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Enforcement discretion

The FDA's decision to temporarily not take action against conduct that technically violates the rules, such as the grace periods it gave compounders after the GLP-1 shortages ended.

By the glp1.how editorial teamReviewed

Enforcement discretion is the FDA's stated intention not to take action against something it could otherwise regulate, usually for a defined period and a stated reason. The underlying rule stays on the books; the agency simply chooses not to enforce it for now.

In the GLP-1 world it explains how the compounding boom wound down. While semaglutide and tirzepatide were on the FDA's shortage list, federal law itself allowed compounders to make copies of them. Once the shortages were declared resolved, that permission ended, and the FDA used enforcement discretion to give compounders short grace periods before it would act.

Those windows have closed. The tirzepatide shortage was declared resolved in December 2024 and the semaglutide shortage on February 21, 2025. Enforcement discretion for compounded semaglutide (external link) ended April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B facilities. Since then, compounding "essentially a copy" of the approved products is not permitted outside narrow individualized cases. See pharmacy sources for GLP-1 medications.

fdacompoundingregulation

Revision history

Updated 1 time since Sep 2, 2026 · show changes
  1. v2

    Summary rewritten; Body revised; Metadata updated

  2. v1

    Change tracking began

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Related terms

  • Tirzepatide · A once-weekly dual GIP and GLP-1 receptor agonist made by Eli Lilly, marketed as Mounjaro for type 2 diabetes and Zepbound for weight management and obstructive sleep apnea.
  • Semaglutide · A GLP-1 receptor agonist medication made by Novo Nordisk, sold under the brand names Ozempic (type 2 diabetes) and Wegovy (weight management), each as an injection or a pill.
  • GLP-1 · A gut hormone (glucagon-like peptide-1) that stimulates insulin release, slows digestion, and reduces appetite; the target of drugs like semaglutide and liraglutide.

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