Quickly Take Your Medicine: FDA's Secure Supply Chain Pilot Program Presents Opportunity for Expedited Imports of API and Finished Drug Products

Taking a page from an established Customs program, importers of active pharmaceutical ingredients (APIs) and finished drug products may now have the opportunity to become eligible for expedited entry into the United States. Could this help your business? If so, consider the U.S. Food and Drug Administration’s (FDA) August 20, 2013 notice of a new Secure Supply Chain Pilot Program (SSCPP), which will enable qualified importers to receive a “May Proceed” without human entry review or examination for APIs and finished drug products offered for import into the United States. Given the fact that more than 80% of APIs and 40% of finished drugs are currently imported into the U.S., this new program may significantly improve the approval time for those few qualified importers and products under this Pilot Program.

The FDA is initially limiting the SSCPP voluntary program to only 100 qualified applicants. Each firm accepted to participate in the program will be allowed up to five drugs that will be subject to expedited import entry review. In order to participate in the pilot program, the importing company must meet certain criteria, which include, but are not limited to, the following...

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Topics:  ANDA, APIs, C-TPAT, FDA, Imports, Pharmaceutical, Prescription Drugs, Supply Chain

Published In: International Trade Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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