; and (2) in paragraph (7)(A)— (A) by striking an original new drug application and inserting a new drug application each place it appears; (B) in clause (i), by striking (not including any drug described in paragraph (5)) and inserting , including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4), ; (C) in clause (ii)— (i) by striking was originally marketed and inserting is marketed ; and (ii) by inserting , unless the Secretary determines that a narrow exception applies (as described in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation)) before the period; and (D) in clause (iv)— (i) by inserting , including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4), after covered outpatient drug ; (ii) by inserting unless the Secretary determines that a narrow exception applies (as described in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation)) after under the new drug application