FDA Launches Supply Chain Pilot Program
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has launched the Secure Supply Chain Pilot Program (SSCPP) to enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drugs 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. Participating firms will demonstrate a commitment to securing their drug supply chains in the Customs-Trade Partnership Against Terrorism (C-TPAT).
The SSCPP, administered by FDA’s Center for Drug Evaluation and Research and Office of Regulatory Affairs, is a voluntary program open to 100 qualified applicants. Each firm accepted to participate in the program will be allowed to have up to five drugs subject to expedited import entry review. Firms that apply must meet certain criteria that include, but are not limited to: 1) The applicant must be the NDA/ANDA sponsor or the foreign manufacturer of the imported finished drug product or active pharmaceutical ingredient. 2) Foreign drug manufacturers and U.S. establishments receiving drugs must comply with good manufacturing practices and also be in compliance with the registration and listing requirements outlined in sections 510(i) and 510(j) of the Federal Food, Drug and Cosmetic Act. 3) Applicants must have a validated secure supply chain protocol per the U.S. Customs and Border Protection’s C-TPAT program as either C-TPAT Tier II or Tier III.
FDA began accepting applications on Sept. 26 and will continue through Dec. 31. The pilot program will run from February 2014 through February 2016. To view the application for the program, go to www.fda.gov/cder/fedreg/fda-3676.pdf. To view the displayed federal register notice, go to www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0656-N.pdf.
