FDA Issues Revised Guidance on Reporting Drug Impurity Data

The FDA has made significant revisions to a November 1999 guidance that provides recommendations on the types of drug impurity data included with drug applications.

The agency released a new draft guidance that supersedes the November 1999 guidance titled, "ANDAs: Impurities in Drug Substances." Both the revised and the original guidances provide recommendations on what chemistry, manufacturing and controls information to include regarding drug substance impurities when submitting abbreviated new drug applications (ANDAs), ANDA supplements or drug master files.

The revisions were necessary, the FDA said, to update information on the listing of impurities, setting of acceptance criteria and qualifying impurities. Additionally, sections of the 1999 guidance needed to be removed because they are addressed in the International Conference on Harmonisation's "Q3A Impurities in New Drug Substances" (Q3A(R)) guidance, which offers guidance on impurities in drug substances for new drug applications. The FDA said many of the recommendations included in the Q3A(R) can also be applied to ANDAs.

The sections of the 1999 guidance that were removed addressed the classification of impurities, the rationale for the reporting and control of impurities, analytical procedures, and reporting impurity content of batches. Drugmakers needing guidance on those subjects should refer to the Q3A(R) document.

To view the new draft guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/1998d-0514-gdl0003.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/1998d-0514-gdl0003.pdf).