Code of Federal Regulations · Section
§ 610.17 — Permissible Combinations
21 C.F.R. § 610.17
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Licensed products may not be combined with other licensed products either therapeutic, prophylactic or diagnostic, except as a license is obtained for the combined product. Licensed products may not be combined with nonlicensable therapeutic, prophylactic, or diagnostic substances except as a license is obtained for such combination.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Definitions; generally21 U.S.C. § 321