21 CFR 314.540

§ 314.540 Postmarketing safety reporting.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 314.540, § 314.540 Postmarketing safety reporting, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86395
Permanent ID: ys:prov:86395@1
SHA-256: 892bfe72e28a3315de176ab5d491e2594f27a9d2b701059df12e0f44f16929ae

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Full text

Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§ 314.80 and 314.81.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.