; (2) in clause (i), by inserting but including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4) after drug described in paragraph (5) ; (3) in clause (ii), by striking was originally marketed and inserting is marketed ; and (4) in clause (iv)— (A) 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 ; and (B) by adding at the end the following new sentence: Such term also includes a covered outpatient drug that is a biological product licensed, produced, or distributed under a biologics license application approved by the Food and Drug Administration. (d) Exclusion of manufacturers for knowing misclassification of covered outpatient drugs Section 1128(b) of the Social Security Act ( 42 U.S.C. 1320a–7(b) ) is amended by adding at the end the following new paragraph: (17) Knowingly misclassifying covered outpatient drugs Any manufacturer or officer, director, agent, or managing employee of such manufacturer that knowingly misclassifies a covered outpatient drug under an agreement under section 1927, knowingly fails to correct such mis­clas­si­fi­ca­tion, or knowingly provides false information related to drug pricing, drug product information, or data related to drug pricing or drug product information. . (e) Effective date The amendments made by this section shall take effect on the date of the enactment of this Act, and shall apply to covered outpatient drugs supplied by manufacturers under agreements under section 1927 of the Social Security Act ( 42 U.S.C. 1396r–8 ) on or after such date.