Title 21

PART 117 SUBPART E

Subpart E - Withdrawal of a Qualified Facility Exemption

21:2.0.1.1.16.5.1.1SECTION 117.251
   117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.2SECTION 117.254
   117.254 Issuance of an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.3SECTION 117.257
   117.257 Contents of an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.4SECTION 117.260
   117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.5SECTION 117.264
   117.264 Procedure for submitting an appeal.
21:2.0.1.1.16.5.1.6SECTION 117.267
   117.267 Procedure for requesting an informal hearing.
21:2.0.1.1.16.5.1.7SECTION 117.270
   117.270 Requirements applicable to an informal hearing.
21:2.0.1.1.16.5.1.8SECTION 117.274
   117.274 Presiding officer for an appeal and for an informal hearing.
21:2.0.1.1.16.5.1.9SECTION 117.277
   117.277 Timeframe for issuing a decision on an appeal.
21:2.0.1.1.16.5.1.10SECTION 117.280
   117.280 Revocation of an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.11SECTION 117.284
   117.284 Final agency action.
21:2.0.1.1.16.5.1.12SECTION 117.287
   117.287 Reinstatement of a qualified facility exemption that was withdrawn.