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Bi-weekly Member Newsletter
May 4, 2018
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Keep up-to-date with the latest legislative and regulatory news. Visit
IACP's website.
Archived
Capitol Connections
newsletters here. Send your suggestions and questions to
[email protected]
.
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Final Executive Vice President Address: Thank you for our time together!
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Cynthia Blankenship, Esq. IACP Executive Vice President
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(As published on Monday, April 30, 2018)
Dear IACP Members:
Following my father's passing, I have given a lot of thought and spent a lot of time praying and discussing with my family as to what is best for my family. It is with great gratitude for the opportunity to work for IACP for the past six years, that I come to you with a heavy heart to announce my resignation. My last day will be May 4
th.
I feel we accomplished a great deal together these past six years, and I have enjoyed how much we've done together during the past year during my term as Executive Vice President. I am confident that IACP is in a much better place and has leaders in place that will only improve IACP in the future. The engagement and participation of the IACP Board and Chairs is absolutely essential for the success of IACP.
In anticipation of my departure, I am preparing a very extensive departure memo that will be sent to the Executive Committee to be provided to the incoming EVP. The memo will be a deep dive into all IACP programs, changes we have incorporated, and any outstanding matters. We have completed our projects launch calendar with only CCH promotion remaining, but I have detailed every program and the rationale behind it in the memo to provide insight into what each new program offers. The memo will also contain contact information for everyone we work with, including the DQSA Coalition, affiliates, those we have contracts with, etc. It will be my way of introducing the new EVP to all those I've worked with over the past six years.
Thank you for the opportunity to serve IACP and its members for the past six years. It has been a journey I will always remember and cherish. I will always consider pharmacists family. After pouring my heart and soul into IACP the past six years and pharmacists the past 11 years of my career, I wish each of the Board members, EC, IACP members, and IACP the absolute best, with what I hope to be many prosperous years. Thank you for the friendships I will carry with me for a lifetime.
Sincerely,
Cynthia Blankenship
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President's Thank you to EVP
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| Erik Tosh, D.Ph., FIACP, FACA, IACP President |
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(As published Monday, April 30, 2018)
The IACP Board and Executive Committee (EC) thank Cynthia for her many years of service to our organization, membership, and ultimately the patients we serve. Cynthia has been with IACP during some of the most challenging times compounding has encountered. Her guidance and leadership were invaluable. We will miss her energy and sharp focus on the issues.
Cynthia is working closely with the EC and staff to ensure a smooth transition in leadership. Additionally, her input on the evolution of the organization during her time with us will provide the next leader with strategic tools that are needed to grow IACP.
During this period, I and the IACP Board EC will ensure member-driven initiatives are implemented. We will announce Interim EVP as soon as possible.
We encourage every member to take a minute to send a thank you to Cynthia.
Lastly, I want to personally thank Cynthia for her profound sense of duty and love of family.
With deepest regret on your departure and best wishes for your future,
Erik Tosh, D.Ph., FIACP, FACA
President, IACP
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EVP and IACP Ambassador Tracking
The
NEW IACP Ambassador Program, created by the
IACP Membership Committee and chaired by Doug Yoch, has been announced and we have already received two applications from interested IACP Members. The IACP Ambassador Program give IACP members an opportunity to
represent IACP as an ambassador at specific conferences and events. In return, IACP Ambassadors will receive discounts on registration to IACP events and other benefits. This is one more way we are listening to your feedback and requests! We heard that you want to be able to represent IACP more at other conferences and events by speaking and we are answering your call! For more information click
here.
- IACP Executive Vice President and USP Delegate, Cynthia Blankenship, attended the USP Compounding Expert Committee (CEC) on April 11th. The USP CEC met to develop and revise existing compounding-related general chapters describing quality and practice standards for compounding sterile and nonsterile preparation. The CEC will continue to develop compounded preparation monographs containing formulations for both human and veterinary patients.
- IACP attended the PCCA ACT Legislative Conference in Washington D.C. on April 18th - 19th. The conference began with a half day of educational programming on Wednesday afternoon followed by an opening dinner, and a legislative breakfast on Thursday was followed by Congressional visits and a closing reception.
- IACP will be hosting Compounders on Capitol Hill (CCH) on June 23-26, 2018 in Washington D.C. This is one event you don't want to miss! We hope to see you there while we discuss current events in compounding pharmacy and Storm the Hill to preserve patient access!
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BOOK ASAP TO GET CONFERENCE RATE OF $229/NIGHT!!
Advanced Registration Discount ends, Monday, May 14th!
Congressman Morgan Griffith to speak at #CCH2018!
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Hear Congressman Griffith explain why you need to attend #CCH2018 |
You do not want to miss this opportunity! Congressman Griffith is a longstanding champion for patient access to vital compounded medications. Congressman Griffith is a member of the House Energy and Commerce Committee, and was instrumental in leading the Congressional DQSA hearing held by the House Energy and Commerce Committee. Congressman Griffith also introduced bipartisan legislation that seeks to address concerns with FDA's implementation of the DQSA that are negatively impacting patient access to compounded medications.
Don't miss this session and the opportunity to share your stories and thank Congressman Morgan Griffith for his true leadership in preserving patient access to compounded medications! Don't miss CCH 2018!
CLICK HERE
to register for #CCH2018 and meet Congressman Griffith!
CLICK HERE
to view the #CCH2018 Schedule at a Glance.
Storm the Hill with Your Colleagues in Washington, DC and Share Your Patients' Voices with Capitol Hill to Preserve Patient Access to Compounded Medications!
Join us in Washington, D.C. for the 24th Annual Compounders on Capitol Hill (CCH), June 23-26, 2018 at the Renaissance Washington D.C. Downtown Hotel.
Register today for CCH 2018 to walk the halls of Congress to protect, promote, and advanced the art of compounding. This is not the time to sit on the sidelines, we need you and your voice at CCH more than ever!
LET THE GAMES BEGIN!
IACP Announces Competitions that Offer FREE or Greatly Reduced CCH
Registration as Awards!
CCH 2018 Overall Champion and State Captain Competition
GET ACTIVE, GET INVOLVED, GET ENGAGED!
This competition is as simple as telling others why attending CCH is so important
. Compounding is personal and so are the stories from you and your patients. Your Voice Matters - Your Vote Matters. YOU have something that no one else has - YOUR vote which spans in every Congressional district. YOUR presence is important as we Storm the Hill and walk the Halls of Congress at CCH! The stakes are too high, and this is not the time to sit on the sidelines and hope that someone else will represent compounding pharmacy. Join your colleagues in preserving patient access and join us in the Halls of Congress to deliver this messaging like ONLY YOU can.
#CCH2018 Exhibitor Prospectus Now OPEN!
Exhibitors and Sponsors, Come Join Us in D.C.
IACP's annual Compounders on Capitol Hill is attended by top-level compounding pharmacists and pharmacy technicians from across the country. We anticipate hosting more than 300 registrants in 2018. Attendees are the leaders in the compounding profession and the decision makers in the pharmacy.
This exhibition provides vendors an opportunity to network with attendees and promote your business among the decision makers in pharmacy compounding. The Exhibition Hall is located directly across from the registration area where all attendees must check-in and the CE General Session room. It is also the location for the attendee's breakfast and lunch for two days of the conference. All traffic to and from the General Session meeting room will travel in front of the Exhibition Hall.
We have added additional Exhibit Time! Over the course of three days, vendors will have eight hours dedicated solely to exhibition time. In addition, vendors are invited to participate in all educational sessions, social events, and appointments on Capitol Hill. We know you will agree that with 300 total attendees and approximately 50 exhibitors, this is an intimate gathering perfect for face-to-face business opportunities.
In addition, sponsorship provides an excellent opportunity to spread the message that your company supports compounding pharmacy! By agreeing to sponsor CCH, your company will gain access to the following benefits:
- Increased exposure to CCH attendees
- Company name and logo listed on the item selected
- Prominent listing on signage located in the registration, exhibit and breakfast/lunch areas
- Recognized in all conference program materials including the meeting syllabus
- Acknowledged in the meeting website, the bi-weekly newsletter, Capitol Connections and the meeting newsletter.
How Can You Support this Event?
We would love to have your support as an exhibitor and sponsor! Please consider both, today!
We would like to thank the following exhibitors for their commitment to Compounders on Capitol Hill:
Accreditation Commission for Health Care (ACHC), AirClean Systems, American College of Apothecaries (ACA), ARL Bio Pharma, Associates of Cape Cod, Inc., AX Pharmaceutical Corp, B&B Pharmaceuticals, Inc., Becton Dickinson, Cardinal Health OptiFreight Logistics, Charles River, DoseLogix /Topi-CLICK, DUTCH test by Precision Analytical, Eagle Analytical Services, Encore Scientific, Fagron, Inc., FlackTek, Inc., Hardy Diagnostics, Humco Holding Group (CS), IJPC, Infinity Laboratories, Lakeland Industries, Letco Medical, MEDISCA, National Community Pharmacists Association (NAPC), PCCA, Pestle® Pharmacy Compliance Software, Prudential Cleanroom Services, Q.I. Medical, Rxinsider, Specialized Rx, Spectrum Pharmacy Products, Storey Marketing, SV Enviornmental Consulting, Willow Birch Pharma, World Wide Medical Distributors, Inc.
We would like to thank the following meeting sponsors for their support of the 2018 Compounders on Capitol Hill: DoseLogix/Topi-CLICK (Meeting Notepad/Pen Combo); Flacktek, Inc. (Happy Hour); Letco Medical (Welcome Reception, President's Reception, Meeting Hotel Key Cards, Congressional Handbooks); PCCA (Meeting Syllabus, Name Badge Holder, Travel Mugs, CE Session).
We would like to thank the following individual and pharmacy meeting sponsors for their support of
Compounders on Capitol Hill:
Presidential Sponsor
: Jeffery Bray, CEO, MedQuest Pharmacy, North Salt Lake, Utah.; Congressional Sponsor: Billy Chatoff, Pharmacist, Colchester, Vermont; Judicial Sponsor: Bradley McCloskey, Owner, University Compounding Pharmacy, Troy, Michigan.; Contributor Sponsor: Amy Blackwell, Chief Marketing Officer, Monument Pharmacy Inc., Monument, Colorado; Kevin Borg, Owner/Pharmacist, Potter's House Apothecary, Peoria, Arizona; Rod Haselhorst, Pharmacist, Letco Medical, Decatur, Alabama; Jim Hrncir, RPh/Owner, Las Colinas Pharmacy Compounding and Wellness, Irving, Texas; Charles Lipeles, VP, Mecart Cleanrooms, Michleton, New Jersey, Phung Matthews, Pharmacy Director, MedQuest Pharmacy, North Salt Lake, Utah; Steve Moore, PharmD, Condo Pharmacy, Plattsburgh, New York; Hali O'Malley, Pharmacy Compliance Director, MedQuest Pharmacy, North Salt Lake, Utah, Gener Tejero, RPh, Solutions Specialty Pharmacy, Las Vegas, Nevada.
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To help keep up with IACP. We want to make sure you can connect with us on all our social media channels.
Please like, follow, share and comment on our social media posts! Here is a quick list of links and all the places you can interact with us!
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IACP's Education Committee has been working diligently to ensure we provide the continuing education (CE) compounding pharmacy professionals need. IACP kicked off 2018 with an awesome Educational Conference program, which embarked our journey to providing you more LIVE CE's!
IACP is continuing our commitment to provide you with more Live CEs by launching the IACP AdvanCE Webinar program! Under the new webinar program, IACP AdvanCE will now be offering quarterly educational tracks with multiple LIVE webinars throughout the year to be your one-stop shop for all CE related to pharmacy compounding! IACP AdvanCE is a one-stop shop to find a comprehensive selection of compounding specific continuing education that specializes in legislative, regulatory and practice topics that can affect you and your practice.
If you're unable to attend LIVE webinars, IACP will be offering self-paced programming. The LIVE webinars and self-paced online programming are open to members and non-members offering a variety of continuing education and in an effort to reach more compounding pharmacy professionals. There is something for everyone with the new IACP AdvanCE Webinar and self-paced programs!
Interested in Sponsoring a LIVE Webinar, click here.
(Dates and titles are subject to change)
11:00 a.m. - 12:00 p.m.
Patricia Storey, RPh, President, Storey Marketing
Social media is an effective and economical way to spread the word about your pharmacy, products, and services. Social media marketing should share your brand and direct visitors to your website, in turn generating new customers and introducing visitors to additional services that you offer. However, it's important to follow guidelines for every platform and to make regular page updates to take advantage of new opportunities from Facebook and Google.
May 23, 2018
Rafi Benamoz, CEO, Benamoz Entrepreneur Solutionz
May 30, 2018
Jim Hrncir, RPh, Owner, Las Colinas Pharmacy
This program is made possible through an unrestricted educational grant-in-aid from the IACP Foundation
.
June 6, 2018
Scotty Sykes, CPA, Sykes & Company, P.A.
June 27, 2018
John Preckshot, RPh, CNN, FAARM, Director, Wellness Works Nutrition
** Webinars may be purchased by the bundle or individually**
Interested in Sponsoring a
LIVE
Webinar
,
click here
.
*
All sessions carrying the ACPE program number are approved for continuing education credit. The UNC Eshelman School of Pharmacy are accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education. The International Academy of Compounding Pharmacists' programming is co-sponsored by the American Society of Health-System Pharmacists and UNC Eshelman School of Pharmacy.
Don't miss these upcoming LIVE webinars!
Multiple webinars throughout the year - please click title for exact dates.
Featured
Webinar Programs:
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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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IACP's THREE NEW Membership Categories are NOW Available!
Educational Institutional Membership
Pharmacy Technician Student Membership
Executive Membership
IACP heard your request and is thrilled to announce three new categories. We launched the Executive category a few weeks ago and now we have two more to better fit the needs of current and new members.
Educational / Institutional membership ($100/yr)
was created for Program Directors, full-time pharmacy or pharmacy technician program educators, State Board of Pharmacy members and Board staff.
Benefits:
Pharmacy Technician Student membership (FREE)
was created to include Pharmacy Technician Students that are currently enrolled in any ASHP/ACPE accredited pharmacy technician program and would like to learn more about compounding and become more involved either through scholarships, networking or volunteer opportunities.
Benefits:
IACP's
Executive Membership
Want to be an
IACP VIP?
Then the
Executive Membership
is for you! If you are thinking about going to CCH this year, this is the perfect time to upgrade or renew your membership to the Executive level and receive a
FREE CCH registration
! This benefit starts right away! We would love to see you there and Storm the Hill with your peers. Registration rates for CCH go up on May 15
th
!
Benefits of the Executive Category include:
- One ticket to the annual President's Gala
- Additional 10% discount on registration to the Educational Conference
- Reserved seating at live educational events
- One FREE registration to Compounders on Capitol Hill (registration may be transferred to another person if not used by the owner of the membership within the calendar year, if not used the monies will be considered a donation to IACP's One Fund)
PLUS
- One listing on IACP's Locator Service
- Use of the IACP Member logo
- Access to IACP AdvanCE series live and on-demand webinars
- Discounts from Corporate Members and Affiliates
- Access to a variety of IACP Member communications and information including: Legislative & Regulatory Affairs monitoring, State Compounding updates, State Board of Pharmacy updates, Capitol Connections bi-weekly e-newsletter, Member Alert emails, Breaking News on our website, Partnership for Personalized Prescriptions (P3) Advocates, DConnection Blog, discounts to educational seminars, networking, exclusive IACP Members Only website access, IACP Career Center, published white papers and more.
You get all this for only $1,500/year!
We are now up to 14 new Executive Members! Will you be next?
Thank you, Jennifer, Shawn, Jeff, Linda, Joe and all the other Executive Members!
To join them - upgrade your membership today!
If you are ready renew now, you can
upgrade your membership online
. If you are interested in upgrading your current membership today, give us a call at (281) 933-844 and we will make it happen!
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Let's Keep the Momentum Going - Please Contribute to IACP's One Fund! We need your help, TODAY! Make the donation that will help Preserve Patient Access to Compounded Medications, and help support IACP's HR 2871 efforts. IACP is working to Protect, Promote & Advance Pharmacy Compounding!
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New IACP Committees Are Starting to Meet - It's Not Too Late to Join!
IACP is thrilled to see the outpouring interest we have had in joining IACP Committees and the fantastic chairs at the helm. The new committees and subcommittees below are really ramping up. They are setting their meeting schedules and will be meeting soon. If you are interested in joining one of these committees or subcommittees, or a different committee, please let us know!
Please take a look at all of the IACP Committees HERE
and let us know where you would like to serve! We would love to have you on an IACP Committee. Stay tuned next week for an announcement of a new Committee Chair as well!
IACP Needs YOU!
We have immediate openings on the following committees, but if you see a different committee you are interested in, please let us know!
- IACP Legislative State Sub-committee, Chaired by Mike Blaire, this committee will be focusing on State Compounding issues and have already been instrumental in providing input for recent State actions.
- IACP Legislative Animal Compounding Sub-committee is seeking a Chair and committee members. The Animal Compounding Sub-committee has been formed due to member-driven requests for IACP to engage in activities for animal compounding.
- IACP Strategic Planning Infrastructure Review Sub-committee is also seeking committee members. Do you have experience with things like association management software, websites, IT services and all things that help a business run smoothly? We need people to help IACP review our current internal programs and services.
Join a Committee and Help Work on the Exciting New Programs We Have in Store for 2018!
IACP is a success because of YOU! Please take a moment and look at what
IACP Committees
are doing and let us know if you would like to join a Committee. We would love to have YOU on an IACP Committee. In addition, in response to your direct feedback on the IACP Membership Survey, the IACP Board has responded by creating new Committees and one new Committee Subgroup.
Please email IACP's Jennifer Petska, BS, CPhT, IACP Director of Development & Membership, at [email protected] for more information or if you are interested in joining any committee.
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IACP MEMBER ALERTS
IACP Weekly Roundup
provides a new way to keep you up-to-date on IACP's Member Communications! We know you're busy, so we are making sure you don't miss a beat by rounding up all the IACP news that goes out to members in one location to make it easier for you to never miss any news on compounding!
Check out what news
your Academy has been sending.
INDUSTRY NEWS
- It has been five years since the passage of the Drug Quality and Security Act (DQSA) meant to address safety concerns about compounded drugs.1 The Food and Drug Administration (FDA) is still laboring to fulfill the law's provisions, which were intended to allow the agency to walk the fine line between assuring public safety while ensuring access to legitimately and safely compounded drugs. It is a tough balancing act, especially given the FDA's chronic funding shortage, which impedes regulation development, inspections, and enforcement. At hearings in front of the House Energy and Commerce Committee on January 30, FDA Commissioner Scott Gottlieb, MD, admitted that the FDA's compounding regulatory program "is a program where we do operate by, in some cases, begging, borrowing, and stealing from other aspects of the agency.
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IACP MEMBER NEWS
IACP Executive Memberships Total 14 Since Announced
IACP is so pleased to announce we are now at fourteen (14) Executive Memberships! Thank you for supporting IACP and our efforts to preserve patient access.
We heard your request! Many of you responded to the IACP Membership Survey that you would love to see an IACP membership category that gives you additional benefits to IACP events. Thanks to your feedback, we have hit it out of the park! As soon as it was announced we had four members upgrade their existing memberships, and the momentum just keeps going. For more information about our Executive Membership please click
HERE.
If you are thinking about going to CCH this year, this is the perfect time to upgrade or renew your membership to the Executive level and receive a
FREE CCH registration
! We would love to see you there and Storm the Hill with your peers! For full details visit our
WEBSITE
or click
HERE FOR A PDF
.
Will you be our next IACP VIP, as an Executive Member? Let's keep the momentum going!
Members of Senator Orrin Hatch's office tour MedQuest Pharmacy
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Jeffery Bray, Stuart Portman, Hali O'Malley, Phung Matthews, Lauren Paulos and Kathy Varley |
Lauren Paulos and Stuart Portman from Senator Orrin Hatch's office toured MedQuest Pharmacy to learn more, and to gain first-hand knowledge, of compounding and how MedQuest approaches both quality and compliance.
MedQuest gave them an overview of the company's history and walked through the process of how MedQuest receives prescriptions, their relationships with both patients and prescribers and the flow from start to finish. The majority of the visit was spent in the actual compounding lab.
MedQuest was able to show Paulos and Portman every delivery form MedQuest makes, demonstrate compounding of those delivery forms and answer all of their questions. They asked many informed questions, were extremely interested and had fun as well.
2018 HR Achievement Awards
Utah Business Editors Apr 9, 2018
HR leaders are usually more accustomed to giving out kudos than receiving them. That's why we're delighted to turn the tables and give some stellar HR professionals the recognition they deserve.
Mrs.
Heidi Humphries, Director of Human Resources of
MedQuest Pharmacy was honored on April 9, 2018 at a reception with the 2018 HR Achievement Award from Utah Business Magazine. Heidi is a key member of the MedQuest Pharmacy team and does an incredible job of bringing in and supporting talented pharmacy professionals, many of these are IACP members themselves.
The NPA Congratulates New Board of Pharmacy Member
The NPA congratulates, Angie Svoboda, PharmD, as the newest member of the Nebraska Board of Pharmacy.
Dr. Svoboda is the Pharmacist-In-Charge at Good Life Pharmacy in Ord. She received her Doctor of Pharmacy from the University of Nebraska Medical Center College of Pharmacy and is an Associate Professor of the University of Nebraska College of Pharmacy, as well as a Fellow of the International Association of Compounding Pharmacists.
Dr. Svoboda replaced Board of Pharmacy member, Maggie Kucera, and now joins the other pharmacist members of the Board of Pharmacy: Sabrina Beck, Omaha; Patty Gollner, Hastings; and Ken Saunders, Omaha.
IACP Board Member, Erika Fallon
was recently on an episode of
Pharmacy Inspection Podcast
and shared more about IACP and why it was important to be involved. Thank you, Erika!
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IACP CORPORATE MEMBER SPOTLIGHT
AirClean® Systems is North America's largest manufacturer of ductless containment solutions, offering the widest range of application capability, innovative safety features, and construction material. Independently tested and certified PowderSafe™ ductless balance enclosures are the compounder's choice for powder, particulate, and vapor containment within the pharmacy. AirClean® Systems also manufactures other ductless containment solutions suitable for the pharmacy setting, including laminar flow workstations, clean benches, and chemical workstations. All products are shipped fully assembled and manufactured in the USA.
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Federal Advocacy
DQSA Coalition Meeting with FDA
The DQSA Coalition met with FDA on Monday, April 30th at FDA's White Oak facility to discuss patient access to compounded medications issues. IACP's Vice President, Shawn Hodges and IACP Board Member, A.J. Day presented during the meeting. The meeting was positive in nature and the Coalition's goal was to increase communication, collaboration and to positively impact policy from the agency that will protect patient access to compounded medications.
- The FDA has introduced draft guidance that, if finalized, would expand the agency's oversight of drug compounding and restrict the production of compounded drugs in FDA-registered outsourcing facilities.
- Although the guidance - which is open for public comment until the end of May - aims to protect patients from potentially harmful drugs, there is concern that the proposed regulations may decrease patients' access to affordable treatment alternatives to FDA-approved products.
- Moreover, because the more stringent regulations apply only to drug compounding facilities that are registered under the FDA, some argue the guidance could discourage facilities to work with the agency, thereby resulting in more drugs that are developed under lower compounding standards.
- The FDA defines drug compounding as a practice in which a licensed pharmacist, physician or individual under the supervision of a licensed pharmacist modifies the ingredients of a drug to create a treatment for an individual patient whose needs cannot be fulfilled by an FDA-approved product. Drug compounders can either develop their products using an FDA-approved drug or a "bulk drug substance" that is identical to an active pharmaceutical ingredient (API). Bulk drug substances are often used when the FDA-approved product contains ingredients that are "inappropriate" for the patient, according to the FDA, However, the agency warns that using bulk drug substances in compounded drugs may be not be as safe for patients.
FDA Nomination Slide Posting
FDA is planning to post the nominator slides from past PCAC meetings. Moving forward, FDA will be posting nominator slides shortly after the meeting along with all other post-meeting documents.
The
International Academy of Compounding Pharmacists (IACP)
on behalf
of our more than 4,000 compounding pharmacists and the patients and providers they serve, is sharing the information from FDA regarding a request for nomination to the Pharmacy Compounding Advisory Committee.
IACP has worked diligently along with the DQSA Coalition members and Members of Congress to send Congressional letters, letters from the Coalition, obtain numerous statements from Congress, and obtain Appropriations Report Language urging FDA to implement the DQSA in manner that is consistent with Congressional intent by allowing stakeholder input in the form of voting positions on the PCAC.
Throughout all of these efforts, IACP has expressed strong concern with the only compounding pharmacist on the PCAC being designated as a non-voting position and has urged FDA to include stakeholders that provide and depend on compounded medications as these stakeholders thoroughly understand patients' need for access to these vital compounded medications.
Most recently, during the Congressional Hearing held by the House Energy and Commerce Committee where IACP Vice President, Shawn Hodges, testified, IACP submitted written testimony expressing many concerns with FDA's implementation of the DQSA, including concerns with the structure and process of the PCAC. During that hearing, Members of Congress, urged Commissioner Gottlieb to move forward with including stakeholders as voting members of the PCAC.
As FDA moves forward in soliciting nominations, IACP strongly encourages FDA to follow the will of Congress and allow compounding pharmacists to serve on the PCAC as voting members.
If you want a Letter of Recommendation from IACP or for IACP to officially submit your application, please let us know if you would like to serve on the PCAC by filling out the application and submitting your CV to IACP HERE
. The IACP Legislative Committee and Board of Directors will be considering nominations over the coming weeks.
To find out more about serving on the PCAC and the process, please click
HERE.
IACP's Initial Comments Regarding the FDA Press Release, Guidance document and additional FDA comments
IACP's general impression is that the FDA's draft guidance, "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act", is a disincentive for anybody to register as a 503B, which makes it contrary to Commissioner Gottlieb's statements before the House E&C committee. As mentioned in the current guidance document lines 47-53,
"Drug products compounded under the conditions in section 503B are not exempt from current good manufacturing practice (CGMP) requirements in section 501(a)(2)(B) of the FD&C Act.5 Outsourcing facilities are also subject to FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that help to mitigate the risks of the drug products they compound.6 Outsourcing facilities may or may not obtain prescriptions for identified individual patients and can, therefore, distribute compounded drugs to healthcare practitioners for "office stock," to hold in their offices in advance of patient need. 7"
Within this framework, it is difficult to follow FDA's concerns about sources of pure ingredients (what FDA refers to as "bulk"). 503B Outsourcing Facilities are required to purchase all ingredients according to statutory requirements, including that the pure ingredient manufacturers are FDA-registered and comply with all applicable quality standards. Since FDA inspects the pure ingredient manufacturers and the outsourcing facilities to hold them accountable to those standards, the statements in this draft guidance that question the quality of the pure ingredients used by outsourcing facilities vs. those in FDA-approved drugs are false and misleading. To read the full statement click here.
To read the guidance document
"Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act." Click
here
.
Statement from FDA Commissioner Scott Gottlieb, M.D
., on a key step in advancing FDA's oversight of drug compounding and implementing new laws governing outsourcing facilities. Click here.
FDA Releases Guidance Directed at 503B Outsourcing Facilities
Today, FDA released guidance entitled
"Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.". IACP is currently reviewing this guidance and will provide a full statement next week. Upon our initial reading, there are strong concerns with this guidance and how it will impact patient access to compounded medications. Please stay tuned for IACP's full analysis and statement next week!
To read the guidance document "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act." click
here
.
Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA's oversight of drug compounding and implementing new laws governing outsourcing facilities
For Immediate Release
March 23, 2018
Statement
Today, we're taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need - the 503B bulks list.
Today, we're issuing a critical policy document that addresses how that list will be formulated, and what bulk drug substances the outsourcing facilities can use to compound drugs.
Compounding can be critical for advancing the health of patients who have specific medical needs that cannot be met by FDA-approved drugs. However, because compounded drugs are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness and quality; they also present a greater risk to patients than FDA-approved drugs. This was illustrated by the 2012 nationwide fungal meningitis outbreak. This tragic outbreak led to more than 750 cases of illness and the deaths of 64 individuals who had used a compounded drug for injection that was supposed to be sterile, but became contaminated.
In response to that public health tragedy, Congress enacted the DQSA in 2013 to enhance the safety and quality of these medicines. Advancing the FDA's compounding program is a high priority for the agency. We're fully committed to implementing the DQSA requirements in a way that preserves access to compounded drugs for patients who have a medical need for them, while protecting patients from poor quality or otherwise unsafe compounded drugs that could cause them serious harm.
The draft guidance we're releasing today is one part of a comprehensive policy framework. In January, we released our compounding policy priorities plan, which lays out how the agency will implement, over the course of 2018, certain key provisions of DQSA and other requirements of the law relevant to compounders. The plan is comprised of a series of draft and final guidance documents, proposed and final rules, and a revised draft memorandum of understanding (MOU) between the FDA and states. To read more click here.
Bipartisan Legislation Addressing Patient Access Concerns that Have Resulted from FDA's Implementation of the DQSA
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Your Efforts are Making a HUGE Difference!
We Now Have
44 HR 2871 Cosponsors
! Has Your Representative Signed On? Please send a
direct communication
to your Member of Congress.
HR 2871
will help clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and most importantly, better balance public safety and patient access.
DOJ Releases Memo Stating Guidance Documents are Unenforceable
- On Thursday, January 25th, the Associate Attorney General issued a memorandum that prohibits the Department of Justice from using civil enforcement authority to "convert agency guidance documents into binding rules." According to the Memorandum published on the Department of Justice website, Justice Department civil litigators are prohibited from using guidance documents - or noncompliance with guidance documents - to establish violations of law in affirmative civil enforcement actions. Further, in that same news release, DOJ Associate Attorney General Brand stated, "Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking."
Let's Keep the Momentum Going! We Need Your Patients' Stories!
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State Advocacy
- IACP provides our members with a weekly state tracking report - including legislative and regulatory updates! Check out this week's Compounders Stateside report here - you will need to log-in to view this members-only report.
- Check out IACP's State-by-State Analysis of Office-Use Compounding Regulations! Your Government Affairs team just released a State-by-State Analysis of Office-Use Regulations! We researched State regulations, State notices, State activity, and called State Boards of Pharmacy when regulations conflicted with actions to determine each State's office-use actions. In the instance where a State had recently changed its office-use practices, we called to determine why, and the response was noted when FDA had communicated that State law was pre-empted with Federal law.
You will find two documents - (1) the State-by-State analysis and (2) a complete supplemental document where all State regulations and actions are housed. The State-by-State analysis is a quick reference guide that demonstrates State regulations and current thinking on office-use and all supporting documents to this research can be found in the supplemental document. The DQSA Coalition intends to use this document to see whether model office-use State laws exist, to educate and assist States that are attempting to change office-use practices on the intent of Congress, and to focus on specific states for the State Board of Pharmacy/Board of Medicine Coalition Letter that is coming soon!
- USP General Chapter <800> State Adoption Status Chart. NASPA has developed a chart providing each state's current adoption status of USP's General Chapter <800>. Thank you, IACP Affiliate NASPA, for developing this invaluable tool!
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Grassroots Advocacy
- Tell Your Patients and Providers to sign up for the P3 Patient Advocacy Website! Patient Advocacy efforts make a real difference. That's why we need our IACP members' help to encourage more people to Join P3 and to Share their Stories! So many of our own IACP members have joined the P3 effort. Share this resource with everyone in your communities - your patients, your providers, your staff, your friends and family.
- Your Patients and Providers are asking their Representatives to Support HR 2871 with 540 messages sent to the Hill! Encourage your patients and providers to visit P3's Patient Advocacy Website. Advocates can instantly send a direct message to their Congressional Representatives, asking them to cosponsor the bipartisan legislation, HR 2871. Visit P3's Patient Advocacy Website. It's easy to use and will only take a few minutes to send an important HR 2871 message to Congress.
- IACP MEMBERS: We NEED your patient stories to feature on the P3 website - how have compounded medications helped your community? Share YOUR Stories! Please ask your patients and providers to also share their stories on the P3 website!
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IACP CORPORATE MEMBER NEWS
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IACP AFFILIATE NEWS
USP Announces Comment Period for
Chapters <795> and <797>
USP General Chapters <795> Pharmaceutical Compounding - Nonsterile Preparations, and <797> Pharmaceutical Compounding - Sterile Preparations are in the active revision process. The purpose of this alert is to provide you details of upcoming opportunities where you can participate in the public comment process for the proposed revisions.
To provide a unified approach to quality compounding, USP intends to align the timing and content of General Chapters <795>, <797>, and <800>Hazardous Drugs-Handling in Healthcare Settings. Among other proposed content in the revisions, hazardous drug handling sections in <795> and <797> will reference General Chapter <800>.
General Chapter <800> was completed and published in February 2016, and the content of that chapter is not currently under revision.
Below are the timeline and associated web links for you to engage and provide input during the public comment periods for <795> and <797>. You will be able to provide written comments through the USP website from March 30, 2018 to July 31, 2018 for USP <795>, and from July 28, 2018 to November 30, 2018 for USP <797>.
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Schedule & Links for Compounding Standards
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Click the links for access where the respective information will be posted
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Pharmaceutical Compounding -
Nonsterile Preparations
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Pharmaceutical Compounding
- Sterile Preparations
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Pre-Posted on the USP Website for Public Comment**
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Published in thePharmacopeial Forum
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Open Microphone Session
Registration will open
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March 15, 2018
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August 5, 2018
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Public Comment Period will close
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Intended Publication DateUSP - NF
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Anticipated Official Date
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December 1, 2019
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December 1, 2019
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* The current published versions of USP-NF General Chapters <795> and <797> are official until new chapters
become official.
** This pre-posting allows extra time, beyond the typical 90 day period, for stakeholders to review and provide
input.
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USP Debuts New Resource - USP <800> HazRx™ Mobile App.
The <800> HazRx™ Mobile App
is an innovative tool that combines information from three trusted data resources (NIOSH, RxNorm, General Chapter <800>) to help identify hazardous drugs at the point of practice and to inform the healthcare worker on what measures to take to help reduce their risk in accordance with established standards.
As we all move toward safer handling of hazardous drugs in the work place, USP encourages early adoption and implementation of USP General Chapter <800> to protect the public health in all healthcare settings.
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IACP COMP PAC NEWS
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The year is off and running, and it's been an amazing 2018 so far for your IACP COMP PAC Committee!
Your IACP COMP PAC Committee is launching all new COMP PAC Programs!
The COMP PAC Committee has been working diligently to bring you new programs that give you the opportunity to be more involved with the IACP COMP PAC, to share your stories and your patients' stories with Members of Congress, and to become more engaged in preserving patient access through the IACP COMP PAC!
The new IACP COMP PAC Newsletter
was released to keep IACP members informed on what the Committee is working on, where the donations have been made and what new programs and events are on the horizon. To read the first edition click
HERE
and the second edition click
HERE
.
Join us at the COMP PAC Dinner and Fundraiser during CCH!
Make plans now to attend the IACP COMP PAC Dinner and Fundraiser to be held during IACP's Compounders on Capitol Hill, on Monday, June 25, 2018 from 7 to 9 pm EST at Ruth's Chris Steak House in Washington D.C.! This is an exclusive opportunity to meet the Champions of Compounding face-to-face in Washington, D.C. Stay tuned for the announcement of our high-profile influencer who will personally meet with our COMP PAC attendees, and talk about the future of pharmacy compounding, and how we continue to protect our patients' access to compounded medications! You can get your tickets HERE!
IACP COMP PAC Lunch Fundraiser for Congressman Morgan Griffith!
Congressman Griffith is a member of the House Energy and Commerce Committee, and was instrumental in leading the Congressional DQSA hearing held by the House Energy and Commerce Committee. Congressman Griffith also introduced bipartisan legislation that seeks to address concerns with FDA's implementation of the DQSA that are negatively impacting patient access to compounded medications. The NEW IACP COMP PAC Lunch Fundraiser will be held Monday, June 25th in the Penn Quarter at the Renaissance Washington D.C. Downtown Hotel from 12:00 PM - 1:00 PM. This will be a great opportunity to meet a true pharmacy champion and share you and your patients' stories, you don't want to miss this!
Click here
to learn more about
Congressman Griffith
and to attend the COMP PAC Lunch Fundraiser.
Please
CLICK HERE
to access the contribution form for this vitally important COMP PAC Dinner and Fundraiser!
Your attendance and donations to COMP PAC
events are essential in helping preserve patient access to compounded medications. Your voice makes a tremendous difference - we need YOU at IACP COMP PAC events this year!
So Get Involved! Meet with Your Members of Congress! Donate to COMP PAC!
Thank You to our COMP PAC Committee members. What an amazing group of folks we have this year! If you're interested in joining the COMP PAC Committee, it's not too late. Email us at [email protected]
and let us know if you'd like to join.
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14th Annual Rx Mixer -
Aloha State of Mind
Plans to Raise More than $200,000!
IACP Foundation's 14th Annual Rx Mixer - Aloha State of Mind benefiting the IACP Foundation is being held Sunday, June 24, 2018 from 6:30 pm - 11:00 pm at the Renaissance Washington D.C. Downtown. The Regular Price is $175 (includes one event ticket and three drink tickets) and Late Registration is $200 after June 10, 2018. This is a separate ticketed event.
Join us in paradise and come relax with your colleagues and friends. Our guests will be treated to a fun evening of classic food, cold drinks, fellowship, and Dueling Pianos to lead us in song and cheer! Try your hand at the Live Auction, Silent Auction by the IACP Foundation, Memorabilia Silent Auction by GrandStand Sports and the Reverse Card Draw! All for a really good cause as we support the IACP Foundation's research and education initiatives. As we gather again with our colleagues and friends, we want to emphasize that Rx Mixer is much more than a fun party. It's a Party with a Purpose!
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