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21 C.F.R. §§ 1302.03–1302.05

3 sections in range

§1302.03. Symbol required; exceptions.

21 C.F.R. § 1302.03

(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:
(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.
Notes, amendments, and revision history

Amendments

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

Authority

Authority: 21 U.S.C. 821, 825, 871(b), 958(e).

Source

Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

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

§1302.04. Location and size of symbol on label and labeling.

21 C.F.R. § 1302.04

The symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf. The symbol on all other labeling shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.
Notes, amendments, and revision history

Amendments

[62 FR 13958, Mar. 24, 1997]

Authority

Authority: 21 U.S.C. 821, 825, 871(b), 958(e).

Source

Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

[62 FR 13958, Mar. 24, 1997]

§1302.05. Effective dates of labeling requirements.

21 C.F.R. § 1302.05

All labels on commercial containers of, and all labeling of, a controlled substance which either is transferred to another schedule or is added to any schedule shall comply with the requirements of § 1302.03, on or before the effective date established in the final order for the transfer or addition.
Notes, amendments, and revision history

Amendments

[62 FR 13958, Mar. 24, 1997]

Authority

Authority: 21 U.S.C. 821, 825, 871(b), 958(e).

Source

Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

[62 FR 13958, Mar. 24, 1997]