APC: CC: May 6, 2022 issue

The voice for pharmacy compounding | May 6, 2022
From APC’s President
Animal compounding takes center stage at APC
Like most compounders, I am happy to serve my local veterinarians. I have pets of my own and know how important customized medicine is to them.
Unfortunately, our ability to serve our furry or slithering patients may be in jeopardy.
In 2015, FDA released a guidance for industry (also known as a GFI) #230. This GFI is a “non-binding resolution which gives the FDA’s thoughts on a subject” at that time. GFI 230 would have placed restrictions on the type of compounding we could do for pets and restated FDA’s long held policy that compounding for animals from bulk ingredients was illegal. The agency withdrew GFI 230 in 2017.
In 2019, FDA released a draft GFI 256, which was a revision of GFI 230. Again, the agency stated that it was illegal to compound from bulk APIs but that it would practice “regulatory discretion” (meaning turning a blind eye) if some conditions were met. Find a copy of GFI 256 here.
APC has expressed concerns with the agency, and, in an unprecedented move, the agency reached out to APC to 1) let us know in advance that the final GFI would be released and 2) invited APC to meet with them to discuss the GFI.
On May 4, APC leadership and the executive members of the board of director met with FDA’s deputy director of the Center for Veterinary Medicine, Dr. William Flynn (DVM) and senior members of his team. 
We had a good conversation with the agency team, and they seemed genuinely interested in listening to APC’s concerns over GFI 256. I am thankful for their willingness to meet with us and hear our input and concerns regarding GFI 256. I believe it was a fruitful and very cordial discussion. We do not know what the final impact of GFI 256 is on your practice, but we are thankful for the discussion. I am hopeful that APC is entering a new era of collaboration with FDA to ensure safe access of customized medications for our patients.
APC is working diligently to protect and defend your ability to compound customized medications for you and your pets every day. If you know someone who is not a member, give them a call and ask them “Why not?”!
• • •
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
APC, CVM leaders meet, discuss GFI #256
On Wednesday, APC leaders met with officials from FDA’s Center for Veterinary Medicine to enunciate concerns about what APC sees as ambiguity and uncertainty in CVM’s final GFI #256, regarding animal compounding.
The hour-long virtual Q&A session was the result of an invitation from CVM’s Deputy Director of Science Policy Dr. Bill Flynn, who participated along with CVM’s Drs. Cindy Burnsteel and Amber McCoig.
Leaving aside any questions of FDA’s statutory authority for the regulatory framework GFI #256 imposes, APC Board Chair Michael Blair noted that the GFI goes well farther than restrictions placed on human compounding in DQSA.
Flynn replied that “the law does not lay out a clear pathway for compounding on the animal side” and that the agency has sought “to develop a framework that enables compounding for animal use, including from API.”
Much of the discussion in the meeting focused on the GFI’s restrictions on compounding for from bulk API. In addition, Also raised was the issue of how CVM’s “trust us” approach to enforcement discretion might not be shared by state boards of pharmacy, who may likely seek more restrictive enforcement in their state regulations and inspection regime.
Flynn indicated that the agency is aware of the concern and plans to “coordinate with state boards,” understanding there may be variations in enforcement.
“That response was not a particularly reassuring one,” said APC’s CEO Scott Brunner after the call.
The allocated hour was insufficient for covering APC’s extensive list of questions; the group agreed to schedule a follow-up meeting for later this month to take up, among other issues, concerns about adverse event reporting in the GFI. After that second meeting, APC will share publicly the document containing all our questions of CVM. APC will also be formally commenting on GFI #256 shortly.
PCAC to consider glutathione
This just in: FDA’s Pharmacy Compounding Advisory Committee will meet June 8, when a number of substances will be up for review, notably glutathione.
Glutathione was nominated for inclusion on the 503A bulk drug substances list by PCCA, so presenting on its behalf will be APC board member and PCCA’s vice president of clinical services, AJ Day, PharmD, RPh, among others.
What else is on the list? Ammonium tetrathiomolybdate, enclomiphene citrate, and ferric subsulfate. Click here to read more about the meeting.
Meet our newest team member
We’re pleased to announce that Betsy Keck has joined the APC team as director of communications. In this role, she will maintain the association’s voice and ensure our messages are shared at the right time to the right audiences via the right platforms.
A native of Ohio, Betsy holds a BA in Journalism and Religious Studies from Indiana University in Bloomington, Indiana. After graduating, she moved to Japan, where she taught English for eight years. Since returning to Northeast Ohio in 2001, Betsy has worked her marketing and communications magic in both the private and public sectors.
In her free time, Betsy enjoys learning to play the violin, spending time with her kids, and defending her garden against the neighborhood’s flourishing deer population.
Betsy can be reached at betsy@a4pc.org or 216.333.3008.
Spotlight on PFM benefits
Audible Sunshine
No one particularly enjoys maneuvering automated phone systems. No one.
We suspect that none of you particularly enjoy recording those messages, either.
Luckily, APC’s Pharmacy/Facility Members (PFMs) can help make the experience a pleasant one by using Audible Sunshine, a professional voiceover service.
This is just one of the many exclusive benefits available to PFMs. Not a PFM yet? Click here for details and to sign up.
Meet the compounding pharmacies’ new BFF: OutcomeMD.
A web-based platform, OutcomeMD allows compounding pharmacies to collect information on how their patients’ therapies are working in the same standardized, validated format that FDA uses. It also allows APC to leverage nonpatient-specific outcomes data to demonstrate to FDA and others that compounded preparations do indeed benefit patients.
Thanks to our partnership with OutcomeMD, APC Pharmacy/Facility Members receive more than half off OutcomeMD’s standard subscription rates. This is just one of the many exclusive benefits available to PFMs.
Learn more about everything an OutcomeMD subscription provides at OutcomeMD.com. Then reach out to Lorraine Kaiser at lkaiser@outcomemd.com to schedule your demo.
Not a PFM yet? Click here for details or you can contact APC’s Jason Dunn at jason@a4pc.org or 918.770.6333.
One big aim for 2022 focusing on educating prescribers of compounded hormones about the threat — and through those prescribers, reaching a patient base that doesn’t yet know that FDA may be planning to restrict their compounded hormone therapy.
You and your relationships with prescribers will be key to that effort.
But we can’t do it without funding. Make your investment NOW.
And don’t forget: You’ll find all sorts of useful tools and resources for engaging patients and prescribers in this effort at A4PC.org/cbhttools.
Thanks. Together, we’ll save compounded hormone therapy and enrich the lives of millions of patients who benefit from it.
Short Takes
  • An FDA warning to learn from: Miami University of Ohio got an FDA warning letter for “falsifying data” in its heparin testing. Some of the issues it found were test results in an ‘uncontrolled’ folder (i.e., not password-protected), no software audit trail, and our favorite, “All users shared one master login.” Take note and remember to never, ever say, “Oh, just use my login….”
  • Time travel, Covid-style: If you get a bad enough case of Covid-19 to put you in the hospital, you could emerge with brain fog as bad as if you had aged 20 years — and it could last months. Keep this in mind if you hear a 40-year-old yelling at those whippersnappers to get off his lawn.
  • Help kids find cheeses: A preliminary study from Canada found that kids who ate more cheese had lower LDL cholesterol. Other dairy didn’t help; they specifically needed cheeses in their lives. (And before you ask: No, this study was not sponsored by Big Cheese. It’s legit.)
Coming Up