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The voice for compounding pharmacy | June 14, 2019
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From IACP's President...
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Busy few days ahead.
Not only are there two important FDA listening sessions in which IACP leaders will be offering testimony, but the IACP Board of Directors will also be meeting and will be grappling with several strategic issues.
About the FDA listening sessions:
On Monday, June 17, Erik Tosh of Letco (IACP's chairman of the board) and PCCA's Amy Shank will speak at a pharmacy compounding stakeholder listening session . Then on Thursday, June 27, a group of IACP leaders and state board of pharmacy members will speak with FDA officials about our concerns with the second draft MOU currently under consideration. In that session, we aim to offer a middle way that we believe can address FDA's, IACP's, and boards of pharmacies' concerns. We'll have more to say about that in our next Capitol Connections. For now, know that FDA has asked to hear from us, and we're responding with practical ideas that will preserve patient access to compounded medications.
About the Board meeting:
IACP's board is refocusing on its three strategic roles: holding the association accountable to the membership, determining the strategic outcomes the association should be focused on, and engaging external stakeholders in conversations that can build relationships and lead to collaboration. In the past month, the board or executive committee have conducted stakeholder conversations with leaders of NCPA, NABP, and our corporate member Medisca. During the next board meeting we'll meet with representatives of USP. And going forward, this kind of outreach and engagement will be a major priority for the board.
Also at the next board meeting, the board will have a conversation about reimagining our two annual conferences, CCH and EduCon; they'll discuss restructuring our corporate member program to provide association sponsors maximum exposure - and to maximize non-dues revenue to IACP; and they'll discuss the appointment of an Ethics Task Force whose mission will be to strengthen the IACP Code of Ethics.
Like I said, a busy few days. For now, a big, big, BIG thank you to our IACP board of directors for the time and energy they give to their role, and to our leaders who are representing us so well before FDA. Good stuff is going on, and I'm grateful to the multitude of folks making it happen. Read on below for other news about your association and profession.
Jennifer Burch, PharmD, RPh, CDE
President
P.S. Thanks for your response to our quick survey last week about the new format we're considering for CCH 2020. Almost 50 percent of respondents said they'd be more likely to attend if the event was scaled back to a day-and-a-half and held in September. Almost 60 percent said they'd me more inclined to participate if the trip would cost them less than $1,000 - which is what we're aiming for. The IACP Board will take up the issue when it meets next, so stay tuned.
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New USP <797> doesn't provide for BUD extensions
Does your pharmacy compound sterile preparations? Recent Changes to USP <797> will limit Beyond Use Dates (BUDs) and does not provide a way for pharmacies to use valid scientific data to support longer BUDs.
The vast majority of compounding pharmacies will be preparing Category 2 CSPs under the new system. The Beyond Use Dates (BUDs) allowed for Category 2 CSPs are provided in Table 11 of the new Chapter <797>[1]:
In plain language, the maximum BUDs you can have for any Category 2 CSP under the new <797> are the ones in the chart, despite any valid scientific data you may have obtained to substantiate a longer BUD. The result for formulations stored under refrigeration and sterility tested is approximately 30 useable days for aseptically processed CSPs and 45 useable days for terminally sterilized CSPs when considering the time required to obtain a USP <71> compliant sterility test.
OUR CONCERN:
These new restrictive BUDs will force pharmacies to make
smaller batches of compounded sterile preparations much more frequently. Pharmacies will have to devote more time to compounding more small batches and will have a higher utilization of consumable items in the process. When pharmacies make a batch, the testing requirements - and thus costs - are approximately the same independent of the size of the batch.
All of this will lead to much higher costs for patients, which will create a patient access issue as these medications are pushed out of affordable price ranges for more and more Americans.
Can you think of other ways
this
will impact your patients and your practice? Let us know.
Read our briefing paper here.
[1] United States Pharmacopeia.
General Chapter <797>
Pharmaceutical Compounding
- Sterile Preparations. USP-NF 42-NF37. 2019.
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IACP office to relocate to DC area
Several years ago, through the generosity of many IACP members and corporate sponsors, the IACP Foundation built and furnished a beautiful office building in the Houston area, with IACP as its primary tenant. "We continue to be deeply grateful for that support, which has provided the academy and the foundation a home base from which to serve our members and supporters," said IACP Foundation President Erin Michael of Cottonwood, Calif.
Beginning July 1, IACP will begin a new chapter in its illustrious history. To strengthen its focus on legislative and regulatory advocacy, IACP will be re-orienting and relocating the IACP office to the Washington, DC. "This move will allow us to better leverage our influence on behalf of our members in the place where most decisions affecting federal oversight of the compounding profession originate," said IACP President Jennifer Burch of Durham, NC.
While the IACP executive vice president will be based in the DC area, its other staff will work remotely.
The IACP Foundation will relocate along with IACP, and will sell the foundation-owned office building in the Houston area. "It's a bittersweet decision but the right one, we believe, in light of the potential to expand our influence from a home base in our nation's capital," said IACP EVP Scott Brunner, CAE.
"One important upside is that expected proceeds from sale of the building will buttress the IACP Foundation's endowment in such a way that its ability to continue its mission in coming years is assured," said Michael.
Starting July 1, the IACP and IACP Foundation mailing address will be 100 Daingerfield Road, Suite 401, Alexandria, Virginia 22314.
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IACP member hosts Congressman for pharmacy tour
IACP's Jeffery Bray and team hosted Congressman John Curtis (UT-R-3) at MedQuest Pharmacy in Salt Lake City last Friday. "We walked him through the entire process from when a prescription enters the building to when the prescribed medication leaves the building," said Bray. [HINT: Inviting your members of Congress to visit your pharmacy is a great way to cultivate relationships and educate them about your challenges. Summer recess is coming. Call your Congressperson's office now to schedule a visit.] Thanks, Jeff, for your continuing leadership.
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NEW: No-cost risk management analysis for IACP members
Have you heard about our newest member benefit? It's called
RiskAlert-RxSM
-- a comprehensive risk exposure and insurance policy gap analysis service specially designed to assist IACP member owners better understand their risks of loss, how their current insurance program addresses exposures, and provides step-by-step solutions to address any deficiencies with their current insurance program.
The new service is offered at no cost to IACP members, with no requirement that the pharmacies create a business relationship with Britton Gallagher, the service provider.
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CALL TO ACTION on pharmacy DIR fees
Please support NCPA's efforts to address DIR fees by responding to these calls to action:
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LAST CHANCE: Save $200 on next week's Compounding Compliance Conference
Attend CBI's
2nd Annual Compounding Pharmacy Compliance Conference this week in Silver Spring, Maryland.
Visit the
conference website
to
download the brochure. Use the exclusive IACP Members Discount Code KAN583 to get $200 off the standard registration fee.
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$500 discount on PCAB accreditation for IACP members
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Follow us, would ya?
When you like and share our social media posts you amplify IACP's voice.
- On Twitter: Search @IACPrx and click "follow."
- On Facebook: Search for International Academy of Compounding Pharmacists and "like" our page.
- On LinkedIn: Search for International Academy of Compounding Pharmacists and join our group.
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Other stuff worth reading
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IACP Compounder Calendar
IACP's
Compounder Calendar
is your one-stop resource for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs.
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LIVE Summer Webinars:
1:00 - 2:00 p.m. CST
L. Rad Dillon, RPh, ASQ CMQ/OE
Certified Accreditation Consultant - ACHC/PCAB
The audience will be provided with a prioritized description of the most common deficiencies resulting from PCAB surveys. Methods of avoiding these findings will be reviewed. Strategies and tactics to be used to prepare for survey will be discussed.
1:00 - 2:00 p.m. CST
Omar Allibhai, PharmD, RPh, FACA, FIACP
Compounding Pharmacy Fellow - Johnson Compounding & Wellness
The intention of this program is to review critical calculations needed in pharmaceutical compounding to ensure accurate dispensing, safeguarding optimal patient outcomes and safety.
1:00 - 2:00 p.m. CST
Mark Compo
Director of Process Cleaning and Healthcare Divisions - Veltek Associates, Inc.
Too often we focus on decontamination of HD's in the workplace. Our focus should be to deactivate whenever possible. We should also formulate a sound program which incorporates verification of the program's overall objectives. This session will address the core concepts of both.
And don't miss these pre-recorded
webinars, ready when you need them, from IACP:
These are perfect for self-paced learning. Click title for details.
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It's an investment with a return... Please
INVEST in IACP's One Fund and help preserve patient access to compounded medications via IACP's advocacy efforts!
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