APC sent a letter to the New Mexico Board of Pharmacy this week commenting on its proposed amendments that would align the state with USP (good), but would also require that pharmacists ensure all flavors are inert (yikes). read more →
The APC Board of Directors has voted to name Gina Besteman (previously vice president) the board chair-elect after the resignation of Michelle Moser from the position. Besteman will assume the chair in January 2025. read more →
Earlier this week APC received a letter from the FDA explaining the agency's concerns regarding dosing and patient usage of compounded semaglutide and tirzepatide. read more →
The voice for pharmacy compounding | February 4, 2022
THIS EDITION SPONSORED BY PCCA
Thank you PCCA member pharmacies for all you do to make a difference in patients’ lives and for your continued support. Wishing you joy, prosperity and good health throughout the New Year!
From APC’s President
40 Thumbs
What has 40 thumbs and is working tirelessly to protect your right to provide compounded medications to your patients? These guys!
This past week and weekend, your APC board of directors met for two days to talk about the threats and opportunities that face and present themselves to our profession respectively.
David J. Miller, RPh APC President
The items upon which we worked included (among other things):
Ensuring continued patient access to customized medication
Strategies for protecting compounded hormones from FDA restrictions
Strategies for protecting veterinary compounding from FDA overreach
Strengthening APC’s advocacy efforts to protect compounding and the patients it serves
Encouraging our members to uphold the highest possible standards of ethics
Ensuring that APC members have access to training and knowledge to keep them practicing at the top of their game
Strengthening the relationships that APC has with key stakeholders in the compounding space
Thank you to the 40 thumbs and the brilliant minds attached to those thumbs who work tirelessly for your profession. Next year, I hope you’ll consider becoming two of the 40 thumbs.
David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.
This Week
Topi-Click to match new contributions to save cBHT!
Now is a great time to contribute to the Campaign to Save Compounded Hormones. Why? Because, for the entire month of February, Topi-Click is matching every new contribution (not recurring ones) dollar-for-dollar up to $10,000. Yes, that means if you give this month, your contribution is effectively doubled thanks to Topi-Click!
APC leaders meet with FDA officials
APC leaders met virtually this week with FDA Center for Drug Evaluation and Research (CDER) officials to discuss APC proposals related to adverse event reporting, strengthening the 503B business model, and finding common ground on a narrow, permanent pathway for 503As to source shortage drugs to hospitals and clinics. It was the second such meeting in two months, both initiated at the invitation of CDER director Gail Bormel.
“One of the reasons we’re here is to cultivate trust between APC and the agency,” APC President Dave Miller told FDA representatives. “Our hope is that we can work together, in concert, on a range of issues that will advance FDA’s policy agenda and, frankly, ours as well.”
Other issues discussed on the call were APC concerns about FDA’s slowness is closing out 483s and warning letters and the prospect of restrictions on compounded hormones.
“We do understand that the agency has concerns about compounded hormones,” APC Treasurer Alexander Pytlarz told officials. “But you certainly don’t have a strong case for the kind of over-the-top, across-the-board restrictions called for by the NASEM report. So we ask you to go slow. Allow us time to provide you with good data – both from patients and researchers. And then, we’d ask that you not act unilaterally, but that you’d seek counsel from pharmacists and prescribers alike before you make any decisions on compounded hormones. The beneficiaries of these therapies number in the millions – women, men, and many in the transgendered community as well. Any effort to restrict their ability to access treatment based on flimsy science is not likely to go over well.”
Agency officials asked a number of questions and seemed interested in APC’s proposals. “The best outcome right now,” said APC Board Chair Mike Blaire after the meeting, “Is that we agreed to keep talking.”
The State of the Alliance in 2022
Where does APC stand as we get rolling into 2022? CEO Scott Brunner, President David Miller, and Board Chair Michael Blaire go over the once and future alliance — where we are, what our plans include, and how we’re going to continue support the practice of pharmacy compounding in this video presented at EduCon 2022 Virtual.
Foundation and Pharmacist Mutual announce scholarship award winners
Congratulations to the two winners of the 2022 Pharmacy Compounding Foundation and Pharmacists Mutual Compounding Scholarships:
Ryan DeGuzman
Virginia Commonwealth University, Richmond, Va.
Kaitlin Martin
Northeast Ohio Medical University, Cuyahoga Falls, Ohio
Click for info and to register (if you haven’t already) — or go to A4PC.org/educon
Short Takes
Letco acquired: ICYMI, Letco Medical has been purchased by Fagron, the international pharmaceutical compounding firm, for $34 million.
Get briefed on our concerns about proposed restrictions to USP <795> and <797> and how they might affect patient care. Our briefing to prescribers is the perfect place to get that critical understanding of the issue. Read the slides presented at the town hall here (PDF) or watch (and share with your prescribers!) this video of the briefing.
Attention, Kentuckians: The Kentucky Board of Pharmacy is accepting applications for a vacancy on its Advisory Council. You’ll need to submit an application and your résumé or CV. This PDF has all the information as well as the application, which is due by close of business February 15, 2022.
Remember, please take the peds-compounding survey. It will help “identify current oral extemporaneous pediatric compounding practices, challenges and needs in different geographic regions.” In other words, help establish standards for pediatric compounding. You can click here to take the survey, and you can learn more about the group conducting it here.
September 14–15, 2022 — APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC
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.
