21 U.S.C. § 825 — Labeling and packaging
submitted 56 years ago by Pub. L. 91-513 to r/title-21-FOOD-AND-DRUGS · 441 words · no verdicts yet
A translation hasn’t been published for this section yet. The official text below is complete and authoritative.
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.
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).
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.].
A product is described in this subparagraph if the product—
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
is exempt from the provisions of section 505 of such Act relating to new drugs because—
it is intended solely for investigational use as described in section 505(i) of such Act; and
such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.
Source credit: (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.)
- 1970Enacted · Pub. L. 91-513 · 84 Stat. 1256
- 2014Amended · Pub. L. 113-260 · 128 Stat. 2931
A history note hasn’t been published yet. The record shows enactment by Pub. L. 91-513 on 1970-10-27.
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