The U.S. Food and Drug Administration (FDA) recently announced that 13 pharmaceutical companies have qualified to participate in its two-year pilot program to improve the security of imported drugs. The companies “will receive expedited entry for the importation of up to five selected drug products into the united states.” According to the agency, the program’s goal “is to enable the FDA to evaluate resource savings that will allow the agency to focus 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.”
Limited to 100 qualified applicants, the program will be evaluated for effectiveness “at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain.” If it succeeds, the agency could establish a more permanent program with participation extended to additional companies.
The participating companies have apparently met a number of conditions, including promising to comply with U.S. drug safety laws, having a “validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program,” having effective recall and corrective action plans, and “maintaining control over their drugs from the time of manufacture abroad through entry into the united states.”
Click here for more information about the FDA Secure Supply Chain Pilot Program