List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations

概要

The Food and Drug Administration (FDA) intends to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA's draft guidance for industry #230, "Compounding Animal Drugs from Bulk Drug Substances." You may nominate specific bulk drug substances for this list. This notice describes the information that should be provided to the Agency in support of each nomination.