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The voice for compounding pharmacy | August 9, 2019
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From IACP's President...
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In that email, we also told you about the appeal we filed last week - along with Wedgewood and Innovation Compounding - concerning BUD extension issues with USP <797>. Our timing was good. USP's Compounding Expert Committee met yesterday and kindly invited us, as well as appellants in two other similar appeals, to meet with the committee and share our concerns. IACP Legislative Chairman Anthony Grzib and EVP Scott Brunner represented us at that meeting, and Anthony made a compelling case about the faulty assumptions behind prohibitions on BUD date extensions in both new chapters. I'm told committee members listened intently and asked pertinent follow-up questions. After hearing from appellants, the committee went into executive session to deliberate. We've not yet heard what was decided, if anything - but we'll keep you posted.
Lastly, a heads-up: Your IACP Board of Directors will travel to Salt Lake City next weekend for a strategic retreat hosted at board member Jeff Bray's MedQuest Pharmacy. We'll be looking to chart a new path for IACP by addressing a handful of important questions about how we serve you, including:
- Who do we aim to serve? How wide a net should we cast?
- What are our core competencies? What kind of work should we be most focused on?
- Is our current name the right reflection of who we aim to serve and the work we do, and if not, what should our name be?
- Is our governance structure conducive to the work we need to do and the outcomes we want to achieve, and if not, how can it be restructured to be more effective?
We're deeply grateful to the folks at Letco Medical for their sponsorship of our retreat facilitator and the membership survey
that will inform our discussion next weekend. I also appreciate our IACP directors, who are willing to spend their own money to come to Salt Lake City to do important work for our academy. I know they see it as an investment, like I do. Stay tuned for a report in a couple of weeks.
For now,
you keep taking care of your patients. We'll take care of your compounding practice.
Cheers!
Jennifer Burch, PharmD, RPh, CDE
President
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For IACP members only: New 'State Compounding for Office Use and Veterinary Use' Resource
This week IACP debuted a new members-only guide to current state laws and regulations for compounding pharmacists pertaining to compounding for office use and compounding for veterinarians and veterinary office use. The
'State Compounding for Office Use and Veterinary Office Use' Resource
was 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 informational only. The information contained in the compilation is not an IACP or NASPA legal review or interpretation of state laws and regulations, nor is it a compliance interpretation. It is not intended as a substitute for professional legal or other advice. Compounding pharmacies should always have legal counsel review applicable laws and regulations to ensure compliance, and should contact their state's Board of Pharmacy if there are questions regarding compliance.
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IACP joins formal appeal of USP regarding <797> BUDs
Last week we joined a formal appeal of the new USP <797> BUD extension restrictions.
The appeal challenges the scientific basis for what we believe are unnecessary restrictions on BUD extensions under the new USP <797> chapter set to take effect December 1, 2019. The process for such an appeal is stipulated under Article VII, Section 7 of the Bylaws of the United States Pharmacopeia Convention. Our aim is for USP to issue a revision prior to the effective date of the new chapter or to delay implementation until our concerns are addressed, and we've offered the Compounding Expert Committee our assistance as it considers our concerns. Wedgewood Village Pharmacy of Swedesboro, New Jersey, and Innovation Compounding of Kennesaw, Georgia, joined IACP in the appeal.
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What to be concerned about ...and what to 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:
- Read our twice-monthly Capitol Connections e-newsletter and respond to the calls to action we include in it.
- 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.
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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.
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IACP PAC chairman meets with Senators in Wyoming
IACP Board Member and PAC Chairman, Jeffery Bray met with Senator John Barrasso (WY), Senator Bill Cassidy (LA) and Senator Mike Enzi (WY) this week in Jackson Hole, WY and updated them on IACP's work with our partner pharmacy trade associations, FDA and other stakeholders to preserve patient access to compounded medications.
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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.
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Sign up for live courses on revised USP Chapters <795>, <797>, and <800>
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Money-saving, risk-mitigating services for IACP members only
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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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
Scotty Sykes, CPA
This course will identify concerns we see all too often in pharmacy, poor accounting fundamentals. Fundamentals are key for tax planning. Also, we will discuss areas of tax law applicable for pharmacies that are often overloaded by those unfamiliar with the industry.
ALSO COMING SOON: LIVE Webinar on Cannabis, CBD and Compounding.
Stay tuned for details.
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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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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