Lists of Bulk Drug Substances for Compounding: Office Stock Drugs for Use in Nonfood-Producing Animals or Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species; Request for Nominations

概要

The Food and Drug Administration (FDA, the Agency, or we) is announcing updated information for interested parties to nominate bulk drug substances or renominate bulk drug substances that were previously nominated without adequate supporting information, for inclusion on a list of bulk drug substances for compounding certain animal drugs without a patient specific prescription (i.e., office stock) for use in nonfood-producing animals or for inclusion on a list of compounded drugs for use as antidotes for food-producing animals or for use as sedatives or anesthetics for free-ranging wildlife species, as described in the guidance for industry #256 entitled "Compounding Animal Drugs from Bulk Drug Substances." Individuals may also comment on bulk drug substances that have been reviewed by FDA and added to these lists, or nominations that are currently under FDA review.