The addition by FDA of several peptides to Category 2 on September 29 officially placed them out of...
Showing PCAC a third way
We’ve been saying it over and over, and now APC has put it into a letter to the FDA’s Pharmacy Compounding Advisory Committee, which is meeting later this month to talk peptides. The gist: There is a smart third way for the agency to handle peptides other than “keep them banned” and “legalize them all.”
Our goal — everyone’s goal — is patient safety. But like it or not, people are getting peptides from the black and gray markets. We can blunt those markets and protect patients by allowing compounding pharmacists to produce and dispense some peptides with tight regulation and clinical oversight.
Read our letter for the full effect of what we’re recommending.
And don’t take our word on it. Former US Surgeon General Jerome Adams tackled this very issue in a piece for STAT News where he urged the FDA to “pursue a structured, clinician-guided framework that brings existing demand under professional oversight while maintaining rigorous safety, quality, and research standards.”
The bottom line is that the goal (ours, PCAC’s, FDA’s, and of course patients’) must be safer access to peptides, and there’s a clear step forward the FDA can take to make that happen.