[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.72]

[Page 263]
 
                        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).