APC offers a pharmacy/facility membership (PFM) as an alternative to purchasing several individual memberships. This is a relatively new program, so we'd like to thank our 38 PFM members so far for being the trailblazers they are. read more →
In a recent follow-up meeting with APC leaders, FDA’s Center for Veterinary Medicine’s Dr. Bill Flynn acknowledged APC's questions about the practical implications of certain provisions of GFI256 may result in tweaks to the doc. read more →
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. read more →
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. read more →
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:
Central Compounding Center
Central Ohio Compounding Pharmacy
Civic Center Pharmacy
Elements Compounding Pharmacy
Flourish Integrative Pharmacy
Golden Gate Veterinary Compounding Pharmacy
Innovative Pharmacy Solutions
Las Colinas Pharmacy
Lloyd Central Compounding Pharmacy
Makers Compounding Pharmacy
Montecito Rx dba San Ysidro Pharmacy
NextGenRx Compound Pharmacy
North Fulton Compounding Pharmacy
Pacific NW Specialty Pharmacy
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
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 firstname.lastname@example.org or 918.770.6333.
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.”
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.
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.
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.
*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.
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.
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.
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.
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….”