引言：昨日，美国食品药品监督管理局（FDA）公布了一封对销售调配药品机构发出的警告信。该信基于FDA 2025年12月对该公司网站内容的审查，指出其网站提供的司美格鲁肽和替尔泊肽等调配药品存在宣传误导问题。下面对信中指出的问题进行分析 ：

1、标签标注与实际不符

该网站展示的调配药品标签上显示公司名称，暗示该公司是这些药品的调配方。根据FDA的认定，该企业并非这些药品的实际调配方，标签标注与实际情况不符。

2、“仿制调配药品”表述不当

网站使用“generic compounded medication”（仿制调配药品）描述其产品。这一表述存在概念混淆：

• generic：译为“仿制药”，指与原研药具有相同活性成分、剂型、规格、给药途径且已获得FDA批准、证明其与品牌药具有生物等效性的药品；
• compounded drug：译为“调配药”，指药房或外包设施根据处方为特定患者混合、配制药物，非大规模工业化生产，根据处方为特定患者配制的药品，未经FDA批准。

将两者混为一谈，可能使消费者误以为这些调配药已获得FDA批准或与获批仿制药具有同等药效。

3、借助原研药暗示产品属性

网站声称其产品含有“Semaglutide (the active ingredient used in Ozempic® and Wegovy®)”和“Tirzepatide (active ingredient used in Mounjaro®)”。

从化学成分角度而言，此类表述在技术上是准确的。但从消费者认知角度看，这种表述可能被理解为该产品与知名原研药具有相同的安全性和有效性。这种暗示被判定为虚假或误导性。调配药品未经FDA审评，其安全性、有效性和质量可控性未经过官方评估。

监管视角

本封信的关注点从生产现场延伸至企业网站。FDA对于药品合规的审查，不限于生产环节，也覆盖产品上市后的标签及宣传行为，体现其全产业链的监管思路。

此次被点名的产品——司美格鲁肽和替尔泊肽——是当前关注度较高的热门减肥/降糖药物 。FDA选择以此类产品为例发出警告信，传递出清晰的信号：热点药物的合规问题更容易进入监管视野，从生产到宣传，任何环节的疏漏都可能触发监管行动。

Warning Letter警告信(中英对照)

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content in December 2025 and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. 1As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products 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)], result 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)].

本函旨在通知贵公司，美国食品药品监督管理局（FDA）于2025年12月审查了贵公司网站的内容，并注意到贵公司网站提供调配药品，包括司美格鲁肽和替尔泊肽药品。¹ 如下所述，贵公司网站关于调配司美格鲁肽和替尔泊肽产品的虚假或误导性声明，违反了《联邦食品、药品和化妆品法案》（FDCA）第502(a)条和第502(bb)条，导致相关产品在州际贸易中引入或交付引入，违反了FDCA第301(a)条。

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.

根据FDCA第502(a)条，如果药品的标签在任何方面具有虚假或误导性，则该药品属于错标药品。此外，根据FDCA第502(bb)条，如果调配药品的广告或宣传在任何方面具有虚假或误导性，则该调配药品属于错标药品。

The compounded semaglutide and tirzepatide products displayed on your website identify “P** Health” on the pictured label, suggesting P** Health is the compounder of those drugs when in fact it is not.2 Accordingly, the representations on your website that P** Health is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].

贵公司网站上展示的调配司美格鲁肽和替尔泊肽产品，其图片标签上显示“P** Health”，暗示P** Health是这些药品的调配方，而事实上并非如此。² 因此，贵公司网站上关于P** Health是这些药品调配方的陈述是虚假或误导性的，根据FDCA第502(a)条和第502(bb)条，这些产品属于错标药品。

Additionally, the following claims concerning compounded semaglutide and tirzepatide products appear on your website:

此外，贵公司网站上出现了以下关于调配司美格鲁肽和替尔泊肽产品的声明：

• “generic compounded medication” 仿制调配药品
• “Semaglutide (the active ingredient used in Ozempic® and Wegovy®)” 司美格鲁肽——（Ozempic®和Wegovy®中使用的活性成分）
• “Tirzepatide (active ingredient used in Mounjaro®)” 替尔泊肽——（Mounjaro®中使用的活性成分）

Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have 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)].

调配药品未经FDA批准。贵公司的声明暗示其产品已获得FDA批准或以其他方式经过安全性和有效性评估，而事实并非如此。因此，这些声明是虚假或误导性的，根据FDCA第502(a)条和第502(bb)条，贵公司的产品属于错标药品。

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 representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.

在州际贸易中引入或交付引入这些错标产品，属于FDCA第301(a)条禁止的行为。本函中认定的陈述和声明旨在告知贵公司我们的关切，但并不代表所有违规行为的详尽清单。

For 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)].

基于上述原因，贵公司的调配司美格鲁肽和替尔泊肽产品是根据FDCA第502(a)条和第502(bb)条认定的错标药品，其在州际贸易中引入或交付引入的行为违反了FDCA第301(a)条。请注意，在州际贸易中接收错标药品，以及交付或提议交付此类药品，也违反了FDCA第301(c)条。

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. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the Act, including the new drug approval requirements.

如前所述，本函引用的违规行为并非旨在全面陈述可能与贵公司产品相关的所有违规行为。贵公司有责任调查并确定任何违规行为的原因，并防止其再次发生或发生其他违规行为。贵公司有责任确保其运营符合联邦法律的所有要求，包括FDA法规。例如，调配药品必须满足FDCA第503A条或第503B条的条件，才能豁免该法案下的某些要求，包括新药批准要求。

You should take immediate 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.

贵公司应立即采取行动解决任何违规行为。未能充分解决任何违规行为可能导致法律行动，恕不另行通知，包括但不限于查封和禁令。

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 any violations, as well as copies of related documentation. Such steps may include:

请在收到本函后十五（15）个工作日内，向药品审评与研究中心（CDER）合规办公室下属的调配质量与合规办公室（OCQC）提交书面回复，说明为解决任何违规行为所采取的具体步骤。请附上为防止任何违规行为再次发生而采取的每一步骤的解释，以及相关文件的副本。此类步骤可包括：

1) Identifying the entities that produce the compounded products offered on your website; 确定贵公司网站上提供的调配药品的生产实体；

2) Providing a representative sample of labeling for such products; 提供此类药品的代表性标签样本；

3) Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)]. 说明网站上其他可能被解释为虚假或误导性声明的依据，或证明此类声明已根据FDCA第502(a)条和第502(bb)条进行了修改或删除。

This letter notifies you of our concerns and provides you an opportunity to address them. In your written response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. 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.

本函旨在告知贵公司我们的关切，并为贵公司提供解决问题的机会。在贵公司对本函的书面回复中，可以补充信息供我们参考，我们将继续评估贵公司的活动与实践。如果贵公司无法在十五（15）个工作日内完全解决此事，请说明延迟的原因以及预计完成的时间。

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 products that cannot be legally sold to consumers in the U.S.

如果贵公司不在美国境内，请注意，涉嫌错标的产品可能会被扣留或拒绝入境。我们可能会通知贵公司所在国的相关监管官员，贵公司上述产品涉嫌为错标产品，不能合法销售给美国消费者。

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.

所有信函应在主题行中明确标识为“对警告信的回复”。如果对本函内容有疑问，请联系compoundinginspections@fda.hhs.gov。

_______________________

注释：

1 The 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.

贵公司网站上提供的司美格鲁肽和替尔泊肽产品属于FDCA第201(g)条定义的药品，因为它们旨在用于疾病诊断、治愈、缓解、治疗或预防，和/或旨在影响身体结构或任何功能。此外，它们属于FDCA第201(p)条定义的新药，因为其标示用途尚未被普遍认为是安全和有效的。

2 See also 21 CFR § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 CFR § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FDCA [21 USC § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FDCA [21 USC § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 USC § 353(b)(2)].

另见21 CFR § 201.1(h)(2)：“药品标签上出现某人的姓名而未加限定，即表示该人是该产品的独家生产商。如果该人并非根据本节规定生产该产品，则该表示是虚假和误导性的，且该药品根据法案第502(a)条属于错标药品。”；FDCA第503(b)条，FDCA第503B(a)(10)(A)(ii)条。我们注意到，21 CFR § 201.1(a)不适用于根据FDCA第503(b)(1)条调配的药品。然而，参见45 Fed. Reg. 25760, 25765（1980年4月15日）： “……如果药剂师调配的处方药标签上确实包含有关生产商、包装商或经销商的陈述，则必须遵守§ 201.1的所有规定……” 此外，贵公司网站上显示的药品标签并未表明它们是依据FDCA第503(b)(1)条调配的，也似乎不符合第503(b)(2)条的要求。