[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.54]

[Page 235]
 
                        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.