CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR21.72]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 21 -- PROTECTION OF PRIVACY

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 § 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 § 21.71(e)(2).