the summary above is solid but I want to add legal context. The "essentially a copy" doctrine is being challenged in multiple federal courts right now. The Outsourcing Facilities Association filed suit arguing that compounded semaglutide using different salt forms (like semaglutide sodium vs. semaglutide base used in Ozempic) are NOT essentially copies.
This matters because if the courts agree, compounding could continue even after the shortage resolves. Several cases are working through the 5th Circuit right now.
Not legal advice, obviously. But worth tracking. ⚖️