IWLA has been working with the Device Distribution Uniform Standards Alliance coalition of interested companies and associations on legislation to establish uniform national licensing standards for 3PLs and wholesalers with respect to medical devices. The legislative proposal tracks closely with the Drug Supply Chain Security Act.
Sections 5081 through 5088 of the 21st Century Cures discussion draft issued by the U.S. House Energy and Commerce Committee would establish the Device Distribution Licensing Act of 2015 (the Act). This overview summarizes the Act’s requirements:
- The Act establishes uniform national standards for licensing third-party logistics providers (3PLs) and wholesale distributors of prescription medical devices. Related state requirements will be preempted.
- Individual states will continue to license wholesale distributors and 3PLs, but must do so using the uniform national standards. A federal license will be available in states that choose not to license wholesale distributors and 3PLs.
- The Act does not affect federal licensing requirements for manufacturers or state licensure requirements for dispensers.
- The Act does not affect medical device tracing. The Unique Device Identifier (UDI) system addresses traceability, and this Act does not add to or otherwise impact existing medical device identification or tracing requirements.
- Licensure is only required for prescription medical devices defined in the Act. Licensure of over the counter (OTC) devices are preempted at the federal and state level.
(IWLA Washington Representative Pat O’Connor contributed this article.)