21 CFR 20.112 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 1.1 To § 99.501) — Food And Drug Administration, Department Of Health And Human Services (§ 1.1 To § 99.501) — General (§ 1.1 To § 99.501) — Public Information (§ 20.1 To § 20.120) — Availability Of Specific Categories Of Records (§ 20.100 To § 20.120) — Voluntary drug experience reports submitted by physicians and hospitals.

(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.