Sample storage times are discussed in 21 CFR 320.38 and 21 CFR 320.63 in
connection with bioequivalence study samples. In general, ANDA
submission batch samples should be stored for 1 year after approval of the
ANDA, and samples of the drug product used for bioequivalence studies must
be stored following the requirements listed in 21 CFR 320.38 and 21 CFR
320.63. In addition, the guidance for industry on Handling and Retention of
BA and BE Testing Samples8 may be helpful regarding the procedure for
handling reserve samples from relevant bioavailability and bioequivalence
studies. Additional information on sample quantities (for retention purposes)
is discussed in 21 CFR 211.170 (a) and (b), Reserve Samples.
