Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Vitals RXUnited Stateshttps://vitalsrx.cominfo@vedzilla.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERSeptember 9, 2025Vitals RX:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://vitalsrx.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.1As described below, your claim concerning compounded semaglutide and tirzepatide products is 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 claim appears on your website, where the only semaglutide and tirzepatide products offered are compounded:• “Vitals RX - Semaglutide/Tirzepatide/Ozempic Weight Loss Clinic”Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not. As a result, this claim is 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 claim identified in this letter puts you on notice of our concerns but does 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:Matthew Stern, CEO MyStart Health LLC.254 Chapman Rd.STE: 208 #17801Newark,DE19702United Statessupport@mystarthealth.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Mr. Stern: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.mystarthealth.com in August 2025 and has observed that your website offers compounded 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:• “Generic Ozempic”• “Save with generics that offer the same active ingredients and results.”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 - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Andrew DudumChief Executive OfficerHims & Hers Health, Inc. dba Hers2269 Chestnut St., # 523San Francisco,CA94123United Stateslegal@forhims.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited 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.forhers.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 your compounded semaglutide products appear on your website:• “Weekly injectable GLP-1 with the 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:iVisitDoc, Inc. dba iVisitDoc7345 Woodland Drive, Suite IIndianapolis,IN46278United Statesinfo@ivisitdoc.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERSeptember 9, 2025iVisitDoc:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://ivisitdoc.com in August 2025 and has observed that your website offers various compounded semaglutide drug products.1 As 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:• “Compounded semaglutide from iVisitDoc has the same active ingredients as Wegovy and Ozempic, but doesn’t come in a preloaded pen.”• “Clinically Validated 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 Administration

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Amazing Meds5777 North Academy BlvdColorado Springs,CO80918United Statessupport@amazing-meds.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERSeptember 9, 2025Amazing Meds:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://amazing-meds.com in August 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 claim concerning compounded semaglutide products is 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.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 its 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 this product 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 claim regarding your compounded semaglutide products appears on your website:• “Compounded semaglutide (same as Ozempic/Wegovy)”Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not. As a result, this claim is 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 claim identified in this letter puts you on notice of our concerns but does 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 claim concerning compounded semaglutide drug products is 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 AdministrationThese 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 evaluaGuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf.1The 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 evaluaGuidanceComplianceRegulatoryInformation/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.

按照《医疗器械监督管理条例》《2025年云南省医疗器械监督抽检工作方案》有关要求，我局组织对公众关注的12个品种医疗器械开展“你用我检”质量监督抽检。第二阶段抽检72批次，检验结果71批次符合规定，1批次不符合规定，现通告如下：附件：2025年云南省医疗器械“你用我检”抽检情况统计表（2025年第2期）云南省药品监督管理局2025年9月10日

为深入贯彻落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》，近日，江西省药监局印发《江西省药品生产分类分级管理办法（试行）》。该办法以科学配置监管资源、提升药品质量安全水平为目标，创新构建基于风险管理的差异化监管模式。分类管理，精准施策。按产品风险属性将药品生产企业分为Ⅰ类（高风险）、Ⅱ类（一般风险）和Ⅲ类（较低风险），实施类别化监管，避免监管资源“平均分配”。动态评级，量化操作。每年依据监督检查、案件查办、质量抽检等多项动态信息对企业进行量化评分，按质量体系水平从高到低划定A、B、C、D四级，实现风险显性化、监管可视化。差异检查，拒绝“一刀切”。根据企业类别与等级科学设定检查频次和方式。基于风险管理，实现监管资源配置最优化，确保监管强度与风险水平相匹配。优化环境，减轻企业负担。对信用好、体系完善的企业实施宽松监管、减少打扰，助力企业集中精力推进研发创新和高质量发展。严守底线，强化风险防控。对评级较低的企业加大监管力度，实施高频次飞行检查，并通过动态评级机制鼓励企业整改提升。该办法通过分类、评级、差异监管等机制，逐步形成企业自律、政府监管与社会协同共治的药品安全治理新格局，为江西医药产业持续健康发展提供制度保障。（省药监局药品生产处供稿）

根据《广东省食品药品监督管理局关于〈药品经营许可证〉注销的管理规定》（粤食药监法〔2013〕26号），2025年6月5日至2025年9月15日，我局已依法注销高要区金利镇祥艳食品店等10家药品零售企业的《药品经营许可证》，现予以公布。　　附：高要区注销情况表肇庆市高要区市场监督管理局2025年09月15日高要区注销情况表序号许可证号许可证标明的有效期限企业名称法定代表人（负责人）注销原因注销日期1粤CB758A1742027-09-18高要区金利镇祥艳食品店周飞祥企业申请2025-09-152粤DB75896122026-01-20肇庆市众健医药有限公司陈永全企业申请2025-09-153粤DA758A1572027-12-13华佗国药（广东）大药房有限公司高要金利第二分店杨云企业申请2025-09-114粤DB758A1442028-06-29华佗国药（广东）大药房有限公司高要金利第三分店杨云企业申请2025-09-115粤CB7580000772029-04-25肇庆高要富怡药店（个人独资）黎壬妙企业申请2025-09-106粤DB75895722025-12-06肇庆市大家好药房有限公司高要区金渡大山分店罗小铭企业申请2025-07-287粤DB7580000102028-01-29金成医药（肇庆）有限公司韩影企业申请2025-07-078粤CB7580001722025-12-29肇庆市养天和康民大药房连锁有限公司高要中源明珠分店谢少锋企业申请2025-06-309粤DB758A0232026-07-27华佗国药（广东）大药房有限公司肇庆高要金利分店杨云企业申请2025-06-2410粤DB7580000362029-04-06肇庆好药师健康大药房有限公司高要大湾窦头分店温楚予企业申请2025-06-10

今年以来，盐城市亭湖区市场监管局围绕冷链药品经营风险问题，以《药品经营质量管理规范》及其附录为准绳，通过法规培训、自查自纠、合规指导等方式，狠抓关键环节，有效落实企业主体责任，确保冷链全过程持续合规。一是设备验证不断档以8月1日新实施的《医药产品冷链物流温控设施设备验证性能确认技术规范》为要求，指导企业及时对冷库、冷藏箱、保温箱等设备定期验证，确保验证报告在年度有效期内，杜绝冷链设备超期服役。验证使用的温湿度记录仪，须在有效期内，并附检定校准报告。对验证流于形式的2户企业，指导其重新开展验证。截至目前，已有78家企业完成97份年度定期验证。二是冷链储运不脱节冷链药品收货验收时，以《冷链运输交接单》为重点，一方面，核实运输工具、冷藏方式，另一方面，核实启运时间和温度、在途温度、到达时间和温度，并由相关责任人签名确认。对温度记录不全或不符合要求的，要求企业拒绝收货。三是温度监测不打烊严格按照每台冷链设备验证报告的要求，准确放置温湿度计或自动监测终端，确保反映温度高点和低点。严格对冷链设备进行温度监测，及时调控，并按规定进行温度记录，以保证符合药品包装标示的温度要求。对温度记录不完整的2户企业，进行了行政约谈。四是风险隐患不过夜建立问题清单和整改清单，做到即查即改，确保整改闭环。对设施设备运行存在问题的1户企业，指导其现场下架冷藏药品；对冷链质量管理存在缺位的2户企业，督促其核减冷藏药品经营范围。

根据《药品管理法》、《药品生产监督管理办法》有关规定，经现场检查并综合评定，现将福建基诺厚普生物科技有限公司《药品生产质量管理规范》符合性检查结果公告。企业名称检查地址检查范围检查时间类型检查结果福建基诺厚普生物科技有限公司福建省莆田市秀屿区笏石镇丙仑村仁洋288号出口欧盟原料药替尔泊肽（532车间、541车间、512车间）2025年8月5日-8月7日依申请符合福建省药品监督管理局2025年9月15日