§507.67. Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
21 C.F.R. § 507.67
If you receive an order under § 507.65 to withdraw a qualified facility exemption, you must either:
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
Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 507.69.
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.
If you appeal the order, and FDA confirms the order:
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
You are no longer subject to the requirements in § 507.7.
Notes, amendments, and revision history
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 56337, Sept. 17, 2015, unless otherwise noted.