The voice for pharmacy compounding │ 5 January 2024             

This edition sponsored by Empower Pharma

Empower Pharma is an FDA-registered 503B outsourcing facility serving thousands of clients across the United States. We manufacture sterile and non-sterile medications that are not available through commercial manufacturers or may require customization by a prescriber. Our ability to accommodate any dosage form allows us to meet our clients’ custom pharmaceutical needs.

From our Board Chair

We've got a story to tell

Happy new year! As incoming APC Board Chair, I want to thank outgoing Chair Anthony Grzib. Thanks to his leadership and that of our Board of Directors, committees, and staff, 2023 was a great chapter for our profession. Just look at these accomplishments:


Thanks to what we achieved in 2023 — especially our membership revenue growth — we’re well positioned to do even more in 2024. 


One focus in this new year will be to tell the real story of pharmacy compounding, the story that often goes untold in news reports and FDA statements. 


It’s a story of a profession that serves millions of patients and helps them live more normal lives. 


It’s a story of folks like you who create customized medications that meet patient needs — in the judgment of a prescriber — when a commercially available drug just isn’t suited.


It’s a story of vibrant small businesses that employ local folks, pay taxes, and support the local economy.


It’s a story of professionals who operate in a rigorous compliance framework designed to assure the medications they prepare are safe and efficacious for patients.


It’s a story of healthcare professionals filling the breech — assuring patients get their meds — during drug shortages.


Unfortunately, that’s not the story we often see in reporting about compounding. In the year ahead, our Board of Directors has allocated funding to help us tell our story — to educate reporters and others about the real work you do, the real benefit you provide in the American healthcare system. 


So keep reading — because 2024 is gonna be a real page-turner!


– Tenille


Tenille Davis, PharmD, RPh, FAPC, is pharmacist-in-charge at Civic Center Pharmacy in Scottsdale, Arizona. You can reach her at tenille@civiccenterpharmacy.com.

ICYMI



This week's news

Tell us what didn't work for you

APC’s fourth annual Owner Summit April 4-6 in LaJolla, Calif., will include a session called “Don’t Bother: Things Not to Try.”  Facilitated by APC’s Savannah Cunningham, the session will be a fast-paced look at ideas, projects, products, and techniques compounding pharmacy owners and teams have tried that … well, they just didn’t work. You don’t have to be present to share a failure with us. Just shoot your “tried and untrue” idea to Savannah@a4pc.org as soon as possible. And sure, we’ll keep your identity anonymous if you like.

By the way: Owner Summit early-bird registration opens Tuesday, January 16!

PCF awards 8 compounding education grants to state associations

The Pharmacy Compounding Foundation has awarded $1,500 compounding education grants to eight state pharmacy associations for 2024. The grant program, now in its second year, was created to spur state associations to include live continuing education on pharmacy compounding topics at their state conventions.


State associations receiving grants for 2024 are:

  • Alabama Pharmacy Association
  • Arizona Pharmacy Association
  • Indiana Pharmacy Association
  • Kentucky Pharmacists Association
  • Maryland Pharmacists Association
  • New Jersey Pharmacists Association
  • Tennessee Pharmacists Association
  • Wyoming Pharmacy Association

PCF’s mission is to elevate the practice of pharmacy compounding. It is funded by contributions from pharmacy compounders like you.

APC submits comments for Senate hearing on drug shortages


On December 5, APC submitted comments to the Senate Finance Committee for a hearing titled “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective.” Our letter included four asks that would expand compounding pharmacies’ ability to alleviate drug shortages:


  1. Update the statutory definition of drug shortages to include regional shortages and input from hospitals and other health care practitioners.
  2. Codify FDA’s current guidance that states 503A pharmacies can compound drugs on FDA’s shortage list without violating rules against copying FDA approved drugs.
  3. Establish a narrow pathway, through law or policy guidance, allowing 503As to compound shortage and other drugs urgently needed for treatment of patients by practitioners when unavailable from 503B outsourcing facilities. 
  4. Provide flexibility in the manufacturing standards that apply to 503B outsourcing facilities for drugs on the FDA shortage list so they can react more quickly when shortages occur.

Short takes

Congresswoman visits Belmar. Belmar Pharmacy hosted House Energy & Commerce Committee member — and compounding champion — Diana DeGette for a fundraiser and tour of the Golden, Colorado-based pharmacy on December 19. We’re grateful to Belmar’s Dave Hill and his team for their leadership — and we thank Congresswoman DeGette for her support.

FDA warns about counterfeit Ozempic. On December 21, FDA issued a warning about counterfeit Ozempic found in the U.S. drug supply chain. Make sure to check any product you receive and do not distribute, use, or sell those labeled with lot number NAR0074 and serial number 430834149057. 


Want to help your staff implement the revised USP 795 chapter? Revelation Pharma’s Emily Durham provides some excellent practice pearls in the latest edition of RxInsider.  


Listen to this: Brigham Buhler, cofounder Revive RX (an APC PFM), was a guest on The Joe Rogan Experience podcast last month, and yes, he talked compounding.


Cuteness: APC’s Board Vice President Michelle Moser is on safari in South Africa and sent us the pics below. If her aim was to make us jealous, she succeeded.

Scam Alert: Beware (and be aware).

Pharmacies across the country have been flooded with the fax pictured to the left. Thing is, it’s a scam.


Some red flags: No physical address. No direct dial number. Fax numbers for multiple countries on the website. And despite APC’s logo, they’re not remotely affiliated with us (and we question their PCAB accreditation claim, too).


Scams like this give legitimate compounders like y’all a bad name. If you come across any similarly questionable ads for compounding services, send them our way so we can warn others. Email us at info@a4pc.org.

Save these dates

January 18: APC webinar: Survey of State Compounding Law Changes 2023 and Proposed 2024

April 4–6: Owner Summit, La Jolla, CA [Early-bird registration opens January 16]

June 20–21: EduCon Virtual: The Ethical Compounding Conference

September 17–18: Compounders on Capitol Hill (CCH) in Washington, DC


On demand

Now available: The FDA Compounding Quality Center of Excellence is announcing the availability of these self-guided, online courses:

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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