21 C.F.R. § 610.17
Permissible combinations.
Cite as 21 C.F.R. § 610.17 (2026)
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.