21 USC 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
Terms Used In 21 USC 825
- anabolic steroid: means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes&mdash. See 21 USC 802
- controlled substance: means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. See 21 USC 802
- dispense: means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. See 21 USC 802
- distribute: means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. See 21 USC 802
- drug: has the meaning given that term by section 321(g)(1) of this title. See 21 USC 802
- manufacture: means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container. See 21 USC 802
- manufacturer: means a person who manufactures a drug or other substance. See 21 USC 802
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
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.