[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR112.1]

[Page 609]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 112_PACKAGING AND LABELING--Table of Contents
 
Sec. 112.1  General.




Sec.
112.1 General.
112.2 Final container label, carton label, and enclosure.
112.3 Diluent labels.
112.4 Subsidiaries, divisions, distributors, and permittees.
112.5 Review and approval of labeling.
112.6 Packaging biological products.
112.7 Special additional requirements.
112.8 For export only.
112.9 Biological products imported for research and evaluation.
112.10 Special packaging and labeling.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Source: 38 FR 12094, May 9, 1973, unless otherwise noted.


    (a) Unless otherwise authorized or directed by the Administrator, 
each biological product prepared at a licensed establishment, or 
imported, shall be packaged and labeled as prescribed in this part 
before it is removed from the licensed establishment or presented for 
importation: Provided, That biological products to be imported for 
research and evaluation shall be subject to packaging and labeling 
requirements in Sec. 112.9. Provided further, That, unless otherwise 
exempted, all preparation, including packaging and labeling, of 
biological products shall only be performed in a licensed establishment 
under an approved Outline of Production.
    (b) No person shall apply or affix to or include with, or cause to 
be applied or affixed to or included with, any carton or final container 
of a biological product, any label, stamp, mark or statement that is 
false or misleading in any particular, is not in compliance with the 
regulations, or is not approved by APHIS.
    (c) No person shall alter, mark or remove any approved labeling 
affixed to or included with any biological product prior to selling or 
otherwise distributing such product. In addition, no person shall mark 
any carton, other container, or final container of a biological product 
so as to falsify the labeling, make it misleading, or cause it to be 
illegible.
    (d) Labels that are stamped, printed or glued directly on cartons, 
other containers, or final containers shall be legible throughout the 
dating period. Biological products bearing labels, which have been 
altered, mutilated, destroyed, obliterated or removed, shall be withheld 
from the market.

[38 FR 12094, May 9, 1973, as amended at 59 FR 43445, Aug. 24, 1994]