Mississippi Establishes New Medical Device Establishment License and Expands Definition of “Device”

By Rebecca Zadaka

The Mississippi Board of Pharmacy (the “Board”) has introduced a new Medical Device Establishment license through recent updates to the Mississippi Pharmacy Practice Act. A key change is the revised definition of “device,” which no longer requires that a device be dispensed by a pharmacist, thereby capturing prescription devices intended for professional use. This update mandates that the distribution of any legend/prescription devices in or to Mississippi requires licensure. As a result, entities that previously operated outside Mississippi licensure requirements may now fall within the Board’s jurisdiction.

"Mississippi has broadened its definition of medical devices in a way that may capture companies that previously fell outside of licensing requirements. It is crucial companies reassess whether a license in Mississippi  is now required."
Rebecca Zadaka, Associate Attorney

The new framework may apply to a broad range of supply chain participants, including manufacturers, wholesale distributors, repackagers, and third-party logistics providers (3PLs). Entities handling only medical devices may be required to obtain a Medical Device Establishment license, while those already licensed as drug manufacturers or wholesalers generally will not need a separate device license.

To allow awareness and facilitate the initial licensure of both entities, initial licensure is required by 7/1/2026, with an initial expiration of 12/31/2027. Subsequent licensure renewals will commence prior to 1/1/2028 for a 12-month period. For questions about how these developments may affect your operations or for support coordinating state licensure strategy, please reach out to Gardner Law.