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- Kurt thought there was a 50% chance all GLP-1 compounding would end in the next 6 months (both 503A and 503B) - Did not mention direct communication from the FDA telling them to stop compounding GLP-1s - ProRx felt it was time to stop due to the end of the shortage in March 2025, and did not feel influenced by the April 1 FDA statement - Kurt thinks 503B production of GLP-1s are underreported and much larger than thought - 503As can't take care of the compounded GLP-1 market at their current capacity - We both have concerns about patient access without compounded GLP-1s and worry it will send more patients to the grey market for RUO injections that don't have the same level of sterility and regulation To view or add a comment, sign in Yesterday the FDA proposed removing GLP-1s from the 503B bulk list, and I spoke to Kurt Lunkwitz from ProRx to talk about changes to GLP-1 compounding
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