Enforcement discretion

The vocabulary of getting a claim paid, of FDA enforcement, and of what on-label and off-label really mean.

Definition

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 It is a decision, not a permission, and it can be withdrawn — which is exactly what happened here: discretion for compounded semaglutide ended 22 April 2025 for 503A pharmacies and 22 May 2025 for 503B facilities.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. Not one of them is an AI-generated summary.

Other terms under Insurance and regulatory

FDA Warning Letter
Prior authorization (PA)
Step therapy
Off-label use
FDA Drug Shortage List
Formulary tier
Untitled letter
Close-out letter
Consent decree
FTC action
LegitScript certification
State board of pharmacy
Asynchronous intake
“Research chemical” / not for human consumption

Where the evidence lives

Compounded GLP-1s are ending
The full GLP-1 glossary (149 terms, 8 categories)
Research articles — written from primary sources
Tools and calculators
Compare GLP-1 telehealth providers