21 CFR § 507.67 - Compliance with, or appeal of, an order to withdraw a qualified facility exemption.

---
identifier: "/us/cfr/t21/s507.67"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 507.67 - Compliance with, or appeal of, an order to withdraw a qualified facility exemption."
title_number: 21
title_name: "Food and Drugs"
section_number: "507.67"
section_name: "Compliance with, or appeal of, an order to withdraw a qualified facility exemption."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "507"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS"
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. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 56337, Sept. 17, 2015, unless otherwise noted."
cfr_part: "507"
---


# 507.67 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.

(a) If you receive an order under § 507.65 to withdraw a qualified facility exemption, you must either:

(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

(2) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 507.69.

(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.

(c) If you appeal the order, and FDA confirms the order:

(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

(2) You are no longer subject to the requirements in § 507.7.