21 C.F.R. § 20.112 Voluntary drug experience reports submitted by physicians and hospitals.
Title 21 - Food and Drugs
(a) A voluntary drug experience report to the Food and Drug Administration on FDA Form 3500 shall be handled in accordance with the rules established in §20.111(c)(3)(iii). (b) If a person requests a copy of any such record relating to a specific individual or a specific incident, such request will be denied unless accompanied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Administration and the individual who is the subject of the report. [42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 62 FR 52249, Oct. 7, 1997]
Title 21: Food and Drugs
PART 20—PUBLIC INFORMATION
Subpart F—Availability of Specific Categories of Records
§ 20.112 Voluntary drug experience reports submitted by physicians and hospitals.
