The FDA issued a draft guidance implementing penalties for manufacturers who delay inspections or deny access to inspectors, the agency announced at a day-long public meeting on July 12 on drug supply chains.
The guidance is the agency's latest action under new authority granted last year in the FDA Safety and Innovation Act (FDASIA) in order to ensure drug products shipped to and distributed in the U.S. are what they purport to be and not counterfeit.
Section VII of the law gives the FDA broad new powers to regulate the global supply chain in an era where 40% of finished products and 80% of active ingredients come from outside the U.S. -- many passing through hands that can't be accounted for. The number and variety of manufacturers, shippers, and distributors continues to grow, creating challenges for the FDA in regulating them and opportunities for criminals to introduce counterfeit drugs into the supply chain. Read more