United Nations LAWS and REGULATIONS FRANCE

E/NL.1950/9-16 1 March 1950 United Nations

LAWS AND REGULATIONS

PROMULGATED TO GIVE EFFECT TO THE PROVISIONS OF THE CONVENTION OF 13 JULY 1931 FOR LIMITING THE MANUFACTURE AND REGULATING THE DISTRIBUTION OF NARCOTIC DRUGS AS AMENDED BY THE PROTOCOL OF 11 DECEMBER 1946

FRANCE

COMMUNICATED BY THE GOVERNMENT OF FRANCE

Lake Success, New York, 1950 Note by the Secretary-General

In accordance with Article 21 of the Convention of 13 July 1931 for Limiting the Manufacture and Regulating the Distribution of Narcotic Drugs, as amended by the Protocol of 11 December 1946, the Secretary-General has the honour to communicate here• after the texts of regulations. Ori gina1: English E/NL.1950/9

COMPOSITION OF PART II OF THE SCHEDULES OF POISONOUS SUBSTANCES*

1he Minister of Public Health and Population, •Considering the amended Act of 19 July 1845, Considering the Decree of 19 November 1943, and in particular Article 1 of the said Decree, Orders as follows:

Article 1

The following substances shall be included in Schedule A, Part II: Arsenious oxide and arsenic acid Hydrocyanic acid Aconite (leaves, roots, extract and tincture) Aconitine and its salts Adrenaline Alkaloids of opium, their salts and their derivatives, other than those specifically mentioned in Schedule B Apomorphine and its salts Arecoline and its salts Arsenates and arsenites Metallic arsenic (cobalt) Atropine and its salts Belladonna (leaves, roots, powder and extract) Benzoate of mercury Dichloride of mercury Bi-iodide of mercury Bromo form Methyl bromide Brucine and its salts Cantharides (whole, powder and tincture) Cantharidin and its salts Chloroform Chloropicrin Hemlock (fruit, powder and extract) Codeine and its salts Colchicine and its salts Colchicum (seeds and extract) Conine and its salts Convalla toxin Indian berry

The poisonous substances classified in the Codex without legal authority as "toxic" substances or as substances "to be kept separately" are not listed here. On the advice of various commissions they will probably be included in these schedules. E.g., codeine syrup is legally included in Schedule A (for its exemptions, see under Codeine, E/NL.1950/15, page 2o). 3 Curare and curarine Metallic cyanides Digitalis (leaves, powder and extract) Digitalin Duboisine and' its salts Tartar emetic Ergotinine Ergot Eserine and its salts Extract of ergot (ergotine) Fluid extract of ergot Calabar bean Ignatius bean Homatropine and its salts Croton oil Hydrastine Hydrastinine and its salts Hyoscyamine and its salts Juniperus phoenicia (leaves, powder and essence) Henbane (leaves, seeds, powder and extract) Methylene dihydroxycoumarin Me thylnonylke tone Nicotine and its salts Nitrates of mercury Nitroglycerine Nux vomica (powder, extract and tincture) Ouabain (strophanthin G) Ethylene oxide Oxides of mercury Phosphorized pastes Poppy, Papaver somniferum (dry capsules) Phosphorus Calcium phosphide Zinc phosphide Picrotoxin Pilocarpine and its salts Radio-active elements of the uranium and radium series, of the actinium series, of the thorium series and their salts, excluding natural radio-active water and natural radio-active mud Intermediate products or radio-active residues from the preparation of these salts Artificial radio-active elements Preparations of any kind rendered radio-active by the incorporation of radio• active elements or by any other procedure Rue (leaves, powder and essence) Savine (leaves, powder and essence) Scopolamine and its salts Thallium salts Stramonium, (leaves, powder and extract) Strophanthin and its salts

4 Strophanthus (seeds, extract and tincture) Strychnine and its salts Sulphides of arsenic Trinitroglycerine Triiodide of arsenic Veratrine and its salts Yohimbine (hydrochloride)

Article 2

The following substances shall be included in Schedule B, Part II:

Raw opium Powdered opium Opium extract Poppy extracts Morphine and its salts Diacetylmorphine and its salts Benzoylmorphines and their salts Hydrocodeinone and its salts Dihydrohydrooxycodeinone and its salts Dihydromorphinone and its salts Dihydromorphine and its salts Morphine-N-oxide Morphine-N-oxide derivatives Pentavalent nitrogen morphine derivatives Thebaine Coca leaves Raw cocaine Ecgonine Cocaine and its salts Indian hemp Resin of Indian hemp Extract and tincture of Indian hemp Acetyldemethyldihydrothebaine and its salts 2-Dimethylamino 4.4-diphenyl-heptanone-5 and its salts Ethyl ester of methyl phenyl piperidine carbonic acid and its salts Isodianisyl ethanolamine and its salts 8-Hydroxy-

Article 3

The following substances shall be included in Schedule C, Part II:

Lead acetates Solution of lead subacetate Crystallizable acetic acid Hydrochloric acid Chromic acid Nitric acid Oxalic acid

5 Picric acid Sulphuric acid Thioglycolic acid Adonis vemalis Alcoholic tincture of aconite Aminophenol Aminoresorcinol Ammoni a Chlorinated amylen.es Pulsatilla Local anaesthetics: Alpha-butyloxycinchoninate of diethylethylene diamine and its salts Benzoyl-2-ethylamino-3-phenylpropanol and its salts Benzoyl-tetramethyldiamino-dimethylethylcarbinol and its salts Benzbyl-trimethyl-oxypiperidine and its salts Cinnamyl-diethylaminopropanol and its salts Benzoyl-dimethylamino-dimethylethylcarbinol and its salts (amyleine) Para-amino-benzoyl-diethylaminoethaiiol and its salts (procaine) Para-amino-benzoyl-di-isopropylaminoethanol and its salts Para-amino-benzoyl-diLutylaminopropanol and its salts Para-amino-benzoyl-l-diethylamino-2-methyl-3-butanol and its salts Para-amirto-benzoyl-N-diethyleucinol and its salts 1 Para-amino-benzoyl-2-dimethyl-3-diethylaminopropanol and its salts Para-beta-methoxyethyl-aminobenzoyl-piperidinoethanol and its salts Para-butyl-amino-benzoyl-dimethylaminoethanol and its salts (tetracaine) Penta-methyl-benzoyl-oxypiperidine carbonate of methyl and its salts Pseudo-dextro-cocaine (salts of) Preparations with an aniline base for dyes Bromine Basic lead carbonate (white lead) Chloral hydrate Chloralose (glucochloral, anhydrogluco chloral) Metallic chlorates Antimony chloride Zinc chloride Colocynth The following chlorine compounds: Dichloromethane (methylene bichloride) Alpha-dichloroethane (ethylidene chloride) Beta-dichloroethane (ethylene chloride) Alpha-trichloroethane (methylchloroform) Alpha-dichloroethylene (acetylidene chloride) Beta-cichloroethyline (acetylene dichloride) Trichlorethylene Organic arsenic compounds Creosote Cresylol and sodium cresylate Nitrated derivatives of carbazole Diamidopheno1 Diamido-resorcinol Dichlorodiphenyltrichloroethane (D.D.T.)

6 Dihydro-fdlliculin and its salts Dinitrophenols Distilled water of cherry-laurel Paregoric elixir Plaster of opium extract Essence of chenopodium Essence of mustard Metallic fluorides Soluble metallic fluosilicates Insoluble metallic fluosilicates Folliculin and its salts Formaldehyde (formol) Guaiacol Hexachlorocyclohexane (H.C.H.) and its sulphuretted derivatives Anthracene oil Phosphorated cod liver oil Hydroquinone Dissolved potassium hydroxide Iodine Lead iodide Van Swieten's liquor Derivatives of malonylurea and their salts: Cyclopentenyl-ethyl-barbituric acid Dial1ylmalonylurea Diethylmalonylurea (barbital) Dipropylma1onylurea Ethylbutylmalonylurea Ethylcyclohexenylmalonylurea (cyclobarbital) Ethylisoamylmalonylurea Ethylmethylbutylmalonylurea Isobutyla11ylmalonylurea Isopropyla11ylmalonylurea N. Methylcyclohexenylmethylmalonylurea (hexobarbital) Phenylethylmalonylurea (phenobarbital) Phenylmethylmalonylurea, and unnamed derivatives of malonylurea Mercury Metaldehyde Black nightshade Naphthylthiourea (Alpha) Silver nitrate Lead nitrate Amyl nitrite Metallic nitrites Ni tropruss ides Synthetic oestrogens Orthotoluidine Alkaline oxalates Lead oxide Sublimate paper Pelletierine and its salts Phenol and phenolates 7 Phenylamino-propane and its salts Phenylenediamine (meta and para) Opiated mercuric chloride pills Opiated cynoglossum pills Opiated mercurous iodide pills Ointment treated with corrosive sublimate Mercurial ointment in equal parts Mercurial ointment treated with belladonna Mercuric oxide ointment Caustic potash Potassium (acid bichromate of) Opiated ipecac powder Ousting powders treated with nicotine Sulphated benzene products of the sulphonamide group and anilides, whether coloured or not (sulphonamides, aniline dyes etc.) Mercurous chloride (calomel, white precipitate) Mercurous iodide Pyridine Pyrogallol Santonin Squills (powder, extract and tincture) Barium salts (except barium sulphate) Aconite syrup Belladonna syrup Digitalis syrup Mercuric iodide syrup (Gibert) Morphine syrup Opium syrup and diacodion syrup Peptonized mercury solution Solution of the posterior lobe of the pituitary gland, for injection Caustic soda Streptomycin Mercuric sulphate Sparteine bisulphate Zinc sulphate Alkaline thiocarbonates Carbon bisulphide Mercuric bisulphide Mercuric sulphocyanide Tincture of belladonna Tincture of colchicum Tincture of digitalis Tincture of henbane Carbon tetrachloride Tetra-, penta- and hexa-chloroethane Thiodiphenylamine (phenothiazine) Trioxymethylene Vitamin D Alkaline xanthates and alkylxanthates 8 Article 4

This Order shall be put into effect by the Chief of the Central Pharmaceutical Office {Service central de la pharmacie).

Done at Paris on 7 December 1948.*

* Journal Officiel, 25 December 1948.

E/NL.1950/10

MODEL COUNTERFOIL BOOK FOR THE PRESCRIPTION OF NARCOTIC DRUGS

THE MINISTER OF PUBLIC HEALTH AND POPULATION,

Considering the amended Act of 19 July 1945, Considering the Decree of 19 November 1948 and in particular Article 49 of the said Decree, Orders as follows: Article 1. The Counterfoil books specified in the iJecree of 19 November 1948 for the prescription of medicaments containing substances listed in Schedule 3, in accordance with the provisions of Article 49 of the aforesaid Decree, should be white, except for those issued to medical heads of departments for the exclusive use of hospital out-patient services, which shal1 be red. Books of both classes should conform to the following model: 1. Dimensions: 13.5 cm. by 10.5 cm.; counterfoil: 4.5 cm.; prescription: 9 cm.; 2. Each book shall bear a serial number; 3. Each right-hand page shall contain the following headings:

Doctor Book N( Street Prescription No. 1 City

Doctor Book No Street prescription No. 1 City 9 SCHEDULE B

(Decree of 19 November 1948)

The following text shall be printed on the cover of the book:

Extract from the Decree of 19 November 1948

"Article 49. Form of prescriptions. It is forbidden to issue and to dispense prescriptions involving the" use of substances in their pure form listed in Sched• ule B. "Substances in Schedule B may not be supplied except in a form compatible with their therapeutical use. "With the exception of those prescribing liniments or ointments, prescriptions for preparations containing substances in Schedule B in quantities exceeding the quantities exempted under Article 19 shall be made out, after examination of the patient, on sheets taken from a counterfoil book of a type prescribed by the Min• ister of Public Health and Population. "The National Medical Association, the National Veterinary Association and the Dental Surgeons' Association shall be responsible for the printing and distribution of these counterfoil booki, in their respective branches of medicine. "The author of a prescription is required, subject to the penalties provided in the Law of 19 July 1845, to date and sign it and state in legible characters his name and address, the name and address of the patient and how the medicine is to be used. "In the case of magistral preparations, he shall write out in full the quan• tities of the substances in Schedule B prescribed, and, where appropriate, the number of therapeutic units. "In the case of patent medicines, he shall write out in full the number of therapeutic units. "The counterfoils must be preserved by the practitioners for three years. "Article 50. Limitation of quantities prescribed. (Regulation period of seven days.) With the exception of those prescribing liniments or ointments, it is forbidden to issue or dispense prescriptions for substances in Schedule B to cover more than a seven-day period. "Doctors are forbidden to issue and chemists to dispense or renew for a user a prescription for substances in Schedule B, during the period covered by a previous prescription for substances in the said Schedule, unless the prescription contains an express indication by the prescribing practitioner and takes into account the previous prescription. "Persons already holding a prescription involving the use of one or more of the substances listed in Schedule B are forbidden, during the period of treatment specified in such prescription, to receive a further prescription involving the use of substances in Schedule B, unless they have informed their new practitioner of the previous prescription or prescriptions. "The latter shall indicate on the new prescription that he has examined the copy or copies of the previous prescriptions. "Article 55. Emergency stocks for practitioners. Doctors and veterinary surgeons are authorized to stock medicines containing substances in Schedule B to the extent required for emergency treatment* "Such stocks shall be determined qualitatively and quantitatively by the Departmental Director of Health upon the recommendation of the Association concerned. "Any amounts withdrawn from such stocks shall be made good on the basis of orders

made out by the doctor or veterinary surgeon in conformity with the provisionsvof Article 49. "Such orders may be carried out only by a chemist located in the commune of the practitioner, or by a chemist in the nearest commune if the practitioner*-s own commune has no chemist's shop. The name of the chemist selected by the doctor or veterinary surgeon shall in all cases be notified by him to the Departmental Council of the Association to which he belongs. "Article 56. Stocks held by dental surgeons. Dental surgeons are authorized to stock for their professional use, and subject to the conditions laid down in the foregoing article, preparations containing such substances in Schedule B as are listed in an order of the Ministry of Health and Population. "Article 57. Quarterly return. Dispensing chemists shall preserve for three years, for production to the competent authority when required, the orders referred to in Articles 55 and 56 and issued by doctors, veterinary surgeons and dental surgeons and shall lodge a return thereof with the Departmental Director of Health at the end of each quarter." Article 2. The President of the National Council of the Medical Association, the President of the National Council of the Veterinary Association, the President of the National Council of the Dental Surgeons' Association, and the Chief of the Central Pharmaceutical Office ("Service central de la pharmacie) shall be responsible, so far as each is concerned, for giving effect to this Order. Done in Paris on 14 December 1948.*

Journal Officiel of 3 January 19t9. E/NL.1950/11

ORDER

establishing the model lor the counterfoil book for ordering narcotic drugs

THE MINISTER OF PUBLIC HEALTH AND POPULATION Considering the amended Act of 19 July 1345, Considering the Decree of 19 November 1943, and especially Article 47 of the said Decree, Orders as follows: Article 1. The counterfoil books specified in Article 47 of the Decree of 19 November 1948 for ordering the substances listed in Schedule B shall conform with the model attached to the present Order (this annex will not be reproduced in the Journal Officiel). The dimensions of the book shall be as follows: 15 cm. by 28 cm; counterfoils: 4 cm.; sheets: 12 cm. each. Each book shall bear a serial number. The following text shall be printed on the cover of the book: "Extracts from the Decree of 19 November 1948 "Article 45. Supplies. With the exception of anounts supplied for therapeutic use or on prescriptions of practitioners entitled to prescribe them, the said substances shall not be sold or supplied to any person who cannot prove that he has complied with the requirements of Article 38. "The said substances may be supplied only against orders drawn up in conformity with Article 47.

"Article 47. Supplies. The deposit for endorsement of the chemist's diploma shall take the place of a licence in the case of dispensing chemists, but only for the preparation and supply in their dispensaries of medicines containing the said substances. "Purchases of the substances in Schedule B shall not be made by a dispensing chemist except in a metropolitan establishment holding a licence under Article 38 and upon production by the chemist of two numbered sheets taken from a counterfoil book of a type prescribed for the whole territory by the Ministry of Public Health and Population. The National Pharmaceutical Association shall be responsible for the printing and distribution of such counterfoil books. "One of the sheets shall bear the name and address of the purchaser, his signature, the date of the order and the stamp of the establishment, and shall contain, in full, the name of the product and the quantity ordered. "The second sheet shall state only the name and address of the purchaser and the nature of the medicine. It shall be returned by the vendor to the purchaser and shall indicate: "(a) the issue number in the vendor's register; "(b) the quantities actually delivered; "(c) the date of delivery and the stamp and signature of the vendor. "The documents shall be preserved by the persons concerned for three years and produced whenever asked for by the competent authority.

12 "The products supplied shall bear the number under which they were entered in the vendor's register." Article 2. The Chairman of the National Pharmaceutical Association and the Chief of the Central Pharmaceutical Office (Service central de la pharnacie) shall be responsible, so far as each is concerned, for giving effect to this Order. Done in Paris on 21 December 1948.*

Pierre SCHNEITER

Journal Offlciel. of 14 January 19*9. 13 MODEL COUNTERFOIL BOOK FOR ORDERING NARCOTIC DRUGS

Names of Products Ordered Received s? s- z

To be returned, attached to the order, by the vendor to the purchaser. SHEET NO. 2 May in no circumstances be used as an invoice.

Name and Address of Purchaser No Voucher No.

TO BE COMPLETED BY THE VENDOR

ISSUE No. in vendor's register

Products supplied Quantities (in full)

Vendor's stamp At , on (date of delivery) Vendor's signature Purchaser SHEET No. 1 -o to § 10 No. 1 ...... u Vendor Voucher No. . B cit

Products order Quantities.'(in full)

Purchaser's stamp At on , (date of order)

Pharmacist's signature

14 E/NL. 1950/12

ORDER

Concerning the Issue to Doctors and Veterinary Surgeons of Medical Samples containing Substances listed in Schedule B

THE MINISTER OF PUBLIC HEALTH AND POPULATION Considering the amended Act of 19 July 1845, Considering the validate and amended Act of 11 September 1941, Considering the Decree of 19 November 1948, and in particular Article 45 of the said Decree, Orders as follows: Article 1. In accordance with the provisions of Article 45 of the Decree of 19 November 1948, manufacturers of patent medicines may supply to doctors and veterinary surgeons medical samples containing substances listed in Schedule B under the following conditions: 1. such samples may be supplied only against a receipt dated and signed by the doctor or veterinary surgeon, stating the quantities supplied; 2. such supplies shall not exceed three therapeutic units per consignment per month per practitioner; 3. the manufacturers shall send to die Central Pharmaceutical Office {Service central de la pharmacie) (Bureau of Narcotic Drugs) a quarterly return of supplies of medical samples issued during the preceding quarter, giving the name and address of the practitioners to whom samples were sent and the amounts supplied to them. Article 2. This order shall be put into effect by the Chief of the Central pharmaceutical Office. Done in Paris on 23 December 1948.*

INFORMATION AND DOCUMENTS REQUIRED FOR ISSUE OF THE LICENCE TO TRADE IN NARCOTIC DRUGS PROVIDED FOR IN ARTICLE 38 OF THE DECREE OF 19 NOVEMBER 1948

1. An application drawn up on stamped paper, giving: (a) surname and given names of the applicant. In the case of a Company, the surnames and given names of the person or persons responsible at law should be given as well as the trade name of the firm; (b) the names and addresses (department, district, street, number) of the head office and of factories, workhouses, branches, depots etc., all of which require separate licences;

* Journal Official of 14 January 1949. 15 (c) a.detailed description of the premises .and installations; (d) the nature of the operations for which the licence is requested; (e) the names of the substances listed in Schedule B which are to be used (codeine and dionine, although listed in Schedule A, are affected by the provisions of international conventions and should be mentioned in the same category as the products listed in Schedule B). Where patent medicines and products are manufactured under trademarks, give the trade name, the weight of the Schedule B substances contained in the preparation, and its strength, even if the doses are exempted. 2. The application should be accompanied by the following documents: (a) a copy, certified true to the original by the mayor of the comnune and, in Paris, by the commissioner of police, of the diploma of the pharmacist and of die certificates thereon concerning his attendance at the prefecture and his registration for practice; (b) a certificate of enrolment in the Pharmaceutical Association; (c) a copy of the entries in the classified trade register (Form J, K or K (a)), issued by the Clerk of the Commercial Court. The application and the attached documents should be addressed to the Ministry of Public Health and Population, Central Pharmaceutical Office, (Service central de la pharmacie) 45, rue Cardinet, Paris 17.

INFORMATION AND DOCUMENTS REQUIRED FOR ISSUE OF A LICENCE TO CARRY OUT CUSTOMS OPERATIONS IN CONNEXION WITH NARCOTIC DRUGS (Article 38 of the Decree of 19 November 1948)

An application drawn up on stamped paper and containing the following information: 1. The surname and given names of the applicant. In the case of a company, the surname and given names of the person or persons responsible at law should be given as well as the trade name of the firm; 2. The number assigned to the firm in the list of persons approved for customs operations, drawn up by the Customs Administration; 3. The names and addresses (district, street, number) of the head office and of warehouses, branches, depots etc. A licence must be obtained' for each of these; 4. A detailed description of the premises and installations; 5. The nature of the operations (commissions, transit, import, export) for which the licence is required. The application for a licence should be accompanied by a copy of the entries in the classified trade register (Form J, K or K (a)), issued by the Clerk .of the Conmercial Court.

16 E/NL. 1950/13

ORDER concerning, the supply of certain poisonous substances by pharmacists to midwives

THE MINISTER OF PUBLIC HEALTH AND POPULATION Considering the amended Act of 19 July 1845, Considering the Decree of 19 November 1948, Orders as follows:

Article 1. Pharmacists may supply, against a prescription signed by a certified midwife, or to a certified midwife for her own professional use, the following preparations containing poisonous substances: 1. Fluid extract of ergot: in the form of an injectable solution, at a rate of two 1 cm. ampoules per prescription, and only in case of post-partum haemorrhage; 2. Silver nitrate collyrium of strength not exceeding 1 per cent, to be prescribed against ophthalmia neonatorum. Article 2. The author of the prescription shall date and sign it and state in legible characters her name and address and how the preparation is to be used. Article 3. All provisions contrary to this Order, and in particular those of the regulations made under the repealed Decree of 14 September 1916, are hereby repealed. Article 4. This Order shall be put into effect by the Chief of the Central Pharmaceutical Office (Service central de la pharmacie). Done in Paris on 4 January 1949.*

* Journal Offlciel of 23 January 1949.

E/NL. 1950/14

ORDER concerning the supply of certain.poisonous substances by pharmacists to dental surgeons

THE MINISTER OF PUBLIC HEALTH AND POPULATION Considering the amended Act of 19 July 1845, 17 Considering the Decree of 19 November 1948 and in particular Articles 21, 22 and 56 thereof, Orders as follows:

Article 1. Pharmacists may supply, against a prescription signed by a dental surgeon or a dentist who is a member of the National Dental Surgeons' Association, preparations containing the poisonous substances included in the following list: I. Preparations for use in the local treatment of the buccal cavity, containing one or more of the. following poisonous substances: SCHEDULE A Tincture of aconite. Compounded in gingival stimulants. Chloroform water. Compounded with antiseptics and chloral. Poppy (dried capsules). In mouth washes, pure or compounded with indigenous species. SCHEDULE B Cocaine hydrochloride. In mouth washes, gargles, compounded with phenol and tincture of saffron, provided that the proportion of cocaine does not exceed 1 per cent. Tincture of Indian hemp. Compounded with counter-irritants in gingival stimulants. Sydenham laudanum. Compounded with counter-irritants, in gingival stimulants, provided that the proportion of laudanum does not exceed 50 per cent. Tincture of opium. Compounded with counter-irritants in gingival stimulants, provided that the proportion of tincture of opium does not exceed 50 per cent.

II. Preparations to be administered per os, containing one or more of the following poisonous substances:

SCHEDULE C Derivatives of malonylurea. Opium syrup. Sulphureted benzenoid products of the sulphonamide group, to be administered through the mouth. Article 2. Hie author of a prescription shall comply, subject to the penalties provided in the amended Act of 19 July 1845, with the provisions of the Decree of 19 November 1948, and shall in particular date and sign the prescription and state his name and address in legible characters; furthermore, with regard to the substances listed in Schedules B and A, he shall state, spelt out, .the amounts of the substances and how the preparation is to be used. Article 3. Pharmacists may supply to dental surgeons and dentists who are members of the National Dental Surgeons' Association, for professional use and not for issue to patients either for payment or free of charge, under the conditions provided for in the Decree of 19 November 1948, poisonous substances, or preparations containing such substances, included in the following list: SCHEDULE A Arsenious acid Aconite (tincture) Adrenaline (1/1000 solution) Mercury bichloride Chloroform 18 Metallic cyanides Henbane (extract) Extract of ergot (ergotine) Mercury nitrates Poppy (dried capsules) SCHEDULE B Extract of opium: in the form of arsenical ointment Sydenham laudanum: compounded, in proportion not exceeding 50 per cent Bonain's mixture Indian hemp: in solution and at a maximum rate of 33 per cent Tincture of Indian hemp: compounded in gingival stimulants Cocaine hydrochloride: in injectable solution in strength not exceeding 1 per cent, whether or not compounded with a local anaesthetic listed in Schedule C Cocaine hydrochloride: as a mixture with 10 per

Article 4. Practitioners must comply with the provisions of the Decree of 19 November 1948 and in particular with the regulations on keeping poisonous substances. Article 5. All provisions contrary to the present Order, and in particular those of the regulations made under the repealed Decree of 14 September 1916, are hereby repealed. Article 6. This Order shall be put into effect by the Chief of the Central Pharmaceutical Office (.Service central de la pharmacie). Done in Paris on 4 January 1949.*

Journal Offielel of 23 January 1949. 19 E/NL. 1950/15

ORDER concerning preparations containing small amounts of poisonous substances

THE MINISTER OF PUBLIC HEALTH AND POPULATION Considering the Decree of 19 November 1948 containing public administrative regulations made under the amended Act of 19 July 1945 on trade in poisonous substances, and in particular Article 19 of the aforesaid Decree, Considering the opinion of the Academy of Pharmacy, Orders as follows:

Article 1. The provisions of Section II of the Decree of 19 November 1948, except Article 58, paragraphs 3 and 4, shall not apply to medical preparations intended for medical use and containing poisonous substances in quantities and strengths equal to or smaller than the quantities and strengths indicated in the schedules to this Order.

Article 2. All provisions contrary to the present Order, and in particular those of the regulations made under the repealed Decree of 14 September 1916, are hereby repealed Article 3. This Order shall be put into effect by the chief of the Central Pharmaceutical Office (Service central de la pharmacie). Done in Paris on 11 January 1949.*

* Journal Officiel of 9 February 19H9.

20 Metallic cyanides Henbane (extract) Extract of ergot (ergotine) Mercury nitrates Poppy (dried capsules) SCHEDULE B Extract of opium: in the form of arsenical ointment Sydenham laudanum: compounded, in proportion not exceeding 50 per cent Bon a in's mixture Indian hemp: in solution and at a maximum rate of 33 per cent Tincture of Indian hemp: compounded in gingival stimulants Cocaine hydrochloride: in injectable solution in strength not exceeding 1 per cent, whether or not compounded with a local anaesthetic listed in Schedule C Cocaine hydrochloride: as a mixture with 10 per qent trioxymethylene "Morphine hydrochloride: as a mixture with 10 per cent trioxymethylene The latter two substances also in preparations with the following formulae: (a) Arsenious acid Morphine hydrochloride Cocaine hydrochloride Creosote...... q.s. to obtain a thick paste (b) Arsenious acid Morphine hydrochloride Cocaine hydrochloride Cannabis indica (extract).... q.s. .to obtain a thick paste (c) Arsenious acid ) two parts Morphine hydrochloride ) one part Cocaine hydrochloride ) one part Carbolic acid , q.s. to obtain a paste A dental surgeon or dentist may be supplied with any of the substances listed above and included in Schedule B by one pharmacist only, chosen by him, whose name he shall submit to the National Dental Surgeons' Association, and under the conditions laid down in the Decree of 19 November 1948.

Article 4. Practitioners must comply with the provisions of the Decree of 19 November 1948 and in particular with the regulations on keeping poisonous substances. Article 5. All provisions contrary to the present Order, and in particular those of the regulations made under the repealed Decree of 14 September 1916, are hereby repealed. Article 6. This Order shall be put into effect by the Chief of the Central Pharmaceutical Office (Service central de la pharmacie). Done in Paris on 4 January 1949.*

Journal Officlel of 23 January 19t9. 19 E/NL. 1950/15

ORDER concerning preparations containing small amounts of poisonous substances

* Journal Official of 9 February 19*9.

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Extract from, the Order of 18 January 1949

Article 1. In accordance with the provisions of Article 25 of the Decree of 19 November 1948, the provisions-of this Order shall apply to every hospital having a pharmacy authorized by law and managed by a pharmacist duly enrolled in the Central Council, Section D, of the Pharmaceutical Association. Hospitals having no managing pharmacist shalj comply strictly with the provisions of Article 25 of the aforesaid Decree. Article 2. Medical heads of departments, their approved assistants, and, in case of emergency or during their period on duty, resident medical students expressly appointed by the medical head of the department, are authorized to prescribe preparations containing poisonous substances. A list of the persons competent to prescribe such substances, with their signatures, shall be kept in the hospital pharmacy. Article 3. The substances listed in Schedules A and C and preparations containing them may be supplied only under the following conditions: 1. By the pharmacy, against a prescription written on a medical inspection register or, if there is no inspection, against a voucher signed by a competent person as provided by Article 2. Vouchers shall be kept by the pharmacist for three years, and then by the hospital administration, to which the pharmacist shall transmit vouchers in support of his stock accounts. 2. By doses taken from the medicine cupboard against a prescription of a competent person. Amounts taken shall be entered on the inspection register and the arrival of the substances at their destination shall be certified. The contents of the cupuoard shall be fixed at the beginning of the year on the proposal of the medical head of each department after consultation with the phar• macist. The list shall be countersigned by the director of the hospital. The cupboard shall contain medicaments only. The classes of medicaments listed in Schedules A, B and C respectively shall be kept separately from one another and from other medicaments. The ward sister on duty shall personally keep the key of the medicine cupboard. According to the amounts taken out, the contents of the cupboard listed in Schedules A and C shall be replenished once a week against a special voucher signed by the head of the department. The pharmacist may call for any evidence concerning the use of such medicaments. Article 4. Medicaments containing substances listed in Schedule B may be supplied only under the following conditions: 1. By the pharmacy against a voucher taken from a numbered book in a form used exclusively for this purpose in the hospital. Reference to the prescription shall be entered in the inspection register. The voucher shall include the following information: the date; the name and bed number of the patient; the nature of the medicament; the amount used, spelt out; and the name of the author of the prescription.

24 i The voucher may be signed only by a competent person as provided by Article 2; in no circumstances shall a blank voucher.be signed. Such vouchers shall be preserved under the conditions laid down in Article 3 hereof. 2. Doses taken from the medicine cupboard against a prescription of a competent person. Such prescriptions shall also be entered in the inspection register, and the arrival of the substances at their destination shall be certified. •Medicaments listed in Schedule 8 should be kept in a separate compartment of the cupboard with a lock and key of its own. In each department a nominal list of all injections of narcotic drugs sha'll be prepared as the drugs are administered, on the special form attached hereto, and shall include: the date; the name and bed number of the patient; the nature of the medicament; the amount used; the signature of the nurse administering the injection. Each completed form shall be submitted to the medical head of the department for signature. It. shall serve as evidence supporting replenishment by the hospital pharmacy of that department's stock of narcotic drugs.

HOSPITAL . .

DEPARTMENT OF DOCTOR