

#### [160] empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026 | issued 09/18/2026 | Empower Clinic Services, LLC dba Empower Pharmacy | SUBJ: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
WARNING LETTER WL # 738238 September 18, 2026 Dear Mr. Noorian: From November 3, 2025, through November 14, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Empower Clinic Services, LLC dba Empower Pharmacy, located at 7601 N. Sam Houston Pkwy W., Ste. 100, Houston, TX 77064. During the inspection, the investigators collected evidence indicating that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 353a] for exemption from certain provisions of the FD&C Act. In addition, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk. FDA issued a Form FDA 483 to your firm on November 14, 2025. FDA acknowledges receipt of your facility’s responses, dated December 8, 2025, March 18, 2026, and April 30, 2026. Based on this inspection, it appears that you produced drug products that violate the FD&C Act. A. Compounded Drug Products Under the FD&C Act Section 503A of the FD&C Act 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 FD&C Act: 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)]. 1 Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A. In addition, for a compounded drug product to qualify for the exemptions under section 503A, a licensed pharmacist or physician must not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. 2 Section 503A(b)(2) provides that a compounded drug product is not essentially a copy of a commercially available drug product if “there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.” (sections 503A(b)(1)(D) and 503A(b)(2) of the FD&C Act [21 U.S.C. §§ 353a(b)(1)(D) and 353a(b)(2)]). B. Failure to Meet the Conditions of Section 503A During the inspection, the FDA investigators collected evidence indicating that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigators collected evidence indicating that your firm compounded drug products that are essentially copies of commercially available drug products regularly and in inordinate amounts. Specifically, your firm compounded products including TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML), SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML), and TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML), which appear to be essentially copies of FDA-approved semaglutide and tirzepatide products. 3, 4 FDA is aware of high demand for compounded versions of FDA-approved semaglutide and tirzepatide products. The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual. According to your firm's records, for example, you compounded and filled orders for the aforementioned drug products in the following quantities: During July 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML). During August 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML). During September 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML). During October 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML). During July 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML). During August 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML). During September 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML). During October 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML). During July 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML). During August 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML). During September 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML). During October 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML). Evidence collected includes (1) orders/prescriptions that lack any prescriber determination of significant difference from the commercially available product; (2) orders/prescriptions with purported prescriber determinations of “significant difference” that appear to be repeated verbatim across many records, suggesting that they may be pre-generated for selection by the prescriber, rather than written by the prescriber for an identified individual patient; and (3) the volume of particular products compounded and orders filled. Generating prescriptions through means that undermine the individualized nature of a prescriber's clinical judgment (for example through third-party technology platforms that provide prescribers with pre-selected menu options for choosing a statement of significant difference) call the individualized nature of those determinations into question, potentially undermining claims that such prescriber determinations of significant difference are sufficient to meet the conditions of section 503A. Furthermore, production records collected during the inspection indicate that your firm compounded these drug products regularly or in inordinate amounts. Therefore, you compounded drug products that do not meet the conditions of section 503A and are not eligible for the exemptions in that section, including the FDA approval requirement of section 505 of the FD&C Act, the requirement under section 502(f)(1) of the FD&C Act that labeling bear adequate directions for use, and the requirement of compliance with CGMP under section 501(a)(2)(B) of the FD&C Act. In the remainder of this letter, we refer to your drug products that do not qualify for exemptions under section 503A as the “ineligible drug products.” Specific violations are described below. C. Violations of the FD&C Act Adulterated Drug Products The FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FD&C Act. For example, the investigators observed the following: 1. [B219] [B148] 2. Your media fills were not performed under the most challenging or stressful conditions. [B249] Furthermore, the manufacture of the ineligible drug products is subject to FDA’s CGMP regulations, Title 21, Code of Federal Regulations (CFR), parts 210 and 211. The FDA investigators observed significant CGMP violations at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The violations included, for example: 1. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)). 2. [B183] 3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). 4. [B216] 5. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated. Unapproved New Drug Products You do not have any FDA-approved applications on file for the ineligible drug products that you compounded. 5 Under sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. § 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 FD&C Act is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FD&C Act. Misbranded Drug Products The ineligible drug products you compounded 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 uses. Consequently, their labeling fails to bear adequate directions for their intended uses. 6 Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FD&C Act. It is also a prohibited act under section 301(k) of the FD&C Act to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded. D. Corrective Actions We have reviewed your firm’s response to the Form FDA 483. Regarding your response related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation. Specifically, your response states that the smoke study under Rev. 005 was executed March 30 – April 3, 2026, but the April 2026 study is still under post-execution review and has not been finalized or provided to FDA. Per your response, the study “remains in controlled post-execution review.” It is unclear whether your firm has completed the post-execution review, as no final formal summary report has been provided. Regarding your response related to the insanitary conditions, the following corrective actions appear deficient. With respect to your aseptic media fill simulation executed in January 2026, we note that the summary states, “Following the 14-day incubation period, all vials were visually inspected for turbidity or microbial growth. No contamination was observed in any of the (b)(4) vials, confirming the sterility assurance of the process.” However, our review of the media fill test records and the vials documented across the (b)(4) revealed gaps and discrepancies. The summary report does not appear to match the number of vials inspected per the documents provided in the media fill test records. Specifically, based on the vials recorded across all the (b)(4) records, it appears up to (b)(4) vials were examined. No explanation was provided for the discrepancy in the total number of vials. The documents provided show no records for (b)(4) . Furthermore, the records document results for (b)(4) , with no documentation or explanation for (b)(4) . It is unknown if these (b)(4) exist. Additionally, upon review of the documents, multiple (b)(4) were labeled as “N/A.” It is unknown what the designation “N/A” means, as it is not defined or explained in the records. Based on the documents provided, it is unclear how your firm counted and determined that no contamination was present in a total of (b)(4) vials. There appears to be a gap in the documentation with no explanation provided. The summary report claims all vials were inspected and none showed contamination; however, based on the information provided the claim cannot be supported if records do not clearly demonstrate that all vials were accounted for and inspected. Finally, our review also noted multiple media fill records were transcribed on Form Revision 3 because the original results were documented on the wrong form. Transcribing original data onto a different document, even if done for legitimate administrative reasons, must be carefully controlled, documented, and justified. Without a clear audit trail showing why results were rewritten and who authorized it, this practice raises concerns about whether the data accurately reflects what actually occurred during the media fill. Please be aware that section 501(a)(2)(A) of the FD&C Act concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A, including the condition that drug products that are essentially copies of commercially available drug products not be compounded regularly or in inordinate amounts. Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations. 7 In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FD&C Act. [B154] [B152] [See 21 CFR 210.1(b), 21 CFR 200.10(b)]. [B150] [B155] [B253] E. [B126] [B2] [B20] [B153] [B1] [B166] [B17] [B0] If you believe your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. [B4] [B251] In your response, refer to the Warning Letter Number above (# 738238) and include a subject line that clearly identifies the submission as a Response to Warning Letter. Sincerely, /S/ Clint L. Narver, JD Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration _________________________ 1 We 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 FD&C Act. 2 FDA considers a drug product to be commercially available if it is a marketed drug product. 3 FDA previously exercised enforcement discretion for state-licensed pharmacies compounding semaglutide and tirzepatide injection products that are essentially copies of commercially available drug products under section 503A. That enforcement discretion period ended with respect to tirzepatide injection products on March 5, 2025, and with respect to semaglutide injection products on April 24, 2025. 4 See, e.g., (b)(6) . 5 The specific products made by your firm are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of 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 FD&C Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses. 6 Your ineligible drug products are not exempted from the requirements of section 502(f)(1) of the FD&C Act by regulations issued by the FDA (see, e.g., 21 CFR 201.115). 7 In this letter we do not address whether your proposed corrective actions would resolve the CGMP violations noted above. Content current as of: 09/22/2026 Regulated Product(s)

#### [161] online-generic-medicinewwwonlinegenericmedicinecom-737806-09232026 | issued 09/23/2026 | Online Generic Medicine/www.onlinegenericmedicine.com | SUBJ: Unapproved New Drug/Misbranded (Internet Pharmacy)
WARNING LETTER Reference Number: MARCS-CMS 737806 To Online Generic Medicine: [B46] Food and Drug Administration (FDA) review of your website www.onlinegenericmedicine.com. [B26] [B159] It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. [B160] As discussed below, FDA has observed that www.onlinegenericmedicine.com introduces into interstate commerce unapproved and misbranded injectable semaglutide drug products. There are inherent risks to consumers who purchase unapproved and misbranded drug products. [B90] [B91] Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.onlinegenericmedicine.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. [B185] FDA Review Violations were identified and documented during a review of your website www.onlinegenericmedicine.com, FDA Establishment Identifier (FEI) 3048678145, on August 26, 2026, and September 2, 2026. Violations of the Federal Food, Drug, and Cosmetic Act On your website at internet address www.onlinegenericmedicine.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)). The following are violations identified during our review. [B28] Unapproved New Drug Violations Certain products offered for sale by www.onlinegenericmedicine.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act. You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. An example of an unapproved semaglutide drug product you offer for sale on www.onlinegenericmedicine.com is semaglutide marketed as "Semanat Injection (Semaglutide)." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Semanat Injection, [sic] is a potent glucagon-like peptide-1 (GLP-1) receptor agonist wich [sic] is designed to help manage blood sugar levels in type 2 diabetes and support weight management." While there are FDA-approved versions of semaglutide drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Semanat Injection (Semaglutide)” offered by www.onlinegenericmedicine.com. Currently there are several semaglutide products FDA-approved for the U.S. market, and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes mellitus and established CV disease; and to reduce the risk of sustained eGFR decline, end-stage kidney disease, and CV death in adults with type 2 diabetes mellitus and chronic kidney disease. FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity to reduce the risk of major adverse CV events in adults with established CV disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in certain adult and pediatric patients, and for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis in adults. Furthermore, FDA-approved semaglutide products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. [B116] Misbranded Drug Violations A drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner. You failed to bear adequate directions for use on the labeling for this drug product that you have introduced into interstate commerce. Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for their intended use. Consequently, the labeling for this drug product fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.onlinegenericmedicine.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act. Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug product without requiring a prescription, www.onlinegenericmedicine.com jeopardizes patient safety and misbrands the drug product under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act. [B29] Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. [B27] Identify your written response with reference number “MARCS-CMS 737806” in the subject line of the email. [B25] If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States. [B158] Sincerely, /S/ Sangeeta Vaswani Chatterjee, PharmD Director Office of Drug Security, Integrity, and Response Office of Compliance Center for Drug Evaluation and Research U.S. [B247] 10/06/2026 Regulated Product(s)

#### [162] cheap-medicine-shopwwwcheapmedicineshopcom-737810-09242026 | issued 09/24/2026 | Cheap Medicine Shop/www.cheapmedicineshop.com | SUBJ: Unapproved New Drugs/Misbranded (Internet Pharmacy)
WARNING LETTER Reference Number: MARCS-CMS 737810 To Cheap Medicine shop: [B46] Food and Drug Administration (FDA) review of your website www.cheapmedicineshop.com. [B26] [B159] It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. [B160] As discussed below, FDA has observed that www.cheapmedicineshop.com introduces into interstate commerce unapproved and misbranded injectable semaglutide drug products. There are inherent risks to consumers who purchase unapproved and misbranded drug products. [B90] [B91] Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.cheapmedicineshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. [B185] FDA Review Violations were identified and documented during a review of your website www.cheapmedicineshop.com, FDA Establishment Identifier (FEI) 3041109073, on August 26, 2026, and September 2, 2026. Violations of the Federal Food, Drug, and Cosmetic Act On your website at internet address www.cheapmedicineshop.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 352(f)(1), 353(b)(1), and 355(a)). The following are violations identified during our review. [B28] Unapproved New Drug Violations Certain products offered for sale by www.cheapmedicineshop.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act. You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. An example of an unapproved semaglutide drug product you offer for sale on www.cheapmedicineshop.com is semaglutide marketed as "Semanext Injection." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Semanext Injection is a weekly injectable medicine used for controlling blood sugar in adults. It also supports weight loss and obesity management in individuals with weight-related health conditions." While there are FDA-approved versions of semaglutide drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Semanext Injection” offered by www.cheapmedicineshop.com. Currently there are several semaglutide products FDA-approved for the U.S. market, and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes mellitus and established CV disease; and to reduce the risk of sustained eGFR decline, end-stage kidney disease, and CV death in adults with type 2 diabetes mellitus and chronic kidney disease. FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity to reduce the risk of major adverse CV events in adults with established CV disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in certain adult and pediatric patients, and for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis in adults. Furthermore, FDA-approved semaglutide products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. [B116] Misbranded Drug Violations A drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner. You failed to bear adequate directions for use on the labeling for this drug product that you have introduced into interstate commerce. Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for their intended use. Consequently, the labeling for this drug product fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.cheapmedicineshop.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act. [B29] Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. [B27] Identify your written response with reference number “MARCS-CMS 737810” in the subject line of the email. [B25] If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States. [B158] Sincerely, /S/ Sangeeta Vaswani Chatterjee, PharmD Director Office of Drug Security, Integrity, and Response Office of Compliance Center for Drug Evaluation and Research U.S. [B247] 10/06/2026 Regulated Product(s)