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...
Please see full alert below for more information.
Firefox recommends the PDF Plugin for Mac OS X for viewing PDF documents in your browser.
We can also show you Legal Updates using the Google Viewer; however, you will need to be logged into Google Docs to view them.
Please choose one of the above to proceed!
LOADING PDF: If there are any problems, click here to download the file.