APC: CC: May 20, 2022 issue

 

The voice for pharmacy compounding | May 20, 2022
 
From APC’s President
First-rate Advocacy
Last week, PCCA held its ACT (Action, Commitment and Time) Conference—an annual advocacy event where compounders meet virtually with their members of Congress.
 
PCCA reports that more than 75 pharmacy professionals, representing 51 pharmacies, participated. I was one of those. In total, compounders held more than 110 congressional visits representing 28 states. The conference was well run and a lot of fun.
 
Maybe for some of you, when I mention political advocacy, your eyes glaze over. You’re a clinician, right? I have talked with many of you who may not value political advocacy the way I do—but you should, because Congress has everything to say about the future of your profession.
 
During last week’s conference, we built relationships with many members of Congress who sit on key committees that oversee FDA and compounding. Many of those members of Congress agreed to our asks—to help defend us and our patients against FDA overreach. I guarantee you that there are many forces which are working against the compounding profession and their voices are heard because they are on the Hill EVERY DAY. If we are not out there advocating for our profession, only opposing voices will be heard and—no doubt about it—we will lose.
 
If you couldn’t make the ACT Conference, don’t despair. APC will be hosting Compounders on Capitol Hill—an in-person event this year—September 14-15 in Washington, DC. Compounding professionals from around the country will attend, and you should join us. Not only is it fun to reconnect with colleagues, talk about best practices, and see the vendors, but it is our chance to go to Capitol Hill and meet face-to-face with our elected officials. It’s our chance to show the strength of our commitment and to voice our passion for our patients.
 
So, thanks PCCA, for the “first bite at the apple” last week. And to the rest of you: Mark your calendars for CCH (a second bite, so to speak). Your stories are important, and you need to tell them!
 
See you in DC in September.
 
• • •
 
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
 
We’re 38 PFMs-strong (and growing)
For small and large 503A and 503B pharmacies and outsourcing facilities, APC offers a pharmacy/facility membership (PFM) as an alternative to purchasing several individual memberships.
 
With a pharmacy/facility membership, you pay one annual dues amount to receive all the benefits of APC membership, PLUS your company receives a buffet of additional value-added services and all your employees become APC members.
 
This is a relatively new program, so we’d like to thank our 38 PFM members so far for being the trailblazers that they are:
Just in case you could use just a tiny bit more to sway your decision, here’s some feedback from a colleague and new APC PFM:
 
“When I read that APC was offering a corporate membership, the details seemed too good to pass up! As a PFM, not only was I able to enroll my entire pharmacy staff, I also had access to various vendor discounts that would enhance my patients’ experience.“ 
Michelle Moser, RPh, FACA, FAVCP, Makers Compounding Pharmacy
 
Ready to join as a PFM? Click here for details or you can contact APC’s Jason Dunn at jason@a4pc.org or 918.770.6333.
APC and CVM leaders meet (again)
In a follow-up meeting Wednesday with APC leaders, the FDA’s Center for Veterinary Medicine’s Dr. Bill Flynn acknowledged that questions raised by APC about the practical implications of certain provisions of GFI #256 may result in tweaks to the document, reiterating that the agency was focused on making it a GFI that works and does not impede animal healthcare.
 
APC had shared with CVM in advance a list of questions, seeking to understand how FDA intends to enforce certain provisions of the GFI.
 
“While we continue to question the agency’s authority to regulate animal drug compounding via this GFI, we do understand the positive role a well-structured GFI could play in protecting animal health,” APC’s Scott Brunner told CVM officials in the meeting. “But we’re just not yet confident that you’ve fully vetted the implications of this GFI, and we believe without some amendment and clarifications, it’s premature to finalize it.”
 
A few highlights of the conversation:
  • To tutor compounders on the provisions of the GFI, CVM pointed to this Checklist for Pharmacists: Compounding Animal Drugs and to this online resource for nominators in submitting substances for the office-administration bulks list.
  • CVM’s Flynn noted that the bulk compounding list to be created under the GFI was for office-administration compounds only, and not for patient-specific compounding.
  • Related to questions about ambiguity in the definition of adverse events in the GFI, CVM said they would expect reporting on “atypical reactions that are not known side effects.” APC urged a more specific, robust definition, saying, “Too ambiguous a definition will lead to reporting of huge amounts of useless information on routine effects that will cast the compounder in a negative light.”
  • APC also raised liability concerns about beginning with a manufactured drug for which the pharmacist only knows the active ingredient. “What is the compounder’s liability – or FDA’s liability when an adverse event occurs as a result of an excipient the compounder did not know was in the manufactured drug?” an APC leader asked.
  • APC urged CVM leaders to engage NABP and conduct training on the GFI for state boards of pharmacy to help align state policies with FDA’s intentions.
 
The leaders agreed to continue the dialogue on this issue in coming days.
Save these dates
Short takes
HRT shows promise in fight against COVID-19: An Oxford University Press/Family Practice research paper published on May 17 revealed preliminary results indicating that hormone replacement therapy may reduce the severity of COVID-19 disease.
 
US COVID-19 death toll ticks past 1 mil: According to Johns Hopkins University’s COVID-19 dashboard, the US death toll from the disease passed the 1 million mark earlier this week. The website also reported a total of 82,680,909 cases and 579,387,321 total vaccine doses administered for the US.
 
To end on a good note…Congratulations to PCCA’s Matt Martin, PharmD, BCSCP on his election to serve as Compounding Special Interest Group Coordinator Elect for the APhA (American Pharmacists Association).
 
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.