biosimilar biological product establishment

(7) (A) The term “biosimilar biological product establishment” means a foreign or domestic place of business— (i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and (ii) at which one or more biosimilar biological products are manufactured in final dosage form. (B) For purposes of subparagraph (A)(ii), the term “manufactured” does not include packaging.


21 USC § 379j-51(7)

Scoping language

For purposes of this subpart
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