为进一步加强化妆品质量监管，切实保障公众化妆品使用安全，根据2025年陕西省化妆品监督抽检计划，陕西省药品监督管理局组织在全省范围开展化妆品监督抽检工作。现对2批次不符合标准规定产品予以公告（见附件）。针对监督抽检中发现的不合格化妆品，陕西省药品监督管理局已要求各相关地药品监管部门对不合格化妆品生产经营单位进行依法处置。特此公告。附件：陕西省化妆品监督抽检不符合标准规定产品名单陕西省药品监督管理局2026年3月10日（公开属性：主动公开）附件陕西省化妆品监督抽检不符合标准规定产品名单

序号1企业名称丹东医创药业有限责任公司企业类型药品生产检查时间2026年1月26日-2026年1月30日所在地市丹东市检查依据《中华人民共和国药品管理法》、《药品生产监督管理办法》、《药品生产质 量管理规范》检查事项药品生产检查方式常规检查（日常）检查内容检查企业贯彻执行《中华人民共和国药品管理法》、《药品生产监督管理办法》、《药品生产质 量管理规范》等法律法规情况存在问题在人员管理方面，存在部分岗位人员培训不到位的问题；在文件管理方面，存在个别记录内容不完整，个别文件内容不完善的问题；在生产管理方面，存在个别操作与文件规定不一致的问题；在设备管理方面，存在个别设备未及时校准的问题。处理措施限期整改整改情况已按《药品生产监督检查缺陷整改指南（试行）》的要求完成整改。

河北胡氏宇博药业有限公司：我局在2026年1月和2026年3月的两次现场检查中，发现你公司存在未遵守《药品生产质量管理规范》的行为，已分别对你公司采取暂停生产和销售的风险控制措施，范围包括中药饮片、毒性饮片。2026年4月，经我局对你公司进行现场检查，确认此前检查发现的中药饮片风险隐患已消除。依据《药品生产监督管理办法》第五十九条第三款规定，现依法解除对你公司的部分风险控制措施，解除范围：中药饮片的生产、销售。河北省药品监督管理局2026年4月14日（信息公开类型：主动公开）

主体名称桐乡市崇溪中医诊所有限公司处罚决定书文号桐市监处罚﹝2026﹞612号处罚类别没收违法所得处罚决定时间2026-04-14处罚内容当事人使用的炒酸枣仁经嘉兴市食品药品与产品质量检验检测院检验,未检出酸枣仁皂苷A的成分,不符合《中国药典》2020年版一部的规定。根据《中华人民共和国药品管理法》第一百二十一条“对假药、劣药的处罚决定,应当依法载明药品检验机构的质量检验结论。”的规定,该炒酸枣仁经嘉兴市食品药品与产品质量检验检测院、嘉兴市市场监督管理局认定,符合《中华人民共和国药品管理法》第九十八条第二款第(一)项“有下列情形之一的,为假药:(一)药品所含成份与国家药品标准规定的成份不符……”规定的假药定义。当事人上述行为违反了《中华人民共和国药品管理法》第九十八条第一款“禁止生产(包括配制,下同)、销售、使用假药、劣药……”的规定,属使用假药的违法行为。因当事人购进上述药品时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,且有充分证据证明其不知道使用的药品为假药,根据《中华人民共和国药品管理法实施条例》第七十五条:“药品经营企业、医疗机构未违反《药品管理法》和本条例的有关规定,并有充分证据证明其不知道所销售或者使用的药品是假药、劣药的,应当没收其销售或者使用的假药、劣药和违法所得;但是,可以免除其他行政处罚。”的规定,决定减轻处罚(仅没收违法所得)。根据《中华人民共和国药品管理法》第一百一十九条:“药品使用单位使用假药、劣药的,按照销售假药、零售劣药的规定处罚;情节严重的,法定代表人、主要负责人、直接负责的主管人员和其他责任人员有医疗卫生人员执业证书的,还应当吊销执业证书。”、第一百一十六条:“生产、销售假药的,没收违法生产、销售的药品和违法所得,责令停产停业整顿,吊销药品批准证明文件,并处违法生产、销售的药品货值金额十五倍以上三十倍以下的罚款;货值金额不足十万元的,按十万元计算;情节严重的,吊销药品生产许可证、药品经营许可证或者医疗机构制剂许可证,十年内不受理其相应申请;药品上市许可持有人为境外企业的,十年内禁止其药品进口。”、《中华人民共和国药品管理法实施条例》第七十五条的规定,决定对当事人处罚如下:没收违法所得217.62元。罚款金额（万元）0.000000没收违法所得0.021762暂扣或吊销证照名称及编号-违法行为类型桐乡市崇溪中医诊所有限公司销售假药案处罚依据《中华人民共和国药品管理法》第一百一十九条药品使用单位使用假药、劣药的,按照销售假药、零售劣药的规定处罚;情节严重的,法定代表人、主要负责人、直接负责的主管人员和其他责任人员有医疗卫生人员执业证书的,还应当吊销执业证书。;违法事实主要违法事实:当事人桐乡市崇溪中医诊所有限公司经营中医诊疗服务,具有中医诊所备案证,备案编号为MA*****7D2182,诊疗范围为中医科,备案日期为2023年6月27日。2023年10月27日,当事人从湖北**药材科技有限公司处采购了批次号为230504的炒酸枣仁0.5千克,批号:230504,生产许可证号:鄂20***7,执行标准:《中国药典》2020年版,内附合格证,盖有湖北**药材科技有限公司质检专用章,进货单价为930元每千克,进货总价为465元。当事人于2023年10月30日收到该批次炒酸枣仁,并于同日对该药品进行进货检查验收,当事人核对药品票、货、证的一致性,核对外观情况,质量情况,验收结论为合格。经核对验收后,当事人将上述炒酸枣仁置于自己店铺内销售。2024年5月8日,我局收到嘉兴市市场监督管理局假药认定意见(嘉市监药认(2024)2号)认定上述批次炒酸枣仁符合《中华人民共和国药品管理法》第九十八条第二款第(一)项“有下列情形之一的,为假药:(一)药品所含成份与国家药品标准规定的成份不符……”之规定的假药定义。认定该批次炒酸枣仁为假药。另查明,当事人店内批次号为230504的炒酸枣仁仅于2024年2月22日售出450克,单价为1.4136元/克,销售金额为636.12元,违法所得217.62元。行政处罚种类、依据、内容:当事人使用的炒酸枣仁经嘉兴市食品药品与产品质量检验检测院检验,未检出酸枣仁皂苷A的成分,不符合《中国药典》2020年版一部的规定。根据《中华人民共和国药品管理法》第一百二十一条“对假药、劣药的处罚决定,应当依法载明药品检验机构的质量检验结论。”的规定,该炒酸枣仁经嘉兴市食品药品与产品质量检验检测院、嘉兴市市场监督管理局认定,符合《中华人民共和国药品管理法》第九十八条第二款第(一)项“有下列情形之一的,为假药:(一)药品所含成份与国家药品标准规定的成份不符……”规定的假药定义。当事人上述行为违反了《中华人民共和国药品管理法》第九十八条第一款“禁止生产(包括配制,下同)、销售、使用假药、劣药……”的规定,属使用假药的违法行为。因当事人购进上述药品时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,且有充分证据证明其不知道使用的药品为假药,根据《中华人民共和国药品管理法实施条例》第七十五条:“药品经营企业、医疗机构未违反《药品管理法》和本条例的有关规定,并有充分证据证明其不知道所销售或者使用的药品是假药、劣药的,应当没收其销售或者使用的假药、劣药和违法所得;但是,可以免除其他行政处罚。”的规定,决定减轻处罚(仅没收违法所得)。根据《中华人民共和国药品管理法》第一百一十九条:“药品使用单位使用假药、劣药的,按照销售假药、零售劣药的规定处罚;情节严重的,法定代表人、主要负责人、直接负责的主管人员和其他责任人员有医疗卫生人员执业证书的,还应当吊销执业证书。”、第一百一十六条:“生产、销售假药的,没收违法生产、销售的药品和违法所得,责令停产停业整顿,吊销药品批准证明文件,并处违法生产、销售的药品货值金额十五倍以上三十倍以下的罚款;货值金额不足十万元的,按十万元计算;情节严重的,吊销药品生产许可证、药品经营许可证或者医疗机构制剂许可证,十年内不受理其相应申请;药品上市许可持有人为境外企业的,十年内禁止其药品进口。”、《中华人民共和国药品管理法实施条例》第七十五条的规定,决定对当事人处罚如下:没收违法所得217.62元。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关桐乡市市场监督管理局处罚机关统一社会信用代码11330483002559924T数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420

    根据《中华人民共和国药品管理法》及其实施条例规定，经我局依照《药品检查管理办法（试行）》组织现场检查，以下新开办企业符合《药品经营质量管理规范》规定的内容，现予以公告。    监督电话：0898-66811655通讯地址：海南省海口市南海大道53号邮    编：570216企业名称经营方式经营范围企  业所在地经营地址检查时间及检查类型现  场检查员海南博鳌乐城先行港医院管理有限公司批发中药饮片、中成药、化学药、生物制品（以上不含冷藏、冷冻药品）海南省琼海市海南省琼海市博鳌镇乐城国际医疗旅游先行区乐天路001号C327、C329室2026年03月24-25日（GSP符合性检查）林  丽林宏领刘云海特此公告。                                              海南省药品监督管理局                                                 2026年4月13日（此件主动公开）

行政处罚案件信息摘要行政处罚决定书文号湘药监械罚〔2026〕5号当事人湖南康富泰医疗器械有限公司 组织机构代码91430525MA4RAJ3Q77法定代表人卿国良违法类型未按照经注册的产品技术要求组织生产医疗器械行政处罚内容1.没收一次性使用无菌采样拭子2000支；2.处10000元罚款。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2026年4月14日备注

一、荔波县周某某贪污医保基金及受贿案例2018年至2024年，被告人周某某为让其母亲赵某某享受“特殊”医疗服务，利用担任荔波县人民医院院长的职务便利，安排其母亲长期在县人民医院ICU病房住院，通过编造住院记录、虚构医药服务项目、伪造虚假病历等方式，非法占有医保基金45万余元。2013年至2024年，被告人周某某利用担任荔波县人民医院副院长、院长等职务便利，在医药用品、医疗器械、耗材采购、工程项目承接、款项拨付等方面提供帮助，先后多次非法收受何某某、张某某等28人财物共计693万余元。2025年12月10日，荔波县人民法院作出一审判决：被告人周某某犯贪污罪，判处有期徒刑二年，并处罚金人民币十万元；犯受贿罪，判处有期徒刑十年六个月，并处罚金人民币六十万元。数罪并罚，决定执行有期徒刑十一年六个月，并处罚金人民币七十万元；退缴在案的贪污款由扣押机关依法发还被害单位；对被告人周某某受贿所得财物及孳息依法予以追缴，上缴国库。一审宣判后，被告人周某某不服判决，提起上诉。黔南州中级人民法院经审理，依法作出驳回上诉、维持原判的终审裁定。二、凯里市陈某某办理虚假住院骗取医保基金案例陈某某任凯里仁济医院院长期间，告知医院职工使用亲属朋友身份信息，在该院办理一次虚假住院可获得200元好处费。2022年8月至2023年9月，以非法占有为目的，通过办理虚假住院的方式骗取医保基金65704元。经相关部门立案侦查、起诉，凯里市人民法院于2025年9月受理后判决：被告人陈某某犯诈骗罪，判处有期徒刑三年，并处罚金20000元。被告人陈某某已退缴的违法所得65704元，由凯里市公安局发还凯里市医疗保障局。戴某某、彭某某退缴的好处费予以没收，由凯里市公安局上缴国库。三、盘州市柳某某利用享受特殊药品医保待遇倒卖特殊药品案例2023年11月2日，盘州市医保基金监管专项检查组到盘州市人民医院开展现场检查，发现盘州市人民医院原职工柳某某涉嫌利用享受特殊药品医保待遇倒卖药品。经盘州市医保局立案调查，柳某某利用享受特殊药品医保待遇，以600元左右每盒的价格向周某某转卖15盒甲磺酸奥希替尼片，获利9060元，涉及医保基金报销80631元。盘州市医保局对柳某某作出责令退回造成医保基金损失80631元，没收柳某某违法所得9060元，并处造成医保基金损失金额的5倍罚款403155元。经相关部门立案侦查、起诉，盘州市人民法院2025年6月受理后判决：被告人柳某某犯诈骗罪，判处有期徒刑三年，缓刑三年，并处罚金人民币二万元。四、长顺县梁某某冒用他人身份信息就医骗取医保基金案例2025年10月12日，长顺县医保局在核查疑点线索时，发现长顺县摆所镇村民梁某某，涉嫌冒用他人身份信息就医。经相关部门核实，梁某某因未按时缴纳个人医保费用，患病后无法享受医疗保障待遇，故隐瞒自己真实身份信息，冒用他人身份信息住院治疗和购买药品，涉及医保基金187582.94元。经相关部门立案侦查、起诉，长顺县人民法院2025年12月受理后判决：梁某某犯诈骗罪，判处有期徒刑一年二个月，缓刑，责令退赔。

Product:DrugsRecipient:Beauty of Aztlan LLCUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 2, 2026MARCS-CMS 723532Beauty of Aztlan LLC:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.beautyofaztlan.squarespace.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)]. As discussed below, FDA has observed that www.beautyofaztlan.squarespace.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.beautyofaztlan.squarespace.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.beautyofaztlan.squarespace.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].An example of unapproved botulinum toxin drug product you offer for sale on ww.beautyofaztlan.squarespace.com is botulinum toxin type A marketed as “Botulax 100units” and “Innotox 50units”. Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “Correction of blepharospasm” and “Hyperhidrosis (increased sweating)” under “Application Areas”.While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Botulax 100units” and “Innotox 50units” offered by www.beautyofaztlan.squarespace.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.beautyofaztlan.squarespace.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.beautyofaztlan.squarespace.com jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.beautyofaztlan.squarespace.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs 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 unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:Dry Springs PharmacyHong Kong SAR ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 1, 2026MARCS-CMS 723460Dry Springs Pharmacy:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.dryspringspharmacy.net and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)].As discussed below, FDA has observed that www.dryspringspharmacy.net introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.FDA has also observed that www.dryspringspharmacy.net introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.Finally, FDA has observed that www.dryspringspharmacy.net introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.dryspringspharmacy.net cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.dryspringspharmacy.net are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].An example of an unapproved opioid you offer for sale on www.dryspringspharmacy.net is oxycodone marketed as “OxyNorm” and “Oxycodone-Hydrochloride”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “OxyNorm is a Oxycodone/Hydrochloride combination is a combined opioid/non-opioid pain reliever used to relieve moderate to severe pain.” While there are FDA-approved versions of oxycodone on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “OxyNorm” and “Oxycodone-Hydrochloride” offered by www.dryspringspharmacy.net. FDA-approved oxycodone is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.FDA-approved oxycodone is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.An example of an unapproved benzodiazepine you offer for sale on www.dryspringspharmacy.net is alprazolam marketed as “Yellow Xanax” and “Yellow Xanax 2 mg Bars R039”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Xanax is used to treat anxiety disorders, panic disorders, and anxiety caused by depression.” While there are FDA-approved versions of alprazolam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Yellow Xanax” and “Yellow Xanax 2 mg Bars R039” offered by www.dryspringspharmacy.net. FDA-approved alprazolam (XANAX®) is indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia.FDA-approved alprazolam is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.An example of unapproved Schedule II stimulant you offer for sale on www.dryspringspharmacy.net is amphetamine (MAS) (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate tablets) marketed as “Adderall”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Adderall appears to improve brain development and nerve growth” and “Buy Adderall online legally here without prescription. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems.” While there are FDA-approved versions of amphetamine (MAS) on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Adderall” offered by www.dryspringspharmacy.net. FDA-approved amphetamine (MAS) (ADDERALL®) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat ADHD and narcolepsy.FDA-approved amphetamine (MAS) is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, this drug product can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including this drug product, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. By offering these drugs for sale to U.S. consumers, www.dryspringspharmacy.net is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.dryspringspharmacy.net jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.dryspringspharmacy.net because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs 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 unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research