The Lots of News and State Taxes, Too Edition | Essential: The Pharmacy Compounding Podcast

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Andrew Kanter (0:26)

Welcome to Essential, Pharmacy Compounding News and Analysis from the Alliance for Pharmacy Compounding. I'm Andrew Kanter. As usual, we'll give you a bit of compounding news before we get to the main event. That's where we'll talk to CPA Scott Sykes about compounding pharmacy taxes, which are more interesting and probably more important than you might realize. But first, the news.

Peptides are big news and they're also, you know, big business. Thing is, many of the peptides in question are not approved for patients, and they certainly can't legally be compounded. But demand is there, and thanks in large part to peptides being pushed by, let's say, questionable parties. Looking at you, Tik Tok. The point is, the only way consumers are getting these peptides is outside the health care system, the regulated health care system. So at best, they're getting research-only-grade active ingredients, and at worst, they're getting, I mean, could be anything. Baking soda? Grandpa's ashes? This is not a healthy system. What we need is what we've talked about before. Careful, well-thought-out path to compounding within reasonable patient safety guardrails. Patients should be able to get appropriate peptides via legitimate, licensed compounding pharmacies rather than someone with a PO box for an address. I'm just giving you a really high-level overview of what APC believes is a smart solution to the peptides gray market. Something that protects patients and, you know, acknowledges the current state of the marketplace, which ain't great.

So APC has done a couple of things. We've created a new web page that outlines the whole situation and our recommendations. And that is at a4pc.org/peptides.

We've also released a much more detailed issue brief. It outlines exactly what we think is the right way to regulate what's now essentially an unregulated market. And that's on that same peptides page, a4pc.org/peptides.

Because we really need an alternative to the wild west we're in right now. And there are plenty of people, legislators, the media, for starters. People who ought to know there's a middle ground between what we've got now and, you know, opening the peptide spigots completely. So share that news.

We've talked about animal-derived thyroid products, ADT, and how the FDA reclassified them as biologics, meaning they would be off limits for compounding. There's some questionable science and logic behind the decision, and APC pushed back in January with a citizen petition to the agency. Well, now there's another citizen petition filed with the FDA that, like ours, asks it to reverse its decision on ADT.

What this filing does is amp up the science behind the request. It gets deep into the amino acid weeds to argue, well, to explain how the active ingredients in ADT are not biologic, at least by the legal definition, and why that means the FDA's decision doesn't make any sense. Not to mention that the agency doesn't seem to have followed its own procedures, but that's a whole other argument. This newer petition is actually a pretty nice complement to APC's. We focused on the effect on patients that a ban on ADT compounding will have, and it's good to see there's broad pushback against FDA's policy.

So, what will happen next? These days, it's anyone's guess, and there's no timetable.

So a quick note about documentation and judgment and crossing your T's and dotting your I's. The FDA recently took some enforcement action against a compounding pharmacy. It was a 503A pharmacy that was dispensing compounded GLP-1 drugs. If you read the complaint quickly, you might make the mistake of thinking that the FDA had a problem with the volume of GLP-1 dispensing that the pharmacy was doing. But that's actually not the case. First of all, there's no real limit on how much a 503A pharmacy can compound, as long as every prescription is valid. Now what happened here is that the FDA believed the pharmacy didn't have enough documentation. Specifically, it was looking for the paperwork that showed how prescribers determined that a compounded GLP-1 had a significant difference for each patient. Without that documentation, the FDA said, the medications the pharmacy was dispensing were essentially copies of the commercial products. And that's what the issue was. Not volume, just insufficient documentation. And there's a lesson here. Prescriber judgment, it's important. But so is taking the time to document that judgment. The FDA, it's watching.

One of the benefits for pharmacies and facilities that are APC members is getting great deals on credit card processing. Like possibly the best rates in the industry. How do we save your money? It's easy to find out. Grab a recent credit card processing statement and you'll need about 60 seconds. Head over to apcpayments.com.