July 16, 2024
GLP-1s: A California clarification of sorts
We’ve been bugging the California Board of Pharmacy (politely!) for a while, trying to get a statement on its position and enforcement posture regarding the compounding of FDA-approved drugs that are currently in shortage. There has been some confusion — mixed messages, you might say — coming out of the Golden State regarding how the BoP views GLP-1 compounding, and we wanted some official clarification.
Good things, apparently, come to those who wait. In this case, it’s a response from the board in a letter last week saying that, “In general, the Board does try to align with FDA when possible,” and also reminding us that compounding pharmacies “must comply with a myriad of state and federal laws.” The bottom line, though — and our take on the letter (you can read it here) — is that the CA BoP’s position on GLP-1 compounding is consistent with that of FDA.
APC will soon be releasing a best practices document related to shortage drug compounding, including GLP-1s, that tracks to law, FDA guidance, and USP standards … and also recommends certain testing and other measures that go beyond those standards. Stay tuned.