Our business (or an affiliated business) has an FDA Form 483 Notification. Are we eligible to apply for Healthcare Merchant Accreditation?
If you or your affiliate (as that term is defined in the program standards) is subject to an Food and Drug Administration (FDA) Form 483 Notification, you need to:
- Close out the matter with FDA. This may be demonstrated with an Establishment Inspection Report (EIR) release letter from FDA under FMD-145, a letter from FDA referring all follow-up action to a state board of pharmacy, or a status of “closed” on FDA’s Registered Outsourcing Facilities webpage;
- Obtain Drug Distributor Accreditation, if eligible, through NABP; or
- If, prior to applying, you wish to resolve this eligibility issue, you may email email@example.com to request the option of a Verified Pharmacy Program (VPP) inspection. If NABP Healthcare Merchant Accreditation staff determines, in its sole discretion, that a VPP inspection could resolve this eligibility issue, we may request that you complete a VPP inspection. The VPP inspection report will then be reviewed by NABP Healthcare Merchant Accreditation staff to determine if you are eligible to apply for Healthcare Merchant Accreditation. This option is offered solely at NABP’s discretion.