Comment from American Pharmacists Association (APhA)
AnonymousOpposeTrade association
Summary: The American Pharmacists Association (APhA) opposes the inclusion of the nominated peptides on the 503A Bulks List at this time due to a lack of peer-reviewed clinical and nonclinical safety data. They urge the FDA to focus on patient and provider education regarding the risks of unregulated peptide markets while calling for more research and standardization before any regulatory action is taken.
Dear Deputy Commissioner Graham and Members of the Pharmacy Compounding Advisory Committee,
The American Pharmacists Association (APhA) appreciates the opportunity to provide FDA and the Pharmacy Compounding Advisory Committee (PCAC) with comments on the “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List.”
Full comments are attached.