Title 21

PART 507 SUBPART D

Subpart D - 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 56337, Sept. 17, 2015, unless otherwise noted.

21:6.0.1.1.4.4.1.1	SECTION 507.60	507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.2	SECTION 507.62	507.62 Issuance of an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.3	SECTION 507.65	507.65 Contents of an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.4	SECTION 507.67	507.67 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.5	SECTION 507.69	507.69 Procedure for submitting an appeal.
21:6.0.1.1.4.4.1.6	SECTION 507.71	507.71 Procedure for requesting an informal hearing.
21:6.0.1.1.4.4.1.7	SECTION 507.73	507.73 Requirements applicable to an informal hearing.
21:6.0.1.1.4.4.1.8	SECTION 507.75	507.75 Presiding officer for an appeal and for an informal hearing.
21:6.0.1.1.4.4.1.9	SECTION 507.77	507.77 Timeframe for issuing a decision on an appeal.
21:6.0.1.1.4.4.1.10	SECTION 507.80	507.80 Revocation of an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.11	SECTION 507.83	507.83 Final agency action.
21:6.0.1.1.4.4.1.12	SECTION 507.85	507.85 Reinstatement of a qualified facility exemption that was withdrawn.

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