Explanation of "Administrative Measures for Medical Toxic Drugs"
On December 15, 1988, the 25th executive meeting of the State Council passed the "Measures for the Administration of Toxic Drugs for Medical Use" (hereinafter referred to as the "Measures"), which was promulgated and implemented on December 27 of the same year.
1. Purpose and significance
Toxic drugs refer to drugs that are highly toxic, have a therapeutic dose similar to the toxic dose, and may cause poisoning or death if improperly used. Proper use can prevent and treat diseases and relieve the suffering of patients. Improper use can easily cause poisoning and directly endanger people’s lives. Therefore, the management of toxic drugs is more stringent than general drugs, and the management is missed or neglected. , The harm is great. In order to strengthen the management of toxic drugs, ensure medical needs, strictly prevent random production, random sales, abuse, and prevent poisoning or fatal accidents, it is included as a specially managed drug into the track of legal management, marking my country's medical and health laws The continuous improvement of the system, and at the same time, such management is consistent with the requirements of international conventions.
2. Formulation process and basis
The "Drug Administration Law" lists a single chapter, which provides for special management of narcotic drugs, psychotropic drugs, toxic drugs, and radioactive drugs. The management measures are formulated by the State Council, which is the legal basis for the formulation of the "Measures." Special management of toxic drugs is a consistent policy of our country. As early as April 20, 1964, the Ministry of Health, the Ministry of Commerce, and the Ministry of Chemical Industry issued the "Interim Regulations on the Management of Poisons and Restrictive Drugs." On December 7, the Ministry of Health and the Ministry of Commerce issued the "Interim Measures for the Administration of Toxic Chinese Medicines". "On June 30, 1979, shortly after the establishment of the State Administration of Medicine and the Ministry of Health, the "Regulations on the Administration of Medical Poisons and Restrictive Drugs" were jointly issued. After the "Drug Administration Law" was implemented, on the basis of previous administrative regulations, the State Council formulated and issued the "Administrative Measures for Toxic Drugs for Medical Use" on December 27, 1988.
3. Basic content
There are 14 articles in the "Measures", which clearly stipulate the purpose of the legislation, the basis of the legislation, the concept of toxic drugs, production management, operation, use, storage, and legal responsibilities.
(1) Production acquisition, supply and preparation plan. The "Measures" stipulate that the annual production, purchase, supply, and preparation plan of toxic drugs shall be formulated by the pharmaceutical management departments of provinces, autonomous regions, and municipalities directly under the Central Government in accordance with medical needs, and will be issued by the pharmaceutical management departments to the designated The production, purchase and supply unit of toxic drugs should be reported to the Ministry of Health, the State Administration of Medicine and the State Administration of Traditional Chinese Medicine. The production unit shall not change the production plan without authorization and sell it on its own.
(2) The pharmaceutical manufacturer must be responsible for the production, preparation and quality inspection by medical professionals, and establish a strict management system to prevent mixing with other drugs. Each ingredient must be reviewed by more than 2 people to be correct, and each production must be recorded in detail The number of raw materials and finished products used must be identified by the handlers for future reference. All tools and containers must be cleaned to prevent contamination of other drugs. The labeling quantity must be accurate and the packaging container must have a poison mark. All processing and processing of toxic traditional Chinese medicines must be carried out in accordance with the "Pharmaceuticals of the People's Republic of China" or the "Processing Regulations" formulated by the health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government. Only when the medicinal materials meet the requirements for medicinal use can be supplied with formulas and used in the production of proprietary Chinese medicines . The production of toxic drugs and their preparations must strictly implement the production process operating procedures, accurately feed the materials under the supervision of the drug inspectors of the unit, and establish a complete production record, which is kept for 5 years for future reference. The waste generated in the process of producing toxic drugs must be properly handled and not pollute the environment.
(3) Operation. The purchase and management of toxic drugs shall be the responsibility of the drug business units designated by the medical management departments at all levels; the use of prescription drugs shall be the responsibility of state-owned pharmacies and medical units, and no other units or individuals shall be engaged in the purchase, operation and formulation of toxic drugs. Medical units supply and dispense toxic drugs with the official prescription signed by the doctor, and state-owned pharmacies supply and dispense toxic drugs with the official prescription with the official seal of the medical unit where the doctor is located. Each prescription dose shall not exceed the two-day limit.
When formulating prescriptions, you must be responsible, accurately measure, specify the requirements according to the doctor’s advice, and be signed and stamped by the formulating staff and reviewers with the technical title of pharmacist or above. For processed products, if there is any doubt about the prescription, it must be re-approved by the original prescribing doctor before dispensing. The prescription is valid for one time, and the prescription is kept for two years for future reference.
(4) Toxic drugs required by scientific research and teaching units must be issued by the unit’s certificate letter and approved by the health administration department above the county where the unit is located. Toxic traditional Chinese medicine is required for the people to prepare private bills, secrets, and prescriptions. When purchasing, they must hold a certificate letter from the unit or city street office, township (town) people’s government, and the supply department can sell it, and the amount of each purchase shall not exceed 2 Daily extremes.
(5) Units purchasing, operating, processing, and using toxic drugs must strictly establish the above-mentioned inspection and distribution system to strictly prevent false and mis-issued products. It is strictly forbidden to mix with other drugs. Warehouses or warehouses are delineated and special counters are locked and kept by special personnel. Regarding the investigation and treatment of poisoning caused by toxic drugs: When dealing with patients who are poisoned by toxic drugs, the amount of poisoning and the source of the drugs should be ascertained. If the prescription complies with the regulations, it may be caused by individual patient differences or decoction pieces. If it is caused by excessive amounts of toxic ingredients, if it is from an illegal source or illegally used excessively, causing the patient's disability or death, the judicial organ shall hold the drug supply personnel and the unit criminally responsible.
Regarding the destruction of toxic drugs: For toxic drugs that are not available for medicinal use, they can be destroyed after being reviewed by the unit leader and reported to the health administrative department at the same level for approval. A signature must be provided before the destruction, including the date, time, location, name, quantity, and method of destruction Wait, take pictures if necessary.
(6) Liability for violation of law. Violation of the "Measures" should bear legal responsibility, in two forms:
Administrative penalties include confiscation, warning, and fines, of which confiscation and warning, confiscation and fines can be imposed concurrently; if the circumstances are serious, causing disability or death, which constitutes a crime, the judicial organ shall pursue criminal responsibility according to law. Regarding the pre-reconsideration procedures, the "Measures" stipulate that: if the party dissatisfied with the penalty, he must apply for reconsideration to the higher-level agency of the agency that handled the penalty within 15 days from the date of receiving the penalty notice. The reconsideration period shall not affect the implementation of the original penalty decision. The higher-level authority shall give a reply within 10 days from the date of receipt of the application, and if it is dissatisfied with the reply, it may file a lawsuit in the people's court within 15 days from the date of receipt of the reply.
The Ministry of Health is responsible for the interpretation of the Measures.
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