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The voice for compounding pharmacy | June 28, 2019
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From IACP's President...
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Lots to report.
Last week we represented your interests at two listening sessions at FDA. The first, on Monday, June 17, was a general listening session in which FDA sought input on a range of issues related t compounding. IACP Chairman Erik Tosh of Letco and PCCA's Amy Shank spoke at that session, laying out concerns about the current proposed MOU, as well as FDA's slow progress on the bulk lists.
The second, last Thursday, June 20, was an invitation-only session focused on concerns about the MOU. Our sister associations NCPA, APhA, and NHIA joined us for that one, and we were unified in the concerns we enunciated about the regulatory burden imposed by the proposed MOU on state boards of pharmacy and about FDA's conflation of the definitions of distribute and dispense, which stand to severely curtail patient access to compounded meds in states that don't sign the MOU. Representing you in that session were two members of state boards of pharmacy, Dave Rochefort of New Hampshire and Michael Blaire of Arizona; pharmacy owners Jeff Bray of Utah and Shawn Hodges of Georgia; PCCA's Matt Martin; Wedgewood's Anthony Grzib, who is IACP's legislative chairman; and IACP's Scott Brunner and David Pore. In the session, we laid out what we think is a "middle path," a way out of this corner FDA has painted itself into, with boards of pharmacy vowing not to sign the current proposed MOU and pharmacy groups unified in the belief that FDA has exceeded its legislative mandate in redefining distribution to include patient-specific dispensing. We'll say more about that in coming weeks, after we've formally submitted the proposal to FDA in writing. For now, know that we felt heard by FDA - they asked several great questions - and I suspect they will at least consider our proposal.
Next: The IACP Board met this week and approved a new footprint and timing for Compounders on Capitol Hill 2020. Next year's event will be September 9-10, 2020, at the Omni Shoreham Hotel in Washington, DC. The new day-and-a-half format means that most members should be able to participate for less than $1,000 and with only a single night away from home. We think that will translate in higher attendance at Hill visits with members of Congress. You'll hear more about it in coming months, but for now, mark your calendar.
The IACP Board will also be convening in Salt Lake City August 16-18 for a strategic planning retreat aimed at charting a new course for the academy. We'll have (lots) more to say about that in the next couple of months.
Lastly, as you'll see below, an op-ed by our EVP Scott Brunner appeared in STAT last week. It urges FDA to be practical in its approach to the MOU. It's a piece that states our concerns well, and it's worth reading...and sharing.
Jennifer Burch, PharmD, RPh, CDE
President
P.S. We've reversed a three-year membership decline, but there are an awful lot of you whose team members are not a part of IACP. Let's do something about that. They can join here. (Use the code CCH25 and they'll get 25% off first-year dues!)
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It's time to reach out to USP about the <797> BUD extension problem
We alerted you a couple of weeks ago that 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.
IACP is working hard on this issue, which threatens the ability of our members who do sterile compounding to provide their patients affordable compounded medications. In addition to sending a letter to USP stating our concerns and requesting a revision, IACP Board members will be meeting with USP representatives in the next couple of weeks to discuss the issue. Given the implications of the problem, we're also considering a formal appeal of the provisions. We'll have more to share on these actions in coming weeks.
For now, we're asking YOU to take action.
Reach out to USP via email and social media. Explain to them your concerns with the restriction on BUD extensions and ask them about the scientific basis for that restriction
. Your outreach will help alert USP to the extent of the concern about the new chapter. USP's Twitter handle is @USPharmacopeia. You can email them at [email protected].
The restriction on BUD extensions under the new <797> will force pharmacies to make smaller batches of compounded sterile preparations much more frequently and incur a higher utilization of consumable items in the process. Why? Because 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.
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IACP to FDA: Don't throw the baby out with the bathwater
In a June 19 op-ed in the publication STAT, IACP executive vice president Scott Brunner says
FDA's overreach will harm compounding pharmacies and the patients they serve. He writes:
America's compounding pharmacists and pharmacy owners are not seeking to operate in an unregulated or underregulated environment. And they don't want incidents like the New England Compounding Center tragedy to ever happen again. The fact is that this industry - and the patients it serves - benefit from a strong regulatory framework.
But it needs to be a practical framework, too: one that recognizes there is a proper role for compounding pharmacists in serving patients. One that assures that patients have continued access to safe, affordable compounded medications. And one that doesn't throw out the baby with the bathwater.
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Welch/Griffith MOU letter goes to FDA
Thanks largely to your efforts to engage them, twenty-two members of Congress signed an IACP-supported letter that was sent to FDA this week encouraging the agency to work with stakeholders to address concerns about provisions of the MOU opposed by boards of pharmacy and compounding groups.
Read the letter here.
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Another strong congressional letter to FDA
Thanks to U.S. Senators Kevin Cramer and John Hoeven of North Dakota
for writing to FDA this week urging reconsideration of provisions in the proposed MOU. Congressional support like this gets FDA's attention. We're grateful to our North Dakota members who put our concerns on the senators' radar.
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Tell your members of Congress: Fix DIRs
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Compounding pharmacist input needed for cBHRT study
Last fall, the FDA commissioned the National Academies of Sciences, Engineering, and Medicine to conduct an 18-month research
study to examine the clinical utility of treating patients with compounded bioidentical hormone replacement therapy, or cBHRT. To inform the report's conclusions and recommendations, the study's expert committee seeks stakeholder input from consumers, licensed providers, compounders, and pharmacists regarding the use, safety, and effectiveness of cBHRT as an alternative treatment for hormone-related health concerns.
Complete this survey
by
July 12
, and ask your providers and patients to as well, to provide vital information about the scientific rationale for prescribing compounds.
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USP presents: Evolution and Advances
in Compounding
On August 6 & 7, 2019, USP will host the 2nd workshop on improving the quality of compounding to enhance patient safety through the development of standards for compounded medicines.
'Evolution and Advances in Compounding'
will convene a wide range of stakeholders to explore current and emerging stakeholder needs in the compounding realm. Registration ends August 2. Registration details and the agenda are available here.
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Members-only benefits, just for you...
Are you taking advantage of our members-only discounts on a range of products and services
that more than cover the costs of your annual IACP dues
? Here's a short list:
- Get $500 off the cost of PCAB accreditation, the gold-standard certification for compounding pharmacies.
- Save $200 on the registration for CBI's Compounding Compliance Conference. Details here.
- Get a no-cost, no obligation gap analysis of your business and liability insurance coverage via RiskAlert-Rx - a service specially designed to help IACP member owners better understand risks of loss, plus you'll get step-by-step solutions to address any deficiencies.
- Get 10% off $500 or more of marketing services from Storey Marketing. (Valid one time per pharmacy owner.)
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Corporate Member Spotlight
Increase pharmacy productivity and safety with innovative and economical devices designed to protect your compounded preparations.
For 50 years,
IMI
has worked closely with pharmacists and compounding professionals to create innovative products that meet very specialized needs.
One of the most commonly used products is our Prep-Seal™ Luer Lock Caps. These caps are ideal for the closure of batch preparations. Our unique tray design allows the compounding tech to attach the Luer Lock cap directly from the tray, minimizing touch contamination. More information here.
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Follow us!
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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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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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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