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The voice for compounding pharmacy | November 27, 2019
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From IACP's President...
In voting that closed this past Friday, IACP members have overwhelmingly approved bylaws amendments that change IACP's name to the Alliance for Pharmacy Compounding.
Additional approved changes include:
- Clearly delineating the strategic role of the Board of Directors.
- Changing the title of our executive vice president to chief executive officer.
- Changing the title of our secretary-treasurer to treasurer and assigning duties as corporate secretary to our CEO.
- Clarifying that the Board may determine the headquarters of our organization.
- Clarifying certain timelines and roles related to Board and officer elections and proposed bylaws changes.
I'm grateful to those who supported these changes, which I think set the stage for our organization to cast a broader net in pharmacy compounding and help us grow in number and influence. More about that in the days ahead.
Our plan is to formally announce the name change in January. However, as you'll surely understand, changing an organization's name is a bit like turning a battleship, with multiple steps in the process (our name-change to-do list is six pages long!). You'll see some of those steps begin immediately, as we formally change our logo (see above photo), website URL (the new one, a4pc.org, rolls out this Monday, December 2), staff email addresses, and the acronym we use: IACP becomes APC. For now, we'll continue to attach the words "Formerly IACP" to most items, as audiences adjust to the changes. And for the next few months, our old iacprx URL and email addresses will automatically redirect to the new ones.
Behind the scenes, we'll be changing our name in our Articles of Incorporation and with the IRS, vendors and a wide range of other groups. We'll also be rebranding APC materials with the new logo and name. Then in January, with all those pieces in place, we'll announce our new name externally to media, sister organizations, regulatory agencies and members of Congress.
I'm excited about our new name, new energy and new vision, and I hope you are, too. IACP's future ... er, I mean APC's future ... is bright. I'm glad you'll be a part of it.
Read on for news about our newly elected 2020 Board of Directors, a hearing date (finally) in our USP appeals, and the latest draft regs from FDA regarding animal compounding - and have a joyful, restful Thanksgiving!
Jennifer Burch, PharmD, RPh, CDE
President
P.S. With all the good stuff happening right now, there's no better time to urge your pharmacy team members to join APC. Pharmacist dues are $450 annually and technician dues are only $125.
It's easy to join online.
One more thing:
Registration for EduCon 2020 opens this Monday, December 2. It's looking to be our biggest and best EduCon ever. Register before December 31 and save $100!
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USP <795> and <797> appeals hearings set for January
IACP and its fellow appellants have agreed to USP's suggested January 21-22 hearing dates on our appeal of beyond-use-date restrictions in the new <795> and <797> chapters. After the initial appeal by IACP, Innovation Compounding and Wedgewood was denied by the USP Compounding Expert Committee in August, we requested an appeal hearing as provided for in the USP bylaws. At the January 21-22, IACP and its partners will be allowed two hours to present to an appeals panel selected, USP says, to include relevant scientific and USP process expertise. The appellants may present both process and scientific arguments relevant to the BUD restrictions in the new chapters. In light of the appeals, USP in September indefinitely postponed enforcement of the new chapters.
Here are links to documents and other info about IACP's appeal and USP's postponement of the chapters:
- IACP's initial reporting on the BUD date restrictions in <795> and <797>
- IACP's Appeal (with Wedgewood and Innovations Compounding)
- USP Compounding Expert Committee's notification of rejection of the appeal
- IACP's (and partners') request for hearing on the appeal
- USP's announcement of indefinite postponement of the chapters
- IACP's briefing paper for members and state boards of pharmacy
- IACP's CALL TO ACTION to members to urge state BOPs to express concerns to USP
- USP's November 4 FAQ on Compounding Appeals
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Membership elects new APC board members
About 20 percent of IACP members voted in Board of Directors elections that concluded last Friday, November 22. David J. Miller of Grand Rapids, Michigan, was elected vice president, which puts him on track to be APC president in 2022. Alexander Pytlarz of St. Petersburg, Florida was elected to serve as treasurer.
Following were elected as 2020 APC board members:
President: Shawn Hodges, Kennesaw, Georgia
Chairman: Jennifer Burch, Durham, North Carolina
President-elect: Michael Blaire, Scottsdale, Arizona
Vice President: David Miller, Alto, Michigan
Secretary/Treasurer: Alexander Pytlarz, St. Petersburg, Florida
CEO: Scott Brunner, CAE, Alexandria, Virginia
District II: Joseph Navarro, Woodbury, New York;
Anthony Grzib, Swedesboro, New Jersey
District III: Jim Perry, Rock Island, Illinois;
Jeffrey Reses, Holly Springs, North Carolina
District IV: Ginny Isbell, Huntsville, Alabama;
Keith Guy, McComb, Mississippi
District V: A.J. Day, Houston, Texas;
Jim Hrncir, Irving, Texas
District VI: Cheri Kraemer, Sioux Falls, South Dakota
District VII: Stephanie Chacon, Scottsdale, Arizona;
Erin Michael, Cottonwood, California
At-Large Members: Amy Frost, Stevensville, Montanna; M
arina Holt, New South Wales, Australia
The first Board meeting of 2020 is set for January 17 - 18 in Las Colinas, Texas.
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EduCon 2020 registration opens this Monday, December 2
Registration for APC's EduCon event opens this coming Monday.
To be held April 6-9 in Denver in conjunction with the National Home Infusion Association's Annual Convention, EduCon aims to be the pharmacy compounding event of the year, an event you can't afford to miss.
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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FDA issues draft GFI on animal compounding from bulks
FDA
posted two important notices last week, one announcing a new guidance document on Compounding
Animal
Drugs from Bulk Substances and the other soliciting nominations for a positive bulks list for compounded veterinary office stock. We'll be reviewing both carefully and will almost certainly offer formal comment.
Please send your thoughts on this GFI or bulks list request to
[email protected]
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FDA will reclassify HCG as a biologic
FDA's reclassification of several Section 505 drugs as biologics is set to take effect March 23, 2020. Drugs reclassified as biologics may not be compounded without a biologics license, according to the FDA. Among the drugs to be reclassified is HCG. Because many compounders may not be aware of that reclassification, we are sharing documentation below:
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Upcoming LIVE Webinar: Pitfalls to Avoid in the CBD Arena
Tuesday, December 10, 2019
10:00 - 11:00 a.m. CST
Jeffrey S Baird, Esq.
Chairman, Health Care Group - Brown & Fortunato, P.C.
Bradley W. Howard
J.D. - Brown & Fortunato, P.C.
As is normally the case, the law is several years behind technological advancements. A case in point pertains to cannabidiol ("CBD"). Emerging evidence indicates that CBD has positive effects on a number of medical conditions. However, CBD has not been subjected to rigorous FDA-sanctioned clinical trials. While a number of states allow the sale of CBD for multiple uses, federal law remains restrictive. This program will discuss (i) federal and state laws pertaining to the sale of CBD,(ii) state law, specific to pharmacies, that is relevant to the sale of CBD by pharmacies, (iii) risks that pharmacies assume by selling CBD, and (iv) steps that pharmacies can take to reduce such risks.
Learning Objectives for Pharmacists and Technicians:
1. Describe the federal laws pertaining to the sale of CBD.
2. Recall the various state laws pertaining to the sale of CBD.
3. Outline the risks that pharmacies face in selling CBD.
4. Explain how the pharmacy can reduce risks arising from the sale of CBD.
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Empower your patients to push the point:
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Have you used IACP's members-only compounding policy resources?
- Compilation of State-Adopted USP 795/797/800 Rules Need to know which states have adopted which parts of USP chapters <795>, <797> or <800>? You'll find answers in our new "Compilation of State-Adopted USP 795, 797, 800 Rules." Click here to access the resource.
- 'State Compounding for Office Use and Veterinary Office Use' Resource 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 'State Compounding for Office Use and Veterinary Office Use' Resource, available here.
Both resources were created in collaboration with the National Alliance of State Pharmacy Associations and funded by generous grants from the IACP Foundation. Because both resources are for IACP members only, you are required to log-in to access them. If you need to renew your membership or are interested in joining IACP,
here's where to do that.
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Help fuel our advocacy success ... ...
Invest NOW in IACP's OneFund.
It's what fuels our advocacy work 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.a4pc.org/onefund
and invest today.
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Try these pre-recorded webinars, ready when you need them:
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