APC: APC amicus brief addresses ambiguity in FDA insanitary conditions guidance

APC News

APC amicus brief addresses ambiguity in FDA insanitary conditions guidance

Published May 5, 2022

Image of man signing legal document

Image by Leandro Aguilar from Pixabay.com

“Insanitary conditions” are whatever FDA says they are. This is neither legal nor fair.

That’s the gist of APC’s argument in a “friend of the court” brief filed in U.S. District Court in New Jersey on May 13.

Funded by member contributions to the APC’s Legal Action Fund, the amicus brief was authorized in response to an urgent request from Wedgewood Pharmacy that APC support its filing for a temporary restraining order against FDA.

Wedgewood filed its papers seeking a TRO on May 5, 2022, only after FDA demanded that Wedgewood immediately recall all nonsterile products within their expiry period, gave the pharmacy only 24 hours to respond, and failed to provide the pharmacy any information supporting the need for such an extraordinary, broad recall. Wedgewood told the court it suspected that, without the TRO, FDA would move quickly to publish a news release impugning Wedgewood based on FDA’s unsubstantiated findings of “insanitary conditions” at the pharmacy.

In the TRO filing, Wedgewood and its lawyers argued that FDA had inspected the pharmacy and issued eight observations in a Form 483 related to vague notions of insanitary conditions, which focused on areas well outside the pharmacy’s compounding areas. Wedgewood further stated that none of the observations listed on the Form 483 FDA violated applicable USP standards.

APC’s amicus brief, approved by the Executive Committee*, focused solely on the lack of standards in FDA’s Insanitary Conditions GFI and FDA’s failure to promulgate any enforceable rules concerning the same.

APC engaged in the matter because we were—and remain—concerned about the significant implications on other APC-member compounding pharmacies if FDA continues to impose what appears to be the vague, subjective disciplinary standard suffered by Wedgewood. In particular, FDA derives its enforcement authority from a non-binding guidance document that contains not any objective standards, but instead relies on what appears to be a bunch of examples and the nebulous statement that “other conditions not described in the guidance may also be considered unsanitary.” How is a compounder to know what is in fact violative conduct?

In that vein, we argue in the amicus that a pharmacy “would have no basis to know under the plain meaning of the term ‘insanitary conditions’ or under the explanation set forth in the Insanitary Conditions Guidance that ‘observed personnel who moved rapidly in a sterile compounding area’ or who ‘was noted to have their safety glasses down on their nose’ would meet the standard for insanitary conditions.” Both of those were among FDA’s Form 483 observations against Wedgewood.

Last week the District Court denied Wedgewood’s request for a TRO. The judge said she could not issue a restraining order on an action that had not yet occurred—in this case, FDA’s publishing of a damning press release. But during oral argument, she also made clear that she expected FDA to work with Wedgewood to settle their difference and seemed to suggest she wanted that to occur without FDA publishing a news release that could unnecessarily damage Wedgewood’s reputation based on unsubstantiated or exaggerated claims of “insanitary conditions.”

While APC strongly supports the maintenance of sanitary workspaces where compounded drugs are prepared—it’s simply essential for assuring patient safety—there must be standards for what constitute “insanitary conditions,” and those standards need to be rooted in science and the law. Our amicus brief in this matter is the clearest elucidation of the flaws in FDA’s Insanitary Condition Guidance I’ve seen. I do urge you to read it.

APC is proud of our involvement in this matter. Just another way we’re looking out for you.

By the way, if you’d like to fuel our ability to be involved in other legal cases related to pharmacy compounding, please give to APC’s Legal Action Fund.

* Two Wedgewood employees who are members of APC’s Executive Committee recused themselves entirely from the deliberation and voting on the funding request.

CC: May 20, 2022 issue

Published May 5, 2022

 

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.
 
 

Our list of PFMs keeps going (and growing)

Published May 5, 2022

For 503A pharmacies and 503B outsourcing facilities of any size, 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.

CC: May 13, 2022 issue

Published May 5, 2022

The voice for pharmacy compounding | May 13, 2022
From APC’s President
Jolly good APC Fellows
One of the proudest moments of my professional career was being recognized as an IACP Fellow, which of course is now referred to as an APC Fellow.
 
For the past several years, the APC Fellows Program has been…quiet. It was one of my goals as APC president to reinvigorate it. I am pleased to report that our Fellows Committee—composed of Fellows, of course—is re-launching the program, albeit with a few minor tweaks.
 
The most important change is that technicians may now apply. Technicians, you are so vitally important to the compounding profession and your ability to be recognized as Fellows is long overdue.
 
Below you’ll find a link to apply. Please note the deadline for application is June 30.
 
In order to be considered for this exclusive recognition, candidates must be nominated by at least one current Fellow and submit a letter of recommendation. You’ll also need to start collecting several items to include with your application, including your compounding-related continuing education, leadership positions held on a state and national level, and publications (peer reviewed, newsletters, etc).
 
All new fellows for the 2022 class will be inducted during a ceremony at APC’s Compounders on Capitol Hill in Washington, DC on September 14, 2022.
 
I look forward to welcoming you to our ranks as APC Fellows in the alliance.
 
• • •
 
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 Fellows Program gets reboot
Established in 1997, the Fellows Program distinguishes pharmacistsand, new this year, pharmacy technicianswho 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.
 
Don’t lollygag too long: the application deadline is June 30, 2022.
 
Click here to learn more about the requirements and to submit an application.
Coming soon: Compounding Pharmacy Compliance
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.
 
Reserve your spot by May 20 to save $100. 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.
PFM Benefit Spotlight: HealNow
 
A Pharmacy/Facility Membership provides many benefits, including fee waivers with HealNow, a HIPAA-compliant online payment solution for pharmacies.
 
HealNow enables pharmacies to offer online payments of prescriptions for a faster on-boarding and payments process, in a frictionless way. Become a PFM and offer your customers a new and improved pharmacy experience today.
Not a PFM yet? Click here for details or you can contact APC’s Jason Dunn at jason@a4pc.org or 918.770.6333.
So long, farewell: Andrew Kantor
APC bids a fond farewell to our outgoing director of communications, Andrew Kantor, whose last day was Thursday.
 
Andrew’s new chapter will include doing odd jobs on his farm in Upstate New York while continuing his freelance writing career.
 
Lucky for APC, Andrew will remain with us as an occasional consultant, offering pearls of wisdom such as, “I think Helvetica would look nice.”
 
His insight, expertise and wit have made our time working together a delight, and we wish him the best.
 
*Andrew’s very large shoes (size 12½!) have been filled by Betsy Keck. Moving forward, please contact her for any communications-related business.
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.
Save these dates
Short Takes
Sprinkles really are only for winners: According to this article on the University of California, Riverside’s news website, a spoonful of sugar not only helps the medicine go down, it also squashes the efforts of would-be drug counterfeiters.
 
BYOPO (Bring Your Own Pulse Oximeter): Why bother carrying around a pesky pulse oximeter when you can get a tattoo that shows your blood-ox level anytime and anywhere? Luckily, engineers at Tufts University have created tattoo-like sensors that reveal blood oxygen levels, among other things. Alas, this tattoo technology isn’t permanent and is broken down by the body within a year or less.
 
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.
 
 

 

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.

CC: May 6, 2022 issue

Published May 5, 2022

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.
 
OutcomeMD
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
 
 
 

 

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