OpenClosed - ImplementedClosed - Not Implemented
No. 1 to Office of Acquisitions, Logistics, and Construction (OALC)
Issue guidance clarifying that allergens are exempt from the public law and include how the determination was reached.
No. 2 to Office of Acquisitions, Logistics, and Construction (OALC)
Formalize and communicate the process for manufacturers to request exemptions.
No. 3 to Office of Acquisitions, Logistics, and Construction (OALC)
Formalize the internal process for granting exemptions.
No. 4 to Office of Acquisitions, Logistics, and Construction (OALC)
Establish a procedure for monitoring covered drugs identified in this report as not commercially sold.
No. 5 to Office of Acquisitions, Logistics, and Construction (OALC)
Develop a procedure to monitor covered drugs identified in this report as newly launched to ensure they have an established ceiling price, and make certain they are made available on the Federal Supply Schedule at the end of the 75-day period.
No. 6 to Office of Acquisitions, Logistics, and Construction (OALC)
Request that noncompliant manufacturers identified by the Office of Inspector General conduct a self-audit and submit their findings for remediation.
No. 7 to Office of Acquisitions, Logistics, and Construction (OALC)
Engage with the Food and Drug Administration to ensure that when manufacturers request new national drug codes, they are made aware of the public law requirements.
No. 8 to Office of Acquisitions, Logistics, and Construction (OALC)
Require contracting staff at the National Acquisition Center to conduct a covered drug check for all of a manufacturer’s drugs when any pharmaceutical Federal Supply Schedule proposal or product addition modification is submitted.
Total Monetary Impact of All Recommendations
Open: $ 28,100,000.00
Closed: $ 0.00