KYB CHINA(1988年11月15日国务院第25次常务会议通过 1988年12月27日中华人民共和国国务院令第23号发布 自发布之日起施行)
(Adopted at the 25th Executive Meeting of the State Council on November 15, 1988, promulgated by Decree No. 23 of the State Council of the People's Republic of China on December 27, 1988, and effective as of the date of promulgation.)
为加强医疗用毒性药品的管理，防止中毒或死亡事故的发生，根据《中华人民共和国药品管理法》的规定，制定本办法。
These Regulations are formulated in accordance with the provisions of the Drug Administration Law of the People's Republic of China to strengthen the administration of toxic drugs for medical use and prevent the occurrence of poisoning or death accidents.
医疗用毒性药品(以下简称毒性药品)，系指毒性剧烈、治疗剂量与中毒剂量相近，使用不当会致人中毒或死亡的药品。
Toxic drugs for medical use (hereinafter referred to as toxic drugs) refer to drugs that are highly toxic, with a therapeutic dose close to the toxic dose, and that may cause poisoning or death if used improperly.
毒性药品的管理品种，由卫生部会同国家医药管理局、国家中医药管理局规定。
The varieties of toxic drugs under administration shall be prescribed by the Ministry of Health jointly with the State Pharmaceutical Administration and the State Administration of Traditional Chinese Medicine.
毒性药品年度生产、收购、供应和配制计划，由省、自治区、直辖市医药管理部门根据医疗需要制定，经省、自治区、直辖市卫生行政部门审核后，由医药管理部门下达给指定的毒性药品生产、收购、供应单位，并抄报卫生部、国家医药管理局和国家中医药管理局。生产单位不得擅自改变生产计划自行销售。
The annual plans for the production, procurement, supply, and preparation of toxic drugs shall be formulated by the pharmaceutical administration departments of provinces, autonomous regions, and municipalities directly under the Central Government based on medical needs. After review by the health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government, the plans shall be issued by the pharmaceutical administration departments to designated toxic drug production, procurement, and supply units, and copies shall be submitted to the Ministry of Health, the State Pharmaceutical Administration, and the State Administration of Traditional Chinese Medicine. Production units shall not change the production plan without authorization or sell products on their own.
药厂必须由医药专业人员负责生产、配制和质量检验，并建立严格的管理制度。严防与其他药品混杂。每次配料，必须经二人以上复核无误，并详细记录每次生产所用原料和成品数。经手人要签字备查。所有工具、容器要处理干净，以防污染其他药品。标示量要准确无误，包装容器要有毒药标志。
Pharmaceutical factories must assign pharmaceutical professionals to be responsible for production, preparation, and quality inspection, and establish strict management systems. Strict measures shall be taken to prevent mixing with other drugs. Each batch of ingredients must be double-checked by at least two persons, and detailed records of the raw materials and finished product quantities used in each production shall be kept. The handlers shall sign for future reference. All tools and containers shall be cleaned thoroughly to prevent contamination of other drugs. Labeled quantities shall be accurate, and packaging containers shall bear a poison symbol.
毒性药品的收购、经营，由各级医药管理部门指定的药品经营单位负责；配方用药由国营药店、医疗单位负责。其他任何单位或者个人均不得从事毒性药品的收购、经营和配方业务。
The procurement and operation of toxic drugs shall be handled by drug business units designated by pharmaceutical administration departments at all levels; dispensing shall be handled by state-owned pharmacies and medical units. No other unit or individual may engage in the procurement, operation, or dispensing of toxic drugs.
收购、经营、加工、使用毒性药品的单位必须建立健全保管、验收、领发、核对等制度，严防收假、发错，严禁与其他药品混杂，做到划定仓间或仓位，专柜加锁并由专人保管。
Units that procure, operate, process, or use toxic drugs must establish and improve systems for storage, acceptance, issuance, and verification, strictly prevent acceptance of counterfeit or erroneous items, and strictly prohibit mixing with other drugs. They shall designate specific warehouses or storage areas, use special cabinets with locks, and assign dedicated personnel for custody.
毒性药品的包装容器上必须印有毒药标志。在运输毒性药品的过程中，应当采取有效措施，防止发生事故。
The packaging containers of toxic drugs must bear a poison symbol. During the transportation of toxic drugs, effective measures shall be taken to prevent accidents.
凡加工炮制毒性中药，必须按照《中华人民共和国药典》或者省、自治区、直辖市卫生行政部门制定的《炮制规范》的规定进行。药材符合药用要求的，方可供应、配方和用于中成药生产。
The processing and preparation of toxic traditional Chinese medicines must be carried out in accordance with the Pharmacopoeia of the People's Republic of China or the Processing Standards 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 may they be supplied, dispensed, or used in the production of Chinese patent medicines.
生产毒性药品及其制剂，必须严格执行生产工艺操作规程，在本单位药品检验人员的监督下准确投料，并建立完整的生产记录，保存五年备查。
The production of toxic drugs and their preparations must strictly follow the production process operating procedures, with accurate ingredient input under the supervision of the unit's drug inspection personnel, and complete production records shall be established and kept for five years for future reference.
在生产毒性药品过程中产生的废弃物，必须妥善处理，不得污染环境。
Waste generated during the production of toxic drugs must be properly disposed of and shall not pollute the environment.
医疗单位供应和调配毒性药品，凭医生签名的正式处方。国营药店供应和调配毒性药品，凭盖有医生所在的医疗单位公章的正式处方。每次处方剂量不得超过二日极量。
Medical units shall supply and dispense toxic drugs only upon a formal prescription signed by a doctor. State-owned pharmacies shall supply and dispense toxic drugs only upon a formal prescription bearing the official seal of the medical unit where the doctor practices. The dosage per prescription shall not exceed the maximum daily dose for two days.
调配处方时，必须认真负责，计量准确，按医嘱注明要求，并由配方人员及具有药师以上技术职称的复核人员签名盖章后方可发出。对处方未注明“生用”的毒性中药，应当付炮制品。如发现处方有疑问时，须经原处方医生重新审定后再行调配。处方一次有效，取药后处方保存二年备查。
When dispensing a prescription, the personnel must be conscientious and responsible, ensure accurate measurement, follow the instructions indicated on the prescription, and the prescription may only be issued after being signed and sealed by the dispensing personnel and a reviewer with the technical title of pharmacist or above. For toxic traditional Chinese medicines where the prescription does not indicate 'raw use,' the processed product shall be dispensed. If any doubt arises regarding the prescription, it must be re-evaluated by the original prescribing doctor before dispensing. The prescription is valid for one use only, and after dispensing, the prescription shall be kept for two years for future reference.
科研和教学单位所需的毒性药品，必须持本单位的证明信，经单位所在地县以上卫生行政部门批准后，供应部门方能发售。
Toxic drugs required by scientific research and teaching units must be supplied only after the unit presents its certification letter and obtains approval from the health administrative department at or above the county level where the unit is located.
群众自配民间单、秘、验方需用毒性中药，购买时要持有本单位或者城市街道办事处、乡(镇)人民政府的证明信，供应部门方可发售。每次购用量不得超过二日极量。
If the general public needs toxic traditional Chinese medicines for self-prepared folk prescriptions, secret prescriptions, or proven prescriptions, they must hold a certification letter from their unit, or from the urban sub-district office or the people's government of the township (town) when purchasing. The supply department may only sell the drugs upon such certification. The quantity purchased each time shall not exceed the maximum daily dose for two days.
对违反本办法的规定，擅自生产、收购、经营毒性药品的单位或者个人，由县以上卫生行政部门没收其全部毒性药品，并处以警告或按非法所得的五至十倍罚款。情节严重、致人伤残或死亡，构成犯罪的，由司法机关依法追究其刑事责任。
Any unit or individual that violates the provisions of these Regulations by producing, procuring, or operating toxic drugs without authorization shall have all toxic drugs confiscated by the health administrative department at or above the county level, and shall be given a warning or a fine of five to ten times the illegal income. If the circumstances are serious, causing injury or death, and constituting a crime, the judicial authorities shall investigate criminal liability according to law.
当事人对处罚不服的，可在接到处罚通知之日起十五日内，向作出处理的机关的上级机关申请复议。但申请复议期间仍应执行原处罚决定。上级机关应在接到申请之日起十日内作出答复。对答复不服的，可在接到答复之日起十五日内，向人民法院起诉。
If a party disagrees with the penalty, it may apply for reconsideration to the superior authority of the authority that made the decision within 15 days from the date of receipt of the penalty notice. However, the original penalty decision shall still be executed during the reconsideration period. The superior authority shall make a reply within 10 days from the date of receipt of the application. If the party disagrees with the reply, it may file a lawsuit with the people's court within 15 days from the date of receipt of the reply.
本办法由卫生部负责解释。
These Regulations shall be interpreted by the Ministry of Health.
本办法自发布之日起施行。1964年4月20日卫生部、商业部、化工部发布的《管理毒药、限制性剧药暂行规定》，1964年12月7日卫生部、商业部发布的《管理毒性中药的暂行办法》，1979年6月30日卫生部、国家医药管理总局发布的《医疗用毒药、限制性剧药管理规定》，同时废止。
These Regulations shall come into force as of the date of promulgation. The Interim Provisions on the Administration of Poisons and Restricted Potent Drugs issued by the Ministry of Health, the Ministry of Commerce, and the Ministry of Chemical Industry on April 20, 1964, the Interim Measures for the Administration of Toxic Traditional Chinese Medicines issued by the Ministry of Health and the Ministry of Commerce on December 7, 1964, and the Provisions on the Administration of Toxic Drugs and Restricted Potent Drugs for Medical Use issued by the Ministry of Health and the State Pharmaceutical Administration on June 30, 1979, shall be simultaneously abolished.