The voice for pharmacy compounding │ 8 March 2024             

This edition sponsored by Empower Pharma

Learn how Empower Pharma utilizes cutting-edge processes and technologies to serve pharmacies, healthcare facilities and specialty clinics. Contact us to find out how our personalized medications and tailored pharmaceutical medicines can help you today.

From our CEO

Lilly gets cute, we respond

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.

Two Congressmen will attend Owner Summit

Two members of Congress will attend our CompPAC Fundraising Reception at APC's upcoming Owner Summit — Rep. Buddy Carter (GA) and Rep. Jay Obernolte (CA). Both Rep. Carter and Rep. Obernolte are members of the House Committee on Energy & Commerce – the influential committee with oversight of FDA and pharmacy compounding. 

The reception is on Friday, April 5 from 5:15–6:15pm PST at the Hilton La Jolla Torrey Pines. 



  • Admission requires a CompPAC investment of at least $1,000 for pharmacists/owners or $250 for technicians.
  • An additional $1,000 contribution to Rep. Carter's campaign and $500 contribution to Rep. Obernolte's campaign is suggested. 
  • Admission is free for APC members who have already invested $5,000 in CompPAC for 2024.
  • You don’t have to attend to support CompPAC. Make your 2024 investment here.
  • Under federal law, CompPAC may accept personal checks or credit cards only. 

ICYMI


This week's news

Only 25 spots left for Owner Summit - register now!

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)
  • Question Time with Tara Thompson
  • Briefing: 2023 Snapshot of Pharmacy Compounding
Register Here

Golfers: We have 4 spots left



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.

Kalchem rises, Hanszen Laporte comes in

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.

Pharmacists and Technicians: Apply now for APC Fellowship


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. 

A flurry of state activity


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.


Short takes

U.S. Senator visits O’Brien Pharmacy. O’Brien Pharmacy hosted Senate HELP Committee member and physician Roger Marshall for a tour of the Mission, Kansas-based pharmacy in late February. We’re grateful to O’Brien’s Lisa Everett Andersen and Tyler Chamberlain for their leadership and advocacy for the compounding profession.


FDA Law Blog: Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing


Love notes to FDA. APC was successful in securing to the House’s FY24 FDA appropriation legislation a number of notes and directives for FDA related to compounding. Though the notes don't carry the weight of law, they do indicate to FDA the thinking and preferences of Congress. Thanks to APC's governmental affairs counsel David Pore and PCCA's Amy Shank for their work in bringing this about.

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Quick links

APC Career Center

• Job seekers

• Employers


APC's Code of Ethics


Compounding Connections archive


Compounders on Capitol Hill


Continuing education

• Live webinars

• On-demand webinars


Current issues:

GFI #256 on animal compounding

Urgent-use compounding (HR 167)

Adverse events reporting framework 

Saving compounded hormones


EduCon


Owner Summit


Prescriber Briefing Resources


Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund


Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members


Affinity service providers

Accounting & Tax Services: Rx Advisors

Audible Sunshine

Office Equipment: TUI Solutions

Online Payments Platform: HealNow

Patient-Reported Outcomes: OutcomeMD

Pharmacy Technician Certification Board

• Shipment Trackers, a shipping costs auditor 

• TUI Total Solutions

• TxtSquad


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.

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