[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.54]
[Page 230]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 21 PROTECTION OF PRIVACY--Table of Contents
Subpart E Procedures for Requests for Amendment of Records
Sec. 21.54 Amended or disputed records received from other agencies.
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 Sec. 21.71 (d) and (e) of the
disclosure of the record under Sec. 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.
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