[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.51]

[Page 10]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
              Subpart C--Animal Drug Labeling Requirements
 
Sec.  500.51  Labeling of animal drugs; misbranding.


    (a) Among the representations on the label or labeling of an animal 
drug which will render the drug misbranded are any broad statements 
suggesting or implying that the drug is not safe and effective for use 
when used in accordance with labeling direction, or suggesting or 
implying that the labeling does not contain adequate warnings or 
adequate directions for use. Such statements include, but are not 
limited to:
    (1) Any statement that disclaims liability when the drug is used in 
accordance with directions for use contained on the label or labeling.
    (2) Any statement that disclaims liability when the drug is used 
under ``abnormal'' or ``unforeseeable'' conditions.
    (3) Any statement limiting the warranty for the products to a 
warranty that the drug in the package contains the ingredients listed on 
the label.
    (b) This regulation is not intended to prohibit any liability 
disclaimer that purports to limit the amount of damages or that sets 
forth the legal theory under which damages are to be recovered.
    (c) Any person wishing to obtain an evaluation of an animal drug 
liability disclaimer under this regulation may submit it to Division of 
Compliance, (HFV-230), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855. A supplemental 
NADA providing appropriately revised labeling shall be submitted for any 
approved new animal drug the labeling of which is not in compliance with 
this regulation.

[41 FR 8473, Feb. 27, 1976, as amended at 54 FR 18279, Apr. 28, 1989; 57 
FR 6475, Feb. 25, 1992]