Introduction
Section I
Section II
Chapter II. Drugs in Schedule II
Chapter III Drugs in Schedule III
Section III
Chapter II.
Chapter III.
Section IV
Section V
Chapter II. First-aid kits
Chapter III Measures of control over legally authorized persons and institutions
Author: Charles Vaille
Pages: 1 to 12
Creation Date: 1969/01/01
The obligations resulting from the Single Convention on Narcotic Drugs of 10 March 1961 have been analysed in an earlier article by Professor Paul Reuter. [ 1] The following Model Law is intended to facilitate the application of the Convention by States having ratified it or adhered to it. States which already have legislation on this subject may wish to study the provisions suggested here in order to see how far these have been covered in their own law. For countries in the process of drafting such legislation, the Model Law will have an obvious utility.
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INTRODUCTION
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SECTION I:
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Scope of control
- Prohibitions. Articles 1 to 5 (covering the following articles of the Convention: Preamble, article 2, paras. 4, 5 and 9; and articles 4, 21, 22 and 25)
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SECTION II:
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Measures relating to wholesale trade and manufacture. Articles 6 to 21 (covering the following articles of the Convention: article 2, paras. 3 and 4; articles 20, 21, 29, 30, 30, paras. 3, 4 and 5; and articles 31, 33, 34, 34
(b) and 39)
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SECTION III:
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Measures relating to the retail trade. Articles 22 to 38 (covering the following articles of the Convention: articles 2 and 2, paras. 2 and 4; articles 30 and 30, paras. 2, 2
(b), 2
(b)(i) and (ii), 4 and 6; and articles 34, 34
(a) and
(b) and 39)
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SECTION IV:
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Penal provisions - Seizures. Articles 39 to 41 (covering the following articles of the Convention: articles 36 and 37)
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SECTION V:
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Miscellaneous provisions, e.g. Treatment of drug addicts. Articles 42 to 46 (covering the following articles of the Convention: articles 32, 34, 34(b) and 38)
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It is assumed that the 1961 Convention and the "Administrative Guide for the Application of the Single Convention on Narcotic Drugs, 1961" [ 2] prepared by the Secretary-General of the United Nations are available to the reader.
The Convention requires States to adopt two types of measures: [ 1] administrative and [ 2] legislative or statutory.
The original of this article is in French.
The application of some kinds of administrative measures may entail changes in the existing legislation or regulations in a particular country, but these will not be dealt with here, and readers are referred to the recommendations in the Administrative Guide, particularly those in article 4, paragraph 24. Similarly, this Model Law does not consider article 35 of the Convention (Action against the Illicit Traffic), which mainly calls for certain administrative and diplomatic arrangements.
The basic assumption of this Model Law is that the country concerned is a consumer country in which "manufacture" of drugs (article 1, paragraph 1 (n) of the Convention) is permitted, whether it takes place or not, but "production" (article 1, paragraph 1 (t) of the Convention) is prohibited and does not take place. Production in the sense of the Convention means: "Separation of opium, coca leaves, cannabis and cannabis resin from the plants from which they are obtained." Opium production is covered by the legislation in the producing countries. The production of cannabis and coca leaf for medical purposes covers very small quantities. As concerns the production of cannabis and coca leaf for non-medical purposes, this is either illegal or in the process of suppression; what it requires is a simple law of prohibition either immediate or progressive, and not a positive legislation. With the exclusion of production, therefore, the Model Law below is of interest to much the larger number of countries, who have nothing to do with production.
One of the difficulties involved in framing a Model Law of this kind arises from the differences in domestic law from State to State: while in some States specific measures must be enacted, in others they need only appear in regulations.
These texts vary in importance or appellation: (law, ordinance, administrative regulation, decree, order, instruction, circular, etc.). The articles proposed here can be put into effect in any one of these forms, depending on the juridical practice and principles obtaining in the country concerned.
Each article is preceded by a reference to the Convention in the form of a brief commentary in italics.
SCOPE OF CONTROL - PROHIBITIONS
This initial article of the Model Law is based on the Preamble, article 2, paragraph 9, and articles 4 and 21 of the Convention.
Art. 1. The production, conversion, extraction, preparation, possession, supplying, distribution, broking, purchase, sale, import and export of drugs and in general all agricultural, industrial and commercial activities relating to drugs, otherwise than under licence, are hereby prohibited. Where a licence is issued, it shall cover only medical and scientific uses, in accordance with the provisions hereinafter set out.
However, narcotic substances commonly used in industry for other than medical or scientific purposes may be covered by a special licence, provided that they shall be suitably treated to prevent their use for illicit purposes.
Article 2 is in a sense the first: it defines the drugs subject to control under article 2 of the Convention. A general definition might give rise to divergent interpretations; it might, for instance, apply or not apply to alcohol or tobacco. Hence this article refers to a specific list. Schedules I and II of the 1961 Convention cover narcotics as a whole. Schedule III lists preparations containing one of the drugs in Schedules I or II. Since this list has the disadvantage of being restrictive, it must be constantly kept up to date, as specified in the Convention. This is an illustration of the fact that in spirit of the Convention the basic law empowers the executive authority to act. The Government must be able to promptly adapt regulations to scientific developments as assessed by the World Health Organization and the UN Commission on Narcotic Drugs.
Art. 2. Different régimes shall apply to the production, manufacture, export, import, purchase, sale, possession, distribution and/or use of narcotic drugs according as they are listed in Schedules I, II or III.
Application clause: Schedules I, II and III of narcotic drugs are as follows: (here reproduced are Schedules I, II and III of the 1961 Convention, which must be kept up to date, in accordance with communications received from the Secretary-General of the United Nations under the provisions of article 3 of the Convention).
The application clause may reproduce the definitions of "production" and "manufacture" contained in article 1 of the 1961 Convention.
Similarly, the definitions of "cannabis ", "cannabis resin ", "coca leaf" and "opium" contained in article 1 of the Convention may be reproduced in Schedule I.
Article 3 deals with the preparations defined in article 1, paragraph 1 (s) of the Convention. It is based on the provisions of article 2, paragraph 4, and article 4 of the Convention.
Art. 3. Preparations shall be subject to the same régime as the drugs they contain, except for those listed by name in Schedule III. The latter shall be subject to the same control measures as preparations containing drugs listed in Schedule II, except that the special provisions relating to international trade shall not apply to them, and that for purposes of estimates and statistical returns the information required shall be restricted to the quantities of drugs in Schedules I or II used in the manufacture of such preparations.
Article 4, which prohibits production, is based on articles 22 and 25 of the Convention.
Art. 4. 1. The import, export, production, use and possession of cannabis and cannabis resin, and of preparations containing or manufactured from them are hereby prohibited.
The cultivation of the opium poppy, of the coca bush and of the cannabis plant for the production of cannabis or cannabis resin is hereby prohibited.
An exception may, however, be made for the cultivation of the opium poppy for purposes other than the production of opium. In this case, poppy straw used for the preparation of drugs shall be subject to narcotics control as soon as it reaches the stage of the poppy-straw concentrate named in Schedule I.
Article 5, which prohibits certain synthetic and semisynthetic drugs is based on the provision relating to Schedule IV in article 2, paragraph 5, of the Convention, under which it is a recommendation, not an obligation. For the reasons already given in connexion with article 2 of the Model Law, amendments to the list of drugs given in this article should be a matter for the executive authority.
Art. 5. 1. The production, manufacture, export and import of, trade in, possession and use of desomorphine (dihydrodeoxymorphine), heroin (diacetylmorphine), ketobemidone (4-meta-hydroxyphenyl-1methyl-4-propionylpiperidine), and their salts, are hereby prohibited.
2. However, special licences may be issued to research workers for the use of specified quantities of these drugs exclusively for purposes of medical or scientific research. Each licence shall prescribe requirements for the care and use of the drug by the licensee.
MEASURES RELATING TO WHOLESALE TRADE AND MANUFACTURE
Chapter I. Drugs in Schedule I
Article 6 gives effect to the provisions of articles 29, 30 and 34 of the Convention. It specifies the formalities for obtaining a licence.
Art. 6. 1. The licence referred to in article 1 above shall be issued by the Minister of Public Health, on the recommendation of a Board composed of members appointed by the Minister.
The licence may only be issued to a natural person. It shall be strictly personal, and shall specify each drug or preparation that may be extracted, processed, manufactured or traded in.
The special control measures set forth in article 7 shall also apply to industrial manufacturers who extract alkaloids from opium, poppy straw and coca leaf and to manufacturers who synthetize drugs listed in Schedules I and II.
The licence may be withdrawn on the recommendation of the above-mentioned Board. The licence shall not be granted to, or shall be withdrawn from, any person convicted of illicit traffic in narcotic drugs.
The licensee shall report any change in his industrial or trading address to the Minister of Public Health before new premises are opened; otherwise the licence may be withdrawn.
If a licensee ceases manufacture of or trade in drugs, he shall inform the Minister aforesaid, who shall then order withdrawal of the licence.
Without prejudice to the provisions of articles 4 and 5, no person not licensed under the provisions of this article or of articles 23, 30, 31, 32 and 34 may possess, purchase or be supplied with narcotic drugs, save on prescription by a practitioner entitled under the relevant regulations to prescribe them solely for therapeutic use and in accordance with the special requirements set forth in this Law.
Article 7 could be a matter for the statutory authority. It lists measures required to give effect to the above article 6 of this Law.
Art. 7. The following information must be submitted to the administration when applying for the licence referred to in article 6:
The applicant's surname, first name(s) and profession and the firm's trade name.
Addresses of head office, works, shops, branches, warehouses, etc. (As a separate licence is required for each independent set of premises, the information shown under 3 and 4 shall be given on a separate sheet for each and a person in charge designated for each licence.)
The type of operation for which the licence is requested. (Full and precise particulars of the activities relating to the drugs must be supplied.)
The names of the drugs purchased, used for the manufacture of medicaments, manufactured or sold.
In the case of the manufacture of proprietary medicine, the trade name and the weight of drug content per unit of sale must be indicated, even if the dose comes within the provisions of Schedule III.
In the case of galenical products, the alkaloid narcotic content must be indicated; if this content is unspecified, particulars must be given of the proportion of raw material contained in the manufactured product. Where manufacture is concerned, full and accurate particulars must be given of all the processes involved from raw material to finished product ready for distribution.
Manufacturers holding the licence referred to in article 6 must also take out every year a permit specifying the categories and quantities of drugs which they are entitled to manufacture during the year.
In the case of imports or exports, the applicant shall list the type(s) of operation for which the licence is requested: brokerage, transit, import, export.
Article 8 gives effect to articles 31, 33 and 34 of the Convention, with due regard to the obligations arising from its article 2, paragraph 4. Its subject is international trade.
Art. 8. It is hereby forbidden to import or export, to consign to a Customs or bonded warehouse, or to withdraw from such warehouse, any of the drugs in Schedule I or II without a special permit for each operation issued as prescribed [ 1] by the Single Convention on Narcotic Drugs of 30 March 1961.
Importers must take out from the Customs office of entry a bond-note indicating the quantity of each drug imported and the name and address of the consignee.
The bond-note shall be delivered on production of the permit to import the drugs or take them out of bond for consumption, in the country, as prescribed in the first paragraph of this article. The bond-note must be forwarded to the Customs office of issue within one month from its date of issue, together with a clearance certificate from the municipal authority of the place of residence of the consignee.
Exporters shall obtain an export certificate from the Customs office of exit for every consignment sent abroad.
The said certificate shall indicate the type and quantity of the drug exported and the name of the preparation or product.
Export certificates must be kept for three years by the vendor and must be produced on request to the competent authority.
The insertion of any narcotic drug in letters or parcels sent by post is prohibited; but this prohibition does not apply to the posting of drugs for medical use to countries so accepting them for preparation in Schedule III, in which case consignments may be sent only by "insured box" post.
Article 9, which sets forth measures to ensure application of article 8 above, might lie within the competence of the statutory authority.
Art. 9. The following information and documents must be supplied in order to obtain the licence prescribed in the first paragraph of article 8:
A. Applications for export permits:
Number of the foreign country's import permit, with the permit itself attached;
Authority issuing the import permit;
Date of issue of the import permit;
Name and address of exporter;
Goods to be exported: net weight and particulars of goods, followed by statement of total drug content;
Name and address of consignee;
Customs office of exit;
Name and address of forwarding agent;
Period of validity requested.
B. Applications for import permits:
Name and address of importer;
Goods to be imported: net weight and particulars of goods, followed by statement of total narcotic drug content;
Name and address of exporter;
Customs office of entry;
Name and address of forwarding agent;
Period of validity requested.
Exporters and importers must notify to the competent authority, namely the authority which issued the permit prescribed in article 8, the date on which each operation was carried out, and indicate the quantities of drugs actually exported or imported.
Article 10 is designed to ensure the application of article 30, paragraph 5, of the Convention relating to labelling and possession of drugs in trade and distribution.
Art. 10. 1. No drug may be held for purposes of the trade, or move in trade or be imported or exported unless its immediate wrapping or container bears an orange-red label so affixed that it cannot be accidentally detached. Such label shall show, in addition to the name of the drug, the gross and net weights, the name and address of the vendor and a reference number for each wrapping or container. These entries shall be accompanied by the word "poison" in clearly visible letters on an orange-red band going right round the wrapping or container.
Any trader or manufacturer affected by these provisions must store all drugs in lock-fast cupboards or premises.
Article 11 might concern only the statutory authority. Its provisions, which deal with appellations, implement the recommendation contained in article 30, paragraph 3, of the Convention.
Art. 11. The name referred to in article 10 shall, wherever possible, be the international non-proprietary name of the drug communicated to the World Health Organization.
Article 12 concerns the transport of drugs. It is based, inter alia, on article 30, paragraph 4.
Art. 12. No drug, or preparation containing a drug except preparations in Schedule III, may move in trade unless their immediate containers are labelled as prescribed in articles 10, 35 or 39. The outer wrappings of packages shall show only the names and addresses of the sender and consignee, and shall be sealed with the sender's mark.
Article 13 is based on a combination of provisions of articles 30 and 34(b) of the Convention applicable to the wholesale trade.
Art. 13. 1. Every purchase or transfer, even free of charge, of drugs must be recorded in a special register with serially numbered pages initialled by a public authority of the locality in which the premises mentioned in article 7, paragraph 2 are situated.
The authority initialling the special register shall require the person concerned to produce his permit, and indicate on the first page of the register the date on which the permit was issued.
Every operation recorded in the register shall be given a serial number, which may cover all the drugs contained in one and the same consignment received or supplied. The entry must be made, without blanks, erasures or interlineating, at the precise moment when the consignment is received or supplied.
The entry shall indicate the name, profession and address of the purchaser or vendor, the quantity of drug, the name under which it appears in the narcotics Schedules, and the reference number referred to in article 10. In the case of preparations, the same particulars shall be entered, as well as the drug content.
In the case of purchase or receipt of drugs, the reference number given by the vendor of the drugs supplied shall also be entered in the register.
In the case of the re-sale of a drug or preparation in a wrapping bearing a stamp showing its provenance, the reference number or numbers on the original label shall be entered in the register.
Article 14 deals with the special obligations affecting manufacture arising out of articles 29 and 34(b ).
Art. 14. 1. Manufacturers making or processing drugs shall, after entering these operations in the special register prescribed under article 13, add the quantity and type of raw material used and the quantity and type of drug or drugs obtained.
Pharmacists who, by virtue of their occupation, hold the licence referred to in article 6 shall observe the same obligations regarding drugs not exclusively intended for dispensing on their premises.
Any deficit shall be discharged on the register by the inspectors referred to in article 52, if they consider it a normal result of the conversion or handling processes declared.
Article 15 gives effect to the provisions of article 20 of the Convention, on statistics, and article 21, on limitations.
Art. 15. 1. The manufacturers and pharmacists referred to in article 14 shall send the Minister of Public Health - by 1 February, 1 May, 1 August and 1 November - a quarterly return showing for each drug: the quantities received, used for manufacture, manufactured and/or sold during the previous quarter.
A statement of stocks of drugs in Schedules I and II and/or preparations containing them and of stocks of conversion products held at 31 December of the previous year must be attached to the quarterly return to be forwarded by 1 February.
Concerns engaged in wholesale trade (druggists and distributors) in such drugs are required to send the Minister of Public Health by 1 February of each year, a return showing the quantities of each drug received and sold during the previous year and the quantities in stock at 31 December.
Under article 34(b ) of the Convention, records relating to drugs must be preserved for not less than two years. Under article 16 of this Law, the period is ten years, because in many countries that is the statutory limitation on penal prosecution. Advantage has accordingly been taken here of the possibilities offered by article 39 of the Convention.
Art. 16. 1. The register referred to in articles 13 and 14 must be preserved for ten years and be produced for inspection at any time by the competent authority.
The vendor shall be discharged of liability for quantities of drugs received only proportionally to his sales entered in the register or discharge under article 14.
Article 17 is essential to the application of article 30 of the Convention. It concerns medical samples and supplies for scientific research to which latter article 34(b) of the Convention must also apply.
Art. 17. Save in the case of drugs supplied for therapeutic uses on prescription by authorized practitioners, the sale or supply of narcotic drugs to any person failing to comply with the requirements of article 6 is prohibited.
Drugs in Schedules I and II may only be supplied against an application made out in accordance with the provisions of article 34 (for drugs in Schedule I) or of article 43, paragraph 3 (for drugs in Schedule II).
The foregoing provisions notwithstanding:
Manufacturers of proprietary medicines containing drugs may supply doctors and veterinary surgeons with medical samples within the limits, and subject to the conditions, specified in article 18;
Laboratories and scientific research institutions may obtain such drugs on a permit from the Minister of Public Health specifying the quantities they may possess and use; and they are under obligation to record the drugs in registers which they must preserve for not less than two years.
The provisions of article 18, relating to medical samples, are designed to give effect to article 17 of the Law; they should come under regulations rather than the Law itself. The measures prescribed in paragraphs 2 and 3 go beyond the obligations laid down in the Convention.
Art. 18. 1. The medical samples referred to in article 17 may only be supplied against a receipt, dated and signed by the doctor or veterinary surgeon concerned, specifying the type and quantity of the product supplied;
The quantities supplied may not exceed, for each practitioner, three therapeutic doses per annual consignment;
Supplies of samples of each proprietary medicine shall cease three years from the date on which sale of the product was authorized;
Manufacturers shall send the Minister of Public Health a quarterly return of medical samples supplied during the previous quarter, giving the names and addresses of the practitioners supplied.
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Article 19 lays down for drugs in Schedule II less strict requirements than for those in Schedule I, while still conforming with the Convention.
Art. 19. The wholesale trade in, and the manufacture of, drugs in Schedule II shall be subject to the same control measures as drugs in Schedule I, except that:
The reference number for labelling referred to in article 10 may be dispensed with;
Requirements under article 13 may be simplified to comprise for drugs in Schedule II, only the registration of quantities manufactured and of each transaction involving purchase or conveyance of drugs in Schedule II;
The statistical returns referred to in article 15 shall be furnished only once a year, not later than 1 February;
The restrictions on the supply of medical samples prescribed in articles 17 and 18 shall not apply to preparations containing drugs in Schedule II.
Article 20, concerning preparations gives effect to article 2, paragraph 3, of the Convention.
Art. 20. Preparations other than those in Schedule III:
Shall be subject to the same control measures as the drugs they contain, but no returns such as prescribed in article 15 shall be required for them, other than those relating to the drugs themselves;
Shall not be subject to the provisions of article 8 concerning periodic manufacturing licences;
Shall not be subject to the provisions of article 6 on the licensing of establishments and premises where the trade in and distribution of drugs can take place.
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Article 21, relating to Schedule III, is based on the provisions of article 2, paragraph 4 of the Convention.
Art. 21. As stated in article 3, preparations in Schedule III are subject to the same control measures as preparations containing drugs in Schedule II except that:
Exports of these preparations shall not be subject to the requirements relating to estimates prescribed in article 19, paragraph 2, of the 1961 Convention, save at the express request of the country concerned;
The special provisions governing international trade referred to in article 31, paragraphs 3-15, of the said Convention shall not apply.
MEASURES RELATING TO THE RETAIL TRADE
Chapter I. Drugs in Schedule I
Article 22, concerning persons authorized to supply drugs to the public, gives effect to article 30 and article 34( a ) of the 1961 Convention.
Art. 22. Drugs and preparations containing them may not be supplied in any form:
For use in human medicine, except by doctors or pharmacists legally authorized to supply medicaments to their patients or customers;
For use in veterinary medicine, except by such a pharmacist or, subject to the reservations set forth in the following paragraph, by a qualified veterinary surgeon.
A legally authorized veterinary surgeon may hold drugs for use in veterinary medicine, but may not keep an open dispensary, although he may supply preparations containing drugs to his clients, when the latter reside in a locality without a pharmacy.
Article 23, relating to the supply of drugs to practitioners, gives effect to article 30 of the Convention. It conforms to the recommendation contained in article 30, paragraph 2(b )(ii).
Art. 23. 1. Doctors and qualified veterinary surgeons may, on application made out in accordance with the provisions of article 36, obtain drugs for use by them either in cases of emergency or for operations or dressings.
These medicaments must be used by the practitioners themselves, who are forbidden to sell or give them to their patients.
These drugs may be supplied only in the pharmaceutical form adapted to their medical use, and must be so kept by the practitioners as to prevent any diversion.
Article 24 concerns the supply of drugs by pharmacists under article 30 of the Convention. It implies the issuing of a regulation by the statutory authority, to avoid needless cluttering of the Law and to allow for scientific developments.
Art. 24. 1. Pharmacists may supply drugs or preparations containing them for use in human or veterinary medicine only on prescription by a doctor or a veterinary surgeon.
They may, however, supply on a dental surgeon's or qualified midwife's prescription any preparation listed by decision of the Minister of Public Health.
Article 25 covers exceptional cases in which practitioners may themselves supply medicaments.
Art. 25. Doctors and veterinary surgeons authorized by law to supply medicaments in exceptional cases shall be subject to the obligations presented in this section for pharmacists.
Article 26, based on the provisions of articles 30 and 34(b ) of the Convention; concerns hospitals. The measures prescribed are a matter for the executive rather than the legislative authority.
Art. 26. 1. Hospitals having a pharmacist on their staff shall be governed by the provisions of this section as prescribed in paragraph 3 of this article.
Hospitals having no pharmacist on the staff may not possess drugs; although they may keep, in a lockfast cupboard, preparations containing drugs for use in emergency, provided that a doctor accepts responsibility for the store.
Such cupboards shall be re-stocked on prescriptions made out in accordance with the provisions of article 36 as and when the medicaments concerned are used up.
In hospitals having a pharmacist on the staff, a list shall be kept at the hospital pharmacy of the practitioners empowered to prescribe narcotic drugs, together with their signatures.
Medicaments containing drugs may only be supplied as under:
By hospital pharmacy against a voucher taken from a numbered counterfoil book of a type used solely for that purpose in the hospital. The prescription shall be entered in the case record or the patient's file. The voucher shall specify the date, the name of the patient, the type of medicament, the dose administered (in words) and the name of the person prescribing it; shall be signed by one of the above-mentioned authorized persons. These vouchers must be kept for not less than two years.
From stocks in the medicine cupboard on prescription by an authorized person. Such prescriptions shall also be entered in the case record or the patient's file.
The medicine cupboard of a hospital department must have a separate compartment with its own key to keep narcotic preparations in.
Quantities of drugs taken from the first-aid cupboard may be replaced only on submission of the abovementioned special vouchers; in the case of substances used for injections, the hospital pharmacy shall require the return of the empty ampoules representing the quantities consumed, hence perforce kept by the hospital staff.
Article 27, concerning entries in the prescription register, is based on the provisions of articles 30 and 34(b ) of the Convention.
Art. 27. 1. A practitioner authorized to dispense prescriptions for drugs and preparations containing them shall immediately copy each prescription into a register with serially-numbered pages initialled by a public authority of the locality where he practises. Entries to be made without blank spaces, erasures or interlineations.
Each entry shall bear a serial number, and show the name of the person prescribing, the name and address of the patient or customer, and the date on which the medicament was supplied and its ingredients.
Pharmacists may similarly enter medical prescriptions free of narcotic drugs in the same register.
The register shall be preserved for not less than ten years.
Article 28 exempts dispensing chemists from having to apply for the licence referred to in article 6, and prescribes the requirements for their purchases, which might be a matter for the executive authority alone, particularly since they are not expressly prescribed in article 30 of the Convention.
Art. 28. 1. The production for stamping of a pharmacist's diploma shall replace the licence referred to in articles 1 and 6, but only for the preparation and dispensing in his pharmacy of medicaments containing drugs.
Pharmacists may purchase drugs only from a home concern licensed in terms of article 6, and only on production of two serially-numbered sheets from a counterfoil book of a type prescribed for the whole country by the Minister of Public Health. The cost of printing and distributing these counterfoil books shall be borne by the practitioners concerned.
One of the two sheets shall bear the name, address and signature of the purchaser, the application date and the concern's stamp, and shall show in full the name of the drug and the quantity requested. The second sheet shall show only the name and address of the purchaser and the type of medicament, and shall be returned by the vendor to the purchaser complete with the order-book number, the quantities actually supplied, the date of delivery, and the purchaser's signature and stamp.
These documents shall be preserved by the persons concerned for not less than two years, for production on request by the competent authority.
Any substance supplied shall bear the entry number from the vendor's register.
Article 29, which is based on articles 2 and 30 of the Convention, concerns the possession of narcotic drugs. Its provisions are a matter for the executive rather than the legislative authority. For the pharmacist they follow naturally from those of article 10 of the Law (relating to the trade).
Art. 29. 1. With the exception of the coca leaf and poppy-straw concentrate drugs in Schedules I and II must be stored in lock-fast cupboards or premises.
Storing in such cupboards or premises of medicaments other than those in Schedule III is prohibited.
Containers of drugs or their dilutions must bear the name of the drug as given in the Schedule or the international non-proprietary name notified by the World Health Organization.
The inscription must be made very clearly in black on an orange-red label so affixed that it cannot be accidentally detached.
It must be accompanied by the word "poison" in very clear black letters On an orange-red band going right round the wrapping or container.
Article 30 gives effect to articles 30, paragraph 2 and 34(b ) of the Convention. It concerns the making-out of prescriptions and follows the recommendation in article 30, paragraph 2( b )(ii).
Art. 30. 1. The prescribing or dispensing of any substance, other than the coca leaf or poppy-straw concentrate specifically listed in Schedules I and II is prohibited.
Drugs may only be supplied in a form compatible with their therapeutic use.
Prescriptions, other than those for liniments and ointments, for preparations containing narcotic drugs shall be made out, after examination of the patient, on sheets taken from a counterfoil book of a type prescribed by the Minister of Public Health, who shall also determine how the counterfoil books shall be printed and distributed.
The person prescribing shall sign and date the prescription and give legibly on it his name and address, those of the patient and instructions for the use of the medicament.
In the case of a magistral preparation, he shall name in full the doses of drugs prescribed and, if need be, the number of therapeutic units; in the case of a proprietary medicine, he shall name in full the number of therapeutic units.
The counterfoils must be preserved by practitioners for not less than two years.
Article 31, which gives effect to article 30 of the Convention, is founded on article 39, whereby stricter measures may be taken at national level than those prescribed in the Convention. It lays down the rules applicable to prescriptions.
Art. 31. 1. The making-out and dispensing of prescriptions for drugs, other than liniments and ointments, covering a period of more than seven days is prohibited.
Doctors may not make out, and pharmacists may not dispense or re-dispense a drug prescription for a patient or customer during a period covered by a previous drug prescription, unless that previous prescription is specifically mentioned by the practitioner concerned on the new prescription.
No holder of a prescription for one or more drugs may during the period of treatment therein specified obtain a further drug prescription without informing the other practitioner of the previous prescription or prescriptions.
The other practitioner shall indicate on his prescription that he is aware of the previous prescription or prescriptions.
Article 32, which concerns entries to be made on prescriptions, gives effect to article 30 of the Convention.
Art 32. After a prescription is dispensed it must bear the pharmacy's stamp together with its number in the prescription register and the dispensing date.
Article 33, giving effect to the provisions of article 30 of the Convention, concerns the labelling of drug preparations supplied to the public. It follows the recommendation in article 30, paragraph 4, of the Convention. These provisions might be a matter for the executive authority.
Art. 33. 1. Magistral preparations containing drugs shall bear a label indicating the name and address of the pharmacist, the entry number of the prescription in the prescription register, and instructions for use of the medicament.
If the medicament is intended for human use, and for oral, perlingual, rectal, vaginal, urethral or subcutaneous administration, the label shall be white and an additional label shall be affixed with the words "DO NOT EXCEED THE DOSE PRESCRIBED" printed in black on an orange-red background.
In other cases, the label shall be orange-red in colour with the words "DO NOT SWALLOW" printed in black. It may have a blank space in which to enter instructions for use.
Proprietary medicines containing one or more drugs shall, in addition, show on both inner and outer labels the name(s) of the drug(s), its (their) concentration stated in words, and the quantity in the container; and on the outer wrapping a blank space framed in a double orange-red line, for the pharmacist to enter his name and address, the registration number from the prescription register and instructions for use given by the person prescribing.
Where the medicament is for veterinary use, the preparation shall also, in all cases, bear a label with the words "VETERINARY USE" printed in black on an orange-red background.
The name used for the drug shall be that appearing in the appropriate Schedule or the non-proprietary name communicated by the World Health Organization.
Article 34, which concerns the renewal of prescriptions, gives effect to article 30 of the Convention.
Art. 34. No prescription for preparations containing drugs, apart from liniments and ointments, may be renewed.
As regards liniments and ointments, no prescription may be renewed before expiry of the period specified in the instructions given by the person who made out the prescription. Renewals must be entered in the prescription register under a new serial number.
The entry may consist of the number under which the prescription was originally registered and the name and quantity of the drug prescribed.
The prescription must show the date and number of the renewal.
Article 35, which gives effect to articles 30 and 34(b) of the Convention, refers to the preservation of prescriptions by the pharmacist.
Art. 35. 1. Pharmacists may supply preparations containing drugs only against a prescription made out in accordance with the provisions of article 36.
The pharmacist shall enter in the prescription register the name and address of the patient and, if need be, those of the third party submitting the prescription.
If the bearer of the prescription is not known to the pharmacist, the latter shall request him to produce proof of his identity, in which case the name of the authority that issued the identity document and the number and date of issue, shall be entered in the prescription register.
Non-renewable prescriptions shall be preserved by pharmacists for not less than two years. They shall be filed away monthly for production on request by the competent authority.
A copy of every non-renewable prescription shall be handed to the customer, complete with the entries referred to in article 38.
Article 36, which gives effect to articles 30, paragraph 2(b )(i) and 34(b ) of the Convention, concerns the possession of emergency stocks: [ 1] by practitioners; [ 2] by dental surgeons; and [ 3] by midwives.
Art. 36. 1. Doctors and veterinary surgeons may possess a sufficient stock of medicaments containing drugs to cover first-aid needs.
The types and quantities of this stock shall be determined by the Minister of Public Health.
Used-up stock shall be replaced on application by the doctor or veterinary surgeon under the provisions of article 36.
Such applications can be met only by a pharmacist resident in the practitioner's locality or, if there is no pharmacy there, by one in the nearest locality.
The pharmacist selected by the doctor or veterinary surgeon shall in all cases be indicated by him to the competent authority.
Dental surgeons may, subject to the provisions of the previous paragraph, possess for their professional use preparations containing drugs listed by decision of the Minister of Public Health.
Midwives may possess for their professional use preparations containing drugs listed in type and quantity by decision of the Minister of Public Health with specifications as to the supply of such medicaments to, and their use by, midwives.
Pharmacists shall preserve for not less than two years, for production on request by the competent authority, the applications mentioned in the three foregoing paragraphs.
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Drugs in Schedule II
Article 37, concerning Schedule II, gives effect to article 2, paragraph 2, and to article 30, paragraph 6, of the Convention.
Art. 37. The provisions of section III, chapter I, shall apply to drugs in Schedule II, with the following modifications:
The applications referred to in article 23 may be made by ordinary prescription;
Re-stocking and supply under article 32 may be effected by ordinary prescription;
The purchases referred to in article 34 may be made on an ordinary order voucher and the substances supplied need have no reference number;
Preparations may be kept in cupboards or premises other than those indicated in article 35;
Preparations may be prescribed by ordinary prescription, the provisions of article 36 notwithstanding, so that the practitioner need not keep track of his prescription;
The provisions of article 37 do not apply;
The provisions of article 39, paragraph 3, do not apply;
Prescriptions for preparations may be repeated in accordance with the requirements restricted to liniments and ointments under article 40;
Article 41 does not apply;
Orders for preparations referred to in article 42 may be placed by ordinary prescription, which pharmacists need not preserve.
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Drugs in Schedule III
Article 38, concerning Schedule III, gives effect to article 2, paragraph 4, and article 30 of the Convention.
Art. 38. The provisions of article 43 concerning drugs in Schedule II apply to preparations in Schedule IV, with the following modifications:
Pharmacists may purchase such preparations merely by placing an order;
The preparations may be supplied to the public without prescription; hence articles 23, 30, 31, 32, 38 and 40 do not apply, and renewal is free;
Article 33 does not apply;
The provisions of article 34, paragraph 2, do not apply.
PENAL PROVISIONS - SEIZURES
Article 39 sets forth the penal provisions prescribed under article 36 of the Convention.
Art. 39. 1. Any infringement of this Law or of the regulations for its enforcement shall be punishable by the same prison sentences and fine as are inflicted under the Penal Code for housebreaking.
Any attempt to commit such infringement shall be punished as the infringement itself, the same applying to association or conspiracy to infringe the Law.
The penalties set forth in the foregoing paragraphs may be imposed even where the various acts contributing to the infringement have been committed in different countries. Each infringement committed in a different country shall be treated as a separate offence.
The same penalties shall apply to persons associating together in the use of drugs in Schedule I or facilitating their use, whether for reward or free of charge, by obtaining premises for the purpose or in any other way.
In all the cases mentioned in the foregoing paragraphs the courts may also order deprivation of civil rights for a period of one to five years.
The courts shall sentence to local banishment for a minimum period of five and a maximum period of ten years persons convicted of assisting others to use drugs in Schedule I by obtaining premises for the purpose or in any other way.
The penalties set forth in paragraph 1 of this article shall apply to any person who by means of a forged or gratuitous prescription has obtained or tried to obtain a narcotic drug that can only be supplied on prescription or who has knowingly dispensed such a drug against such a prescription, or who has been found in possession of such a drug without valid reason.
Article 40, which gives effect to article 36 of the Convention, stiffens the penalties for illicit manufacture and for encouraging drug addiction among minors.
Art. 40. 1. The penalties set forth in article 45, including local banishment, shall be doubled when the offence consists of the illicit manufacture of drugs in Schedules I and II or the illicit production of substances referred to in article 4 of this Law.
The same shall apply where a minor has been encouraged to use a drug in Schedule I.
Article 41, which deals with seizure and confiscation, is based on article 37 of the Convention.
Art. 41. 1. In all cases coming under this section the courts may order the confiscation of drugs seized, but confiscation may not be ordered if the offence is found to have been committed in a pharmacy not owned by the offender, unless the actual owner was an accomplice.
In cases covered by article 45, paragraph 4, the courts shall order confiscation of the substances, utensils, equipment, furniture furnishings and decorations of the premises.
In cases covered by article 46, paragraph 1, the confiscation shall be ordered of the materials, equipment and installations used for the manufacture and transport of the drugs.
The courts may, for a maximum period of five years, debar the convicted person from exercising the profession in which the offence was committed.
If the offence is repeated, the above-mentioned penalties, including debarment from the profession, may be doubled.
MISCELLANEOUS PROVISIONS
Chapter I Treatment of drug addicts
Article 42, concerning the treatment of drug addicts, is based on the recommendations of article 38 of the Convention.
Art. 42. 1. Known users of drugs and persons charged with an offence under this Law may be committed by the examining magistrate to a nursing home for a course of detoxication treatment of a type regulated by the Ministers of Justice and Public Health.
The same regulations shall specify how the cost of equipping such nursing-homes and of accommodating and treating the inmates shall be met.
Rules shall also be laid down for the treatment in such nursing-homes of unconvicted drug addicts and dangerous alcoholics.
Persons evading their obligations under paragraph 1 of this article shall be liable to imprisonment for a period of from six days to two months. The said penalty shall not run concurrently with the penalties specified in article 45.
Article 43 is based on article 32 of the Convention which contains special provisions concerning the carriage of drugs in first-aid kits of ships or aircraft engaged in international traffic, and on the Convention on International Civil Aviation.
Art. 43. 1. The international carriage by ships or aircraft of such limited quantities of drugs as may be needed during the journey for first-aid or emergency shall not be considered as imports or exports.
The Minister of Public Health shall make the necessary orders to prevent misuses of the abovementioned drugs or their diversion for illicit purposes. He shall specify the maximum permissible quantity of narcotic preparations per first-aid kit and their qualitative ingredients. First-aid kits shall be stocked on prescription by a doctor, who shall specify the purpose for which the substances are prescribed.
The administration of the above-mentioned drugs in an emergency shall not be considered as an infringement of the provisions of section III, chapter I, of this Law.
Article 44 amplifies the foregoing provisions for the application of article 34 of the Convention, on measures of supervision and inspection.
Art. 44. 1. Pharmacists shall enter upon receipt every purchase or delivery to their premises, even without payment, of drugs and preparations containing them, other than those in Schedule III, in a special register with serially-numbered pages initialled by the competent local authority. The authority inspecting the register shall require production of the pharmacist's diploma.
Entries in the register shall show the date, the name of the supplier, the designation of the substance and the quantities received.
Pharmacists shall enter in this register the types, and quantities of drugs used in the manufacture of officinal preparations and the quantities of the latter obtained.
As regards magistral preparations entered in the prescription register and such officinal preparations as are entered therein on the day of manufacture, pharmacists need keep only a monthly record in the register prescribed in paragraph 1 of this article.
All entries must be made without blanks, erasures or interlineations.
The register of ingoing and outgoing drugs must be preserved for not less than ten years.
The pharmacist shall at least once a year inventory the drugs and preparations containing them in his possession and strike the balance of ingoings and outgoings. Any deficit recorded shall be submitted for validation to the competent inspector on the first inspection following the striking of the balance.
Article 45, concerning the transfer of a pharmacy, gives effect to article 34(b)
Art. 45. 1. Any pharmacist selling his pharmacy shall with the purchaser present, inventory the drugs and preparations containing them; the inventory shall be entered in the register referred to in the previous article and countersigned by the parties.
The vendor shall hand over to the purchaser, against the latter's receipt, the register of drugs and the documents that are to be preserved in pursuance of articles 33, 34, 41 and 42.
Article 46, which gives effect to article 34 of the Convention, prescribes measures for the inspection and supervision of licensed establishments.
Art. 46. 1. Police superintendents shall have joint responsibility with the inspectors duly appointed by the Minister of Public Health for the enforcement of the provisions of this article.
Police superintendents shall be empowered to inspect, with the assistance of one of the inspectors referred to in paragraph 1 or, failing him, of a pharmacist designated by the regional authority, pharmacies, doctors' and veterinary surgeons' stocks of medicaments, warehouses and stores of druggists and commission agents or traders in drugs, laboratories in which narcotic substances are processed for the extraction of alkaloids or for conversion into pharmaceutical products, shops and all premises where products governed by this Law are manufactured, stored or offered for sale.
The inspecting authority shall require production of the licence to practise or to use drugs, failing which substances found that infringe the Law shall be confiscated and the premises concerned may be closed by order of the competent administrative authority.
If the licence is produced, the inspecting authority shall make sure that the registers are being properly kept. In the event of infringement of the Law or regulations under it, an official record shall be made of the findings and measures taken. Any quantity of narcotic drugs found outside the cupboards or premises referred to in article 10, paragraph 2, shall be confiscated. The official record made shall be transmitted to the judicial authority and a copy sent to the administrative authority.
NOTE. - The Bulletin on Narcotics will be pleased to arrange for clarification or further assistance in the preparing of any legislation arising out of this Model Law. Inquiries from Governments (and others interested) may be addressed to the Editor, Bulletin on Narcotics, United Nations, Geneva.
1Paul Reuter, "The Obligations of States under the Single Convention on Narcotic Drugs, 1961 " - Bulletin on Narcotics, Vol. XX, No. 4, October-December 1968.
2Document E/CN.7/484/Rev. 1, of 1 March 1966.
003A special text can be devoted to the provisions of article 31 of the Single Convention. This solution seems preferable to their inclusion in the Law itself, which it would help to lighten, the measures governing imports and exports being applicable to only a few persons.
