February 20, 2024

Can 503Bs distribute to 503As yet? Well, maybe.

We’ve heard from a few APC members who received communication recently from an entity claiming to represent a 503B outsourcing facility marketing sterile products to 503A compounding pharmacies.

Last June, FDA published draft guidance on the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The draft guidance clarifies that state-licensed pharmacies may dispense drugs compounded and sourced from 503B outsourcing facilities and provides examples of activities prohibited and not prohibited. It gets complicated, to say the least. APC submitted comments to FDA in September generally supporting the draft guidance but seeking clarification on several points. 

But remember: That guidance is a draft and has not been finalized yet. Still, some states are already considering if and/or how to implement this language into their existing laws and rules. APC is working on a tool for PFMs that will outline where each state’s laws currently land on the issue, so keep watch for that.

In the meantime, you should check with a pharmacy attorney familiar with the laws and rules in your state before sourcing anything in your 503A pharmacy from a 503B outsourcing facility.