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The voice for compounding pharmacy | September 6, 2019
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From IACP's President...
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It's been fantastic over the past month to hear about IACP members who have hosted members of Congress in their pharmacies during Congress' summer recess. That sort of face-to-face, on-your-turf interaction with policymakers is absolutely the best way to brief members of Congress on what you do and how it helps patients and to talk with them about the challenges your practice is facing. Thank you, thank you, thank you to those of you who have gone the extra mile, extended the invitation, given the tour, and done a great service for your profession. My message to the rest of you: Go and do likewise! (And don't wait for a recess. Members of Congress are home many weekends, and it's a perfect time to host them.)
Speaking of exemplary pharmacy compounding leadership, I want to express my deepest appreciation, both personally and on IACP's behalf, to Jeff Bray, owner of MedQuest Pharmacy in North Salt Lake City, Utah. With his business growing as it is -- a great thing! -- he's made the decision to resign from the IACP Board and as our COMP PAC chairman -- a great loss for us. Jeff's passion for and leadership of our political advocacy efforts have been nothing short of marvelous, and his successor will have big shoes to fill. Thank you, Jeff. We wish you well as you focus on MedQuest's growth, and we look forward to your continued support as a rank-and-file IACP member.
One more thing:
PAY CLOSE ATTENTION TO THE FIRST ITEM THAT FOLLOWS BELOW
. This Tuesday, September 10, we'll be hosting an Advocacy Town Hall Call to brief members like you on our actions and progress in achieving several advocacy priorities. I promise it will be worth your time to listen in. Note, however, that our conference line can only accommodate the first 100 callers. We'll open the line 5 minutes before the call begins, so call early to assure your spot. We'll also share a recording of the call on our website after the fact.
Thanks for your continued support for IACP.
Cheers!
Jennifer Burch, PharmD, RPh, CDE
President
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Oklahoma will delay USP <800> enforcement until 2021
The Oklahoma Board of Pharmacy has announced it will not begin enforcing USP General Chapter <800> until July 1, 2021. This applies only to compounding pharmacies and other facilities handling hazardous drugs in Oklahoma. The state board members approved the USP <800> rules in March 2019, but informed board staff to not start enforcing them until July 1, 2021. The Board of Pharmacy urges Oklahoma pharmacies with any type of accreditation to check with the accreditation body to verify specific compliance deadlines. The Oklahoma USP <800> rules can be found here.
For other states that are implementing USP <800> without delay, the implementation date is Dec. 1, 2019. Be sure to check with your state's board of pharmacy for implementation details. Our sister association, NCPA, has developed a blank USP <800> risk assessment template and a sample template for testosterone to help its members create their own risk assessments for each hazardous drug as required by USP <800>.
Access their USP <800> Risk Assessment Templates here
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After vasopressin ruling, FDA speeds forward on bulk list recs
Last week, FDA released
notice List of Bulk Drug Substances for which there is a Clinical Need under the Federal Food, Drug, and Cosmetic Act
. The notice proposes NOT including 9 substances on 503B bulks list: dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide.
Both proposed regulations require a 90-day public comment period. IACP will be submitting comments. We urge our members and partners to review the proposed rules and submit comments as well.
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IACP and partners submit USP resolution focused on BUDs
Last week a group of associations whose members are involved with pharmacy compounding submitted to USP a proposed resolution urging USP to create an information chapter on beyond-use dates.
In addition to IACP, supporters of the resolution include
NCPA, APhA, ASCP and NASPA.
"USP should work proactively to create an Informational General Chapter to provide consistent interpretations of scientific rationale that compounders can utilize to extend beyond use dates on compounded sterile and nonsterile products," the resolution reads. "A separate Informational General Chapter would improve global health, as stated in USP's mission, as it would help maintain a safe supply of CSPs and CNSPs for patients who have benefited from compounded medications. A chapter on BUDs would also ensure pharmacies can continue providing CSPs and CNSPs that follow reliable scientific rationale to support BUD extensions."
When USP finalized Chapters <795> and <797>, it did not provide resources allowing compounders to extend BUDs for CSPs, thereby impeding patient access to medically necessary compounded products. IACP and other groups have appealed the BUD restrictions in both new chapters and are awaiting the next step in that process.
Proposed resolutions
will be taken up at the next USP Convention Meeting in Washington DC, scheduled for May 3-6, 2020.
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CALL TO ACTION ON BUD RESTRICTIONS: Here's what's needed...
As we reported in August, USP rejected three appeals by compounding pharmacy groups, including one to which IACP was a party, regarding beyond-use date restrictions in the new <795> and <797> chapters set to take effect December 1.
Read USP's response here.
Under USP Bylaws, the next step in the appeals process is to request a hearing by a USP panel whose appointees are outlined in the Bylaws. IACP and its partners will formally request that hearing in the next few days.
In the meantime, YOU CAN BE HELPFUL IN ASSURING USP HEARS CONCERNS FROM THOSE WHO WILL ENFORCE THE NEW STANDARDS IN STATES: Your state board of pharmacy. Read on...
We seek your immediate help
in seeing that expert input and perspective are shared with USP in advance of the expected hearing. USP needs to hear from your state board of pharmacy in particular.
ASAP, please contact your state board of pharmacy
, alert them to the problems with the new chapters, and urge them to write to USP to share their concerns.
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IACP leader visits Spectrum + member pharmacies in New England
IACP's EVP Scott Brunner has been on the road these past two weeks representing IACP at NASPA's summer meeting in Boston, visiting members across New England, sitting in on a New Hampshire Board of Pharmacy Compounding Committee meeting chaired by IACP member Dave Rochfort, and touring corporate member Spectrum's New Brunswick, NJ, facility.
Among the pharmacies he visited were Joe Lorello's Coastal Pharmacy + Wellness in Portland, Maine; Bill Beckman's Custom Medicine in Beverly, Mass.; Saad Dinno's Acton Pharmacy in Acton, Mass.; John Walczyk's Johnson Custom Compounding and Wellness in Waltham, Mass.; and Apothocare in Brockton, Mass., hosted by Rudy Dajie, a prospective IACP member. Scott was accompanied on the Massachusetts visits by IACP member Ernie Gates. Here's a photo recap:
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Big week for compounding pharmacy visits by Congressmen
As the Congress' summer recess comes to a close, we're delighted to spotlight (and thank!) three more IACP members who recently hosted members of Congress in their pharmacy or met with them at their local office. Hosting a member of Congress in your pharmacy - and taking pictures - is the very best way to build relationships and help elected officials understand what you do for your patients and community.
IACP member Larry Frieders met with Congressman Bill Foster (D-IL) recently to brief him on compounding pharmacy issues. IACP is grateful to Congressman Foster for his interest in our challenges and to Larry for reaching out to him!
IACP member Ed Zatta and the team at RXQ Compounding in Albany, OH who hosted Senator Rob Portman (R-OH) for a pharmacy tour recently. Thanks to Senator Portman for his interest in and support for pharmacy compounding and the millions of patients it serves - and to Ed and team for inviti
ng him!
And thank you to IACP member Mark Mandel from Mark Drugs for hosting Congressman Raja Krishnamoorthi (D-IL) recently and brief him on issues that compounding pharmacy is facing.
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Save these 2020 dates!
IACP's two annual conferences have been completely reimagined for 2020. You'll hear more about that soon, but for now, hold these dates on your calendar:
IACP's EduCon2020
April 7-9, 2020
Denver, Colorado
Co-located with NHIA's Annual Convention
Compounders on Capitol Hill 2020
September 9-10, 2020
Omni Shoreham Hotel
Washington, DC
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Call for nominations: IACP 2020 Officers and Board of Directors
We're seeking passionate, informed, influential compounding leaders to help guide our academy as members of the IACP Board of Directors.
Here's the job description:
- Strategic thinking.
- Stakeholder engagement.
- Resource allocation.
- Holding IACP accountable to the Board-ordained outcomes we're pursuing.
- Occasional crystal ball-reading.
Now is no time to sit back. The challenges confronting the profession are many. If compounding has been good to you, consider lending us what you've learned. Consider putting your knowledge and leadership ability to work on behalf of your profession. Work with us to confront those challenges.
Convinced? Click the link below.
The Process:
The Nominating Committee will receive nominations and recommend a slate of candidates to run for office. The
IACP Board of Directors
will approve the slate of candidates, which is then presented to the IACP membership for voting.
2020 Board of Directors Board Seats Available
For 2020 eight Board seats will stand for election, including the position of IACP Vice President (who in most instances will ascend to the IACP presidency). Please see detailed information below, including candidate eligibility and term length for each board position.
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Board Position
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Eligible Candidates
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Term
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Vice President
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The Vice President automatically becomes the IACP President-Elect, and then IACP President. Nominees must be a current or past Board member who have served at least one year on the Board.
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One seat available
for a one-year term expiring December 31, 2020
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Secretary/Treasurer
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Secretary/Treasurer nominees must have served at least one year on the Board prior to nomination.
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One seat available
for a three-year term expiring December 31, 2022
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District II
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(Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, Pennsylvania, Delaware, Maryland and Washington D.C.)
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One seat available
for a three-year term expiring December 31, 2022
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District III
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(Ohio, Indiana, Illinois, Virginia, West Virginia, Kentucky, North Carolina, South Carolina)
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One seat available
for a three-year term expiring December 31, 2022
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District IV
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(Florida, Georgia, Alabama, Mississippi, Arkansas, Tennessee)
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One seat available
for a three-year term expiring December 31, 2022
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District VII
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(Arizona, Nevada, California, Oregon, Washington, Idaho, Alaska, Hawaii)
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One seat available
for a three-year term expiring December 31, 2022
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At-Large Members
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Any eligible member from the United States, International members or a U.S. territory.
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Two seats available
for three-year terms expiring December 31, 2022
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Click the button above to submit your nomination to IACP
no later than midnight EDT
on Friday, October 11, 2019. Balloting will commence in November.
Important Dates
September 5, 2019: Call for nominations
October 11, 2019: Nominations closed
October 16, 2019: Report of the Nominating Committee
October 31, 2019: Election ballots distributed to IACP members
November 29, 2019: Balloting closes
December 13, 2019: Elected candidates contacted
January 3, 2020: 2020 Board of Directors announced to membership
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New state-by-state resounce on office-use and vet compounding
Need to know what a particular state's law or regulation has to say about office-use or veterinary compounding? You'll find answers in our new
'State Compounding for Office Use and Veterinary Office Use' Resource,
created in collaboration with the National Alliance of State Pharmacy Associations and thanks to a grant from the IACP Foundation.
The resource is available at
www.iacprx.org/StateCompoundingLaw
. Because it is a members-only tool, IACP members are required to log-in to access it.
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ONE WAY to protect your practice
Invest NOW in IACP's OneFund. It's what fuels our advocacy efforts on your behalf, from our work on Capitol Hill to our work at FDA and USP. Your IACP dues alone are not enough to allow us to accomplish our mission. OneFund covers the costs of our lobbyist, attorneys and more. PLEASE go to www.iacprx.org/onefund and invest today. |
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Membership has its privileges. Here are a few...
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.
- 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.
- Save $200 on the registration for CBI's upcoming West Coast Compounding Compliance Conference. Details here.
- Get 10% off $500 or more of marketing services from Storey Marketing. (Valid one time per pharmacy owner.)
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Help us build a following...
Help amplify IACP's voice by liking and sharing our tweets. Facebook posts, too.
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Other stuff worth reading
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LIVE Webinars:
Tuesday, September 17, 2019
1:00 - 2:00 p.m. CST
Registration Open Now!
Christine Roussel
Cannabidiol offers an interesting mix of pharmacological effects on various receptors expressing physiologic changes on multiple body systems, including metabolism of other medications. The goal is this presentation provide clinical clarity, as well as delve into the FDA and DEA positions on the molecule and understand the scope of the Farm Bill.
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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