Reading the website, there is this quote:
"There are several differences between the 503A and 503B operations.503B outsourcing facilities are entities that can produce a large volume of sterile compounded medications and are under the direct regulation of the FDA.Save My Compounds is most concerned with the traditional practice of pharmacy compounding and will focus on the regulatory framework for 503A entities, which are primarily regulated by state boards of pharmacy."
Places like Empower are 503B and are, according to this, directly regulated by the FDA. It seems the proposed changes involve only 503A pharmacies. The proposed changes here pertain to how these pharmacies must report to state boards of pharmacy (some kind of "MOA" to be signed), and so it would follow that 503B pharmacies would not be at risk here?
