This week, APC submitted a comment letter to the Massachusetts Board of Pharmacy about two issues on which the Board recently expressed concern. read more →
This week, APC wrote to state boards of pharmacy and FDA to make them aware of delays in completing stability studies as USP 797 is enforced across the country. read more →
You may know EduCon as APC’s “Ethical Compounding Conference” – a virtual event that delivers “best practices” training to compounding pharmacists and technicians. This year, it’s back with a new user-friendly format. read more →
With the passing of Dr. Loyd V. Allen, Jr., PhD, this week, our profession lost a giant. No hyperbole here: His passion for and influence over the ethical practice of pharmacy compounding is simply unequalled. read more →
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1099 was intended to allow veterinarians and veterinary technicians to compound medications, but the bill has now been withdrawn.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.”
A new NCPA survey reveals local pharmacies are struggling to stay afloat after the January 1 implementation of the CMS DIR rule, requiring all pharmacy price concessions (i.e., DIR fees) to be assessed at the point of sale.
Almost one-third of respondents indicated they may close their doors this year because of the financial pressure.
The Massachusetts Board of Registration in Pharmacy held a hearing February 28 on proposed new fees for pharmacy licenses in the state. The proposal would establish non-resident pharmacy license fees and increase resident pharmacy license fees significantly—well beyond other states’ fees— particularly for non-sterile and sterile compounding. APC submitted a letter this week expressing concern and asking the board to clarify and provide justification for the proposed changes.
The Florida Board of Pharmacy Compounding Subcommittee met last week to discuss the state’s USP 797 inspection process. Though USP 797 is not enforceable until November 1, 2025, the board will begin inspecting immediately based on the new chapter and indicating “no” if the pharmacy is not in compliance on inspection reports. The board intends for the reports to be educational, not punitive, as pharmacies begin moving toward compliance.
Florida is one of a number of states following this approach. APC is preparing a state-by-state analysis of USP enforcement approaches that should be available in the next month. Stay tuned.
Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at 
