[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR112.8]

[Page 585]
 
                  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. 112.8  For export only.

    The applicable regulations for packaging and labeling a biological 
product produced in the United States shall apply to such biological 
product if exported from the United States except as otherwise provided 
in this section. Only labels approved as provided in Sec. 112.5 shall be 
used.
    (a) Biological products which have been packaged and labeled for 
export or which have been exported, shall be subject to the applicable 
provisions in this paragraph.
    (1) After leaving the licensed establishment, a biological product 
shall not be bottled, repackaged, relabeled, or otherwise altered in any 
way while in the United States; and
    (2) An exported biological product shall not be returned to the 
United States: Provided, That, in the case of a biological product 
exported in labeled final containers, the Administrator may authorize by 
permit the importation of a limited number for research and evaluation 
by the producing licensee; and
    (3) An exported biological product which is bottled, rebottled, or 
altered in any way in a foreign country shall not bear a label which 
indicates by establishment license number that it has been prepared in 
the United States.
    (b) Desiccated and frozen liquid products, packaged and labeled as 
for domestic use, may be exported without the diluent required for 
rehydration or dilution, as the case may be, if the labeling includes 
adequate instructions for preparing the product for use and the words 
``For Export Only''.
    (c) Final containers of products, labeled or unlabeled, may be 
exported in sealed shipping boxes, adequately identified as to contents 
with an approved label, and plainly marked ``For Export Only'': 
Provided, That such products shall not be diverted to domestic use.
    (d) Completed inactivated liquid products, antiserums, and 
antitoxins, may be exported in large multiple-dose containers identified 
with an approved label that contains the words ``For Export Only'' 
prominently displayed.
    (e) Concentrated inactivated liquid product, completed except for 
dilution to the proper strength for use, may be exported in large 
multiple-dose containers identified with an approved label that contains 
the words ``For Export Only'' prominently displayed.

[38 FR 12094, May 9, 1973, as amended at 39 FR 19202, May 31, 1974; 40 
FR 46093, Oct. 6, 1975; 43 FR 11145, Mar. 17, 1978; 56 FR 66784, Dec. 
26, 1991]