toxoid) |\n\nFIRST SCHEDULE—continued.\n\n| Item No. | Name or Formula. |\n| -------- | ------------------------------------------------------------- |\n| 44 | Diphtheria Prophylactic (Purified Toxoid Aluminium Phosphate) |\n| 45 | Diphtheria Toxoid Purified (diluted for skin test only) |\n| 46 | Emetine Hydrochloride |\n| 47 | Emetine Bismuth Iodide |\n| 48 | Entero-Vioform |\n| 49 | Ephedrine Hydrochloride |\n| 50 | Ephedrine Sulphate |\n| 51 | Ergometrine Maleate |\n| 52 | Ergotamine Tartrate |\n| 53 | Ethopropazine Hydrochloride |\n| 54 | Ethyl Biscoumacetate |\n| 55 | Ethylidene Dicoumarin |\n| 56 | Gas Gangrene Antitoxin (Oedematiens) |\n| 57 | Gas Gangrene Antitoxin (Perfringens) |\n| 58 | Gas Gangrene Antitoxin (Polyvalent) |\n| 59 | Gas Gangrene Antitoxin (Septique) |\n| 60 | Glyceryl Trinitrate |\n| 61 | Hartmann’s Solution |\n| 62 | Hartmann’s Solution with Dextrose |\n| 63 | Heparin |\n| 64 | Heparin Retard |\n| 65 | Hexamethonium Bromide |\n| 66 | Hexamethonium Bromide with Ephedrine |\n| 67 | Hexamethonium Tartrate |\n| 68 | Hyaluronidase |\n| 69 | Hyoscine Hydrobromide |\n| 70 | Insulin |\n| 71 | Insulin Globin Zinc |\n| 72 | Insulin Isophane |\n| 73 | Insulin (Special P) |\n| 74 | Insulin Protamine Zinc |\n| 75 | Insulin Zinc Suspension |\n| 76 | Insulin Zinc Suspension (Amorphous) |\n| 77 | Insulin Zinc Suspension (Crystalline) |\n| 78 | Isoprenaline Hydrochloride |\n| 79 | Isoprenaline Sulphate |\n| 80 | Leptazol |\n| 81 | Mecholyl Chloride |\n| 82 | Mepacrine Hydrochloride |\n| 83 | Meprochol |\n| 84 | Mepyramine Maleate |\n| 85 | Mercaptomerin Sodium |\n| 86 | Mercuramide with Theophylline |\n| 87 | Mersalyl |\n| 88 | Methoin |\n| 89 | Methyl Atropine Nitrate |\n| 90 | Methylergometrine Tartrate |\n| 91 | Morphine Sulphate |\n| 92 | Morphine with Atropine |\n| 93 | Morphine with Hyoscine |\n| 94 | Nalorphine Hydrobromide |\n| 95 | Neoarsphenamine |\n| 96 | Neostigmine Bromide |\n| 97 | Neostigmine Methylsulphate |\n| 98 | Nikethamide |\n| 99 | Noradrenaline |\n| 100 | Nucleotides |\n| 101 | Ouabain |\n| . 102 | Oxophenarsine Hydrochloride |\n| 103 | Oxytocin |\n| 104 | Pamaquin |\n\n \nFIRST SCHEDULE—continued.\n\n| Item No. | Name or Formula. |\n| -------- | ------------------------------------------------------------------- |\n| 105 | Papaveretum |\n| 106 | Papaveretum with Hyoscine Hydrobromide |\n| 107 | Papaverine Hydrochloride |\n| 108 | Paramethadione |\n| 109 | Penicillin, Injection of |\n| 110 | Penicillin, Procaine Aqueous Suspension |\n| 111 | Penicillin, Procaine (Crystalline) |\n| 112 | Pentaerythritol Tetranitrate |\n| 113 | Pentolinium Tartrate |\n| 114 | Pentolinium Tartrate with Ephedrine |\n| 115 | Pertussis Prophylactic (Hemagglutinin Aluminium Phosphate Adsorbed) |\n| 116 | Pertussis Vaccine (Phase 1) |\n| 117 | Pethidine Hydrochloride |\n| 118 | Pethidine Scopolamine |\n| 119 | Phemitone |\n| 120 | Phenobarbitone Sodium |\n| 121 | Phenylindanedione |\n| 122 | Phenytoin Sodium |\n| 123 | Phthalylsulphacetamide |\n| 124 | Phthalylsulphathiazole |\n| 125 | Physostigmine Sulphate |\n| 126 | Picrotoxin |\n| 127 | Pitressin Tannate in Oil |\n| 128 | Primaquine |\n| 129 | Primidone |\n| 130 | Procaine Amide Hydrochloride |\n| 131 | Procaine Hydrochloride in Normal Saline |\n| 132 | Procyclidine Hydrochloride |\n| 133 | Proguanil Hydrochloride |\n| 134 | Promethazine Hydrochloride |\n| 135 | Prophenpyridamine Para Aminosalicylate |\n| 136 | Protamine Sulphate |\n| 137 | Pyridoxine Hydrochloride |\n| 138 | Quinidine Sulphate |\n| 139 | Ringer’s Solution |\n| 140 | Sodium Aurothiomalate Aqueous |\n| 141 | Sodium Chloride Hypertonic Solution |\n| 142 | Sodium Chloride Physiological Solution |\n| 143 | Sodium Chloride Physiological Solution (with Dextrose) |\n| 144 | Sodium Lactate Solution |\n| 145 | Sodium Sulphate Solution |\n| 146 | Solapsone |\n| 147 | Succinylsulphathiazole |\n| 148 | Sulphadiazine |\n| 149 | Sulphadimidine |\n| 150 | Sulphafurazole |\n| 151 | Sulphaguanidine |\n| 152 | Sulphamerazine |\n| 153 | Sulphamethizole |\n| 154 | Sulphapyridine |\n| 155 | Sulpharsphenamine |\n| 156 | Sulphathiazole |\n| 157 | Sulphonamides, Mixed (A): Two Sulphonamides |\n| 158 | Sulphonamides, Mixed (B): Three Sulphonamides |\n| 159 | Sulphonamides, Mixed (C): Four Sulphonamides |\n| 160 | Suprarenal Cortex Extract |\n| 161 | T.A.B. Vaccine (Anti-Typhoid-Para-Typhoid) |\n| 162 | Tetanus Antitoxin |\n| 163 | Tetanus Toxoid (Formalinized) |\n| 164 | Tetanus Toxoid (Purified Aluminium Phosphate Adsorbed) |\n| 165 | Theophylline with Ethylenediamine |\n\nFIRST SCHEDULE—continued.\n\n| Item No. | Name or Formula. |\n| -------- | -------------------------- |\n| 166 | Thiacetazone |\n| 167 | Thiouracil, Methyl |\n| 168 | Thiouracil, Propyl |\n| 169 | Thyroid |\n| 170 | Tiger Snake Anti-Venene |\n| 171 | Triethanolamine Trinitrate |\n| 172 | Troxidone |\n| 173 | Vasopressin |\n| 174 | Vitamin K Aqueous |\n| 175 | Vitamin K Oily |\n| 176 | Vitamin K Oral |\n| 177 | Water for Injection |\n\nSECOND SCHEDULE\n\nRegulation 11.\n\nDRUGS 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.\n\n```html\n

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)

\n```\n\n \nSecond 'Schedule—continued.\n\n```html\n

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

\n```\n\n \nSECOND SCHEDULE—continued.\n\n```html\n

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

\n```\n\n \nTHIRD SCHEDULE.\n\nFORM A.\n\nRegulation 8.\n\nCOMMONWEALTH OF AUSTRALIA.\n\nNational Health Act 1953-1955.\n\nAPPLICATION FOR APPROVAL AS A PHARMACEUTICAL CHEMIST.\n\n(By a Registered Pharmaceutical Chemist.)\n\n```html\n

*I,

of

We,

\n```\n\ntrading as , hereby apply for approval as a pharmaceutical chemist under the National Health Act 1953-1955 in respect of premises situated at\n\n```html\n

*I,

hereby declare that

*I, am a

pharmaceutical

*chemist

chemists

registered as such

We,

we are,

under the law of the

*State of

*Territory

\n```\n\n```html\n

*I,

further declare that

*I, am

willing to supply on demand, at or from the premises

We,

we are,

\n```\n\nspecified above, pharmaceutical benefits in accordance with Part VII. of the National Health Act 1953-1955.\n\nDated this day of , 19 .\n\n(Signature of Applicant.)\n\nTo the Director-General of Health, Commonwealth of Australia.\n\n![](image.004.png)\\* Strike out whichever is inapplicable.\n\n![](image.001.png)FORM B.\n\nRegulation 8.\n\nCommonwealth of Australia.\n\nNational Health Act 1953-1955.\n\nAPPLICATION FOR APPROVAL AS A PHARMACEUTICAL CHEMIST.\n\n(By a Friendly Society, &c.)\n\nI, of \nthe person authorized to make this application by \n, 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\n\nThe 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.\n\n\\*I declare that the Friendly Society or body was carrying on the business of a pharmaceutical chemist on the first day of August, 1945.\n\nDated this day of , 19 .\n\n(Signature of person authorized to make application.)\n\nTo the Director-General of Health, Commonwealth of Australia.\n\n![](image.004.png)\\* Strike out if inapplicable.\n\n \nTHIRD SCHEDULE—continued.\n\nFORM C.\n\nRegulation 8.\n\nCOMMONWEALTH OF AUSTRALIA.\n\nNational Health Act 1953-1955.\n\nAPPLICATION FOR APPROVAL AS A HOSPITAL AUTHORITY.\n\n```html\n

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

\n```\n\napproval of that hospital authority for the purpose of supplying general pharmaceutical benefits to patients receiving treatment in or at that hospital.\n\nThe hospital authority is prepared to supply pharmaceutical benefits in accordance with Part VII. of the National Health Act 1953-1955.\n\nThe dispensing of drugs and medicinal preparations at the hospital is performed by or under the direct\n\n```html\n

supervision of who is a

*medical practitioner.

pharmaceutical chemist.

\n```\n\nDated this day of , 19 .\n\n(Signature of person authorized to make application.)\n\nTo the Director-General of Health, Commonwealth of Australia.\n\n![](image.004.png)\\* Strike out whichever is inapplicable.\n\n![](image.001.png)FORM D.\n\nRegulation 17 (4.).\n\nCOMMONWEALTH OF AUSTRALIA.\n\nNational Health Act 1953-1955.\n\nAPPLICATION FOR AUTHORITY TO PRESCRIBE CORTISONE ACETATE.\n\n(By a Medical Practitioner.)\n\nI, 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:—\n\nI certify that the pharmaceutical benefit is required for the treatment of \nof , 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.\n\nDated this day of , 19 .\n\n(Signature of Medical Practitioner.)\n\nTo the Director-General of Health, Commonwealth of Australia.\n\n![](image.005.png)By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":1848},"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"The legislation remains focused on its original purpose of regulating pharmaceutical benefits under the National Health Act 1953-1955. It covers chemist approvals, prescription requirements, drug scheduling, and supply mechanisms consistent with the enabling Act's intent to provide subsidized medicines."},"complexity_factors":["Two separate drug schedules with different prescribing rules (First Schedule for general use, Second Schedule restricted to specific diseases)","Detailed prescription writing requirements including paper size, ink color, duplicate forms, and specific endorsements for restricted drugs","Special authorization system for Cortisone Acetate requiring Director-General approval","Complex repeat prescription authorization system involving serial numbers, duplicate forms, and tracking mechanisms","Cross-references to external standards (British Pharmacopoeia 1948, Australian Pharmaceutical Formulary, Therapeutic Substances Act 1953)","Multiple conditional exceptions (e.g., pensioner benefits, urgent prescriptions, dangerous drugs)","Detailed administrative forms (Forms A, B, C, D) with specific requirements for chemist and hospital approvals"],"plain_english_summary":"These 1956 regulations set the rules for Australia’s Pharmaceutical Benefits Scheme, defining which prescription medicines are subsidized, who may supply them, and how prescriptions must be written and dispensed. They affect doctors, pharmacists, hospitals and patients by imposing approval, record‑keeping and prescribing controls, restricting some drugs to specified diseases, and limiting repeats.\n\nThey protect public funds and patient safety while enabling affordable access, backed by fines for breaches."},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"Regulation 3 expressly repeals earlier Pharmaceutical Benefits Regulations, and the instrument consolidates and replaces prior rules by restating lists, prescription formalities, approval processes and payment/penalty schemes. Mechanically, it narrows or clarifies prescribing by attaching specific permitted uses to items in the Second Schedule, creates ministerial determination powers (payment rates, repeat limits, special authorisations) and imposes record‑keeping and operational duties on approved suppliers—thereby altering administrative scope and procedural detail compared with the repealed regulations."},"complexity_factors":["Extensive schedules listing specific drugs and formulation forms (First and Second Schedules) that must be cross‑referenced when prescribing (Regulation 10–11).","Detailed, formal prescription rules (authorized form, duplicate, dating, endorsements, pensioner identification, restrictions on brands and repeats) with multiple provisos and exceptions (Regulations 5, 17–26).","Ministerial and Director‑General discretion to determine lists, payment rates, repeat limits and special authorisations (e.g. Cortisone Acetate) creating administrative variability (Regulations 5, 16, 23).","Delegation and revocation powers for Minister and Director‑General, limited delegations by Director‑General to specific officers, concentrating decision authority (Regulation 7(1), (4)).","Interplay with other statutes and standards (National Health Act, Therapeutic Substances Act, Australian Pharmaceutical Formulary, British Pharmacopoeia) requiring cross‑statutory interpretation (Regulation 5, 35).","Operational obligations on suppliers (stocking, trading hours notices, retention of duplicates for three years, special charges and delivery rules) imposing compliance burdens (Regulations 28, 30–33, 32).","Specific offences and monetary penalties of varying amounts tied to procedural breaches and fraudulent activity, producing enforcement complexity (Regulations 9(b), 14–16, 21, 24, 27, 32, 37).","Special regimes for medical practitioners obtaining supplies for section 93 purposes, with identification, ordering and brand‑specification rules (Regulations 12–16).","Exceptions where State or Territory law requires different prescription handling (Regulation 21(5)), adding multi‑jurisdictional compliance considerations."],"plain_english_summary":"These Regulations implement Part VII of the National Health Act by naming which drugs are pharmaceutical benefits, restricting some drugs to specified diseases or purposes, standardising authorised prescription forms and supply procedures, and setting approval, record‑keeping and payment rules for chemists and hospitals. They also create offences and penalties for non‑compliance.\n\nThe rules primarily affect medical practitioners, approved pharmaceutical chemists, hospital authorities and pensioners. The Minister and the Director‑General decide lists, approvals and payment conditions; the Commonwealth pays benefits while providers carry administrative and compliance costs."}},"importantCases":[],"_links":{"self":"/api/acts/c1956l00054","history":"/api/acts/c1956l00054/history","analysis":"/api/acts/c1956l00054/analysis","conflicts":"/api/acts/c1956l00054/conflicts","importantCases":"/api/acts/c1956l00054/important-cases","documents":"/api/acts/c1956l00054/documents"}}