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# FDA Clarifies Compounded GLP-1 Enforcement
- URL: https://www.fdaweb.com/fda-clarifies-compounded-glp-1-enforcement/
- Published: 2025-02-12T12:00:00.000Z
- Updated: 2026-09-14T14:53:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158647

FDA says it has not changed its intentions on enforcement discretion for drug compounders as the national GLP-1 (glucagon-like peptide-1) supply begins to stabilize. An agency [statement](https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize?ref=fdaweb.com) says the timeframes during which it does not intend to take action against compounders for violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) arising from conditions that depend on tirzepatide (Lilly’s Zepbound and Mounjaro) products’ inclusion on the FDA drug shortage list. The timeframes are:

- for a state-licensed pharmacy or physician compounding under Section 503A of the FFDCA until 2/18 or until the date of a Texas federal court’s decision on the plaintiffs’ preliminary injunction motion in *Outsourcing Facilities Association v. FDA*, whichever is longer; and
- for outsourcing facilities under Section 503B until 3/19 or until the date of a Texas federal court’s decision on the plaintiffs’ preliminary injunction motion in *Outsourcing Facilities Association v. FDA*, whichever is longer.

“FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be on substandard quality or otherwise unsafe,” the notice says.