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Evaluation of the Department of Defense’s Mitigation of Foreign Suppliers in the Pharmaceutical Supply Chain

Submitting OIG: 
Department of Defense OIG
Date Issued: 
Monday, September 20, 2021
Agency Reviewed / Investigated: 
Department of Defense
Submitting OIG-Specific Report Number: 
DODIG-2021-126
Location(s): 
Agency-Wide
Type of Report: 
Inspection / Evaluation
Questioned Costs: 
$0
Funds for Better Use: 
$0
Number of Recommendations: 
11
View Document: 
AttachmentSize
PDF icon DODIG-2021-126Redacted.pdf6.81 MB

Related Open Recommendations

Recommendation Number Recommendation Status Significant Recommendation Additional Details
D-2021-2126-DEV0PB-0001-0001.a Open No
Rec. 1.a: The DoD OIG recommended that the Under Secretary of Defense for Acquisition and Sustainment develop and issue implementing guidance for DoD supply chain risk management for DoD materiel in accordance with DoD Instruction 4140.01.
D-2021-2126-DEV0PB-0001-0001.b Open No
Rec. 1.b: The DoD OIG recommended that the Under Secretary of Defense for Acquisition and Sustainment coordinate with the U.S. Department of Health and Human Services to communicate the importance of the Food and Drug Administration implementing the recommendation outlined in the 100-Day Reviews under Executive Order 14017 to "Seek Additional Authority Through Which FDA Can Collect Additional Data and Take Action to Improve Surveillance, Oversight, and Resilience of the Supply Chain."
D-2021-2126-DEV0PB-0001-0001.c Open No
Rec. 1.c: The DoD OIG recommended that the Under Secretary of Defense for Acquisition and Sustainment pursue Federal legislation requiring pharmaceutical manufacturers to include active pharmaceutical ingredients and final drug product country of origin information of the pharmaceuticals' lot on the pharmaceuticals' packaging through modification of the Drug Quality and Security Act, Public Law 113-54 §582(b)(2)(A), or through development or modification of other statutes.
D-2021-2126-DEV0PB-0001-0002.a Open No
Rec. 2.a: The DoD OIG recommended that the Director of the Defense Health Agency, after the new DoD implementing guidance for supply chain risk management is published, develop and publish implementing guidance for supply chain risk management specifically for pharmaceuticals, that includes the Component responsible for policy execution.
D-2021-2126-DEV0PB-0001-0002.b1 Open No
Rec. 2.b.1: The DoD OIG recommended that the Director of the Defense Health Agency complete the implementation of its Drug Supply Chain Security Act Compliance Strategy by establishing policies and procedures for drugs purchased with Government Purchase Cards or local contracts to comply with the Drug Supply Chain Security Act.
D-2021-2126-DEV0PB-0001-0002.b2 Open No
Rec. 2.b.2: The DoD OIG recommended that the Director of the Defense Health Agency complete the implementation of its Drug Supply Chain Security Act Compliance Strategy by, in coordination with the Commander of Defense Logistics Agency Troop Support, establishing policy and procedures for drugs purchased with Defense Logistics Agency-managed processes, including Defense Logistics Agency Depot Stock, Direct Vendor Delivery, and Defense Logistics Agency Electronic Catalog.
Displaying 6 of 6 Recommendations