21 CFR 507.80 - Revocation of an order to withdraw a qualified facility exemption.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Subpart D [§ 507.60 - § 507.85]

§ 507.80 - Revocation of an order to withdraw a qualified facility exemption.

An order to withdraw a qualified facility exemption is revoked if:

(a) You appeal the order and request an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10 calendar days after the hearing, or issues a decision revoking the order within that time; or

(b) You appeal the order and request an informal hearing, FDA denies the request for an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time; or

(c) You appeal the order without requesting an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time.

authority: 21 U.S.C. 331,342,343,350d,350g,350g note,371,374; 42 U.S.C. 243,264,271

source: 80 FR 56337, Sept. 17, 2015, unless otherwise noted.

cite as: 21 CFR 507.80