July 16, 1997
HUMAN DRUG PRODUCT NOT EQUIVALENT TO VETERINARY CEFTIOFUR
FDA continues to receive reports that human labeled cefazolin products are being promoted as generic equivalents to the animal drug product Naxcel (ceftiofur sodium). In 1996, letters were sent to all known manufacturers and distributors of human cefazolin advising them that this type of promotion was illegal.
Cefazolin and ceftiofur are not generic equivalents. Promoting human cefazolin products for animal uses causes the products to be adulterated or misbranded, and could subject the products and/or the distributors to regulatory action. The promotion of human labeled products for use in animals as equivalent to an approved animal drug is a violation of the Federal Food, Drug, and Cosmetic Act [Section 502 (f)(1)] since the human product does not have adequate directions for animal use. If the promotional material is also found to constitute labeling, the products would be considered unapproved new animal drugs in violation of Section 501 (a)(5) of the Federal Food, Drug, and Cosmetic Act.
Claims that cefazolin and ceftiofur are equivalent not only misbrands the human product, but are not true statements. Cefazolin and ceftiofur are different generations of cephalosporins that have different pharmacokinetics and effectiveness against different organisms. If a milk or tissue residue occurs as a result of this misrepresentation, the responsible party could be held accountable for the residue as well as for the misbranding violation. There is no approval for any cefazolin product in animals.
Questions about this subject may be directed to CVM's Division of Compliance at 7500 Standish Place, HFV-232, Rockville, MD 20855, or by telephone on 301-594-1785.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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