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Companies out of state who sell used RX only branded medical devices beware!

       Companies out of state who sell used RX only branded medical devices beware! If a device is labeled RX only or “dangerous medical device”, you will need a license from the California Board of Pharmacy to sell such equipment in California. This requirement for distributing medical devices became effective in 2006. CA Pharmacy Code 4022

CA Pharmacy Code: 4161
Nonresident Wholesaler or Nonresident Third-Party Logistics Provider; Requirements (a) A person located outside this state that (1) ships, sells, mails, warehouses, distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells, brokers, warehouses, or distributes dangerous drugs or devices within this state shall be considered a nonresident wholesaler or a nonresident third-party logistics provider. (b) A nonresident wholesaler or nonresident third-party logistics provider shall be licensed by the board prior to shipping, selling, mailing, warehousing, distributing, or delivering dangerous drugs or dangerous devices to a site located in this state or selling, brokering, warehousing, or distributing dangerous drugs or devices within this state.

(c) (1) A separate license shall be required for each place of business owned or operated by a nonresident wholesaler or nonresident third-party logistics provider from or through which dangerous drugs or dangerous devices are shipped, sold, mailed, warehoused, distributed, or delivered to a site located in this state or sold, brokered, warehoused, or distributed within this state. Each place of business may only be issued a single license by the board, except as provided in paragraph.

(h) A nonresident wholesaler or nonresident third-party logistics provider shall at all times maintain a valid, unexpired license, permit, or registration to conduct the business of the wholesaler or nonresident third-party logistics provider in compliance with the laws of the state in which it is a resident. An application for a nonresident wholesaler or nonresident third-party logistics provider license in this state shall include a license verification from the licensing authority in the applicant’s state of residence.

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.
CA Pharmacy Code 4161.

Such a wholesaler must not only apply for a Calif Pharmacy 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
CA Pharmacy Code 4161

ZRG Medical adheres to the strict CA Pharmacy policies and holds a current CA Pharmacy License: # WLS 7367.

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