21 CFR § 111.320 - What requirements apply to laboratory methods for testing and examination?

---
identifier: "/us/cfr/t21/s111.320"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 111.320 - What requirements apply to laboratory methods for testing and examination?"
title_number: 21
title_name: "Food and Drugs"
section_number: "111.320"
section_name: "What requirements apply to laboratory methods for testing and examination?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "111"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
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. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264."
regulatory_source: "72 FR 34942, June 25, 2007, unless otherwise noted."
cfr_part: "111"
---


# 111.320 What requirements apply to laboratory methods for testing and examination?

(a) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.

(b) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met.