The Peptide Possibilities Edition | Essential: The Pharmacy Compounding Podcast

SPEAKER_1 (0:05)

You are listening to the global network of podcasters dedicated to the pharmacy profession. Welcome to the Pharmacy Podcast Network.

Andrew Kanter (0:24)

Welcome to Essential, the pharmacy compounding news and analysis from the Alliance for Pharmacy Compounding. I'm Andrew Kanter. As usual, let's start with a bit of compounding news before we get to the main event. That's where we'll talk about peptides, specifically the guardrails that can make them available in a much safer and smarter way than the current wild west of plain brown wrappers and shady websites. But first, let's do some news.

Federal prosecutors charged two Indian nationals with conspiracy and smuggling for, allegedly, trying to bring into the country counterfeit ozempic they obtained from unauthorized Chinese sources. We're not talking just the drug, but packaging, inserts, labeling, needles, the whole shebang. And this, ladies and gents, is actual counterfeiting. It's clearly a very different animal than licensed pharmacy compounding, no matter how much drug makers try to muddy those waters. And it also makes pretty clear that regulators have, and use, their ability to fight counterfeiters. We are 100% behind that.

Some of the big issues in the compounding world that we've covered here are pretty complex.

And APC has just published a couple of pages on our website to help make sense out of them, and how we think regulators ought to handle them. The first is peptides. Yeah, that again. It's important. We'll talk in detail about peptide policy in a minute with our deep dive, but we have created a one-stop shop for all the background on the issue, along with our recommendations for how it should be handled, and how it can help keep patients safe, and away from these shady pop-up peptide shops. You'll find this at a4pc.org/peptides, and there's a link in the show notes. The other page we've launched covers animal-derived thyroid products, ADT or DTE for desiccated thyroid extract. The FDA says it's a biologic, and thus it's off-limits for compounding. But honestly, it's not. We've compiled a bunch of information on the subject, including what your patients can do to protect their access. Think that it is showing our work? You'll find it at a4pc.org/dte, and of course, there's a link in the show notes.

If you dispense compounded meds to California, but you don't live there, you might be aware that the State Board of Pharmacy is proposing raising the annual fees for out-of-state compounding pharmacies and outsourcing facilities. Pharmacies would see the fee jump a whopping 76% to $15,000 a year, while out-of-state outsourcing facilities would see an increase of 32% to $37,500 a year. And that is not chump change. It can be a real burden, especially for smaller operations. APC has submitted official comments to the California Board, and we point out that such big increases can make it harder for California patients to get the compounded medications they need. You can read that too with the link in the show notes.

And with that, it is time for our deep dive, peptides. Definitely a hot topic and one that's getting a lot of attention from the FDA, policymakers, and obviously patients. For a while, APC has been making the case that there's a middle ground, a sensible middle ground, between what's basically an unregulated gray market for peptides today and a blanket prohibition against pharmacies compounding the substances that prescribers and patients are interested in, very interested in. The middle ground. It's a framework of meaningful guardrails. We're talking safeguards for ingredient quality and patient safety, plus regulatory oversight that could allow certain peptides to be compounded responsibly by licensed pharmacies. And a critical part of that is making sure pharmacies can rely on the quality of the ingredients they're using, especially when those ingredients are going to be injected into patients.

So, here to talk about APC's proposed approach, and what it could mean if the FDA does decide to open a pathway for compounding peptides, we've got APC Board Chair Philip Smith and CEO Scott Bruner. Philip, Scott, welcome.

Scott Bruner (4:49)

Hey, Philip.

Philip Smith (4:50)

Sir.

Scott Bruner (4:51)

You want to buy a peptide?

Philip Smith (4:55)

If I had a nickel for every time.

Scott Bruner (4:58)

Really, for all those emails that are landing in your email box.

Philip Smith (5:01)

You know, you Google enough things, and this is what you get.

Scott Bruner (5:04)

Absolutely, yeah. For about three weeks now, we've been hearing that the FDA or the Trump administration is just about to announce something on peptides.

And depending on who you talk to, it's coming yesterday, it's coming tomorrow, it's coming next week, it was supposed to happen last Friday. Philip, I know you've been hearing some of the same things. What do you make of this?