Licensure

Background

Medical products distributors often fall under the jurisdiction of the Food and Drug Administration Center for Devices and Radiological Health at the federal level. In addition, more than 30 states require some type of licensure to distribute medical devices, however there is no standard set of requirements, processes, or stipulations, creating a confusing array of laws and regulations.

What Members Need to Know

HIDA Supports a uniform national standard for licensing wholesale distributors of prescription and medical devices. A national standard will create a more streamlined and efficient way of doing business for wholesale distributors. Specifically, HIDA supports a tiered legislative and regulatory licensure approach for prescription device wholesalers that:

• Implements a national standard but allows individual states to continue to license wholesale distributors; and
• Does not require a separate prescription device license if the wholesaler has a pharmaceutical wholesaler license pursuant to the Drug Supply Chain Security Act (DSCSA).

HIDA monitors state legislative and regulatory activity for potential changes to the current licensure standards. 

Outlook

Licensure standards are needed because:

• 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.

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