The peptides situation in the US shows no signs of certainty

The FDA’s positions on peptide therapy have created more confusion than clarity. To sort through the noise, Peptides Business Wire spoke with Edgar J. Asebey, an FDA regulatory attorney with Frier Levitt who brings 24 years of experience across pharma, biotech, life sciences, and dietary supplements.

Here is his take on the aftermath of July’s CPAC recommendations, shifting FDA enforcement tactics, and Big Pharma’s new legal playbook.

Let’s dive in.

Do you have a sense of how compounding pharmacies reacted to July's CPAC recommendations?

Edgar Asebey: The biggest thing that we saw were inquiries asking, 'When can I compound these? When can I start compounding?' This got on everyone's radar, but compounding pharmacies often are not aware of the required rulemaking process.

The CPAC committee is an external advisory committee. FDA has yet to announced whether they will follow the recommendations of the CPAC committee.  FDA must determine based on all what was presented at the meetings: Will we begin a process to place these six peptides put on the bulk list, thus making it lawful to compound? That rulemaking process takes anywhere from 12 to 18 months in normal times.

At this point, we don't yet have the decision from FDA as to whether they're going to follow the CPAC’s recommendations or, frankly, that of their own scientists at CDER who were opposed to adding any of the peptides to the 503A Bulk List. If tomorrow Secretary Kennedy says yes, I'm going with the CPAC, or FDA announces that they're going to follow the CPAC committee decision, under the normal process, it would take at least another year after that before those peptides could be lawfully compounded. So, we're talking a year to two years before these peptides are lawful to compound.

What should practitioners be thinking?

This whole research use only peptide sector is a ‘horses are out of the barn

 situation. There are so many hundreds, if not thousands, of direct-to-consumer RUO [Resaearch Use Only] peptide sellers. Some state boards of pharmacy are now saying, 'Hey, you're selling an unapproved drug and calling it RUO peptides. We believe that you're actually selling it to consumers,' and they're initiating investigations. We've already seen some reprimands of prescribers that their professional state boards investigated—a prescriber that was writing scripts and having patients sign a disclaimer saying, 'I know this is not FDA approved, I won't sue you, blah blah blah.' That potentially protects you from that patient, but not from your professional board.

So, what does your state medical board think if you're writing scrips for an unapproved drug, which is what an RUO peptide is? Not cool. That is the potential penalty for any pharmacy that is compounding peptides that are not already on the Bulk list.

What messages are the recent FDA warning letters sending?

I think they're catching on to what the industry has been doing.

Before, when there was a shortage of terzepatide and semaglutide, compounding pharmacies were able to make exact copies of the dosage forms that Lilly and Novo Nordisk couldn't make enough of. During that period, compounding pharmacies made a lot of doses, a lot of profit, etc. Then that shortage ended. Lilly and Novo Nordisk got their act together, created more capacity. There's no more shortage, and so we go back to the normal 503A rules, which is that you cannot make essentially a copy of a branded drug.

However, there's a second exemption in Section 503A, and that is if a doctor or a prescribing professional writes a prescription for what would otherwise be essentially a copy of a branded drug, but contains another active that causes a clinical difference for that specific patient, then you can write a script justifying that formulation, and it is not considered essentially a copy. It’s intended to be prescription by prescription.

Well, last week, FDA issued a warning letter to Empower, a big compounding pharmacy, basically saying, ‘You are manufacturing essential copies, not responding to specific prescriptions and using the additional ingredient as a pretext.’ The objective of adding Vitamin B12 or niacinamide, what was intended to be custom formulations that a doctor believed was necessary for that particular patient, has now become 'just tag something else on and make large batches and then dispense them and advertise them.' FDA just sent the shot over the bow with one of the biggest compounding pharmacies in the country saying, 'You are violating the prohibition on compounding essentially  copies of a branded drug, and the addition of B12 and things like that is a pretext.'"

Those are warning letters. What about actual investigations?

"FDA during DOGE [Department of Government Efficiency] lost around  3,500 workers, many of them enforcement officers. FDA has never had enough employees to enforce all the rules that are on the books. After you have a purge of 3,500, that's reduced even more. This makes it challenging to take on new vast initiatives of enforcement action.

Where we're seeing more investigations than on the FDA side is at state boards of pharmacy level. They are now saying, 'Hey, you're selling an unapproved drug.’  We are see an uptick in these types of investigations.

Have you seen or can you predict any reaction to retatrutide lawsuits from Eli Lilly?

Back when Lilly and Novo Nordisk were sending out cease and desist letters to compound pharmacies making tirzepatide and semaglutide, they were not very effective. What they were arguing at that time was that the pharmacies were violating the Food Drug and Cosmetics Act, and some compounding pharmacies said ‘Ok, we see Lilly, a big pharmaceutical company with deep pockets. We don't want to mess with these guys, so they complied. Other pharmacies might have said, "Thank you, Lily, but you're not the FDA, and there's no private enforcement of the Food, Drug, and Cosmetics Act. So, bye.”

What's different about the actions they are taking with retatrutide is that they are primarily using state law. They're no longer using the largely ineffective 'you're violating the Food, Drug, and Cosmetics Act.' Now they're using state law— accusing companies of deceptive practices, making unfair competition claims and consumer protection claims—and so they have a much better chance of traction there.

The other thing Lilly has shown in conjunction with that: They said that they have given the names of 200 individuals or companies to the U.S. Department of Justice and to state regulatory authorities. Basically, what they're doing is putting files together, sending them to regulators, making it easy for those regulators to construct a case or initiate an investigation on companies that are unlawfully selling retatrutide.  They're putting a lot of lawyers and investigators on the job to then generate data that can be easily shared with regulators."

You think more compound pharmacies and practitioners will take it seriously now?

Absolutely. First of all, Lilly has the history of the how they've gone about this. They've learned from that. Now, they're using a different legal approach, accusing these sellers of something different that could have much better traction, and also they realize that enforcement agencies don't have the bandwidth to start investigating all the sellers of their retatrutide. So, they're trying to make it easier for regulators by preparing all the documentation. That right there could be a big deal. Why? Because Lilly has very deep pockets. They've hired big law. They're putting a lot of lawyers and and investigators on the job to generate data that can be easily shared with regulators at the state level or at the FDA and FTC level,

Do you expect companies like Lilly to go after compound pharmacies and prescribers for patent infringement?

Novo Nordisk and and Lilly hold extensive patent portfolios. When they were sending cease and desist letters, people might have been asking ’Why aren't they suing people for patent infringement?’ It’s because at least in the pharma world, the company that is accused of infringing, their first move is to say ‘We are not infringing because the patent is invalid.’That's number one. Number two is  ‘We're going to the USPTO [US Patent and Trademark Office] and asking for for a reexamination of your patent. When that happens, very often it is found that these patents or portions of them are invalid and they get narrowed. Now I think Lilly made sold $36 billion worth of their GLP-1’s last year, there is no way they're going to endanger the patent portfolio that underlies those profits. This is why they typically do not accuse anyone of patent infringement, which would be the obvious cause of action.

LEGAL UPDATES

Week of September 21-28, 2026

State boards, regulators and reporters close in on compounders and online sellers of unapproved peptides.

Ohio pulls licenses from three Texas compounders

Ohio Board of Pharmacy summary suspensions surfaced publicly this week. Three hit Texas compounding pharmacies. The orders are dated September 8.

Evoluciona Pharma (Stafford, TX).  Seven injectable prescriptions shipped to Ohio from mid-June to mid-August using ingredients ineligible for compounding, including BPC-157, CJC-1295/ipamorelin, tesamorelin and a BPC-157/TB-500/GHK-Cu blend.

Striker Pharmacy LLC (Katy, TX).  Nearly 2,000 Ohio prescriptions since its March licensure; 27 used ineligible drugs, and 16 of those were missing from the records Striker first produced. Striker is also an Eli Lilly retatrutide defendant.

FarmaKeio. Shipping drugs with non-FDA-approved components, with no Ohio-licensed responsible person from 2017 to 2026.

The Board also suspended an Ohio med spa holding unapproved drugs from an unlicensed wholesaler. Its physician told investigators some refrigerated vials were for his personal use.

Summary suspensions are allegations. Each licensee may request a hearing within 30 days.  https://www.pharmacy.ohio.gov/documents/compliance/special/probation/list%20of%20summary%20suspensions%20of%20terminal%20distributors%20of%20dangerous%20drugs.pdf

Also on the radar

LegitScript seal on retatrutide sites. CBS News found at least 35 peptide sellers offering retatrutide while displaying LegitScript certification. Most lost it after CBS asked; several kept selling. https://www.cbsnews.com/projects/2026/legitscript-retatrutide/

Bodega peptides fail testing. WIRED tested PT-141, NAD+, BPC-157 and retatrutide vials bought at New York bodegas. None contained the labeled ingredient. https://www.wired.com/story/viral-bodega-peptides-tests-show-they-arent-peptides-oops/

20 AGs target Chinese ingredients. At least 19 state attorneys general urged a federal probe of weight-loss drug ingredients from China linked to fentanyl-tied warehouses, and asked FDA to scrap its Green List. https://a4pc.org/apc-short-takes/state-ags-raise-alarm-over-chinese-sourced-apis?hs_amp=true

Third Texas glutathione recall. Centric Compounding recalled compounded glutathione over high endotoxin after nine adverse event reports.  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/centric-compounding-issues-nationwide-recall-glutathione-myers-cocktail-and-tri-immune-boost-due

Mississippi boards close ranks. The state's nursing, pharmacy and medical boards jointly barred providers from compounding, recommending or dispensing research-grade peptides. Patient waivers are no defense. https://www.msbml.ms.gov/peptide-statement

Compiled from Ohio Board of Pharmacy records and reporting by CBS News, WIRED, FDA and the Partnership for Safe Medicines. Suspensions, warning letters and indictments reflect allegations pending hearing or adjudication.