---
kind: "section"
citation: "21 C.F.R. § 251.15"
title: "21"
number: "251.15"
heading: "Qualifying laboratory requirements."
url: "https://uscodex.org/cfr/21/251.15"
---

# §251.15. Qualifying laboratory requirements.

- (a) To be considered a qualifying laboratory for purposes of [section 804](/cfr/21/804.md) of the Federal Food, Drug, and Cosmetic Act and this part, a laboratory must have ISO 17025 accreditation.
- (b) To be considered a qualifying laboratory for purposes of [section 804](/cfr/21/804.md) of the Federal Food, Drug, and Cosmetic Act and this part, a laboratory must have an FDA inspection history and it must have satisfactorily addressed any objectionable conditions or practices identified during its most recent FDA inspection, if applicable.
- (c) To be considered a qualifying laboratory for purposes of [section 804](/cfr/21/804.md) of the Federal Food, Drug, and Cosmetic Act and this part, a laboratory must comply with the applicable current good manufacturing practice requirements, including provisions regarding laboratory controls in [§ 211.160](/cfr/21/211.160.md) of this chapter and laboratory records in [§ 211.194](/cfr/21/211.194.md) of this chapter.

## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384.

### Source

Source: 85 FR 62126, Oct. 1, 2020, unless otherwise noted.