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:

Doug Zuvich
Partner and Global Practice Leader
T: 312-665-1022
E: dzuvich@kpmg.com

John L. McLoughlin
Principal and East Coast Leader
T: 267-256-2614
E: jlmcloughlin@kpmg.com

Andy Siciliano
Partner and National Practice Leader
T: 631-425-6057
E: asiciliano@kpmg.com

Steve Brotherton
Principal and Global Export and Sanctions Leader
T: 415-963-7861
E: sbrotherton@kpmg.com

Luis (Lou) Abad
Principal, Washington National Tax
T: 212-954-3094
E: labad@kpmg.com

Irina Vaysfeld
Principal
T: 212-872-2973
E: ivaysfeld@kpmg.com

Amie Ahanchian
Principal
T: 202-533-3247
E: aahanchian@kpmg.com

Christopher Young
Principal
T: 312-665-3229
E: christopheryoung@kpmg.com

Gisele Belotto
Principal
T: 305-913-2779
E: gbelotto@kpmg.com

George Zaharatos
Principal
T: 404-222-3292
E: gzaharatos@kpmg.com

Andy Doornaert
Managing Director
T: 313-230-3080
E: adoornaert@kpmg.com

Jessica Libby
Principal
T: 612-305-5533
E: jlibby@kpmg.com

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