The voice for pharmacy compounding │ 7 July 2023

This issue sponsored by Medisca

Hurry! CCH Early Bird registration ends tonight!

From APC's CEO

Two to do

Couple of things deserve your attention this week:


1) Send a message. To your U.S. senator. Now. Asking them to add their name to the Baldwin/Marshall letter expressing concern about the NASEM report and urging FDA to consider stakeholder input and base any action on compounded hormones on good science. It’s a rare thing to have such a strong Senate letter, and it will be made stronger the more senators who sign on. They won’t know about it if you don’t tell them. We’ve made it easy to send that message. Takes two minutes HERE.

2) Get the scoop. About what, you ask? About PBS airing our six-minute cBHT video nationwide this month. About the launch of our credit card processing GPO. About our new 15-hour compounding curriculum. And about how you can help push back against FDA inferences that compounded medications are unsafe. We’ll share info on those and more at our free July 19 “We Really Need to Talk” briefing. Registration link is below.


Read on for news.

– Scott


Scott Brunner, CAE, is APC’s chief executive officer. Email him at scott@a4pc.org.

Breaking news

New Novo lawsuit targets Tampa compounding pharmacy

Less than a month after Novo Nordisk announced legal action against several clinics and pharmacies over allegedly distributing unauthorized versions of the drug manufacturer’s Ozempic and Wegovy medications, there’s another semaglutide lawsuit on the docket. 


Bloomberg is reporting that last week, Novo filed in Florida’s federal court against Brooksville Rx in Tampa. The suit claims the pharmacy violated state consumer protection laws by selling drugs that weren’t approved by regulators.


We will be watching this one closely.

ICYMI

Catch up on these recent stories that you might've missed:

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This week

We really need to talk:

Join our July 19 issues briefing

There’s a lot going on, and you need to know about it. That’s why we’ve scheduled an APC member briefing for July 19. It’s a free teleconference aimed at sharing essential information, including the introduction of new programs that can save you money and help you minimize risks.


Topics covered include:

  • The upcoming nationwide broadcast of APC's cBHT story on PBS
  • A comprehensive 15-hour compounding curriculum designed for your new hires
  • The launch of our credit card processing GPO
  • FDA's recent statements concerning compounded medications


Attendance is free but registration is required.

FDA briefing on 503B guidance draft 

We reported last week that FDA had issued guidance on 503B wholesaling. Now, the agency has announced it will be presenting an overview of the guidance with an opportunity to ask questions on July 14, 2023, at 11:00am ET. You can tune into the live presentation via this Zoom link (no registration is required).


Please feel free to share this link with your colleagues.

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From Restore Health: discounted on-demand webinars for APC members 

Register now for on-demand webinars by Restore Health Consulting and enjoy 20-30% savings on eligible programs, including quality assurance, quality control, and regulatory compliance. 


To further sweeten the deal, Restore Health Consulting will donate 50 percent of proceeds towards APC's OneFund.


But don’t wait too long: The offer ends September 1, 2023.

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APC sends customized letters to encourage CCH registration

Do you live in a congressional district represented by a member of the House Energy & Commerce committee, or a state represented by a US senator who sits on the Senate Committee on Health, Education, Labor and Pensions Committee? If so, look for a letter from APC coming your way with a special request.


Those are committees that most often deal with issues related to pharmacy compounding, so cultivating relationships with these legislators is essential in order to make progress on our policy priorities. That’s the point we make in the letter, along with a request that you register for APC’s Compounders on Capitol Hill, set for September 19-20 in Washington, DC. 


“When you make the effort to fly to DC to meet with members of Congress on their turf, it makes a difference,” said APC’s Scott Brunner. “They see that you’re passionate about your compounding practice and they listen to your concerns. It’s how we create new compounding champions, and it depends largely on you.”

Short takes

O’Brien Pharmacy advocates for compounding. Recently, US Senator Roger Marshall’s staffer, Tami Bartunek, stopped by O’Brien Pharmacy in Mission, KS to learn more about compounding. She met with owner Lisa Everett Andersen and chief of pharmacy Tyler Chamberlain, pictured here, and also with Arden Andersen from Andersen Medical in Olathe.

Congressional visits like this one go a long way toward cultivating compounding champions in Congress. Kudos to Lisa and her team at O’Brien. If you’d like to invite your member of Congress to visit your pharmacy, APC can help. Contact savannah@a4pc.org.


APC comments on Delaware delivery proposal. This week, APC sent a letter to the Delaware Board of Pharmacy regarding a proposed rule that would make the delivery of compounded medications very difficult. The proposed rule would prohibit delivery of medications intended to be administered by a provider directly to a patient and would require written agreements with any healthcare office receiving deliveries for patient-specific medications.

Save these dates

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


Now until September 1: Discounted webinars via Restore Health. Available topics include quality control, quality assurance, and regulatory compliance. Bonus: APC's OneFund receives 50 percent of proceeds.


July 19: An APC webinar, Leveraging Technicians to Improve Pharmacy Operations, 2pm - 3pm ET


July 19: An APC issues briefing, We Really Need to Talk, free, but registration is required, 4pm ET


August 10: An APC webinar, Business Valuations - Myths, Methodologies, and Planning Ahead. More details coming soon.


August 17-18: Informa Connect's Compounding Pharmacy Compliance, The Westin Copley Place, Boston, MA


September 7: OutcomeMD Express Lunch & Learn for existing users. Free but registration is required.


September 11-13: FDA's Compounding Quality Center of Excellence Annual Conference (free, virtual)


September 14: An APC webinar, Best Practices in Safety & Quality for USP 797 – it’s not just SOPs. More details coming soon.


September 19-20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC


November 2: OutcomeMD Express Lunch & Learn for existing users. Free but registration is required.


2024

April 4-6: Owner Summit, La Jolla, CA

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

off  

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

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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.