# 21 U.S.C. § 353: Exemptions and consideration for certain drugs, devices, and biological products

> Federal · Statutes · In force

URL: https://www.frixlaw.com/law-library/statutes/usc_t21_s353

## Section

- **Citation:** 21 U.S.C. § 353
- **Heading:** Exemptions and consideration for certain drugs, devices, and biological products
- **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

The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.

( June 25, 1938, ch. 675, § 503 , 52 Stat. 1051 ; Oct. 26, 1951, ch. 578, § 1 , 65 Stat. 648 ; Pub. L. 87–781, title I, § 104(e)(2) , Oct. 10, 1962 , 76 Stat. 785 ; Pub. L. 91–601, § 6(e) , formerly § 7(e), Dec. 30, 1970 , 84 Stat. 1673 , renumbered Pub. L. 97–35, title XII, § 1205(c) , Aug. 13, 1981 , 95 Stat. 716 ; Pub. L. 100–293 , §§ 4–6, Apr. 22, 1988 , 102 Stat. 96–98 ; Pub. L. 100–670, title I, § 105 , Nov. 16, 1988 , 102 Stat. 3983 ; Pub. L. 101–629, § 16(a) , Nov. 28, 1990 , 104 Stat. 4526 ; Pub. L. 102–108, § 2(d) , Aug. 17, 1991 , 105 Stat. 550 ; Pub. L. 102–300, § 6(d) , June 16, 1992 , 106 Stat. 240 ; Pub. L. 102–353 , §§ 2(a)–(c), 4, Aug. 26, 1992 , 106 Stat. 941 , 942; Pub. L. 104–250, § 5(a) , Oct. 9, 1996 , 110 Stat. 3155 ; Pub. L. 105–115, title I , §§ 123(e), 126(a), (c)(1), (2), Nov. 21, 1997 , 111 Stat. 2324 , 2327, 2328; Pub. L. 107–250, title II, § 204 , Oct. 26, 2002 , 116 Stat. 1611 ; Pub. L. 108–282, title I, § 102(b)(5)(F) , Aug. 2, 2004 , 118 Stat. 903 ; Pub. L. 113–54, title II, § 204(a)(1) –(4), (b), Nov. 27, 2013 , 127 Stat. 630–635 ; Pub. L. 114–255, div. A, title III, § 3038(a) , Dec. 13, 2016 , 130 Stat. 1105 ; Pub. L. 117–328, div. FF, title III, § 3621 , Dec. 29, 2022 , 136 Stat. 5877 .)

## 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_s353. Check the current official text before relying on it. Not legal advice.