November 3, 2023

A procedural pathway to Category 1

The addition by FDA of several peptides to Category 2 on September 29 officially placed them out of reach for compounding, at least for the time being. That has raised alarms from some prescribers and pharmacy compounders.

They’re concerned that patient access to what they say are legitimate therapies that are clinically effective has been taken away and that the agency has not substantiated the “safety risks” it says it identified related to those substances.

While we would argue that those peptides did not meet the criteria for compounding, APC agrees that in not showing its work – the evidence of safety risk – FDA has once again failed to document its action. “Trust us” is not a sufficient explanation for agency actions.

As we reported here last week, APC has written to FDA to request details of both the process the agency followed in determining safety risks and the risks identified with each of the added substances.

But when it comes to the 503A bulks lists, the agency is not the only one that needs to show its work. Those peptides don’t have to be parked in Category 2 forever. The best way to have them considered in the Pharmacy Compounding Advisory Committee and recommended for inclusion on the Category 1 list – which means they can be compounded – is to make a compelling case for clinical efficacy and submit it to FDA. Such a case would rely on rigorous science, credible research, and potent patient outcome data. It might also want to rebut whatever evidence FDA produces for adding them to Category 2 in the first place – if we can get our hands on that evidence.

Which is all to say there is a procedural avenue for responding to FDA’s recent action. Building such a case is an obvious next step if we think FDA has gotten it wrong.

— Anthony


Anthony Grzib is VP of quality and compliance, state-regulated pharmacies at Wedgewood Pharmacy in Swedesboro, New Jersey. You can reach him at