USA – FDA’s drug volume reporting requirements face pushback

As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.

The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.

Under this new section, 510(j)(3), each person who registers a drug (including repackers, relabelers and anyone that manufactures product) must report to FDA annually the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution…