[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-medisourcerx-717970-12122025":3,"fda-latest-sync-dates":31},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},331,"medisourcerx-717970-12122025","Warning Letter","MedisourceRx",null,"Center for Drug Evaluation and Research (CDER)","Compounding Pharmacy\u002FAdulterated Drug Products","2026-02-24","2025-12-12","2026-07-30","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmedisourcerx-717970-12122025","717970","Drugs","VIA Electronic Mail","Daniel D. Hernandez","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Daniel D. Hernandez\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Director of Quality \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>MedisourceRx\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">10525 Humbolt Street\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Los Alamitos\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">90720-5401\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>\u003Cstrong>WL # 717970\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>December 12, 2025\u003C\u002Fp>\u003Cp>Dear Mr. Hernandez:\u003C\u002Fp>\u003Cp>You registered your facility with the U.S. 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]\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> on February 14, 2017, and most recently on December 31, 2024. From May 27, 2025, to June 10, 2025, FDA investigators inspected your facility, MedisourceRx, located at 10525 Humbolt Street, Los Alamitos, CA 90720. During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA.\u003C\u002Fp>\u003Cp>FDA issued a Form FDA 483 to your facility on June 10, 2024. FDA acknowledges receipt of your facility’s responses, submitted on July 2, 2025, September 5, 2025, and October 10, 2025. Based on this inspection, it appears you produced drugs that violate the FDCA.\u003C\u002Fp>\u003Cp>\u003Cstrong>A. Compounded Drug Products under the FDCA\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Under 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.\u003Cem>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>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; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. 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. 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.\u003C\u002Fp>\u003Cp>For a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to 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)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).\u003C\u002Fp>\u003Cp>\u003Cstrong>B. Failure to Meet the Conditions of Section 503B\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>During the inspection, the FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators noted that 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).\u003Cem>\u003Cstrong>\u003Csup>3\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> Specifically,\u003C\u002Fp>\u003Cp>1. You failed to submit the adverse event report identified in Complaint Log # C25004.\u003C\u002Fp>\u003Cp>2. Your documented procedures for reporting adverse events do not adequately define what constitutes a “serious” adverse event (21 CFR 310.305(b)).\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>Specific violations are described below.\u003C\u002Fp>\u003Cp>\u003Cstrong>C. Violations of the FDCA\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>\u003Cstrong>Unapproved New Drug Products\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>You do not have any FDA-approved applications on file for drug products that you compound.\u003Cem>\u003Cstrong>\u003Csup>4\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> Under sections 505(a) and 301(d) of the FDCA [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 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.\u003C\u002Fp>\u003Cp>\u003Cstrong>Misbranded Drug Products\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>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. 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.\u003Cem>\u003Cstrong>\u003Csup>5\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. 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.\u003C\u002Fp>\u003Cp>\u003Cstrong>Failure to Report Adverse Events\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As noted above, your facility failed to submit an adverse event report (section 503B(b)(5) of the FDCA). The failure to report adverse events by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].\u003C\u002Fp>\u003Cp>\u003Cstrong>D. Corrective Actions\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>We have reviewed your facility’s responses to the Form FDA 483.\u003C\u002Fp>\u003Cp>Some of your corrective actions appear adequate: Your firm retroactively submitted reports of serious, unexpected adverse event reports received prior to FDA’s inspection.\u003C\u002Fp>\u003Cp>Some of your corrective actions appear deficient: Submitted documented procedures for reporting adverse events do not appear to adequately address the submission of adverse event reports to FDA in accordance with 21 CFR 310.305. For example, the procedures do not clearly define a “serious” adverse event in a manner consistent 21 CFR 310.305(b).\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>\u003Cstrong>E. Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. 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 firm complies with all requirements of federal law, including FDA regulations.\u003C\u002Fp>\u003Cp>You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>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. 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.\u003C\u002Fp>\u003Cp>All correspondence should refer to the Warning Letter Number above (# 717970) and 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.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>F. Gail Bormel, JD, RPh\u003Cbr>Director\u003Cbr>Office of Compounding Quality and Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003C\u002Fp>\u003Cp>_____________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> \u003Cem>See\u003C\u002Fem> Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> 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.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fem> For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FDrugs\u002FGuidanceComplianceRegulatoryInformation\u002FGuidances\u002FUCM434188.pdf.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fem> The specific products made by your firm 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\u002For 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.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>5 \u003C\u002Fstrong>\u003C\u002Fem>Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA Electronic Mail\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nDaniel D. Hernandez\n\nRecipient Title\n\nDirector of Quality\n\nMedisourceRx\n\n10525 Humbolt Street\n\nLos Alamitos, CA 90720-5401\n\nUnited States\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\nWL # 717970\nDecember 12, 2025\nDear Mr. Hernandez:\nYou registered your facility with the U.S. 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]1 on February 14, 2017, and most recently on December 31, 2024. From May 27, 2025, to June 10, 2025, FDA investigators inspected your facility, MedisourceRx, located at 10525 Humbolt Street, Los Alamitos, CA 90720. During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA.\nFDA issued a Form FDA 483 to your facility on June 10, 2024. FDA acknowledges receipt of your facility’s responses, submitted on July 2, 2025, September 5, 2025, and October 10, 2025. Based on this inspection, it appears you produced drugs that violate the FDCA.\nA. Compounded Drug Products under the FDCA\nUnder 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.2\nAn 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; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. 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. 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.\nFor a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to 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)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).\nB. Failure to Meet the Conditions of Section 503B\nDuring the inspection, the FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators noted that 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).3 Specifically,\n1. You failed to submit the adverse event report identified in Complaint Log # C25004.\n2. Your documented procedures for reporting adverse events do not adequately define what constitutes a “serious” adverse event (21 CFR 310.305(b)).\nBecause 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.\nSpecific violations are described below.\nC. Violations of the FDCA\nUnapproved New Drug Products\nYou do not have any FDA-approved applications on file for drug products that you compound.4 Under sections 505(a) and 301(d) of the FDCA [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 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.\nMisbranded Drug Products\nYou 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. 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.5 The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. 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.\nFailure to Report Adverse Events\nAs noted above, your facility failed to submit an adverse event report (section 503B(b)(5) of the FDCA). The failure to report adverse events by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].\nD. Corrective Actions\nWe have reviewed your facility’s responses to the Form FDA 483.\nSome of your corrective actions appear adequate: Your firm retroactively submitted reports of serious, unexpected adverse event reports received prior to FDA’s inspection.\nSome of your corrective actions appear deficient: Submitted documented procedures for reporting adverse events do not appear to adequately address the submission of adverse event reports to FDA in accordance with 21 CFR 310.305. For example, the procedures do not clearly define a “serious” adverse event in a manner consistent 21 CFR 310.305(b).\nShould 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.\nE. Conclusion\nThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. 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 firm complies with all requirements of federal law, including FDA regulations.\nYou should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.\nWithin 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. 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.\nAll correspondence should refer to the Warning Letter Number above (# 717970) and 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.\nSincerely,\n\u002FS\u002F\nF. Gail Bormel, JD, RPh\nDirector\nOffice of Compounding Quality and Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\n_____________________\n1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).\n2 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.\n3 For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FDrugs\u002FGuidanceComplianceRegulatoryInformation\u002FGuidances\u002FUCM434188.pdf.\n4 The specific products made by your firm 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\u002For 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.\n5 Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).","2026-08-19T04:57:14.006+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2026-02-24T05:00:00Z\">02\u002F24\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-12-12T05:00:00Z\">12\u002F12\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmedisourcerx-717970-12122025\">MedisourceRx\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmedisourcerx-717970-07272026\">\u003Ctime datetime=\"2026-07-30T04:00:00Z\">07\u002F30\u002F2026\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]