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FDA警告信22/08/16--标签错误或药物未经FDA批准(中英文)

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标签错误或药物未经FDA批准,FDA发出警告信。
WARNING LETTER
Tramadol US
MARCS-CMS 634444 — AUGUST 16, 2022
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) has observed that Tramadol US introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].
兹通知企业,美国(U.S.)美国食品和药物管理局(FDA)已观察到,曲马多美国将虚假品牌和未获批准的新药引入州际商业,违反了联邦食品、药物和化妆品法案(FD&C法案)第301(a)、301(d)、301(k)、503(b)和505(a)条[21 U.S.C.§§331(a)、331(d)、331(k)、353(b)和355(a)]。
As discussed below, FDA has observed that Tramadol US introduces into interstate commerce unapproved and misbranded opioid drug products. 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.
如下所述,FDA已经观察到美国曲马多公司将未经批准和品牌错误的阿片类药物产品引入州际商业。阿片类药物成瘾和滥用造成了巨大的公共卫生危机,死亡人数惊人。鉴于阿片类药物泛滥的严重程度,通过互联网轻松获得阿片类药物给美国消费者带来了巨大的风险。
FDA has also observed that Tramadol US introduces into interstate commerce 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.
FDA还注意到,美国曲马多公司在州际贸易中引入了贴错标签的苯二氮杂卓。苯二氮卓类药物是公认有可能被滥用的药物产品,必须解决其非医疗用途对公共健康的影响。苯二氮卓的非医疗用途广泛,人们经常将苯二氮卓与酒精、处方类阿片类药物和非法药物共同使用。苯二氮卓非医疗用途的相关危害是巨大的,但主要发生在人们将苯二氮卓与其他药物结合使用时。
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. The easy availability of benzodiazepines via the Internet poses additional significant risks to U.S. consumers.
此外,在苯并二氮杂卓与其他物质共同使用的情况下,医疗后果通常比仅使用苯并二氮杂卓的情况更为严重。在记录涉及苯二氮杂卓的过量死亡案例中,绝大多数是由多物质过量死亡造成的。通过互联网容易获得苯二氮对美国消费者构成了额外的重大风险。
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 Tramadol US cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
消费者购买未经批准的新药和假冒药品存在固有风险。未经批准的新药不像那些受FDA监管的药物那样具有安全性和有效性的保证。绕过监管保障措施的药物可能是受污染的、假冒的、含有不同数量的有效成分,或者含有不同的成分。因此,FDA要求曲马多美国公司停止向美国消费者出售任何未经批准和假冒的药物。这对于保护美国公众免受伤害至关重要。
Unapproved New Drugs:

未经批准的新药:

Certain products offered for sale by Tramadol US 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) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.
曲马多US提供销售的某些产品是FD&C法案[21 U.S.C.§321(g)]第201(g)条含义内的药物,因为它们旨在用于诊断、治愈、缓解、治疗或预防疾病和/或因为它们旨在影响身体的结构或功能。这些药物也是FD&C法案(21 U.S.C.§321(p))第201(p)条定义的新药,因为它们通常不被认为对其标签用途是安全有效的。如FD&C法案[21 U.S.C.§355(a)]第505(a)条所述,除此处不适用的某些例外情况外,未经FDA事先批准,新药不得合法引入或交付用于州际贸易。根据FD&C法案第505条批准的申请对这些产品无效。因此,它们引入或交付州际贸易违反了《FD&C法案》第301(d)条[21 U.S.C.§331(d)]和505(a)条。
For example, Tramadol US offers tramadol marketed as “Tramadol 100mg,” described as used to “help to treat moderate pain and difficulty in adults.” While there are FDA-approved versions of tramadol 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 the “Tramadol 100mg” offered by Tramadol US. FDA-approved tramadol is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate and is only available pursuant to a prescription from a licensed practitioner. FDA-approved tramadol 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. The boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.
例如,曲马多美国公司(Tramadol US)提供的曲马多在市场上称为“100毫克曲马多”,被描述为用于“帮助治疗成人的中度疼痛和困难”。虽然美国市场上有FDA批准的曲马多版本,但没有根据FD&C法案第505条批准的由美国曲马多公司提供的“曲马多100mg”的药物申请。经FDA批准的曲马多用于治疗严重到需要阿片类镇痛药的疼痛,替代治疗不充分,只能根据执业医生的处方购买。FDA批准的曲马多带有一个方框警告,通常称为“黑框警告”,这是FDA要求的最强烈的警告,表明该药物存在严重甚至危及生命的不良反应的重大风险。加框的警告涉及成瘾、滥用、误用、危及生命的呼吸抑制(呼吸问题)和新生儿阿片类药物戒断综合征(新生儿戒断症状)等风险。此外,当与其他中枢神经系统抑制剂(包括酒精和苯二氮卓类药物)联合使用时,可能导致昏迷或死亡。
Tramadol US also offers oxymorphone, including a product marketed as “Opana ER 15mg.” Tramadol US describes “Opana ER” as “an opioid pain medication belonging to the group of drugs called narcotic analgesics,” and as a medicine that “has the potential to mitigate severe pain.” There are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Opana ER 15mg” offered by Tramadol US.1 FDA-approved drug products containing oxymorphone are only available pursuant to a prescription from a licensed practitioner.
曲马多美国公司也提供羟吗啡酮,包括一种名为“Opana ER 15mg”的产品。曲马多美国公司将“Opana ER”描述为“一种阿片类镇痛药,属于麻醉性镇痛药”,是一种“有可能减轻严重疼痛”的药物。没有根据FD&C法案第505条批准的由曲马多提供的“Opana ER 15mg”的药物申请。FDA批准的含有羟吗啡酮的药品只有根据执业医师的处方才能获得。
Misbranded Drugs:

错标药品:

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, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
根据FD&C法案(21 U.S.C.§352(f)(1))第502(f)(1)条),如果药品的标签上没有足够的使用说明,那么该药品属于错标药品。“适当的使用说明”是指非专业人员可以根据该说明安全使用药物,并按药物的预期用途使用药物(见21 CFR 201.5)。FD&C法案[21 U.S.C.§353(b)(1)]第503(b)(1)条定义的处方药包括:由于其毒性或其他潜在的有害影响,和/或其使用方法,和/或其使用所需的附带措施,除非在获得法律许可的执业医师监督下使用,否则不安全。根据FD&C法案第503(b)(1)(A)条的定义,处方药只能在有执照的从业人员的指导和监督下安全使用。
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 drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because the 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, Tramadol US 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)].
由于上述药物是针对非专业人员无法自行诊断和治疗的情况而使用的处方药,因此无法编写足够的说明,让非专业人员可以安全地使用这些药物。因此,这些药物的标签没有足够的使用说明,导致他们在FD&C法案的第502(f)(1)条下被定义为错标。此外,由于这些药物在美国未获批准,它们也不能根据21 CFR 201.115(a)豁免FD&C法案第502(f)(1)条的要求。通过向美国消费者出售这些药物,曲马多美国正在导致错误品牌的药物进入州际贸易,违反了FD&C法案第301(a)条[21 U.S.C.§331(a)]。
Additionally, FDA has observed that Tramadol US offers prescription drugs for sale without a prescription. For example, on your website www.yellowxanaxbarsforsale.com, Tramadol US offers alprazolam marketed as “Yellow Xanax Bars” described as “a moderate strength of alprazolam with 2mg of active drug.” In the description for Yellow Xanax Bars, Tramadol US states, “You can order Yellow Xanax online to manage generalized anxiety disorder, panic attacks, and social anxiety disorder.” Tramadol US also states that “Yellow Xanax Bars” are available “Without Prescription.” FDA‐approved alprazolam is a benzodiazepine indicated for the acute treatment of generalized anxiety disorder in adults and treatment of panic disorder with or without agoraphobia in adults and is only available by prescription. FDA‐approved alprazolam bears a boxed warning that includes risks associated with the concomitant use of benzodiazepines and opioids, which may result in profound sedation, respiratory depression, coma, and death. In addition, the boxed warning addresses risks including abuse, misuse, addiction, and physical dependence.
此外,FDA注意到曲马多美国公司提供的处方药没有处方就可以销售。例如,在企业的网站www.yellowxanaxbarsforsale.com上,曲马多美国公司以“黄色阿普唑仑棒”为卖点,描述为“中等强度的阿普唑仑加2mg活性药物”。在黄色阿普唑仑棒的描述中,曲马多美国公司表示,“可以在网上订购黄色阿普唑仑,以缓解广泛性焦虑障碍、恐慌发作和社交焦虑障碍。”曲马多美国公司还表示,“黄色阿普唑仑棒”可以“非处方”购买。FDA批准的阿普唑仑是一种苯二氮卓类药物,用于成人广泛性焦虑障碍的急性治疗,以及治疗伴有或不伴有广泛恐惧症的成人惊恐障碍,仅凭处方供应。FDA批准的阿普唑仑有一个加框警告,其中包括与苯二氮杂卓类药物和阿片类药物同时使用的风险,可能导致深度镇静、呼吸抑制、昏迷和死亡。此外,框内警告还涉及滥用、误用、成瘾和身体依赖等风险。
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 without requiring a prescription, Tramadol US jeopardizes patient safety and misbrands the drug under section 503(b)(1) of the FD&C Act. 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)].
根据美国法律,处方药只能根据法律许可管理处方药的医疗保健从业人员的处方来配发。通过在不需要处方的情况下提供上述药物,曲马多US危害了患者安全,并根据FD&C法案第503(b)(1)条对药物进行了错标。在没有处方的情况下配发处方药是一种导致该药物在待售时被错标的行为,违反了FD&C法案第301(k)条[21 U.S.C.§331(k)]。
FDA is sending this warning letter to Tramadol US 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. Furthermore, included below is a list of websites identified as part of your network (this is not intended to be all‐inclusive). 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 drugs 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 products in violation of the FD&C Act.
FDA向曲马多美国公司发出这封警告信,是因为消费者购买错误品牌和未经批准的新药会面临固有风险。本函并非旨在确定您的产品或运营可能违反法律的所有方式。此外,以下列出了企业的网络中的一些网站(这并不包括所有的网站)。企业有责任确保提供销售的所有产品符合FD&C法案及其实施法规。贵司应立即采取行动处理任何违反FD&C法案的行为(可能包括出售除上述药物以外类似的错误品牌和/或未经批准的新药)。我们建议企业查看网站、产品标签和其他标签和宣传材料,以确保企业没有误导性地宣称 产品在未获得FDA批准的用途上是安全有效的,并且企业没有分销错误品牌的产品,违反FD&C法案。
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.
请在15个工作天内以书面通知本办公室,说明企业已采取的具体步骤,以解决任何违反规定的情况,并防止其再次发生。包括为整改和防止任何违规事件再次发生而采取的每一步骤的说明,以及相关文件的副本。未能充分解决此问题可能导致不另行通知的法律行动,包括但不限于扣押和禁令。如果不能在15个工作日内完成纠正措施,请说明延迟的原因以及企业将完成纠正的时间。这封信告诉企业FDA的担忧,并为企业提供了一个解决它们的机会。如果企业认为产品没有违反FD&C法案,请在15个工作日内提供理由和任何支持信息供FDA考虑。
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.
如果企业不是位于美国,请注意,产品似乎是错误的品牌或未经批准的新药可能会被拘留或拒绝入境。我们可能会向企业所在国家的相关监管官员建议,企业的上述产品似乎是未经批准的和错误品牌的产品,不能合法销售给美国的消费者。
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
请将企业的回复和任何询问直接发送至FDA FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov。
Sincerely,
/S/
S.Leigh Verbois, Ph.D.
Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Table of Websites: 网站列表:
Connecting URL 连接URL
tramadolus.org
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purduepharm.com
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buyadderallpill.com
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www.protocadmus.com
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painmedication.online
ambien10mg.org
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1 In December 2020, at the request of Endo Pharmaceuticals, Inc., FDA announced that it was withdrawing approval of the new drug application (NDA) for OPANA (oxymorphone hydrochloride) extended‐release (ER) tablets, 5 milligrams (mg), 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg, held by Endo Pharmaceuticals, Inc. (Accessible at https://www.federalregister.gov/documents/2020/12/23/2020-28283/endo-pharmaceuticals-inc-withdrawal-of-approval-of-a-new-drug-application-for-opana-oxymorphone)
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发布于 2022-08-25 08:33:27 © 著作权归作者所有
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