On Friday, July 12, 2013, the Food and Drug Administration (FDA) hosted a public meeting to discuss the implementation of the drug supply chain provisions to Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA). The meeting included a host of speakers that shared their perspective on the best course of action for implementation of Section 713 (Standards for Admission of Imported Drugs) and Section 714 (Registration of Commercial Importers of Drugs and Good Importer Practices) of the regulations. The meeting was also open to public comment from industry, trade, and other stakeholders who shared their perspective. Since then, industry groups, drug importers, and other stakeholders have been preparing comments to guide the implementation process. Final comments on the implementation of Sections 713 and 714 are due by August 12, 2013.
The globalization of the drug supply chain has occurred at a rapid pace and enhancements to the registration and certification processes have not been able to keep up with the speed of these changes. While the U.S. has robust laws, regulations, and enforcement by federal and state authorities, with the expansion of the globalized supply chain, the FDA found it necessary to step beyond U.S. borders to ensure a high degree of confidence in the safety and quality of drugs that are imported from wherever they are made. Title VII of FDASIA addresses the need to modernize the drug import regulatory framework to address risks outside the United States by enhancing compliance requirements and authorizing cooperation with foreign regulatory entities.
The focus of the FDA’s public meeting was specifically on Sections 713 and 714 of Title VII. Section 713 authorizes the FDA to require importers, as a condition of entry, to provide information demonstrating that the drugs being imported are compliant with the law. The information requested will include the drug’s regulatory status, a facility identification number, testing results, and other compliance requirements. The FDA has stated that these requirements will be implemented using a “risk-based” approach. Thus, in line with this provision has also been a discussion regarding the FDA’s development of a “trusted importer” program for highly compliant importers, including discussions of what the program should look like and what eligibility requirements might be.
The registration requirements under Section 714 will apply to all commercial importers of drugs and drug products. The requirements will include registration of unique facility identifiers for all foreign facilities used in the supply chain. Also contained in Section 714 is the FDA’s development of “Good Importer Practices” to guide importers in compliance with the new regulations.
While it is unclear at this stage what the final regulations will look like, the changes to the FDA’s drug import regulatory framework and authority are truly historic and will have a significant impact on all importers of drugs and drug products.