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?
FDA choosing not to act against conduct it could act against.
It is a decision, not a permission, and it can be withdrawn, which is exactly what happened here: discretion for compounded semaglutide ended 22 April 2025 for 503A pharmacies and 22 May 2025 for 503B facilities.
Compounded GLP-1s are ending →
GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature.
Where Enforcement discretion comes up on this site
On GLP Watchdog, Enforcement discretion comes up in 1 research article.
Research that discusses it
Connected terms
Other terms under Insurance and regulatory
Where the evidence lives
- Compounded GLP-1s are ending
- The full GLP-1 glossary (149 terms, 8 categories)
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