List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations

概要

FDA is establishing a public docket 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office stock) for use in nonfood-producing animals or as antidotes for food- producing animals, as described in the draft guidance for industry #256, "Compounding Animal Drugs from Bulk Drug Substances," when that guidance is finalized. Individuals may also comment on bulk drug substances that have been reviewed by FDA and added to this list, or nominations that are currently under FDA review.