The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing compounding of animal drugs from bulk drug substances. A separate Notice announced that FDA is soliciting nominations for the Bulk Drug Substance List (Bulk List Notice) for use in the compounding of animal drug products. In the wake of FDA’s publication of a number of guidance documents relating to the implementation of Section 503A and 503B of the Drug Quality and Security Act (DQSA), which is only applicable to the compounding of human drugs, there remained outstanding questions as to the status of compounded animal drugs. Through this Draft Guidance, FDA is trying to provide some clarity on the remaining animal compounding issues. Comments and nominations are due by August 17, 2015.  Read more>>