Title 21

PART 117 SUBPART E

Subpart E - Withdrawal of a Qualified Facility Exemption

• 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
• 80 FR 56145, Sept. 17, 2015, unless otherwise noted.

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21:2.0.1.1.16.5.1.12	SECTION 117.287	117.287 Reinstatement of a qualified facility exemption that was withdrawn.

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