21 CFR 290.5
§ 290.5 Drugs; statement of required warning.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 290.5, § 290.5 Drugs; statement of required warning, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86194
- Permanent ID
ys:prov:86194@1- SHA-256
17f69f181affaddebbea0ceb6b1996c015e56e612059e0f227d7ca7f928679dc
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Full text
The label of any drug listed as a “controlled substance” in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” This statement is not required to appear on the label of a controlled substance dispensed for use in clinical investigations which are “blind.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.