Authorities Cited: United States Code 21 U.S.C. § 301 21 U.S.C. § 321(m) 21 U.S.C. § 337(a) 21 U.S.C. § 352(f) 21 U.S.C. § 352(f)(2) Code of Federal Regulations 21 C.F.R. § 801.109 21 C.F.R. § 801.109(c) 21 C.F.R. § 801.405 Supreme Court 518 U.S. 470, 487 531 U.S. 341, 349 Circuit Courts 836 F.2d 296, 303 927 F.2d 124, 129 949 F.2d 806, 813 116 F.3d 1341 229 F.3d 1012, 1039 275 F.3d 965, 974 291 F.3d 1307, 337-1311 Federal Rules of Civil Procedure Fed. R. Civ. P. 54(d) 46 F. Supp. 2d 1351, 1363 55 F. Supp. 2d 1353, 1361 138 F. Supp. 2d 422, 444-448 884 F. Supp. 1061 906 F. Supp. 334, 337-338