July 22, 2026
By: Harry J. Nelson, Esq.
Many people are unaware that GLP-1 compounding predates the FDA-approved GLP-1s, semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound). For over two decades before Novo Nordisk and Eli Lilly introduced their branded, FDA-approved version, compounding pharmacies made GLP-1 available. Most of the compounded distribution occurred through anti-aging, longevity-focused physicians who promoted these drugs.
The reason for these is that GLP-1 is a “peptide” (amino acid string) that we’ve known about for a long time. Before Novo and Lilly decided to seek approval, the conventional wisdom was that the lack of protectable (patentable) intellectual property made it not worth the effort of seeking FDA approval. As a result, these peptides remained on the edges of medical practice: available and popular in some alternative practices but too risky for most doctors since they were unapproved drugs, which is a problematic status under the Food, Drug and Cosmetic Act (FDCA). All the same, since many people (including physicians) swore by their efficacy, some compounding pharmacies took the risk.
Before Novo and Lilly turned their brands into the hottest drugs out there, the FDA more or less ignored their popularity due to the lack of reported complaints. Even in the years after approval, this was a confusing topic for the last few years due to a declared shortage that opened the door to greater flexibility in compounding as the drugs remained on the shortage list. Compounding pharmacies (and outsourcing facilities) were authorized to prepare compounded versions for patients with legitimate needs who could not obtain commercially available approved products. During the GLP-1 shortages, compounded products filled a real access gap. Demand substantially exceeded branded supply. Insurance coverage was inconsistent. Many patients could not afford the approved products. The compounding pharmacies filled that void.
Over the past year, the FDA has taken steps to close this opening, proposing the exclusion of semaglutide and tirzepatide (as well as another peptide, liraglutide) from the list of bulk substances that Section 503B outsourcing facilities may use based on a demonstrated clinical need. The public comment deadline has been extended to July 30, 2026, but it does not seem likely that there will be a reprieve. That means outsourcing facilities compounding these products risk FDA enforcement. This will narrow the pathway that has been supplying much of the compounded GLP-1 market.
The pressure from Novo and Lilly has unquestionably been a big part of the story as compounders (and the telehealth providers who promote compounded versions at lower prices than the approved drugs) became one of the biggest threats to Novo Nordisk and Eli Lilly GLP-1 profits. The drug companies have lit a fire under the FDA to prevent all the compounding.
For compounders and telehealth weight-loss platforms whose economics depend on mass-marketed compounded semaglutide or tirzepatide, this is a moment of truth. Over the last several months, the FDA has repeatedly stated its intention to take “decisive steps” to restrict GLP-1 active pharmaceutical ingredients used in non-FDA-approved compounded drugs that are being mass-marketed as alternatives to the approved Novo and Lilly products. The FDA called out Hims & Hers, among others, and warned that companies promoting compounded drugs as generic, equivalent to, or clinically proven like FDA-approved products could face enforcement, including seizure and injunction.
The issue goes beyond compounding to an FDA objection to the related marketing claims that the compounded drugs contain the same approved active ingredient in an interchangeable sense or are clinically proven to produce the same results. Even though the FDA does not regulate the practice of medicine (and prescribing, which are regulated at the state level), this line of attack created risk beyond the manufacturing compounders to the telehealth platforms where the drugs are prescribed. The FDA has also pointed to fraudulent labeling, dosing errors, salt forms of semaglutide, and adverse-event reports involving compounded GLP-1 products. All of these highlight that the FDA efforts to tamp down on mass-marketing of compounded GLP-1s are serious and rising. Prescribers are being driven to the safer path of FDA-approved medications, while compounders are being driven to alternative drugs where approved products don’t meet identified patient needs.
One curious facet of this moment is that, thanks to the interests of the current Secretary of the Department of Health and Human Services (HHS), at the same moment of the GLP-1 crackdown, we are moving closer to a broader opening on the status of peptides, of which GLP-1s are just one piece of the puzzle. The RFK-led FDA apparently is considering loosening restrictions on other peptides widely used in longevity, regenerative medicine, wellness, and biohacking circles. Earlier this month, the FDA Pharmacy Compounding Advisory Committee convened to consider seven peptides (BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax, and Epitalon) for potential inclusion on the Section 503A Bulks List.
Longtime FDA reviewers appear to be skeptics in this process based on the limited clinical research to address safety, efficacy, and quality concerns. The advisory committee recommendations are not binding, but are likely to inform FDA’s eventual decisions. While this is far from a “green light” for peptide compounding and prescribing, it reflecting a shifting policy conversation. How do we reconcile these two trends? At the moment, it seems that the FDA is hostile to mass-marketed compounded copies of FDA-approved drugs, but warmer to unapproved peptide substances without approved equivalents where the policy debate is whether regulated prescription compounding may be safer than leaving consumers to an uncontrolled gray market. That distinction is likely to define the next phase of longevity medicine. We are already seeing a strengthening market and greater physician openness to expansion into peptides and other longevity products. Given that Novo Nordisk and Eli Lilly success are already driving greater interest in taking more peptides through FDA approval, will this cycle of a closing window of liberalization repeat? Or will we see greater openness on peptides? Looking forward to sharing more thoughts ahead.
