On June 8, 2020, FDA published a guidance document that answers questions about FDA’s enforcement of Prescription Drug Marketing Act of 1987 (PDMA) requirements during the COVID-19 pandemic, specifically related to the distribution of drug samples. PDMA, which is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), established requirements for the distribution of prescription drug samples by mail or common carrier and requires licensed practitioners to request drug samples in writing. It also mandates requirements for storage, handling, and recordkeeping for drug samples.
