www.fdanews.com/articles/113605-fda-issues-q-38-a-document-about-residual-solvents-standard
FDA Issues Q&A Document About Residual Solvents Standard
January 9, 2009
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 standard <467> for controlling residual solvents.
ANDA sponsors with approvals in that time period will have to submit information supporting their verifications in a special report, due immediately to the FDA, rather than waiting to submit the information in annual reports, OGD says in a question-and-answer (Q&A) document.
The FDA told generic-drug makers last May they had to comply with the new standard, which took effect July 1, 2008. The agency issued a draft guidance last August.
Drug GMP Report