The United States of America v. An Article of Drug . . . "Entrol-C Medicated", Naremco, Inc., Claimant-Appellant

Before WALLACE and SNEED, Circuit Judges, and EAST, District Judge.

Naremco, Inc. appeals from a summary judgment in favor of the Government in a condemnation proceeding which holds that a quantity of the drug “Entrol-C Medicated” constitutes a new animal drug within the meaning of 21 U.S. C.A. § 321(w)(1) for which no new drug application has been filed. The quantity of the drug in question was ordered destroyed. United States v. An Article of Drug . . . “Entrol-C Medicated” . . . , 362 F.Supp. 424 (S.D.Cal.1973). We affirm.

Under 21 U.S.C.A. § 321 (w)(l) an animal drug is “new” if it is not “generally recognized” by experts as safe and effective for its intended purpose. This standard of general recognition also applies to non-animal drugs, 21 U.S.C.A. § 321 (p)(l), and has been held to require “substantial evidence,” dependent “in part on the expert knowledge and experience of scientists based on controlled clinical experimentation and backed by substantial support in scientific literature.” Such experimentation is likewise required for animal drugs. Appellant admits that no tests have been conducted on “Entrol-C Medicated,” 362 F.Supp. 424, 427 , and this fact…