FDA - Pilot program for expedited entry of drug products, active pharmaceutical ingredients 

August 19: The Food and Drug Administration (FDA) today released a notice for publication in the Federal Register announcing a pilot program that will allow for expedited entry of imported drugs into the United States.

The FDA notice [PDF 230 KB] outlines the eligibility requirements and the process for applying for participation in the the Secure Supply Chain Pilot Program (SSCPP).

The FDA pilot program is a two-year, voluntary pilot program, intended to help prevent the importation of adulterated, misbranded, or unapproved drugs while simultaneously increasing expedited entry for specific finished drug products and active pharmaceutical ingredients imported into the United States that meet the criteria for selection under the pilot program.

  • The FDA plans to increase the rate at which entries of the finished drug products and active pharmaceutical ingredients selected for the pilot program are given a "may proceed" without human entry review or examination.
  • The FDA, thus, anticipates that participation in the program will increase the likelihood of expedited entry when products covered by the program are offered for importation into the United States.

The FDA will accept applications for participation in the SSCPP beginning September 16, 2013, and continuing through December 31, 2013.

The SSCPP is intended to be a two-year pilot, from February 2014 through February 2016.

For more information, contact a professional with KPMG’s Trade & Customs practice:

Douglas Zuvich

(312) 665-1022

Andrew Siciliano

(631) 425-6057

John L. McLoughlin

(267) 256-2614

Todd R. Smith

(949) 885-5617

Luis A. Abad

(212) 954-3094

Amie Ahanchian

(202) 533-3247

Or your local KPMG Trade & Customs professional.

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