FDA Reverses Course on Drug Pedigrees: Pedigrees No Longer Required Back to Manufacturer
This post was written by Areta L. Kupchyk and Kevin M. Madagan.
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.
To read the full alert, click here.
