麻醉药品管理办法 MEASURES FOR THE CONTROL OF NARCOTIC DRUGS
颁布日期:19871128 实施日期:19871128 颁布单位:国务院
(Promulgated by the State Council of the People's Republic of China on November 28, 1987)
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Medicine Administration Law of the People's Republic of China, for the purpose of tightening control over narcotic drugs so as to ensure their safe use in medical treatment units, medical colleges and medical research institutions.
Article 2 Narcotic drugs refer to those drugs that may cause dependence and addiction after continuous administration. Article 3 Narcotic drugs include opium, cocaine, marijuana, synthetic anaesthetic drugs and those defined by the Ministry of Public Health as addict-forming drugs, anaesthetic raw herbs and the products made from them.
Article 4 The State shall strictly supervise and control the cultivation of the mother plants of narcotics and the production, supply, export and import of narcotic drugs. Narcotic drugs shall not be used except for the purpose of medical treatment, teaching and research when necessary.
Chapter II The Cultivation of Mother Plants of Narcotics and the Production of Narcotic Drugs
Article 5 The units that cultivate mother plants of narcotics must be examined and approved jointly by the Ministry of Public Health, the Ministry of Agriculture, Animal Husbandry and Fishery and the State Administration for Medicine. A copy of the report shall be sent to the Ministry of Public Security.
The units that produce narcotic drugs must be examined and approved jointly by the Ministry of Public Health and the State Administration for Medicine. Without approval, no unit or individual shall be allowed to produce narcotic drugs.
Article 6 The annual cultivation plan for mother plants of narcotics shall be examined and approved jointly by the Ministry of Public Health and the Ministry of Agriculture, Animal Husbandry and Fishery. The annual production plan of narcotic drugs shall be examined and approved jointly by the Ministry of Public Health and the State Administration for Medicine. The cultivation units and the production units shall not change the plans without authorization. The cultivation unit and the production unit must assign a person or persons with the special responsibility for the storage of the finished products, semi-finished products, poppy capsules and poppy seeds. Sale or use of these things without authorization shall be strictly prohibited.
Article 7 Narcotic drugs must be brought under strict quality control. The quality of the products must meet the standards set for medicines by the State.
Article 8 Before the development of any new kind of narcotic drugs, the research unit must first of all draw up a plan and submit it to the Ministry of Public Health for examination and approval. After the new drug is developed, the research and trial production units must go through the formalities for the approval of such new drugs. The storage and use of the trial products must follow strict procedures so as to prevent their loss.
Chapter III The Supply of Narcotic Drugs
Article 9 Narcotic drugs shall be provided in a planned way according to the demand of medical treatment units, medical colleges and scientific research institutions. A national supply plan of narcotic drugs shall be drawn by a department appointed by the State Administration for Medicine and submitted to the Ministry of Public Health and the State Administration for Medicine for examination and approval before it is issued for implementation.
Article 10 The plan for the setting up of a trading unit of narcotic drugs shall be put forward jointly by the administrative department of health and medicine administrative department in each province, autonomous region, or municipality directly under the Central Government and shall be examined and approved by the Ministry of Public Health and the State Administration for Medicine. The trading units shall provide narcotic drugs only to those consumer units approved by the administrative department of health and within the prescribed quota. No supply for any other unit or person is permitted.
Article 11 Poppy capsules used for medical purposes shall be supplied by the trading units appointed by the State Administration for Medicine and medicine department in each province, autonomous region, or municipality directly under the Central Government. No other unit shall be allowed to engage in such business. Poppy capsules must be allotted to the consumer units in accordance with the plan examined and approved jointly by the Ministry of Public Health and the State Administration for Medicine. Poppy capsules shall be supplied to the medical treatment units for clinical use and to the trading units designated by the administrative departments of health at or above the county level for clinical application endorsed with an office seal of their respective medical treatment units. No retail sale of poppy capsules is allowed. The pharmaceutical factories that need poppy capsules in the production of ready made Chinese medicine must submit plans to the medicine administrative department in their province, autonomous region, or municipality directly under the Central Government for examination and then to the administrative department of health for approval before production.
Article 12 A trading unit of narcotic drugs must have a special storehouse or counter(s) with good storage conditions and assign a person or persons with special responsibility for the storage, transportation and supply of narcotic drugs.
Chapter IV Transportation of Narcotic Drugs
Article 13 A permit for domestic consignment issued by the Ministry of Public Health is needed when going through shipment formalities for transporting medicinal opium. Shipment of medicinal opium from the cultivation unit to the storehouse of the State Administration for Medicine shall be escorted by the people sent by the consignor unit. Shipment of medicinal opium from the storehouse to the production enterprises shall be escorted by the people sent by consignee unit. The number of escorts shall be decided in accordance with the regulations of the transportation department. Permit for domestic transportation of such drugs shall be printed solely by the Ministry of Public Health.
Article 14 When consigning narcotic drugs or poppy capsules (not including medicinal opium), the production unit or the supply unit must put down clearly the words of Narcotic Drug in the blank for the name of goods on the shipping document and a seal for consignment of Narcotic Drug must be stamped in the space left for the consignor.
Article 15 The freighter unit must tighten control over the shipment of narcotic drugs and poppy capsules by dispatching the consignment promptly and shortening its storage time at the station, on the dock or at the airport. They must not be transported in open wagons on railways and, if by ship, no loading on hold surface is allowed and, if by truck, they must be securely fastened up and safely protected.
Article 16 In the event that any of the narcotic drugs or poppy capsules are found missing in the course of transportation, the freighter-unit must report the case promptly to the local public security organ and the administrative department of health for investigation.
Chapter V Import and Export of Narcotic Drugs
Article 17 The import and export of narcotic drugs shall be handled by the units appointed by the Ministry of Foreign Economic Relations and Trade in accordance with State regulations concerning foreign trade.
No other units shall be allowed to engage in the business. The annual plan for import and export of narcotic drugs shall be subject to examination and approval by the Ministry of Public Health.
Article 18 The import of narcotic drugs needed in medical treatment units, medical colleges of or medical science research institutions must be verified and approved by the Ministry of Public Health. Only after an Import License for Narcotic Drugs is granted can these units apply to go through import formalities.
Article 19 The export of narcotic drugs must be verified and approved by the Ministry of Public Health. An application and an import license which is a prerequisite to going through import formalities for narcotic drugs issued by the competent government department of the importing country must be presented before the Ministry of Public Health issues an Export License for Narcotic Drugs.
Article 20 Import and export licenses for narcotic drugs shall be printed exclusively by the Ministry of Public Health.
Chapter VI The Use of Narcotic Drugs
Article 21 Narcotic drugs shall only be used for medical treatment, in teaching at medical colleges and in medical science research. Any medical treatment unit with medical wards and with surgical or other necessary medical treatment facilities may file an application to the local administrative department of health. Upon approval by the administrative department of health at a higher level, and after the level of supply is verified, a Purchase Card for Narcotic Drugs shall be issued. The aforesaid unit may purchase the needed narcotic drugs from the designated trading units according to the fixed quota. When the medical colleges or scientific research institutions are in need of narcotic drugs, they shall file an application to the administrative department of health at a higher level and, upon approval, may purchase these drugs from the trading units of narcotic drugs. The Ministry of Public Health is the authority to make out the grading standard of rations.
Article 22 Narcotic consuming unit must fill out an application form for when purchasing, narcotic drugs and the supplying unit must check the various seals and the number of seals stamped on the form before supplying them with the kind of drugs on quarterly ration as stipulated in the regulations set by the Ministry of Public Health.
Article 23 The unit in need of narcotic drugs can either purchase them directly from the trading units or by mail order. In the latter case, however, the shipping documents and certificates must be sent out by registered mail.
When sending the narcotic drugs by post, the sender-trading unit is required to stamp a Seal for Narcotic Drugs on the parcel form and to present to the post office the invoice with a Seal for Narcotic Drugs stamped on.
Article 24 Preparations that fall under the category of narcotic drugs must be purchased from the trading units of narcotic drugs. In case that they are not available or special preparations are needed by the medical treatment units, the authorized consuming medical units may prepare them by themselves with approval by the administrative department of health at or above the county level. No other unit shall be allowed to prepare any form of anaesthetic.
Article 25 The medical worker who prescribes any anaesthetic for the patient must be a qualified physician or a surgeon, who is tested to have been able to use such drugs properly. The surgeon at the induced abortion ward who is tested to have been able to use such drugs properly may have the right to prescribe anaesthetics for the person to be operated on.
Article 26 Dosage for injection in each prescription must not exceed two days of daily dose, as for the tablet, tincture, syrup, the dosage must not exceed three days of daily dose. Administration of narcotic must not exceed a period of seven days running. Prescription of narcotic drugs must be fully and clearly stated with signature of the physician or surgeon on. When preparing a narcotic drug, the pharmacist and the checker are required to sign their names and keep the prescription of the narcotic drug on file.
No medical worker is allowed to prescribe any narcotic drug for him/herself.
Article 27 In the case of a patient in serious conditions who is diagnosed by a hospital at or above county level to be in need of narcotic drugs as a pain killer, the hospital appointed by the administrative department of health at or above the county level may issue the patient with a Special Purchasing Card for Narcotic on the basis of the Prescription and by checking his permanent residence booklet, and the patient may take this to the appointed medical treatment unit to have the drug prepared. If the patient holding a Special Purchasing Card for Narcotic is in need of a larger dose and the seasonal ration of the medical treatment unit fails to meet the demand, additional amount of narcotic shall be made available only with the approval by the administrative department of health at a higher level.
Article 28 Medical treatment units are required to tighten control over narcotic drugs. Any illegal use, storage, transfer or borrowing of narcotic drugs is prohibited. Narcotic drugs must be put under the charge of a person specially appointed for the purpose and kept in a separate place under lock. The distribution and prescriptions of narcotic drugs must be kept in record separately from those of other medicine. The prescriptions must be kept on file for a period of three years. The medical treatment unit shall have the right to refuse dispensing of drugs to those who abuse them in violation of relevant rules and regulations and shall report the case to the local administrative department of health promptly.
Article 29 In the event of an emergency case which is in need of narcotic drugs, the medical treatment unit so involved and the trading unit of narcotic drugs are required to supply a dose of narcotic promptly for the case only, and the necessary formalities shall be done after the event.
Chapter VII Penalty Provisions
Article 30 Any violation of these Measures shall be subject to penalty by the local administrative department of health according to the seriousness of the case. The penalty shall cover confiscation of all the narcotic drugs and the illegal earnings, a fine ranging from 5-10 times the illegal profits, closing down of the business or revocation of “License for Pharmaceutical Production Enterprise”, “License for Pharmaceutical Business Enterprise” or License for Medicaments“
(1) those who, without authorization, are engaged in the production of narcotic drugs or have changed the production plan and made additional kinds of narcotic drugs;
(2) those who are engaged in unauthorized trading business of narcotic drugs and poppy capsules;
(3) those who supply or oversupply narcotics to any unit or person that has not been granted the permission to use the stuff;
(4) those who prepare and sell any form of narcotic drugs without authorization;
(5) those who are engaged in unauthorized import or export of narcotic drugs;
(6) those who apply any new kind of narcotic drugs to patients clinically or have produced any new kind of narcotic drugs without authorization.
Article 31 Those who have taken advantage of their professional work by prescribing narcotics to other persons without complying with the rules or by prescribing narcotics for themselves, and those who are directly responsible for cheating to obtain or abusing the stuff, shall be given disciplinary sanctions by the authorities of their units.
Article 32 Those who, in violation of these Measures, cultivate poppy without authorization or take in narcotic drugs illegally shall be punished by a public security organ in accordance with the Regulations on Administrative Penalties for Public Security or other related rules.
Article 33 With respect to any one who produces, transports or sells narcotics or poppy capsules, if the circumstances are serious enough to constitute a crime, he shall be prosecuted for criminal liability by the judicial organs according to law.
Article 34 A party, who is dissatisfied with the decision on an administrative sanction may, within 15 days of receiving the notification on the sanction, make a request for reconsideration to the authorities at the level next higher, which shall make a reply within 10 days of receipt of the appeal. If he is dissatisfied with the decision on reconsideration, he may, within 15 days of receiving the reconsideration decision, bring a suit before a people's court. If, upon the expiration of this period, the party has neither complied with the sanction nor has brought a suit before a people's court, the authorities that impose the sanction shall apply to the people's court for compulsory enforcement.
Chapter VIII Supplementary Provisions
Article 35 The specific administration rules for the supply and use of narcotic drugs in the health and medical treatment units of the Chinese People's Liberation Army and the Chinese People's Armed Police Force shall be formulated jointly by the Ministry of Public Health, the General Logistics Department of the Chinese People's Liberation Army and the Logistics Department of the Chinese People's Armed Police Force in accordance with these Measures.
Article 36 The specific administration rules for the supply and use of veterinary narcotic drugs shall be formulated jointly by the Ministry of Public Health and the Ministry of Agriculture, Animal Husbandry and Fishery in accordance with these Measures.
Article 37 The rules for the implementation of these Measures shall be formulated by the Ministry of Public Health.
Article 38 These Measures shall go into effect as of the date of promulgation. The Provisions for the Administration of Narcotic Drugs, promulgated by the State Council of the People's Republic of China on September 13, 1978, shall become null and void on the same day