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Regulations last checked for updates: May 23, 2025

Title 21 - Food and Drugs last revised: May 19, 2025
All TitlesTitle 21Chapter IPart 112Subpart 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  • § 112.213 - If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?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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