FDA Regulatory Practice

Distribution of Drugs, Biologics, and Controlled Substances

After drugs and devices have appropriate FDA marketing authorizations, the FDA regulated products enter a complex distribution chain. Our attorneys are especially knowledgeable about the pharmaceutical distribution chain. We provide a wide variety of legal advice concerning the wholesale distribution of drug products, including controlled substances and biologics; drug importation and re-importation; "pedigree" issues arising under the Prescription Drug Marketing Act of 1987 (PDMA) at the federal and state levels; additional state requirements; the secondary market; repackaging; and combating counterfeiting, diversion, and other avenues by which drugs become unsaleable.