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Laws and Regulations Promulgated to Give Effect to the Provisions of the International Treaties on Narcotic Drugs and Psychotropic Substances

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Laws and Regulations Promulgated to Give Effect to the Provisions of the International Treaties on Narcotic Drugs and Psychotropic Substances E/NL. 1977/26-28 20 March 1979 UNITED NATIONS ENGLISH AND SPANISH ONLY LAWS AND REGULATIONS PROMULGATED TO GIVE EFFECT TO THE PROVISIONS OF THE INTERNATIONAL TREATIES ON NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES CHILE Communicated by the Government of Chile NOTE BY THE SECRETARY GENERAL - In accordance with the relevant Articles of the International Treaties on Narcotic Drugs and Psychotropic Substances, the Secretary-General has the honour to communicate the following legislative texts. INDEX Page E/NL.1977/26 Regulation No. 4 on Dependence-producing Pharmaceutical Products, 2 January 1970 E/NTJ.1977/27 Order No. 90 of 4 February 1970 - Schedule of products subject to control under the Regulations on Dependence-producing Pharmaceutical Products. 5 E/NLol977/28 Order No. 92 of 19 January 1976 13 Official Gazette No. 27.554 E/NL,1977/26 24 January 1970 Recovery of Health Division Pharmaceutical Section REGULATION NO. 4 ON DEPENDENCE-PRODUCING PHARMACEUTICAL PRODUCTS Santiago, 2 January 1970 Considering the information furnished by the National Health Service in Circular No. 19.892 of 1 October 1969; the reports, recommendations and agreement of the United Nations specialized agencies concerning the harmful effects of abuse of dependence- producing drugs; the provisions of articles 2 and 107 of the Health Code; and the authority conferred on the undersigned by article 72 (2) of the Constitution of Chile, IT IS HEREBY DECREED AS FOLLOWS: The "REGULATIONS ON DEPENDENCE PRODUCING PHARMACEUTICAL PRODUCTS" set out below are adopted: Article 1. The production, manufacture, extraction, preparation, import, export, distribution, possession or ownership, removal for whatever reason, transit, transport and use of hypnotic agents, amphetamines and other stimulants of the central nervous system, meprobamates and all other dependence-producing drugs, shall be subject to the norms contained in these Regulations. - 2 - The National Health Service shall establish by means of an internal order the schedule of pharmaceutical products referred to in the above paragraph, and shall publish it in the "Official Gazette»" Article 20 The production, manufacture, extraction, preparation, import, export, distribution, transit and transport over the national territory of dependence-producing drugs shall be subject to authorization from the National Health Service. In the case of importation of the said products, it is the responsibility of the said Service to issue an import authorization for each consignment. Article 3« In the case of new dependence-producing drugs, the authorization referred to in the previous article is conditional upon a prior favourable report of the Commission of the Chilean Pharmacopoeia in accordance with the provisions of article 102 of the Health Code„ Article 4« Production laboratories, drug dispensaries and pharmacies shall keep a "Register of dependence-producing drugs", open to inspection by the National Health Service, and the following information shall be entered on separate folios for each of the products: incoming stock: (a) Date; (b) Quantity; (c) Number and date of the authorization issued by the National Health Service; (d) Number of the invoice, customs clearance slip or other document specifying the supplier, where applicable, and particulars concerning the supplier; (e) Serial number where appropriate. Outgoing stock: (a) Date; (b) Quantity; (c) Name of drug used and serial number where appropriate; (d) Number of the invoice, customs clearance slip or other internal control document of the establishment; (e) Prescription registration number, if any; (f) Particulars of the addressee, and (g) Particulars of the doctor or dentist in the case of prescriptions. The vouchers for incoming and outgoing of products shall be filed separately and in proper order. - 3 - Article 5. Drugs may not be packed in containers of less than 10 or more than 50 units (pills, tablets, dragees or capsules), with the exception of clinical packs for medical care institutions, which may contain more,, The packages shall be labelled as follows: "To be sold on medical prescription"; "For use under medical supervision", and in black letters on a white background: "Subject to dependence-producing drugs control." The labels shall also carry a five-pointed green starc Article 6„ Natural or juridical persons importing, processing or distributing the drugs referred to in these Regulations may only sell them to drug dispensaries, pharmacies, clinics, hospitals and medical care establishments whether public or private, subject to the written request of the pharmaceutical chemist in charge or the Chief Medical Officer, as the case may be. All sales made by the said natural or juridical persons to drug dispensaries, pharmacies, and medical care establishments, shall be reported to the Directorate-General of the National Health Service within the first 10 days of the month following the date of the transaction, by dispatch of a copy of the delivery voucher. The delivery voucher must be clearly legible and contain at least the following data: the date, quantity (in figures and letters), and name of the product sold; and particulars concerning the purchaser or consignee, together with his full name or the trade name of the establishment, domicile and place of business. Article 7<> Iti medical care establishments, whether public or private, including those serving the Armed Forces, the Police and the Prisons Service, the drugs referred to in these Regulations prescribed for their patients shall be subject to the provisions of article 4« It is the duty of the Chief Medical Officer of the establishment to ensure that these provisions are respected. Article 8. Without prejudice to the provisions of the preceding article, the pharmaceutical products referred to in the present Regulations may be sold to the public only by pharmacies against a doctor's prescription. Article 9» Prescriptions for these drugs shall contain particulars enabling the practitioner to be identified, including his name and address. The practitioner shall sign the prescription for the drugs, indicating in letters the quantity of each of them and the date on which the prescription was made out, and he shall indicate at the foot of the document, in his own handwriting, his number in the Medical Register. When these pharmaceutical products are prescribed on forms provided by medical care establishments, the practitioner shall proceed as provided in the previous paragraph, indicating in addition his full name and address. Prescriptions shall be valid for only 30 days from the day of issue. No pharmacy may honour a prescription once the time-limit has expired, with the exception of those referred to in the second and third paragraphs of article 10. - 4 - Pharmacies shall file in sequence prescriptions they have filled, duly cancelling them except in the case of those referred to in the second and third paragraphs of article 10. At the request of 'the interested party, the pharmaceutical chemist in charge shall provide a copy of the prescription filled, adding a note to that effect at the foot of the document under his signature„ Article 10. The drugs prescribed in each prescription shall "be dispensed once only, and in the total quantity prescribed. However, in the case of barbiturates used in the treatment of epilepsy, and other drugs used for similar purposes as determined by the National Health Service, the prescription may be split up. The pharmaceutical chemist in charge at the pharmacy shall certify in the prescription the quantity issued, appending his signature and stamp, and shall make a note to that effect in the prescriptions register, with the name of the doctor who made out the prescription and the date thereof. Article 11. Dental surgeons may prescribe hypnotic agents only for direct administration to their patients. The sale of such drugs to the practitioner must be made personally against a prescription which must comply with the same requirements as those set out in article 9 for medical pre scriptions. Article 12. The National Health Service shall indict and penalize the pharmaceutical chemist in charge, and the owner, of any pharmacy who knowingly or maliciously fills a prescription which has been falsified or tampered with, without prejudice to the option of bringing the facts to the notice of the courts. Ih order to safeguard his responsibility, the pharmaceutical chemist in charge may decline to fill prescriptions about whose authenticity and integrity he has doubts; when he does so he shall record in writing on the prescription itself the reasons for his refusal, appending his signature. In the same way he may, if he thinks it advisable to do so, require full particulars concerning the purchaser, making a note to that effect on the document. Article 13. The dependence-producing drugs covered by the provisions of these Regulations shall be subject to the following restrictions: (a) The sale or disposal of such products for whatever reason to persons under 18 years of age is prohibited; (b) Private pharmacies are prohibited from filling medical prescriptions when they are made out on forms issued by medical care establishments, unless the form itself contains a note from the prescribing doctor certifying that the dispensary of the establishment does not have the product in stock, and bearing the doctor's full name, registration number in the Medical Register, and his signature. In the absence of the practitioner who made out the prescription, certification shall be
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