; (B) the question of the eligibility for approval under this section of any application described in subsection (b)(2) or (j) that omits any other aspect of labeling protected by exclusivity under— (i) clause (iii) or (iv) of subsection (j)(5)(F); (ii) clause (iii) or (iv) of subsection (c)(3)(E); or (iii) section 527(a); or (C) except as expressly provided in paragraphs (1) and (2), the operation of this section or section 527. . 212. Conditions of use for biosimilar biological products Section 351(k)(2)(A)(iii) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A)(iii) ) is amended— (1) in subclause (I), by striking ; and and inserting a semicolon; (2) in subclause (II), by striking the period and inserting ; and ; and (3) by adding at the end the following: (III) may include information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product. . 213. Modernizing the labeling of certain generic drugs Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 503C the following: 503D. Process to update labeling for certain drugs (a) Definitions For purposes of this section: (1) The term covered drug means a drug approved under section 505(c)— (A) for which there are no unexpired patents included in the list under section 505(j)(7) and no unexpired period of market exclusivity; (B) for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and (C) for which, with respect to the labeling— (i) new scientific evidence is available regarding the conditions of use of the drug; (ii) there is a relevant accepted use in clinical practice that is not reflected in the approved labeling