21 CFR 1309.54
§ 1309.54 Burden of proof.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 1309.54, § 1309.54 Burden of proof, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/92033
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Full text
(a) At any hearing for the denial of a registration, the Administration shall have the burden of proving that the requirements for such registration pursuant to section 303 of the Act (21 U.S.C. 823) are not satisfied.
(b) At any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) are satisfied.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.