{"data":{"id":"us/21-cfr-117.260","jurisdiction":"us","citation":"21 CFR 117.260","heading":"Compliance with, or appeal of, an order to withdraw a qualified facility exemption.","body":"(a) If you receive an order under § 117.254 to withdraw a qualified facility exemption, you must either:\n(1) Comply with applicable requirements of this part within 120 calendar days of the date of receipt of the order, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; or\n(2) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 117.264.\n(b) Submission of an appeal, including submission of a request for an informal hearing, will not operate to delay or stay any administrative action, including enforcement action by FDA, unless the Commissioner of Food and Drugs, as a matter of discretion, determines that delay or a stay is in the public interest.\n(c) If you appeal the order, and FDA confirms the order:\n(1) You must comply with applicable requirements of this part within 120 calendar days of the date of receipt of the order, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; and\n(2) You are no longer subject to the modified requirements in § 117.201.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION","PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD","Subpart E—Withdrawal of a Qualified Facility Exemption"],"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":"52f8a17c98b1101d6b18334ea7e0981637f9e300b342c87fc5305ece5fc3e0af","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-117.257","next":"us/21-cfr-117.264"},"notice":"GroundRules: Original legal text. Not legal advice."}