FDA Launches Foreign-Made Drug Safety Pilot Program, Issues Standards for Securing Drug Supply Chain

February 11, 2009

The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.

The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.

The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program’s criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.

The goal of the two-year pilot is to allow the FDA to determine the practicality of developing a secure supply-chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot’s criteria into the United States. Information about the pilot appears in a Federal Register notice available on the FDA’s web site.

The FDA has also released a draft guidance for industry for securing the drug supply chain, which calls for standardized numerical identification for prescription drug packages. The draft guidance can be found on the FDA’s web site.