21 CFR 21.53 - Notation and disclosure of disputed records.
(a) Mark any portion of the record that is disputed to assure that the record will clearly show that portion is disputed whenever the record is disclosed.
(b) In any subsequent disclosure under § 21.70 or § 21.71(a), provide a copy of the statement of disagreement and, if the Food and Drug Administration deems it appropriate, a concise statement of the agency's reasons for not making the amendment(s) requested. While the individual shall have access to any such statement, it shall not be subject to a request for amendment under § 21.50.
(c) If an accounting was made under § 21.71(d) and (e) of a disclosure of the record under § 21.71(a), provide to all previous recipients of the record a copy of the statement of disagreement and the agency statement, if any.