Enforcement discretion
The vocabulary of getting a claim paid, of FDA enforcement, and of what on-label and off-label really mean.
What is Enforcement discretion?
A regulator (FDA or HHS) choosing not to act against conduct it could act against.
It is a decision, not a permission, and it can be withdrawn, which is what happened here: discretion for compounded semaglutide ended for 503A pharmacies in late April 2025, after an April 24 court ruling, and for 503B facilities on May 22, 2025. Peptides are the newest example: on October 28, 2026, HHS said it does not intend to take enforcement action against 503A compounding of BPC-157, TB-500, Epitalon, Semax, KPV and MOTS-c under strict conditions until a final rule decides whether they belong on the 503A bulks list. That policy is interim and is not an approval.
Related reading: Compounded Semaglutide and Tirzepatide Are Ending: What to Do Next
GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature.
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On GLP Watchdog, Enforcement discretion comes up in 3 research articles.
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