21 CFR 20.112
§ 20.112 Voluntary drug experience reports submitted by physicians and hospitals.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 20.112, § 20.112 Voluntary drug experience reports submitted by physicians and hospitals, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83367
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.