New drugs

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.

( June 25, 1938, ch. 675, § 505 , 52 Stat. 1052 ; Pub. L. 86–507, § 1(18) , June 11, 1960 , 74 Stat. 201 ; Pub. L. 87–781, title I , §§ 102(b)–(d), 103(a), (b), 104(a)–(d)(2), Oct. 10, 1962 , 76 Stat. 781–783 , 784, 785; Pub. L. 92–387, § 4(d) , Aug. 16, 1972 , 86 Stat. 562 ; Pub. L. 98–417, title I , §§ 101, 102(a)–(b)(5), 103, 104, Sept. 24, 1984 , 98 Stat. 1585 , 1592, 1593, 1597; Pub. L. 102–282, § 5 , May 13, 1992 , 106 Stat. 161 ; Pub. L. 103–80, § 3(n) , Aug. 13, 1993 , 107 Stat. 777 ; Pub. L. 105–115, title I , §§ 115, 117, 119, 120, 124(a), Nov. 21, 1997 , 111 Stat. 2313 , 2315, 2316, 2318, 2324; Pub. L. 106–113, div. B, § 1000(a)(9) [title IV, § 4732(b)(11)] , Nov. 29, 1999 , 113 Stat. 1536 , 1501A–584; Pub. L. 107–109, § 15(c)(1) , Jan. 4, 2002 , 115 Stat. 1420 ; Pub. L. 108–155, § 2(b)(1) , Dec. 3, 2003 , 117 Stat. 1941 ; Pub. L. 108–173, title XI , §§ 1101(a), (b), 1102(a), 1103(a), Dec. 8, 2003 , 117 Stat. 2448 , 2452, 2457, 2460; Pub. L. 110–85, title VII, § 701(b) , title VIII, § 801(b)(3)(A), (B), title IX, §§ 901(a), 903, 905(a), 914(a), 915, 916, 918, 920, 921, title XI, § 1113, Sept. 27, 2007 , 121 Stat. 903 , 921, 922, 943, 944, 953, 957, 958, 960–962, 976; Pub. L. 110–316, title III, § 301 , Aug. 14, 2008 , 122 Stat. 3524 ; Pub. L. 110–379, § 4(a) , Oct. 8, 2008 , 122 Stat. 4076 ; Pub. L. 111–31, div. A, title I, § 103(e) , June 22, 2009 , 123 Stat. 1837 ; Pub. L. 111–148, title VII, § 7002(d)(1) , title X, § 10609, Mar. 23, 2010 , 124 Stat. 816 , 1014; Pub. L. 112–144, title IX, § 905 , title XI, §§ 1101, 1134(a), 1135, July 9, 2012 , 126 Stat. 1092 , 1108, 1123; Pub. L. 113–5, title III, § 301 , Mar. 13, 2013 , 127 Stat. 179 ; Pub. L. 114–89, § 2(a)(1) , Nov. 25, 2015 , 129 Stat. 698 ; Pub. L. 114–255, div. A, title III , §§ 3024(b), 3031(a), 3075(a), (b), 3101(a)(2)(B), 3102(1), Dec. 13, 2016 , 130 Stat. 1099 , 1138, 1152, 1156; Pub. L. 115–52, title VI, § 601 , title VII, § 706(b), title VIII, §§ 801, 802, 808, title IX, § 901(a), Aug. 18, 2017 , 131 Stat. 1048 , 1059, 1068, 1069, 1074, 1076; Pub. L. 115–271, title III, § 3041(b) , Oct. 24, 2018 , 132 Stat. 3942 ; Pub. L. 116–290, § 2(a) –(d)(1), (g), Jan. 5, 2021 , 134 Stat. 4889–4892 ; Pub. L. 117–9, § 1(a)(1) , (b)(1), Apr. 23, 2021 , 135 Stat. 256 , 258; Pub. L. 117–180, div. F, title V, § 5004 , Sept. 30, 2022 , 136 Stat. 2167 ; Pub. L. 117–229, div. C, title III, § 305 , Dec. 16, 2022 , 136 Stat. 2312 ; Pub. L. 117–328, div. FF, title III , §§ 3105, 3209(a), 3222, 3224, 3601(a), Dec. 29, 2022 , 136 Stat. 5807 , 5821, 5829, 5831, 5860; Pub. L. 119–37, div. F, title V, § 6507(a) , Nov. 12, 2025 , 139 Stat. 645 ; Pub. L. 119–75, div. J, title VII, § 6703(a) , Feb. 3, 2026 , 140 Stat. 737 .)