U.S. pilot program, FDA “nationalized drug entry review”
90-day pilot program intended to maximize entry review staff at the periods of highest volume drug entries
90-day pilot program intended to maximize entry review staff
U.S. Customs and Border Protection (CBP) today issued a release announcing that the U.S. Food and Drug Administration (FDA) has developed a 90-day pilot program that is intended to maximize entry review staff at the periods of highest volume drug entries.
According to the CBP release—CSMS #51230259—the volume of imported FDA-regulated commodities continues to increase, driven in part by e-commerce, trade volume, and supply-chain complexities. The FDA is considering ways to increase efficiency and effectiveness in operational work.
The “nationalized drug entry review pilot” program will run from March 13, 2022, through June 13, 2022. The FDA will conduct entry admissibility reviews on a national basis (versus the current port-by-port entry review approach).
The pilot program will use entry review staff over multiple time zones, thereby allowing the FDA to expand the drug entry review coverage times with staffing for 24-hour daily coverage, seven days a week. The FDA will cover all 336 ports of entry, and this expanded coverage is intended to allow for increased response time of drug entries. Under the pilot program, the potential to automate portions of the entry review process will be evaluated, with a goal of allowing entry reviewers to focus more of their time on potentially higher violation products.
During the period of pilot program, the FDA also intends to determine if efficiencies can be gained by receiving associated documentation at the time the entry is made (rather than waiting for regular “documents requested” communications).
For more information on this topic or to learn more about KPMG’s Trade & Customs Services, contact:
John L. McLoughlin
Luis (Lou) Abad
The KPMG name and logo are trademarks used under license by the independent member firms of the KPMG global organization. KPMG International Limited is a private English company limited by guarantee and does not provide services to clients. No member firm has any authority to obligate or bind KPMG International or any other member firm vis-à-vis third parties, nor does KPMG International have any such authority to obligate or bind any member firm. The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation. For more information, contact KPMG's Federal Tax Legislative and Regulatory Services Group at: + 1 202 533 3712, 1801 K Street NW, Washington, DC 20006.