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Partnering Together to Help Those Who Help Others!
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It was a remarkable week for pharmacy compounding. Our influence was felt in Washington, DC, as we briefed more than 160 members of Congress and gained supporters for several of our legislative priorities.
You can read our CCH recap below, but I do want to thank those compounding professionals who invested time and money in coming to DC for those meetings. It has already made a difference, and we’ll see that investment bear even more fruit in the weeks ahead as our advocacy team follows up with the dozens of congressional offices that requested more info or agreed to support us.
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CCH isn’t the only good thing going right now.
1) APC will soon petition courts to file amicus briefs in the four lawsuits Novo Nordisk has filed against compounding pharmacies. Our intention is to inform the court about the proper and necessary role of pharmacy compounding in preparing copies of FDA-approved drugs when those drugs appear as “currently in shortage” on the FDA Drug Shortage List. We are reviewing similar lawsuits filed this week by Eli Lilly against compounding pharmacies, and will make a decision shortly about whether those suits merit amicus briefs from APC. (This legal work is funded by APC’s Legal Action Fund. Give here.)
2) APC’s Credit Card Processing GPO kicks off. This past week at CCH we announced our new credit card processing GPO for our PFM members. Plan to read more about it in next Week’s Compounding Connections, but for now, the big news is that the new program can cut credit card swipe fees in half or more for many pharmacies and facilities.
3) Compounder Profile Survey to launch. Coming soon in your email box will be a link to our 2023 survey of pharmacy compounders – a biennial effort by APC to create a demographic profile of 503A (including hospitals) and 503B compounding facilities in America. Please complete the 10-minute survey when it comes your way. It will aid APC advocacy efforts by providing a snapshot of the profession for members of Congress and other policymakers.
Like I said, lots of good things going. Read on for even more good news.
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– 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
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Compounders make 162 congressional visits, gain bill sponsors | |
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APC’s Compounders on Capitol Hill 2023 wrapped up Wednesday, having added a half dozen new sponsors to its drug shortage legislation in the House and cultivated serious interest in the bill language from a handful of Senate offices.
In addition to Hill visits, the event included conversations with FDA’s Office of Compounding Quality & Compliance Director Gail Bormel, and Angels for Change founder Laura Bray.
In an interview format presentation, APC’s Scott Brunner queried Bormel on a range of issues, including an FDA-proposed (but as yet not publicly released) rule awaiting review at OMB that would both create new criteria for inclusion on the “demonstrably difficult to compound” list and add certain items to that list.
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“Because of our interest in protecting compounded hormones, our antennae went up on this one,” Brunner told the OCQC director. Though she would not say exactly what is in the proposed rule, Bormel provided context for it by indicating that it represents the necessary rulemaking resulting from items that were recommended for inclusion on the list by the Pharmacy Compounding Advisory Committee over the past several years. She also reiterated that any action on compounded hormones would be via consideration and recommendation by PCAC.
Here’s CCH 2023 by the numbers (with comparison to 2022):
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| 2023 | 2022 | | Registered attendees: 115 | Registered attendee: 85 | | Total attendees, including exhibitors: 182 | Total attendees, including exhibitors: 145 | | Meetings with members of Congress: 162 | Meetings with members of Congress: 162 | | |
Longtime Iowa compounder receives Malmberg Award | |
Iowa pharmacist Sue Horton received APC’s George & Lucy Malmberg Advocacy Champion Award this week during Compounders on Capitol Hill. | | |
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Horton, owner of Central Iowa Pharmacy in Urbandale, was honored in particular for her work over the past year in cultivating a relationship with U.S. Senator Charles Grassley (pictured at left), including hosting him at her pharmacy for a two-hour briefing on pharmacy compounding challenges and a tour of her laboratory. | |
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“A state legislator once told Sue that she was everything an advocate should be: Passionate, persistent, and present,” said the award’s namesake, Lucy Malmberg, who presented the honor.
“We couldn’t agree more. She has been a consistent force in advocating clearly on behalf of our profession.”
The Malmberg award is presented annually to a pharmacy compounding professional who in the previous year has demonstrated "distinguished and extraordinary advocacy and political engagement in support of the pharmacy compounding profession."
Horton was unable to attend the presentation. Watch her pre-recorded acceptance speech here.
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Eight APC Fellows inducted | |
On Wednesday, APC inducted eight new members to its Fellows Program.
The APC Fellows Program was established in 1997 to distinguish those compounding professionals who are exemplary in their commitment and professionalism in the practice of pharmacy compounding.
Inducted were:
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Edward DeCaria, RPh, DeCaria Bros Inc, East Liverpool, OH
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Patricia Douglas, RPh, Wedgewood Pharmacy, Swedesboro, NJ
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Lisa Everett Andersen, RPh, O'Brien Pharmacy, Mission, KS
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Cheri Garvin, RPh, The Compounding Center, Leesburg, VA
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Shawn Hodges, PharmD, Revelation Pharma, Marietta, GA
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James Hrncir, RPh, Las Colinas Pharmacy, Irving, TX
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Masoud Rashidi, PharmD, Innovative Compounding Pharmacy, Folsom, CA
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Nicolas Ruiz, CPhT, Banner University Medical Center - Phoenix, Chandler, AZ
For those of you who may be interested in applying for the 2024 Class of APC Fellows, learn more here.
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Novo drama continues with inspection failure. According to recent news reports, a recent inspection of a Wegovy/Ozempic manufacturing facility in North Carolina earned Novo a 483 letter from FDA.
Now, Eli Lilly is coming for the compounders, too. The makers of the diabetes drug Mounjaro are taking legal action against compounders in several states for “providing drug products in violation of consumer protection laws.” Mounjaro is currently on the FDA’s Drug Shortage List.
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Thank you, Jason Wheeler (and PCCA)! APC owes a great big “thank you” to PCCA’s Jason Wheeler, who served as our AV guy and photographer for this year’s CCH. He did a superb job. Thanks, also, to PCCA for loaning him to us. | |
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Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of these self-guided, online courses:
September 28: An ARL Bio Pharma live webinar, Beyond The Survey: Top Findings and How to Implement Change in Your Pharmacy
October 5: An APC webinar, USP 797 Best Practices - It's Not Just SOPs (Part 2): From Packaging to Handling, Stability, Documentation, and QA/QC
October 24: An APC webinar, Internal Audit Processes – Facilitating Optimal Operations and Compliance of Your Compounding Pharmacy
October 26-28: PCCA’s International Seminar 2023 in Houston, TX
November 9: An APC webinar, Automation and USP 797 Don’t Mix. More details coming soon.
December 12: An APC webinar on quality assurance and medication/patient safety. More details coming soon.
2024
April 4-6: Owner Summit, La Jolla, CA
June 20-21: EduCon Virtual: The Ethical Compounding Conference
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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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