The following conversation with Alliance for Pharmacy Compounding’s Scott Brunner and Tenille Davis discussed challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide, and highlighted the role of compounding pharmacies in addressing these shortages and the importance of distinguishing legitimate compounding pharmacies from illicit actors.
Given the increasing complexity of the pharmaceutical supply chain, what specific challenges have arisen in the supply chain for semaglutide and other medications during the ongoing shortages? How can we ensure that patients continue to have access to essential medications, particularly during shortages?
Scott Brunner, CEO, Alliance for Pharmacy Compounding
Scott Brunner: We are in this remarkable period right now that is, well, it’s remarkable in a lot of ways. It’s very unusual, first of all, to have a branded drug on the FDA drug shortage list. About 80% of the drugs on the shortage list at any given time are generics, 20% or so branded drugs. We not only have a branded drug on the shortage list, but we also have a blockbuster branded drug on the shortage list that has life changing implications for millions of patients. And then on top of that, we have an extended shortage. Semaglutide has been on the GOP the FDA shortage list since March of 2022 tirzepatide, which FDA just moved off of the list last week, had been on the list since December of 2022 and so there was an extraordinary demand that the drug makers were not able to meet. And into that gap have stepped compounding pharmacies.
Compounding is allowed under the Food, Drug and Cosmetic Act in a couple of circumstances. One is when a prescriber judges that there’s no appropriate FDA approved medication for a patient, and she can then prescribe a custom medication that is not commercially available. The other instance is where we find ourselves. The FDA approved drug is the appropriate drug, and yet it’s not available. It’s in shortage, and so compounders are allowed to create copies of FDA approved drugs when the drug appears as currently in shortage on the FDA drug shortage list. That is where we are, where we continue to be, with semaglutide in particular.
Tenille Davis, Chief Advocacy Officer, Alliance for Pharmacy Compounding
Tenille Davis: There’s been some confusion in the media about the semaglutide and terzepatide shortage, saying like, how can compounding pharmacies get these active pharmaceutical ingredients if they’re in shortage, especially because the drug makers have claimed they’re not selling the active form of stable ingredient to compounders. So, one of the things that we like to correct is that there is no shortage of semaglutide the API or tirzepatide the API.
What is in shortage is the FDA approved finished dosage form of Ozempic or Wegovy or Mounjaro in the pen devices or in the vial device, the new vials that are made by Eli Lilly, there’s never been a shortage of semaglutide API, as evidenced by the fact that red belts, as tablets, which also contains semaglutide and are manufactured by Novo Nordisk, have never been in shortage either. And compounding pharmacies have to source this API from the same sorts of FDA registered manufacturers that drug makers use. So, some drug makers manufacture their own API, but a lot of them, including some of our drug makers, in question, source API from contract manufacturers the same way that compounding pharmacies do.
So just like to point that out, because there’s been some confusion that if semaglutides not available, how are the pharmacies getting it? And if they are, are they taking away from the drug supply chain of the manufacturers? And that’s just not how the whole system has worked.
What specific measures can be taken to prevent the proliferation of counterfeit medications and protect patients from harm? How do compounded medications differ from commercially available drugs in terms of their manufacturing process, quality standards, and regulatory oversight? Are there advantages and disadvantages of using compounded medications compared to traditional pharmaceutical products?
Brunner: Counterfeit and illicit substances are a scourge in our healthcare system, and with the growth of GLP-1s, this phenomenon that we’re seeing more and more counterfeit activity is taking place. We are seeing, not only sellers of substances that purport to be GLP one drugs. We’re seeing entities that purport to be pharmacies that are not.
There was a study out of, think it was out of Southern Cal University of Southern California a few months ago that had indicated that as many as 40% of online pharmacies were fake, which means not registered with not licensed by the State Board of Pharmacy or any of that. And those websites, they pop up. Somebody takes them down, and they’ll pop up in another iteration, many of them are selling what purport to be prescription drugs without a prescription, and that is, it’s just remarkably dangerous.
One of our concerns is the way that drug makers and others have conflated legitimate compounding with the illicit actors out there. Those aren’t comparable. Those are those are two different things, and we can talk about ways that you can differentiate between what is a legitimate compounding pharmacy and an illicit actor, but we do believe more needs to be done to address that scourge. There was a letter just recently sent from the Republican leaders of the House Energy and Commerce Committee to FDA asking FDA for a thorough report on how the agency is confronting this, the counterfeit activity out there, because patients are absolutely being harmed by this.
Davis: That’s absolutely correct. The FDA approved version of medication should always be the first choice for a patient. It’s only when that’s not appropriate for a patient so they have an allergy to an Excipient, or they need a specialized dosage form, or the FDA approvers not available that compounding is authorized in the Food, Drug and Cosmetic Act. Compounding pharmacies don’t have this the same manufacturing standard as big drug companies. They can’t because, for the most part, they’re making things for a single patient at one time. So, they’re, you know, it’s a lot more custom than a drug maker making millions of dosage forms, potentially. But that doesn’t mean that compounding pharmacies aren’t regulated. So, they are regulated by State Boards of Pharmacy. That’s the primary regulator of compounding pharmacies.
They’re also regulated by the FDA and inspected by the FDA, typically in a four cause basis, so if there’s a problem or a complaint, the FDA can go in and inspect a compounding pharmacy. And most all states have adopted what’s called the US Pharmacopeia standards when it comes to compounding which essentially lay out what pharmacies must and should do with regards to testing and training and cleaning and all of the things that go into the compounded products that they make. A lot of the claims in the media that with compounded drugs, you just don’t know what’s in there are you know, kind of overblown or misunderstood, because compounding pharmacists absolutely know what’s in the products that they make. You know they’re required to send samples of those products out to third party laboratories for all sorts of testing for sterility and potency and container closure and antimicrobial effectiveness, and you name it. So, these claims with legitimate state licensed company pharmacies, they do know what’s in there.
And the conflation and confusion between illicit online drug sellers and counterfeiters is unfortunate because it makes it really difficult for patients and prescribers to have faith in the whole system, because it’s confusing for them to differentiate between these different actors. So, we like to say, if you didn’t go to a doctor, either telehealth visits or an in person, and get your prescription dispensed to you and your name by a pharmacy, probably what you’re getting is not what you think it is, because those things are required for a legal dispensing of a prescription. If there wasn’t a legal dispensing of a prescription, you have no guarantee as to what you purchased, and it was likely, you know, to be not what you think it is.
How can the regulatory framework for compounded medications be further strengthened to ensure quality and safety while maintaining flexibility to address patient needs?
Davis: We’re always in kind of this delicate dance to balance patient access with patient safety. If we make the rules too stringent, sure, it’ll make things really, really, really safe, but it’ll be too expensive or too onerous for pharmacies to comply where patients won’t be able to afford the resultant, you know, medications that come out of that. That being said, there’s been times in the past where there’s been some bad players in in the space that have done real harm to the reputational image of compounding pharmacy. And in those instances, it was less that they were the rules needed to be strengthened. It was more that those pharmacies weren’t following the rules that even existed in the first place.
So, I think that to strengthen what we need is, is regulatory certainty. We need the same rules to be enforced, and we need that those rules to be enforced fairly and uniformly across all states and have the same expectations, whether you’re in one state or the other. So, the rules don’t necessarily need to be strengthened. There was nothing you know really ever shown that was wrong with the rules as they are. It’s just that they need to be enforced more you know, more fairly, more accurately, more evenly.
Brunner: The regulatory framework that compounding pharmacies operate in is rigorous. Are compounded drugs prepared to the same standard as FDA approved drugs, no, but how could a drug that’s made for an individual patient be individually FDA approved and adhere to all that? But that doesn’t mean it’s illogical to say that because the drug is not FDA approved, it is unsafe. There are dozens and dozens, and dozens of substances used in hospitals and clinics all the time that aren’t FDA approved. Many of those are compounded, in fact, and so it’s in a logical leap to say, oh, it’s not FDA approved. It shouldn’t be used. It’s dangerous. Compounded drugs are prepared under rigorous compliance and quality standards that are aimed at keeping the patient safe.
I mean, the honest truth is, pharmacy is not going to stay in business very long if they’re making their patients sick, and so compounding pharmacies adhere to those standards. It’s not only federal law and state law, but also the standards of us Pharmacopeia. Often these pharmacies have special accreditations that help assure compliance. They’re doing third party testing of their API. They’re doing batch testing of every batch of GOP, one drug that they create before they dispense it to the patients. They are inspected, etc. And so, it’s really hard under the regulatory framework that we have for compounding to get away with very much for very long. And so, we don’t see pharmacies doing that. We see pharmacies that are acting with integrity and trying to serve these patients at this extraordinary time when the drug supply chain has broken down, and we’ve got this, this life changing drug and compounding is really right now the only way to get access to it.