21 C.F.R. § 1302.03

Current through October 31, 2024
Section 1302.03 - Symbol required; exceptions
(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Administrator pursuant to § 1308.31 of this chapter) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must bear a label complying with the requirement of this part.
(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the symbol designating the schedule in which such controlled substance is listed.
(c) The following symbols shall designate the schedule corresponding thereto:

Schedule
Schedule ICI or C-I.
Schedule IICII or C-II.
Schedule IIICIII or C-III.
Schedule IVCIV or C-IV.
Schedule VCV or C-V.

The word "schedule" need not be used. No distinction need be made between narcotic and nonnarcotic substances.

(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper.
(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.
(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies.

21 C.F.R. §1302.03

36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973