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The voice for compounding pharmacy | July 12, 2019
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From IACP's President...
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It's summer. It's hot. And I'm betting we'd all rather be under a beach umbrella sipping on a fruity drink right about now. So I'll be brief.
Two big things that are important right now:
- USP <797> BUD extensions. The IACP board of directors met this week via conference call with four USP staffers to discuss our grave concerns about the limitations on BUD extensions in the new USP <797> chapter. The USP folks indicated they're hearing us and are working on how to address our concerns that the curtailment of BUD extensions will force compounders to make more, smaller batches, which could make some compounded medications cost prohibitive for patients. USP reps indicated they were NOT hearing much from state boards of pharmacy on this issue, but they'd like to. Here's a to-do for you: Reach out to your state's board of pharmacy. Brief them on the issue and urge them to offer input to USP soon. It's a big deal.
- FDA's MOU with states. Two weeks ago we shared with FDA a proposal that we're calling "a middle way" to accomplish a state MOU that addresses FDA's need for data on interstate distributions and that compounders can live with. IACP has taken the lead in drafting this middle path, with the support of NCPA and APhA. We're now drafting a letter to FDA from the three organizations, which summarizes the proposal we made to them in person. I hope to be able to share with you in the next issue of this newsletter. Know that we're working hard to help resolve this issue in a way that works for all parties and which hopefully will help avoid continued gridlock - and perhaps, litigation. I'm proud of our leadership on this issue, and I hope you will be, too. For now: Stay tuned.
This week, our IACP staff had two different members contact us to ask why we weren't doing something about issues on which we are in fact doing quite a lot. While my reply to them might have been "Where ya been? We've been working on these for months," our staff was more diplomatic, briefed the members on our efforts, and the members walked away appreciative of our efforts.
So in closing - and at risk of preaching to the choir - I want to encourage you to stay tuned in to IACP so you'll be in the know on what we're doing about issues that impact your business. Not only that, but please talk up IACP to your colleagues. Encourage them to read this very newsletter (just like you are apparently doing right now), as well as our Twitter and Facebook feeds. And urge those who aren't IACP members to join IACP - they can do so
here - and help amplify our voice and enhance our effectiveness in tackling issues that are challenges to their compounding business.
Thanks for being an IACP booster. Until next time ... Stay cool!
Jennifer Burch, PharmD, RPh, CDE
President
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Deadline extended for compounding pharmacist input for cBHRT study
Have you shared your input on compounded bioidentical hormone replacement (cBHRT) therapy yet? If not, there is still time. NASEM is requesting input from c
onsumers, licensed providers, compounders, and pharmacists regarding the use, safety, and effectiveness of cBHRT as an alternative treatment for hormone-related health concerns.
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.
Help preserve patient access to cBHRT by completing this survey by
July 19
, and ask your providers and patients to as well, to provide vital information about the scientific rationale for prescribing compounds.
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CCH 2020 will move to shorter format, new time of year
IACP's Compounders on Capitol Hill 2020 will be held in Washington, DC., September 9-10. Our new only-one-night-away-from-home format will make it easier and more affordable to come to our nation's capital to advocate for your compounding pharmacy. Add those dates to your calendar: September 9-10, 2020 now.
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Save the date for EduCon 2020
We're working on a plan for EduCon 2020. Tentative dates are Tues-Thurs, April 7-9, 2020. More information coming soon.
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You look mahvelous! (Get your CCH 2019 photos here.)
We've got some great photos from CCH, the IACP Foundation's RxMixer and IACP Comp-PAC events held this past May in Washington, DC this year.
Click here to view the photos.
For a limited time, you can download photos for free.
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Have you shared your concerns about <797> BUD extension problems?
We alerted you last month 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.
As reported above, IACP's board of directors hosted a conference call this week to discuss the issue with USP staff. We're also considering a formal appeal of the provisions.
We need YOU to take action, too.
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].
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IACP joins 200+ organizations to tell Congress: Fix DIRs
In a letter to Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) 204 pharmacy stakeholder and patient advocacy groups urged the Senate Finance Committee to include pharmacy DIR fee reform in its forthcoming drug pricing
legislation
. Read the final letter here.
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Don't miss: USP's 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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These benefits are for IACP insiders only...
You're a member, an insider, right? Right. So 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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Some days, our Twitter feed is a ghost town...
We're talking sagebrush and tumbleweeds, folks. IACP is pretty active on Twitter, but some days it feels like no one's there. You can help amplify our voice by liking and sharing our tweets. Facebook posts, too. In doing so, you amplify our voice and energize our social media presence.
- 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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Where's Noah when you need him?
On July 1, the IACP and IACP Foundation opened a new office in Alexandria, Virginia. Precisely a week later, we were welcomed with a flash flood. Three inches of rain in three hours turned the street outside our office building into a river over two feet deep and turned vehicles parked in underground parking garages into muddy, smelly, rusting messes. The good news: Our office is on the fourth floor. Here are a few photos for context.
By the way, our new mailing address is 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
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.
1:00 - 2:00 p.m. CST
Scotty Sykes, CPA
This course will identify concerns we see all to often in pharmacy poor accounting fundamentals. Fundamentals are key for tax planning. Also, will discuss areas of tax law applicable for pharmacies that are often overloading by those unfamiliar with the industry.
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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