经查，曾玉霞、赵秀珍2人存在《执业药师注册证》挂靠行为，根据《执业药师注册管理办法》有关规定，我局依法对曾玉霞、赵秀珍2人的《执业药师注册证》予以撤销、注销，三年内不予注册，并将不良信息录入全国执业药师注册管理信息系统。特此通告。执业药师身份证号码资格证书号“挂证”/执业单位曾玉霞622326********0029SS201910026620000093甘肃心连心药品连锁经营有限公司八十分店赵秀珍622424********392702620241062000001301天祝藏族自治县百惠堂大药房（个人独资）  甘肃省药品监督管理局2025年9月18日

根据《中华人民共和国行政许可法》第七十条和《医疗器械监督管理条例》第六十六条的相关规定，按照《浙江省食品药品监督管理局办公室关于发布第二类医疗器械注册证书补办程序等5个相关工作程序的通知》（浙食药监规[2016]3号）的具体要求，依企业申请，现注销浙江龙德医药有限公司“一次性使用低阻配药用注射器”的医疗器械注册证书（注册证编号：浙械注准20162141078）。 特此通告。 联系电话：0571-88903347 联系地址：杭州市莫干山路文北巷27号 邮编：310012 2025年9月17日

根据《中华人民共和国行政许可法》第七十条和《医疗器械监督管理条例》第六十六条的相关规定，按照《浙江省食品药品监督管理局办公室关于发布第二类医疗器械注册证书补办程序等5个相关工作程序的通知》（浙食药监规[2016]3号）的具体要求，依企业申请，现注销浙江龙德医药有限公司“一次性医用防护服”的医疗器械注册证书（注册证编号：浙械注准20232141986）。 特此通告。 联系电话：0571-88903347 联系地址：杭州市莫干山路文北巷27号 邮编：310012 2025年9月17日

　　省药品监管局紧扣“平安建设”核心目标，有效维护药品安全形势稳定，有力护航生物医药产业高质量发展，在2024年度平安广东建设考评中获评优秀等次且考评结果排名前十位，被授予“优秀成员单位”奖牌，在创建新安全格局上取得新突破。一是智慧赋能，全领域提升依法监管水平。全省省级职业化专业化药品检查员数量稳居全国第一梯队。在全国率先完成“粤安评”“DOP粤药盾”等AI智能辅助工具开发。在全国率先实现省内在产血液制品和疫苗品种批签发全覆盖。顺利通过国家药监局放射性药品检验机构现场考核评审。二是靶向防控，全周期筑牢药品安全底线。聚焦药械临床试验、网络销售等重点环节，紧盯疫苗、血液制品等重点品种处置突出风险。做好十五运会和残特奥会前期药品安全保障和含兴奋剂药品风险管控。开展药品安全巩固提升行动、药品经营环节“清源”行动。三是聚力改革，全链条支持医药产业高质量发展。贯通联动国家重大改革取得重大突破，首批获国家药监局批准开展优化药品补充申请审评审批程序改革试点；首家获批集团内生物制品分段生产试点，试点品种数量全国第一；利拉鲁肽注射液成为全国首个获批落地、实现产能转化的分段生产试点项目。在广州黄埔区、南沙区、佛山三水等产业集聚区设立药械注册指导服务工作站。2024年、2025年共获批58个创新药械，获批数量创历史新高。全省药品、医疗器械、化妆品生产经营企业总量位居全国第一。指定“港澳药械通”医疗机构45家，共批准港澳已上市药品医疗器械115种，获益患者近万人次。（省局法规科技处供稿）

根据《广东省食品药品监督管理局关于〈药品经营许可证〉注销的管理规定》（粤食药监法〔2013〕26号），我局已依法注销肇庆市养天和康民大药房连锁有限公司鼎湖新广分店等1间企业的《药品经营许可证》，现予以公布。序号许可证号许可证有效期限企业名称注销时间注销原因1粤CB75821592026年05月19日肇庆市养天和康民大药房连锁有限公司鼎湖新广分店2025年09月17日企业申请肇庆市鼎湖区市场监督管理局2025年09月17日

针对近期零售药店注销数量上升趋势，近日，自治区药监局发布专项监管提示，通过严格审批关口等三项举措，强化拟注销零售药店库存药品监管，严防注销环节药品流入非法渠道，切实保障公众用药安全。严格审批关口各级市场监管部门与行政审批部门切实履行监管审批职责，严格审核注销申请材料，强化现场核查，从源头把控风险。同步指导辖区上游企业（含药品供应商、连锁总部、集团总部等），规范退货验收、储存、台账登记等环节，确保零售药店库存药品处置合法合规、安全有序。压实企业责任明确拟注销药店需履行“全面盘点备案、规范流转监督、分类处置库存、依法处置不合格药品、落实全程追溯”五项流程，确保注销前依法完成全部库存药品合规处置。靶向监督检查各级监管部门开展差异化针对性核查，重点检查处置记录的完备性、药品流向合法性、接收方资质合规性以及药品储运环节规范性等质量保障措施落实情况。截至目前，全区累计完成836家拟注销零售药店库存药品合规处置，其中连锁门店612家、单体药店224家；销毁处置不合格药品1.8万盒（瓶）。

按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据诚康医药(三门峡)有限公司申请，现注销诚康医药(三门峡)有限公司的《药品经营许可证》（证书编号：豫AA398000447）。　　特此公告。　　附件：诚康医药(三门峡)有限公司《药品经营许可证》有关信息表　　2025年9月17日企业名称企业法人（负责人）质量负责人经营方式经营范围经营地址仓库地址证书编号诚康医药(三门峡)有限公司芮一贤霍新娜批发中药饮片、中成药、化学药、生物制品***河南省三门峡市湖滨区三甘线与南山大道交叉口西南角绿色智慧农产品冷链物流中心办公楼2楼1号河南省三门峡市湖滨区三甘线与南山大道交叉口西南角绿色智慧农产品冷链物流中心一号仓库7号铺位、郑州市新郑市郭店镇中华北路322号深国际新郑知会物流港8号库一层第1-3分区（委托河南诚康医药有限公司储存）《药品经营许可证》（证号：豫AA398000447）

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:ybycmeds6420 Inducon Dr. WSanborn,NY14132United Statessupport@ybycmeds.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERSeptember 9, 2025ybycmeds:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://ybycmeds.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.1As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The following claims concerning compounded semaglutide and tirzepatide products appear on your website:• “Semaglutide for weight loss - Prefilled Syringes, similar to Ozempic or Wegovy”• “Tirzepatide for weight loss - Prefilled Syringes, similar to Mounjaro and Zepbound”• “Tirzepatide Peptide 60mg vial - similar to Mounjaro and Zepbound”• “Semaglutide Compound 10mg vial - similar to Ozempic or Wegovy”Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 operations comply with all requirements of federal law, including FDA regulations.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). 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 provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps 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.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.All correspondence should 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/George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration1The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.