---
kind: "section"
citation: "21 C.F.R. § 1.1405"
title: "21"
number: "1.1405"
heading: "Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?"
url: "https://uscodex.org/cfr/21/1.1405"
---

# §1.1405. Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?


FDA will waive one or more of the requirements of this subpart when we determine that:

- (a) Application of the requirements would result in an economic hardship for an individual entity or a type of entity, due to the unique circumstances of the individual entity or type of entity;
- (b) The waiver will not significantly impair our ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under [section 402](/cfr/21/402.md) of the Federal Food, Drug, and Cosmetic Act or misbranded under [section 403(w)](/cfr/21/403.md?p=w) of the Federal Food, Drug, and Cosmetic Act; and
- (c) The waiver will not otherwise be contrary to the public interest.

## Notes

### Source

Source: 87 FR 71077, Nov. 21, 2022, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.