FDA Announces New Pilot Regarding Drug Imports

Posted by Brian Sandner on 8/20/13 4:58 PM

On August 20, 2013, the Food and Drug Administration (FDA) published a Federal Register notice announcing the start of the Secure Supply Chain Pilot Program (SSCPP), which aims to prevent the importation of adulterated, misbranded or unapproved drugs.

The notice explains that, with the help of the SSCPP, FDA will "focus its resources on imported drugs that fall outside the program and may pose risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and active pharmaceutical ingredients (APIs) imported into the United States that meet the criteria for selection under the program."

Importer Requirements for Eligibility include:
-Compliance with FDA's registration, drug listing, and current good manufacturing practice requirements
-CTPAT Tier II/III certified
-Compliant Recordkeeping
-Qualified for Paperless Entry Filing

FDA will start accepting applications from Importers starting September 16, 2013 through December 31, 2013. The two year trial period will be implemented in February, 2014 and conclude in February, 2016.

The complete Federal Register notice can be accesses online here.

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