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21 U.S.C. § 825

Labeling and packaging

United States · Title 21 — FOOD AND DRUGS · Status: effective

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21 U.S.C. § 825, Labeling and packaging, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454622
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It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in section 321(k) of this title) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances. It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling (as defined in section 321(m) of this title) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection (a). The Secretary shall prescribe regulations under section 353(b) of this title which shall provide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient. It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General. A product is described in this subparagraph if the product— is exempt from the provisions of section 505 of such Act relating to new drugs because—

Legislative history

The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone. The law that originally enacted this section predates the public laws loaded here, so only later amendments are listed.

  • Amended byPub. L. 113-260(H.R. 4771)2014-12-18
    Designer Anabolic Steroid Control Act of 2014
    House: no recorded tallySenate: no recorded tally