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Home » FDA Issues Q&A Document About Residual Solvents Standard
FDA Issues Q&A Document About Residual Solvents Standard
December 8, 2008
The FDA’s Office of Generic Drugs (OGD) says sponsors of ANDA and ANDA supplements approved between July 1, 2008, and July 1, 2009, may provide a commitment within six months of approval to verify excipient makers’ statements used to comply with U.S. Pharmacopeia (USP) standard <467> for controlling residual solvents.