A cardiologist tells the truth

If you haven’t read it yet, an excellent commentary was published in Medscape this week by a cardiologist and obesity specialist. He pushes back against rampant misinformation around compounded GLP-1s. Dr. Eldav Einav distinguishes between counterfeit and compounded products, and he makes a great point — by completely dismissing compounded medications, prescribers and others may be unintentionally bolstering the black market. How? Patients may feel their only option to access these medications is going outside of the legitimate health care system. APC worked with Dr. Einav to prepare the piece. Please share it with prescribers in your area.

Yes, we’re reviewing that ‘demonstrably difficult’ proposed rule

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.

10 days left to apply for APC Fellowship

Since the program’s inception in 1997, 162 professionals have been honored as APC Fellows. Tara Thompson, vice president of clinical and marketing at Revelation Pharma, is one of those professionals: 

“Becoming an APC Fellow has been a transformative experience. It’s more than just an opportunity; it’s a privilege to be part of a distinguished community dedicated to advancing the field of compounding pharmacy. This program has provided me with unparalleled mentorship, resources, and networking opportunities, empowering me to deepen my understanding and expertise in this specialized area of pharmacy practice.”

The deadline to apply for 2024 induction is March 31, so review the information on the APC Fellows webpage and start your application now. The induction will take place at APC’s Compounders on Capitol Hill event in September.

Wedgewood is APC’s newest Silver-level supporter

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.”

FDA wants to issue guidance docs without public comment

In a draft report and plan for guidance documents released by FDA earlier this year, the agency indicated that it intends to issue guidance documents without a public notice and comment period. The draft report is in response to a 2023 federal spending law that requires FDA to identify best practices for prioritization, development, issuance, and use of guidance documents.

“This is one of the more worrisome proposals we’ve seen from FDA,” said APC’s Tenille Davis. “The FDA staff is not all-knowing, and short of a national emergency, FDA needs to hear from stakeholders. That input can only serve to improve FDA guidance documents.”

According to FDA’s draft plan, the agency is considering issuing more Level 1 guidance documents for immediate implementation and categorizing more guidance documents as Level 2 — meaning more guidance documents would be implemented without a prior public comment period. 

The draft report received significant industry pushback, however — with some commenters indicating that this would open FDA up to legal challenges for failing to follow guidance regulation — so we’ll see if the agency moves forward with their plan. 

APC plans to raise the issue in its next listening session with the agency, set for May.

Damned if we do, damned if we don’t

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.

APC Fellowship deadline is March 31

The APC Fellows Program recognizes distinguished contributions APC member compounding pharmacists and technicians have made to the profession and to their respective communities. Since the program’s inception in 1997, 162 professionals have been honored as members of this elite group. This could be your year to join them. 

The deadline to apply for 2024 induction is March 31, so review the information on the APC Fellows webpage and start your application now. The induction will take place at APC’s Compounders on Capitol Hill event in September.

Big deal? Absolutely!

Below, you can read about the amicus brief — also known as a “friend of the court” brief —APC submitted last week in a compounding-related case pending in the U.S. Fifth Circuit Court of Appeals. It’s a big deal, so please pay attention to it.

That filing is the first of a half-dozen “big deals” that APC will announce in the next three weeks, every one of them focused one way or another on assuring your patients can continue to access compounded drugs, assuring your pharmacy or facility stays scrupulously compliant, and assuring your practice can operate at maximum efficiency.

The other five “big deals” will be rolled out at APC’s Owner Summit in La Jolla, California on April 5. 

BY THE WAY: This is shaping up to be our biggest Owner Summit ever, with more than 200 attendees already signed up. If you’re not one of those, there’s still time to register — but hurry: As you’ll read below, the preferred hotel rate ends tonight.

Those include announcement (and discussion!) of the following:

• Best Practices for Ketamine Compounding, a document developed by APC’s Best Practices Work Group.
• Best Practices for Clinic Direct Billing, another document developed by that Best Practices Work Group.
• APC’s 2023-24 Snapshot of Pharmacy Compounding, a demographic profile of your profession that we’ll use to educate policymakers.
• A step forward in collecting patient-reported outcomes, featuring the first full integration of a compounding software with the OutcomeMD platform (and what may be a work-around solution for those of you using other software).
• A new, simpler way to support APC — and stop all those fundraising emails we keep sending you. 

Hopefully, your curiosity is piqued. If you want to know more, get registered for Owner Summit. Because these are big deals, and you’re gonna want to know about them.

Stay tuned and stay informed!

— 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.

OMB concludes review of FDA ‘demonstrably difficult’ proposed rule

On Monday, OMB announced they concluded their review of FDA’s proposed rule on Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act and returned the proposed rule to FDA with changes. 

APC and others have raised procedural concerns with FDA proposing categories of drugs for the list prior to the criteria for evaluation being finalized. We’re watching closely for OMB’s changes to be posted in the Federal Register and will update you once we know more. Stay tuned.

Federal appeals court accepts our amicus brief

Outcome in the Zyla case has major implications for compounding

The U.S. Court of Appeals for the Fifth Circuit has accepted an amicus brief filed by APC in the case Zyla Life Sciences v. Wells Pharma.

In that case, the Southern District of Texas, relying on Ninth Circuit precedent and case law, found that state-law unfair competition claims by a drug manufacturer against a compounding pharmacy are preempted by “the FDA’s sole authority over enforcement of the FDCA’s drug approval requirements.” Zyla appealed that ruling to the Fifth Circuit.

The outcome of that appeal could impact the practice of pharmacy compounding in a couple of significant ways. APC’s Scott Brunner said that’s why APC’s Executive Committee allocated funding from the alliance’s Legal Action Fund for the amicus.

“The principle at stake here is who has oversight over the substances used in pharmacy compounding and the products produced: Is it the federal government and FDA, or is it each of the states?” said Brunner. “Both Novo Nordisk and Eli Lilly have filed lawsuits against pharmacies that compound GLP-1s within FDA’s ‘essentially a copy’ guidance. Those suits rely on state law – not the federal Food, Drug & Cosmetic Act – to assert that compounding is ‘unauthorized drug manufacturing’ and a violation of state deceptive practices laws. The Ninth Circuit has already ruled that federal law preempts state law in this regard. If the Fifth Circuit rules likewise in Zyla – and we believe it will – there’ll be firm precedent that states may regulate pharmacy practice, but only federal law and FDA regulate pharmaceutical substances and products.”

Not only will that provide lower courts direction in the Novo and Lilly lawsuits against compounders, Brunner said, but it will also be a shot across the bow for state pharmacy boards that are attempting to impose restrictions on the use of certain APIs in compounding.

The amicus brief filed by APC in Zyla does not take sides in the dispute. Instead, it enunciates for the court what law and policy say about pharmacy compounding, so that the court has clear understanding, and plaintiff’s lawyers will be less successful in muddying the issue for the court.

APC is represented in this matter by Boesen & Snow. APC’s Legal Action Fund is funded by gifts from pharmacy compounders and service providers like you. Make contributions to the fund here.