经资料审核和网上核查，银川鲸麦互联网医院有限公司符合《中华人民共和国药品管理法》《互联网信息服务管理办法》《药品网络销售监督管理办法》等有关规定，决定予以备案。特此通告。附件：药品网络交易服务第三方平台备案具体信息列表.wps宁夏回族自治区药品监督管理局2026年9月9日

经资料审核和自治区药品审评查验和不良反应监测中心技术核查，乾藏灸医药科技（宁夏）有限公司申请的国产第二类医疗器械灸疗装置延续注册符合《医疗器械监督管理条例》《医疗器械注册管理办法》相关规定，决定予以换发《医疗器械注册证》。特此通告。附件：《医疗器械注册证》具体信息列表.wps宁夏回族自治区药品监督管理局

为持续深化药品监管领域政务服务提质增效，不断提升企业和群众办事便利度和满意度，自治区药品监督管理局现就修订完善后的个人及企业证照清单（涉及药品监管领域）面向社会公开，详细内容见附件。同时，为精准破解企业和群众办事堵点难点，及时回应市场主体新诉求、新期盼，现面向广大企业、社会公众及基层药品监管人员公开征集个人、企业证照办理方面的意见建议，相关意见建议可通过电子邮箱提交（电子邮箱：nxyjj6982685@163.com），本次意见征集截止时间为2026年9月18日。欢迎社会各界予以监督、积极建言，我们将梳理汇总征集到的意见，统筹全区各级药品监管领域相关行政审批机构，改进服务举措，迭代优化办事流程，不断提升药品监管领域政务服务标准化、规范化、便利化水平，助力全区医药产业高质量发展。附件：个人及企业证照清单.xlsx

根据广东省药品监督管理局《2026年全省药品经营企业和使用单位监督检查计划》安排，省药品监管局组织对以下30家药品经营企业进行监督检查，现将综合评定结论通告如下：序号企业名称药品经营许可证号综合评定结论所在地市1汕头市春晖医药连锁有限公司粤BA754000395符合要求汕头2汕头市春晖医药有限公司粤AA754000992符合要求汕头3广州百特侨光医疗用品有限公司粤AA020001659符合要求广州4深圳市健华药业连锁有限公司粤BA755000067符合要求深圳5深圳市金康源药业有限公司粤AA755001048符合要求深圳6深圳市健华医药有限公司粤AA755000385符合要求深圳7深圳市星银医药有限公司粤AA755000048符合要求深圳8深圳朗欧医药集团有限公司粤AA755000528符合要求深圳9湛江贤正医药有限公司粤AA759001395符合要求湛江10广东春天一百连锁药店有限公司粤BA759000269符合要求湛江11广东药宅送云药房有限公司粤BA020000784符合要求广州12广东杰德药业有限公司粤AA020000813符合要求广州13深圳市荣盛堂医药有限公司粤AA755001559符合要求深圳14广东康美冠贤医药有限公司粤AA759000337符合要求湛江15广东铸康药业有限公司粤AA020001548符合要求广州16珠海市民彤医药有限公司粤AA756000303符合要求珠海17广东润良药业有限公司粤AA756000366符合要求珠海18韶关市盛威药业有限公司粤AA751000614符合要求韶关19阳春市信德药业有限公司粤AA662001059符合要求阳江20广东祎昇源医药有限公司粤AA020001091符合要求广州21广东吉药医药有限公司粤AA758000160符合要求肇庆22惠州万通药业有限公司粤AA752000617符合要求惠州23广东易康医药有限公司粤AA752001717符合要求惠州24普宁市华欣药业有限公司粤AA663000522符合要求揭阳25广东同舟药业有限公司粤AA663000268符合要求揭阳26深圳市仁南医药有限公司粤AA755000792符合要求深圳27广东柏恩医药有限公司粤AA020001613符合要求广州28广东华晟药业有限公司粤AA759001021符合要求清远29茂名市健群药业有限公司粤AA668000938符合要求茂名30化州市民生药业有限公司粤AA668001189符合要求茂名特此通告。广东省药品监督管理局2026年9月15日

各市（州）医疗保障局：为继续做好我省执行《基本医疗保险用药管理暂行办法》（国家医疗保障局令第1号，以下简称《办法》，见附件）有关工作，结合我省实际，现将有关事项通知如下。一、统一医保药品目录各统筹地区要严格按照《办法》确定的职责和权限，做好基本医疗保险用药的支付、管理和监督等工作。省医保局按照规定的调整权限和程序，将符合条件的民族药、医疗机构制剂、中药饮片纳入我省医保支付范围，并建立完善动态调整机制。各统筹地区要严格执行国家《基本医疗保险药品目录》和纳入我省基本医疗保险基金支付范围的民族药、医疗机构制剂和中药饮片（以下并称为《药品目录》），不得自行制定目录或用变通的方法扩大医保支付药品范围，也不得自行调整药品的限定支付范围。二、统一乙类药品个人先行自付比例《药品目录》中的“甲类药品”按基本医疗保险规定的支付标准及分担办法支付，不设个人先行自付比例。“乙类药品”按基本医疗保险规定的支付标准，先由参保人自付一定比例后，再按基本医疗保险规定的分担办法支付。各统筹地区“乙类药品”个人先行自付比例在现行10%的基础上，应按国、省统一规定调整，不得擅自进行调整。我省单行支付药品的支付办法按有关政策执行。三、统一医保药品数据库对于因更名、异名等原因需要对药品的目录归属进行认定的，如属于我省民族药、医疗机构制剂和中药饮片目录内的，省医保局按程序进行认定。全省使用统一的药品数据库，省医疗保障事务中心根据国家和我省政策对药品数据库进行政策标识，各地要严格按照我省药品数据库进行动态维护，不得自行调整更改药品数据库信息。原有关文件与本通知内容不符的，以本通知规定为准。执行期间如国家和省有新规定，从其规定。附件：基本医疗保险用药管理暂行办法（国家医疗保障局令第1号）四川省医疗保障局2026年9月15日

为落实国家医保监管工作部署，实现监管关口前移本次将“药品限新生儿使用”“诊断与患者年龄不符”等规则对应知识点明细（共计12563个）面向社会公开，帮助定点医药机构及其工作人员熟悉掌握医保基金监管规则，通过智能化方式主动合规、持续合规。从源头上减少使用医保基金违法违规行为发生。定点医药机构在“两库”运用过程遇到的问题或意见建议可反馈至邮箱：779234836@qq.com附件：第二批智能监管库规则对应的知识点明细

Delivery Method:VIA UNITED PARCEL SERVICEReference #:320-26-123Product:DrugsOver-the-Counter DrugsRecipient:Mr. Robert T. FulopDirector of Site OperationsBausch & Lomb Inc.8500 Hidden River ParkwayTampa, FL 33637-1014United States (b)(4)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesSeptember 4, 2026WARNING LETTERReference number: 320-26-123To Mr. Robert T. Fulop:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA InspectionViolations were observed and documented during an inspection of your drug manufacturing facility, Bausch & Lomb Inc., FDA Establishment Identifier (FEI) 1000113778, at 8500 Hidden River Parkway, Tampa, from March 12 to 20, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your April 10, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).Inadequate Monitoring of Aseptic ProcessingYour firm is a manufacturer of sterile prescription and over-the-counter (OTC) (b)(4) drug products produced by aseptic processing. Your environmental monitoring (EM) program and personnel monitoring (PM) was inadequate for classified areas used to produce your sterile (b)(4) drug products. For example,Your program did not sufficiently monitor significant locations (e.g., phones used in the aseptic processing area).EM procedures used to evaluate the aseptic processing environment were insufficient.Media used to support your EM program was observed to be inadequate to support growth of recovered contamination (e.g., cracked media).From 2023 to 2025 you routinely recovered microorganisms from aseptic ISO 5 areas (air, surface, and personnel) that were out-of-limit (OOL). Notably, recovered microbes in the aseptic processing environment included gram-negative rods such as Serratia marcescens and Stenotrophomonas maltophilia, organisms frequently associated with water sources, suggesting a moisture-related contamination issue. You continued (b)(4) drug production without adequate corrective action and preventive action (CAPA) measures to address the persistent microbiological contamination in your ISO 5 environments that posed a risk to product sterility.Manufacturing Design and Unidirectional AirflowYour restricted access barrier system (RABS) line (b)(4) included design deficiencies, including (b)(4) placement that led to ergonomic difficulties (e.g., when (b)(4) transferring sterilized components (b)(4)). We also noted that line (b)(4) had insufficient barrier protection. In addition, your dynamic smoke studies failed to sufficiently demonstrate unidirectional airflow protection across multiple lines (e.g., during equipment setup and assembly in the filling areas).Basic design deficiencies and excessive recoveries of microorganisms from ISO 5 areas indicate that there is significant inherent contamination risk in your current operation.Your response indicates that your aseptic processing operation is in control based on EM data, sterility test results, and foreign matter complaint rates. Your response also states that you have implemented procedural changes for (b)(4) loading and added mandatory disinfection requirements following recovery of fungi or gram-negative rods from ISO 5 and ISO 7 areas.Overall, your response fails to address how you will ensure adequate aseptic processing operations, proper future assessment of your EM and PM data to support your aseptic processes, and appropriate interpretation and assessment of consumer complaint samples. You also lack a commitment to implement significant design remediations.It should be noted that a sterility test, while a critical quality control for drug products that purport to be sterile, cannot be solely relied upon as justification to release drug product batches. The test is only the last in a series of design provisions and controls intended to protect the consumer from distribution of an unsafe batch.The ISO 5 processing environments are critical because sterile products are exposed during aseptic production and therefore vulnerable to contamination if operations are not well designed and diligently controlled. Your aseptic processes should be designed, and operations executed, to prevent contamination hazards to your sterile product. Flaws in the design of cleanrooms and aseptic processing lines, or improper execution of operations, can promote influx of contamination into the critical processing area.You also failed to adequately investigate microbiological departures from action limits and adverse trends in your water for injection system and environmental and personnel monitoring programs. Your investigations did not evaluate the persistent recovery of microorganisms over time, and you did not perform adequate microorganism identification. Notably, microorganisms recovered from your facility, including Pseudomonas aeruginosa and Aspergillus brasiliensis, were the same genus and species as those recovered from several consumer complaint samples.In response to this letter, provide:An independent, comprehensive review of your EM program to ensure vigilant, timely detection and response to potential product contamination hazards in your manufacturing environment. This assessment should include, but not be limited to, the following:o Establishing appropriate limitso Sampling methodso Sampling locations and frequencieso Trend analysiso Appropriate investigation of deviations and adverse trendso A CAPA plan based on the findings of the assessmentA comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards.A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.Complete investigations into all batches with potential objectionable microbiological contamination or an OOL microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.Appropriate microbiological batch release specifications (i.e., total counts, identification of bioburden to detect objectionable microbes) for each of your drug products.All microbiological test methods used to analyze each of your drug products.A summary of results from testing retain samples of all drug product batches within expiry. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients and microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOL result, indicate the corrective actions you will take, including notifying customers and initiating recalls.Perform a critical evaluation of airflow unidirectionality in your aseptic process, with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions, with thorough and complete evaluations of aseptic processing line airflow unidirectionality, including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.2. Your firm failed 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 and sterilization processes (21 CFR 211.113(b)).Poor Aseptic Technique and Cleanroom BehaviorYour operators were observed repeatedly exhibiting poor aseptic practices during filling operations on (b)(4) line (b)(4), including, but not limited to, the following:Operators reached over exposed (b)(4) bottles while (b)(4) to remove jammed bottles.Operators failed to disinfect (b)(4) (e.g., prior to handling sterile supplies and between use of different (b)(4)).(b)(4) contacted (b)(4) housing and blocked unidirectional air to open sterilized bottles.(b)(4) contacted sterile portions of aseptic tweezers used to remove jammed bottles, and operators returned those bottles back to the (b)(4).Bags used to transfer sterile components (bottles) were exposed to the ISO 7 environment prior to manipulation with (b)(4) and contacted internal portions of the (b)(4) housing.Operators used (b)(4) to push trash into a receptacle located below the processing line rather than using equipment dedicated for this purpose.In your response, you commit to updating your personnel training and using (b)(4) aseptic training (b)(4). Your response does not address the failure of the operations and quality unit to detect and require remediation of these significant aseptic processing hazards. Your response also fails to address how your operations and quality unit will proactively oversee and maintain ongoing control over aseptic conditions, processes, and finished product.Other aseptic line deficiencies were also observed during our inspection. For example, line (b)(4) included aseptic setup hazards related to personnel and line design that could compromise the sterility of product contact equipment.In addition, your process simulations (media fill) were inadequate. Data indicated that the total number of units in your media fills were substantially smaller than your aseptically produced commercial batch sizes and did not sufficiently represent the contamination risks associated with your aseptic processing lines. Significantly, you documented a media fill failure on line 16 in July 2025, in which two units demonstrated fungal (Neovaginatispora magiferae) and spore forming gram-positive Geodermatophilus obscurus, contamination, respectively.See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.In response to this letter, provide:A comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to, the following:o All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)o Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom spaceo Air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flowo Facility layouto Personnel flow and material flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers)o Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessmentA detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of (b)(4) aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.Your systematic plan to assure adherence to appropriate aseptic practices, cleanroom behavior, and written procedures, including but not limited to an independent assessment of the following with accompanying CAPA:o Suitability of actual practices based on extensive retrospective review and prospective observation of aseptic processing operationso Deficiencies in production management oversight, and identification of specific improvements to ensure effective and routine supervisory oversight for all batcheso Frequency and depth of quality unit oversight (e.g., audit, ad hoc, daily interactions) of aseptic processing and its support operationso Adequacy of written proceduresIneffective Quality SystemSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.Request for a Meeting with FDAAfter you submit your response to this warning letter, we recommend you reach out to this office to arrange for a teleconference to discuss your corrective actions and preventive actions in detail. Direct your request to Kathryn Hall Kathryn.Hall@fda.hhs.gov and cc: CDER-OC-OMQ-Communications@fda.hhs.gov.ConclusionYou are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356c(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter1. Identify your written response with FEI 1000113778 and ATTN: Compliance Officer Matthew R. Dionne, in the letter or /in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.FDA posts warning letters to www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration__________________________1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

2026年8月18日，江西省药品监督管理局在官方网站公示拟注销415家企业《互联网药品信息服务资格证书》或互联网药品信息服务备案。经核查确认，现依法对第一批不符合备案条件的301家企业所持《互联网药品信息服务资格证书》或互联网药品信息服务备案予以注销。特此公告。附件：1.注销互联网药品信息服务资格证书或备案企业名单江西省药品监督管理局2026年9月14日

经核查，执业药师王伟、李慎考等10人存在“挂证”行为，现依据《执业药师注册管理办法》第三十四条之规定，依法撤销其《执业药师注册证》，三年内不予注册，并将其个人不良信息记入全国执业药师注册管理信息系统。特此公告。附件：撤销《执业药师注册证》人员名单.pdf河北省药品监督管理局

附件：2026年2季度上海市药品不良反应监测报告.pdf