Regulations on the Administration of Narcotic Drugs and Psychotropic Substances

(2005年8月3日中华人民共和国国务院令第442号公布　根据2013年12月7日《国务院关于修改部分行政法规的决定》第一次修订　根据2016年2月6日《国务院关于修改部分行政法规的决定》第二次修订　根据2024年12月6日《国务院关于修改和废止部分行政法规的决定》第三次修订)

(Promulgated by Decree No. 442 of the State Council of the People's Republic of China on August 3, 2005; first revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on December 7, 2013; second revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016; third revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on December 6, 2024)

为加强麻醉药品和精神药品的管理，保证麻醉药品和精神药品的合法、安全、合理使用，防止流入非法渠道，根据药品管理法和其他有关法律的规定，制定本条例。

These Regulations are formulated in accordance with the Drug Administration Law and other relevant laws to strengthen the management of narcotic drugs and psychotropic substances, ensure their legal, safe, and rational use, and prevent them from flowing into illegal channels.

麻醉药品药用原植物的种植，麻醉药品和精神药品的实验研究、生产、经营、使用、储存、运输等活动以及监督管理，适用本条例。

These Regulations apply to the cultivation of narcotic drug raw plants, experimental research, production, operation, use, storage, transportation, and supervision of narcotic drugs and psychotropic substances.

麻醉药品和精神药品的进出口依照有关法律的规定办理。

The import and export of narcotic drugs and psychotropic substances shall be handled in accordance with relevant laws.

本条例所称麻醉药品和精神药品，是指列入本条第二款规定的目录(以下称目录)的药品和其他物质。

For the purposes of these Regulations, narcotic drugs and psychotropic substances refer to drugs and other substances listed in the catalogues specified in paragraph 2 of this Article (hereinafter referred to as the catalogues).

麻醉药品和精神药品按照药用类和非药用类分类列管。药用类麻醉药品和精神药品目录由国务院药品监督管理部门会同国务院公安部门、国务院卫生主管部门制定、调整并公布。其中，药用类精神药品分为第一类精神药品和第二类精神药品。非药用类麻醉药品和精神药品目录由国务院公安部门会同国务院药品监督管理部门、国务院卫生主管部门制定、调整并公布。非药用类麻醉药品和精神药品发现药用用途的，调整列入药用类麻醉药品和精神药品目录，不再列入非药用类麻醉药品和精神药品目录。

Narcotic drugs and psychotropic substances are classified and controlled as medicinal and non-medicinal categories. The catalogue of medicinal narcotic drugs and psychotropic substances shall be formulated, adjusted, and published by the drug regulatory department of the State Council jointly with the public security department of the State Council and the health department of the State Council. Among them, medicinal psychotropic substances are divided into first-class psychotropic substances and second-class psychotropic substances. The catalogue of non-medicinal narcotic drugs and psychotropic substances shall be formulated, adjusted, and published by the public security department of the State Council jointly with the drug regulatory department of the State Council and the health department of the State Council. If non-medicinal narcotic drugs and psychotropic substances are found to have medicinal uses, they shall be adjusted and included in the catalogue of medicinal narcotic drugs and psychotropic substances and no longer included in the catalogue of non-medicinal narcotic drugs and psychotropic substances.

国家组织开展药品和其他物质滥用监测，对药品和其他物质滥用情况进行评估，建立健全目录动态调整机制。上市销售但尚未列入目录的药品和其他物质或者第二类精神药品发生滥用，已经造成或者可能造成严重社会危害的，国务院药品监督管理部门、国务院公安部门、国务院卫生主管部门应当依照前款的规定及时将该药品和该物质列入目录或者将该第二类精神药品调整为第一类精神药品。

The state organizes monitoring of drug and other substance abuse, evaluates the abuse of drugs and other substances, and establishes a dynamic adjustment mechanism for the catalogues. If drugs or other substances that are marketed but not yet included in the catalogues, or second-class psychotropic substances, are abused and have caused or may cause serious social harm, the drug regulatory department of the State Council, the public security department of the State Council, and the health department of the State Council shall promptly include such drugs or substances in the catalogues or adjust such second-class psychotropic substances to first-class psychotropic substances in accordance with the provisions of the preceding paragraph.

国家对麻醉药品药用原植物以及麻醉药品和精神药品实行管制。除本条例另有规定的外，任何单位、个人不得进行麻醉药品药用原植物的种植以及麻醉药品和精神药品的实验研究、生产、经营、使用、储存、运输等活动。

The state implements control over narcotic drug raw plants and narcotic drugs and psychotropic substances. Unless otherwise provided in these Regulations, no unit or individual may engage in the cultivation of narcotic drug raw plants or the experimental research, production, operation, use, storage, or transportation of narcotic drugs and psychotropic substances.

对药用类麻醉药品和精神药品，可以依照本条例的规定进行实验研究、生产、经营、使用、储存、运输；对非药用类麻醉药品和精神药品，可以依照本条例的规定进行实验研究，不得生产、经营、使用、储存、运输。

Medicinal narcotic drugs and psychotropic substances may be subject to experimental research, production, operation, use, storage, and transportation in accordance with these Regulations; non-medicinal narcotic drugs and psychotropic substances may be subject to experimental research in accordance with these Regulations, but may not be produced, operated, used, stored, or transported.

国家建立麻醉药品和精神药品追溯管理体系。国务院药品监督管理部门应当制定统一的麻醉药品和精神药品追溯标准和规范，推进麻醉药品和精神药品追溯信息互通互享，实现麻醉药品和精神药品可追溯。

The state establishes a traceability management system for narcotic drugs and psychotropic substances. The drug regulatory department of the State Council shall formulate unified traceability standards and specifications for narcotic drugs and psychotropic substances, promote the exchange and sharing of traceability information, and achieve traceability of narcotic drugs and psychotropic substances.

国务院药品监督管理部门负责全国麻醉药品和精神药品的监督管理工作，并会同国务院农业主管部门对麻醉药品药用原植物实施监督管理。国务院公安部门负责对造成麻醉药品药用原植物、麻醉药品和精神药品流入非法渠道的行为进行查处。国务院其他有关主管部门在各自的职责范围内负责与麻醉药品和精神药品有关的管理工作。

The drug regulatory department of the State Council is responsible for the supervision and management of narcotic drugs and psychotropic substances nationwide, and shall jointly with the agricultural department of the State Council implement supervision over narcotic drug raw plants. The public security department of the State Council is responsible for investigating and punishing acts that cause narcotic drug raw plants, narcotic drugs, and psychotropic substances to flow into illegal channels. Other relevant departments of the State Council are responsible for management work related to narcotic drugs and psychotropic substances within their respective duties.

省、自治区、直辖市人民政府药品监督管理部门和设区的市级、县级人民政府承担药品监督管理职责的部门(以下称药品监督管理部门)负责本行政区域内麻醉药品和精神药品的监督管理工作。县级以上地方公安机关负责对本行政区域内造成麻醉药品和精神药品流入非法渠道的行为进行查处。县级以上地方人民政府其他有关主管部门在各自的职责范围内负责与麻醉药品和精神药品有关的管理工作。

The drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government, and the departments responsible for drug supervision and management at the city divided into districts and county levels (hereinafter referred to as drug regulatory departments) are responsible for the supervision and management of narcotic drugs and psychotropic substances within their respective administrative regions. The public security organs at or above the county level are responsible for investigating and punishing acts that cause narcotic drugs and psychotropic substances to flow into illegal channels within their respective administrative regions. Other relevant departments of local people's governments at or above the county level are responsible for management work related to narcotic drugs and psychotropic substances within their respective duties.

麻醉药品和精神药品生产、经营企业和使用单位可以依法参加行业协会。行业协会应当加强行业自律管理。

Enterprises and user units that produce or operate narcotic drugs and psychotropic substances may join industry associations in accordance with the law. Industry associations shall strengthen industry self-discipline management.

国家根据麻醉药品和精神药品的医疗、国家储备和企业生产所需原料的需要确定需求总量，对麻醉药品药用原植物的种植、麻醉药品和精神药品的生产实行总量控制。

The state determines the total demand for narcotic drugs and psychotropic substances based on the needs of medical treatment, national reserves, and raw materials required for enterprise production, and implements total quantity control over the cultivation of narcotic drug raw plants and the production of narcotic drugs and psychotropic substances.

国务院药品监督管理部门根据麻醉药品和精神药品的需求总量制定年度生产计划。

The drug regulatory department of the State Council formulates annual production plans based on the total demand for narcotic drugs and psychotropic substances.

国务院药品监督管理部门和国务院农业主管部门根据麻醉药品年度生产计划，制定麻醉药品药用原植物年度种植计划。

The drug regulatory department of the State Council and the agricultural department of the State Council formulate annual cultivation plans for narcotic drug raw plants based on the annual production plans for narcotic drugs.

麻醉药品药用原植物种植企业应当根据年度种植计划，种植麻醉药品药用原植物。

Enterprises cultivating narcotic drug raw plants shall cultivate such plants in accordance with the annual cultivation plan.

麻醉药品药用原植物种植企业应当向国务院药品监督管理部门和国务院农业主管部门定期报告种植情况。

Enterprises cultivating narcotic drug raw plants shall periodically report cultivation status to the drug regulatory department of the State Council and the agricultural department of the State Council.

麻醉药品药用原植物种植企业由国务院药品监督管理部门和国务院农业主管部门共同确定，其他单位和个人不得种植麻醉药品药用原植物。

Enterprises cultivating narcotic drug raw plants shall be jointly designated by the drug regulatory department of the State Council and the agricultural department of the State Council; no other unit or individual may cultivate narcotic drug raw plants.

开展麻醉药品和精神药品实验研究活动应当具备下列条件，并经国务院药品监督管理部门批准：

To conduct experimental research activities on narcotic drugs and psychotropic substances, the following conditions must be met and approval from the drug regulatory department of the State Council must be obtained:

(一)以医疗、科学研究或者教学为目的；

(1) For the purpose of medical treatment, scientific research, or teaching;

(二)有保证实验所需麻醉药品和精神药品安全的措施和管理制度；

(2) Having measures and management systems to ensure the safety of narcotic drugs and psychotropic substances required for the experiment;

(三)单位及其工作人员2年内没有违反有关禁毒的法律、行政法规规定的行为。

(3) The unit and its staff have not violated laws or administrative regulations on drug control within the past 2 years.

麻醉药品和精神药品的实验研究单位申请相关药品批准证明文件，应当依照药品管理法的规定办理；需要转让研究成果的，应当经国务院药品监督管理部门批准。

Units conducting experimental research on narcotic drugs and psychotropic substances that apply for relevant drug approval certificates shall handle the matter in accordance with the Drug Administration Law; if the research results need to be transferred, approval from the drug regulatory department of the State Council must be obtained.

药品研究单位在普通药品的实验研究过程中，产生本条例规定的管制品种的，应当立即停止实验研究活动，并向国务院药品监督管理部门报告。国务院药品监督管理部门应当根据情况，及时作出是否同意其继续实验研究的决定。

If a drug research unit, during experimental research on ordinary drugs, produces a controlled variety specified in these Regulations, it shall immediately stop the experimental research activities and report to the drug regulatory department of the State Council. The drug regulatory department of the State Council shall, based on the circumstances, promptly decide whether to allow the continuation of the experimental research.

麻醉药品和第一类精神药品的临床试验，不得以健康人为受试对象。

Clinical trials of narcotic drugs and first-class psychotropic substances shall not use healthy individuals as subjects.

国家对麻醉药品和精神药品实行定点生产制度。

The state implements a designated production system for narcotic drugs and psychotropic substances.

国务院药品监督管理部门应当根据麻醉药品和精神药品的需求总量，确定麻醉药品和精神药品定点生产企业的数量和布局，并根据年度需求总量对数量和布局进行调整、公布。

The drug regulatory department of the State Council shall determine the number and layout of designated production enterprises for narcotic drugs and psychotropic substances based on the total demand, and shall adjust and publish the number and layout based on the annual total demand.

麻醉药品和精神药品的定点生产企业应当具备下列条件：

Designated production enterprises for narcotic drugs and psychotropic substances shall meet the following conditions:

(一)有药品生产许可证；

(1) Having a drug production license;

(二)有麻醉药品和精神药品实验研究批准文件；

(2) Having an approval document for experimental research on narcotic drugs and psychotropic substances;

(三)有符合规定的麻醉药品和精神药品生产设施、储存条件和相应的安全管理设施；

(3) Having production facilities, storage conditions, and corresponding safety management facilities for narcotic drugs and psychotropic substances that meet the requirements;

(四)有通过网络实施企业安全生产管理和向药品监督管理部门报告生产信息的能力；

(4) Having the ability to implement enterprise safety production management through the network and report production information to the drug regulatory department;

(五)有保证麻醉药品和精神药品安全生产的管理制度；

(5) Having a management system to ensure the safe production of narcotic drugs and psychotropic substances;

(六)有与麻醉药品和精神药品安全生产要求相适应的管理水平和经营规模；

(6) Having a management level and business scale that meet the requirements for safe production of narcotic drugs and psychotropic substances;

(七)麻醉药品和精神药品生产管理、质量管理部门的人员应当熟悉麻醉药品和精神药品管理以及有关禁毒的法律、行政法规；

(7) Personnel in the production management and quality management departments of narcotic drugs and psychotropic substances shall be familiar with the management of narcotic drugs and psychotropic substances and relevant laws and administrative regulations on drug control;

(八)没有生产、销售假药、劣药或者违反有关禁毒的法律、行政法规规定的行为；

(8) No acts of producing or selling counterfeit or substandard drugs, or violating laws or administrative regulations on drug control;

(九)符合国务院药品监督管理部门公布的麻醉药品和精神药品定点生产企业数量和布局的要求。

(9) Meeting the requirements for the number and layout of designated production enterprises for narcotic drugs and psychotropic substances published by the drug regulatory department of the State Council.

从事麻醉药品、精神药品生产的企业，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准。

Enterprises engaged in the production of narcotic drugs and psychotropic substances shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.

定点生产企业生产麻醉药品和精神药品，应当依照药品管理法的规定取得药品批准文号。

Designated production enterprises producing narcotic drugs and psychotropic substances shall obtain drug approval numbers in accordance with the Drug Administration Law.

国务院药品监督管理部门应当组织医学、药学、社会学、伦理学和禁毒等方面的专家成立专家组，由专家组对申请首次上市的麻醉药品和精神药品的社会危害性和被滥用的可能性进行评价，并提出是否批准的建议。

The drug regulatory department of the State Council shall organize an expert group composed of experts in medicine, pharmacy, sociology, ethics, and drug control to evaluate the social harm and abuse potential of narcotic drugs and psychotropic substances applying for initial marketing, and propose recommendations on whether to approve.

未取得药品批准文号的，不得生产麻醉药品和精神药品。

Without obtaining a drug approval number, no narcotic drugs or psychotropic substances may be produced.

发生重大突发事件，定点生产企业无法正常生产或者不能保证供应麻醉药品和精神药品时，国务院药品监督管理部门可以决定其他药品生产企业生产麻醉药品和精神药品。

In the event of a major emergency where designated production enterprises cannot produce normally or cannot guarantee the supply of narcotic drugs and psychotropic substances, the drug regulatory department of the State Council may decide that other drug production enterprises produce narcotic drugs and psychotropic substances.

重大突发事件结束后，国务院药品监督管理部门应当及时决定前款规定的企业停止麻醉药品和精神药品的生产。

After the major emergency ends, the drug regulatory department of the State Council shall promptly decide that the enterprises specified in the preceding paragraph stop producing narcotic drugs and psychotropic substances.

定点生产企业应当严格按照麻醉药品和精神药品年度生产计划安排生产，并依照规定向所在地省、自治区、直辖市人民政府药品监督管理部门报告生产情况。

Designated production enterprises shall strictly arrange production in accordance with the annual production plan for narcotic drugs and psychotropic substances, and report production status to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located in accordance with regulations.

定点生产企业应当依照本条例的规定，将麻醉药品和精神药品销售给具有麻醉药品和精神药品经营资格的企业或者依照本条例规定批准的其他单位。

Designated production enterprises shall sell narcotic drugs and psychotropic substances to enterprises qualified to operate narcotic drugs and psychotropic substances or other units approved in accordance with these Regulations.

麻醉药品和精神药品的标签应当印有国务院药品监督管理部门规定的标志。

Labels of narcotic drugs and psychotropic substances shall bear the marks specified by the drug regulatory department of the State Council.

国家对麻醉药品和精神药品实行定点经营制度。

The state implements a designated operation system for narcotic drugs and psychotropic substances.

国务院药品监督管理部门应当根据麻醉药品和第一类精神药品的需求总量，确定麻醉药品和第一类精神药品的定点批发企业布局，并应当根据年度需求总量对布局进行调整、公布。

The drug regulatory department of the State Council shall determine the layout of designated wholesale enterprises for narcotic drugs and first-class psychotropic substances based on the total demand, and shall adjust and publish the layout based on the annual total demand.

药品经营企业不得经营麻醉药品原料药和第一类精神药品原料药。但是，供医疗、科学研究、教学使用的小包装的上述药品可以由国务院药品监督管理部门规定的药品批发企业经营。

Drug operation enterprises shall not operate narcotic drug raw materials or first-class psychotropic substance raw materials. However, small packages of the above drugs for medical, scientific research, or teaching use may be operated by drug wholesale enterprises designated by the drug regulatory department of the State Council.

麻醉药品和精神药品定点批发企业除应当具备药品管理法规定的药品经营企业的开办条件外，还应当具备下列条件：

In addition to meeting the conditions for establishing drug operation enterprises as specified in the Drug Administration Law, designated wholesale enterprises for narcotic drugs and psychotropic substances shall also meet the following conditions:

(一)有符合本条例规定的麻醉药品和精神药品储存条件；

(1) Having storage conditions for narcotic drugs and psychotropic substances that meet the requirements of these Regulations;

(二)有通过网络实施企业安全管理和向药品监督管理部门报告经营信息的能力；

(2) Having the ability to implement enterprise safety management through the network and report operation information to the drug regulatory department;

(三)单位及其工作人员2年内没有违反有关禁毒的法律、行政法规规定的行为；

(3) The unit and its staff have not violated laws or administrative regulations on drug control within the past 2 years;

(四)符合国务院药品监督管理部门公布的定点批发企业布局。

(4) Meeting the layout of designated wholesale enterprises published by the drug regulatory department of the State Council.

麻醉药品和第一类精神药品的定点批发企业，还应当具有保证供应责任区域内医疗机构所需麻醉药品和第一类精神药品的能力，并具有保证麻醉药品和第一类精神药品安全经营的管理制度。

Designated wholesale enterprises for narcotic drugs and first-class psychotropic substances shall also have the ability to ensure the supply of narcotic drugs and first-class psychotropic substances needed by medical institutions within their responsible areas, and have a management system to ensure the safe operation of narcotic drugs and first-class psychotropic substances.

跨省、自治区、直辖市从事麻醉药品和第一类精神药品批发业务的企业(以下称全国性批发企业)，应当经国务院药品监督管理部门批准；在本省、自治区、直辖市行政区域内从事麻醉药品和第一类精神药品批发业务的企业(以下称区域性批发企业)，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准。

Enterprises engaged in wholesale business of narcotic drugs and first-class psychotropic substances across provinces, autonomous regions, or municipalities directly under the Central Government (hereinafter referred to as national wholesale enterprises) shall be approved by the drug regulatory department of the State Council; enterprises engaged in wholesale business of narcotic drugs and first-class psychotropic substances within the administrative region of a province, autonomous region, or municipality directly under the Central Government (hereinafter referred to as regional wholesale enterprises) shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.

专门从事第二类精神药品批发业务的企业，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准。

Enterprises exclusively engaged in wholesale business of second-class psychotropic substances shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.

全国性批发企业和区域性批发企业可以从事第二类精神药品批发业务。

National wholesale enterprises and regional wholesale enterprises may engage in wholesale business of second-class psychotropic substances.

全国性批发企业可以向区域性批发企业，或者经批准可以向取得麻醉药品和第一类精神药品使用资格的医疗机构以及依照本条例规定批准的其他单位销售麻醉药品和第一类精神药品。

National wholesale enterprises may sell narcotic drugs and first-class psychotropic substances to regional wholesale enterprises, or, upon approval, to medical institutions qualified to use narcotic drugs and first-class psychotropic substances and other units approved in accordance with these Regulations.

全国性批发企业向取得麻醉药品和第一类精神药品使用资格的医疗机构销售麻醉药品和第一类精神药品，应当经医疗机构所在地省、自治区、直辖市人民政府药品监督管理部门批准。

National wholesale enterprises selling narcotic drugs and first-class psychotropic substances to medical institutions qualified to use narcotic drugs and first-class psychotropic substances shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the medical institution is located.

国务院药品监督管理部门在批准全国性批发企业时，应当明确其所承担供药责任的区域。

When approving a national wholesale enterprise, the drug regulatory department of the State Council shall specify the area for which it is responsible for drug supply.

区域性批发企业可以向本省、自治区、直辖市行政区域内取得麻醉药品和第一类精神药品使用资格的医疗机构销售麻醉药品和第一类精神药品；由于特殊地理位置的原因，需要就近向其他省、自治区、直辖市行政区域内取得麻醉药品和第一类精神药品使用资格的医疗机构销售的，应当经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准。审批情况由负责审批的药品监督管理部门在批准后5日内通报医疗机构所在地省、自治区、直辖市人民政府药品监督管理部门。

Regional wholesale enterprises may sell narcotic drugs and first-class psychotropic substances to medical institutions qualified to use narcotic drugs and first-class psychotropic substances within the administrative region of their province, autonomous region, or municipality directly under the Central Government; if, due to special geographical location, it is necessary to sell to medical institutions qualified to use narcotic drugs and first-class psychotropic substances in other provinces, autonomous regions, or municipalities directly under the Central Government, approval shall be obtained from the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located. The approving drug regulatory department shall, within 5 days after approval, notify the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the medical institution is located.

省、自治区、直辖市人民政府药品监督管理部门在批准区域性批发企业时，应当明确其所承担供药责任的区域。

When approving a regional wholesale enterprise, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall specify the area for which it is responsible for drug supply.

区域性批发企业之间因医疗急需、运输困难等特殊情况需要调剂麻醉药品和第一类精神药品的，应当在调剂后2日内将调剂情况分别报所在地省、自治区、直辖市人民政府药品监督管理部门备案。

If regional wholesale enterprises need to transfer narcotic drugs and first-class psychotropic substances due to special circumstances such as medical emergencies or transportation difficulties, they shall, within 2 days after the transfer, report the transfer details to the drug regulatory departments of the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government where they are located for record.

全国性批发企业应当从定点生产企业购进麻醉药品和第一类精神药品。

National wholesale enterprises shall purchase narcotic drugs and first-class psychotropic substances from designated production enterprises.

区域性批发企业可以从全国性批发企业购进麻醉药品和第一类精神药品；经所在地省、自治区、直辖市人民政府药品监督管理部门批准，也可以从定点生产企业购进麻醉药品和第一类精神药品。

Regional wholesale enterprises may purchase narcotic drugs and first-class psychotropic substances from national wholesale enterprises; with the approval of the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, they may also purchase narcotic drugs and first-class psychotropic substances from designated production enterprises.

全国性批发企业和区域性批发企业向医疗机构销售麻醉药品和第一类精神药品，应当将药品送至医疗机构。医疗机构不得自行提货。

When selling narcotic drugs and first-class psychotropic substances to medical institutions, national wholesale enterprises and regional wholesale enterprises shall deliver the drugs to the medical institutions. Medical institutions shall not pick up the drugs themselves.

第二类精神药品定点批发企业可以向医疗机构、定点批发企业和符合本条例第三十一条规定的药品零售企业以及依照本条例规定批准的其他单位销售第二类精神药品。

Designated wholesale enterprises for second-class psychotropic substances may sell second-class psychotropic substances to medical institutions, designated wholesale enterprises, drug retail enterprises that meet the requirements of Article 31 of these Regulations, and other units approved in accordance with these Regulations.

麻醉药品和第一类精神药品不得零售。

Narcotic drugs and first-class psychotropic substances shall not be retailed.

禁止使用现金进行麻醉药品和精神药品交易，但是个人合法购买麻醉药品和精神药品的除外。

Cash transactions of narcotic drugs and psychotropic substances are prohibited, except for personal legal purchases of narcotic drugs and psychotropic substances.

经所在地设区的市级药品监督管理部门批准，实行统一进货、统一配送、统一管理的药品零售连锁企业可以从事第二类精神药品零售业务。

With the approval of the drug regulatory department at the city divided into districts level where they are located, drug retail chain enterprises that implement unified procurement, unified distribution, and unified management may engage in retail business of second-class psychotropic substances.

第二类精神药品零售企业应当凭执业医师出具的处方，按规定剂量销售第二类精神药品，并将处方保存2年备查；禁止超剂量或者无处方销售第二类精神药品；不得向未成年人销售第二类精神药品。

Retail enterprises of second-class psychotropic substances shall sell second-class psychotropic substances in accordance with the prescription issued by a licensed physician and within the prescribed dosage, and shall keep the prescription for 2 years for reference; it is prohibited to sell second-class psychotropic substances in excess of the dosage or without a prescription; it is prohibited to sell second-class psychotropic substances to minors.

麻醉药品和第一类精神药品实行政府指导价。具体办法由国务院医疗保障主管部门制定。

Government-guided prices shall be implemented for narcotic drugs and first-class psychotropic substances. Specific measures shall be formulated by the medical security department of the State Council.

药品生产企业需要以麻醉药品和第一类精神药品为原料生产普通药品的，应当向所在地省、自治区、直辖市人民政府药品监督管理部门报送年度需求计划，由省、自治区、直辖市人民政府药品监督管理部门汇总报国务院药品监督管理部门批准后，向定点生产企业购买。

If a drug production enterprise needs to use narcotic drugs and first-class psychotropic substances as raw materials to produce ordinary drugs, it shall submit an annual demand plan to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. The drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall summarize and report to the drug regulatory department of the State Council for approval, and then purchase from designated production enterprises.

药品生产企业需要以第二类精神药品为原料生产普通药品的，应当将年度需求计划报所在地省、自治区、直辖市人民政府药品监督管理部门，并向定点批发企业或者定点生产企业购买。

If a drug production enterprise needs to use second-class psychotropic substances as raw materials to produce ordinary drugs, it shall submit the annual demand plan to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located, and purchase from designated wholesale enterprises or designated production enterprises.

食品、食品添加剂、化妆品、油漆等非药品生产企业需要使用咖啡因作为原料的，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准，向定点批发企业或者定点生产企业购买。

If non-drug production enterprises such as food, food additives, cosmetics, and paint need to use caffeine as a raw material, they shall obtain approval from the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, and purchase from designated wholesale enterprises or designated production enterprises.

科学研究、教学单位需要使用麻醉药品和精神药品开展实验、教学活动的，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准，向定点批发企业或者定点生产企业购买。

If scientific research or teaching units need to use narcotic drugs and psychotropic substances for experiments or teaching activities, they shall obtain approval from the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, and purchase from designated wholesale enterprises or designated production enterprises.

需要使用麻醉药品和精神药品的标准品、对照品的，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准，向国务院药品监督管理部门批准的单位购买。

If it is necessary to use reference standards or control samples of narcotic drugs and psychotropic substances, approval shall be obtained from the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the unit is located, and purchase from units approved by the drug regulatory department of the State Council.

医疗机构需要使用麻醉药品和第一类精神药品的，应当经所在地设区的市级人民政府卫生主管部门批准，取得麻醉药品、第一类精神药品购用印鉴卡(以下称印鉴卡)。医疗机构应当凭印鉴卡向本省、自治区、直辖市行政区域内的定点批发企业购买麻醉药品和第一类精神药品。

If a medical institution needs to use narcotic drugs and first-class psychotropic substances, it shall obtain approval from the health department of the people's government at the city divided into districts level where it is located, and obtain a Seal Card for Purchasing Narcotic Drugs and First-Class Psychotropic Substances (hereinafter referred to as the Seal Card). Medical institutions shall purchase narcotic drugs and first-class psychotropic substances from designated wholesale enterprises within the administrative region of their province, autonomous region, or municipality directly under the Central Government based on the Seal Card.

设区的市级人民政府卫生主管部门发给医疗机构印鉴卡时，应当将取得印鉴卡的医疗机构情况抄送所在地设区的市级药品监督管理部门，并报省、自治区、直辖市人民政府卫生主管部门备案。省、自治区、直辖市人民政府卫生主管部门应当将取得印鉴卡的医疗机构名单向本行政区域内的定点批发企业通报。

When issuing the Seal Card to a medical institution, the health department of the people's government at the city divided into districts level shall send a copy of the information of the medical institution that obtained the Seal Card to the drug regulatory department at the same level, and report to the health department of the people's government of the province, autonomous region, or municipality directly under the Central Government for record. The health department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall notify the list of medical institutions that obtained the Seal Card to designated wholesale enterprises within its administrative region.

医疗机构取得印鉴卡应当具备下列条件：

A medical institution shall meet the following conditions to obtain the Seal Card:

(一)有专职的麻醉药品和第一类精神药品管理人员；

(1) Having full-time management personnel for narcotic drugs and first-class psychotropic substances;

(二)有获得麻醉药品和第一类精神药品处方资格的执业医师；

(2) Having licensed physicians qualified to prescribe narcotic drugs and first-class psychotropic substances;

(三)有保证麻醉药品和第一类精神药品安全储存的设施和管理制度。

(3) Having facilities and management systems to ensure the safe storage of narcotic drugs and first-class psychotropic substances.

医疗机构应当按照国务院卫生主管部门的规定，对本单位执业医师进行有关麻醉药品和精神药品使用知识的培训、考核，经考核合格的，授予麻醉药品和第一类精神药品处方资格。执业医师取得麻醉药品和第一类精神药品的处方资格后，方可在本医疗机构开具麻醉药品和第一类精神药品处方，但不得为自己开具该种处方。

Medical institutions shall, in accordance with the provisions of the health department of the State Council, conduct training and assessment on the knowledge of using narcotic drugs and psychotropic substances for their licensed physicians. Those who pass the assessment shall be granted the qualification to prescribe narcotic drugs and first-class psychotropic substances. Only after obtaining the qualification to prescribe narcotic drugs and first-class psychotropic substances may a licensed physician prescribe narcotic drugs and first-class psychotropic substances in that medical institution, but shall not prescribe such prescriptions for themselves.

医疗机构应当将具有麻醉药品和第一类精神药品处方资格的执业医师名单及其变更情况，定期报送所在地设区的市级人民政府卫生主管部门，并抄送同级药品监督管理部门。

Medical institutions shall regularly submit the list of licensed physicians qualified to prescribe narcotic drugs and first-class psychotropic substances and any changes to the health department of the people's government at the city divided into districts level where they are located, and send a copy to the drug regulatory department at the same level.

医务人员应当根据国务院卫生主管部门制定的临床应用指导原则，使用麻醉药品和精神药品。

Medical personnel shall use narcotic drugs and psychotropic substances in accordance with the clinical application guidelines formulated by the health department of the State Council.

具有麻醉药品和第一类精神药品处方资格的执业医师，根据临床应用指导原则，对确需使用麻醉药品或者第一类精神药品的患者，应当满足其合理用药需求。在医疗机构就诊的癌症疼痛患者和其他危重患者得不到麻醉药品或者第一类精神药品时，患者或者其亲属可以向执业医师提出申请。具有麻醉药品和第一类精神药品处方资格的执业医师认为要求合理的，应当及时为患者提供所需麻醉药品或者第一类精神药品。

A licensed physician qualified to prescribe narcotic drugs and first-class psychotropic substances shall, in accordance with the clinical application guidelines, meet the reasonable medication needs of patients who indeed need narcotic drugs or first-class psychotropic substances. If a patient with cancer pain or other critically ill patients treated in a medical institution cannot obtain narcotic drugs or first-class psychotropic substances, the patient or their relatives may apply to the licensed physician. If the licensed physician qualified to prescribe narcotic drugs and first-class psychotropic substances considers the request reasonable, they shall promptly provide the patient with the required narcotic drugs or first-class psychotropic substances.

执业医师应当使用专用处方开具麻醉药品和精神药品，单张处方的最大用量应当符合国务院卫生主管部门的规定。执业医师开具麻醉药品和精神药品处方，应当对患者的信息进行核对；因抢救患者等紧急情况，无法核对患者信息的，执业医师可以先行开具麻醉药品和精神药品处方。

Licensed physicians shall use special prescriptions to prescribe narcotic drugs and psychotropic substances. The maximum dosage per single prescription shall comply with the provisions of the health department of the State Council. When prescribing narcotic drugs and psychotropic substances, licensed physicians shall verify the patient's information; in emergency situations such as rescuing patients where the patient's information cannot be verified, licensed physicians may first issue prescriptions for narcotic drugs and psychotropic substances.

对麻醉药品和第一类精神药品处方，处方的调配人、核对人应当仔细核对，签署姓名，并予以登记；对不符合本条例规定的，处方的调配人、核对人应当拒绝发药。

For prescriptions of narcotic drugs and first-class psychotropic substances, the prescription dispenser and checker shall carefully check, sign their names, and register; if the prescription does not comply with these Regulations, the dispenser and checker shall refuse to dispense the drugs.

麻醉药品和精神药品专用处方的格式由国务院卫生主管部门规定。

The format of special prescriptions for narcotic drugs and psychotropic substances shall be specified by the health department of the State Council.

医疗机构应当对麻醉药品和精神药品处方进行专册登记，加强管理。麻醉药品处方至少保存3年，精神药品处方至少保存2年。医疗机构应当按照国务院卫生主管部门的规定及时报送麻醉药品和精神药品处方信息。

Medical institutions shall keep special registers for prescriptions of narcotic drugs and psychotropic substances and strengthen management. Prescriptions for narcotic drugs shall be kept for at least 3 years, and prescriptions for psychotropic substances shall be kept for at least 2 years. Medical institutions shall promptly report prescription information for narcotic drugs and psychotropic substances in accordance with the provisions of the health department of the State Council.

医疗机构抢救病人急需麻醉药品和第一类精神药品而本医疗机构无法提供时，可以从其他医疗机构或者定点批发企业紧急借用；抢救工作结束后，应当及时将借用情况报所在地设区的市级药品监督管理部门和卫生主管部门备案。

If a medical institution urgently needs narcotic drugs and first-class psychotropic substances for rescuing patients but cannot provide them, it may urgently borrow from other medical institutions or designated wholesale enterprises; after the rescue work is completed, it shall promptly report the borrowing details to the drug regulatory department and the health department at the city divided into districts level where it is located for record.

对临床需要而市场无供应的麻醉药品和精神药品，持有医疗机构制剂许可证和印鉴卡的医疗机构需要配制制剂的，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准。医疗机构配制的麻醉药品和精神药品制剂只能在本医疗机构使用，不得对外销售。

If a medical institution holding a Medical Institution Preparation License and a Seal Card needs to prepare preparations of narcotic drugs and psychotropic substances that are clinically needed but not available on the market, it shall obtain approval from the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. The preparations of narcotic drugs and psychotropic substances prepared by medical institutions may only be used within that medical institution and shall not be sold externally.

因治疗疾病需要，个人凭医疗机构出具的医疗诊断书、本人身份证明，可以携带单张处方最大用量以内的麻醉药品和第一类精神药品；携带麻醉药品和第一类精神药品出入境的，由海关根据自用、合理的原则放行。

For the treatment of diseases, individuals may carry narcotic drugs and first-class psychotropic substances within the maximum dosage of a single prescription based on a medical diagnosis certificate issued by a medical institution and their identity certificate; when carrying narcotic drugs and first-class psychotropic substances into or out of the country, customs shall release them based on the principle of personal use and reasonable quantity.

医务人员为了医疗需要携带少量麻醉药品和精神药品出入境的，应当持有省级以上人民政府药品监督管理部门发放的携带麻醉药品和精神药品证明。海关凭携带麻醉药品和精神药品证明放行。

If medical personnel need to carry small quantities of narcotic drugs and psychotropic substances into or out of the country for medical purposes, they shall hold a certificate for carrying narcotic drugs and psychotropic substances issued by the drug regulatory department at or above the provincial level. Customs shall release them based on the certificate for carrying narcotic drugs and psychotropic substances.

医疗机构、戒毒机构以开展戒毒治疗为目的，可以使用美沙酮或者国家确定的其他用于戒毒治疗的麻醉药品和精神药品。具体管理办法由国务院药品监督管理部门、国务院公安部门和国务院卫生主管部门制定。

Medical institutions and drug rehabilitation institutions may use methadone or other narcotic drugs and psychotropic substances determined by the state for drug rehabilitation treatment. Specific management measures shall be formulated by the drug regulatory department of the State Council, the public security department of the State Council, and the health department of the State Council.

麻醉药品药用原植物种植企业、定点生产企业、全国性批发企业和区域性批发企业以及国家设立的麻醉药品储存单位，应当设置储存麻醉药品和第一类精神药品的专库。该专库应当符合下列要求：

Enterprises cultivating narcotic drug raw plants, designated production enterprises, national wholesale enterprises, regional wholesale enterprises, and state-established narcotic drug storage units shall set up special warehouses for storing narcotic drugs and first-class psychotropic substances. Such special warehouses shall meet the following requirements:

(一)安装专用防盗门，实行双人双锁管理；

(1) Installed with special anti-theft doors, managed with dual-person dual-lock;

(二)具有相应的防火设施；

(2) Having corresponding fire prevention facilities;

(三)具有监控设施和报警装置，报警装置应当与公安机关报警系统联网。

(3) Having monitoring facilities and alarm devices, and the alarm devices shall be connected to the public security alarm system.

全国性批发企业经国务院药品监督管理部门批准设立的药品储存点应当符合前款的规定。

Drug storage points established by national wholesale enterprises with the approval of the drug regulatory department of the State Council shall comply with the provisions of the preceding paragraph.

麻醉药品定点生产企业应当将麻醉药品原料药和制剂分别存放。

Designated production enterprises for narcotic drugs shall store narcotic drug raw materials and preparations separately.

麻醉药品和第一类精神药品的使用单位应当设立专库或者专柜储存麻醉药品和第一类精神药品。专库应当设有防盗设施并安装报警装置；专柜应当使用保险柜。专库和专柜应当实行双人双锁管理。

User units of narcotic drugs and first-class psychotropic substances shall set up special warehouses or cabinets to store narcotic drugs and first-class psychotropic substances. Special warehouses shall be equipped with anti-theft facilities and alarm devices; special cabinets shall use safes. Special warehouses and cabinets shall be managed with dual-person dual-lock.

麻醉药品药用原植物种植企业、定点生产企业、全国性批发企业和区域性批发企业、国家设立的麻醉药品储存单位以及麻醉药品和第一类精神药品的使用单位，应当配备专人负责管理工作，并建立储存麻醉药品和第一类精神药品的专用账册。药品入库双人验收，出库双人复核，做到账物相符。专用账册的保存期限应当自药品有效期期满之日起不少于5年。

Enterprises cultivating narcotic drug raw plants, designated production enterprises, national wholesale enterprises, regional wholesale enterprises, state-established narcotic drug storage units, and user units of narcotic drugs and first-class psychotropic substances shall assign dedicated personnel responsible for management and establish special account books for storing narcotic drugs and first-class psychotropic substances. Drugs shall be checked by two persons upon receipt and verified by two persons upon delivery, ensuring that accounts and items match. The retention period of special account books shall be no less than 5 years from the date of drug expiration.

第二类精神药品经营企业应当在药品库房中设立独立的专库或者专柜储存第二类精神药品，并建立专用账册，实行专人管理。专用账册的保存期限应当自药品有效期期满之日起不少于5年。

Enterprises operating second-class psychotropic substances shall set up independent special warehouses or cabinets in the drug warehouse to store second-class psychotropic substances, establish special account books, and implement dedicated personnel management. The retention period of special account books shall be no less than 5 years from the date of drug expiration.

托运、承运和自行运输麻醉药品和精神药品的，应当采取安全保障措施，防止麻醉药品和精神药品在运输过程中被盗、被抢、丢失。

When consigning, carrying, or self-transporting narcotic drugs and psychotropic substances, safety measures shall be taken to prevent theft, robbery, or loss of narcotic drugs and psychotropic substances during transportation.

通过铁路运输麻醉药品和第一类精神药品的，应当使用集装箱或者铁路行李车运输，具体办法由国务院药品监督管理部门会同国务院铁路主管部门制定。

When transporting narcotic drugs and first-class psychotropic substances by railway, containers or railway luggage cars shall be used. Specific measures shall be formulated by the drug regulatory department of the State Council jointly with the railway department of the State Council.

没有铁路需要通过公路或者水路运输麻醉药品和第一类精神药品的，应当由专人负责押运。

If there is no railway and it is necessary to transport narcotic drugs and first-class psychotropic substances by road or waterway, dedicated personnel shall be responsible for escort.

托运或者自行运输麻醉药品和第一类精神药品的单位，应当向所在地设区的市级药品监督管理部门申请领取运输证明。运输证明有效期为1年。

Units that consign or self-transport narcotic drugs and first-class psychotropic substances shall apply to the drug regulatory department at the city divided into districts level where they are located for a transportation certificate. The transportation certificate is valid for 1 year.

运输证明应当由专人保管，不得涂改、转让、转借。

The transportation certificate shall be kept by dedicated personnel and shall not be altered, transferred, or lent.

托运人办理麻醉药品和第一类精神药品运输手续，应当将运输证明副本交付承运人。承运人应当查验、收存运输证明副本，并检查货物包装。没有运输证明或者货物包装不符合规定的，承运人不得承运。

When handling transportation procedures for narcotic drugs and first-class psychotropic substances, the consignor shall deliver a copy of the transportation certificate to the carrier. The carrier shall inspect and keep the copy of the transportation certificate and check the packaging of the goods. Without a transportation certificate or if the packaging does not meet the requirements, the carrier shall not carry the goods.

承运人在运输过程中应当携带运输证明副本，以备查验。

The carrier shall carry a copy of the transportation certificate during transportation for inspection.

邮寄麻醉药品和精神药品，寄件人应当提交所在地设区的市级药品监督管理部门出具的准予邮寄证明。邮政营业机构应当查验、收存准予邮寄证明；没有准予邮寄证明的，邮政营业机构不得收寄。

When mailing narcotic drugs and psychotropic substances, the sender shall submit a mailing permit certificate issued by the drug regulatory department at the city divided into districts level where they are located. The postal service institution shall inspect and keep the mailing permit certificate; without a mailing permit certificate, the postal service institution shall not accept the mail.

省、自治区、直辖市邮政主管部门指定符合安全保障条件的邮政营业机构负责收寄麻醉药品和精神药品。邮政营业机构收寄麻醉药品和精神药品，应当依法对收寄的麻醉药品和精神药品予以查验。

The postal department of the province, autonomous region, or municipality directly under the Central Government shall designate postal service institutions that meet safety conditions to accept mail of narcotic drugs and psychotropic substances. When accepting mail of narcotic drugs and psychotropic substances, the postal service institution shall inspect the mailed narcotic drugs and psychotropic substances in accordance with the law.

邮寄麻醉药品和精神药品的具体管理办法，由国务院药品监督管理部门会同国务院邮政主管部门制定。

Specific management measures for mailing narcotic drugs and psychotropic substances shall be formulated by the drug regulatory department of the State Council jointly with the postal department of the State Council.

定点生产企业、全国性批发企业和区域性批发企业之间运输麻醉药品、第一类精神药品，发货人在发货前应当向所在地省、自治区、直辖市人民政府药品监督管理部门报送本次运输的相关信息。属于跨省、自治区、直辖市运输的，收到信息的药品监督管理部门应当向收货人所在地的同级药品监督管理部门通报；属于在本省、自治区、直辖市行政区域内运输的，收到信息的药品监督管理部门应当向收货人所在地设区的市级药品监督管理部门通报。

When transporting narcotic drugs and first-class psychotropic substances between designated production enterprises, national wholesale enterprises, and regional wholesale enterprises, the consignor shall, before dispatch, report the relevant information of this transport to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. If the transport crosses provinces, autonomous regions, or municipalities directly under the Central Government, the drug regulatory department receiving the information shall notify the drug regulatory department at the same level where the consignee is located; if the transport is within the administrative region of the same province, autonomous region, or municipality directly under the Central Government, the drug regulatory department receiving the information shall notify the drug regulatory department at the city divided into districts level where the consignee is located.

申请人提出本条例规定的审批事项申请，应当提交能够证明其符合本条例规定条件的相关资料。审批部门应当自收到申请之日起40日内作出是否批准的决定；作出批准决定的，发给许可证明文件或者在相关许可证明文件上加注许可事项；作出不予批准决定的，应当书面说明理由。

An applicant applying for approval of matters specified in these Regulations shall submit relevant materials that can prove compliance with the conditions of these Regulations. The approving department shall decide whether to approve within 40 days from the date of receiving the application; if approval is granted, a license document shall be issued or the licensed item shall be annotated on the relevant license document; if approval is denied, the reasons shall be provided in writing.

确定定点生产企业和定点批发企业，审批部门应当在经审查符合条件的企业中，根据布局的要求，通过公平竞争的方式初步确定定点生产企业和定点批发企业，并予公布。其他符合条件的企业可以自公布之日起10日内向审批部门提出异议。审批部门应当自收到异议之日起20日内对异议进行审查，并作出是否调整的决定。

When determining designated production enterprises and designated wholesale enterprises, the approving department shall, among enterprises that meet the conditions after review, preliminarily determine the designated production enterprises and designated wholesale enterprises through fair competition based on layout requirements, and publish them. Other qualified enterprises may raise objections to the approving department within 10 days from the date of publication. The approving department shall review the objections within 20 days from the date of receipt and decide whether to make adjustments.

药品监督管理部门应当根据规定的职责权限，对麻醉药品药用原植物的种植以及麻醉药品和精神药品的实验研究、生产、经营、使用、储存、运输活动进行监督检查。

Drug regulatory departments shall, in accordance with their prescribed duties and authorities, conduct supervision and inspection of the cultivation of narcotic drug raw plants and the experimental research, production, operation, use, storage, and transportation of narcotic drugs and psychotropic substances.

省级以上人民政府药品监督管理部门根据实际情况建立监控信息网络，对定点生产企业、定点批发企业和使用单位的麻醉药品和精神药品生产、进货、销售、库存、使用的数量以及流向实行实时监控，并与同级公安机关做到信息共享。

Drug regulatory departments at or above the provincial level shall, based on actual conditions, establish monitoring information networks to conduct real-time monitoring of the production, purchase, sales, inventory, usage quantities, and flow directions of narcotic drugs and psychotropic substances of designated production enterprises, designated wholesale enterprises, and user units, and share information with public security organs at the same level.

尚未连接监控信息网络的麻醉药品和精神药品定点生产企业、定点批发企业和使用单位，应当每月通过电子信息、传真、书面等方式，将本单位麻醉药品和精神药品生产、进货、销售、库存、使用的数量以及流向，报所在地设区的市级药品监督管理部门和公安机关；医疗机构还应当报所在地设区的市级人民政府卫生主管部门。

Designated production enterprises, designated wholesale enterprises, and user units of narcotic drugs and psychotropic substances that are not yet connected to the monitoring information network shall, on a monthly basis, report the production, purchase, sales, inventory, usage quantities, and flow directions of narcotic drugs and psychotropic substances of their units to the drug regulatory department and public security organ at the city divided into districts level where they are located via electronic information, fax, or written form; medical institutions shall also report to the health department of the people's government at the city divided into districts level where they are located.

设区的市级药品监督管理部门应当每3个月向上一级药品监督管理部门报告本地区麻醉药品和精神药品的相关情况。

Drug regulatory departments at the city divided into districts level shall report the relevant situation of narcotic drugs and psychotropic substances in their region to the higher-level drug regulatory department every 3 months.

对已经发生滥用，造成严重社会危害的麻醉药品和精神药品品种，国务院药品监督管理部门应当采取在一定期限内中止生产、经营、使用或者限定其使用范围和用途等措施。对不再作为药品使用的麻醉药品和精神药品，国务院药品监督管理部门应当撤销其药品批准文号和药品标准，并予以公布。

For varieties of narcotic drugs and psychotropic substances that have been abused and caused serious social harm, the drug regulatory department of the State Council shall take measures such as suspending production, operation, or use for a certain period, or limiting their scope and purpose of use. For narcotic drugs and psychotropic substances that are no longer used as drugs, the drug regulatory department of the State Council shall revoke their drug approval numbers and drug standards and publish them.

药品监督管理部门、卫生主管部门发现生产、经营企业和使用单位的麻醉药品和精神药品管理存在安全隐患时，应当责令其立即排除或者限期排除；对有证据证明可能流入非法渠道的，应当及时采取查封、扣押的行政强制措施，在7日内作出行政处理决定，并通报同级公安机关。

When drug regulatory departments or health departments discover potential safety hazards in the management of narcotic drugs and psychotropic substances by production enterprises, operation enterprises, or user units, they shall order immediate or timely elimination of the hazards; if there is evidence that the substances may flow into illegal channels, they shall promptly take administrative compulsory measures such as sealing or seizing, make an administrative decision within 7 days, and notify the public security organ at the same level.

药品监督管理部门发现取得印鉴卡的医疗机构未依照规定购买麻醉药品和第一类精神药品时，应当及时通报同级卫生主管部门。接到通报的卫生主管部门应当立即调查处理。必要时，药品监督管理部门可以责令定点批发企业中止向该医疗机构销售麻醉药品和第一类精神药品。

When a drug regulatory department discovers that a medical institution that has obtained a Seal Card has not purchased narcotic drugs and first-class psychotropic substances in accordance with regulations, it shall promptly notify the health department at the same level. The health department receiving the notice shall immediately investigate and handle the matter. If necessary, the drug regulatory department may order designated wholesale enterprises to suspend sales of narcotic drugs and first-class psychotropic substances to that medical institution.

麻醉药品和精神药品的生产、经营企业和使用单位对过期、损坏的麻醉药品和精神药品应当登记造册，并向所在地县级药品监督管理部门申请销毁。药品监督管理部门应当自接到申请之日起5日内到场监督销毁。医疗机构对存放在本单位的过期、损坏麻醉药品和精神药品，应当按照本条规定的程序向卫生主管部门提出申请，由卫生主管部门负责监督销毁。

Production enterprises, operation enterprises, and user units of narcotic drugs and psychotropic substances shall register expired or damaged narcotic drugs and psychotropic substances in a ledger and apply to the drug regulatory department at the county level where they are located for destruction. The drug regulatory department shall supervise the destruction on-site within 5 days from the date of receiving the application. For expired or damaged narcotic drugs and psychotropic substances stored in medical institutions, the medical institution shall apply to the health department in accordance with the procedures specified in this Article, and the health department shall be responsible for supervising the destruction.

对依法收缴的麻醉药品和精神药品，除经国务院药品监督管理部门或者国务院公安部门批准用于科学研究外，应当依照国家有关规定予以销毁。

Narcotic drugs and psychotropic substances legally confiscated shall be destroyed in accordance with relevant state regulations, except those approved by the drug regulatory department of the State Council or the public security department of the State Council for scientific research.

县级以上人民政府卫生主管部门应当对执业医师开具麻醉药品和精神药品处方的情况进行监督检查。

Health departments of people's governments at or above the county level shall conduct supervision and inspection of the prescribing of narcotic drugs and psychotropic substances by licensed physicians.

药品监督管理部门、卫生主管部门和公安机关应当互相通报麻醉药品和精神药品生产、经营企业和使用单位的名单以及其他管理信息。

Drug regulatory departments, health departments, and public security organs shall notify each other of the list of production enterprises, operation enterprises, and user units of narcotic drugs and psychotropic substances, as well as other management information.

各级药品监督管理部门应当将在麻醉药品药用原植物的种植以及麻醉药品和精神药品的实验研究、生产、经营、使用、储存、运输等各环节的管理中的审批、撤销等事项通报同级公安机关。

Drug regulatory departments at all levels shall notify public security organs at the same level of approvals, revocations, and other matters in the management of cultivation of narcotic drug raw plants and experimental research, production, operation, use, storage, and transportation of narcotic drugs and psychotropic substances.

麻醉药品和精神药品的经营企业、使用单位报送各级药品监督管理部门的备案事项，应当同时报送同级公安机关。

Operation enterprises and user units of narcotic drugs and psychotropic substances that submit record-filing matters to drug regulatory departments at all levels shall simultaneously submit them to public security organs at the same level.

发生麻醉药品和精神药品被盗、被抢、丢失或者其他流入非法渠道的情形的，案发单位应当立即采取必要的控制措施，同时报告所在地县级公安机关和药品监督管理部门。医疗机构发生上述情形的，还应当报告其主管部门。

If narcotic drugs and psychotropic substances are stolen, robbed, lost, or otherwise flow into illegal channels, the unit where the incident occurred shall immediately take necessary control measures and simultaneously report to the public security organ and drug regulatory department at the county level where it is located. If the above situation occurs in a medical institution, it shall also report to its competent department.

公安机关接到报告、举报，或者有证据证明麻醉药品和精神药品可能流入非法渠道时，应当及时开展调查，并可以对相关单位采取必要的控制措施。

When a public security organ receives a report or tip, or has evidence that narcotic drugs and psychotropic substances may flow into illegal channels, it shall promptly conduct an investigation and may take necessary control measures against relevant units.

药品监督管理部门、卫生主管部门以及其他有关部门应当配合公安机关开展工作。

Drug regulatory departments, health departments, and other relevant departments shall cooperate with public security organs in carrying out their work.

药品监督管理部门、卫生主管部门违反本条例的规定，有下列情形之一的，由其上级行政机关或者监察机关责令改正；情节严重的，对直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任：

If a drug regulatory department or health department violates the provisions of these Regulations in any of the following circumstances, its superior administrative organ or supervisory organ shall order correction; if the circumstances are serious, the directly responsible supervisor and other directly responsible personnel shall be given administrative sanctions in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law:

(一)对不符合条件的申请人准予行政许可或者超越法定职权作出准予行政许可决定的；

(1) Granting administrative permission to an applicant who does not meet the conditions or exceeding statutory authority to make a decision to grant administrative permission;

(二)未到场监督销毁过期、损坏的麻醉药品和精神药品的；

(2) Failing to supervise the destruction of expired or damaged narcotic drugs and psychotropic substances on-site;

(三)未依法履行监督检查职责，应当发现而未发现违法行为、发现违法行为不及时查处，或者未依照本条例规定的程序实施监督检查的；

(3) Failing to perform supervision and inspection duties according to law, failing to discover illegal acts that should have been discovered, failing to investigate and deal with discovered illegal acts in a timely manner, or failing to implement supervision and inspection in accordance with the procedures specified in these Regulations;

(四)违反本条例规定的其他失职、渎职行为。

(4) Other dereliction of duty or malfeasance in violation of these Regulations.

麻醉药品药用原植物种植企业违反本条例的规定，有下列情形之一的，由药品监督管理部门责令限期改正，给予警告；逾期不改正的，处5万元以上10万元以下的罚款；情节严重的，取消其种植资格：

If an enterprise cultivating narcotic drug raw plants violates the provisions of these Regulations in any of the following circumstances, the drug regulatory department shall order correction within a time limit and give a warning; if correction is not made within the time limit, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, its cultivation qualification shall be revoked:

(一)未依照麻醉药品药用原植物年度种植计划进行种植的；

(1) Failing to cultivate in accordance with the annual cultivation plan for narcotic drug raw plants;

(二)未依照规定报告种植情况的；

(2) Failing to report cultivation status in accordance with regulations;

(三)未依照规定储存麻醉药品的。

(3) Failing to store narcotic drugs in accordance with regulations.

定点生产企业违反本条例的规定，有下列情形之一的，由药品监督管理部门责令限期改正，给予警告，并没收违法所得和违法销售的药品；逾期不改正的，责令停产，并处5万元以上10万元以下的罚款；情节严重的，取消其定点生产资格：

If a designated production enterprise violates the provisions of these Regulations in any of the following circumstances, the drug regulatory department shall order correction within a time limit, give a warning, and confiscate illegal income and illegally sold drugs; if correction is not made within the time limit, order suspension of production, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if the circumstances are serious, its designated production qualification shall be revoked:

(一)未按照麻醉药品和精神药品年度生产计划安排生产的；

(1) Failing to arrange production in accordance with the annual production plan for narcotic drugs and psychotropic substances;

(二)未依照规定向药品监督管理部门报告生产情况的；

(2) Failing to report production status to the drug regulatory department in accordance with regulations;

(三)未依照规定储存麻醉药品和精神药品，或者未依照规定建立、保存专用账册的；

(3) Failing to store narcotic drugs and psychotropic substances in accordance with regulations, or failing to establish or keep special account books in accordance with regulations;

(四)未依照规定销售麻醉药品和精神药品的；

(4) Failing to sell narcotic drugs and psychotropic substances in accordance with regulations;

(五)未依照规定销毁麻醉药品和精神药品的。

(5) Failing to destroy narcotic drugs and psychotropic substances in accordance with regulations.

定点批发企业违反本条例的规定销售麻醉药品和精神药品，或者违反本条例的规定经营麻醉药品原料药和第一类精神药品原料药的，由药品监督管理部门责令限期改正，给予警告，并没收违法所得和违法销售的药品；逾期不改正的，责令停业，并处违法销售药品货值金额2倍以上5倍以下的罚款；情节严重的，取消其定点批发资格。

If a designated wholesale enterprise sells narcotic drugs and psychotropic substances in violation of these Regulations, or operates narcotic drug raw materials or first-class psychotropic substance raw materials in violation of these Regulations, the drug regulatory department shall order correction within a time limit, give a warning, and confiscate illegal income and illegally sold drugs; if correction is not made within the time limit, order suspension of business, and impose a fine of not less than 2 times but not more than 5 times the value of the illegally sold drugs; if the circumstances are serious, its designated wholesale qualification shall be revoked.

定点批发企业违反本条例的规定，有下列情形之一的，由药品监督管理部门责令限期改正，给予警告；逾期不改正的，责令停业，并处2万元以上5万元以下的罚款；情节严重的，取消其定点批发资格：

If a designated wholesale enterprise violates the provisions of these Regulations in any of the following circumstances, the drug regulatory department shall order correction within a time limit and give a warning; if correction is not made within the time limit, order suspension of business, and impose a fine of not less than 20,000 yuan but not more than 50,000 yuan; if the circumstances are serious, its designated wholesale qualification shall be revoked:

(一)未依照规定购进麻醉药品和第一类精神药品的；

(1) Failing to purchase narcotic drugs and first-class psychotropic substances in accordance with regulations;

(二)未保证供药责任区域内的麻醉药品和第一类精神药品的供应的；

(2) Failing to ensure the supply of narcotic drugs and first-class psychotropic substances within its responsible supply area;

(三)未对医疗机构履行送货义务的；

(3) Failing to fulfill the obligation to deliver drugs to medical institutions;

(四)未依照规定报告麻醉药品和精神药品的进货、销售、库存数量以及流向的；

(4) Failing to report the purchase, sales, inventory quantities, and flow directions of narcotic drugs and psychotropic substances in accordance with regulations;

(五)未依照规定储存麻醉药品和精神药品，或者未依照规定建立、保存专用账册的；

(5) Failing to store narcotic drugs and psychotropic substances in accordance with regulations, or failing to establish or keep special account books in accordance with regulations;

(六)未依照规定销毁麻醉药品和精神药品的；

(6) Failing to destroy narcotic drugs and psychotropic substances in accordance with regulations;

(七)区域性批发企业之间违反本条例的规定调剂麻醉药品和第一类精神药品，或者因特殊情况调剂麻醉药品和第一类精神药品后未依照规定备案的。

(7) Regional wholesale enterprises transferring narcotic drugs and first-class psychotropic substances in violation of these Regulations, or failing to report for record after transferring narcotic drugs and first-class psychotropic substances due to special circumstances.

第二类精神药品零售企业违反本条例的规定储存、销售或者销毁第二类精神药品的，由药品监督管理部门责令限期改正，给予警告，并没收违法所得和违法销售的药品；逾期不改正的，责令停业，并处5000元以上2万元以下的罚款；情节严重的，取消其第二类精神药品零售资格。

If a retail enterprise of second-class psychotropic substances stores, sells, or destroys second-class psychotropic substances in violation of these Regulations, the drug regulatory department shall order correction within a time limit, give a warning, and confiscate illegal income and illegally sold drugs; if correction is not made within the time limit, order suspension of business, and impose a fine of not less than 5,000 yuan but not more than 20,000 yuan; if the circumstances are serious, its retail qualification for second-class psychotropic substances shall be revoked.

本条例第三十四条、第三十五条规定的单位违反本条例的规定，购买麻醉药品和精神药品的，由药品监督管理部门没收违法购买的麻醉药品和精神药品，责令限期改正，给予警告；逾期不改正的，责令停产或者停止相关活动，并处2万元以上5万元以下的罚款。

If a unit specified in Articles 34 and 35 of these Regulations purchases narcotic drugs and psychotropic substances in violation of these Regulations, the drug regulatory department shall confiscate the illegally purchased narcotic drugs and psychotropic substances, order correction within a time limit, and give a warning; if correction is not made within the time limit, order suspension of production or relevant activities, and impose a fine of not less than 20,000 yuan but not more than 50,000 yuan.

取得印鉴卡的医疗机构违反本条例的规定，有下列情形之一的，由设区的市级人民政府卫生主管部门责令限期改正，给予警告；逾期不改正的，处5000元以上1万元以下的罚款；情节严重的，吊销其印鉴卡；对直接负责的主管人员和其他直接责任人员，依法给予降级、撤职、开除的处分：

If a medical institution that has obtained a Seal Card violates the provisions of these Regulations in any of the following circumstances, the health department of the people's government at the city divided into districts level shall order correction within a time limit and give a warning; if correction is not made within the time limit, a fine of not less than 5,000 yuan but not more than 10,000 yuan shall be imposed; if the circumstances are serious, its Seal Card shall be revoked; the directly responsible supervisor and other directly responsible personnel shall be given sanctions such as demotion, removal from office, or dismissal in accordance with the law:

(一)未依照规定购买、储存麻醉药品和第一类精神药品的；

(1) Failing to purchase or store narcotic drugs and first-class psychotropic substances in accordance with regulations;

(二)未依照规定保存麻醉药品和精神药品专用处方，或者未依照规定进行处方专册登记的；

(2) Failing to keep special prescriptions for narcotic drugs and psychotropic substances in accordance with regulations, or failing to register prescriptions in special registers in accordance with regulations;

(三)未依照规定报告麻醉药品和精神药品的进货、库存、使用数量的；

(3) Failing to report the purchase, inventory, and usage quantities of narcotic drugs and psychotropic substances in accordance with regulations;

(四)紧急借用麻醉药品和第一类精神药品后未备案的；

(4) Failing to report for record after urgently borrowing narcotic drugs and first-class psychotropic substances;

(五)未依照规定销毁麻醉药品和精神药品的。

(5) Failing to destroy narcotic drugs and psychotropic substances in accordance with regulations.

具有麻醉药品和第一类精神药品处方资格的执业医师，违反本条例的规定开具麻醉药品和第一类精神药品处方，或者未按照临床应用指导原则的要求使用麻醉药品和第一类精神药品的，由其所在医疗机构取消其麻醉药品和第一类精神药品处方资格；造成严重后果的，由原发证部门吊销其执业证书。执业医师未按照临床应用指导原则的要求使用第二类精神药品或者未使用专用处方开具第二类精神药品，造成严重后果的，由原发证部门吊销其执业证书。

If a licensed physician qualified to prescribe narcotic drugs and first-class psychotropic substances prescribes narcotic drugs and first-class psychotropic substances in violation of these Regulations, or uses narcotic drugs and first-class psychotropic substances not in accordance with the clinical application guidelines, the medical institution where he or she works shall revoke his or her qualification to prescribe narcotic drugs and first-class psychotropic substances; if serious consequences are caused, the original issuing department shall revoke his or her practice certificate. If a licensed physician uses second-class psychotropic substances not in accordance with the clinical application guidelines or does not use special prescriptions to prescribe second-class psychotropic substances, causing serious consequences, the original issuing department shall revoke his or her practice certificate.

未取得麻醉药品和第一类精神药品处方资格的执业医师擅自开具麻醉药品和第一类精神药品处方，由县级以上人民政府卫生主管部门给予警告，暂停其执业活动；造成严重后果的，吊销其执业证书；构成犯罪的，依法追究刑事责任。

If a licensed physician who is not qualified to prescribe narcotic drugs and first-class psychotropic substances arbitrarily prescribes narcotic drugs and first-class psychotropic substances, the health department of the people's government at or above the county level shall give a warning and suspend his or her practice activities; if serious consequences are caused, his or her practice certificate shall be revoked; if a crime is constituted, criminal liability shall be pursued in accordance with the law.

处方的调配人、核对人违反本条例的规定未对麻醉药品和第一类精神药品处方进行核对，造成严重后果的，由原发证部门吊销其执业证书。

If a prescription dispenser or checker fails to check prescriptions for narcotic drugs and first-class psychotropic substances in violation of these Regulations, causing serious consequences, the original issuing department shall revoke his or her practice certificate.

违反本条例的规定运输麻醉药品和精神药品的，由药品监督管理部门和运输管理部门依照各自职责，责令改正，给予警告，处2万元以上5万元以下的罚款。

If narcotic drugs and psychotropic substances are transported in violation of these Regulations, the drug regulatory department and the transport management department shall, within their respective duties, order correction, give a warning, and impose a fine of not less than 20,000 yuan but not more than 50,000 yuan.

收寄麻醉药品、精神药品的邮政营业机构未依照本条例的规定办理邮寄手续的，由邮政主管部门责令改正，给予警告；造成麻醉药品、精神药品邮件丢失的，依照邮政法律、行政法规的规定处理。

If a postal service institution that accepts mail of narcotic drugs and psychotropic substances fails to handle mailing procedures in accordance with these Regulations, the postal department shall order correction and give a warning; if the mail of narcotic drugs and psychotropic substances is lost, it shall be handled in accordance with postal laws and administrative regulations.

提供虚假材料、隐瞒有关情况，或者采取其他欺骗手段取得麻醉药品和精神药品的实验研究、生产、经营、使用资格的，由原审批部门撤销其已取得的资格，5年内不得提出有关麻醉药品和精神药品的申请；情节严重的，处1万元以上3万元以下的罚款，有药品生产许可证、药品经营许可证、医疗机构执业许可证的，依法吊销其许可证明文件。

Where a party obtains qualifications for experimental research, production, operation, or use of narcotic drugs and psychotropic substances by providing false materials, concealing relevant information, or using other deceptive means, the original approving authority shall revoke the obtained qualifications, and the party shall not apply for matters related to narcotic drugs and psychotropic substances within five years; if the circumstances are serious, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed; if the party holds a Drug Manufacturing License, Drug Distribution License, or Medical Institution Practice License, the license shall be revoked according to law.

药品研究单位在普通药品的实验研究和研制过程中，产生本条例规定管制的麻醉药品和精神药品，未依照本条例的规定报告的，由药品监督管理部门责令改正，给予警告，没收违法药品；拒不改正的，责令停止实验研究和研制活动。

Where a drug research unit, during the experimental research and development of ordinary drugs, produces narcotic drugs and psychotropic substances controlled under these Regulations and fails to report in accordance with these Regulations, the drug regulatory authority shall order correction, give a warning, and confiscate the illegal drugs; if the unit refuses to correct, it shall be ordered to cease the experimental research and development activities.

药物临床试验机构以健康人为麻醉药品和第一类精神药品临床试验的受试对象的，由药品监督管理部门责令停止违法行为，给予警告；情节严重的，取消其药物临床试验机构的资格；构成犯罪的，依法追究刑事责任。对受试对象造成损害的，药物临床试验机构依法承担治疗和赔偿责任。

Where a drug clinical trial institution uses healthy persons as subjects for clinical trials of narcotic drugs and Category I psychotropic substances, the drug regulatory authority shall order cessation of the illegal act and give a warning; if the circumstances are serious, the institution's qualification as a drug clinical trial institution shall be revoked; if a crime is constituted, criminal liability shall be pursued according to law. If harm is caused to the subjects, the drug clinical trial institution shall bear the costs of treatment and compensation according to law.

定点生产企业、定点批发企业和第二类精神药品零售企业生产、销售假劣麻醉药品和精神药品的，由药品监督管理部门取消其定点生产资格、定点批发资格或者第二类精神药品零售资格，并依照药品管理法的有关规定予以处罚。

Where a designated manufacturer, designated wholesaler, or Category II psychotropic substance retailer produces or sells counterfeit or substandard narcotic drugs or psychotropic substances, the drug regulatory authority shall revoke its designated manufacturing qualification, designated wholesale qualification, or Category II psychotropic substance retail qualification, and impose penalties in accordance with the relevant provisions of the Drug Administration Law.

定点生产企业、定点批发企业和其他单位使用现金进行麻醉药品和精神药品交易的，由药品监督管理部门责令改正，给予警告，没收违法交易的药品，并处5万元以上10万元以下的罚款。

Where a designated manufacturer, designated wholesaler, or other unit uses cash for transactions of narcotic drugs and psychotropic substances, the drug regulatory authority shall order correction, give a warning, confiscate the illegally traded drugs, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan.

发生麻醉药品和精神药品被盗、被抢、丢失案件的单位，违反本条例的规定未采取必要的控制措施或者未依照本条例的规定报告的，由药品监督管理部门和卫生主管部门依照各自职责，责令改正，给予警告；情节严重的，处5000元以上1万元以下的罚款；有上级主管部门的，由其上级主管部门对直接负责的主管人员和其他直接责任人员，依法给予降级、撤职的处分。

Where a unit that experiences theft, robbery, or loss of narcotic drugs or psychotropic substances fails to take necessary control measures or fails to report in accordance with these Regulations, the drug regulatory authority and the health authority shall, within their respective responsibilities, order correction and give a warning; if the circumstances are serious, a fine of not less than 5,000 yuan but not more than 10,000 yuan shall be imposed; if the unit has a superior authority, the superior authority shall impose demotion or removal from office on the directly responsible supervisor and other directly responsible personnel according to law.

依法取得麻醉药品药用原植物种植或者麻醉药品和精神药品实验研究、生产、经营、使用、运输等资格的单位，倒卖、转让、出租、出借、涂改其麻醉药品和精神药品许可证明文件的，由原审批部门吊销相应许可证明文件，没收违法所得；情节严重的，处违法所得2倍以上5倍以下的罚款；没有违法所得的，处2万元以上5万元以下的罚款；构成犯罪的，依法追究刑事责任。

Where a unit that has lawfully obtained qualifications for planting narcotic drug raw material plants or for experimental research, production, operation, use, or transport of narcotic drugs and psychotropic substances resells, transfers, rents, lends, or alters its license documents for narcotic drugs and psychotropic substances, the original approving authority shall revoke the corresponding license documents and confiscate illegal gains; if the circumstances are serious, a fine of not less than two times but not more than five times the illegal gains shall be imposed; if there are no illegal gains, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if a crime is constituted, criminal liability shall be pursued according to law.

违反本条例的规定，致使麻醉药品和精神药品流入非法渠道造成危害，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，由县级以上公安机关处5万元以上10万元以下的罚款；有违法所得的，没收违法所得；情节严重的，处违法所得2倍以上5倍以下的罚款；由原发证部门吊销其药品生产、经营和使用许可证明文件。

Where a violation of these Regulations causes narcotic drugs or psychotropic substances to flow into illegal channels and causes harm, if a crime is constituted, criminal liability shall be pursued according to law; if no crime is constituted, the public security authority at or above the county level shall impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if there are illegal gains, the illegal gains shall be confiscated; if the circumstances are serious, a fine of not less than two times but not more than five times the illegal gains shall be imposed; the original issuing authority shall revoke the drug production, operation, or use license documents.

药品监督管理部门、卫生主管部门在监督管理工作中发现前款规定情形的，应当立即通报所在地同级公安机关，并依照国家有关规定，将案件以及相关材料移送公安机关。

Where the drug regulatory authority or health authority discovers the circumstances specified in the preceding paragraph during supervision and administration, it shall immediately notify the public security authority at the same level in the locality, and transfer the case and relevant materials to the public security authority in accordance with state regulations.

本章规定由药品监督管理部门作出的行政处罚，由县级以上药品监督管理部门按照国务院药品监督管理部门规定的职责分工决定。

The administrative penalties to be imposed by the drug regulatory authority as provided in this Chapter shall be decided by the drug regulatory authority at or above the county level in accordance with the division of responsibilities prescribed by the drug regulatory authority under the State Council.

本条例所称实验研究是指以医疗、科学研究或者教学为目的的临床前药物研究。

For the purposes of these Regulations, 'experimental research' means preclinical drug research conducted for medical, scientific research, or teaching purposes.

药用类麻醉药品中的罂粟壳只能用于中药饮片和中成药的生产以及医疗配方使用。具体管理办法由国务院药品监督管理部门另行制定。

Poppy shells among medicinal narcotic drugs may only be used in the production of traditional Chinese medicine decoction pieces and Chinese patent medicines, as well as for medical prescription use. Specific management measures shall be separately formulated by the drug regulatory authority under the State Council.

生产含麻醉药品的复方制剂，需要购进、储存、使用麻醉药品原料药的，应当遵守本条例有关麻醉药品管理的规定。

Where a unit produces compound preparations containing narcotic drugs and needs to purchase, store, or use narcotic drug raw materials, it shall comply with the provisions of these Regulations on the administration of narcotic drugs.

非药用类麻醉药品和精神药品管理的具体办法，由国务院公安部门会同国务院药品监督管理部门、国务院卫生主管部门依据本条例制定。

Specific measures for the administration of non-medicinal narcotic drugs and psychotropic substances shall be formulated by the public security authority under the State Council jointly with the drug regulatory authority under the State Council and the health authority under the State Council in accordance with these Regulations.

军队医疗机构麻醉药品和精神药品的供应、使用，由国务院药品监督管理部门会同中央军事委员会后勤保障部依据本条例制定具体管理办法。

The supply and use of narcotic drugs and psychotropic substances in military medical institutions shall be subject to specific management measures formulated by the drug regulatory authority under the State Council jointly with the Logistics Support Department of the Central Military Commission in accordance with these Regulations.

对动物用麻醉药品和精神药品的管理，由国务院兽医主管部门会同国务院药品监督管理部门依据本条例制定具体管理办法。

The administration of narcotic drugs and psychotropic substances for veterinary use shall be subject to specific management measures formulated by the veterinary authority under the State Council jointly with the drug regulatory authority under the State Council in accordance with these Regulations.

本条例自2005年11月1日起施行。1987年11月28日国务院发布的《麻醉药品管理办法》和1988年12月27日国务院发布的《精神药品管理办法》同时废止。

These Regulations shall come into force as of November 1, 2005. The 'Measures for the Administration of Narcotic Drugs' promulgated by the State Council on November 28, 1987, and the 'Measures for the Administration of Psychotropic Substances' promulgated by the State Council on December 27, 1988, shall be simultaneously abolished.