The voice for pharmacy compounding │ 19 January 2024             

 
 

From our Board Chair

 

They don't know what they don't know

It was another week of interesting reporting on

GLP-1s—compounded, counterfeit, and commercially available. Even after referencing our extensive online statement on shortage drug compounding and semaglutide, one reporter managed to refer in her story to the API semaglutide as the “generic” for the commercially available products.


APC continues to field multiple media inquiries each week about the GLP-1 craze and compounding’s role when the manufactured drugs are listed as “currently in shortage” on the FDA Drug Shortage List. This week it was Salon and CNN.

On the one hand, it’s great that some major news organizations are recognizing APC as the voice for pharmacy compounding and seeking us out for facts and perspective. On the other hand, there continue to be plenty of stories published about compounded GLP-1s in which the reporter is oblivious to APC, and almost without exception those stories end up containing factual errors about compounding. (Here’s one, just to annoy you.) 


Reporters don’t know what they don’t know. And while for some that’s willful ignorance – they don’t stop to consider there may be another side to the story they’re getting from FDA and drug manufacturers—many are conscientious, looking to learn more, and want to get the story straight. We need to be on their radar.


Your APC Board of Directors has authorized a $50,000 expenditure for us to engage media relations counsel to help us cultivate relationships with national healthcare reporters. It includes exhibiting at the Associations of Healthcare Journalists conference in June, as well as a series of tours of compounding pharmacies by reporters. 


We know the true story of compounding. We want reporters to know it, too. 


We’ll keep you posted as we begin to execute our plan.


– Tenille


Tenille Davis, PharmD, RPh, FAPC, is pharmacist-in-charge at Civic Center Pharmacy in Scottsdale, Arizona (for now). You can reach her at tenille@civiccenterpharmacy.com until January 31. We'll let you know her new email address when she starts at APC in February.

ICYMI


 

This week's news

 

Forget worms—save $300 with early-bird Owner Summit registration

The professional development event of the year for compounding pharmacy and facility owners and managers is back, and it’s better than ever. 



Here’s what you need to know:

  • This year’s Owner Summit will feature more than 30 presenters in two dozen sessions focused on pharmacy care, pain points, and profitability. It’s all about doing business better.
  • You’ll learn from (and share with!) compounding leaders who are facing the same challenges you’re facing – and you’ll take home dozens of ideas to try out in your compounding practice.
  • It’s April 4-6 at the Hilton Torrey Pines in beautiful La Jolla, California – and yes, we’re hosting a fundraiser golf tournament on the world-famous Torrey Pines course.
  • Space is limited to the first 150 owners and managers who register, so don’t wait.
  • We’re offering a discounted early-bird registration. Register by February 15 to save $300!
  • You can find program and hotel details here.
 

Welcome (and welcome back) to our 2024 Corporate Patrons


APC’s Corporate Patron Program allows suppliers, service providers, and others with an interest in compounding pharmacy to increase and leverage their influence and to amplify our effectiveness as the voice for pharmacy compounding. They help us—and you—promote and protect the profession. 


This year, we have 36 Corporate Patrons signed on in support of APC, including 22 Tier Corporate Patrons. You can see a full list of Tier Patrons below, and you can learn a little more about all of them on our website.

2024 Basic-Level Corporate Patrons

  • Brown & Fortunato, P.C.
  • Compounder's International Analytical Labs
  • Elba Labs
  • Exakt Technologies 
  • Galenova
  • Pharmacists Mutual Insurance Company
  • Specialty Process Labs
  • Storey Marketing
  • Torpac
  • Uberlube
  • IJPC
  • A4M
  • LP3 Network 
  • RX Insider
 

Federal judge rules FDA can't publish unsupported concerns


In a significant ruling this week in SCA Pharmaceuticals LLC v. FDA et al, a U.S. district judge granted SCA’s request and issued a sealed temporary restraining order to block FDA from publishing unsupported concerns about the sterility of the 503B facility. 


A little bit of background: After a four-week long facility inspection in September and October last year, FDA requested that SCA "voluntarily" recall all unexpired products and "voluntarily" cease production at its Connecticut facility until FDA determined they were in compliance with what the agency considered to be their most serious observations. However, FDA didn’t specify the health hazard classification of the product they said was in violation, and SCA asserts that all of the issues flagged were technical—none of them related to concerns about product contamination or safety and efficacy. SCA issued a narrow voluntary recall out of an abundance of caution, but they also filed a legal complaint and a request for the temporary restraining order. 


This is certainly not the first time FDA has unfairly tried to wield their authority, strong-arming compounding pharmacies with subjective interpretations of “insanitary conditions” and without the benefit of due process or having to explain their rationale. In 2022, we filed an amicus brief in a very similar case involving another APC member pharmacy that called out the ambiguities in FDA's insanitary conditions guidance. The FDA can basically destroy a pharmacy’s reputation by issuing a press release that alleges insanitary conditions—and pharmacies know this, so they usually capitulate. But that’s not what happened this time, and compounders nationwide are the beneficiaries.


In mid-November, FDA agreed to refrain from publishing its concerns while the court reviewed the order, unless the agency identified a public health concern—and they haven’t identified anything yet. FDA tried to get around that in a recent effort to publish the information in its weekly enforcement report, prompting SCA to file a renewed request for a restraining order. The federal judge ruled in SCA’s favor, calling FDA’s health hazard evaluation “quite weak in terms of its finding regarding a risk to human health.” The case is now being referred to a magistrate judge with the goal of reaching a settlement.

 

Short takes

 

FDA finds no immediate link between weight-loss drugs and suicidal thoughts. They aren’t ruling out the risk yet, though—the next step is reviewing postmarketing data in the FDA Sentinel system.


In other weight-loss drug news: Novo Nordisk has resumed shipments of Wegovy 1.7 mg dose in the US.


Pharmacy techs: This PCCA podcast with Erin Michael and Katie Lewis is pretty great. Katie's career path as a technician is empowering, we'd say—and may be instructive for other technicians. Give a listen! 


Need hours for BCSCP recertification? APhA is doing a full day of live education—both in person and virtually—that will provide board certified sterile compounding pharmacists with 7 hours of recertification credit.  


Set in motion: APC’s motion to file an amicus brief in Novo Nordisk Inc. v. Live Well Drugstore, LLC was filed this week. We’re now waiting on (and hoping for) the court to grant the motion. We’ll keep you updated.

Save these dates

 

Next month


This year

  • March 21: APC webinar: Demystifying the DSCSA for Compounders
  • March 21: APhA Sterile Compounding Recertification Course
  • April 4-6: Owner Summit, La Jolla, CA
  • June 20-21: EduCon Virtual: The Ethical Compounding Conference
  • September 17-18: Compounders on Capitol Hill (CCH) in Washington, DC


On demand

 

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.

X  LinkedIn  Facebook  Instagram