《麻醉药品和精神药品管理条例》已经2005年7月26日国务院第100次常务会议通过，现予公布，自2005年11月1日起施行。

总理：温家宝
2005年8月3日

麻醉药品和精神药品管理条例

　　第一章　总则

　　第一条　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。

　　第二条　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。

　　麻醉药品和精神药品的进出口依照有关法律的规定办理。

　　第三条　本条例所称麻醉药品和精神药品，是指列入麻醉药品目录、精神药品目录（以下称目录）的药品和其他物质。精神药品分为第一类精神药品和第二类精神药品。

　　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。

　　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会同国务院公安部门、国务院卫生主管部门应当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。

　　第四条　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。

　　第五条　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。

　　省、自治区、直辖市人民政府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。

　　第六条　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。

　　第二章　种植、实验研究和生产

　　第七条　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。

　　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。

　　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。

　　第八条　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。

　　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。

　　第九条　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。

　　第十条　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：

　　（一）以医疗、科学研究或者教学为目的；

　　（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；

　　（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。

　　第十一条　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。

　　第十二条　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。

　　第十三条　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。

　　第十四条　国家对麻醉药品和精神药品实行定点生产制度。

　　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。

　　第十五条　麻醉药品和精神药品的定点生产企业应当具备下列条件：

　　（一）有药品生产许可证；

　　（二）有麻醉药品和精神药品实验研究批准文件；

　　（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；

　　（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；

　　（五）有保证麻醉药品和精神药品安全生产的管理制度；

　　（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；

　　（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；

　　（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；

　　（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。

　　第十六条　从事麻醉药品、第一类精神药品生产以及第二类精神药品原料药生产的企业，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初步审查，由国务院药品监督管理部门批准；从事第二类精神药品制剂生产的企业，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。

　　第十七条　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。

　　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。

　　未取得药品批准文号的，不得生产麻醉药品和精神药品。

　　第十八条　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。

　　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。

　　第十九条　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。

　　第二十条　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。

　　第二十一条　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。

　　第三章　经营

　　第二十二条　国家对麻醉药品和精神药品实行定点经营制度。

　　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。

　　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。

　　第二十三条　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第十五条规定的药品经营企业的开办条件外，还应当具备下列条件：

　　（一）有符合本条例规定的麻醉药品和精神药品储存条件；

　　（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；

　　（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；

　　（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。

　　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。

　　第二十四条　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。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。

　　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。

　　第二十五条　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。

　　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。

　　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。

　　第二十六条　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，应当经国务院药品监督管理部门批准。

　　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。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。

　　第二十七条　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。

　　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。

　　第二十八条　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。

　　第二十九条　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。

　　第三十条　麻醉药品和第一类精神药品不得零售。

　　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。

　　第三十一条　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。

　　第三十二条　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。

　　第三十三条　麻醉药品和精神药品实行政府定价，在制定出厂和批发价格的基础上，逐步实行全国统一零售价格。具体办法由国务院价格主管部门制定。

　　第四章　使用

　　第三十四条　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。

　　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。

　　第三十五条　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。

　　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。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。

　　第三十六条　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。

　　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。

　　第三十七条　医疗机构取得印鉴卡应当具备下列条件：

　　（一）有专职的麻醉药品和第一类精神药品管理人员；

　　（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；

　　（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。

　　第三十八条　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。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。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。

　　第三十九条　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。

　　第四十条　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。

　　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。

　　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。

　　第四十一条　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。

　　第四十二条　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。

　　第四十三条　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。

　　第四十四条　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。

　　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。

　　第四十五条　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。

　　第五章　储存

　　第四十六条　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：

　　（一）安装专用防盗门，实行双人双锁管理；

　　（二）具有相应的防火设施；

　　（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。

　　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。

　　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。

　　第四十七条　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。

　　第四十八条　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。

　　第四十九条　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。

　　第六章　运输

　　第五十条　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。

　　第五十一条　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。

　　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。

　　第五十二条　托运或者自行运输麻醉药品和第一类精神药品的单位，应当向所在地省、自治区、直辖市人民政府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。

　　运输证明应当由专人保管，不得涂改、转让、转借。

　　第五十三条　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。

　　承运人在运输过程中应当携带运输证明副本，以备查验。

　　第五十四条　邮寄麻醉药品和精神药品，寄件人应当提交所在地省、自治区、直辖市人民政府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。

　　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。

　　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。

　　第五十五条　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。

　　第七章　审批程序和监督管理

　　第五十六条　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。

　　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。

　　第五十七条　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。

　　第五十八条　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。

　　第五十九条　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。

　　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。

　　第六十条　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。

　　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。

　　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。

　　第六十一条　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。

　　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。

　　第六十二条　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。

　　第六十三条　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。

　　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。

　　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。

　　第六十四条　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。

　　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。

　　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。

　　第八章　法律责任

　　第六十五条　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：

　　（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；

　　（二）未到场监督销毁过期、损坏的麻醉药品和精神药品的；

　　（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；

　　（四）违反本条例规定的其他失职、渎职行为。

　　第六十六条　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：

　　（一）未依照麻醉药品药用原植物年度种植计划进行种植的；

　　（二）未依照规定报告种植情况的；

　　（三）未依照规定储存麻醉药品的。

　　第六十七条　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：

　　（一）未按照麻醉药品和精神药品年度生产计划安排生产的；

　　（二）未依照规定向药品监督管理部门报告生产情况的；

　　（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；

　　（四）未依照规定销售麻醉药品和精神药品的；

　　（五）未依照规定销毁麻醉药品和精神药品的。

　　第六十八条　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。

　　第六十九条　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：

　　（一）未依照规定购进麻醉药品和第一类精神药品的；

　　（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；

　　（三）未对医疗机构履行送货义务的；

　　（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；

　　（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；

　　（六）未依照规定销毁麻醉药品和精神药品的；

　　（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。

　　第七十条　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。

　　第七十一条　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。

　　第七十二条　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：

　　（一）未依照规定购买、储存麻醉药品和第一类精神药品的；

　　（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；

　　（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；

　　（四）紧急借用麻醉药品和第一类精神药品后未备案的；

　　（五）未依照规定销毁麻醉药品和精神药品的。

　　第七十三条　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。

　　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。

　　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。

　　第七十四条　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。

　　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。

　　第七十五条　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。

　　第七十六条　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。

　　第七十七条　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。

　　第七十八条　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。

　　第七十九条　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。

　　第八十条　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。

　　第八十一条　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。

　　第八十二条　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。

　　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。

　　第八十三条　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。

　　第九章　附则

　　第八十四条　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。

　　经批准可以开展与计划生育有关的临床医疗服务的计划生育技术服务机构需要使用麻醉药品和精神药品的，依照本条例有关医疗机构使用麻醉药品和精神药品的规定执行。

　　第八十五条　麻醉药品目录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。

　　第八十六条　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。

　　第八十七条　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国人民解放军总后勤部依据本条例制定具体管理办法。

　　第八十八条　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。

　　第八十九条　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。

　　Regulations on the Control of Anesthetic¹ and Psychoactive Drugs
Augest 3,2005

　　Chapter I General Provision

　　Article 1 These regulations are formulated³ according to the provision of Law on Pharmaceutical⁴ Administration and related laws for the purpose of enhancing the control of anesthetic and psychoactive drugs, ensure their legal, safe and rational use and prevent them from flowing to illegal channels.

　　Article 2 These regulations will apply to the cultivation⁵ of medical original plans of anesthetic drugs, experimental research, production, distribution, use, storage and transport operations and supervision⁶ and management of anesthetic and psychoactive drugs.

　　The import and export of anesthetic and psychoactive drugs shall be conducted according to relative laws and regulations.

　　Article 3 “Anesthetic and psychoactive drugs” used in these regulations refer to the drugs and other substances listed in the catalogues of anesthetic and psychoactive drugs （hereinafter referred to as catalogue（s））. The psychoactive drugs are divided into the first class psychoactive drugs and the second class psychoactive drugs.

　　The catalogues shall be formulated, adjusted and publicized jointly⁸ by the drug regulatory department, public security department and health department under the State Council.

　　If abuse of any drug and other substance not listed into the catalogues but sold in the market or any psychoactive drug occurs, already caused of has the potential to cause serious harm to the society, the drug regulatory department under the State Council shall cooperate with the public security department and health department under the State Council to list this drug or substance into the catalogue or adjust the second class psychoactive drug as the first class psychoactive drug.

　　Article 4 The state enforces control over the original medical plants used as anesthetic drugs as well as anesthetic and psychoactive drugs. Unless otherwise stipulated⁹ in these regulations, any institution and individual should not cultivate original medical plants used as anesthetic drugs or conduct experimental research, production, business, use, storage and transport of anesthetic and psychoactive drugs.

　　Article 5 The regulatory department under the State Council shall be responsible for the supervision and management of the anesthetic and psychoactive drugs of the whole country and cooperate with the competent agricultural department under the State Council to conduct supervision and management over the original medical plants used as anesthetic drugs. The public security department under the State Council takes charge of finding out and dealing¹⁰ with the behavior causing original medical plants used as anesthetic drugs and anesthetic and psychoactive drugs to flow into illegal channels. Other competent departments under the State Council shall be responsible for the administration works with relation to anesthetic and psychoactive drugs in their respective terms of reference.

　　The drug regulatory department of provinces, autonomous¹¹ regions and municipalities shall be responsible for the supervision and management of anesthetic and psychoactive drugs in their administrative¹² areas. Local public security department above county level shall be responsible for finding out and dealing with the behavior causing original medical plants used as anesthetic drugs and anesthetic and psychoactive drugs to flow into illegal channels in their respective district. Other competent administrative departments under local governments above county level shall be responsible for the administration works with relation to anesthetic and psychoactive drugs in their respective terms of reference.

　　Article 6 The producing and distribution enterprises and users of anesthetic and psychoactive drugs can take part in trade associations. The trade associations shall enhance self-discipline and management.

　　Chapter II Cultivation, Experimental Research and Production

　　Article 7 The state will determine the total amount in need according to the demand of raw materials of anesthetic and psychoactive drugs for medical treatment, state reserve and enterprise production and impose total amount control over the cultivation of the original medical plants used as anesthetic drugs and production of anesthetic and psychoactive drugs.

　　The drug regulatory department of the State Council shall formulate² annual production plan according the total demand for the anesthetic and psychoactive drugs.

　　The drug regulatory department and the competent agricultural department under the State Council shall formulate annual cultivation plan of the original medical plants used as anesthetic drugs according the to annual production plan of anesthetic drugs.

　　Article 8 Enterprises cultivating original medical plants used as anesthetic drugs should cultivate the original medical plants used as anesthetic drugs according to the annual cultivation plan.

　　Enterprises cultivating original medical plants used as anesthetic drugs should submit reports on the cultivation regularly to the drug regulatory department and the competent agricultural department under the State Council.

　　Article 9 Enterprises cultivating original medical plants used as anesthetic drugs shall be determined¹³ by the regulatory department and the competent agricultural department under the State Council, and other organizations and individuals should not cultivate any original medical plant used as anesthetic drug.

　　Article 10 Experimental research of anesthetic and psychoactive drugs should be conducted subject to the following conditions and approval of the regulatory department under the State Council.

　　（I） for the purpose of medical treatment, scientific research or education;

　　（II） with measures and management system ensuring the safety of the anesthetic and psychoactive drugs in experiment;

　　（III） the institution or its staff involved in the research has no behavior violating laws or administrative regulations on drug prohibition¹⁴ within 2 years.

　　Article 11 Institutions engaged in experimental research of anesthetic and psychoactive drugs shall apply for approval and certification documents according to the provisions of the Law on Pharmaceutical Administration; and assignment of the research achievements shall be approved by the drug regulatory department under the State Council.

　　Article 12 Drug research institutions engaged in experimental research of common drugs should stop their research activities immediately once finding drug varieties controlled by these regulations are generated in the process of their research and report to the drug regulatory department under the State Council. The drug regulatory department under the State Council shall make decision on whether they could continue the experimental research timely according to the actual situation.

　　Article 13 Clinic tests of anesthetic drugs and the first class psychoactive drugs should not be made on healthy people.

　　Article 14 The state shall appointed special manufacturers to produce anesthetic and psychoactive drugs.

　　The drug regulatory department under the State Council shall decide the quantity and distribution of the appointed manufacturers producing anesthetic and psychoactive drugs according to the total demand of anesthetic and psychoactive drugs, and adjust and publicize the quantity and distribution based on annual total demand.

　　Article 15 The appointed manufacturers producing anesthetic and psychoactive drugs shall meet the following conditions:

　　（I） holding drug production license¹⁵;

　　（II） holding approval documents on experimental research of anesthetic and psychoactive drugs;

　　（III） having qualified¹⁶ production equipment, storage condition and corresponding safety management facilities meeting the provisions for production of anesthetic and psychoactive drugs;

　　（IV） having the ability to carry out safety management of production and report production information to drug regulatory department through network;

　　（V） having safety management system on production of anesthetic and psychoactive drugs;

　　（VI） having management competency and business scale meeting the requirements to safety production of anesthetic and psychoactive drugs;

　　（VII） with staff responsible for production management and quality management of anesthetic and psychoactive drugs knowing well the management of anesthetic and psychoactive drugs and laws and administrative rules and regulations on drug prohibition;

　　（VIII） without behaviors with relation to producing and selling counterfeit¹⁸ drugs or violating laws and administrative rule and regulations on drug prohibition;

　　（IX） according with the requirement on the number and distribution of the appointed enterprises to producing anesthetic and psychoactive drugs publicized by the drug regulatory department under the State Council.

　　Article 16 The enterprises producing anesthetic drugs and the first class psychoactive drugs and enterprises producing raw materials of the second class psychoactive drug shall be primarily examined by local drug regulatory departments under the governments of provinces, autonomous regions or municipalities, and approved by the drug regulatory department under the State Council; the enterprises producing the second class psychoactive drugs shall be approved by the drug regulatory department under the governments of local provinces, autonomous regions and municipalities.

　　Article 17 Appointed enterprises to produce anesthetic and psychoactive drugs should get registered number of approval according to the provisions of the Law on Pharmaceutical Administration.

　　The drug regulatory department under the State Council shall organize expert group composed of experts on medicine, drugs, sociology, ethnics¹⁹ and drug prohibition etc. to make assessment²⁰ on the social harm and the abuse possibility of the anesthetic and psychoactive drugs initially²¹ applied²² for entering into market, and provide recommendations on approval or not.

　　Without the registered number of approval, no enterprise would be permitted to produce anesthetic and psychoactive drugs.

　　Article 18 In case serious emergency incident stopped an enterprise's normal production or made the manufacturer unable to ensure supply of anesthetic and psychoactive drugs, the drug regulatory department under the State Council can assign another drug producing enterprise to produce anesthetic and psychoactive drugs,

　　Once the serious emergency incident passed, the drug regulatory department under the State Council shall immediately decide the enterprises assigned according to above item to stop producing anesthetic and psychoactive drugs.

　　Article 19 The appointed drug producing enterprises shall arrange production strictly²³ according to the annual production plan of anesthetic and psychoactive drugs and provide reports according to the provisions on the situation of production to the drug regulatory departments under the peoples governments of local provinces, autonomous regions and municipalities.

　　Article 20 According to the provision of these regulations, the appointed producing enterprises shall sell anesthetic and psychoactive drugs to the enterprises with competency to distribute anesthetic and psychoactive drugs or other entities²⁴ approved according to the provision of these regulations.

　　Article 21 The labels of anesthetic and psychoactive drugs shall be printed with the marks prescribed by the drug regulatory department under the State Council.

　　Chapter III Distribution

　　Article 22 The state implements²⁵ appointed distribution system on anesthetic and psychoactive drugs.

　　The drug regulatory department under the State Council shall confirm the overall arrangement of the appointed enterprises involved in wholesale²⁶ of anesthetic drugs and the first class psychoactive drugs based on the total demand for anesthetic drugs and the first class psychoactive drugs and readjust and publicize the arrangement based on annual total demand.

　　Drug distributors should not distribute the raw materials of anesthetic drugs and the raw materials of the first class psychoactive drugs. But above mentioned drugs in small package used in medical treatment, scientific research and teaching can be distributed by the drug wholesale enterprises appointed the drug regulatory department under the State Council.

　　Article 23 In addition to the conditions for drug distribution requirements stipulated in article 15 of the Drug Administration Law, the appointed wholesalers of anesthetic and psychoactive drugs also should meet the following requirements:

　　（I） having the condition for storing anesthetic and psychoactive drugs meeting the provisions of these regulations;

　　（II） having the ability to carry out safety management of the enterprise and report production information to drug regulatory department through network;

　　（III） without behavior of the enterprise and its staff violating the laws and administrative rules and regulations with relation to drug prohibition within 2 years;

　　（IV） according with the overall arrangement of the appointed wholesale enterprises publicized by the regulatory department under the State Council.

　　The appointed wholesale enterprises of anesthetic drugs and the first class psychoactive drugs also should have the ability to ensure the supply of anesthetic and the first class psychoactive drugs to the medical institutions in their responsible areas and having the management system to ensure safe distribution of anesthetic and the firs class psychoactive drugs.

　　Article 24 Enterprises involved in inter-province, autonomous region and municipality wholesale of anesthetic drugs and the first class psychoactive drugs （hereinafter referred to as national wholesalers） shall get approval of the drug regulatory department under the State Council; enterprises involved in wholesale of anesthetic drugs and the first class psychoactive drugs in the administrative areas of local provinces, autonomous regions and municipalities （hereinafter referred to as regional wholesalers） shall get approval of the drug regulatory departments under the people's government of the local provinces, autonomous regions and municipalities.

　　Enterprises specialized²⁷ in the wholesale of the second class psychoactive drugs shall get approval of the drug regulatory departments under the people's governments of local provinces, autonomous regions and municipalities. The national wholesalers and regional wholesalers can be involved in wholesale of the second class psychoactive drugs.

　　Article 25 The national wholesalers can distribute anesthetic drugs and the first class psychoactive drugs to the regional wholesalers, or as approved to those medical institutions with qualification to use anesthetic drugs and the first class psychoactive drugs and other institutions as approved according to these regulations.

　　To distribute anesthetic drugs and the first class psychoactive drugs to the medical institutions with qualification to use anesthetic drugs and the first class psychoactive drugs, the national wholesalers shall get approval of the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities where the medical institutions are located.

　　When approving the national wholesalers, the drug regulatory department under the State Council shall define the areas where they bear the responsibilities to supply the drugs.

　　Article 26 The national wholesalers can distribute anesthetic drugs and the first class psychoactive drugs to those medical institutions which have got qualification to use anesthetic drugs and the first class psychoactive drugs within the administrative areas of local provinces, autonomous regions and municipalities; Distribution of anesthetic drugs and the first class psychoactive drugs to those medical institutions which have got qualification to use these drugs in the nearby administrative areas of other provinces, autonomous regions and municipalities in consideration of the special geographical²⁸ locations should be approved by the drug regulatory department under the State Council.

　　When approving the regional drug wholesalers, the drug regulatory departments under the people's governments of provinces, autonomous regions and municipalities shall define the areas where they bear the responsibilities to supply the drugs. In case it is necessary to for regional wholesalers to distribute each other anesthetic drugs and the first class psychoactive drugs because of emergency need in medical treatment or difficulty in transportation and other special circumstances, such distribution should be reported respectively to the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities they are located for record.

　　Article 27 The national wholesalers shall purchase anesthetic drugs and the first class psychoactive drugs from the local appointed producers.

　　The regional wholesalers can purchase anesthetic drugs and the first class psychoactive drugs from the national wholesalers; as approved by the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities they are located, the regional wholesalers also can purchase anesthetic drugs and the first class psychoactive drugs from the local appointed producers.

　　Article 28 The national wholesalers and regional wholesalers who distribute anesthetic drugs and the first class psychoactive drugs to medical institutions should send the drugs to the medical institutions. The medical institutions should not pick up the goods by themselves.

　　Article 29 The appointed wholesalers of the second class psychoactive drugs can distribute the second class psychoactive drugs to medical institutions, appointed wholesalers and drug retailers³⁰ meeting the provisions prescribed by Article 31 of these regulations and other institutions as approved based on the provisions of these regulations.

　　Article 30 Anesthetic drugs and the first class psychoactive drugs cannot be retailed³¹.

　　It should be prohibited to trade anesthetic drugs and psychoactive drugs with cash except individuals buy anesthetic drugs and psychoactive drugs.

　　Article 31 As approved by local drug regulatory departments at city level, the chained retailers with unified³² purchase, unified distribution and unified management can retail²⁹ the second class psychoactive drugs.

　　Article 32 The retailers of the second class psychoactive drugs should sell the second class psychoactive drugs according to the descriptions of certified³³ physicians and based on the defined dosage and keep the descriptions for 2 year for check; over dosage or non-description sales of the second class psychoactive drugs are prohibited; the second class psychoactive drugs should not be sold to juveniles³⁴.

　　Article 33 Anesthetic drugs and psychoactive drugs shall be priced by the government. On the basis of defined ex-factory prices and wholesale prices, the retailing³⁵ prices shall be gradually unified in the whole country. The specific measures with be stipulated by the competent pricing department under the State Council.

　　Chapter IV Use

　　Article 34 The drug producing enterprises that need to produce common drugs with anesthetic drugs and psychoactive drugs as raw materials should submit plans of annual demand to the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities where they are located. The drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities shall collect the plans and report them to the drug regulatory department under the State Council for approval before permitting the producer to purchase from the appointed producing enterprises.

　　The drug producing enterprises that need to produce common drugs with the second class psychoactive drugs as raw materials should submit plans of annual demand to the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities where they are located before purchasing from appointed wholesalers or appointed producing enterprises.

　　Article 35 The enterprises producing non-drug products like foodstuffs³⁶, food additives³⁷, cosmetics³⁸ and paints etc with caffeine as raw materials shall get approval of the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities where they are located before purchasing from appointed wholesalers or appointed producing enterprises.

　　The scientific research and teaching institutions that need to use anesthetic drugs and psychoactive drugs for experiments and teaching activities shall get approval of the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities where they are located before purchasing from appointed wholesalers or appointed producing enterprises. The institutions that need to use anesthetic drugs and psychoactive drugs for standard and comparison shall get approval of the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities where they are located and then purchase them from the institutions approved by the drug regulatory departments under the State Council.

　　Article 36 The medical institutions that need to use anesthetic drugs and the first class psychoactive drugs shall get approval of the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities where they are located and obtain the signature card for purchase and use of anesthetic drugs and the first class psychoactive drugs （hereinafter referred to as signature card）. Medical institutions should show the signatures cards for buy anesthetic drugs and the first class psychoactive drugs from the appointed wholesale enterprises in the provinces, autonomous regions and municipalities they are located.

　　When issuing signature card to an medical institution, the competent department under the people's government of a city with districts should send the information about the medical institution to the drug regulatory department under the people's government of the city with district where the medical institution is located, and report it to the drug regulatory department under the people's government of the province, autonomous region or municipality for record. The drug regulatory department under the people's government of the province, autonomous region or municipality for record shall notice the list of medical institutions with signature cards to the ass⁷ appointed wholesalers of drugs within their administrative areas.

　　Article 37 To get signature card, a medical institutions should meet following requirements:

　　（I） having full time persons to manage anesthetic drugs and the first class psychoactive drugs;

　　（II） having certified physicians with competency to prescribe anesthetic drugs and the first class of psychoactive drugs;

　　（III） having facility and management system to ensure safety storage of anesthetic drugs and the first class psychoactive drugs.

　　Article 38 Medical institutions shall provide training and examination to the certified physicians of their units on use of anesthetic drugs and psychoactive drugs. The certified physicians passing the examinations shall be invested with the competency to prescribe anesthetic drugs and the first class psychoactive drugs. Only getting the competency to prescribe anesthetic drugs and the first class psychoactive drugs can a certified physician prescribe anesthetic drugs and the first class psychoactive drugs in his medical institution, but cannot prescribe such drugs for himself. Medical institutions shall keep the lists of certified physicians with competency to prescribe anesthetic drugs and the first class psychoactive drugs and the information about their change and report them regularly to the competent health department under local people's government at city level and copy them to the drug regulatory department at the same level. Medical staff shall use anesthetic drugs and psychoactive drugs according to the guideline for clinic use stipulated by the competent health department under the State Council.

　　Article 39 The certified physicians with competency to prescribe anesthetic drugs and the first class psychoactive drugs should meet the rational dosage demands of the patients who need to use anesthetic drugs or the first class psychoactive drugs according the guideline of clinic use. In case the patients in pain of cancer or serious case in the medical institutions cannot get necessary anesthetic drugs or the first class psychoactive drugs, the patients or their families can apply to the certified physicians. If the certified physicians with competency to prescribe anesthetic drugs and the first class psychoactive drugs think it is reasonable to use, he should provide the patients anesthetic drugs or the first class psychoactive drugs they need.

　　Article 40 Certified physicians should prescribe anesthetic drugs and psychoactive drugs with specialized prescription³⁹ papers; the maximum dosage of a single prescription should accord with the provision of the competent health department under the State Council.

　　The preparing and checking staff should carefully check, sign and register the prescriptions⁴⁰ of anesthetic and the first class psychoactive drugs; if there is any inconsistence with these regulations, the preparing and checking staff should refuse to deliver the drugs.

　　The format¹⁷ of the specialized prescription of anesthetic drugs and psychoactive drugs shall be formulated by the competent health department of the State Council.

　　Article 41 Medical institutions shall register the prescriptions of anesthetic drugs and psychoactive drugs respectively and enhance their management. The prescriptions of anesthetic drugs shall be kept for at least 3 years, and the prescriptions of psychoactive drugs shall be kept for at least 2 years.

　　Article 42 In case a medical institution is in urgent need to use anesthetic drugs and the first class psychoactive drugs to give emergency treatment to a patient but could not provide, such drugs can be borrowed from other medical institutions or appointed wholesalers. After the emergency treatment completed, the information about the borrowing should be reported to the drug regulatory department and the competent health department of the city with districts for record.

　　Article 43 If the medical institutions with drug preparation licenses⁴¹ and signature cards need to prepare anesthetic drugs and psychoactive drugs in urgent need because there are no such drugs in the market, they should get approval of the drug regulatory departments under the people's governments of provinces, autonomous regions and municipalities they are located. The anesthetic and psychoactive drugs prepared by medical institutions can be used only in their own institutions but cannot be sold out.

　　Article 44 For the need to treat diseases, individuals can take anesthetic and the firs class psychoactive drugs of the maximum dosage of a single prescription along with medical diagnosis⁴² certificates opened by medical institutions and individual IDs. The customs shall give clearance⁴³ to the entry and exit of the anesthetic drugs and the first class psychoactive drugs taken by individuals according to the principles of self-use and rationality.

　　To bring in or out small amount of anesthetic drugs and psychoactive drugs for medical treatment, medical personnel should exhibit the certificates of bringing anesthetic drugs and psychoactive drugs issued by the drug regulatory departments under the people's governments above provincial⁴⁴ level. The customs shall give clearance to the entry and exit of them according to the certificates.

　　Article 45 For the purpose of drug-relief, the medical institutions and drug-relief institutions can use Methadone or other anesthetic and psychoactive drug used for drug-relief determined by the state. The specific management measures shall be stipulated by the drug regulatory department, the public security department and the competent health department under the State Council.

　　Chapter V Storage

　　Article 46 Original medical plants cultivation enterprises, appointed production enterprises, national wholesale enterprises, regional wholesale enterprises and the state established storage units of anesthetic drugs shall arrange specialized warehouses⁴⁵ to store anesthetic drugs and the first class psychoactive drugs. The specialized warehouses should meet the following requirements:

　　（I） equipped with specialized burglarproof doors locked with two locks and managed by two persons;

　　（II） equipped with proper fire-proof facilities;

　　（III） equipped with monitoring and warning devices connected on line with the warning system of local public security departments.

　　The drug storage points established by the national wholesale enterprises as approved by the drug regulatory department under the State Council shall comply with the provision of above item.

　　The appointed production enterprises of anesthetic drugs shall store the raw materials and the products respectively.

　　Article 47 The units using anesthetic drugs and the first class of psychoactive drugs shall arranged specialized warehouses or cabinets to store anesthetic drugs and the first class of psychoactive drugs. The specialized warehouses should be equipped with antitheft and warning devices; the specialized cabinets should have strong boxes. The specialized warehouses and cabinets should be locked with two locks and managed by two persons.

　　Article 48 Original medical plants cultivation enterprises, appointed production enterprises, national wholesale enterprises, regional wholesale enterprises, the state established storage units of anesthetic drugs and the units using anesthetic drugs and the first class psychoactive drugs shall staffed with specialized management persons and establish specialized account books for the inventory⁴⁶ of anesthetic drugs and the first class psychoactive drugs. The warehousing drugs should be inspected by two persons and the discharge of the warehouses should be checked by two persons too to ensure goods to accord with the account. The account books should be kept for at least 5 years after expiration⁴⁷ of the validity of the drugs.

　　Article 49 The distribution enterprises of the second class psychoactive drugs shall arranged specialized warehouses or cabinets to store the second class psychoactive drugs and registered in specialized account books under the management of specialized persons. The specialized account books should be kept for at least 5 years after expiration of the validity of the drugs.

　　Chapter VI Transportation

　　Article 50 Consignment⁴⁹, carriage and self-transport of anesthetic drugs and psychoactive drugs should adopt safety and insurance measure to prevent anesthetic drugs and psychoactive drugs from being theft, robbed or lost in the process of transportation.

　　Article 51 Transportation of anesthetic drugs and the first class psychoactive drugs through railway should use containers or the luggage vans. The specific measures shall be stipulated by the drug regulatory department under the State Council with the competent railway department under the State Council.

　　Transportation of anesthetic drugs and the first class of psychoactive drugs through highway or waterway because there is no railway should be escorted by specialized persons.

　　Article 52 The units planning to consign⁴⁸ the transportation of anesthetic drugs and the first class psychoactive drugs or transport them by themselves shall apply to the drug regulatory departments under the people's governments of provinces, autonomous regions and municipalities they are located for certificates of the transportation. The validity period of the certificate is 1 year.

　　The transportation certificate should be kept by specialized persons; alteration⁵⁰, transference or subtenancy are prohibited.

　　Article 53 To go through the formalities for the transportation of anesthetic drugs and the firs class psychoactive drugs, the consignors should submit the copies of the transportation certificate to the carriers. The carriers shall check, accept and keep the copies of transportation certificates and inspect the package of goods. If transportation certificates are not provided or the package does not meet the requirements, the carrier should refuse to transport.

　　In the process of transportation, the carriers should bring about the copies of transportation certificates for check.

　　Article 54 To mail anesthetic drugs and psychoactive drugs through postal⁵¹ service, the consignors should exhibit the mail-permitting certificates opened by the drug regulatory departments under the people's governments of the provinces, autonomous regions and municipalities they are located. The postal services agencies shall check, accept and keep the mail-permitting certificates. If there is no mail-permitting certificate, the postal service agencies shall refuse to accept and mail the drugs.

　　The drug regulatory departm

上一篇：企业财产损失所得税前扣除管理办法 下一篇：中国保险监督管理委员会关于印发《保险外汇资金境外运用管理暂行