Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Withdrawal of Compliance Policy Guide; Section 608.400 Compounding of Drugs for Use in Animals

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled "Compounding Animal Drugs from Bulk Drug Substances." The draft guidance describes FDA's policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA's current thinking on the issues addressed by the guidance. FDA is also announcing the withdrawal of the compliance policy guide (CPG) entitled "Section 608.400 Compounding of Drugs for Use in Animals," which was issued in July 2003. This 2003 CPG is being withdrawn because it is no longer consistent with FDA's current thinking on the issues it addresses.