Peptide Report Regulatory Watchhttps://peptide-report.com/regulatory-watch/Primary-source peptide, compounding, and GLP-1 regulatory records.en-us FDA advisory committee to review seven peptide-related bulk drug substanceshttps://peptide-report.com/regulatory-watch/fda-pcac-peptide-bulks-meeting-2026-07-23/https://peptide-report.com/regulatory-watch/fda-pcac-peptide-bulks-meeting-2026-07-23/Thu, 23 Jul 2026 12:00:00 GMTAdvisory committee · Scheduled. FDA scheduled a two-day Pharmacy Compounding Advisory Committee meeting to discuss whether BPC-157, KPV, TB-500, MOTS-c, emideltide/DSIP, Semax, and Epitalon-related substances should be included on the 503A Bulks List. The committee provides advice; the meeting itself is not a final agency determination. Ready Med: FDA Warning Letter 730317https://peptide-report.com/regulatory-watch/fda-warning-letter-ready-med-2026-06-08/https://peptide-report.com/regulatory-watch/fda-warning-letter-ready-med-2026-06-08/Mon, 08 Jun 2026 12:00:00 GMTEnforcement · Agency warning. FDA stated that Ready Med's website claims about compounded semaglutide and tirzepatide could imply equivalence with approved drugs and could obscure which entity compounded the products. D&H Medical Services: FDA Warning Letter 728238https://peptide-report.com/regulatory-watch/fda-warning-letter-dh-medical-services-2026-06-08/https://peptide-report.com/regulatory-watch/fda-warning-letter-dh-medical-services-2026-06-08/Mon, 08 Jun 2026 12:00:00 GMTEnforcement · Agency warning. FDA issued a warning letter concerning website presentation and marketing claims for compounded semaglutide and tirzepatide products. The linked source is the agency's complete public record. FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks Listhttps://peptide-report.com/regulatory-watch/fda-503b-bulks-glp1-proposal-2026-04-30/https://peptide-report.com/regulatory-watch/fda-503b-bulks-glp1-proposal-2026-04-30/Thu, 30 Apr 2026 12:00:00 GMTRulemaking and policy · Proposal. FDA proposed excluding three GLP-1 active ingredients from the 503B Bulks List after preliminarily finding no clinical need for outsourcing facilities to compound them from bulk substances. The proposal is not a final determination. Gram Peptides: FDA Warning Letter 721806https://peptide-report.com/regulatory-watch/fda-warning-letter-gram-peptides-2026-03-31/https://peptide-report.com/regulatory-watch/fda-warning-letter-gram-peptides-2026-03-31/Tue, 31 Mar 2026 12:00:00 GMTEnforcement · Agency warning. The FDA said Gram Peptides marketed unapproved new drugs for human use despite research-only labeling. Warning letter 721806 details the finding. FDA announces warning letters to 30 telehealth companies over compounded GLP-1 marketinghttps://peptide-report.com/regulatory-watch/fda-telehealth-glp1-warning-letters-2026-03-03/https://peptide-report.com/regulatory-watch/fda-telehealth-glp1-warning-letters-2026-03-03/Tue, 03 Mar 2026 12:00:00 GMTEnforcement · Agency warnings. FDA announced 30 warning letters addressing claims that could imply compounded GLP-1 products were the same as FDA-approved products or obscure the source of the compounded product. FDA announces intent to act against mass-marketed non-approved compounded GLP-1 drugshttps://peptide-report.com/regulatory-watch/fda-glp1-enforcement-intent-2026-02-06/https://peptide-report.com/regulatory-watch/fda-glp1-enforcement-intent-2026-02-06/Fri, 06 Feb 2026 12:00:00 GMTAgency statement · Intent announced. FDA announced intended enforcement steps involving GLP-1 active pharmaceutical ingredients used in mass-marketed non-approved compounded drugs and misleading direct-to-consumer promotion. The statement named Hims & Hers among the companies in scope but was not itself a final adjudication against that company. FDA finalizes interim policy for 503A compounding with bulk drug substanceshttps://peptide-report.com/regulatory-watch/fda-503a-bulk-substances-guidance-2025-01-06/https://peptide-report.com/regulatory-watch/fda-503a-bulk-substances-guidance-2025-01-06/Mon, 06 Jan 2025 12:00:00 GMTGuidance · Final guidance. FDA published final guidance describing its interim regulatory policy for certain bulk drug substances used by state-licensed pharmacies and physicians under section 503A. FDA finalizes interim policy for 503B outsourcing-facility use of bulk substanceshttps://peptide-report.com/regulatory-watch/fda-503b-bulk-substances-guidance-2025-01-06/https://peptide-report.com/regulatory-watch/fda-503b-bulk-substances-guidance-2025-01-06/Mon, 06 Jan 2025 12:00:00 GMTGuidance · Final guidance. FDA published final guidance describing its interim regulatory policy for bulk drug substances used by registered outsourcing facilities under section 503B. FDA alerts on dosing errors involving compounded injectable semaglutidehttps://peptide-report.com/regulatory-watch/fda-compounded-semaglutide-dosing-alert-2024-07-26/https://peptide-report.com/regulatory-watch/fda-compounded-semaglutide-dosing-alert-2024-07-26/Fri, 26 Jul 2024 12:00:00 GMTSafety alert · Safety communication. FDA reported adverse events, including some requiring hospitalization, associated with dosing errors involving compounded injectable semaglutide and described risks tied to varying concentrations, vial-and-syringe measurement, and unit conversion. FDA proposes categories of drug products presenting demonstrable difficulties for compoundinghttps://peptide-report.com/regulatory-watch/fda-demonstrable-difficulties-proposed-rule-2024-03-19/https://peptide-report.com/regulatory-watch/fda-demonstrable-difficulties-proposed-rule-2024-03-19/Tue, 19 Mar 2024 12:00:00 GMTRulemaking and policy · Proposal. FDA published a proposed rule addressing drug products or categories that present demonstrable difficulties for compounding under sections 503A and 503B. The record is tracked as sector-level policy, not as a company action.