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Agency will begin accepting applications for participants in the expedited import-clearance process in mid-September
The progress might be painfully slow to watch, but FDA is now moving forward on a plan, originally proposed in 2009, to run a pilot program to evaluate expedited clearance of pharmaceutical shipments (APIs or finished products) through ports of entry. Called Secure Supply Chain Pilot Program (SSCPP), the effort was born partly in a response to the slowness of customs clearance at a time when shipments of counterfeit product were (and still are) a concern, and partly to mirror programs like Fast Lane and the Customs-Trade Partnership Against Terrorism (C-TPAT) and others that the Customs and Border Patrol (CBP) have instituted in the aftermath of 9/11.
FDA posted a notice in the Aug. 20 Federal Register (FR Doc. 2013-20215), stating that applications for the voluntary program would be received, beginning Sept. 16 and ending Dec. 31, with the goal of accepting no more than 100 organizations that import drugs and APIs into the United States. The companies must have valid drug approvals (or be ingredients of such drugs), and the foreign manufacturer, importer of record and ultimate consignee must all be known. The importer of record needs to have a Tier II or Tier III C-TPAT program in place. (C-TPAT involves securing warehouses and other logistics facilities to prevent unauthorized movement of product and is itself a means of getting streamlined customs clearance.) Although not making a commitment, FDA says that, pending review of the program for two years beginning in 2014, the agency “anticpates that participation in the program will increase the likelihood of expedited entry.”
Ultimately, the program is hoped to fit with FDA’s risk-based evaluation, inspection and review processes; companies with good records of past operations and secure supply-chain practices in place will have an easier time dealing with Customs than “outsiders” will.