US FDA’s Drug Distributor Licensing Plan Preempts Potentially Stricter State Rules

04 Feb 2022

National plan would close regulatory gaps in licensure of wholesalers and shipping companies, but also backs away from earlier idea to let states set stricter requirements.

Cargo trucks at warehouse — move would preempt pharmaceutical distribution risks • Source: Alamy

State governments would lose their ability to impose tougher licensure standards on wholesale drug distributors and third-party logistics providers under a rule the US Food and Drug Administration has proposed for protecting the pharmaceutical distribution chain from stolen or counterfeit drugs as required by the November 2013 Drug Supply Chain Security Act, or DSCSA.

As proposed, the rule will preempt state licensure requirements for wholesale drug distributors two years after it becomes final and...