new drug
(2) Covered outpatient drug Subject to the exceptions in paragraph (3), the term “covered outpatient drug” means— (A) of those drugs which are treated as prescribed drugs for purposes of section 1396d(a)(12) of this title , a drug which may be dispensed only upon prescription (except as provided in paragraph (4)), and— (i) which is approved for safety and effectiveness as a prescription drug under section 505 [ 21 U.S.C. 355 ] or 507 4 of the Federal Food, Drug, and Cosmetic Act or which is approved under section 505(j) of such Act [ 21 U.S.C. 355(j) ]; (ii) (I) which was commercially used or sold in the United States before October 10, 1962 , or which is identical, similar, or related (within the meaning of section 310.6 (b)(1) of title 21 of the Code of Federal Regulations ) to such a drug, and (II) which has not been the subject of a final determination by the Secretary that it is a “new drug” (within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 321(p) ]) or an action brought by the Secretary under section 301, 302(a), or 304(a) of such Act [ 21 U.S.C. 331 , 332(a), 334(a)] to enforce section 502(f) or 505(a) of such Act [ 21 U.S.C. 352(f) , 355(a)]; or (iii) (I) which is described in section 107(c)(3) of the Drug Amendments of 1962 and for which the Secretary has determined there is a compelling justification for its medical need, or is identical, similar, or related (within the meaning of section 310.6 (b)(1) of title 21 of the Code of Federal Regulations ) to such a drug, and (II) for which the Secretary has not issued a notice of an opportunity for a hearing under section 505(e) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(e) ] on a proposed order of the Secretary to withdraw approval of an application for such drug under such section because the Secretary has determined that the drug is less than effective for some or all conditions of use prescribed, recommended, or suggested in its labeling; and (B) a biological product, other than a vaccine which— (i) may only be dispensed upon prescription, (ii) is licensed under section 262 of this title , and (iii) is produced at an establishment licensed under such section to produce such product; and (C) insulin certified under section 506 3 of the Federal Food, Drug, and Cosmetic Act.