ACT HAITI. (Passed 4 August 1955: Le Moniteur, 15 September 1955) PAUL E. MAGLOIRE, President of the Republic -

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1 ACT HAITI (Passed 4 August 1955: Le Moniteur, 15 September 1955) PAUL E. MAGLOIRE, President of the Republic - Having regard to:- Articles 57 and 79 of the Constitution; The Act of 16 July 1923 on Narcotic Drugs; The Legislative Decree of 10 July 1940 regulating medical, pharmaceutical and dental practice; The Legislative Decree of 22 November 1945 prescribing the functions of the Public Health Service; The Act of 5 February 1948 on the control of medicaments and pharmaceutical products; Considering that the High Authorities of State are bound to safeguard the public health; Considering the provisions of the Geneva Conventions of 19 February 1925 and 13 July 1931, and of the Final Act signed at Geneva on 19 November 1948, and particularly Schedules A, B and C of narcotic drugs and poisonous substances annexed to the said Conventions; Considering that it is essential to control effectively the marketing, manufacture, distribution and sale of pharmaceutical and biological preparations by representatives of laboratories, stockholding agents and pharmacists; Acting on the report of the Secretaries of State for Public Health, for Justice and for Trade; And on the advice of the Council of Secretaries of State; Has introduced and the Legislature has passed the following Act. GENERAL PROVISIONS: Article 1. Pharmacists, manufacturers, representatives and stock-holders of pharmaceutical preparations shall comply with all Acts, orders and administrative regulations concerning the delivery, storage, distribution and sale thereof. Article 2. Pharmacies are hereby placed under the control of the Public Health Department, which may act either directly or through its competent organs

2 or through any commission of control or inspection established for that purpose. Where a pharmacy is established contrary to law, the competent judicial authorities shall, at the request of the competent officer of the Public Health Department, hold an enquiry, and the record thereof shall be forwarded to the Public Prosecutor for section. Article 3. Pharmacies and stores of medicaments shall be inspected at least once a year by the Medicaments Control Service. The Control Commission shall include two pharmacists attached to the Public Health Service and any other officers appointed by the Secretary of State for Public Health. Every inspection, with all remarks, recommendations and suggestions made by the Control Commission, shall be recorded in a register kept for that purpose by the responsible manager. The rooms and furniture of the pharmacy shall be kept in a clean and orderly manner, under penalty of revocation of licence. DEFINITIONS: Article 4. A medicine or remedy is any simple drug, defined chemical product, mixture or compounded preparation intended for the prevention or cure of disease in man or animals. Article 5. Pharmaceutical preparations which may be sold only by a pharmacy comprise - 1. patent medicines and any other products sold for curative purposes; 2. medicated dressings, sterilized drains and ligatures; 3. sera, vaccines, organic liquids and other biological products. QUALIFICATIONS OF PHARMACISTS Article 6. No person may manage, be in technical charge of a dispensary or pharmacy, or prepare, sell or retail to the public any medicine or remedy within the territory of the Republic, unless he is of age and duly in possession of a pharmacistâ s diploma issued by the Haitian State after he has passed the examinations of the Faculty; but a Haitian pharmacist in possession of a diploma of a foreign university may practise in Haiti if he obtains an equivalent diploma after displaying his documentary evidence and complying with the Order of 28 November Article 7. No person, even if he is in due possession of both a medical practitionerâ s and a pharmacistâ s diploma, may simultaneously practise medicine and pharmacy. Article 8.

3 A practising pharmacist may be assisted by one or more assistants, whether holding pharmacistâ s diplomas or not, but shall be liable for their acts. OBLIGATIONS AND DUTIES OF PHARMACISTS Article 9. The French Codex shall be binding and its application shall be compulsory. Pharmacists shall be guided thereby and shall be in possession of its latest edition and of its supplements. Article 10. Pharmacists preparing ampoules or making special preparations shall apply for a licence from the Control Service and shall deposit therewith samples of such products. Article 11. The name "Pharmacy" shall be displayed on the front of the dispensary and on invoices, labels, copies of prescriptions and all the accounting documents of the establishment. Article 12. Pharmacists shall be liable for the composition and the pharmacodynamic properties of the medicaments which they retail. They may not sell nor possess damaged medicaments or goods for which the guarantee has expired. Article 13. In every place with at least seven pharmacies in operation, a night service shall be established according to a scheme and rules approved by the Public Health Department and the said pharmacies, so that each pharmacy shall be on duty once a week. Where fourteen or more pharmacies are in operation in the same place, the Public Health Department may increase the number on duty. Pharmacies on duty according to that system shall remain open to the public all night. For the convenience of customers an occulting red light shall be placed on the main frontage of each pharmacy on night duty and shall be shown all night. The rotation system shall be established not later than one month after the promulgation of this Act. After that time limit has expired the Public Health Department shall have power to compile a list of pharmacies bound to provide night service as aforesaid. In places with less than eight pharmacies there shall likewise be established a rotation service under which no pharmacy need be open all night but pharmacies shall be designated which may be called upon in cases of serious urgency at the direct request of a medical practitioner or of the police. Where a pharmacy refuses to provide night service in accordance with the preceding paragraphs, the cantonal judge shall, at the request of the police, compile a record for the purposes of any necessary legal proceedings.

4 A minimum list of preparations which all pharmacies shall be bound to hold in stock to supply to customers in emergency shall be compiled and published by the Public Health Department. The Control Commission may inspect these preparations at any time without prior notice. PRESCRIPTIONS AND DISPENSING: Article 14. A pharmacist shall be bound to dispense only prescriptions conforming to the Codex, and only up to the maximum doses therein laid down. The pharmacist shall draw the medical practitionerâ s attention to any case in which the prescribed dose exceeds the maximum, and shall dispense the prescription only if the words "I prescribe" appear thereon above the medical practitionerâ s signature. In such a case the dosage shall be written in words and not in figures. Article 15. In dispensing a magistral preparation, a pharmacist shall comply strictly with the medical practitionerâ s prescription. Such prescriptions shall be copied accurately into a register of prescriptions. A pharmacist shall dispense officinal preparations and compounds according to the formulas contained and described in the Codex. Article 16. A pharmacy shall, before supplying any medicament, place on the bottle, pot, box or wrapper in which the medicament is packed a label bearing the name and address of the pharmacy and, where necessary, directions for use and the designation of the medicament. Article 17. Dentists, midwives and veterinary surgeons may prescribe certain pharmaceutical products necessary for the practice of their profession. Separate lists of such substances shall be published in Orders issued by the President of the Republic after this Act has been promulgated. No pharmacy may dispense prescriptions for substances other than those specified in the saidlists. Article 18. Prescriptions shall be legible and drafted in clear and explicit language. It shall be unlawful to issue a code prescription in which medicaments are denoted by numbers, and any person doing so shall be arraigned before the Correctional Court on information laid by the Public Health Department. The person issuing a magistral prescription shall cause to be inscribed therein in easily legible characters his name, address and qualifications as well as his signature. Pharmacists shall refuse to dispense any prescription failing to comply with these requirements. NARCOTIC DRUGS AND POISONOUS SUBSTANCES:

5 Article 19. Poisons, sulphonamides and antibiotics may be sold only by pharmacists on the prescription of a qualified medical practitioner, dentist or veterinary surgeon: provided that ointments for external use with a sulphonamide or antibiotic base may be sold without a prescription. Article 20. Any pharmacist who, in breach of the Geneva Convention and of the law governing pharmaceutical practice in Haiti, dispenses a prescription for narcotic drugs not issued by a medical practitioner shall be liable to a fine of 2,500 to 5,000 gourdes or to imprisonment for three to six months to be awarded by the correctional court in proceedings instituted by the State Counsel in the Civil Court at the request of the Public Health Department. A sentence of imprisonment shall entail loss of licence. Article 21. Substances in Schedule A annexed to the Geneva Conventions may not be supplied in any form whatsoever for medical or veterinary purposes except by a pharmacist. Article 22. Subject to the provisions of article 17, pharmacists may not supply any of the aforesaid substances for medical and veterinary purposes except on the prescription of a medical practitioner, dentist or veterinary surgeon. Certain licensed tradesmen may obtain, strictly for the purposes of their own trade, certain substances mentioned in Schedule A. The list of such substances shall be published immediately after the present Act has been promulgated. For the purposes of supply by pharmacists, such tradesmen shall register their establishments with the Central Office of Public Health or with its authorized local representative. The list of such establishments shall be communicated to the pharmacists of each locality by the competent public health authority. All purchases shall be made by an order voucher, duly signed and dated and clearly stating the names and quantities of the substances purchased. Article 23. The person issuing any prescription shall sign and date it and state legibly his name and address, the dose in words of any poisonous substance prescribed, and directions for use. Article 24. Except on the written request of a medical practitioner, pharmacists may not dis- pense more than once prescriptions for substances in Schedule B annexed to the Geneva Conventions. It is strictly prohibited to dispense any substance included in Schedule B a second time on the mere sight of a package or label or of a prescription

6 already dispensed. Dispensing may be repeated only against the signed request of a medical practitioner. Article 25. Pharmacists may likewise not dispense a second time prescriptions for powders prepared with cocaine or any similar substance, or prescriptions for peroral preparations containing any quantity of a substance included in Schedule B. Article 26. A pharmacy or dispensary shall keep or retain for at least three years the original of every prescription for a substance mentioned in Schedule B which it has dispensed. The bearer of the prescription shall be supplied only with a copy thereof. The original of the prescription shall be entered in a special register. Article 27. No person other than a pharmacist may import, store, distribute or sell a substance included in Schedule B or any similar substance. Article 28. A pharmacist shall be personally liable for the storing of narcotic drugs included in Schedule B on a special shelf. A special register with numbered pages, signed by the cantonal judge, showing imports of such drugs shall be kept up to date without erasure or addition and shall be produced immediately at the request of any representative of the Public Health Department. Any person contravening these provisions shall be liable to be sentenced by the competent court to a fine of 250 to 1,000 gourdes and to imprisonment for one to six months. The licence of a person convicted of a second or subsequent offence shall be revoked. Article 29. A pharmacist may not supply to the public without a medical practitioner's prescription any substance included in Schedule C annexed to the Geneva Convention; provided that a manufacturer, planter or tradesman may purchase from a pharmacist on the security of his signature certain substances included in Schedule C which are necessary for the practice of his calling. A list of substances which may be sold without a prescription shall be published in an Order to be made by the President of the Republic immediately after the promulgation of this Act. RESTRICTIONS ON THE SALE OF MEDICINES: Article 30. The owner of a pharmacy may not sell on the premises of his pharmacy or dispensary any article other than medicaments, simple drugs, dietetic and

7 hygienic chemical products, other articles of use in therapy or hygiene, cosmetics and toilet preparations. Article 31. Establishments other than pharmacies, such as grocers, shops and general stores, may not sell any medicament or any pharmaceutical compound or preparation. A list of products for medicinal use which may be sold by commercial establishments other than pharmacies shall be published in an Order to be made by the President of the Republic immediately after the publication of this Act. Article 32. The peddling of medicines other than those mentioned in the list referred to in the preceding article is strictly prohibited. Article 33. Under the supervision of the Public Health Department, certain medicines strictly essential for urgent cases may be kept in the dispensaries of medical practitioners, clinics and nursing homes. Article 34. Manufacturers and planters may order by leave of the Public Health Department chemical products necessary for their industry but are strictly prohibited from re-selling such products to the public. The transfer by one such person to another of the whole or any part of his stock shall require the approval of the Public Health Department. Article 35. An agent for pharmaceutical preparations may not open or conduct a pharmacy unless he is a pharmacist. Article 36. Any pharmacist or qualified chemist and any partnership or co-operative association of chemists or pharmacists may set up in business in Haiti as a manufacturer or agent for pharmaceutical preparations. Such persons may however sell their products only to pharmacies or to authorized institutions or persons. Article 37. Any merchant may, with leave of the Public Health Department and after due inquiry, act as agent for laboratories or factories making chemical or pharmaceutical preparations. If, however, he holds stocks of such preparations he shall employ permanently a pharmacist who shall be liable for the handling and delivery thereof. A merchant or agent may sell a medicament direct to the public or to a medical practitioner only in a case to which article 46, second paragraph, applies.

8 Samples advertising a product shall be given free of charge. No such sample may be sold by an agent, medical practitioner or pharmacist. Any person contravening the foregoing provision shall be liable to be sentenced by a court of summary jurisdiction to pay a fine of 50 to 150 gourdes. A person convicted of a second or subsequent offence shall be sentenced to the maximum fine and to one monthâ s imprisonment. Article 38. Every agent for pharmaceutical preparations shall keep his stock book up to date and shall also keep a sales ledger showing the names of buyers and the dates on which products have been received and issued. He shall at all times permit members of the Control Commission to inspect his stock card index and his sales ledger. The inspector shall ascertain that the stock card index corresponds with the stock and that sales have been made only to pharmacists or other authorized persons or institutions. PENALTIES AND SANCTIONS Article 39. In addition to the provisions of article 37, final paragraph, any pharmacist, medical practitioner, dentist, veterinary surgeon or midwife committing an offence against this Act in the practice of his profession shall be punished by a fine of 200 to 500 gourdes, or by one to six monthsâ imprisonment, to be awarded by a correctional court. Such a person convicted of a second or subsequent offence shall be sentenced to both these penalties, without prejudice to any other penalty he may have incurred under the general law. Article 40. Subject to the penalties and sanctions already provided in the Civil Code, the Criminal Code and the Commercial Code for specified crimes and correctional offences, the general rules governing penalties and sanctions for the purposes of this Act shall be applied in accordance with articles 37, 39, 41, 42 and 43 of this Act. Article 41. Where a pharmacy is closed permanently by order of a court on account of grave irregularities or offences against the law, the court shall give directions for its winding up in accordance with law in the presence of a member of the Medicaments Control Commission. Article 42. A responsible pharmacist shall, under pain of correctional prosecution, report forthwith to the Medicaments Control Service every attempt by the proprietor, not being himself a pharmacist, to induce him to infringe the rules

9 of the Codex, to alter a dose, or to commit any falsification whatever; and the said Service shall hold an enquiry. If the offence is approved, the proprietor of the pharmacy shall be punished in accordance with law and the establishment shall be treated in accordance with the provisions of article 39. Where a pharmacist has been induced by the proprietor to commit an act as aforesaid, both shall be punished in accordance with law, notwithstanding that the offence has been disclosed only through a confession or accusation made by either. Article 43. Any person who opens a dispensary or pharmacy or sells medicines without satisfying the requirements of this Act shall be guilty of unlawful practice of pharmacy and shall be sentenced by a correctional court to imprisonment for three months to two years and to a fine of 250-2,500 gourdes. TRANSFER OF PHARMACY Article 44. A pharmacist taking possession of or becoming employed in an established pharmacy, or establishing a new pharmacy, shall give previous written notice thereof, stating his address to the Public Health Department. 1. He shall produce his diploma when giving such notice. 2. A pharmacist who takes over the management of a pharmacy by reason of the absence or death of the proprietor, or on acquiring title thereto by purchase or otherwise, shall likewise satisfy the requirements aforesaid. Article 45. Where a pharmacist owning a pharmacy dies, his personal representatives shall select a qualified pharmacist to manage the pharmacy. Article 46. The provisions of article 7 of this Act shall not apply to an owner of a pharmacy who held both diplomas and practised both professions before the promulgation of this Act. In villages and places where there is no pharmacy a medical practitioner may, on applying in writing to the general director of the Public Health Service be authorized to supply pharmaceutical preparations and patent medicines to his patients without the assistance of a pharmacist. If a pharmacy is subsequently established in the place, the authorization shall expire after a period to be fixed according to the circumstances by the Public Health Department. TRANSITIONAL PROVISIONS Article 47.

10 Only a pharmacist licensed under the Order of 15 November 1920 may continue to practise under the provisions of this Act. Other persons shall be obliged to satisfy the requirements of this Act within a period of three months after its promulgation. Article 48. Any schedule or list required by this Act to be published may be amended in accordance with scientific progress or with a recommendation in an international convention. Amendments shall be published in the same manner as the original lists. Article 49. On the promulgation of this Act, the Trade Department shall forthwith determine the maximum profit margin to apply to any person concerned in the sale of pharmaceutical or chemical preparations. Article 50. Every statute or provision thereof and every legislative decree or provision thereof contrary to this Act is repealed hereby; and this Act shall be put into effect by the Secretaries of State for Public Health, for Trade and for Justice each within his own competence. Enacted in the Senate of the Republic, Port-au-Prince, 4 August 1955, 152nd year of Independence. President: CHARLES FOMBRUN Secretaries: W. SANSARICQ, E. JONASSAINT Enacted in the Chamber of Deputies, Port-au-Prince, 10 August 1955, 152nd year of Independence. President: ADELPHIN TELSON Acting Secretaries: L. MILORD, H. BRIGHT. IN THE NAME OF THE REPUBLIC The President of the Republic orders that the foregoing Act shall be sealed with the seal of the Republic, printed, published and put into effect. Given at the Palais National, Port-au-Prince, 19 August 1955, 152nd year of Independence. By the President: Paul E. MAGLOIRE The Secretary of State for Public Health and Labour: ROGER DORSINVILLE The Secretary of State for Justice, Home Affairs and National Defence: LUC PROPHETE The Secretary of State for Trade and for the Presidency: MARCEL FOMBRUN The Secretary of State for Foreign Relations and Religious Affairs: MAUCLAIR ZEPHIRIN The Secretary for State for Finance and National Economy: CLEMENT JUMELLE

11 The Acting Secretary of State for Agriculture: ROGER DORSINVILLE The Acting Secretary of State for National Education: MAUCLAIR ZEPHIRIN The Secretary of State for Public Works: RAOUL ST. LO.