ASHP Following Compounding Legislation

Tom Kraus of ASHP discusses what they'll be watching for at upcoming FDA listening sessions regarding compounding legislation

Tom Kraus, MHS, JD, American Society of Health-System Pharmacists (ASHP) vice president of government relations discusses upcoming compounding legislation. This video was filmed during the 2019 American Society of Health-System Pharmacists Summer Meeting in Boston, MA.

Tom Kraus, MJS, JD: ASHP has been a supporter of DQSA and doesn’t want to see legislative changes to that compounding legislation. FDA does have some listening sessions coming up later this month and we’ll be watching those sessions for a few things. Number 1, to try to get some clarity on timelines for compounding, for when the final guidance will be out from FDA. We’ve also had concerns about the 1-mile radius for compounding—this is a carve-out that was included in the draft rule—and we think that’s arbitrary. We’d propose that the FDA include language that reflects BUD dating like that in USP 797 and USP 800.