Code of Federal Regulations · Section
§ 206.1 — Scope
21 C.F.R. § 206.1
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This part applies to all solid oral dosage form human drug products, including prescription drug products, over-the-counter drug products, biological drug products, and homeopathic drug products, unless otherwise exempted under § 206.7.
Authorizing Statute
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Regulation of biological products42 U.S.C. § 262
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Definitions; generally21 U.S.C. § 321