The voice for pharmacy compounding │ 23 June 2023

From APC's Chairman

We really need to talk...

It is often hard to know if our written communications are getting the attention of APC members like you, even when what we want to tell you about could protect your compounding practice, save you money, or help streamline your operations. 


And it just so happens that we’re excited to tell you about a handful of new APC programs and projects, each of which will do at least one of those things.

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That’s why on July 19, we’ll host "We Really Need to Talk,” an hour-long issues briefing for pharmacy compounders where we will brief you on the following:


  • PBS’ upcoming nationwide airing of APC’s video about the threat to compounded hormones (and how you can amplify the story)
  • APC’s new 15-hour certificate program, The Ethical, Legal & Regulatory Foundations of Pharmacy Compounding (a new low-cost training tool for new hires)
  • Upcoming launch of our credit card processing group purchasing arrangement for PFMs (We think you’ll be pleased with the money we can save you)
  • FDA’s recent statements casting a shadow over compounded medications – and what we’re doing about it.


…and more.


It’s a free briefing, but you need to register. It’ll take about 30 seconds to do that:

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So yeah, we really need to talk. Join us on July 19. It will be well worth your time.


– Anthony


Anthony Grzib is VP of quality and compliance, state-regulated pharmacies at Wedgewood Pharmacy in Swedesboro, New Jersey. You can reach him at agrzib@wedgewoodpharmacy.com.

ICYMI

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

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This week

NEW: Ping your patients with TxtSquad

Introducing our newest benefit for APC Pharmacy/Facility members: TxtSquad, a text messaging platform that allows you to take control and streamline your patient communications with easy-to-use texting and data-driven automations. PFMs receive at least 20 percent off all TxtSquad plans.


Not a PFM yet? Click here to learn more or you can contact APC’s Jason Dunn at jason@a4pc.org or 918.770.6333.

25 members of Congress send hormone letter to FDA

Twenty-five members of Congress signed a joint letter that was sent this week to FDA urging that the agency protect compounded hormone therapy and emphasizing the importance of continued patient access to compounded medications. The letter was anchored by Representative Jennifer Wexton (VA) and Representative Michael Burgess (TX). 


Other signers on the letter include: Mark E. Amodei (NV), Brian Babin, D.D.S. (TX), Stephanie Bice (OK), Jerry L. Carl (AL), Earl L. “ Buddy” Carter (GA), Kathy Castor (FL), Henry Cuellar (TX), Diana DeGette (CO), Mario Diaz-Balart (FL), Neal P. Dunn, M.D. (FL), Brian Fitzpatrick (PA), Diana Harshbarger (TN), Clay Higgins (LA), Debbie Lesko (AZ), Marianne Miller-Meeks (IA), John R. Moolenaar (MI), Gregory F. Murphy, M.D. (NC), Gary J. Palmer (AL), Jimmy Panetta (CA), Mark Pocan (WI), C.A. Dutch Ruppersberger (MD), Austin Scott (GA), and Robert J. Wittman (VA)


Want to help save compounded hormone therapy? Invest here. Find marketing tools you can use here. And send your patients and prescribers to compounding.com to learn more and share testimonials.

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Nevada authorizes 503Bs to sell compounded drugs to 503As

Nevada SB 161 has been signed into law by the governor and contains provisions that affect 503B outsourcing facilities:

Any entity authorized to dispense controlled substances and dangerous drugs (including a pharmacy) may purchase controlled substances and dangerous drugs compounded or repackaged by a 503B outsourcing facility directly from the outsourcing facility without an order from a practitioner and dispense them to the same extent as any acquired through other authorized means.

This is a pivot by the state, says APC’s Scott Brunner. "Nevada previously was one of the only states to explicitly prohibit in law a 503B outsourcing facility wholesaling compounded medications to 503A pharmacies. Now the state has explicitly authorized it. This syncs well with the model that FDA implemented via guidance document related to ibuprofen suspension in February 2023, and it may be a sign of things to come with continued adoption of this standard going forward. If so, it’s a positive step in strengthening the 503B model.”

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APC advises BOPs on USP <797> restrictions

This week, APC sent an advisory memo to state boards of pharmacy raising concerns about adopting without careful consideration the new USP Chapter <797> restrictions on beyond-use dates and batch sizes.


“We think it’s important that state boards have context and perspective as they contemplate implementation of this new USP chapter ahead of the upcoming enforcement date of November 1, 2023,” said APC’s Savannah Cunningham.


From the memo:

“While the CEC can demonstrate that many of the changes instituted under the new chapters will enhance compounding quality and patient safety, that is not true for all of the changes – most notably a couple of restrictions for which the CEC has not enunciated the scientific basis for the restriction or how those restrictions keep patients safer. That not only represents a striking departure from the norm for an independent organization like USP, whose credibility is rooted in its laser-like focus on hard data to document the standards it issues. It also will almost certainly create impediments to patient access to certain compounded sterile preparations.”

Weigh in on drug shortages via RFI

House Energy & Commerce Committee Chair Cathy McMorris Rodgers (WA) and Senate Finance Committee Chair Mike Crapo (ID) have issued a joint request for information, asking stakeholders to weigh in on the country’s ongoing drug shortage issue. 


APC plans to submit comments about the role pharmacy compounders can play in alleviating drug shortages, and we encourage members to submit input as well. Please send your comments to drugshortages@mail.house.gov by July 7.

Short takes

Excelsior! Congratulations to APC Pharmacy/Facility Member Acton Pharmacy in Acton, Massachusetts on being named “Business of the Year” by the Middlesex West Chamber of Commerce.


Bring back manners, too, please. APC member David Kazarian, a retired Infuserve pharmacist, was recently interviewed for an article that called for airlines to move towards a firmer, dressier dress code for its passengers. We couldn’t agree more, David.

Meet April Xie. Please join us in welcoming April Xie (at right), a rising P4 School of Pharmacy student at Virginia Commonwealth University. She will be at APC for the next few weeks for a pharmacy association management rotation. APC’s director of public policy Savannah Cunningham is her preceptor. 

Credit card fees weigh heavier for small biz owners. The Institute for Local Self-Reliance has released a fact sheet on the damage that credit card fees have on small businesses, calling it essentially a monopoly tax. Now Congress has introduced the bipartisan Credit Card Competition Act of 2023, which aims to reduce excessive credit card swipe fees. APC supports the bill.


No heartache with T-therapy? Results of a recent study showed that male patients receiving testosterone therapy didn’t experience an increased risk of heart attacks or other cardiac events over the placebo cohort, but they also didn't receive any additional cardiovascular protection from the treatment.

Save these dates

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


June 27: An ARL live webinar, Rapid Sterility Testing: An Alternative Microbiological Method, 12pm CST, free


June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know


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


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


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


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

Prohibition on peptide compounding

La Vita Case amicus filing

Insanitary Conditions amicus filing


EduCon 2023


Owner Summit 2023


Prescriber Briefing Resources

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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  

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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.