United States v. An Article of Drug, Etc., and Palmer Chemical & Equipment Company, Inc., Claimant-Appellant

Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., an animal drug may not be marketed in interstate commerce unless (1) the FDA has approved a new drug application pursuant to 21 U.S.C. § 360b, or (2) the drug is not a “new animal drug” because it is “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 321(w)(l). If neither of these conditions is met, the…