C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 20—PUBLIC INFORMATION › Subpart F—Availability of Specific Categories of Records

21 C.F.R. § 20.112

Voluntary drug experience reports submitted by physicians and hospitals

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(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]
Notes of Decisions
Cited in 1 case, 1987–1987 · leading case: Harris v. Upjohn Co., 115 F.R.D. 191 (S.D. Ill. 1987).
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Harris v. Upjohn Co., 115 F.R.D. 191 (S.D. Ill. 1987). “This policy of non-disclosure has been expressed in federal regulation 21 C.F.R. § 20.112 (1986). This regulation states the Federal Drug Administration will not release voluntarily-submitted drug experience reports without the permission of the party submitting the report.”
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