{"data":{"id":"us/21-cfr-251.15","jurisdiction":"us","citation":"21 CFR 251.15","heading":"Qualifying laboratory requirements.","body":"(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.\n(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—DRUGS: GENERAL","PART 251—SECTION 804 IMPORTATION PROGRAM","Subpart C—Certain Requirements for Section 804 Importation Programs"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e207b60c114c120f44fb311c2bf7ec62dbd9e900dd459230fdcfd455b7d5d1ff","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-251.14","next":"us/21-cfr-251.16"},"notice":"GroundRules: Original legal text. Not legal advice."}