The U.S. Food and Drug Administration published a notice announcing the launch of the Secure Supply Chain Pilot Program (SSCPP), which will enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States.
The goal of the program is to enable FDA to focus its imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply. In addition, participating firms will also demonstrate a commitment to securing their drug supply chains as participants in the Customs-Trade Partnership Against Terrorism (C-TPAT).
The SSCPP is a voluntary program open to 100 qualified applicants. Each firm accepting to participate in the program will be allowed to have up to five drugs subject to expedited import entry review. The SSCPP will be jointly administered by FDA's Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA).
Firms that apply to participate in the pilot program must meet certain criteria that include, but are not limited to, the following:
FDA will accept applications for participation beginning September 16, 2013, through December 31, 2013. The pilot program will run from February 2014 through February 2016.