Compounded and Unapproved Peptides: Regulatory Exposure and Defense for Prescribers and Clinics

This session examines the FDA’s regulatory framework governing peptide compounding under 503A and 503B of the FD&C Act, the enforcement cascade triggered by Category 2 designations and shortage-list determinations, and the state-level medical board and pharmacy board actions now targeting peptide-prescribing clinics. Attorneys will gain working knowledge of the compliance obligations, documentation standards, and defense strategies applicable to prescribers and clinics facing regulatory scrutiny. Attendees will leave able to identify the specific legal theories being deployed by state and federal regulators and to counsel clients on reducing exposure before and during an investigation.

This session examines the malpractice and insurance coverage risks facing clinics and prescribers who administer or prescribe compounded and unapproved peptide therapies. Attorneys will learn how to identify and counter the malpractice per se theory, build a documentation-based defense, and navigate coverage gaps that standard medical malpractice policies routinely create for unapproved substances. Participants will leave with a concrete framework for pre-claim risk reduction, post-claim defense strategy, and coverage dispute litigation in an area where appellate precedent is still forming.