Complying with US Drug Supply Regulations

The Drug Supply Chain Security Act (DSCSA) is a federal regulation introduced in 2013 and applicable to nearly ALL entities that buy, sell, produce or wholesale prescription drugs in the United States.

This regulation literally touches every point in the cycle of exchange of product, down to the point at which a prescription is given to a patient at the local pharmacy. Its impact has been substantial, requiring suppliers, repackagers and wholesalers to sizably overhaul their production lines, software and tracking systems. From a pharmacy and hospital provider perspective, the new regulations added a new burden of compliance, with inspections eminent.

In addition, the US is instituting a nationwide exchange of DSCSA serialized data, whose intention is to track a product from manufacturer all the way to current owner.

Despite these challenges, new products are able to reduce the burden. For example, the SaaS service I created and that was recently acquired, RxTrail, solved the issue of complying with DSCSA regulations for hospitals and retail pharmacies.