[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: 21CFR21.72]
[Page 234]
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 G Disclosure of Records in Privacy Act Record Systems to Persons
Other Than the Subject Individual
Sec. 21.72 Individual consent to disclosure of records to other persons.
(a) Individuals may consent to disclosure of records about
themselves to other persons in several ways, for example:
(1) An individual may give consent at the time that the information
is collected for disclosure for specific purposes or to specific
persons.
(2) An individual may give consent for disclosure of his records to
a specific person.
(3) An individual may request the Food and Drug Administration to
transcribe a specific record for submission to another person.
(b) In each case the consent shall be in writing and shall specify
the individual, organizational unit, or class of individuals or
organizational units to whom the record may be disclosed, which record
may be disclosed, and, if applicable, for what time period. A blanket
consent to release all of an individual's records to unspecified
individuals or organizational units will not be honored. Verification of
the identity of the individual and, where applicable, of the person to
whom the record is to be disclosed shall be made in accordance with
Sec. 21.44. Consent documents shall be retained for a period of at
least 2 years. If such documents are used as a means of accounting for
the disclosure, they shall be retained as provided in Sec. 21.71(e)(2).
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