FDA Guidance Tracker

Updated labeling requirements for compounded peptide preparations, clarifying required disclosure language, prohibited claims, and documentation standards for 503A and 503B facilities. Effective immediately upon publication.

Proposed revision to 503B outsourcing facility inspection standards introducing expanded supplier qualification documentation requirements. Comment period open through April 2026. Expected effective date Q3 2026 pending finalization.

Final guidance clarifying FDA expectations for CoA verification practices at compounding facilities. Specifies acceptable third-party testing methodologies, documentation retention requirements, and supplier re-qualification timelines.

Draft guidance outlining updated manufacturing standards for injectable peptide preparations, including sterility assurance requirements, environmental monitoring, and container closure integrity testing. Comment period open through December 2025.

Expanded import safety program targeting peptide API quality standards for foreign manufacturers. Framework under review following significant increase in adverse event reports linked to compounded injectable peptides in Q3 2025.

Comprehensive update to the compounding pharmacy compliance framework addressing documentation requirements, facility registration standards, and adverse event reporting obligations. Supersedes 2022 framework guidance.

Proposed update to the bulk drug substance nomination process for peptide compounds, including revised criteria for inclusion on the 503B bulks list and new clinical need documentation requirements. Public comment period open through May 2025.