March 1, 2024
Peptides: Still complicated
A couple of years ago, APC released a brief for prescribers on peptide compounding. It was a response to a request from many of our members who were being asked by prescribers to compound peptides that fell outside federal law and FDA guidance for use in compounding. The title of that brief was “Compounded Peptides: It’s Complicated.”
Since the release of that brief, it hasn’t gotten any less complicated.
That’s why at its February 15 meeting, your APC Board of Directors authorized an update of and elaboration on that statement, with a direction to broaden the audience to not only prescribers and our members but also non-members and even regulators. The purpose: To educate us all not only about federal law and FDA guidance on peptides – particularly in light of FDA’s September 2023 addition of several peptides to Category 2 – but also to explain the pathway for re-nominating some of those substances for reconsideration by the agency.
Here’s an advance copy of our revised statement, titled “Understanding Law and Regulation Governing the Compounding of Peptide Products.”
Next week we’ll release that revised statement broadly to the media, state boards of pharmacy, and of course to our members and other compounders. We hope you’ll also share it with your colleagues and the prescribers you work with.
We don’t have to agree with FDA’s actions on peptides – and on plenty of other things as well. But we do have to adhere to laws and regulations. It’s a duty we owe our patients … and the credibility of our profession.
– Joe
Joseph P. Navarra, RPh, FACA, FAPC is the owner of Town Total Compounding Center in Woodbury, New York. You can reach him at joseph.navarra@towntotalcompound.com.
