FDA

The FDA has announced exemptions for certain trading partners from the enhanced drug distribution security requirements under section 582 of the Food, Drug, and Cosmetic Act (FD&C Act). These exemptions aim to avoid disruptions in the pharmaceutical supply chain, ensuring patients have continuous access to...

INTRODUCTION On November 27, 2019, the Drug Supply Chain Security Act (DSCSA) will considerably change how wholesale distributors must process serialized pharmaceutical returns from customers. Every wholesaler will have to verify that the identifier on the product corresponds to the standardized numerical identifier (SNI) assigned by...