Code of Federal Regulations · Section
§ 207.21 — When Must Initial Registration Information Be Provided?
21 C.F.R. § 207.21
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(a) Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or an animal feed bearing or containing a new animal drug at such establishment.
(b) Registrants must register each foreign establishment before a drug or an animal feed bearing or containing a new animal drug manufactured, repacked, relabeled, or salvaged at the establishment is imported or offered for import into the United States.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321
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Regulation of biological products42 U.S.C. § 262