The voice for pharmacy compounding | December 20, 2019
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From APC's President...
The first responsibility of a leader is to define reality. The last is to say thank you.
In between, the leader is a servant." -- Max Depree
It has been an extraordinary honor leading this association for the past 12 months. Serving as your president will forever be a highlight of my career. As I wrap-up my term, the Max Depree quote above seems to me to be the measure of the year.
I hope I've used the office of APC president to define reality for you, our members - including the reality that:
- Our profession is under fire, and we can't protect it without your active participation and financial support.
- Our organization must continue to evolve, to collaborate, to test the ongoing value of our traditions if we are to succeed.
- We can't survive (much less succeed!) as an organization if we don't grow, and you are our best ambassadors for recruiting new pharmacy compounding professionals - pharmacists and technicians alike - to our ranks.
- Supporting the organization is more than just paying dues. It's funding OneFund - which as you'll see below, fuels our entire advocacy operation, and is hurting at the moment - and it's supporting COMP-PAC to help us elect candidates who think like you do about compounding.
As I hand the reins to Shawn Hodges, our incoming president, those realities affect our ability to thrive. Your response to them matters. Please support both Shawn and APC in grappling with them in 2020.
About that last duty of a leader - saying thank you - these are some folks whose efforts made this year a success, I'm grateful to and for them:
- My fellow APC officers, who gave so lavishly of their time in steering APC toward a brighter future: Erik Tosh, Shawn Hodges, Michael Blaire, and Bill Letendre. (As Bill and Erik retire from APC positions after years of service, I'm particularly thankful for their leadership.)
- Your APC Board of Directors, who drive strategy and hold APC accountable to its members: Stephanie Chacon, AJ Day, Erika Fallon, Anthony Grzib, Keith Guy, Jim Hrncir, Willie James, Ginny Isbell, Cheri Kraemer, Erin Michael, Jim Perry, Alexander Pytlarz, Sarah Simmers, Doug Yoch and Jeff Bray.
- Dozens of committee members who volunteered their expertise and passion in support of your profession in 2019.
- Our generous corporate members whose support and collaboration and funding enable us to do more for you, our members.
- Your APC staff, lean and mean, who've facilitated and implemented the remarkable strides we've made this year: Scott, Jen, Ashlyn, Melissa, Deigh, and our newest team member, Drew.
I'll leave it to you to evaluate our service over the past year. My hope is that you've seen (and will continue to see) passion and value and hope in your association leaders' work - and that you'll tell others about APC and urge them to join. I look forward to continuing to serve in my role as 2020 board chair.
Wishing all the best for you and yours this holiday season and for the new year.
Jennifer Burch, PharmD, RPh, CDE
President
P.S. Speaking of Max Depree, consider reading his short masterpiece,
Leadership is an Art. Great way to prime the pump for the new year.
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URGENT PLEA: OneFund is $95k short, will limit APC's effectiveness
It fuels APC's entire advocacy operation, from our work on Capitol Hill to our work at FDA and USP. Yet here, with only a little more than a week left in the year, OneFund is $95,000 short of budget.
That shortfall will affect APC's cashflow and what we can accomplish in 2020 on a range of issues, from the proposed animal compounding GFI to the USP appeals to bulks lists to legislation on dietary supplement monographs.
OneFund is supported by investments from APC members and corporate partners - investments on top of annual dues you pay, because dues revenue alone is not sufficient to allow us to fund our advocacy efforts.
Here at year-end, we're looking to you to help assure we can be effective in 2020.
PLEASE INVEST IN OneFund NOW
and help us make-up this shortfall. It takes only a couple of minutes at
www.a4pc.org/onefund
- and you'll be doing the right thing for your profession.
We've got new briefs! (One-pagers on APC advocacy priorities, that is)
We've uploaded a handful of new one-pagers on APC advocacy priorities under the 'Federal Advocacy' tab on our website. They're perfect for briefing policy-makers or as a refresher for you and your teammates. Included are new briefs on the draft GFI on animal compounding, dietary supplement monograph issues,
503A and 503B bulk lists, and HR1959.
Op-ed in Morning Consult: Regulation yes, but don't impede access
In an op-ed this week in Morning Consult
,
Arizona Board of Pharmacy member (and APC vice president) Michael Blaire called for robust regulation that is consistently enforced and that does not impede patient access. An excerpt:
...The overwhelming majority of compounding pharmacies are run by well-trained, caring practitioners who provide critical support to patients with very specific needs. They serve millions of patients across America. They pride themselves on patient safety and compliance and view regulation and enforcement as a good thing for their profession. They want robust standards that are fairly enforced.
These practitioners, who are educated and licensed in the science of pharmacy and drug compounding, know that the solution to quality concerns is not creating more regulation; rather, it is ensuring that there is consistent and uniform enforcement of the regulations that are already on the books. Had that been the case some seven years ago, there would have been no NECC tragedy.
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LAST CALL: Apply for a 2020 committee appointment
2020 is coming, and with it, new opportunities for you to serve and advance your profession. Lend your expertise as a member of a 2020 APC volunteer committee. Committees are the workhorses of the Alliance, developing programming, chasing possibilities, and recommending policy to the APC Board of Directors.
We're seeking knowledgeable members for several 2020 APC standing committees, including Membership, Communications, Legislative & Regulatory, Education, Finance, Bylaws, and COMP-PAC.
Here's the nomination form
. Deadline for nominations is December 31, 2019.
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Actual USP <800> enforcement may vary...
In light of appeals of beyond-use date restrictions in the new USP<795> and <797> chapters, USP in September indefinitely postponed enforcement of those new chapters, and also of USP <800>. However, state regulators may still choose to enforce <800. For more information about whether your state will be enforcing <800> under state law or regulation, contact your state board of pharmacy.
You can also check out APC's
Compilation of State-Adopted USP 795/797/800 Rules
for answers to your questions.
Click here to access the resource.
Note that the compilation is an APC members-only resource, so you'll need your login and password to access.
The appeal of the new chapters will be heard at a January 21-22 hearing at USP offices.
Inconsistent DEA enforcement?
An APC member had a recent visit from DEA
and was advised that the patient-specific sterile test pellets he compounds cannot be sent to the prescriber's office and that he cannot do anticipatory compounding. The agent told him the only path forward is to register with DEA as a 503B and do office stock.
On the other hand, there's this 2015 letter from DEA to Janssen regarding constructive transfer of Spravato (esketamine), which seems to say that it is not a violation of the controlled substance act or DEA law to constructively transfer this medication from a pharmacy to a practitioner's office for administration in the office as long as the conditions in the letter are met.
We're sharing this to illustrate the enforcement discretion that may exist between different field offices. Also, the Janssen letter may represent deference to a manufactured drug. In any case, take note.
Still seeking input on FDA's reclassification of HCG as a biologic
At the request of several members, APC is considering whether to offer input to FDA on its announced reclassification of HCG and several other Section 505 drugs as biologics, announced back in August and set to take effect March 23, 2020.
Drugs reclassified as biologics may not be compounded without a biologics license, according to the FDA.
We're seeking your input about circumstances that you believe warrant compounding with HCG, and - more importantly - the scientific basis or documentation that validates that compounding need. Your input will help us in determining if there is a path forward for commenting on the reclassification.
Send to [email protected].
Following is documentation from FDA on the matter:
Congress gives FDA direction on compounding in appropriation bill
Thanks to extensive advocacy by APC and its partners - and the help of our champions in Congress -
FDA's FY2020 spending bill includes directives from Congress:
- Encouraging the Food and Drug Administration to work with the States before finalizing the Memorandum of Understanding on compounding regulation.
- Noting awareness of concerns with the Food and Drug Administration's implementation of the Drug Quality Standards.
- Encouraging the Food and Drug Administration to appoint a qualified voting member with recent, actual, and diverse pharmacy experience to the Pharmacy Compounding Advisory Committee.
- Requiring FDA to provide a briefing to Congress on the agency's position on compounding with substances the subject of a USP dietary supplement monograph.
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ANOTHER LAST CALL:
Only one more week to save $100 on EduCon 2020 registration
Go to
www.a4pc.org/educon2020
to register. And remember, you won't be able to reserve your hotel room at the preferred rate until you've registered for the conference.
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"Remind me why IACP changed its name?"
A few of you have asked why IACP has changed its name, so we thought it might be worth mentioning again. In short, Alliance for Pharmacy Compounding more accurately reflects the 'big tent' of pharmacy compounding and our role as the primary advocacy organization for compounders. The fact is, IACP represented a broader swath of compounding professionals than just pharmacists, so the new name is more inclusive. In addition, we have always been largely a U.S.-oriented organization, and having the word "International" in our name was a bit misleading. Our membership apparently agreed; It approved the new name by an overwhelming margin in November.
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FDA draft GFI on animal compounding: By what authority?
As noted above,
we've posted a new brief
on FDA's draft guidance document on Compounding Animal Drugs from Bulk Substances and solicitation of nominations for a positive bulks list for compounded veterinary office stock.
We believe FDA lacks specific statutory authority in this area, and we will be offering formal comments on that and other concerns at the proper time.
Please send your thoughts on this GFI or bulks list request to
[email protected]
.
Your input can help inform APC's comment letter.
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Cassidy visits Medquest Pharmacy in Salt Lake City
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Try these pre-recorded webinars, ready when you need them:
Happy holidays and best wishes for 2020!
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