June 30, 2023
FDA issues draft guidance on 503B wholesaling
This week, FDA published a new draft guidance on the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The draft would clarify that state-licensed pharmacies may dispense drugs compounded and sourced from 503B outsourcing facilities and provides examples of activities prohibited and not prohibited. The Outsourcing Facility Association has long encouraged FDA to issue this guidance.
“It’s a welcome clarification, and it should help solidify what appears to be the agency’s preferred model for meeting longer-term drug shortages—those shortages for which 503Bs have both an economic incentive to incur the costs of producing the drug and time to ramp-up production,” said APC’s Scott Brunner.
“It follows a point we made to FDA earlier this year when FDA issued guidance allowing 503Bs to prepare ibuprofen suspension, which was in shortage, and sell it to 503As for patient-specific dispensing. That looked an awful lot like wholesaling, so there was not a lot of uptake by 503As. With this draft guidance, FDA makes it clear that the B-to-A model is encouraged.”
