Out of state companies who distribute medical devices beware! If your device is a “dangerous medical device” under California law, and you distribute this device in California, you need a license from the California Board of Pharmacy to sell such a device in California. This requirement became effective in 2006.
California law defines “dangerous medical device” as any device that can be dispensed lawfully under state or federal law or regulations with a prescription or any device that bears the statement:
“Caution: federal law restricts this device to sale by or on the order of a ____,” “Rx only,” or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device.” (Business and Professions Code § 4022(b)).
If you are selling such a device in California, even if you are a wholesaler who sells it for resale, negotiates for distribution, or even stores the devices in a warehouse, then you are required to obtain a wholesaler’s license from the California Board of Pharmacy. And an out-of-state company that engages in the wholesale sales or distribution of such devices “shall be licensed by the board prior to shipping, selling, mailing, or delivering dangerous drugs or dangerous devices to a site located in this state or selling, brokering, or distributing dangerous drugs or devices” in California. (Business & Professions Code § 4161(b)).
Such a wholesaler must not only apply for a corporate or company license, but must also license each separate place of business operated, and designate a representative who is responsible for compliance with the state and federal laws regarding wholesalers (Business & Professions Code § 4161(b)).
For assistance regarding these licensing requirements, please contact our experienced team of healthcare licensing attorneys at Simas & Associates, Ltd.