Our business (or an affiliated business) has an FDA Warning Letter regarding compounding. 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 FDA Warning Letter regarding compounding, you need to:
- Hold a “close-out” letter or a status of “closed” on FDA’s Registered Outsourcing Facilities page; or
- Obtain Drug Distributor Accreditation, if eligible, through NABP.