FDA has announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. FDA published a notice in the Federal Register (78 FR 51192) in August 2013 to solicit companies to voluntarily submit applications for participation in the program. Thirteen prequalified companies have been designated to take part in the program. Participating companies will receive expedited entry for the importation of up to five selected drug products into the United States.
The companies met multiple participation conditions, including committing to comply with requirements of the Food, Drug, and Cosmetics Act (FDCA); having a validated secure supply-chain protocol per the US Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program; having a plan in place to quickly correct potential problems FDA identifies regarding importation of specific products; having effective recall and corrective action plans in place; and maintaining control over their drugs from the time of manufacture abroad through entry into the US.
FDA hopes the pilot program will enable the agency to evaluate resource savings 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 US drug supply. FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. FDA may establish a permanent program based on the outcome of the pilot program.
“By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”
The prequalified companies accepted into the program that will receive expedited entry, are the following:
• AbbVie Inc.
• Allergan, Inc.
• Astellas U.S. Technologies, Inc.
• Bristol-Myers Squibb Company
• Celgene Corporation
• GE Healthcare Inc.
• GlaxoSmithKline LLC
• Merck Sharp & Dohme Corporation
• Mylan Pharmaceuticals Inc.
• Novartis Pharmaceuticals Corporation
• Pfizer, Inc.
• Teva Pharmaceutcials USA, Inc.
• Watson Laboratories, Inc.