# 21 C.F.R. § 251.15 (2026): Qualifying laboratory requirements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_15

## Section

- **Citation:** 21 C.F.R. § 251.15 (2026)
- **Heading:** Qualifying laboratory requirements
- **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 / Part 251 / Subpart C / § 251.15: § 251.15   Qualifying laboratory requirements.

## Text

(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.

## Nearby sections

- [21 C.F.R. § 251.9 (2026) § 251.9   Registration of Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_9.md)
- [21 C.F.R. § 251.10 (2026) § 251.10   Reviewing and updating registration information for Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_10.md)
- [21 C.F.R. § 251.11 (2026) § 251.11   Official contact and U.S. agent for Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_11.md)
- [21 C.F.R. § 251.12 (2026) § 251.12   Importer responsibilities.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_12.md)
- [21 C.F.R. § 251.13 (2026) § 251.13   Labeling of eligible prescription drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_13.md)
- [21 C.F.R. § 251.14 (2026) § 251.14   Supply chain security requirements for eligible prescription drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_14.md)
- [21 C.F.R. § 251.15 (2026) § 251.15   Qualifying laboratory requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_15.md)
- [21 C.F.R. § 251.16 (2026) § 251.16   Laboratory testing requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_16.md)
- [21 C.F.R. § 251.17 (2026) § 251.17   Importation requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_17.md)
- [21 C.F.R. § 251.18 (2026) § 251.18   Post-importation requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_18.md)
- [21 C.F.R. § 251.19 (2026) § 251.19   Reports to FDA.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_19.md)
- [21 C.F.R. § 251.20 (2026) § 251.20   Severability.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_20.md)
- [21 C.F.R. § 251.21 (2026) § 251.21   Consequences for violations.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_21.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_15. Check the current official text before relying on it. Not legal advice.