21 CFR 21.54
§ 21.54 Amended or disputed records received from other agencies.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 21.54, § 21.54 Amended or disputed records received from other agencies, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83401
- Permanent ID
ys:prov:83401@1- SHA-256
879a582b78eed376dc9df534a756960ca77e522534bfbf1548bf3d9962295135
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Full text
Whenever the Food and Drug Administration is notified that a record that it received from another agency was amended or is the subject of a statement of disagreement, the Food and Drug Administration shall:
(a) Discard the record, or clearly note the amendment or the fact of disagreement in its copy of the record, and
(b) Refer persons who subsequently request the record to the agency that provided it.
(c) If an accounting was made under § 21.71 (d) and (e) of the disclosure of the record under § 21.71(a), inform all previous recipients of the record about the amendment or provide to them the statement of disagreement and the agency statement, if any.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.