Us Code § 825 - Labeling and packaging
Full text of Us Code United States Code § 825 — Labeling and packaging, with citation guidance and answers to common questions.
§ 825. Labeling and packaging
(a) Symbol
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.
(b) Unlawful distribution without identifying symbol
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).
(c) Warning on label
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.
(d) Containers to be securely sealed
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.
(e) False labeling of anabolic steroids
(1) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).
(2)(A) A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(B) A product is described in this subparagraph if the product—
(i) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b), (j)]; or
(ii) is exempt from the provisions of section 505 of such Act relating to new drugs because—
(I) it is intended solely for investigational use as described in section 505(i) of such Act; and
(II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.
(Pub. L. 91–513, title II, §305, Oct. 27, 1970, 84 Stat. 1256; Pub. L. 113–260, §3(a), Dec. 18, 2014, 128 Stat. 2931.)
Editorial Notes
References in Text
Schedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in section 812(c) of this title.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
Amendments
2014—Subsec. (e). Pub. L. 113–260 added subsec. (e).
Statutory Notes and Related Subsidiaries
Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title.
Identification and Publication of List of Products Containing Anabolic Steroids
Pub. L. 113–260, §4, Dec. 18, 2014, 128 Stat. 2932, provided that:
"(a)
"(b)
About This Section
21 U.S.C. § 825 is part of Title 21 of the United States Code. The United States Code is the official codification of federal statutes maintained by the Office of the Law Revision Counsel of the U.S. House of Representatives. Congress amends the Code through new public laws, which are eventually incorporated into the relevant title.
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