Licensure For Healthcare Distributors

HIDA monitors state legislative and regulatory activity for potential changes to the current licensure standards. Prior to enactment of the DSCSA, distributors faced significant uncertainty as to how to be properly licensed to do business in different states. The preemption of state licensure requirements for drug distribution pursuant to the DSCSA has significant potential to create additional confusion as to the regulation of medical device distribution because nearly every state that requires licensure for medical device distribution does so as part of its prescription drug licensure requirements.

Why Medical Device Licensure Standards Are Needed

• The divergence of licensure standards used by states creates unnecessary burden. The standards for wholesale distribution of medical devices vary widely from state to state. Some states have no licensure requirements for medical device distributors, while others rely on only minimal requirements. Many states impose licensure requirements that do not have logical application to device distributors because they have deviated from federal definitions set by the Food and Drug Administration. This variation can make compliance challenging for even the most well-intentioned and sophisticated distributors.

• State-specific “fixes” to uncertainty created by DSCSA could lead to more complex patchwork of regulations. Nearly every state with prescription device distribution and pharmaceutical licensing requirements issues a joint drug/device distribution license. However, pharmaceutical wholesalers will soon have national licensure standards per the DSCSA. The DSCSA requires the FDA to establish national licensure standards for pharmaceutical wholesalers, which will likely require legislative or regulatory action in state legislatures for appropriate implementation.

The proposed prescription device wholesaler standard legislative language will avoid this confusion. Implementing licensure standards for both chains provides a stable and cohesive standard for wholesale licensure.

HIDA continues to work with Representative Robert Latta (R-OH) on draft legislation that will provide for a uniform national standard for licensing wholesale distributors of prescription and medical devices, and will provide updates on the effort as it progresses.