The FDA has stated that it does not intend to take action against compounders for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) arising from conditions
that depend on tirzepatide's inclusion on the FDA drug shortage list. Compounding pharmacies should still exercise their own best judgment as individual State Boards may still decide to take action against a compounder licensed in their state.
Further, compounders should be aware that this does not insulate compounders from FDA action for violations unrelated to tirzepatide's inclusion the shortage list, such as those for substandard or unsafe products.
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