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In order to reduce barriers to the production of drugs intended to treat or prevent New World Screwworm, the Food and Drug Administration (FDA) is issuing a direct final rule amending its regulations to exempt drugs in bulk package (primarily active pharmaceutical ingredients for use in drug manufacturing) from the adequate directions for use requirement when they are intended to produce drugs covered by an Emergency Use Authorization (EUA).  FDA’s regulations currently exempt bulk drugs intended for use in manufacturing for all other types of drugs that can be legally marketed (e.g., approved human and animal drugs, conditionally approved animal drugs, and indexed listed animal drugs), and this amendment extends the exemption to cover EUAs.