The voice for compounding pharmacy  |  August 23, 2019
Enjoy our latest edition. Send your suggestions and questions to  iacpinfo@iacprx.org .
From IACP's President...
If you follow IACP on social media --   and I hope you do   (if not, the postscript below may be helpful...) -- you already know that your IACP Board of Directors spent last weekend in a strategic retreat in Salt Lake City, basically reimagining our organization. It was a great couple of days.
 
We emerged from that retreat as a stronger, closer-knit board, with an expanded view of who IACP serves and should engage, and with a draft set of outcomes we aim to achieve that will be polished over the next month or so and then voted on in October. Once approved, those draft ends will serve as IACP's road map, the lens through which we allocate resources and determine the services we offer and issues we're engaged in.  Those ends will drive everything.
 
Because they're still in draft form, I can only tease you with snippets here, but if approved, IACP will be focused on outcomes related to the following five things:
  1. Assuring patient access to compounded medications.
  2. Advocating on policy, legislation and regulation that supports the needs of pharmacy compounding professionals.
  3. Providing information and knowledge resources to help our members excel.
  4. Holding our members to the highest standards of ethical practice.
  5. Building a robust, multi-disciplinary pharmacy compounding community focused on the needs of members and patients.
Lots of work still to be done to determine how we measure our progress, and then our staff will develop plans and actions to get us there. For now, I want you to know where (we think) we're headed.  Stay tuned as we flesh-out and fine-tune.
     
The board also spent time at the retreat talking about how our association name should reflect our stakeholders and strategic purpose. As a result, we're considering a couple of options for a new association name. I'll have more to share with you about that in a few weeks, after we've done our due diligence.
 
I do want to thank IACP board member Jeff Bray for hosting the board at his beautiful MedQuest Pharmacy in North Salt Lake. I'm grateful, too, to our friends at Letco Medical for generously underwriting the cost of our retreat facilitator and member survey. And lastly, I sure do appreciate my fellow board members who joined us for the retreat. I'm grateful to be able to work with such a great, passionate group of professionals committed to elevating our profession.

Cheers!

Jennifer Burch, PharmD, RPh, CDE
President

P.S. Read on and you'll come to an item explaining how to follow us on Twitter, Facebook and LinkedIn.
USP to appellants: 'Thanks, but no thanks'
USP has 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.

"USP's response fails to address the lack of scientific basis for the BUD restrictions they are imposing, and thus is insufficient," said IACP's Executive Vice President Scott Brunner, CAE. "We are working with our coalition partners to determine next steps, including requesting a hearing, which is the proper next step under USP's bylaws."

You can read the appeal at  www.iacprx.org/USPAppeal . Also, you'll find our member briefing on the <797> BUD extension issue at  www.iacprx.org/USP797BUDs .

Want to be helpful? Read on...
CALL TO ACTION: USP <795> and <797> BUD Restrictions
We seek your immediate help in seeing that expert input and perspective are shared with USPC in advance of the expected hearing. USPC needs to hear from you, your state pharmacy association, and -- perhaps most importantly -- your state board of pharmacy.

ASAP, PLEASE:
  1. Contact your state board of pharmacy, alert them to the problems with the new chapters, and urge them to write to USPC to share their concerns.
  2. Email USPC yourself: CompoundingSL@USP.org.
  3. Urge your state association to write to USP, too.
  4. Education your patients and other stakeholders about our concerns. Utilize your social media channels, and don't forget to tag USPC. It's @USPharmacopeia. (Tag IACP, too: @iacpRx.)

Together, we can make a big difference for your compounding members and patients they serve.
New 'State Compounding for Office Use and Veterinary Use' Resource, for members only
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 new resource provides information about:
  • Which states allow office-use compounding and veterinary office-use compounding.
  • Special provisions, prohibitions, or requirements where office-use compounding is permissible.
  • Applicable law and rule text.
  • Links to state websites where compounding laws and regulations may be found. 
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.
Your compounding operation is under fire. Here's what you can do about it.
Are you concerned about:
  • FDA's plans to finalize an MOU this year that states may not sign?
  • BUD extension restrictions in USP <797> and the impact on patients?
  • USP <800> compliance and how it will affect your pharmacy operation?
  • How the NASEM study on cBHRT may be used by FDA to limit access?
  • FDA's slowness and restrictiveness on the 503A and 503B bulk lists?
IACP is, too. That's why those issues are our top priorities,  and we're working hard to assure they're settled in ways that don't disadvantage your compounding patients and business. This summer alone, we've:
  • Recommended to FDA an MOU compromise that can satisfy most concerns.
  • Joined in a formal appeal of USP <797> BUD extension prohibitions.
  • Testified at a NASEM hearing about the value and necessity of cBHRT.
  • Reiterated to FDA our concerns about its overly-restrictive approach to the bulks list and the uncertainty that's creating in the 503B world.
But we can't assure a positive outcome on these issues without your help. Here are three things you can do to help us address these concerns:
  1. Read our twice-monthly Capitol Connections e-newsletter and respond to the calls to action we include in it.
  2. Contact your members of Congress and invite them to visit your pharmacy during summer recess. Give a tour and talk with them about these concerns.
  3. 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.
 
Lots of concerns, but also lots of opportunity. Help us achieve the outcomes you want for your compounding business. Thanks for supporting our work.
IACP members meet with Congressmen in their pharmacies
IACP Board Member and PAC Chairman, Jeffery Bray hosted Senator Mike Lee (UT) on August 17 during IACP board's recent retreat at MedQuest Pharmacy. Bray and his fellow board members updated Lee on IACP's work to encourage FDA to consider our 'middle way' proposal on the state MOU.

IACP members, David and Cathy Miller, Mike Collins, and Brad McCloskey hosted Congressman John Moolenar at Heathway Pharmacy in Saginaw, MI on August 21. 
Ever wondered what your FDA investigator is focusing on?
Subscribe to FDAnews' 483s Online and you can find out. Use it to help you stay in compliance with FDA regulations.  The site has multiple search options for Form 483s and other information.
Need training on USP Chapters <795>, <797>, and <800>?
Early bird discounts are available until August 30.  Seating is limited, register today for the 2019 Fall Session. Classroom and webcast registrations available. 
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.)
Help us build a following...
Help amplify IACP's voice by liking and sharing our tweets. Facebook posts, too. 
Other stuff worth reading (and to listen to, too)
Corporate Member spotlight
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Features:
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LIVE Webinars:

Tuesday, September 17, 2019
1:00 - 2:00 p.m. CST
Cannabidiol: Clinical & Legal Considerations 
Registration Opening Soon!
Christine Roussel
Doylestown Hospital

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.



Help us help you. INVEST in IACP's One Fund and you'll fuel IACP's legislative and regulatory advocacy efforts!

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