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 made by the pharmaceutical chemist in charge of the dispensary of the said establishment, given the same particulars and signed by him;
(c) Ownership or possession not in accordance with these rules is prohibited; - 5—
(d) It is forbidden to split up a container in order to sell the tablets, dragees or capsules in small packets or individually.
Article 14. It is the duty of production laboratories, drug dispensaries, pharmacies, and medical care establishments, to adopt the necessary security and control measures to ensure that the products referred to in these Regulations shall be used only for therapeutic ends, thus avoiding by strict application of those measures any possibility of theft, pilfering or misuse for ends other than those mentioned above.
Article 15. The provisions of these Regulations shall not stand in the way of compliance with the rules contained in other regulations under the Public Health Code, insofar as they are compatible.
Article 16. Infringement of the provisions of these Regulations shall be punished in accordance with the provisions of articles 165 "et seq." of the Public Health Code. —
Article 17. Supreme Decree No. 189 dated 17 October 1963 of this Ministry is hereby repealed, as from the end of a period of 60 days from the publication of this Decree in the "Official Gazette", the date on which these Regulations shall come into force.
Transitional Article. Registration as referred to in article 4 shall begin with the stocks held by production laboratories, drug dispensaries and pharmacies on the date of entry into force of these Regulations.
Let this be duly noted, registered, made public, and published in the digest complied by the Office of the Comptroller-General of the Republic:
E. PREI M. - Ramdh Valdivieso Delaunay.
Patricio Silva Gaxin Under-Secretary for Public Health.
Official Gazette No. 27.581 E/tTL.1977/27 25 February 1970
SCHEDULE OP PRODUCTS SUBJECT TO CONTROL UNDER THE "REGULATIONS ON DEPENDENCE-PRODUCING PHARMACEUTICAL PRODUCTS"
ORDER NO. 90
Santiago, 4 February 1970
CONSIDERING Decree No. 4 dated 2 January 1970 l/ of the Ministry of Public Health, article 1, second paragraph of which states that the National Health Service shall establish the schedule of pharmaceutical products subject to control under the "Regulations on dependence-producing pharmaceutical products", and shall publish it in the "Official Gazette";
l/ Note by the Secretariat; E/NL„1977/26. - 6 -
CONSIDERING that in recent years the use of hypnotic agents, amphetamines, stimulants of the central nervous system and meprobamates, has greatly increased far exceeding, according to our estimates, the quantities needed for medical use in the country, and that this calls for stricter control;
CONSIDERING that abuses in the consumption of these drugs produce disturbances and side-effects which are harmful to the health of the individual and to society;
CONSIDERING the recommendations of the World Health Organization and of international organizations specializing in these matters; and
BEARING IN MIND the provisions of the above-mentioned decree No. 4, the
relevant provisions of the Health Code and article 72 (a) of Act. 10.5839 the following order is enacted:
ORDER
1. The following is the schedule of products subject to control under the "REGULATIONS ON DEPENDENCE-PRODUCING DRUGS":
1. HYPNOTIC DRUGS AND THEIR SALTS
(Barbiturates and related substances)
Acetylcarbromal
Diallylbarbituric acid
Allyl isopropyl acetylurea
Allyl isopropyl diethylamine barbiturate
Amobarbital sodium
Glucochloral anhydride
Barbital 2/
Barbital sodium
Bromisoval
Butabarbital
Butallylonal
Butethai 1 - ethinyl-cyclohexyl carbamate
Carbromal Cyclobarbital Cyclobarbital calcium
Cyclobarbital sodium
Chlorhexadol Codethyline diallylbarbiturate
2/ Note by the Secretariat: International non-proprietary names of drugs are underlined. - 7 -
Diethylamine diallylbarbiturate D i chloralphen azon e
1,3-Dihydro 7-nitro-5-phenyl-2 H-l, 4 Benzodiazepin-2-one (nitrazepam) Ethchlorvynol Ethinamate
Phenylethylcart in ol carbamate Phen obarb i t al Phenobarbital sodium Glutethimide He ptobarbital
Hexobarbital Chloralhydrate
Mecloqualone Mephobarbital
Methaqualone
Methylphenobarbital Methylpentynol Methyprylon
Paraldehyde
Diethyl p-amino benzamide Pentobarbital calcium Pentobarbital sodium Probarbital Secobarbital sodium Talbutal
2. DRUGS WHICH HAVE A STIMULATING EFFECT ON THE CENTRAL NERVOUS SYSTEM, AND THEIR SALTS (AMPHETAMINES AND RELATED SUBSTANCES)
Amphetamine
Amphetamine pentobarbiturate
Chlorphentermine hydrochloride
Dexamphe tamine
Phenmetrazine
Phentermine
Me thamphe tamine - 8 -
3. TRANQUILLIZERS
Meprobamate
4. MEDICINES AND HYPNOTIC DRUGS
(Barbiturates and related substances)
Adalin, tablets Bayer Laboratories Amorectol suppositories Larroche Navarron ii
Andriosedil pills Andr<5maco it Andriosedil drops for children II II
Barbitaleta suspension Industrial Panamericana
Bromural Knoll tablets Quimifarm Potassium Bromide and Labor Phenobarbital pills
Calciminal pills it
Comital tablets Bayer Comital "L" tablets it
Dentoxil syrup Pasteur
Dormalyla tablets Isesa Doridan pills Ciba
Dormex tablets Parmo-Qufm i c a Dormex soluble tablets II
Dormopan tablets Bayer Fanodortno pills Merck Penilas pills Sanitas
Phenobarbital pills 15 mg Chilean Pharmacopoeia Phenobarbital pills 100 mg
Phenobarbital sodium ampoules
Phenobarbital Becker tablets Industrial Panamericana Laboratories Phenobarbital Becker suspension (for use in paediatrics)
Phenobarbital strong Chile (Nat. Health Service) pills
Phenobarbital weak (Nat. Health Service) pills
Phenobarbital 15 mg (Ch. Pharm.) pills Phenobarbital 100 mg
(Ch0 Pharm.) pills Phenobarbital sodium 200 mg (Nat. Health Service) ampoules
Phenobarbital sodium 50 Big (Nat. Health Service) ampoules - 9 -
Phenobarbital sodium Erba Laboratories freeze-dried, ph. ampoules
Phenobarbital 100 mg Labor (Nat. Health Service) pills
Phenobarbital 15 nig (Nat. Health Service) pills Quimifarm Phenobarbital strong tablets
Phenobarbital weak " Phenobarbital (for children and adults) pills Phenobarbital ampoules Phenobarbital strong Recalcine (Nat. Health Service) tablets
Phenobarbital strong Sanitas (Nat. Health Service) "
Phenobarbital weak (Nat. Health Service) " Quimifarm II Irifan tablets Petrizzio II Labotal pills n Luminal tablets Bayer ti II Luminal ampoules it II Luminal sodium powder it II Luminaletas tablets it Medomina pills Duncan Fox II Meprodormio tablets Merck II Metaqualone pills Lepetit n Mogadon pills and drops Duncan Fox II Namuron tablets Vinthrop II Nembutal calcium capsules Abbott ti Nembutal gradumet slow-action tablets II Nerval solution Petrizzio II Nervolta syrup Volta it Neurinase pills Colliers ti Neurinase solution ii it Neubromal syrup Recalcine ti Nevroseda pills Norgine II Norgineta pills II II Normalina liquid Sanino Nubarene tablets Cirsa, Chile Laboratories Pe mbro mal syrup Recalcine it
Pentobarbital sodium 100 mg Chilean Pharmacopoeia pills and capsules
Pentobarbital sodium 100 mg Chile pills
Pentobarbital tablets Pasteur Pentobarbital (adults and Recius children) tablets Placidon tablets Columbia
Plexonal dragees San do z Prominal tablets Merck
Prominaletas tablets ii Quaalude Rorer tablets Norgine Raurital sodium pills Benguerel
Seclar pills Andr6"maco Sedarin syrup Norgine Raurich nerve sedative syrup Benguerel
Sedeneu tablets Andromaco Secobarbital sodium 100 mg Chilean Pharmacopoeia pills and capsules Secobarbital sodium capsules Bengeurel Seconal Lilly capsules Duncan Pox
Somnipron tablets Sanitas
Somnoverina tablets Silbe Tanodon tablets Recalcine Tridomal tablets Quimifarm
Tuinal capsules Duncan Pox Valerobromil elixir Pasteur
Vesparax U.C.B. pills Norgine
Zoridorm pills Quimifarm
5. MEDICINES AND DRUGS WHICH HAVE A STIMULATING EFFECT ON THE CENTRAL NERVOUS SYSTEM (AMPHETAMINES AND RELATED SUBSTANCES)
Amphetamine 10 mg pills Chilean Pharmacopoeia
Alentol tablets Farmo-Qufmica it Alentol compound tablets Amphetamine prolonged-action Silesia capsules - 11 -
Amphetamine (Nat.H.S.) pills Chile Laboratories Ansiven Filmtabs tablets Abbott II Benzedrine Sulphate pills Arditi & Corry II
Birobin tablets Columbia II Cafilon sugar-coated pills Silbe II Carbamet pills Labor II
Clorphentermine tablets Saval II Delgose tablets Panqufmica II Deltrax pills Petrizzio II
Desbutal Gradumets prolonged- Abbott II action tablets
Desfedrah tablets it it
Desfedran Gradumets prolonged- II II action tablets Desoxiephedrine ampoules Silesia ti
Dexamil Spansule capsules Arditi & Corry II
Dexamil pills II II Dexadrina tablets it II Dexedrina Spansule capsules it II
II Difetam prolonged-action capsules Silesia
II Escancil pills Beta
II Escancil compound pills II
II Phenmetrazine (Abinol) pills Columbia
II Phenmetrazine pills Pel it Phenmetrazine pills Maver ti Phenmetrazine pills Silesia II Grifoneral Dietetico capsules Chile n Katonium pills Sanderson II loner prolonged-action capsules Silesia ti Lucofen dragees Cirsa, Chile II Lucofen sustained-action tablets II it Me thanphe tamine-Phenobarbital Silesia dragees it Oxidrene pills it Oxidrene ampoules it Oximate pills ii Preuludin tablets Bayer it Sicodrol pills Petrizzio - 12 -
MEDICINES AND TRANQUILLIZING DRUGS WHICH CONTAJJT MEPROBAMATE
Catensfn pills Sanitas Laboratories Diurnal pills Norgine 11
Diurnal suppositories 11
Distanzil dragee s Lepetit 11 Ecuanil Wyeth pills Wyeth " Meprobamate pills Chilean Pharmacopoeia
Meprobamate (Ch0 Pharm.) pills Chile Laboratories
Meprobamate (Nat» H.S.) pills and suppositories
Meprobamate pills Quimifarm Meprobamate pills Labor
Meprobamate pills Socorex Meprobamate pills Industrial Panamericana
Meprobamate pills Silbe Meprobamate pills Estabo Chilenos Coliere Meprobamate pills Benguerel
Meprobamate (adults and Pel children) pills
Meprobamate (50, 100 and Recalcine 400 mg) pills
Meprobamate (adults and Lepetit children) pills Milucil pills Petrizzio Miltown pills Norgine
Miltown capsules 11 Miltown compound pills 11 11
Melval pills Saval ti
Melval suppositories 11 11 Meprocolin pills Labor it Miltopat compound dragees Norgine 11
Miltopat compound tablets n 11
11 Pertranquil pills Lepetit 11 Panthibamate tablets Chile 11 Retrasin (adults and Silesia children) suppositories 15 -
Retrasin (adults and Silesia Laboratories children) pills
Sedo-Caleobrol granulate Recalcine II Zentralin pills Pasteur II
2. Pharmaceutical establishments holding registered preparations, with authorization to produce and sell, may distribute their products to the establishments listed in article 6 of the Decree.
In the same way, drug dispensaries and pharmacies may distribute them to other drug dispensaries, pharmacies and clinics, subject to the provisions of the said article 6.
3. The production, extraction, import, export, transit and transport through the country to other countries, shall be subject to a special authorization of the Directorate-General of the National Health Service.
Let this be noted, distributed and published in the "Official Gazette".
Director-General of Public Health.
Official Gazette No. 27«554 E/NX.1977/28 24 January 1970.
Ministry of Health Directorate-General of Health Technical Department Pharmaceutical Section.
ORDER NO. 92
Santiago, 19 January 1976
CONSIDERING that the labelling of many pharmaceutical products subject to legal control and to special regulations because of their dependence-producing properties, does not require mention of this fact or of any other special conditions; that some manufacturers have not complied with the legal requirements in the labelling of these products because the labels used were printed before the date on which the requirements came into force or have not concerned themselves with the new text; that labelling in the special form established makes it possible for anyone selling or distributing such products to submit them to the registration control and other requirements governing the handling of such drugs;
BEARING IN MIND: the provisions of article 72 (a) and (f) of Act 10.383; article 9 (a) and (b) and article 107 of the Health Code; articles 37 and 43 of the Regulations on Pharmaceutical Products, Invalid Poods and Cosmetics, and article 5 °f 'the Regulations, on Dependence-producing Pharmaceutical Products, l/
The undersigned issues the following:
ORDER
1. Authorized undertakings which produce or import dependence-producing pharmaceutical products shall comply strictly with the stipulation set out in - 14 -
article 5 of Regulation Ho. 4 dated 2 January 1970 of the Ministry of Public Health that the labels on the packaging shall bear the following wording: "Sold only cm;medical prescription", "For use under medical supervision", and in black letters against a white background: "Subject to dependence-producing drugs control". The labels shall also bear a five-pointed green star.
2. As from the date of the present order, all consignments of dependence- producing drugs, whether manufactured or imported, shall comply without fail with the labelling requirements set out in paragraph 1 above. Notice is hereby given that anyone failing to comply shall be committing an offence punishable in accordance with the provisions of Chapter IX of the Health Code.
LET THIS BE NOTED AND COMMUNICATED (SIGNED) Dr. ARN0LD0 RENE MERINO GUTIERREZ DIRECTOR GENERAL OF HEALTH