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FDA confirms tirzepatide shortage is over, starting wind-down of compounded copies

Regulatory

After re-evaluating its October 2, 2024 decision, which a compounding industry group had challenged in court, the FDA again determined that the national shortage of tirzepatide injection (Mounjaro, Zepbound) was resolved. Because copies of approved drugs can only be compounded routinely during a shortage, the agency set grace periods ending February 18, 2025 for state-licensed pharmacies (503A) and March 19, 2025 for outsourcing facilities (503B).

Sources

  1. 01FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize(opens the source in a new tab) U.S. Food and Drug Administration
  2. 02FDA Roundup: December 20, 2024(opens the source in a new tab) U.S. Food and Drug Administration

Peptides involved

  1. ApprovedTirzepatideDual GIP and GLP-1 receptor agonist39