The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners … Continue Reading
FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS regulatory agenda. Under the Drug Supply Chain Security Act (“DSCSA”), FDA was required to issue these regulations no later than two years following the law’s November 2013 … Continue Reading
On July 14, 2011, the Food and Drug Administration ("FDA") proposed to permit wholesale distributors to document the chain of custody (also known as a drug "pedigree") of prescription drug products only back to the last authorized distributor of record ("ADR"), instead of all the way back to the manufacturer. As explained in our client alert, FDA's proposal (if implemented) will not impact the current operations of wholesale drug distributors, and it does absolutely nothing to address a more pressing problem facing the industry - an increasingly complex patchwork of diverse state pedigree requirements.… Continue Reading
