FDA Announces Start of Voluntary Supply Chain Pilot Program
In a February 18, 2014, news release, the U.S. Food and Drug Administration (FDA) announced the launch of its Secure Supply Chain Pilot Program (SSCPP) and the names of the 13 companies selected to participate in the program. The FDA originally proposed the pilot in 2009 and officially announced the start of the program and the selection criteria for participation in August 2013. The pilot is scheduled to run for two years, until February 2016.
As background, the FDA designed the program with the intent to reduce scrutiny of low-risk imports so that it may increase its attention on less trustworthy foreign-made medicine. It hopes to create incentives for manufacturers to adopt best practices for supply-chain safety so that it can enhance the quality and safety of all imported drugs. Its aim is to stop the importation of contaminated, misbranded or … Read More »
FDA and CBP to Begin New Pilot Programs
Both the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) are expected to begin pilot programs to give additional benefits to importers who have secured their supply chains and internal controls this September. On August 20, 2013, the FDA announced it will begin accepting applications to participate in its Secure Supply Chain Pilot Program (SSCPP) which will run for two years, from February 2014 through February 2016. CBP has not yet officially announced, but is expected to announce within the next month, that it will begin a test pilot for its Trusted Trader Program.
Through the SSCPP, the FDA hopes to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks. The FDA plans to increase the rate at … Read More »