48 C.F.R. § 46.408
46.408 Single-agency assignments of Government contract quality assurance.
(a) Government-wide responsibility for quality assurance support for acquisitions of certain commodities is assigned as follows:
(1) For drugs, biologics, and other medical supplies—the Food and Drug Administration;
(2) For food, except seafood—the Department of Agriculture.
(3) For seafood—the National Marine Fisheries Service of the Department of Commerce.
(b) Agencies requiring quality assurance support for acquiring these supplies should request the support directly from the cognizant office.
Notes of Decisions
Cited in 2
cases (1 in the last 5 years), 2017–2021 · leading case: United States Ex Rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017).
United States Ex Rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017). “, 48 C.F.R. § 46.408 (direct payment); 42 U.”
United States of Am. ex rel. Allen Timothy Yu v. Grifols USA, LLC (S.D.N.Y. 2021). “, AC ¶ 87 (alleging that reimbursement by the Veterans Administration relies on the “quality assurance” of drug products by the FDA) (citing 48 C.F.R. § 46.408 ); id. ¶ 65 (“Medicaid expressly limits coverage of outpatient drugs to those that meet all the requirements and…”
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