Brand name biological product

Brand name biological product means a product licensed under section 351 (42 U.S.C. 262(a)) or 351(k) (42 U.S.C. 262(k)) of the Public Health Service Act and marketed under a brand name.

Source

42 CFR § 423.4

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Scoping language

The following definitions apply to this part, unless the context indicates otherwise:

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