Strengthening Regulatory Framework for Compounded Medications

Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss the challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide and other medications. It highlighted the role of compounding pharmacies in addressing these shortages and the importance of distinguishing legitimate compounding pharmacies from illicit actors. The conversation also emphasized the need for collaboration between pharmaceutical manufacturers, healthcare providers, and regulatory agencies to improve the drug supply chain and ensure patient access to essential medications.

How can the regulatory framework for compounded medications be further strengthened to ensure quality and safety while maintaining flexibility to address patient needs?

Tenille 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.

Scott 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,