# 21 U.S.C. § 355: New drugs

> Federal · Statutes · In force

URL: https://www.frixlaw.com/law-library/statutes/usc_t21_s355

## Section

- **Citation:** 21 U.S.C. § 355
- **Heading:** New drugs
- **Jurisdiction:** Federal
- **Kind:** Statutes
- **Status:** In force
- **Text as of:** April 17, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—FOOD AND DRUGS > CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V—DRUGS AND DEVICES > Part A—Drugs and Devices

## Text

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 .)

## Nearby sections

- [21 U.S.C. § 351 Adulterated drugs and devices](https://www.frixlaw.com/law-library/statutes/usc_t21_s351.md)
- [21 U.S.C. § 352 Misbranded drugs and devices](https://www.frixlaw.com/law-library/statutes/usc_t21_s352.md)
- [21 U.S.C. § 353 Exemptions and consideration for certain drugs, devices, and biological products](https://www.frixlaw.com/law-library/statutes/usc_t21_s353.md)
- [21 U.S.C. § 353a Pharmacy compounding](https://www.frixlaw.com/law-library/statutes/usc_t21_s353a.md)
- [21 U.S.C. § 353a–1 Enhanced communication](https://www.frixlaw.com/law-library/statutes/usc_t21_s353a%E2%80%931.md)
- [21 U.S.C. § 353b Outsourcing facilities](https://www.frixlaw.com/law-library/statutes/usc_t21_s353b.md)
- [21 U.S.C. § 353c Prereview of television advertisements](https://www.frixlaw.com/law-library/statutes/usc_t21_s353c.md)
- [21 U.S.C. § 353d Process to update labeling for certain generic drugs](https://www.frixlaw.com/law-library/statutes/usc_t21_s353d.md)
- [21 U.S.C. § 354 Veterinary feed directive drugs](https://www.frixlaw.com/law-library/statutes/usc_t21_s354.md)
- [21 U.S.C. § 355 New drugs](https://www.frixlaw.com/law-library/statutes/usc_t21_s355.md)
- [21 U.S.C. § 355–1 Risk evaluation and mitigation strategies](https://www.frixlaw.com/law-library/statutes/usc_t21_s355%E2%80%931.md)
- [21 U.S.C. § 355–2 Actions for delays of generic drugs and biosimilar biological products](https://www.frixlaw.com/law-library/statutes/usc_t21_s355%E2%80%932.md)
- [21 U.S.C. § 355a Pediatric studies of drugs](https://www.frixlaw.com/law-library/statutes/usc_t21_s355a.md)
- [21 U.S.C. § 355b Adverse-event reporting](https://www.frixlaw.com/law-library/statutes/usc_t21_s355b.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/usc_t21_s355. Check the current official text before relying on it. Not legal advice.