---
kind: "section"
citation: "21 C.F.R. § 600.90"
title: "21"
number: "600.90"
heading: "Waivers."
url: "https://uscodex.org/cfr/21/600.90"
---

# §600.90. Waivers.

- (a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ [600.80](/cfr/21/600.80.md) and [600.81](/cfr/21/600.81.md). A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following:
  - (1) An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved,
  - (2) A description of an alternative submission that satisfies the purpose of the requirement, or
  - (3) **Other information justifying a waiver.**
- (b) FDA may grant a waiver if it finds one of the following:
  - (1) The applicant's compliance with the requirement is unnecessary or cannot be achieved,
  - (2) The applicant's alternative submission satisfies the requirement, or
  - (3) **The applicant's submission otherwise justifies a waiver.**

## Notes

### Amendments

[59 FR 54042, Oct. 27, 1994, as amended at 79 FR 33092, June 10, 2014]

### Source

Source: 59 FR 54042, Oct. 27, 1994, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i, 371, 374, 379k-l; 42 U.S.C. 216, 262, 263, 263a, 264.

### Amendments

[59 FR 54042, Oct. 27, 1994, as amended at 79 FR 33092, June 10, 2014]