21 CFR 117.254
§ 117.254 Issuance of an order to withdraw a qualified facility exemption.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 117.254, § 117.254 Issuance of an order to withdraw a qualified facility exemption, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84415
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Full text
(a) An FDA Division Director in whose division the qualified facility is located (or, in the case of a foreign facility, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition), or an FDA official senior to either such Director, must approve an order to withdraw the exemption before the order is issued.
(b) Any officer or qualified employee of FDA may issue an order to withdraw the exemption after it has been approved in accordance with paragraph (a) of this section.
(c) FDA must issue an order to withdraw the exemption to the owner, operator, or agent in charge of the facility.
(d) FDA must issue an order to withdraw the exemption in writing, signed and dated by the officer or qualified employee of FDA who is issuing the order.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.