21 U.S. Code § 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) of this section.
(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.


(Pub. L. 91–513, title II, § 305,Oct. 27, 1970, 84 Stat. 1256.)
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.
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) ofPub. L. 91–513, set out as a note under section 801 of this title.

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

21 CFR - Food and Drugs



LII has no control over and does not endorse any external Internet site that contains links to or references LII.