This edition sponsored by

APC's Campaign to Save Compounded Hormones

From our Board Chair

I’m learning that when you’re APC’s Board Chair, you get to participate in discussions and presentations that you otherwise might not even know were occurring, and yet those meetings point toward all kinds of good things for pharmacy compounding.

Progress is almost always incremental, of course. A single meeting is seldom a touchdown. But this past Monday I joined an APC work group in a presentation that definitely moved the ball down the field in terms of expanded patient access to compounded therapies.

For months now, APC has been seeking an opportunity to conduct a pilot project with a state Medicaid program. Thanks to an unexpected introduction, we’ve cultivated a relationship with a Medicaid Managed Care provider in the Southeastern Conference. That led to this week’s presentation by an APC working group quarterbacked by past Board Chair Shawn Hodges, supported by teammates Brian Harrison, Philip Smyth, Matt Martin, Joey Mattingly, as well as APC’s Savannah Cunningham and Tenille Davis.

Our pitch: That via a pilot program focused on compounded wound care therapies, we believe we can speed patient healing, reduce hospital stays, and—importantly—contain costs.

The good news is that the pharmacist and medical directors for that managed care company seemed genuinely interested in the idea – so much so that they not only requested additional info, including diagnosis codes for the conditions we’d treat via the pilot, but they would like to visit a compounding pharmacy that would be involved in the pilot program. Based on their review, we feel confident we’ll get a follow up meeting to discuss next steps. 

So no big scores this week, but we definitely moved the ball down the field. Let’s call it a first down.

And here’s the thing: We believe this project has legs. A score with one state Medicaid contractor can open doors in other states and for other therapies beyond wound care.

This is just one example of the kinds of projects APC is leading, all with an eye toward building your credibility and your compounding business. There are more meetings to come. I look forward to telling you about them.

Go team!

– Joe

Joseph P. Navarra, RPh, FACA, FAPC is the owner of Town Total Compounding Center in Woodbury, New York. You can reach him at joseph.navarra@towntotalcompound.com.

ICYMI

• Judge denies motion to dismiss in Novo Nordisk v. Brooksville
• Now accepting APC Fellow applications
• APC submits comments on Hawaii, Mississippi bills

This week's news

We’ve heard from a few APC members who received communication recently from an entity claiming to represent a 503B outsourcing facility marketing sterile products to 503A compounding pharmacies.

Last June, FDA published draft guidance on the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The draft guidance clarifies that state-licensed pharmacies may dispense drugs compounded and sourced from 503B outsourcing facilities and provides examples of activities prohibited and not prohibited. It gets complicated, to say the least. APC submitted comments to FDA in September generally supporting the draft guidance but seeking clarification on several points. 

But remember: That guidance is a draft and has not been finalized yet. Still, some states are already considering if and/or how to implement this language into their existing laws and rules. APC is working on a tool for PFMs that will outline where each state’s laws currently land on the issue, so keep watch for that.

In the meantime, you should check with a pharmacy attorney familiar with the laws and rules in your state before sourcing anything in your 503A pharmacy from a 503B outsourcing facility.

Last week, Novo Nordisk reached confidential settlements in its trademark infringement lawsuits with a med spa and a weight loss clinic in Florida. As part of the settlement, permanent injunction orders require the two companies to stop using Novo trademarks and to disclose for 12 months that compounded semaglutide has not gone through the safety and efficacy standards required by the FDA for approved drugs.

These settlements are important reminders of what you can and cannot say about compounded medications in your marketing. So important, in fact, that we have a session at Owner Summit dedicated to the do’s and (definitely) do-not’s of compounding marketing claims. Led by PCCA Director of Member Engagement Erin Michael, it’s a session you can’t afford to miss. Register for Owner Summit here.

Short takes

Meet your new APC Board Vice President, Gina Besteman! Gina, Director of Compounding and Dispensing at Women’s International Pharmacy in Madison, Wisc., was elected at yesterday’s APC board meeting to fill the vacant position. This puts her in line to be APC's board chair in 2026.

For decades, retired pharmacist Rich Hoffman has sought out and collected mortars and pestles. He’s now donating his collection of more than 100 sets to a medical museum in Ohio.

FDA issues warning letters to two online vendors selling unapproved and misbranded versions of semaglutide and tirzepatide. The agency says it found evidence the two vendors were selling research-grade versions of the two ingredients accompanied by claims of medical benefit.

Save these dates

This month

• February 22: APC webinar: Patient Communications - Are You HIPAA Compliant?

This year

• March 21: APC webinar: Demystifying the DSCSA for Compounders
• March 21: APhA Sterile Compounding Recertification Course
• March 31: APC Fellows Program applications due
• April 4-6: APC Compounding Pharmacy Owner Summit, La Jolla, CA
• April 11: APC webinar: Vet GFI 256 One Year Later – Where Are We? (registration link available soon)
• April 12-14: Personalized Medicine Certification Course 1: Endocrinology in Scottsdale, Ariz.
• May 9: APC webinar: Soft Skills for Hard Jobs (registration link available soon)
• September 17-18: Compounders on Capitol Hill (CCH) in Washington, DC
• November 15-17: Personalized Medicine Certification Course 1: Endocrinology in St. Pete Beach, Fla.

On demand

• The FDA Compounding Quality Center of Excellence provides these self-guided online courses:
• Aseptic Process Simulations (Media Fills)
• Regulatory Framework for Human Compounding
• Stability and Beyond-Use Dates

Quick links

Alliance for Pharmacy Compounding | A4PC.org

APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org.