Primary-source regulatory database
Track enforcement, safety communications, policy changes, and advisory proceedings from the original government record. Each item is stored once and connected to affected company and compound profiles.
Showing 11 records
Scheduled · Scheduled public meeting
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.
Compounds: BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, Epitalon
Agency warning · Open public record
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.
Compounds: Semaglutide, Tirzepatide
Agency warning · Open public record
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.
Compounds: Semaglutide, Tirzepatide
Proposal · Proposal; comment period closed
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.
Compounds: Semaglutide, Tirzepatide
Agency warning · Open public record
The FDA said Gram Peptides marketed unapproved new drugs for human use despite research-only labeling. Warning letter 721806 details the finding.
Companies: Gram Peptides
Compounds: Retatrutide, Tirzepatide
Agency warnings · Agency initiative announced
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.
Compounds: Semaglutide, Tirzepatide
Intent announced · Policy statement
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.
Companies: Hims & Hers
Compounds: Semaglutide, Tirzepatide
Final guidance · 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.
Final guidance · Final guidance
FDA published final guidance describing its interim regulatory policy for bulk drug substances used by registered outsourcing facilities under section 503B.
Safety communication · Active 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.
Compounds: Semaglutide
Proposal · Proposed rule
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.
Warning letters, proposals, safety alerts, guidance, and advisory meetings have different legal weight. Peptide Report labels the record type and stage instead of collapsing everything into a severity score. A linked public record is not, by itself, a finding about a company's current status.