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Regulations last checked for updates: Jan 18, 2025
Title 21 - Food and Drugs last revised: Dec 26, 2025
All Titles
Title 21
Chapter I
Part 112
Subpart R - Subpart R—Withdrawal of Qualified Exemption
§ 112.201 - Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?
§ 112.202 - What procedure will FDA use to withdraw an exemption?
§ 112.203 - What information must FDA include in an order to withdraw a qualified exemption?
§ 112.204 - What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?
§ 112.205 - Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?
§ 112.206 - What is the procedure for submitting an appeal?
§ 112.207 - What is the procedure for requesting an informal hearing?
§ 112.208 - What requirements are applicable to an informal hearing?
§ 112.209 - Who is the presiding officer for an appeal and for an informal hearing?
§ 112.210 - What is the timeframe for issuing a decision on an appeal?
§ 112.211 - When is an order to withdraw a qualified exemption applicable to a farm revoked?
§ 112.213 - If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?
authority:
21 U.S.C. 321
,
331
,
342
,
350h
,
371
;
42 U.S.C. 243
,
264
,
271
source:
80 FR 74547, Nov. 27, 2015, unless otherwise noted.
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