; (ii) a drug approved under subsection (c) or (j) of section 505 has been withdrawn or discontinued; or (iii) the Secretary has any other reasonable basis to conclude that a drug approved under subsection (c) or (j) of section 505 is not competitively relevant. (B) Holder of approved application In determining whether 5 drugs are commercially available under paragraph (1)(A), in the case of a single person who is the holder of more than one application approved as described in paragraph (1)(A) with respect to an applicable drug, only one such drug shall be considered to be commercially available. (c) Applicable drug In this section, the term applicable drug means a drug that is not a radio pharmaceutical drug product or any other product as designated by the Secretary. . (c) Annual reporting on drug shortages Section 506C–1(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1(a)(3)(B) ) is amended— (1) in clause (i), by striking ; and and inserting ; ; (2) in clause (ii), by adding and after the semicolon; and (3) by inserting after clause (ii) the following: (iii) the number of drugs authorized for temporary importation under section 506C(h); .