为切实保障群众夏季用药安全，防范高温高湿天气带来的药品质量风险，北仑区局紧盯季节特点，精准施策，全面加强零售药店药品安全监管，筑牢药品安全防线。一、聚焦夏季储存风险，严守药品质量“生命线”。针对夏季高温高湿气候特点，重点围绕零售药店药品储存条件开展集中整治。以线上线下联动方式，织密温湿度监控网络。通过线上“黑匣子”系统，对零售药店温湿度远程、不间断监测，同时加强线下“回头看”，对温湿度多次异常、拒不改正的零售药店开展重点巡查，严防因储存不当导致药品变质失效。截至6月4日，已对辖区79家温湿度监测异常的零售药店发出线上“提醒单”，督促其及时整改。二、规范药品经营行为，全面排查夏季用药隐患。北仑区局在加强储存条件监管的同时，统筹推进零售药店日常经营行为的规范化管理。重点核查药品购销存记录是否真实完整，是否存在非法渠道购药、超范围经营处方药、执业药师不在岗履职不到位、近效期药品管理混乱等问题。针对夏季高温环境下药品易变质等特点，加大对近效期药品的排查频次，严防变质药品流入市场。截至6月4日，完成83家零售药店巡查。三、拓宽宣传引导维度，构建社会共治格局。针对季节性储药特点，北仑区局积极利用药店电子屏、公众号等渠道，普及夏季家庭常备药（如益生菌、糖浆、软膏）的储存要点、识别药品变质（变色、异味、沉淀等）知识及合理用药常识。同时畅通“12315”等举报投诉渠道，鼓励公众参与监督，形成“专业监管+社会监督”合力。

各医疗机构:为严厉防范和打击“回流药”等违法违规行为，斩断非法利益链条，规范医疗机构药品采购与储存管理，坚决维护医疗保障基金安全，切实保障人民群众用药安全与合法权益，依据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律法规，现就医疗机构药品使用质量管理要求提示如下:一、严格合法渠道购进医疗机构应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品，购进药品时，应当核实供货单位的药品生产或者经营许可证等资质证明文件、药品的批准证明文件等，并保存加盖其公章原印章的复印件。医疗机构购进药品时应当索取、留存合法票据，包括税票及详细清单，清单上应当载明供货单位名称、药品通用名称、药品上市许可持有人(中药饮片标明生产企业、产地)、批准文号、产品批号、剂型、规格、销售数量、销售价格等内容。二、规范进货检查验收与记录医疗机构购进药品，应当建立并执行进货检查验收制度，验明药品合格证明和其他标识;不符合规定要求的，不得购进和使用。购进药品必须有真实、完整的购进记录，记录应当注明药品的通用名称、药品上市许可持有人(中药饮片标明生产企业、产地)、批准文号、产品批号、剂型、规格、有效期、供货单位、购进数量、购进价格、购进日期。医疗机构应当建立要盖药品购进、储存、使用的全过程追溯体系，开展追溯数据校验和采集，按规定提供药品追溯信息。三、依法依规储存保管医疗机构应当有与所使用药品相适应的场所、设备、仓储设施和卫生环境。应当制定和执行药品保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保证药品质量。应当根据药品包装标示的温度要求，在相应温度条件的场所存放药品，并采取避光、遮光、通风等措施,各医疗机构应切实履行药品使用质量安全的主体责任，严格对照上述法定要求开展自查自纠。对违法违规购进、储存药品的，药品监督管理部门将依法严肃查处;涉及套取医保基金的，将依法移送医保部门及公安机关严肃处理。

陶春华代表：您提出的《关于林下经济产业规模化发展种植的建议（2026194号）》由自治区人大常委会办公厅交由我单位协同自治区工业和信息化厅、农业农村厅、中医药局、药监局等单位办理。经研究，现答复如下：一、广西林下经济总体情况广西是南方重点集体林区、重要生态屏障，林下空间充裕、资源丰富、生态良好，非常适合发展林下经济。2011年以来，广西将发展林下经济作为深化集体林权制度改革、激活林业生产力、破解林业生产周期长与林农“靠山吃山难”的重要突破口，努力探索创新“不砍树也能致富”的新路。截至2025年底，全区林下经济经营和利用林地面积稳定在7000万亩以上，产值超过1400亿元，居全国第3位；全区现有国家林下经济示范基地11个、广西林下经济示范县5个、林下经济精品示范基地26个，与林下经济相关的自治区现代产业示范园区15个，涉及林下种植的自治区中药材示范基地31个、“定制药园”20个。林下经济发展惠及林农超过1200万人、促进林农年人均增收超过4000元。二、持续加大政策、资金扶持力度和技术指导我区大力支持林下经济产业发展，配套出台相关政策，持续加大资金投入和技术支持。一是强化政策支撑。印发《“广西林下经济产业综合体”建设试点工作方案》，推动融水苗族自治县、资源县、富川瑶族自治县作为首批试点单位启动建设工作。自治区中医药局推动印发《广西中医药产业高质量发展三年行动方案（2026—2028年）》《关于广西推进中药材生产质量管理规范实施促进中医药产业高质量发展的意见》等文件，为中药材产业在内的林下经济产业提供政策指导。二是加大资金支持。持续加大林下经济发展补助、林业规模经营奖补等涉林资金支持，“十四五”以来，我局累计安排自治区林下经济发展补助资金1.12亿元。统筹中医药发展补助、农业新质生产力发展、工业和信息化发展等其他相关行业专项资金，引导社会资本参与发展林下经济产业。三是强化技术指导。积极推广“龙头企业+专业合作社+基地+村级集体经济组织（林农）”等经营模式，鼓励村集体、林农流转分散经营的林地开展规模经营，培育壮大中小生产主体。建立完善稳定利益联结机制，带动更多林农参与发展林下经济，让村集体、林农获得更多资产性、经营性收益。指导成立广西林学会林下经济专业委员会，在柳州市融水苗族自治县举办第十届全国林下经济发展学术研讨会，搭建政产学研用协同创新平台。三、积极拓宽销售渠道、发展壮大品牌我区加力推动林下经济市场构建，招引优质企业，大力支持“桂十味”等特色品牌建设。我局以建设林下经济产业综合体为契机，协调完善供水供电、晒场、初加工、仓储物流等设施，通过出让、租赁、入股及“产业+基金”等形式，搭建线上线下信息服务平台，招引产业链上下游企业“拎包入住”，打造林下优势品类核心县域“中央工厂”，辐射带动周边县（市、区）建设“卫星基地”。组织开展“三品一标”、国家森林生态标志产品认定、香港高端品质等系列认证，推动制定广西地方标准和团体标准，利用世界林木业大会等平台宣传推广我区林下经济产品，培育打造区域公用品牌、企业品牌和产品品牌。自治区农业农村厅指导支持“融水灵芝”“田林林芝”“西林灵芝”等林下中药材产品（基地）获得国家地理标志农产品认证或有机农产品认证。四、下一步工作下一步，我局将认真采纳您提出的意见建议，全面贯彻落实中央、自治区关于发展林下经济的部署要求，进一步找准切口、创新机制，在资源配置、资金统筹、市场建设等方面持续发力，推动我区林下经济产业高质量发展，努力实现绿富同兴、绿富共赢。专此答复，诚挚感谢您对自治区林业局工作的关心和支持。                                        2026年6月4日

6月10日，黑龙江省林业和草原局组织制定的《林下刺五加复合种植技术规程》《林下山参复合生态栽培技术规程》《林下黄精复合种植技术规程》《林下赤芍复合种植技术规程》《林下龙牙楤木复合种植技术规程》《林下白鲜复合种植技术规程》《林下茖葱复合种植技术规程》等7项林下复合种植团体标准由省林学会正式发布。这一系列标准的落地实施，是黑龙江省积极响应国家林草局《关于促进林下经济发展的若干措施》的具体行动，率先打通国家二级公益林林下经济标准化发展路径，破解黑龙江省森林林下空间利用瓶颈，为全省林下特色种植产业高质量发展筑牢标准化根基、划定规范底线、指明前行方向。近年来，黑龙江省深入践行“绿水青山就是金山银山”理念与大食物观，依托广袤的森林资源，将林下经济作为林草产业转型升级、助力乡村振兴、推动生态产品价值实现的核心抓手。国家林草局相关政策明确提出，在坚守生态保护底线、不破坏森林生态功能的前提下，允许科学有序利用二级公益林、地方公益林发展林下经济，鼓励各地结合实际制定配套技术标准，实现森林资源空间复合利用与功能协同提升。此前，受技术规范缺失、经营模式模糊等因素制约，二级公益林林下资源开发始终面临“不敢用、不会用、乱利用”的困境，广阔的林下空间资源难以转化为产业优势与民生福祉。此次黑龙江省7项团体标准的出台，精准回应政策要求与产业痛点，实现生态保护与产业发展的双向统筹。此次发布的7项团体标准，聚焦林下山参、刺五加、黄精等七种龙江道地林药、林菜品种，结合本地气候与林地条件，贯穿种植全流程。标准区分商品林与公益林管理模式，针对二级公益林明确轻扰动整地、低密度栽植、生态化抚育等要求，坚持生态优先原则，既守护森林生态，又打通公益林合规利用技术壁垒。同时，整套标准搭建起黑龙江省林下复合特色种植标准化技术体系，针对传统散户经营模式粗放、产品品质不一、易破坏生态等问题，新规统一土壤、郁闭度、农药化肥使用等关键指标，细化各项实操流程，推广仿生态复合栽培模式。下一步，黑龙江省林业科学院将持续做好标准的宣传解读、技术推广与落地指导工作，组织技术人员深入林区、林场开展实操培训，引导经营主体严格按照标准规范生产，并持续完善林下经济标准体系，不断丰富标准品类，以标准化引领规范化、以规范化促进产业化，全力推动黑龙江省林下经济提质增效、行稳致远，真正把森林“四库”资源优势转化为生态优势、产业优势和民生优势，奋力书写新时代龙江林草高质量发展新篇章。

根据《贵州省医疗保障定点零售药店协议管理经办规程（试行）》（黔医保中心发〔2021〕26号）《贵州省医疗保障定点医疗机构协议管理经办规程（试行）》（黔医保中心发〔2021〕27号）要求，现将2025年第三批（第二轮）及2026年第二批拟新增为省本级医疗保障定点的12家医疗机构和2家零售药店名单予以公示。公示期间如对公示单位的相关资格有异议的，可通过来人、来电或来信等形式，直接向贵州省医疗保障事务中心反映，须提供真实姓名、工作单位和确切的联系方式，以便查结后回复，反映内容须实事求是，并提供反映问题的真实证据，受理部门将对反映信息予以严格保密。反映内容不实或隐瞒真实身份的，受理部门将不予受理。公示时间：7个工作日（2026年6月10日—2026年6月18日）受理部门电话：0851-85977752中心纪检部门电话：0851-85976461受理时间：工作日8:30-12:00,14:00-17:30附件-新增省本级基本医疗保障定点医药机构名单.xlsx序号医疗机构名称机构类型医药机构地址1息烽县养龙司镇中心卫生院医疗机构息烽县养龙司镇养龙司村龙腾路88号2贵阳市乌当区东风镇卫生院医疗机构贵阳市乌当区东风镇街上3修文县大石布依族乡卫生院医疗机构修文县大石布依族乡4修文县谷堡镇卫生院医疗机构修文县谷堡镇折溪村/乌栗村5贵阳市花溪区燕楼镇卫生院医疗机构贵阳市花溪区燕楼镇燕楼村6花溪区青岩镇卫生院医疗机构花溪区青岩镇交通路程252号7贵阳市花溪区久安乡卫生院医疗机构花溪区久安乡小山村8息烽县石硐镇卫生院医疗机构息烽县石硐镇石硐街和谐路210号9息烽县九庄镇中心卫生院医疗机构息烽县九庄镇兴隆路134号10贵阳观山湖一牙兔口腔门诊部医疗机构观山湖区世纪城街道金阳南路6号贵阳世纪城E组团购物中心三2层1号贵阳世纪金源购物中心C区三层童兜天地CF3S001A11南明新洲诊所医疗机构贵阳市南明区大理石路润丰家园4-5号楼负一层12号12云岩区黔灵镇社区第三卫生服务站医疗机构云岩区沙河村百花山二组29A13贵阳湘禾合朋大药房零售药店贵州省贵阳市花溪区石板镇合朋村三农创业发展有限公司二组团C区加一层商铺14清镇一树吾悦大药房（个人独资）零售药店贵州省贵阳市清镇市青龙山街道吾悦广场建设项目自14、20栋（20）1-5号贵州省医疗保障事务中心 2026年6月9日 

各区市场监管局：《天津市自动售械机监督管理规定（试行）》已经2026年第2次局长办公会议审议通过，现予印发，请遵照施行。2026年6月9日（此件主动公开）天津市自动售械机监督管理规定（试行）第一章 总则第一条为鼓励医疗器械零售业态创新，方便群众购买医疗器械，规范本市自动售械机的监督管理，防范医疗器械质量安全风险，保障医疗器械质量安全，根据《医疗器械监督管理条例》《医疗器械经营监督管理办法》《医疗器械经营质量管理规范》等有关规定，结合本市实际，制定本规定。第二条天津市行政区域内设置自动售械机从事医疗器械零售经营活动及其监督管理，应当遵守本规定。第三条本规定所称自动售械机，是指在无人值守场景下，通过硬件设施与软件系统，实现医疗器械自助选购、支付及取货，或线上下单、线下自取/配送的销售设备。自动售械机作为医疗器械零售经营场所的延伸，其经营活动应当纳入医疗器械经营质量管理体系。第四条设置自动售械机从事医疗器械零售经营活动的经营者，应当依法承担医疗器械质量安全责任，对自动售械机的管理及其所经营医疗器械的质量安全负责。第五条天津市药品监督管理局负责指导全市自动售械机的监督管理工作。各区市场监督管理局负责本行政区域内自动售械机的监督管理工作。第二章 经营许可与备案管理第六条通过设置自动售械机从事第三类医疗器械和第二类医疗器械零售经营活动的企业，应当依法取得医疗器械经营许可或完成医疗器械经营备案。自动售械机的经营范围不得超出企业经营许可或备案的范围，其运营期限不得超过医疗器械经营许可证的有效期，且企业的经营方式应当包含“零售”或者“批零兼营”。外省市企业在本市行政区域内设置自动售械机的，应当在本市依法取得医疗器械经营许可或备案，并遵守本规定。仅销售第一类医疗器械和免于经营备案第二类医疗器械的除外。第七条首次申请医疗器械经营许可或办理经营备案的企业，可同时申请设置自动售械机，作为医疗器械零售经营场所之一。已经取得《医疗器械经营许可证》《第二类医疗器械经营备案凭证》的企业，申请设置、增加、减少或取消自动售械机的，应当按照经营场所变更的有关规定，向企业所在地区市场监督管理局申请许可变更或办理备案变更。第八条企业设置自动售械机，应当依据《医疗器械经营监督管理办法》等相关规定，向企业所在地区市场监督管理局申请许可变更或办理备案变更，并提交下列资料：（一）自动售械机设置场所信息列表，以及对应的地理位置图、平面图、房屋产权文件或租赁协议复印件；（二）主要经营设施、设备目录；（三）自动售械机管理制度、工作程序等文件目录；（四）自动售械机计算机管理系统情况说明；（五）经办人授权文件。企业首次申请医疗器械经营许可或办理经营备案同时设置自动售械机的，应当同时提交前款规定的全部资料。已取得《医疗器械经营许可证》或《第二类医疗器械经营备案凭证》的企业，申请增加自动售械机的，可免予提交第（二）（三）（四）项材料；减少或取消设置自动售械机的，仅需提交第（五）项材料。企业应当确保提交的资料合法、真实、准确、完整且可追溯。第九条企业所在地区市场监督管理局应当按照《医疗器械经营监督管理办法》等规定，及时办理经营备案或许可的审批、变更手续，必要时按照医疗器械经营质量管理规范和本规定的要求开展现场核查。第十条自动售械机设置信息应当在医疗器械经营许可证或备案凭证中予以登载，格式为：“设置自动售械机，详见《天津市自动售械机设置场所登记表》（见附件）。”《天津市自动售械机设置场所登记表》与医疗器械经营许可证或备案凭证共同使用，作为企业经营场所的有效证明。登记表中的设置场所应当具体到街道门牌号及设置单位的楼层、房间。同一场所内设置多台自动售械机的，应当逐一编号。第三章 经营质量管理第十一条设置自动售械机从事医疗器械零售经营活动，应当遵循以下要求：（一）对所属自动售械机应当实行统一企业标识、统一设备管理、统一质量管理制度、统一计算机管理系统、统一采购配送、统一票据管理、统一售后服务等；（二）按照医疗器械经营质量管理规范的要求，建立包括贮存（陈列）、效期管理、出货、取货、销售、信息展示、售后服务、设备维护等覆盖自动售械机经营全过程的质量管理体系文件、工作程序和质量记录，记录内容应当真实、准确、完整和可追溯，确保医疗器械产品在自动销售特殊场景下的质量安全与可追溯。（三）具备与自动售械机设置规模、经营范围相适应的贮存及配送条件，配备质量管理、设备维护及售后服务等质量安全关键岗位人员，并为其履职提供必要的资源和制度保障，确保质量安全关键岗位人员充分履行职责。（四）计算机管理系统应当符合《医疗器械经营质量管理规范》要求，能够对每台自动售械机实行一机一号联网管理，实现与经营主体本部管理系统互联互通，实时交互自动售械机的相关数据；（五）根据医疗器械产品说明书要求，建立适宜通过自动售械机零售经营产品目录（注明医疗器械分类编码和产品名称）；（六）建立自动售械机管理档案，至少包括每台自动售械机的品牌型号、合格证明、设置时间、地点、维护维修记录等内容；（七）定期对自动售械机陈列、存放的医疗器械进行检查，重点检查产品外观、有效期等。发现存在质量疑问的，应当立即停止销售、撤出设备，交由质量管理人员确认和处理，并保留相关记录。第十二条经营者设置自动售械机的位置、数量等应当与其管理能力相适应，并符合以下要求：（一）放置场所应当取得房屋或场所合法使用资格，放置地点应当环境整洁卫生，避免日晒雨淋，不得与有毒、有害、有污染的物质同场所存放，不得设在户外、居民住宅、军事管理区（不含可租赁区）及其他不适合经营的场所，并需具备保证所陈列医疗器械质量安全的相应条件和措施；（二）自动售械机设备应当采用全封闭式设计，并配备温湿度监测设备或仪器；其内部陈列环境应当符合所经营医疗器械说明书或标签标示的贮存要求，产品摆放整齐有序；经营需冷藏、冷冻管理的医疗器械，应当符合医疗器械冷链管理有关规定，并具备温湿度自动监测、显示、记录、调控及报警等功能；（三）自动售械机的贮存、陈列、出货及取货方式，应当能有效防止产品的污染及破损；（四）自动售械机应当具备开具纸质或电子销售凭据的功能，零售第三类医疗器械应当具备生成销售记录的功能，销售凭据和销售记录应当符合相关规定要求；（五）在同一自动售械机内经营药品及其他产品时，应当分区陈列，与医疗器械区域明显隔离，设置醒目标志，类别标签字迹清晰、放置准确，并遵守药品及其他产品监管相关规定。第十三条自动售械机应当在醒目位置展示以下信息，且保证信息清晰、完整、不易脱落：（一）经营主体的《营业执照》《医疗器械经营许可证》或《第二类医疗器械经营备案凭证》等资质信息（可展示电子证照或清晰复印件），所展示信息应当真实有效；（二）“购买和使用前请仔细阅读产品说明书或者在医务人员指导下购买和使用”等警示用语。产品说明书中对贮存、运输及安全使用有特别说明的，还应当展示医疗器械产品说明书。（三）售后服务电话和投诉举报电话，同时应建立畅通的顾客意见反馈机制及退货等售后服务渠道。（四）鼓励企业利用电子触摸屏幕、手机APP或扫码等现代信息技术，以文本、图片或者链接标识等方式向消费者展示医疗器械产品资质、说明书等信息。相关展示信息应当与经注册或者备案的内容保持一致，并且清晰，容易辨识。相关信息发生变更的，应当及时更新展示内容。第十四条鼓励企业通过自动售械机销售终端、手机APP或扫码等方式收集、记录消费者反馈的医疗器械不良事件，并及时向医疗器械注册人、备案人及监测机构报告。第十五条企业应当将自动售械机经营质量管理情况纳入年度质量管理自查报告，并于每年3月31日前报送所在地的区市场监督管理局。第四章 监督管理第十六条各区市场监督管理局应当将设置自动售械机的经营企业列入年度监督检查计划，按照医疗器械经营企业分类分级监管要求，根据企业和产品风险等级，科学合理确定检查频次，减少重复检查。各区市场监督管理局应当通过合并检查、联合检查、书面核查、信息共享、智慧监管等监管方式，对企业的质量管理体系运行情况和自动售械机的实际运营状况进行监督检查，大力推进精准检查，督促企业严格履行法定责任与义务。第十七条各区市场监督管理局应当将自动售械机经营情况纳入风险会商范畴。对监督检查、投诉举报、舆情信息、网络监测、不良事件监测、行政处罚等显示可能存在的风险信息，应及时研判分析，并可采取责任约谈、现场核查、监督抽检、飞行检查、行政处罚等监管措施。第十八条利用自动售械机通过互联网开展线上下单、线下自取/配送业务的，其线上下单环节涉及的信息发布、交易过程等，应当同时遵守药品互联网信息服务和医疗器械网络销售管理等有关规定。第十九条设置自动售械机从事第一类医疗器械和免于经营备案第二类医疗器械经营活动，应当符合医疗器械经营质量管理规范的要求。第五章 附则第二十条本规定相关内容与国家药品监督管理局新出台的医疗器械经营监管政策规定不一致的，从其规定。第二十一条本规定自2026年7月1日起施行，有效期至2031年6月30日。附件：天津市自动售械机设置场所登记表附件天津市自动售械机设置场所登记表                                                  第 页，共 页企业名称许可证/备案编号许可证有效期限统一社会信用代码序号设置场所（具体到街道门牌号及设置单位楼层、房间）登载日期备注发证部门（公章）：    注：本登记表与第三类医疗器械经营许可证、第二类医疗器械经营备案凭证共同使用。附件：天津市药品监督管理局关于印发《天津市自动售械机监督管理规定（试行）》的通知.doc| 相关政策| 相关报道

近日，自治区药监局、自治区医保局联合印发《宁夏回族自治区医疗器械跨部门会商管理机制》，进一步畅通两部门沟通协作渠道，构建常态化、制度化协同工作格局。跨部门会商管理机制明确了三大核心工作内容。一是建立联合会商制度，聚焦医疗器械全链条质量安全风险，根据工作需要召开专题会商，共同分析研判风险隐患，研究制定针对性防控措施，实现风险早发现、早预警、早处置。二是强化双向信息共享，两部门及时共享涉及企业信息、监管动态、监督抽检、不良事件监测、挂网采购等信息，提升数据资源利用效能。三是深化联合执法与案件查办协作，根据工作需要在日常监管、专项检查、投诉举报处置中加强联合执法，及时移送反馈违法违规线索，形成监管合力，提升执法效能。下一步，两部门将严格落实会商机制要求，加强沟通协作，共享监管信息，保障产业高质量发展和群众用械安全。

　　为贯彻落实《国家医疗保障局办公室关于开展智能监管改革试点的通知》（医保办函〔2025〕40号）有关要求，做好我省医保智能监管改革试点工作，进一步提升全省医疗保障基金智能化监管水平，引导定点医药机构及其工作人员精准掌握医保基金使用规则，有效推动监管关口前移，根据国家医保局公开发布的智能监管“两库”规则和知识点，现面向社会公开发布我省2026年第三批医疗保障智能监管规则库相关规则及其知识点。　　本次公开“手术项目未按规定折价收费”“超互联网医院药品支付范围”“药品限二线使用”“中药饮片单方使用不予支付”“中药饮片单复方均不予支付”共5类规则对应知识点明细（共计1255条），适用于全省所有定点医药机构。　　全省各级医保部门要切实强化智能审核规则的掌握与应用，引导辖区内定点医药机构接入并应用智能审核事前提醒功能。全省各定点医药机构可将智能监管“两库”置于本机构智能提醒等信息化系统中，也可以对接医保部门智能监管系统事前提醒功能模块，对医保基金使用行为开展自动提醒和自查自纠，将不合规的行为消除在“萌芽”阶段，从源头上减少使用医保基金违法违规行为发生。　　省医保局实行智能审核“两库”动态调整机制，定点医药机构对“两库”执行中的问题和意见建议可反馈至邮箱：QHJJJGC001@163.com。　　附件：1.第三批-1.手术项目未按规定折价收费　　　　　2.第三批-2.超互联网医院药品支付范围　　　　　3.第三批-3.药品限二线使用　　　　　4.第三批-4.中药饮片单方使用不予支付　　　　　5.第三批-5.中药饮片单复方不予支付青海省医疗保障局2026年6月9日

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPTProduct:DrugsRecipient:Rafael PadillaCEOFagron BVFascinatio Boulevard 3503065 WB RotterdamNetherlandsIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 724551May 12, 2026Dear Mr. Padilla:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1 on April 21, 2017, and most recently on November 22, 2025. From October 9, 2025, to November 5, 2025, FDA investigators inspected your facility, Fresenius Kabi Compounding, LLC dba Fagron Sterile Services, located at 20 Dan Rd, Canton, MA 02021. During the inspection, investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on November 5, 2025. FDA reviewed your facility’s responses, dated November 26, 2025, December 1, 2025, and December 5, 2025, and acknowledge receipt of your subsequent correspondence. FDA further acknowledges that your firm initiated a voluntary recall on February 5, 2026, of various lots of drug products, within expiry, produced using (b)(4) IV Bags intended or expected to be sterile due to lack of sterility assurance. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that:1. You exposed sterile drugs and materials to lower than ISO-5 quality air.Specifically, operators' arms blocked the first air to sterile vancomycin vials during reconstitution. Additionally, operators vigorously shook the vials during this process. This rapid movement likely disrupts the unidirectional airflow within the ISO 5 aseptic processing area, creating a contamination risk.2. You failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.Specifically, airflow visualization studies (i.e., smoke studies) do not accurately reflect the actual quantity and positioning of equipment, materials, and other components used during production. Consequently, it cannot be determined whether adequate, uninterrupted, unidirectional airflow is maintained throughout the aseptic drug production process.The FDA investigators also noted CGMP violations at your facility that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. Your quality control unit failed to exercise its responsibility to ensure that drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity (21 CFR 211.22).2. You failed to thoroughly investigate any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed (21 CFR 211.192).3. You failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)).4. You failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).5. You failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).6. You failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.C. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483, dated November 26, 2025, December 1, 2025, and December 5, 2025. We also acknowledge your firm initiated a voluntary recall on February 5, 2026, of various lots of drug products, within expiry, produced using (b)(4) IV Bags intended or expected to be sterile due to lack of sterility assurance.We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your firm’s failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic processes:a. We acknowledge your interim and long-term corrective action plans to address deficiencies in your current (b)(4) process for intravenous fluid bags. We note your intention to (b)(4) and, if necessary, (b)(4)—are implemented and qualified. Once these planned enhancements are complete, and the revised process implemented, FDA will evaluate the adequacy and safety of your (b)(4) processes. This evaluation will include an assessment to ensure there is no adverse impact on the quality of drug components and finished drug products.b. Regarding your firm's failure to ensure that personnel monitoring practices (i.e., gloved fingertip and gowned (b)(4) sampling) provide meaningful results, we acknowledge your plan to modify SOP # FSSBOS-SOP-0014, Aseptic Technique for the (b)(4) at the Canton Compounding Facility. However, the adequacy of this corrective action cannot be fully evaluated until the modifications are fully implemented and supporting documentation, such as executed batch production records, are provided for assessment.c. We acknowledge your plan to conduct a new “Dynamic Airflow Qualification” study to address your firm's failure to perform adequate smoke studies under dynamic conditions representative of actual production. However, since you estimate the study will not be complete until March 31, 2026, we cannot evaluate the adequacy of your corrective action at this time. We remain concerned about your inability to verify adequate airflow patterns within the ISO 5 aseptic processing area.2. Regarding your failure to establish an adequate system for cleaning and disinfecting the room to produce aseptic conditions:We acknowledge your response regarding the brown, rust-like residue found on the wheelbases of the laminar flow hoods and tables in your ISO 7 areas. We note your plan to update procedures to enhance inspection and cleaning of these surfaces as necessary. However, your response did not include evidence—such as photographs or other documentation—demonstrating that remedial actions (e.g., cleaning) have been completed. Without this documentation, we are unable to evaluate the adequacy of your corrective action at this time.3. Regarding your failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair, including paint chipping on air returns and a door, and a divot in the floor, all in ISO 7 areas:We acknowledge your plans to repair and refinish the affected air returns and doors, as well as to repair the floor. However, you failed to provide evidence, such as photos or executed work orders, demonstrating that the repairs have been completed. Consequently, we cannot evaluate the adequacy of your corrective action at this time.Some of your corrective actions appear deficient:1. Regarding your Quality Unit’s failure to exercise its responsibility to ensure drug products produced are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity:We acknowledge the actions your firm has planned in response to its failure to adequately manage an adverse trend involving defects associated with your intravenous fluid bags. We note the following action items:Assess Fresenius Kabi vendor status based on review of defects noted.Target completion due date: 31Jan2025 [sic; date assumed to be 31Jan2026]Assess supplier qualification process regarding managing vendor complaints and escalations.Target completion due date: 31Jan2025 [sic; date assumed to be 31Jan2026]Update supplier qualification SOP based on closure of assessment.Target completion due date: 31Jan2025[sic; date assumed to be 31Jan2026]However, your response fails to address fundamental deficiencies in how your Quality Unit managed a significant adverse trend related to the container-closure system of your sterile drug products. For example, although the IV bag manufacturer/supplier acknowledged defects in the IV bags’ injection and infusion ports, they never communicated a definitive root cause. Without this root cause determination, you could not verify whether the manufacturer/supplier's corrective actions (e.g., equipment “maintenance”) adequately resolved the issue. Your firm continued to rely solely on visual inspection processes as the primary control mechanism to prevent defective units from reaching patients.Furthermore, requiring personnel to focus primarily on detecting port defects during visual inspection of finished sterile drug products raises concerns, as this may compromise their ability to identify particulates and other defects unrelated to ports.2. Regarding your failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed:We acknowledge the actions your firm has planned in response to its failure to adequately investigate and respond to an adverse trend involving defects associated with your intravenous fluid bags. We note the following action items:Assess bag storage and shipping configuration to determine if current storage & configuration has potential compressive stress on the seam of the (b)(4) IV Bag units.Target completion due date: 06Jan2026Assess the need for updates to the incoming inspection requirements of (b)(4) IV Bags.Target completion due date: 06Jan2026Update the customer complaint investigation process in FSSBOS-SOP-0041 to require that for “leaking unit” complaints, photos of the defective unit(s) are requested, and the units be returned to the facility for inspection.Target completion due date: 06Jan2026However, although you identified a trend involving defects with the (b)(4) infusion port seal across multiple supplier lots of various (b)(4) IV Bag configurations, you failed to take meaningful action such as pausing production or distribution. Instead, you opened an “Issue” to document and trend the events. You did not conduct a comprehensive risk analysis and never identified a definitive root cause. Despite failing to determine a definitive root cause through communication with the IV bag supplier ((b)(4)) for the observed defects—including (b)(4) port seals with (b)(4) “stress” marks, loose (b)(4) port seals, and partially seated (b)(4) port seals—you continued using these IV bags in production. You relied solely on visual inspection to identify and segregate defective units. This practice is inconsistent with good manufacturing practices, which require a drug process to remain in a state of control throughout its lifecycle. Knowingly using potentially defective container-closures in the production of a sterile drug product places the product at risk of contamination and puts patients at risk.3. Regarding your failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile:a. We acknowledge your response to the failure to ensure that operators’ behavior in the ISO 5 aseptic processing area does not block or otherwise compromise “first-air” to critical surfaces such as vials. We note your contention that vial reconstitution is not an aseptic practice, as well as your plans to reclassify this as such. However, sterile drug vial reconstitution is an aseptic process that must be performed in an ISO 5 area because it involves exposing a sterile product to the environment during manipulation. When reconstituting a sterile drug, the vial's closure system is breached to introduce a diluent, creating opportunities for microbial contamination. An ISO 5 environment provides the highest level of air cleanliness in the immediate work area, with stringent limits on airborne particulates that could carry microorganisms. This controlled environment, combined with proper aseptic technique, is essential to maintain product sterility and prevent contamination that could lead to serious patient harm. Additionally, while subsequent sterile (b)(4) of the bulk drug solution may provide a layer of protection, it does not eliminate the requirement to maintain aseptic conditions throughout the sterile drug production process.We further acknowledge your claim that vigorous shaking of the [vancomycin] vials is necessary to ensure complete dissolution of the drug in the diluent, as well as your intent to improve this process by requiring the hood to “(b)(4)” following reconstitution and prior to resumption of aseptic activities. However, this strategy fails to address the primary risk. As previously stated, rapid movement (i.e., vigorous shaking of vials) creates significant air turbulence that disrupts laminar airflow and increases contamination risk. A (b)(4) alone without supporting scientific evidence is not an effective contamination control strategy.b. We acknowledge your response regarding the failure to conduct all aseptic operations, including reconstitution of sterile vials and pooling of the resultant bulk drug solution, in a properly qualified ISO 5 environment. As previously stated, reconstituting sterile drug product vials and pooling them outside an ISO 5 environment creates a direct contamination risk. When performed outside an ISO 5 space, the process is no longer considered a sterile-to-sterile aseptic process. While we acknowledge the information you provided regarding sterilizing (b)(4) qualification (including compatibility and capacity) and additional controls such as full gowning, environmental monitoring within the ISO 7 mixing room, and sanitization of pooling bags, these measures do not replace the comprehensive validation process, including process simulation studies, necessary to validate such a process.4. Regarding your failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas:We acknowledge your response regarding the failure to adequately perform active and passive air sampling within the ISO 5 area during aseptic operations, including your plan to initiate active air monitoring during filling operations. We recognize the importance of conducting effective environmental monitoring while minimizing the risk of contamination. However, your response fails to fully address the scope of the violation. Although conducting viable air sampling during filling represents an improvement, it does not address other critical steps in the aseptic operation where contamination risk is high and viable air monitoring may be necessary. Additionally, your response does not specify the duration of the production process or explain whether the frequency of viable air sampling adequately represents the processing environment throughout the entire production cycle. Furthermore, your response indicates that settle plate placement is described in FSSBOS-SOP-0013, “Cleaning Procedure for Classified Areas at the Canton Compounding Facility.” However, our review of this SOP indicates that it applies only to ISO-7, ISO-8, and ISO-9 areas. Consequently, the location of settle plates, used for passive air monitoring of the ISO 5 (b)(4) during aseptic operations, cannot be determined.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b)].FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.All correspondence should refer to the Warning Letter Number above (# 724551) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Researchcc:Deborah E. McHugh, Vice President of Quality for North AmericaFresenius Kabi Compounding, LLC20 Dan RdCanton, MA, 02021-2809___________________1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2 We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.

为了进一步规范特殊食品注册申报，做好受理审评工作，现将有关要求公告如下：一、注册申请人现场提交行政许可项目申报材料、领取许可决定文书或配合开展特殊食品注册现场核查工作时，具体办理人员应当为注册申请人正式在职员工（现行法律法规有其他要求的情形除外），须同时提交注册申请人（与申请表盖章单位一致）向具体办理人员出具的授权委托书，以及具体办理人员的身份证明原件及复印件（原件核对后退回）。授权委托书参考式样详见附件1、附件2、附件3。二、注册申请人在注册、备案系统注册账号或者申报具体产品时，在注册系统和申请表中填写的联系方式应为注册申请人正式在职员工的联系方式（现行法律法规有其他要求的情形除外）。三、对于保健食品注册申请的联系人或联系方式等信息发生改变的，申请人可通过现场或邮寄的方式，及时向我中心受理大厅提交《保健食品联系方式变更申请书》。我中心将根据注册申请人提供的信息对保健食品注册审评系统中具体产品的联系人、联系方式等信息进行更新。对于信息更新不及时影响注册审评及注册现场核查工作开展的，由申请人承担相应责任。四、注册申请人应对提交的上述材料的真实性负责。经审核发现不属实的，将按《中华人民共和国行政许可法》中“隐瞒有关情况”或者“提供虚假材料”的情形处理。本公告内容自2026年6月9日起执行。特此公告。附件:1.授权委托书—办理行政许可事项受理业务用2.授权委托书—办理行政许可决定文书领取业务用3.授权委托书—办理特殊食品注册现场核查业务用国家市场监督管理总局食品审评中心2026年6月9日