This week, FDA announced that it does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, under specific conditions. read more →
APC’s Scott Brunner and Savannah Cunningham attended PCCA ACT Legislative Conference this week — as did APC Board Vice President Gina Besteman and many other APC members. read more →
Kudos to the Outsourcing Facilities Association for their work in shepherding through South Carolina HB 3592. Signed into law on Monday, it explicitly allows 503B sourcing. read more →
Our 15-hour virtual course is a thorough, convenient, and affordable resource for learning the ethical, legal, and regulatory framework in which compounding is done. read more →
We’ll be in the Tampa/St. Pete area on June 12 for our next CompoundED UpDATE — part of a series of regional meetings made possible by a grant from PCCA. We’ll also be in Boston on June 18 for a compounder get-together. read more →
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.
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.
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.
This week, we updated our statement on rules governing compounding, what FDA guidance says about permissibility of compounding “essentially a copy” of an FDA-approved drug – and what those have to do with GLP-1s.
The revised statement provides additional information on the difference between legitimate compounding and illegal online sales, context related to adverse events attributed to compounded GLP-1s, and further elaboration on lawsuits filed by drug manufacturers against compounding pharmacies.
We’ve been busy this week on the state regulatory front, submitting comments on bills in Illinois and Maryland and sending our new statement on peptide compounding to all state boards of pharmacy. Here’s the lowdown:
Illinois HB 5517 would require both 503A compounding pharmacies and 503B outsourcing facilities to register as a pharmaceutical marketing firm and provide a list of all employees who are sales representatives. Our comments assert that the bill is an invasion of privacy, imposes an unnecessary hardship to pharmacies and outsourcing facilities, and will not decrease the cost of medications dispensed by pharmacies or outsourcing facilities.
Maryland HB 1099 was intended to allow veterinarians and veterinary technicians to compound medications, but the bill has now been withdrawn. APC’s comments outline the numerous conflicts with compounding regulations and best practices that the bill language presented.
Are you a pharmacist or technician committed to patient care through quality pharmacy compounding and the highest ethical and professional standards? If so, you should apply to be an APC Fellow.
Erin Michael—pharmacy technician, APC board member, and director of member engagement for PCCA—had this to say about being an APC Fellow:
“I chose to acquire the APC fellowship because of its unparalleled reputation for fostering innovation and excellence in compounding pharmacy. The program offers a unique blend of mentorship, resources, and networking opportunities that have significantly enhanced my professional growth and opened doors to exciting collaborations. I highly recommend the APC fellowship to anyone who has a passion for advancing our profession and seeking to push the boundaries of their expertise to make meaningful contributions in the compounding pharmacy industry.”
The deadline to apply for 2024 induction is March 31, so review the available information and start your application now. The induction will take place at APC’s Compounders on Capitol Hill event in September. And by the way, we’ve updated the application, so if you started one last year and didn’t submit it, make sure you’re using the new form.
Long-time APC booster Kalchem International has increased its support for APC to become a $25,000 Silver level Corporate Patron for this year.
“We’re grateful to have Kalchem as one of our patrons, and it’s great to know they’re seeing so much value in APC that they’re increasing their level of support,” said APC’s Scott Brunner.
Hanszen Laporte law firm has also become a Bronze-level APC Corporate Patron this week. We’re grateful to have them on the team.
There are only 25 spots left for the professional development event of the year for compounding pharmacy and facility owners and managers.
With more than 30 presenters in two dozen sessions focused on pharmacy care, pain points, and profitability, you’re guaranteed to go home with dozens of ideas to try out in your compounding practice.
Pharmacy Care
Eliminating Barriers to Patient-Reported Outcomes
What to Expect When You’re Expecting … To Run a Stability Study
Why You Need a Patient Follow-Up Program
Pain Points
Billing for Compounded Meds: Best Practices
What Not to Say (or Show) about Compounded Medications: A Marketing Claims Primer
You Can’t Manage What You Don’t Measure
There Goes My Baby: Selling My Pharmacy and What I Learned
How FDA Thinks (sponsored by Hyman, Phelps & McNamara)
Profitability
There’s No Such Thing as a Marketing Rep: How Sales and Marketing are Two Different Things … and Why it Matters
Compounding and Clinical Trials: Opportunity, Red Tape, and Reality
503B Wholesaling Guidance: Trick or Treat?
Your True Cost of Compliance: Do You Know It?
The Economics of Quality
PLUS!
KEYNOTE: Unveiling Influence – Harnessing the Power of Your Story (sponsored by Revelation Pharma)
Best Practices for Ketamine Compounding
A Conversation with NABP’s Al Carter
Compounding Cases: A Survey of Legal Action By and Against Compounding Pharmacies (sponsored by Fagron)
Join us at 8 a.m. PST on Thursday, April 4 for the inaugural APC OneFund Golf Tournament Fundraiser and play where the pros play—on the world-renowned Torrey Pines golf course. You can register for the golf tournament while registering for Owner Summit. If you’re already registered and want to add golf, email info@a4pc.org and we’ll get you sorted out.
In an open letter released yesterday, drugmaker Eli Lilly had plenty to say about compounded GLP-1s, and – surprise! – not all of it accurate.
The good news is that our strategy to reach reporters and educate them is apparently working. Reuters immediately reached out to APC for comment for their reporting on Lilly’s letter. We’re seeing the same thing from other media outlets. In the past two weeks alone, we’ve briefed reporters from Bloomberg, Scripps, National Geographic, EverydayHealth and WebMD. Next week I’m recording a Wall Street Journal podcast on compounded GLP-1s.
It’s been a long time since compounding has had this kind of exposure. Our aim is to make sure reporters are accurate in what they write about pharmacy compounding and to position APC as a highly credible source of information about the industry. We can’t influence every story, but we’re providing perspective wherever we can. Your dues dollars allow us to do that.
About that Lilly letter: Here’s our complete statement to Reuters, a bit of which is excerpted below (but click and read the entire thing – especially the parts about Lilly’s effort to grab headlines).
In its letter, Lilly rather cleverly conflates legitimate compounded medications prepared by a compounding pharmacy with illicit counterfeit substances obtained without a prescription. Surely the drugmaker knows this is misleading.
Legitimate compounded drugs are prescribed by a physician for a specific patient when an FDA-approved drug is not appropriate for or available to that patient. They are prepared and dispensed by state-licensed compounding pharmacies using documented pure active pharmaceutical ingredients that come from FDA-registered facilities.
Lilly rightly notes that compounded drugs are not FDA-approved. But that fact does not mean compounded drugs are unsafe – any more than it means that FDA-approved drugs are always safe.
— Scott
Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at scott@a4pc.org.
The purpose of the statement is to educate pharmacy compounders and prescribers on federal law and FDA guidance on peptides, especially in light of FDA’s September 2023 addition of several peptides to Category 2 of its 503A Interim Bulks Guidance. The statement also describes the proper pathway for renominating substances for reconsideration by the agency.
Please review the statement carefully and share it with your colleagues and the prescribers you work with. An updated APC Prescriber Brief on compounding of peptide products will also be made available later this week and will be posted with APC’s other Prescriber Briefs.
“We don’t have to agree with FDA’s actions on peptides — and on plenty of other things as well,” said APC Board Chair Joseph P. Navarra, RPh, FACA, FAPC. “But we do have to adhere to laws and regulations. It’s a duty we owe our patients … and the credibility of our profession.”
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.
Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at 
