21 CFR 314.520
§ 314.520 Approval with restrictions to assure safe use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 314.520, § 314.520 Approval with restrictions to assure safe use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86393
- Permanent ID
ys:prov:86393@1- SHA-256
7d94777f48487442c97666eb51c48fa2f9125a5856d03737eca2efdfc3178f96
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) If FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the drug product, such as:
(1) Distribution restricted to certain facilities or physicians with special training or experience; or
(2) Distribution conditioned on the performance of specified medical procedures.
(b) The limitations imposed will be commensurate with the specific safety concerns presented by the drug product.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.