21 CFR § 251.15 - Qualifying laboratory requirements.

---
identifier: "/us/cfr/t21/s251.15"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 251.15 - Qualifying laboratory requirements."
title_number: 21
title_name: "Food and Drugs"
section_number: "251.15"
section_name: "Qualifying laboratory requirements."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "251"
part_name: "SECTION 804 IMPORTATION PROGRAM"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384."
regulatory_source: "85 FR 62126, Oct. 1, 2020, unless otherwise noted."
cfr_part: "251"
---


# 251.15 Qualifying laboratory requirements.

(a) To be considered a qualifying laboratory for purposes of section 804 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 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 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 of this chapter and laboratory records in § 211.194 of this chapter.