[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR112.4]

[Page 588]
 
                  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. 112.4  Subsidiaries, divisions, distributors, and permittees.

    Labels used by subsidiaries, divisions, distributors, and permittees 
shall be affixed by the licensee in a licensed establishment where the 
product is produced. Such labels shall comply with requirements for 
their review, approval, and filing as provided in the regulations.
    (a) Subsidiaries. Labels to be used on a licensed biological product 
prepared by a subsidiary operating in a licensed establishment shall be 
submitted in accordance with Sec. 112.5. Only labels approved for use on 
such product shall be used by the subsidiary.
    (b) Divisions. Labels to be used on a licensed biological product 
prepared in a licensed establishment for distribution by a division or 
marketing unit of the licensee shall be submitted in accordance with 
Sec. 112.5. The name, address, and license number of the licensee shall 
be prominently placed on such labels. The relationship of the division 
or marketing unit to the licensee shall appear prominently on the label 
by use of the term ``division of'' or equivalent.
    (c) Distributors. The name and address of the distributor or any 
statement, design, or device shall not be placed on the labels or 
containers of a licensed biological product in a manner which could be 
false or misleading or which could indicate that the distributor is the 
manufacturer of such product or operating under the license number shown 
on the label. The manufacturer shall be identified by name, address, and 
license number with the term ``manufactured by,'' ``produced by,'' or an 
equivalent term prominently placed in connection therewith. The name and 
address of the distributor may be placed on labels or containers if the 
term ``distributor,'' or ``distributed by,'' or an equivalent term is 
prominently placed in connection therewith.
    (d) Permittees. The name and address of the permittee and any 
statement, design, or device shall not be placed on the labels or 
containers of a biological product imported for sale and distribution in 
accordance with Sec. 104.5 in a manner which could be false or 
misleading or which could falsely indicate that the permittee is the 
manufacturer of such product. The manufacturer shall be identified by 
name and address with the term ``manufactured by,'' ``produced by,'' or 
an equivalent term prominently placed in connection therewith. Reference 
to the permittee shall be made by name, address, and permit number with 
the term ``imported by,'' ``produced for,'' or an equivalent term 
prominently placed in connection therewith.

[50 FR 46417, Nov. 8, 1985, as amended at 59 FR 43445, Aug. 24, 1994]