Title 21

SECTION 500.51

500.51 Labeling of animal drugs; misbranding.

§ 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]

---