食品药品监管总局办公厅关于进一步加强麻黄草药品生产经营管理的通知
食品药品监管总局办公厅关于进一步加强麻黄草药品生产经营管理的通知
食药监办药化监〔2013〕84号
2013年10月10日 发布
各省、自治区、直辖市食品药品监督管理局：
2013年5月，最高人民法院、最高人民检察院、公安部、农业部、国家食品药品监督管理总局联合印发《关于进一步加强麻黄草管理严厉打击非法买卖麻黄草等违法犯罪活动的通知》（公通字〔2013〕16号），要求进一步加强麻黄草管理，严厉打击非法买卖麻黄草等违法犯罪行为。为进一步加强药品生产经营企业涉及麻黄草的管理，现就有关要求通知如下：
一、除有麻黄草收购资质的药品生产经营企业外，任何药品生产经营企业不得收购、经营麻黄草。有麻黄草收购资质的药品生产经营企业销售麻黄草，需严格审核购买单位的资质，只能将麻黄草销售给药品生产企业。
二、有麻黄草收购资质的药品生产经营企业必须建立健全各项管理制度，加强麻黄草购、销、存管理，保证来源清楚，流向可核查、可追溯。要建立麻黄草收购、销售台账，并保存3年备查。麻黄草收购资质不得转借他人使用。
三、使用麻黄草作为原料的中药饮片生产企业、中成药生产企业、麻黄碱类药品原料生产企业，必须从有麻黄草收购资质的单位购买麻黄草。必须建立健全各项管理制度，保证来源清楚，流向可核查、可追溯。应建立麻黄草购买、相关产品的加工和销售台账，保存2年备查。麻黄草购买、使用、库存数量应符合《药品生产质量管理规范》物料管理的相关规定。
四、中药材专业市场不得经营麻黄草类药材。
各级食品药品监管部门要进一步加强药品生产经营企业麻黄草经营、使用的监督检查，发现药品生产经营过程中违反规定采挖、销售、收购、加工、使用麻黄草的，要按照有关法律法规严肃查处。涉嫌构成犯罪的，一律移送公安机关予以严惩。
国家食品药品监督管理总局办公厅
2013年10月15日
相关链接：http://www.sfda.gov.cn/WS01/CL0844/93355.html
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