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U.S. v. ALGON CHEMICAL INC.

No. 88-5478.

879 F.2d 1154 (1989)

UNITED STATES of America, Appellant, v. ALGON CHEMICAL INC., a corporation, and Edward Latinsky, an individual.

United States Court of Appeals, Third Circuit.

Decided July 11, 1989.

Attorney(s) appearing for the Case

John R. Bolton, Asst. Atty. Gen., Samuel A. Alito, Jr., U.S. Atty., Kevin J. McKenna, Asst. U.S. Atty., John R. Fleder, Director, Lawrence G. McDade (argued), Asst. Director, Office of Consumer Litigation, Civil Div., U.S. Dept. of Justice, Washington, D.C., (Thomas Scarlett, Chief Counsel, Richard E. Geyer, Associate Chief Counsel, Food and Drug Administration, of counsel), Rockville, Md., for appellant.

James R. Phelps (argued), Robert A. Dormer, A. Wes Siegner, Jr., Washington, D.C., for appellees.

Before STAPLETON, and MANSMANN, Circuit Judges, and HUYETT, District Judge .

OPINION OF THE COURT

STAPLETON, Circuit Judge:

In this case we are asked to decide whether the Food and Drug Administration ("FDA") can enforce regulations promulgated pursuant to its delegated authority under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. ("FDCA" or the "Act"), that essentially limit the sale of new bulk pharmaceuticals exclusively to holders of "new animal drug applications...

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