This edition sponsored by Medisca

From our Board Chair

Let’s say you’re APC. You get a call from a producer at a major news network saying that their celebrity medical doctor is doing a story on GLP-1 drugs and wants to include compounded GLP-1s in the piece. You spend over an hour on the phone briefing her, and you can tell she’s impressed with what she’s learning about compounding. She says the celebrity doc likes compounding, that it will be sympathetic coverage, not a hit job.

Then she asks what you knew all along she was going to ask: Can you recommend a pharmacy that compounds GLP-1s that would let us bring a camera crew to film that process, maybe interview the pharmacist? 

What do you do? Well, if you’re our APC staff you pause, because you know a few things.

You know that this could be a great opportunity to showcase compounding, to get sympathetic coverage that millions will see. 

And yet you know that sterile compounding pharmacy owners aren’t likely to want cameras in their compounding labs – FDA could be watching, right?

You also know those owners prefer to keep their heads down, not to draw the attention of drugmakers that would come with a nationally televised news story – and not just attention but a possible lawsuit – even though the pharmacy is 100 percent compliant with law and reg.

And yeah, you know that not just any sterile compounding pharmacy will do. Pharmacies with a recent FDA 483 or warning letter won’t do. Neither will a pharmacy that persists in advertising peptides that don’t meet the criteria for compounding. Because those things would certainly come out in the news story and would not be helpful.

But … You also know that if you don’t recommend the right compounding pharmacy, that producer will likely go out and find one on her own … and it may just be one of those pharmacies with FDA citations or reputations for skirting the rules.

So with all of that in mind, you pick up the phone, and you begin to beg and plead and cajole, only to be told no again and again and again.

I’d love to tell you this is all hypothetical, but it’s an accurate depiction of events of the past three weeks or so for our staff team.

And for me it’s the reminder that as a profession, we’re damned if we do, damned if we don’t. Damned with a lawsuit if we tell our story, damned with inaccurate reporting or the airing of dirty laundry if we don’t. The risks are high either way, of course, but we all tend to lean toward “don’t.”

Speaking just for myself, I’m beginning to rethink whether that’s the better answer. Maybe you, too. If so, let me hear from you. Because the media is still calling. And we need to seize opportunities when they present themselves.

– 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

• We’ve updated our shortage-drug/GLP-1 compounding statement
• Federal appeals court accepts our amicus brief
• OMB concludes review of FDA ‘demonstrably difficult’ proposed rule

This week's news

Long-time APC supporter Wedgewood Pharmacy, a compounder focused exclusively on animal health, is our newest 2024 Silver-level Corporate Patron — a $25,000 commitment.

“I’m grateful to Wedgewood CEO Marcy Bliss and her team for this vote of confidence in APC,” said APC’s Scott Brunner. “It’s just the latest in the multitude of ways Wedgewood has supported our work over many years.”

It’s been breathlessly anticipated for months, and this week it finally published: an FDA proposed rule regarding the Demonstrably Difficult to Compound list.  

First: It does not restrict compounded hormone therapy, as some feared it might. FDA CDER OCQC Director Gail Bormel had hinted in comments at last years’ Compounders on Capitol Hill event that the rule would not affect compounded hormones. (But that sure doesn’t mean the threat to restrict compounded hormone therapy has gone away.)

So: The proposed rule would classify as "demonstrably difficult to compound" three particular types of compounding: oral solid modified-release drug products that employ coated systems; liposome drug products; and drug products produced using hot melt extrusion. 

APC is still evaluating the proposed rule, in particular the six criteria the FDA indicates it will use to evaluate inclusion of additional substances on the Demonstrably Difficult to Compound List. Stay tuned.

Short takes

Korbutov joins ASKP3’s Expert Faculty. Jack Korbutov, president of APC PFM member The Art of Medicine in Philadelphia, has become the only pharmacist serving as Expert Faculty for the American Society of Ketamine Physicians, Psychotherapists, and Practitioners. Congrats, Jack. (He’s also on a panel at Owner Summit discussing our soon-to-be-released document on best practices for ketamine compounding.)  

FDA launches a new portal for reporting potential drug shortages. The portal expands access to CDER’s NextGen system and allows patients, providers, and professional organizations to report directly into the NextGen system without needing a NextGen account.

Tenille visits Wells. APC’s Tenille Davis visited APC PFM member Wells Pharmacy Network, in Ocala, Fla., this week for a tour. Thanks to the Wells team for hosting her.

Attending the APhA Convention this weekend? Drop by our booth (837) in the exhibit hall. And tell any students to drop by, too — we have a deal just for them on our 15-hour compounding course. 

Planning to attend AMMG in Miami? As an APC member, you can get 20% off the 3-day conference price with code ACR. We’ll be exhibiting there, too, so look for us.

Save these dates

This month

• March 31: APC Fellows Program applications due

This year

• April 4-6: APC Compounding Pharmacy Owner Summit, La Jolla, CA
• April 11: APC webinar: Vet GFI 256 One Year Later – Where Are We? 
• 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)
• May 14-15: PCCA ACT Legislative Conference, Washington, DC
• 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.