安徽长源药业有限公司：本局于2025年7月14日发布《安徽省药品监督管理局暂停生产通知书》（皖药监药暂停〔2025〕中化-5号），通知你单位暂停生产中药饮片。依据《药品生产监督管理办法》第五十九条第三款的规定，鉴于你单位安全隐患已依法处理，现决定解除相关产品的暂停生产措施。具体产品为：中药饮片。安徽省药品监督管理局2025年9月16日

安徽聚草中药饮片有限责任公司：本局于2025年7月14日发布《安徽省药品监督管理局暂停生产销售通知书》（皖药监药暂停〔2025〕中化-6号），通知你单位暂停生产销售中药饮片。依据《药品生产监督管理办法》第五十九条第三款的规定，鉴于你单位安全隐患已依法处理，现决定解除相关产品的暂停生产销售措施。具体产品为：中药饮片。安徽省药品监督管理局2025年9月16日

安徽宝珠中药饮片科技有限公司：本局于2025年6月9日发布《安徽省药品监督管理局暂停生产通知书》（皖药监药暂停〔2025〕中化-2号），通知你单位暂停生产中药饮片。依据《药品生产监督管理办法》第五十九条第三款的规定，鉴于你单位安全隐患已依法处理，现决定解除相关产品的暂停生产措施。具体产品为：中药饮片。安徽省药品监督管理局2025年9月16日

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:ASN-LABS1450 Ala Moana BlvdHonolulu,HI96814United Statescs@asn-labs.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025ASN-LABS:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://asn-labs.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 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.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 product. 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.6introduction 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 compounded semaglutide products appear on your website:• “The same active ingredient as Wegovy and Ozempic”• “Semaglutide is the generic drug 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 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, 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.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Body Good Studio290 NW 165ᵗʰ StMiami,FL33169United Stateslegal@bodygoodstudio.comsupport@bodygoodstudio.comhello@bodygoodstudio.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Body Good Studio: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.bodygoodstudio.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.1As described below, your claim concerning compounded semaglutide 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 concerning compounded semaglutide products appears on your website:• “Compound semaglutide is made of the same active ingredients as Ozempic and Wegovy, which are GLP-1 receptor agonist [sic]….”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 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:Canada Med StopPO BOX 75026 Main Street South POVancouverBCV5X 4V7Canadainfo@canadamedstop.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Canada Med Stop: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.canadamedstop.com in August 2025 and has observed that your website offers compounded semaglutide drug products.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 compounded semaglutide products appear on your website:• “The same active ingredient in branded weight loss medications.”• “FDA-Approved Medication”• “GENERIC”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.

Product:DrugsRecipient:Josh DisbrowChief Executive OfficerAytu Biopharma7900 E. Union Avenue, Suite 920Denver,CO80237United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERSeptember 9, 2025Dear Josh Disbrow:As part of its monitoring and surveillance program, the U.S. Food and Drug Administration (FDA) has reviewed the promotional communications, Aytu Biopharma’s (Aytu) sponsored links1for ADZENYS XR-ODT (amphetamine) extended-release orally disintegrating tablets, CII (Adzenys XR-ODT). FDA has determined that the sponsored links are false or misleading. Thus, the sponsored links misbrand Adzenys XR-ODT and make the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (e)(1)(B), (n); 321(n); 331(a). See 21 CFR 201.10(g)(1); 202.1(b)(1); 202.1 (e)(5); 314.81(b)(3)(i). These violations are especially concerning from a public health perspective because the promotional communications create a misleading impression about the safety and efficacy of Adzenys XR-ODT, a Schedule II controlled substance that bears a boxed warning due to the high potential for abuse and misuse, which can lead to overdose, death, and the development of a substance use disorder, including addiction.BackgroundBelow are the indication and summary of the most serious and most common risks associated with the use of Adzenys XR-ODT.2According to the INDICATIONS AND USAGE section of the FDA-approved Prescribing Information (PI):ADZENYS XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.The PI for Adzenys XR-ODT contains a boxed warning regarding a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Adzenys XR-ODT is contraindicated in patients with a known hypersensitivity to amphetamine or other components of Adzenys XR-ODT and in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs. In addition, the PI for Adzenys XR-ODT includes warnings and precautions regarding risks to patients with serious cardiac disease; increased blood pressure and heart rate; psychiatric adverse reactions; long-term suppression of growth in pediatric patients; peripheral vasculopathy, including Raynaud’s phenomenon; serotonin syndrome; motor and verbal tics, and worsening of Tourette’s syndrome; and potential for overdose due to medication errors. The most common adverse reactions associated with single-entity amphetamine product extended-release capsules are loss of appetite, abdominal pain, insomnia, emotional lability, vomiting, nervousness, fever, nausea, infection, weight loss, accidental injury, asthenia, dyspepsia, dizziness, headache, dry mouth, diarrhea, agitation, anxiety, tachycardia, and urinary tract infection.False or Misleading Risk PresentationPrescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.The sponsored links are misleading because they include representations about the efficacy of Adzenys XR-ODT but fail to communicateanyrisk information. For example, the sponsored links for Adzenys XR-ODT appearing in searches include the statement “Adzenys XR-ODT for ADHD.”We acknowledge that some variations of the sponsored links include the statements “Medication Guide”, “Important Safety Info”, and/or “Side Effects”; however, these statements, alone or in combination, do not mitigate the misleading omission of risk information. By omitting risk information associated with Adzenys XR-ODT, the sponsored links fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety.Failure to Use Required Established NameThe established name of a prescription drug must be presented prominently, in direct conjunction with the proprietary name. The sponsored links fail to present the established name for Adzenys XR-ODT, thereby misbranding the product.Failure to Submit Under Form FDA-2253FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the sponsored links was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).Conclusion and Requested ActionFor the reasons discussed above, the sponsored links misbrand Adzenys XR-ODT and make the distribution of the drug in violation of the FD&C Act. 21 U.S.C. 352(a), (e)(1)(B), (n); 321(n); 331(a). See 21 CFR 201.10(g)(1); 202.1(b)(1); 202.1 (e)(5). Furthermore, Aytu did not comply with 21 CFR 314.81(b)(3)(i).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 Adzenys XR-ODT that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Adzenys XR-ODT.If you believe that your products are 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 Adzenys XR-ODT; 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 FDA implementing regulations.Please direct your response to theFood and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B AmmendaleRoad, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 303 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to CDEROPDP- RPM@fda.hhs.gov.Sincerely,{See appended electronic signature page}George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and Research--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------CARTER M BEACH09/09/2025 05:08:14 PMOn behalf of George Tidmarsh, M.D., Ph.DPromotional Material

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:All American WellnessUnited Stateshttps://all-american-wellness.comzak@allamericangroups.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025All American Wellness:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://all-american-wellness.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:• “Mounjaro’s compounded version- Tirzepatide Prescription”• “Ozempic’s compounded version- Semaglutide”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 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.

Product:DrugsRecipient:Josh DisbrowChief Executive OfficerAytu Biopharma7900 E. Union Avenue, Suite 920Denver,CO80237United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERSeptember 9, 2025Dear Josh Disbrow:As part of its monitoring and surveillance program, the U.S. Food and Drug Administration (FDA) has reviewed the promotional communications, Aytu Biopharma’s (Aytu) sponsored links1for COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), CII (Cotempla XR-ODT). FDA has determined that the sponsored links are false or misleading. Thus, the sponsored links misbrand Cotempla XR-ODT and make the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (e)(1)(B), (n); 321(n); 331(a). See 21 CFR 201.10(g)(1); 202.1(b)(1); 202.1 (e)(5); 314.81(b)(3)(i). These violations are especially concerning from a public health perspective because the promotional communications create a misleading impression about the safety and efficacy of Cotempla XR-ODT, a Schedule II controlled substance that bears a boxed warning due to the high potential for abuse and misuse, which can lead to overdose, death, and the development of a substance use disorder, including addiction.BackgroundBelow are the indication and summary of the most serious and most common risks associated with the use of Cotempla XR-ODT.2According to the INDICATIONS AND USAGE section of the PI:COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.The PI for Cotempla XR-ODT contains a boxed warning regarding a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Cotempla XR-ODT is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Cotempla XR-ODT and in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI. In addition, the PI for Cotempla XR-ODT includes warnings and precautions regarding risks to patients with serious cardiac disease; increased blood pressure and heart rate; psychiatric adverse reactions; priapism; peripheral vasculopathy, including Raynaud’s phenomenon; long-term suppression of growth in pediatric patients; acute angle closure glaucoma; increased intraocular pressure and glaucoma; and motor and verbal tics, and worsening of Tourette’s syndrome. The most common adverse reactions associated with methylphenidate products like Cotempla XR-ODT are appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.False or Misleading Risk PresentationPrescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.The sponsored links are misleading because they include representations about the efficacy of Cotempla XR-ODT but fail to communicateanyrisk information. For example, the sponsored links for Cotempla XR-ODT appearing in searches include statements such as “Cotempla XR-ODT for ADHD” or “Cotempla XR-ODT Works Fast - Once-Daily ADHD Medication” in the headline.We acknowledge that some variations of the sponsored links include the statements “Medication Guide”, “Important Safety Info”, and/or “Side Effects”; however, these statements, alone or in combination, do not mitigate the misleading omission of risk information. By omitting risk information associated with Cotempla XR-ODT, the sponsored links fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety.False or Misleading Claims about EfficacyPromotional communications misbrand a drug if they are false or misleading with respect to efficacy. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.The sponsored links for Cotempla XR-ODT include misleading representations about its efficacy, such as:Cotempla XR-ODT for ADHD – Concerta SubstituteLearn how Cotempla XR-ODT may help your child. Talk to your child’s doctor today. Having a hard time finding Concerta? Equivalent option to Concerta is available. Medication Guide. Important Safety Info. Patient Savings Offer.The representation that Cotempla XR-ODT is a “substitute” for or is “equivalent” to Concerta® is misleading because it suggests that Cotempla XR-ODT is therapeutically equivalent to, and therefore substitutable for, Concerta, when that has not been demonstrated. Cotempla XR-ODT and Concerta are variations of methylphenidate;3however, they have not been shown to be therapeutically equivalent to one another.4An approved drug may be determined to be therapeutically equivalent to another if it is a pharmaceutical equivalent for which bioequivalence has been demonstrated, and it can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.5In this case, the Cotempla XR-ODT PI states a dosage form, dosage strength, and maximum daily dosage that are different from those of Concerta. For example, the PI for Cotempla XR-ODT states that the drug is an extended-release orally disintegrating tablet, with dosage strengths of 8.6 mg, 17.3 mg, and 25.9 mg, and a maximum daily dosage not to exceed 51.8 mg. On the other hand, the Concerta PI states the drug is a tablet to be swallowed whole, with dosage strengths of 18 mg, 27 mg, 36 mg, and 54 mg, and a maximum daily dosage of 54 mg in children and 72 mg in adolescents and adults. Given Cotempla XR-ODT’s differences from Concerta in dosage form, dosage strengths, and maximum daily dosage, the drugs are not substitutable and representations suggesting the drugs are “equivalent” are misleading.Failure to Use Required Established NameThe established name of a prescription drug must be presented prominently, in direct conjunction with the proprietary name. The sponsored links fail to present the established name for Cotempla XR-ODT, thereby misbranding the product.Failure to Submit Under Form FDA-2253FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the sponsored links was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).Conclusion and Requested ActionFor the reasons discussed above, the sponsored links misbrand Cotempla XR-ODT and make the distribution of the drug in violation of the FD&C Act. 21 U.S.C. 352(a), (e)(1)(B), (n); 321(n); 331(a). See 21 CFR 201.10(g)(1); 202.1(b)(1); 202.1 (e)(5). Furthermore, Aytu did not comply with 21 CFR 314.81(b)(3)(i).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 Cotempla XR-ODT that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Cotempla XR-ODT.If you believe that your products are 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 Cotempla XR-ODT; 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 FDA implementing regulations.Please direct your response to theFood and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 143 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to CDEROPDP- RPM@fda.hhs.gov.Sincerely,{See appended electronic signature page}George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and Research--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------CARTER M BEACH09/09/2025 05:08:26 PMOn behalf of George Tidmarsh, M.D., Ph.DPromotional Material

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Healthy Male5801 S. McClintock Drive Suite 107Tempe,AZ85283United Statessmedicalaz@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Healthy Male:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healthymale.com in August 2025 and has observed that your website offers various compounded drug products, including tirzepatide.1As described below, your claims concerning compounded 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 tirzepatide products appear on your website:• “Clinically shown to support 15-22% average body weight reduction.”• “Clinically proven medications and compounds for sustainable weight management”• “Clinically proven to deliver sustainable 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 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 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.