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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2018]
[CITE: 21CFR1302]





TITLE 21--FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE
 
PART 1302LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
 
Sec. 1302.01 Scope of part 1302.

Requirements governing the labeling and packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d)) are set forth generally by those sections and specifically by the sections of this part.

[36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

Sec. 1302.02 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]

Sec. 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.

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

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

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.

[62 FR 13958, Mar. 24, 1997]

Sec. 1302.05 Effective dates of labeling requirements.

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.

[62 FR 13958, Mar. 24, 1997]

Sec. 1302.06 Sealing of controlled substances.

On each bottle, multiple dose vial, or other commercial container of any controlled substance, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper or such container a seal to disclose upon inspection any tampering or opening of the container.

[62 FR 13958, Mar. 24, 1997]

Sec. 1302.07 Labeling and packaging requirements for imported and exported substances.

(a) The symbol requirements of 1302.03 through 1302.05 apply to every commercial container containing, and to all labeling of, controlled substances imported into the customs territory of the United States from any place outside thereof (but within the United States), or imported into the United States from any place outside thereof.

(b) The symbol requirements of 1302.03 through 1302.05 do not apply to any commercial containers containing, or any labeling of, a controlled substance intended for export.

(c) The sealing requirements of 1302.06 apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedule I or II, or any narcotic controlled substance listed in schedule III or IV imported into the customs territory of the United States from any place outside thereof (but within the United States), or imported into the United States from any place outside thereof. The sealing requirements of 1302.06 apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedule I or II, or any narcotic controlled substance listed in schedule III or IV, exported or intended for export from the United States. These sealing and labeling requirements are in addition to any sealing requirements required under applicable customs laws.

[81 FR 97020, Dec. 30, 2016]

Authority: 21 U.S.C. 821, 825, 871(b), 958(e).
Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

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