Tag Archives: DSCSA

Preemption: What Does It Mean?

State pedigree laws rearviewOn November 27, 2013 President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  That act has many provisions, but one is to preempt all existing and future state pharmaceutical serialization and pedigree laws like those that previously existed in California and Florida.  Because of the preemption language contained within the DQSA, the information contained within many previous RxTrace essays is now obsolete.  Some essays are entirely obsolete and some are only partially obsolete.  This is because many of these essays contain ideas and discussion about topics that will also apply to the new federal law in almost the same way that they applied to the California and/or other state laws that are now inoperative.  In those cases, the ideas and discussion are not obsolete, only their application to the state law(s) is now obsolete.

To address this issue I have Continue reading Preemption: What Does It Mean?

DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure

iStock_000021010135XSmallIf there is one overriding lesson exposed by my essays last week it is that the companies in the U.S. pharmaceutical supply chain must quickly organize to work out technology and process issues that stand in the way of an efficient implementation of phase 1 of Title II of the Drug Quality and Security Act of 2013 (see “DQSA: Getting To Electronic Transaction Data Exchange” and “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”).  Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA).

The law gives the FDA one year to publish guidance containing standards for use by companies in the supply chain for the exchange of Continue reading DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure