Product:Biologics、DrugsRecipient:Kim Aubrey-LarcineseSenior Manager, Advertising & Promotion Global Regulatory AffairsCSL Behring1020 First AvenueKing of Prussia,PA19406United StatesIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesSeptember 9, 2025RE: BLA 125350/1472HIZENTRA (Immune Globulin Subcutaneous (Human))WARNING LETTERDear Ms. Aubrey-Larcinese:The U.S. Food and Drug Administration (FDA) has reviewed the Direct-to-Consumer broadcast advertisement (DTC TV ad),Live in Strength: Supermarket(USA-HIZ-0963), submitted at time of first use by CSL Behring (CSL) for HIZENTRA (Immune Globulin Subcutaneous (Human)) under cover of Form FDA 2253.1FDA has determined that this DTC TV ad overstates the effectiveness and minimizes the information about the safety of HIZENTRA. Thus, the DTC TV ad misbrands HIZENTRA and makes distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).See21 U.S.C. §§ 352(n), 321(n), & 331(a); cf. 21 CFR § 202.1(e)(1) & (e)(5). This is concerning from a public health perspective because it creates the misleading impression that HIZENTRA is more effective than has been demonstrated by substantial evidence and minimizes the risks of treatment with HIZENTRA.BackgroundAccording to the FDA-approved prescribing information (PI) for HIZENTRA:HIZENTRA is a 20% liquid subcutaneous immune globulin (IGSC) indicated for the treatment of (1) primary humoral immunodeficiency in adults and pediatric patients 2 years of age and older and (2) chronic inflammatory demyelinating polyneuropathy (CIDP) in adults, as a maintenance therapy or to prevent relapse of neuromuscular disability and impairment.HIZENTRA has a BOXED WARNING regarding the potential of thrombosis. It is contraindicated in patients who have 1) a history of anaphylactic or a severe systemic reaction to human immune globulin or ingredients such as polysorbate 80, 2) hyperprolinemia, or 3) IgA-deficiency with antibodies against IgA.HIZENTRA’s WARNINGS AND PRECAUTIONS include, but are not limited to, hypersensitivity reactions, thrombosis, aseptic meningitis syndrome renal dysfunction or failure, hemolysis, and transfusion-related acute lung injury. The most common adverse reactions (>5%) are local infusion reactions, headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis.The FDA Center for Biologics Evaluation and Research’s Advertising and Promotional Labeling Branch (APLB) reviewed a storyboard for this advertisement, which was submitted by CSL for advisory comment on January 10, 2025. On April 7, 2025, APLB sent CSL an advisory letter, stating that the overall impression of the storyboard for this DTC TV ad misleadingly overstated the efficacy of HIZENTRA because an immune globulin infusion cannot protect anyone against all the bacteria and viruses that one would encounter in their environment. In addition, much of the risk information seemed to be in small font relegated to the bottom of each screen and only appeared in a small portion of the whole storyboard. Therefore, the storyboard failed to present important safety information in a manner that was reasonably comparable to the presentation of information relating to the benefits of HIZENTRA. APLB recommended revising the DTC TV ad to address these issues and reminded CSL that a storyboard does not enable FDA to evaluate all aspects of audio and video production that will be apparent when the advertisement is produced in final format. Thus, our comments were limited by what could be assessed from the materials presented.Overstatement of EffectivenessInLive in Strength: Supermarket, a woman enters a grocery store with computer generated imagery (CGI) “germs” depicted on various items she would touch, from the handle of her grocery cart to the produce she is selecting to the self-checkout screen. At first, she hesitates and worries about touching things. In another aisle, she encounters a young child in a shopping cart who sneezes directly at her, causing a spray of germs to cascade toward her. The sneeze causes her to do a spin that triggers a superpowered protection around her (depicted as swirls) and, as she spins, the germs scatter away from her. She says (in voiceover), “But now I’ve turned things around. With HIZENTRA, I’m more protected.” She also claims (in voiceover), “My immune system is being restored.” After this transformation, she navigates through the aisles and other shoppers with ease, eventually meeting a friend for coffee at the café.The overall impression of this DTC TV ad, including its imagery and the above statements, misleadingly overstates the efficacy of HIZENTRA. HIZENTRA is indicated as replacement therapy for primary humoral immunodeficiency. Yet, in this DTC TV ad, the woman treated with HIZENTRA effectively is protected fromallthe germs around her, and her statement that her immune system is being restored is particularly concerning. Replacement therapy replaces what is missing or not functioning properly; it is not a cure and does not make one impervious or provide an extra layer of protection or effectiveness beyond that in the infusion, which is derived from normal human plasma.Presentation of Risk InformationThe presentation of limitations and risk information in the DTC TV ad is not reasonably comparable to the presentation of benefits. Specifically, the fast pacing and the compelling and attention-grabbing visuals during the presentation of risk information, all of which are unrelated to the risk message, compete for the viewers’ attention and make it difficult for the viewer to adequately process and comprehend the risks. Moreover, the presentation of the major statement is not presented in a clear, conspicuous, and neutral manner. The distractions, including frequent scene changes, quick camera movements, close-ups, and background music intensifying as the video progresses, interfere with the viewers’ ability to read the text portion of the major statement, which is not easily seen on the screen because the text is in small font, relegated to the bottom, and lacking contrast with the background. The overall effect undermines the communication of the risk information and the consequences that may result from the use of HIZENTRA.Conclusion and Requested ActionFor the reasons described above, the DTC TV ad misbrands HIZENTRA and makes the distribution of the drug in violation of the FD&C Act. See 21 U.S.C. §§ 352(n), 321(n), & 331(a); cf. 21 CFR § 202.1(e)(1) & (e)(5).This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for HIZENTRA that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of HIZENTRA.If you believe that your product is not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand HIZENTRA; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and its implementing regulations.Please direct your response to the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Building 71, 5th Floor, 10903 New Hampshire Avenue, Silver Spring, MD 20993. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter and refer to the BLA/STN numbers. Submit your response to your eCTD under the heading 1.15.1.6. We remind you that only written communications are considered official responses.Questions related to the submission of your response letter should be emailed to CBERAPLB@fda.hhs.gov.Sincerely,/S/Vinay Prasad M.D., M.P.H.DirectorCenter for Biologics Evaluation and Research_____________________1The Form FDA 2253 was submitted on May 2, 2025.

序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业社会信用代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1闽药监厦稽办处罚〔2025〕010号福建利康供应链股份有限公司销售劣药菠萝蛋白酶肠溶片案福建利康供应链股份有限公司91350503683089365E邓**经查，当事人销售的菠萝蛋白酶肠溶片（批号：20231203，生产单位/上市许可持有人：海南通用同盟药业有限公司）经国家药品抽检，“效价检验”项目不符合规定。当事人实际销售药品1823盒，实际销售金额27053.78元，进价为25522元，实际销售药品的差价1531.78元。“效价检验”项目不符合规定的菠萝蛋白酶肠溶片属于《中华人民共和国药品管理法》第九十八条第三款第七项规定的情形，为劣药。当事人销售劣药菠萝蛋白酶肠溶片的行为违反《中华人民共和国药品管理法》第九十八条第一款的规定，构成销售劣药的违法行为。当事人在药品购销过程中程序合法，票据、上游供应商资料齐全，履行了药品资质审核、购进验收和储存养护义务，符合《药品监督管理行政处罚裁量适用规则》第十五条和《福建省药品监管行政处罚裁量适用细则》第八条的规定，属于可以适用《中华人民共和国药品管理法实施条例》第七十五条的情形。依据《中华人民共和国行政处罚法》第二十八条第一款、第三十三条第二款、《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国药品管理法实施条例》第七十五条的规定，决定对当事人处理如下：1.责令改正违法行为；2.没收涉案批次药品违法所得1531.78元（人民币壹仟伍佰叁拾壹元柒角捌分）。当事人应自接到本行政处罚决定之日起15日内缴纳上述罚没款。当事人根据厦门药品稽查办公室开具的行政处罚缴款通知书，自行选择缴款方式。逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，我办将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。福建省药品监督管理局厦门药品稽查办公室，2025年8月21日。

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:directmeds.com, Inc. dba DirectMeds14572 S 790 W #A100Bluffdale,UT84065United Stateshelp@directmeds.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025DirectMeds:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://directmeds.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:• “If you’ve looked into brand-name versions of semaglutide, you know the cost can be steep – especially without insurance. That’s where buying compounded semaglutide online can make a big difference. Compounded medications are created by licensed compounding pharmacies using the same active ingredients.”• “Compounded semaglutide contains the same active ingredient as branded semaglutide.”• “Don’t give up hope if brand-name Mounjaro is out of reach due to cost. You may be able to get compounded tirzepatide online, which is an effective and budget-friendly alternative. Compounded formulations use the same active ingredient as the brand-name drug, customized by licensed compounding pharmacies to meet your needs.”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.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Andrew DudumChief Executive OfficerHims & Hers Health, Inc. dba Hims2269 Chestnut St., # 523San Francisco,CA94123United Stateslegal@forhims.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Mr. Dudum:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.hims.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.1As described below, your claims concerning your compounded semaglutide 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 your compounded semaglutide products appear on your website:• “Same active ingredient as Ozempic and Wegovy”• “Clinically proven ingredients”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 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 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.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Dr. Jenn Guthrie, MDMedClub by Dr. Jenn333 Southern Blvd, Suite 404West Palm Beach,FLUnited Statesjennguthriemd@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Dr. Guthrie:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://drjennpb.com in June 2025 and has observed that your website offers various compounded drug products, including retatrutide and semaglutide.1As described below, your retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)]. In addition, your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the 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)].A. Compounded Drug Products Under the FDCASection 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].2Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.3³Among the conditions of sections 503A and 503B are restrictions on the bulk drug substances (active pharmaceutical ingredients or APIs) that may be used to compound human drug products. Under section 503A, one of the conditions that must be met for a compounded drug product to qualify for the exemptions is that, if the product is compounded using bulk drug substances, such bulk drug substances (I) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (II) if such a monograph does not exist, be components of drugs approved by the Secretary; or (III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appear on a list developed by the Secretary through regulation (“503A bulks list”) (section 503A(b)(1)(A)(i) of the FDCA [21 U.S.C. § 353a(b)(1)(A)(i)]).Similarly, one of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FDCA, is that the outsourcing facility does not compound drug products using bulk drug substances unless the bulk drug substances that are used appear on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“503B bulks list”), or the compounded drug appears on the drug shortage list in effect under section 506E of the FDCA at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A)(i) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]).B. Failure to Meet the Conditions of Sections 503A and 503BYour compounded retatrutide drug products fail to meet the conditions of sections 503A and 503B. Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503A, because retatrutide is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list.4Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503B, because retatrutide does not appear on the 503B bulks list, and is not used to compound a drug that appears on the drug shortage list.5Because your compounded retatrutide drug products have not met all of the conditions of either section 503A or section 503B, they are not eligible for the exemptions in those sections from certain requirements of the FDCA, including FDA approval requirements of section 505 and the requirement under section 502(f)(1) that labeling bear adequate directions for use.Specific violations are described below.C. Violations of the FDCAUnapproved New Drugs & Misbranded DrugsThere are no FDA-approved applications on file for your compounded retatrutide drug products. Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a) and 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.Furthermore, your compounded retatrutide drug products are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended use. Consequently, their labeling fails to bear adequate directions for their intended use causing them to be misbranded under section 502(f)(1) of the FDCA.6The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA.False or Misleading ClaimsUnder 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 regarding compounded semaglutide products appear on your website:• “FDA Approved”• “USA Compounded” or “Custom Compounded”• “Generic Ozempic”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.7D. ConclusionFor the reasons discussed above, your compounded retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)]. In addition, your claims concerning compounded semaglutide drug products are false or misleading under sections 502(a) and 502(bb) of the 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)]. 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 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 misbranded and unapproved new 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 retatrutide and semaglutide 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.2We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.3We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.4These substances are also not eligible for the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. This guidance describes FDA’s interim regulatory policy for State-licensed pharmacies, Federal facilities, and licensed physicians that compound human drug products using bulk drug substances that do not otherwise meet the conditions of section 503A(b)(1)(A)(i) while the 503A bulks list is being developed. Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA- approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf.5These substances are also not eligible for the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1). This guidance describes FDA’s interim regulatory policy for outsourcing facilities registered under section 503B of the FDCA while the 503B bulks list is being developed. Specifically, the guidance sets out conditions under which FDA generally does not intend to take action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not included on the 503B list where the drug product also does not appear on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing. These conditions include that the drug product appears on “503B Category 1 – Bulk Drug Substances Under Evaluation”, which includes substances that may be eligible for inclusion on the 503B bulks list, was nominated with adequate support for FDA to evaluate it and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf6Your compounded retatrutide drug products are not exempt from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).7Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Mane & Steel, LLC. dba Mane & Steel1401 21ˢᵗ St., Suite RSacramento,CA95811United Statesinfo@maneandsteel.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Mane & Steel:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://maneandsteel.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.1As described below, your claims concerning compounded semaglutide 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 products appear on your website:• “Clinically Proven Weight Loss”• “Clinically proven GLP-1 therapy to suppress appetite, regulate blood sugar, and accelerate fat loss—trusted by medical professionals worldwide.”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 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 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.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:LumimedsLas Vegas,NVUnited Stateshttps://lumimeds.comhelp@lumimeds.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Lumimeds:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://lumimeds.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:• “Doctors frequently recommend Compounded Tirzepatide or Compounded Semaglutide, both of which are GLP-1 agonists with the same active ingredient as the brand name medications.”• “GLP-1 Injections contain GLP-1, which mimics a naturally occurring hormone in the body. This is the same active ingredient used in brand name GLP-1 weight-loss medications. GLP-1 was FDA-approved in 2017 . . . . It was FDA-approved in 2021 for weight loss.”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.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:GLP-1 Solution785 15h Street, Office 47881566BerlinGermanysales@glp1solution.storeIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025GLP-1 Solution:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://glp1solution.store in August 2025 and has observed that your website offers various compounded drug products, including retatrutide, semaglutide and tirzepatide.1As described below, your retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)]. In addition, 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)].A. Compounded Drug Products Under the FDCASection 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].2Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.3Among the conditions of sections 503A and 503B are restrictions on the bulk drug substances (active pharmaceutical ingredients or APIs) that may be used to compound human drug products. Under section 503A, one of the conditions that must be met for a compounded drug product to qualify for the exemptions is that, if the product is compounded using bulk drug substances, such bulk drug substances (I) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (II) if such a monograph does not exist, be components of drugs approved by the Secretary; or (III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appear on a list developed by the Secretary through regulation (“503A bulks list”) (section 503A(b)(1)(A)(i) of the FDCA [21 U.S.C. § 353a(b)(1)(A)(i)]).Similarly, one of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FDCA, is that the outsourcing facility does not compound drug products using bulk drug substances unless the bulk drug substances that are used appear on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“503B bulks list”), or the compounded drug appears on the drug shortage list in effect under section 506E of the FDCA at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A)(i) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]).B. Failure to Meet the Conditions of Sections 503A and 503BYour compounded retatrutide drug products fail to meet the conditions of sections 503A and 503B. Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503A, because retatrutide is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list.4Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503B, because retatrutide does not appear on the 503B bulks list, and is not used to compound a drug that appears on the drug shortage list.5Because your compounded retatrutide drug products have not met all of the conditions of either section 503A or section 503B, they are not eligible for the exemptions in those sections from certain requirements of the FDCA, including FDA approval requirements of section 505 and the requirement under section 502(f)(1) that labeling bear adequate directions for use.Specific violations are described below.C. Violations of the FDCAUnapproved New Drugs & Misbranded DrugsThere are no FDA-approved applications on file for your compounded retatrutide drug products. Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a) and 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.Furthermore, your compounded retatrutide drug products are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended use. Consequently, their labeling fails to bear adequate directions for their intended use causing them to be misbranded under section 502(f)(1) of the FDCA.6The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA.False or Misleading ClaimsUnder 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 your compounded semaglutide and tirzepatide products appear on your website:• “MOUNJARO”• “Semaglutide is the generic drug delivered in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.”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.7D. ConclusionFor the reasons discussed above, your compounded retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)]. In addition, your claims concerning compounded semaglutide, and tirzepatide drug products are false or misleading under sections 502(a) and 502(bb) of the 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)]. 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 [21U.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 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 misbranded and unapproved new 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 retatrutide, 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.2We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.3We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.4These substances are also not eligible for the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. This guidance describes FDA’s interim regulatory policy for State-licensed pharmacies, Federal facilities, and licensed physicians that compound human drug products using bulk drug substances that do not otherwise meet the conditions of section 503A(b)(1)(A)(i) while the 503A bulks list is being developed. Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA- approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf.5These substances are also not eligible for the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1). This guidance describes FDA’s interim regulatory policy for outsourcing facilities registered under section 503B of the FDCA while the 503B bulks list is being developed. Specifically, the guidance sets out conditions under which FDA generally does not intend to take action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not included on the 503B list where the drug product also does not appear on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing. These conditions include that the drug product appears on “503B Category 1 – Bulk Drug Substances Under Evaluation”, which includes substances that may be eligible for inclusion on the 503B bulks list, was nominated with adequate support for FDA to evaluate it and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf6Your compounded retatrutide drug products are not exempt from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).7Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

9月11日至12日，省药监局在泉州组织开展全省 “两品一械” 行政处罚案卷交叉评查工作，对随机抽取的各设区市、平潭综合实验区市场监管局及省局各药品稽查办自2024年1月1日后作出的52份行政处罚案卷进行全面检阅。此次评查通过分组交叉互查模式，重点围绕违法事实认定、执法程序合规性、证据链完整性、法律适用准确性、处罚裁量适当性及文书规范化等六大核心环节开展 “一案一表” 式细致评查。评查组不仅严格对标行政执法标准，更注重结合实际案件剖析执法痛点难点，通过 “现场评查 + 集中研讨” 模式促进各地执法经验交流。此次评查共梳理出执法共性问题及突出问题若干类，为针对性改进执法工作提供了精准靶向。通过系统总结问题成因，进一步完善了执法流程中的薄弱环节，推动执法工作从 “个案合规” 向 “系统规范” 跃升。下一步，省药监局将严格落实 “四个最严” 要求，以执法监督为抓手，常态化开展执法培训、案卷评查等互动交流活动，持续加强执法规范化建设，进一步提升全省 “两品一械” 案件查办质效，为筑牢药品安全底线、保障群众用药用械安全提供坚实保障。

近日，内蒙古自治区药品审评和药物警戒中心（以下简称自治区审评警戒中心）圆满完成国家“十四五”规划期间一次性使用活检针、气管插管和婴儿培养箱三个品种的不良事件重点监测工作，为保障公众用械安全提供了内蒙古支撑。国家医疗器械不良事件重点监测是为研究产品上市后风险而开展的阶段性主动监测。此次工作中，自治区审评警戒中心负责组织哨点医院监测、收集数据及风险分析等工作。为确保监测成效，自治区审评警戒中心前期调研55家三级医疗机构并制定方案，组织19家次哨点调研督导，召开11次专项会议，动态调整绩效指标以优化工作流程。在收集数据工作中创新方式，通过医疗机构质控中心病例点评排查风险，依托患者诊疗记录和器械出入库信息主动挖掘不良事件，并将报告质量纳入考核。此次共收集“气管插管”“婴儿培养箱”病例使用报告11523份、不良事件报告125份，“一次性使用活检针”不良事件报告711份。为做好风险分析工作，自治区审评警戒中心联合重点监测哨点医院，综合全国监测数据、文献资料、产品召回及抽检结果等多维度风险信息，形成详实的风险分析评价报告并按时完成上报。作为每5年开展一次的医疗器械全生命周期管理重要举措，此次工作提升了内蒙古相关监测水平与风险防控能力。下一步，自治区审评警戒中心将不断创新工作方法、提升监测能力，为医疗器械全生命周期管理、公众用械安全及内蒙古医疗器械产业高质量发展贡献更多力量。