§ 117.260. Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
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/us/cfr/t21/s§ 117.260·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)If you receive an order under § 117.254 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.
(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.