[B0] (n=133) This letter notifies you of our concerns and provides you an opportunity to address them.
[B1] (n=123) Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
[B2] (n=110) You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
[B3] (n=110) It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations.
[B4] (n=91) 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.
[B5] (n=90) 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.
[B6] (n=90) If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.
[B7] (n=89) All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter.
[B8] (n=85) 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.
[B9] (n=85) 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)].
[B10] (n=85) 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.
[B11] (n=85) 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)].
[B12] (n=84) 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.
[B13] (n=79) If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission.
[B14] (n=79) 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.
[B15] (n=68) 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)].
[B16] (n=63) If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration.
[B17] (n=62) Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
[B18] (n=55) Director Center for Drug Evaluation and Research U.S.
[B19] (n=55) 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).
[B20] (n=54) It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
[B21] (n=49) 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.
[B22] (n=48) 2 Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.
[B23] (n=44) The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.
[B24] (n=44) Your claims imply that your products are the same as an FDA-approved product when they are not.
[B25] (n=32) If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
[B26] (n=32) Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence.
[B27] (n=32) Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
[B28] (n=32) As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
[B29] (n=32) Conclusion As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
[B30] (n=30) Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.
[B31] (n=30) You should take immediate action to address any violations.
[B32] (n=30) That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”);
[B33] (n=30) 1) Identifying the entities that produce the compounded products offered on your website;
[B34] (n=30) We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.
[B35] (n=30) 2) Providing a representative sample of labeling for such products; and 3) Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
[B36] (n=30) We note that 21 CFR § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FDCA [21 USC § 353(b)(1)].
[B37] (n=30) For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the Act, including the new drug approval requirements.
[B38] (n=30) In your written response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices.
[B39] (n=30) 2 See also 21 CFR § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product.
[B40] (n=30) In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FDCA [21 USC § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 USC § 353(b)(2)].
[B41] (n=30) Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review.
[B42] (n=30) Food and Drug Administration (FDA) review of your website.
[B43] (n=29) 2 For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].
[B44] (n=29) 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”).
[B45] (n=28) 353(b)], FDCA §503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)].
[B46] (n=27) This warning letter advises you of significant violations identified during a U.S.
[B47] (n=26) 1 As 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)].
[B48] (n=25) For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].
[B49] (n=25) This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.
[B50] (n=25) You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
[B51] (n=25) Providing a representative sample of labeling for such drug products; and 3.
[B52] (n=25) 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.
[B53] (n=25) Identifying the entities that produce the compounded drug products offered on your website;
[B54] (n=25) Please note FDA posts warning letters on www.FDA.gov.
[B55] (n=25) Lash, JD Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research U.S.
[B56] (n=25) The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products.
[B57] (n=25) We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.
[B58] (n=25) Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter.
[B59] (n=25) The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations.
[B60] (n=25) Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular.
[B61] (n=25) Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.
[B62] (n=25) The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
[B63] (n=25) If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.
[B64] (n=25) If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission.
[B65] (n=25) For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the FD&C Act, including the new drug approval requirements.
[B66] (n=25) Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
[B67] (n=25) Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].
[B68] (n=24) 1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].
[B69] (n=23) The representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.
[B70] (n=23) Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
[B71] (n=22) FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.
[B72] (n=22) 1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
[B73] (n=22) Your representations regarding compounded semaglutide and tirzepatide products are false or misleading.
[B74] (n=21) The following claims concerning compounded semaglutide and tirzepatide products appear on your website:
[B75] (n=21) Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)].
[B76] (n=21) 2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product.
[B77] (n=21) In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].
[B78] (n=21) 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”).
[B79] (n=21) We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)].
[B80] (n=21) That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)].
[B81] (n=18) 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.
[B82] (n=18) Additionally, the following claims concerning compounded semaglutide and tirzepatide products appear on your website:
[B83] (n=17) This letter notifies you of our concerns and provides you with an opportunity to address them.
[B84] (n=17) If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
[B85] (n=17) Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
[B86] (n=15) No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C.
[B87] (n=15) Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
[B88] (n=15) Food and Drug Administration 1 The 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.
[B89] (n=15) 2 For 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)].
[B90] (n=14) Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.
[B91] (n=14) Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
[B92] (n=13) Food and Drug Administration 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body.
[B93] (n=12) You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above).
[B94] (n=12) It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations.
[B95] (n=12) 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 U.S.
[B96] (n=12) This letter is not intended to identify all the ways in which your products or operations might be in violation of the law.
[B97] (n=12) Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.
[B98] (n=12) No approved applications pursuant to section 505 of the FD&C Act are in effect for these products.
[B99] (n=12) If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.
[B100] (n=12) 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 [21 U.S.C. § 355(a)].
[B101] (n=12) A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use.
[B102] (n=12) If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
[B103] (n=12) Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
[B104] (n=12) Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation.
[B105] (n=12) Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
[B106] (n=12) 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.
[B107] (n=12) With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C.
[B108] (n=11) “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).
[B109] (n=11) 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.
[B110] (n=11) There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs.
[B111] (n=11) Your claim implies that your products are the same as an FDA-approved product when they are not.
[B112] (n=11) 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)].
[B113] (n=11) Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities.
[B114] (n=11) Compounded drug products are not FDA-approved drugs; they have not been evaluated by FDA for safety, effectiveness, or quality before marketing as is required for new drug applications (NDAs) or abbreviated new drug applications (ANDAs).
[B115] (n=11) Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products.
[B116] (n=10) The boxed warning addresses the risk of thyroid C-cell tumors.
[B117] (n=10) Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
[B118] (n=10) If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
[B119] (n=10) The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C.
[B120] (n=10) As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C.
[B121] (n=10) These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users.
[B122] (n=10) Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
[B123] (n=10) Accordingly, these products are unapproved new drugs.
[B124] (n=9) Because the aforementioned drugs are prescription drugs 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 products safely for their intended use.
[B125] (n=9) Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice.
[B126] (n=9) Conclusion The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility.
[B127] (n=9) The claim identified in this letter puts you on notice of our concerns but does not represent an exhaustive list of misbranding violations.
[B128] (n=9) The following claims concerning compounded semaglutide products appear on your website:
[B129] (n=9) 3 Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products.
[B130] (n=9) 3 While an entity may elect to register with FDA as an outsourcing facility under section 503B of the FD&C Act [21 U.S.C. § 353b], this registration does not constitute FDA approval or licensure of the facility or its compounded drug products.
[B131] (n=8) 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.
[B132] (n=8) We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act.
[B133] (n=8) In addition, because the drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act.
[B134] (n=8) 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 [21 U.S.C. § 331(k)].
[B135] (n=8) Conclusion This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products.
[B136] (n=8) Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
[B137] (n=8) Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C.
[B138] (n=8) Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration Content current as of:
[B139] (n=8) Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations.
[B140] (n=8) Further, it is a prohibited act under section 301(k) of the FDCA [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.
[B141] (n=8) Compounded Drug Products Under the FDCA Section 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)].
[B142] (n=7) Consequently, the labeling for these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.
[B143] (n=7) Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] 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.
[B144] (n=7) Prescription drugs, as defined in section 503(b)(1) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
[B145] (n=7) Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C.
[B146] (n=7) Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C.
[B147] (n=7) Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.
[B148] (n=7) Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.
[B149] (n=7) 3 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 503B of the FDCA.
[B150] (n=7) FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems.
[B151] (n=7) Under section 301(a) of the FDCA [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.
[B152] (n=7) Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded.
[B153] (n=7) You should take prompt action to address any violations.
[B154] (n=7) If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant.
[B155] (n=7) In particular, this review should assess your aseptic processing operations.
[B156] (n=7) 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.
[B157] (n=7) 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.
[B158] (n=7) Please note FDA posts warning letters on www.fda.gov.
[B159] (n=7) This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations.
[B160] (n=7) Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
[B161] (n=6) FDA-approved semaglutide injection marketed under the brand name Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
[B162] (n=6) 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.
[B163] (n=6) 321(g)(1) because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body.
[B164] (n=6) Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.
[B165] (n=6) Currently there are three semaglutide products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner.
[B166] (n=6) Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
[B167] (n=6) Further, it is also a prohibited act under section 301(k) of the FDCA 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.
[B168] (n=6) Compounded Drug Products under the FDCA Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA.
[B169] (n=6) FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211.
[B170] (n=6) 6 The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA.
[B171] (n=6) Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.
[B172] (n=6) (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).
[B173] (n=6) FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act .
[B174] (n=6) Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions.
[B175] (n=6) 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.
[B176] (n=6) Based on this inspection, it appears you produced drugs that violate the FDCA.
[B177] (n=6) This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.
[B178] (n=6) Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA.
[B179] (n=6) Unapproved New Drug Products You do not have any FDA-approved applications on file for drug products that you compound.
[B180] (n=6) FDA intends to promulgate more specific CGMP regulations for outsourcing facilities.
[B181] (n=6) Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]
[B182] (n=6) (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section.
[B183] (n=6) Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
[B184] (n=6) Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.
[B185] (n=6) This is critical to shielding the American public from harm.
[B186] (n=6) Conclusion For 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)].
[B187] (n=6) 2 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 FDCA.
[B188] (n=6) 2 Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA.
[B189] (n=6) 4 Drug 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.
[B190] (n=6) (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)]).
[B191] (n=6) For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf 6 Your 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).
[B192] (n=6) 1 As 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)].
[B193] (n=6) Failure to Meet the Conditions of Sections 503A and 503B Your compounded retatrutide drug products fail to meet the conditions of sections 503A and 503B.
[B194] (n=6) 5 Because 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.
[B195] (n=6) 4 These 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.
[B196] (n=6) 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.
[B197] (n=6) 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.
[B198] (n=6) False or Misleading Claims 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.
[B199] (n=6) 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.
[B200] (n=6) 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.
[B201] (n=6) 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.
[B202] (n=6) 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;
[B203] (n=6) 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.
[B204] (n=6) 5 These 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).
[B205] (n=6) 7 Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.
[B206] (n=6) 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)]).
[B207] (n=6) 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)].
[B208] (n=6) The representations identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.
[B209] (n=6) Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
[B210] (n=6) Conclusion 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.
[B211] (n=6) The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities.
[B212] (n=5) Director, Office of Drug Security, Integrity, and Response Office of Compliance Center for Drug Evaluation and Research Content current as of:
[B213] (n=5) Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
[B214] (n=5) Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/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.
[B215] (n=5) Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
[B216] (n=5) Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
[B217] (n=5) Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.
[B218] (n=5) Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).
[B219] (n=5) Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
[B220] (n=5) Misbranded Drug Products You compound drug products that 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.
[B221] (n=5) 2 An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs;
[B222] (n=5) 2 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 503B of the FDCA.
[B223] (n=5) Sincerely, /S/ Sangeeta Vaswani Chatterjee, Pharm.D.
[B224] (n=5) For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf.
[B225] (n=5) 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.
[B226] (n=5) 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.
[B227] (n=5) 3 Among 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.
[B228] (n=5) Violations of the FDCA Unapproved New Drugs & Misbranded Drugs There are no FDA-approved applications on file for your compounded retatrutide drug products.
[B229] (n=5) 1 As 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)].
[B230] (n=5) Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C.
[B231] (n=5) Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
[B232] (n=5) 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling.
[B233] (n=5) Food and Drug Administration ________________________ 1 The semaglutide and tirzepatide products offered on your website 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.
[B234] (n=5) The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities.
[B235] (n=5) 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.
[B236] (n=5) Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter.
[B237] (n=5) This warning letter advises you of significant violations observed during a U.S.
[B238] (n=5) This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
[B239] (n=5) Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S.
[B240] (n=4) Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs.
[B241] (n=4) 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C.
[B242] (n=4) Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
[B243] (n=4) Examples of claims observed on your website that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:
[B244] (n=4) 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
[B245] (n=4) Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
[B246] (n=4) FDA-approved semaglutide injection marketed under the brand name Wegovy is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients.
[B247] (n=4) Food and Drug Administration Content current as of:
[B248] (n=4) Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs.
[B249] (n=4) Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.
[B250] (n=4) A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
[B251] (n=4) Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov.
[B252] (n=4) Violations of the FDCA Adulterated Drug Products The FDA investigator 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 FDCA.
[B253] (n=4) A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
[B254] (n=4) In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act.
[B255] (n=4) Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.
[B256] (n=4) Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.
[B257] (n=4) Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering.
[B258] (n=4) 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.
[B259] (n=4) Food and Drug Administration 1 The 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.
[B260] (n=4) It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.
[B261] (n=4) You are encouraged, but not required, to submit your response in eCTD format.
[B262] (n=4) Director Center for Drug Evaluation and Research -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically.
[B263] (n=4) Sincerely, {See appended electronic signature page} George Tidmarsh, M.D., Ph.D.
[B264] (n=4) All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6.
[B265] (n=4) Failure to Submit Under Form FDA-2253 FDA 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.
[B266] (n=4) 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.
[B267] (n=4) A courtesy copy can be sent by facsimile to (301) 847-8444.
[B268] (n=4) You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above).
[B269] (n=4) 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.
[B270] (n=4) 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.
[B271] (n=4) In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i).
[B272] (n=4) 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.
[B273] (n=4) False or Misleading Risk Presentation Prescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk.
[B274] (n=4) FDA has determined that the video is false or misleading.
[B275] (n=4) Corrective communication(s) should be free of promotional claims and presentations.
[B276] (n=4) 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.
[B277] (n=4) The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations.
[B278] (n=4) 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.
[B279] (n=4) After you receive this letter, respond to this office in writing within 15 working days.
[B280] (n=4) Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.
[B281] (n=4) If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
[B282] (n=4) Specify what you have done to address any deviations and to prevent their recurrence.
[B283] (n=4) Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.
[B284] (n=4) Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research _______________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body.
[B285] (n=4) Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research ______________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body.
[B286] (n=4) 2 Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)].
[B287] (n=4) Food and Drug Administration __________________________ 1 The semaglutide and tirzepatide products offered on your website 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.
