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# Policy on Bioavailability/Bioequivalence Retention Samples
- URL: https://www.fdaweb.com/policy-on-bioavailability-bioequivalence-retention-samples/
- Published: 2020-08-19T12:00:00.000Z
- Updated: 2026-09-14T16:25:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147460

*Federal Register* notice: FDA has made available a final guidance entitled *Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)*. The document describes FDA’s policy concerning the conditions under which it generally does not intend to take regulatory action against an applicant or a contract research organization that retains less than the recommended quantity of reserve samples (test article and reference standard that were used in bioavailability or bioequivalence testing). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-08-19/pdf/2020-17798.pdf?ref=fdaweb.com).