; and (B) consists of an integrated process that consists of a series of 2 or more unit operations. (3) Sterile injectable drug The term sterile injectable drug means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), a biological product licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), or a combination product (as described in section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ) whose primary mode of action is that of a drug or biological product, that is intended for injection for intravenous use of infusion and whose manufacturing, distribution, and administration processes require sterile conditions. . (b) GAO study on quality management purchasing The Comptroller General of the United States shall conduct a study on including quality management maturity as a factor in prescription drug purchasing by Federal health care programs (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))), and not later than 2 years after the date of enactment of this Act, shall submit a report on such study to Congress. 5. Authority to use alternative payment under the Medicare program for drugs and biologicals to prevent potential drug shortages (a) Payment under part B Section 1847A(e) of the Social Security Act (42 U.S.C. 1395w–3a(e)) is amended— (1) by striking Payment in Response to Public Health Emergency.— In the case and inserting “ Payments.— (1) In response to public health emergency In the case