Regulatory

FDA and compounding updates

Approvals, warnings, compounding actions, and safety concerns that affect peptide claims.

Compounding and approval status

Standing pages for approvals, compounding rules, and safety warnings.

FDA compounding tracker

See which peptide products are FDA-approved, which bulk substances are under review, and where FDA has flagged safety or quality concerns.

FDA releases and warnings

Primary FDA updates that change how peptide-related claims should be read.

PCAC Meeting

FDA PCAC meeting scheduled for selected peptide bulk substances

FDA scheduled July 23-24, 2026 PCAC discussions for BPC-157, KPV, TB-500, MOTs-C, emideltide/DSIP, Semax, and Epitalon bulk substances nominated for the 503A Bulks List.

PCAC Meeting

PCAC recommends six of seven nominated peptide bulk substances for the 503A Bulks List

PCAC voted on July 23-24, 2026 to recommend BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon for the 503A Bulks List, and voted 7-6 against emideltide (DSIP). All recommendations are non-binding; FDA rulemaking decides final list placement.

Safety Risk

FDA safety-risk page flags missing or limited safety information for several peptides

FDA lists potential safety and quality concerns for multiple nominated bulk drug substances, including peptide-related impurities, immunogenicity concerns, and missing human exposure data.

Consumer Warning

FDA distinguishes approved semaglutide products from compounded semaglutide risk

FDA describes approved semaglutide products and warns about dosing errors and quality concerns associated with compounded semaglutide products.

Approval

FDA approves Zepbound, a tirzepatide product, for chronic weight management

FDA approved Zepbound, containing tirzepatide, for chronic weight management in adults with obesity or overweight with at least one weight-related condition.