[Title 21 CFR 1302]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT]
[Part 1302 - LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  9
  1996-04-01
  1996-04-01
  false
  
  1302
  PART 1302
  
    FOOD AND DRUGS
    DRUG ENFORCEMENT
  


PART 1302--LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES--Table of Contents




Sec.
1302.01  Scope of Part 1302.
1302.02  Definitions.
1302.03  Symbol required; exceptions.
1302.04  Location and size of symbol on label.
1302.05  Location and size of symbol on labeling.
1302.06  Effective dates of labeling requirements.
1302.07  Sealing of controlled substances.
1302.08  Labeling and packaging requirements for imported and exported 
          substances.

    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.



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, 
l973]



Sec. 1302.02   Definitions.

    As used in this part, the following terms shall have the meanings 
specified:
    (a) The term commercial container means any bottle, jar, tube, 
ampule, or other receptacle in which a substance is held for 
distribution or dispensing to an ultimate user, and in addition, any box 
or package in which the receptacle is held for distribution or 
dispensing to an ultimate user. The term commercial

[[Page 32]]

container does not include any package liner, package insert or other 
material kept with or within a commercial container, nor any carton, 
crate, drum, or other package in which commercial containers are stored 
or are used for shipment of controlled substances.
    (b) The term label means any display of written, printed, or graphic 
matter placed upon the commercial container of any controlled substance 
by any manufacturer of such substance.
    (c) The term labeling means all labels and other written, printed, 
or graphic matter (1) upon any controlled substance or any of its 
commercial containers or wrappers, or (2) accompanying such controlled 
substance.
    (d) The term manufacture means the producing, preparation, 
propagation, compounding, or processing of a drug or other substance or 
the packaging or repackaging of such substance, or the labeling or 
relabeling of the commercial container of such substance, but does not 
include the activities of a practitioner who, as an incident to his 
administration or dispensing such substance in the course of his 
professional practice, prepares, compounds, packages or labels such 
substance. The term manufacturer means a person who manufactures a drug 
or other substance, whether under a registration as a manufacturer or 
under authority of registration as a researcher or chemical analyst.
    (e) Any term not defined in this section shall have the definition 
set forth in section 102 of the Act (21 U.S.C. 802) or Sec. 1301.02 of 
this chapter.

[36 FR 7785, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



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 
Sec. 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 I................................  CI or C-I.                  
Schedule II...............................  CII or C-II.                
Schedule III..............................  CIII or C-III.              
Schedule IV...............................  CIV or C-IV.                
Schedule V................................  CV 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.

    (a) The symbol shall be prominently located on the right upper 
corner of the principal panel of the label of the commercial container 
and/or the panel of the commercial container normally displayed to 
dispensers of any controlled substance listed in Schedules I through V. 
The symbol must be at least two times as large as the largest type 
otherwise printed on the label.
    (b) In lieu of locating the symbol in the corner of the label, as 
prescribed in paragraph (a) of this section, the symbol may be 
overprinted on the label, in which case the symbol must be printed at 
least one-half the height of the label and in a contrasting color 
providing clear visibility against the background color of the label.

[[Page 33]]

    (c) In all cases the symbol 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.



Sec. 1302.05   Location and size of symbol on labeling.

    The symbol shall be prominently located on all labeling other than 
labels covered by Sec. 1302.04. In all cases the symbol shall be clear 
and large enough to afford prompt identification of the controlled 
substance upon inspection of the labeling.



Sec. 1302.06   Effective dates of labeling requirements.

    (a) All labels on commercial containers of, and all labeling of, a 
controlled substance which is listed in any schedule on May 1, 1971, and 
which is packaged after December 1, 1971, shall comply with the 
requirements of Sec. 1302.03.
    (b) All labels on commercial containers of, and all labeling of, a 
controlled substance which either is listed in any schedule on May 1, 
1971, and thereafter transferred to another schedule or is added to any 
schedule after May 1, 1971, and which is packaged more than 180 days 
following the date on which the transfer or addition becomes effective, 
shall comply with the requirements of Sec. 1302.03.
    (c) The Administrator may, in the case of any controlled substance, 
require compliance with the requirements of Sec. 1302.03 within a period 
of time shorter than required by this section if he finds that public 
health or safety necessitate an earlier effective date.
    (d) Until compliance is required under this section, the label on 
commercial container containing, and the labeling of, any controlled 
substance shall comply with any requirements under Federal law as to 
labels of such containers and as to labeling of such substances existing 
prior to the effective date prescribed in this section.



Sec. 1302.07   Sealing of controlled substances.

    (a) On each bottle, multiple dose vial, or other commercial 
container of any controlled substance listed in Schedules I or II or of 
any narcotic controlled substance listed in Schedule III or IV, 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.
    (b) Any seal accepted for use under Federal law prior to May 1, 
1971, shall be deemed acceptable for use under this section.

[36 FR 7785, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1302.08   Labeling and packaging requirements for imported and exported substances.

    (a) The symbol requirements of Secs. 1302.03-1302.06 apply to every 
commercial container containing, and to all labeling of, controlled 
substances imported into the jurisdiction of and/or the customs 
territory of the United States, as defined in Sec. 1311.02 of this 
chapter.
    (b) The symbol requirements of Secs. 1302.03-1302.06 do not apply to 
any commercial containers containing, or any labeling of, a controlled 
substance intended for export from the jurisdiction of the United 
States, as defined in Sec. 1311.02 of this chapter.
    (c) The sealing requirements of Sec. 1302.07 apply to every bottle, 
multiple dose vial, or other commercial container of any controlled 
substance listed in schedule I or II, or of any narcotic controlled 
substance listed in schedule III or IV, imported into, exported from, or 
intended for export from, the jurisdiction of and/or the customs 
territory of the United States, as defined in Sec. 1311.02 of this 
chapter.

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