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Code · CFR · Title 21 — Food and Drugs · Part 1309 — Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals · § 1309.43

§ 1309.43. Suspension or revocation of registration.

402 words·~2 min read·/us/cfr/t21/s§ 1309.43·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)The Administrator may suspend any registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he determines.
(b)The Administrator may revoke any registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)).
(c)Before revoking or suspending any registration, the Administrator shall issue an order to show cause pursuant to Section 1309.46 and, if requested by the registrant, shall hold a hearing pursuant to Section 1309.51. Notwithstanding the requirements of this Section, however, the Administrator may suspend any registration pending a final order pursuant to § 1309.44.
(d)Upon service of the order of the Administrator suspending or revoking registration, the registrant shall immediately deliver his or her Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of the Administrator revoking or suspending registration, the registrant shall, as instructed by the Administrator:
(1)Deliver all List I chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, to the nearest office of the Administration or to authorized agents of the Administration; or
(2)Place all such List I chemicals in his or her possession under seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).
(e)In the event that revocation or suspension is limited to a particular chemical or chemicals, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of the Administrator revoking or suspending registration with respect to a particular chemical or chemicals, the registrant shall, as instructed by the Administrator:
(1)Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the particular chemical or chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, which are affected by the revocation or suspension; or
(2)Place all of such chemicals under seal as described in section 304(f) of the Act (21 U.S.C. 824(f)). [60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]
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§ 1309.43
Suspension or revocation of registration.
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