FDA Offers Guidance on Who’s Who Under Drug Supply-Chain Law

A company that warehouses drugs but doesn’t own them fits into a new category to be regulated under a 2013 federal law that aims to tighten security over the drug supply chain by 2023, according to FDA draft guidance released Aug. 18.

To be eligible to participate in the supply chain, such third-party logistics providers (3PLs) must hold a state or federal license to be authorized as a trading partner under the law.

The requirements apply only to operators who physically possess drugs in a building in a permanent location, excluding brokers, software-services providers and others who may be involved in transactions along the supply chain but don’t meet those criteria.

(Note: The agency later withdrew its notice calling for comment on the draft document, scheduled for publication in the Federal Register Aug. 21.)