Residual Solvents in Animal Drug Products; Questions and Answers; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #211 entitled "Residual Solvents in Animal Drug Products; Questions and Answers." The questions and answers guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and non-compendial drug products. This document answers questions regarding the Center for Veterinary Medicine's (CVM) implementation of USP Residual Solvents.