# 21 C.F.R. § 600.90 (2026): Waivers

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P600_S600_90

## Section

- **Citation:** 21 C.F.R. § 600.90 (2026)
- **Heading:** Waivers
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 600: BIOLOGICAL PRODUCTS: GENERAL / Subpart D: Reporting of Adverse Experiences / § 600.90: § 600.90   Waivers.

## Text

(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 and 600.81. 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.
[59 FR 54042, Oct. 27, 1994, as amended at 79 FR 33092, June 10, 2014]

## Nearby sections

- [21 C.F.R. § 600.80 (2026) § 600.80   Postmarketing reporting of adverse experiences.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P600_S600_80.md)
- [21 C.F.R. § 600.81 (2026) § 600.81   Distribution reports.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P600_S600_81.md)
- [21 C.F.R. § 600.82 (2026) § 600.82   Notification of a permanent discontinuance or an interruption in manufacturing.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P600_S600_82.md)
- [21 C.F.R. § 600.90 (2026) § 600.90   Waivers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P600_S600_90.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P600_S600_90. Check the current official text before relying on it. Not legal advice.