DENVER, Co. – March 30, 2023
The Obesity Medicine Association has released its Position Statement on Compounded Peptides, with a summary that states:
“The Obesity Medicine Association recommends that anti-obesity medications, and their formulations, undergo clinical trial testing for efficacy and safety via processes overseen by the Food and Drug Administration (FDA). The FDA does not approve compounded drugs (e.g., compounded peptides), and without their review, the FDA cannot assure that compounded drugs have the same safety, efficacy, and purity of FDA-approved medications that have gone through clinical trial testing. If compounded peptides are prescribed, then they should be legally produced by source companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
Dr. Angela Fitch, first author and President of the Obesity Medicine Association, stated: “Compounding medications by a pharmacist is sometimes performed to provide a custom formulation of a medication to fit a unique patient need, not otherwise met with a commercially available medicinal product; however, compounding peptides should not be intended for pharmacists to mass produce, store, market, and sell replications of patented medications.”
The Obesity Medicine Association recommends that anti-obesity medications and their formulations should undergo clinical trial testing for efficacy and safety as overseen by the FDA, the components of compounded peptides should be legally produced by source companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies, prescribers, and patients should avoid the use of compounded polypeptides from undisclosed sources, and prescribers should be cautious of compounded peptides where the safety, efficacy, quality, and purity of the source molecule, and their combination with other molecules, cannot be assured.
“At minimum, patients should be informed of potential limitation of compounded peptides, and most of all, the principle of “primum non nocere” (“first do no harm”)” should be a priority if prescribing compounded medications”, said Dr. Fitch.