---
kind: "section"
citation: "21 C.F.R. § 117.260"
title: "21"
number: "117.260"
heading: "Compliance with, or appeal of, an order to withdraw a qualified facility exemption."
url: "https://uscodex.org/cfr/21/117.260"
---

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

- (a) If you receive an order under [§ 117.254](/cfr/21/117.254.md) 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 [§ 117.264](/cfr/21/117.264.md).
- (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 modified requirements in [§ 117.201](/cfr/21/117.201.md).

## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.