# 21 U.S.C. § 352: Misbranded drugs and devices

> Federal · Statutes · In force

URL: https://www.frixlaw.com/law-library/statutes/usc_t21_s352

## Section

- **Citation:** 21 U.S.C. § 352
- **Heading:** Misbranded drugs and devices
- **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

If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 . The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.

( June 25, 1938, ch. 675, § 502 , 52 Stat. 1050 ; June 23, 1939, ch. 242, § 3 , 53 Stat. 854 ; Dec. 22, 1941, ch. 613, § 2 , 55 Stat. 851 ; July 6, 1945, ch. 281, § 2 , 59 Stat. 463 ; Mar. 10, 1947, ch. 16, § 2 , 61 Stat. 11 ; July 13, 1949, ch. 305, § 1 , 63 Stat. 409 ; Aug. 5, 1953, ch. 334, § 1 , 67 Stat. 389 ; Pub. L. 86–618, title I, § 102(b)(2) , July 12, 1960 , 74 Stat. 398 ; Pub. L. 87–781, title I , §§ 105(c), 112(a), (b), 131(a), title III, § 305, Oct. 10, 1962 , 76 Stat. 785 , 790, 791, 795; Pub. L. 90–399, § 105(a) , July 13, 1968 , 82 Stat. 352 ; Pub. L. 91–601, § 6(d) , formerly § 7(d), Dec. 30, 1970 , 84 Stat. 1673 , renumbered Pub. L. 97–35, title XII, § 1205(c) , Aug. 13, 1981 , 95 Stat. 716 ; Pub. L. 94–295 , §§ 3(e), 4(b)(2), 5(a), 9(b)(2), May 28, 1976 , 90 Stat. 577 , 580, 583; Pub. L. 95–633, title I, § 111 , Nov. 10, 1978 , 92 Stat. 3773 ; Pub. L. 102–300, § 3(a)(2) , June 16, 1992 , 106 Stat. 239 ; Pub. L. 102–571, title I, § 107(9) , Oct. 29, 1992 , 106 Stat. 4499 ; Pub. L. 103–80, § 3(m) , Aug. 13, 1993 , 107 Stat. 777 ; Pub. L. 105–115, title I , §§ 114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, § 412(c), Nov. 21, 1997 , 111 Stat. 2312 , 2325, 2327, 2375; Pub. L. 107–250, title II, § 206 , title III, §§ 301(a), 302(a)(1), Oct. 26, 2002 , 116 Stat. 1613 , 1616; Pub. L. 108–214, § 2(b)(2)(B) , Apr. 1, 2004 , 118 Stat. 575 ; Pub. L. 108–282, title I, § 102(b)(5)(E) , Aug. 2, 2004 , 118 Stat. 902 ; Pub. L. 109–43, § 2(c)(1) , Aug. 1, 2005 , 119 Stat. 441 ; Pub. L. 109–462, § 2(d) , Dec. 22, 2006 , 120 Stat. 3472 ; Pub. L. 110–85, title IX , §§ 901(d)(3)(A), (6), 902(a), 906(a), Sept. 27, 2007 , 121 Stat. 940 , 942, 943, 949; Pub. L. 112–144, title III, § 306 , title VII, §§ 702(a), 714(c), July 9, 2012 , 126 Stat. 1024 , 1065, 1074; Pub. L. 112–193, § 2(a) , Oct. 5, 2012 , 126 Stat. 1443 ; Pub. L. 113–54, title I, § 103(b) , title II, § 206(b), Nov. 27, 2013 , 127 Stat. 597 , 639; Pub. L. 114–255, div. A, title III , §§ 3037, 3044(b)(2), Dec. 13, 2016 , 130 Stat. 1105 , 1121; Pub. L. 115–234, title III, § 303(a) , Aug. 14, 2018 , 132 Stat. 2436 ; Pub. L. 116–136, div. A, title III, § 3852 , Mar. 27, 2020 , 134 Stat. 454 ; Pub. L. 117–328, div. FF, title III, § 3630(a) , Dec. 29, 2022 , 136 Stat. 5893 .)

## 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_s352. Check the current official text before relying on it. Not legal advice.