Regulatory Open Forum

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  • 1.  Customer Licenses to sell prescription devices

    This message was posted by a user wishing to remain anonymous
    Posted 27-Feb-2017 15:57
    This message was posted by a user wishing to remain anonymous

    This question pertains to Manufacturers (who also are the importer and distributor) of prescription medical devices who are not VAWD certified.  At one time our company was VAWD accredited and there was a requirements that we verify customer licenses for the customers to which we sell prescription devices. Recently we decided NOT to maintain that accreditation.  Does anyone know on an FDA requirement which states that manufacturers are required to maintain evidence that our customers have a valid license to sell prescription devices?


  • 2.  RE: Customer Licenses to sell prescription devices

    Posted 28-Feb-2017 06:02
    VAWD is an entity which carries out third part inspections for licensing at the state level for distributors of drugs and legacy devices.

    FDA by definition does not get involved with state licensure requirements except to ensure that these are not more stringent than Federal requirements.

    Furthermore, only a few states require VAWD accreditation to obtain state licenses as wholesale distributors.
    https://nabp.pharmacy/programs/vawd/faqs/

    The short answer is that FDA does not require VAWD accreditation.

    It is possible that this will change if FDA recognizes VAWD accreditation as implementing Federal Standards, but this is currently not the case.

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    Jean Bigoney PHD, RAC
    Managing Member
    Nu Device Consulting LLC
    Murphy NC
    United States
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