The Pharmacy Formulation Coalition (APC), an industry trade group, wrote in an email to Medical Today that semaglutide for sale likely meets the criteria needed to be used to formulate a product because it is not considered a "biological agent" and cannot be used to formulate drugs, and it is an integral part of a product approved by the U.S. Food and Drug Administration.
The APC noted that a recent rule change related to the definition of "biologics" has raised more questions from members "as their prescribing physicians pressure them to use substances that formulators know are now prohibited." But the APC failed to acknowledge that compounding pharmacies actually used the same substance protected by Novo Nordisk's patent in the compounding substance.
"We did not say that it is possible to compound with semaglutide powder, nor did we say that pharmacies should compound Semaglutide peptide, only that it is a peptide that meets the criteria," the email read. .
A spokesperson for the FDA's Center for Drug Evaluation and Research (CDER) also didn't rule out the possibility, noting that under federal law, if "manufactured using an API (active ingredient) that is an ingredient in an FDA-approved human pharmaceutical product, as long as all other conditions are met..." The drugs used in the formulation are not subject to normal approval by the U.S. Food and Drug Administration. "semaglutide is an active ingredient in drugs approved by the U.S. Food and Drug Administration."
APC also argues that ingredients are stepping in to fill the gap in Wegovy's supply.
"The truth is that Wegovy has been on and off back orders from manufacturers and is currently on the FDA's drug shortage list - a distinction that means 503a compounding pharmacies may be able to compounding it," the email read.