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APC News

Our list of PFMs keeps going (and growing)

Published May 5, 2022

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: 

Absolute Pharmacy
Advanced Rx
Belmar Pharmacy
Central Compounding Center
Central Ohio Compounding Pharmacy
Civic Center Pharmacy
Elements Compounding Pharmacy
Empower Pharmacy
Flourish Integrative Pharmacy
Golden Gate Veterinary Compounding Pharmacy
Innovative Pharmacy Solutions
Keystone Pharmacy
Koshland Pharm
Las Colinas Pharmacy
Lloyd Central Compounding Pharmacy
Madison Drugs
Makers Compounding Pharmacy
MedQuest Pharmacy
Montecito Rx dba San Ysidro Pharmacy
NextGenRx Compound Pharmacy
North Fulton Compounding Pharmacy
Nubratori RX
Pacific NW Specialty Pharmacy
Pharmco LLC
Puramint
Rivertown Compounding Pharmacy
Sixth Avenue Pharmacy
The Art of Medicine
The Compounding Center
The Wellness Center Pharmacy DBA Designer Drugs
Three Oaks Pharmacy
Town & Country Compounding & Consultation Services
Town Total Compounding Center
Tri-State Compounding Pharmacy
Union Avenue Compounding Pharmacy
Williamsburg Drug Co
Women’s International

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.

Avoid becoming an insurance statistic, a $25 webinar from APC

Published May 5, 2022

When it comes to insurance claims, there are some that compounders can face above and beyond what other pharmacists do—and boy, are they costly (they don’t help your reputation much, either).

Thanks to our friends at Pharmacists Mutual, we can tell you and your team members what they are and how to avoid them.

Please join us for a webinar, Pharmacists Mutual’s Most “Popular” Insurance Claims in Compounding (and how not to be one of them) this coming Tuesday, May 24 from 2:00pm–3:00pm EDT.

Webinar details
Tuesday, May 24
2:00pm – 3:00pm EDT
$25
To register, please click here.

Note: This webinar does not offer CE credit

APC and CVM leaders meet (again)

Published May 5, 2022

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.

APC Fellows Program gets 2022 reboot

Published May 5, 2022

Established in 1997, the APC Fellows Program distinguishes pharmacists—and, new this year, pharmacy technicians—who are exemplary in their professionalism and commitment to the practice of pharmacy compounding.

This is the highest distinction awarded by APC. Since the program’s inception, 99 compounding professionals have been honored as members of this elite group.

All interested candidates must be registered pharmacists or pharmacy technicians who are APC members and who have practiced pharmacy for at least five years and practiced in the compounding pharmacy profession for at least three years.

The deadline to apply is June 30, 2022. Click here to learn more about the requirements and to submit an application.

Upcoming programs: Compounding Pharmacy Compliance and two webinars

Published May 5, 2022

Registration is open for Informa Connect’s hybrid conference, Compounding Pharmacy Compliance, June 21-22, 2022, at the Hilton Alexandria Mark Center in Alexandria, VA.

This hybrid conference will provide insights into best practices for processes, protocols and facility improvements, sterility and stability testing and data analysis through informative presentations, panel discussions, case studies and breakout discussions.

For more details and to register, click here.

*But wait, there’s more!
Registration is still open for these upcoming APC webinars:
May 19: Compounding for Long Covid (lessons from research and the trenches). Details and registration here.
May 24: Pharmacist Mutual’s Most Popular Insurance Claims in Compounding (and how now to be one of them). Click here for details and to register.

Thanks for the memories, Mr. Kantor

Published May 5, 2022

Andrew Kantor

The APC Team recently said goodbye to our outgoing director of communications, Andrew Kantor, whose last day was Thursday, May 12.

Andrew’s next chapter will include doing odd jobs on his farm in Upstate New York while continuing his freelance writing career.

His insight, expertise and wit have made our time working together a delight, and we wish him the best. Lucky for APC, Andrew will remain with us as an occasional consultant. 

*Betsy Keck has taken over the director of communications role. Moving forward, please contact her at betsy@a4pc.org for any communications-related business.

APC, CVM leaders meet, discuss GFI #256

Published May 5, 2022

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

Published May 5, 2022

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, 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

Published May 5, 2022

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.

FDA’s warning letter to university is worth noting

Published May 5, 2022

If you just read the news story, this seems like a not-interesting-to-compounders FDA warning letter — in this case to Miami University of Ohio for “falsifying data.”

But if you read the actual letter, you get a much fuller picture of why MU was scolded for its heparin testing: Test results in an ‘uncontrolled’ folder on the computer. No software audit trail. “All users shared one master login.”

While the biggest problem seems to be “falsified data” — apparently a lazy user who didn’t feel like re-running an analysis — the various issues FDA highlights are worth noting because they’re easy traps to fall into: “Oh, just use my login….”

 

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