Frier Levitt Partner Edgar J. Asebey recently spoke with Peptides Business Wire about the evolving regulatory landscape for peptides, including the FDA Pharmacy Compounding Advisory Committee’s (PCAC) recent recommendations, increased enforcement activity, and new legal strategies being pursued by pharmaceutical manufacturers.
While PCAC recommended adding six peptides to the 503A Bulks List, Edgar cautioned that the recommendations do not make those peptides immediately available for lawful compounding. The FDA must still decide whether to adopt the recommendations and complete the required rulemaking process, which could take one to two years.
Edgar also discussed increased scrutiny of compounded GLP-1 products, including recent FDA enforcement involving compounded combination products:
“You are manufacturing essential copies, not responding to specific prescriptions and using the additional ingredient as a pretext.”
The developments underscore the importance for peptide businesses, compounding pharmacies, and practitioners to closely monitor FDA rulemaking, enforcement activity, and litigation as the regulatory landscape continues to evolve.
