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):

1. Ensuring continued patient access to customized medication
2. Strategies for protecting compounded hormones from FDA restrictions
3. Strategies for protecting veterinary compounding from FDA overreach
4. Strengthening APC’s advocacy efforts to protect compounding and the patients it serves
5. Encouraging our members to uphold the highest possible standards of ethics
6. Ensuring that APC members have access to training and knowledge to keep them practicing at the top of their game
7. 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.

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 here to see the video presented at EduCon 2022

Click for info and to register (if you haven’t already)
— or go to A4PC.org/educon