Solely in the case of drug products for which the analytical methods described in subparagraphs (A) and (B) cannot be applied, because such drug products have been demonstrated not to rely primarily on systemic absorption to achieve their effectiveness, bioavailability and bioequivalence may be based on other types of evidence, as prescribed by regulation promulgated by the Secretary.

BIO's Primary Concerns on Redraft of S. 812

Sec. 8 - Bioequivalence