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IACP News Roundup - January 5, 2018
To keep you informed on all of IACP
member-driven initiatives
and latest legislative & regulatory updates, IACP has debuted a weekly
News Roundup
! Check out this week's report below, and email us at
[email protected]
with questions.
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ABOUT
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Announcing IACP's 2018 Board of Directors
IACP is pleased to announce the results of the 2018 Board of Directors Election. Thank you to all IACP Members who voted in this important leadership election. Your participation directly sets the future success and path of your Academy.
Thank you to all of our members who ran for the board this year! IACP received an unprecedented number of nominations this year. The Nominating Committee had the unenviable task of narrowing the list of incredibly qualified and amazing candidates, to the proposal of candidates that was presented to the IACP Board of Directors for approval.
We applaud all nominees for your interest in serving the IACP Board, and for your passion in preserving patient access to compounded medications. We urge those who were not ultimately elected this year to join our IACP Committees. We need you on these incredibly active and engaged committees to further advance our mission of serving patients and providers with the custom medications upon which they rely.
The IACP Board of Directors sets the direction for the organization, serves as visionaries for the future of pharmacy compounding, and works diligently to implement the IACP strategic plan through every IACP action. Board members contribute their time, energy, and ideas to lead the organization forward and in turn, lead the compounding profession to greater success and work to preserve patient access to vital compounded medications.
Your vote is so important to IACP as we elect individuals to lead our association into the future. Thank you for taking the time to vote!
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EVP Tracker
- IACP wants you to have access to the EVP, the staff, as well as the Board of Directors. Stay up-to-date on where IACP's Executive Vice President Cynthia Blankenship, Esq. is traveling, and set-up meetings or come by and say hi! Keep up-to-date on Cynthia's whereabouts with the EVP Tracker and let her know if you would like to host a townhall or meeting at your pharmacy!
Next on Cynthia's travel plans:
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Cynthia Blankenship,Esq.
IACP Executive Vice President
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IACP EVP Cynthia Blankenship has been appointed as the United States Pharmacopeia (USP) delegate representing IACP. The delegate is invited to attend the USP five-year meeting in 2020 and the twice per year Compounding Expert Committee (CEC) meeting as an observer.
Member Initiatives
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IACP Initiatives - A Progress Report Card! Keep tuning in to IACP's
Executive Vice President (EVP) Cynthia Blankenship's
Member Initiatives
t
o see where we're making progress and what we're checking off the list! You asked IACP for several key changes - and we're making them! IACP is in the midst of reviewing & revitalizing ALL of our current programs. We want to ensure we're completely in tune with our membership, providing you with what you need. Do you have suggestions or questions? Please email
[email protected]
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NEWSROOM
Member Alerts
Media
Compounding In the News
The New England Journal of Medicine: Toward Better-Quality Compounded Drugs - An Update from the FDA - Janet Woodcock, MD and Julie Dohm, JD, PhD
Article Excerpt: Five years ago, methylprednisolone acetate and other drugs compounded by the New England Compounding Center (NECC; Framingham, Mass.) and administered to patients throughout the United States caused a fungal meningitis outbreak involving more than 750 infections and at least 64 deaths. The extent of this episode drew widespread attention, but smaller clusters of infections and other adverse events caused by contaminated or otherwise improperly made drugs compounded by various U.S. pharmacies occurred before this outbreak and continue to occur. In 2013, in the wake of the NECC case, Congress passed the Drug Quality and Security Act, which created a new category of compounder, called an "outsourcing facility," that is held to higher production standards than other compounding facilities. Our experiences at the Food and Drug Administration (FDA) with pharmacy compounding since the passage of this law reinforce the ongoing need to improve the quality of compounded drugs, particularly those intended to be sterile. Read complete article here.
TAKE ACTION, IACP MEMBERS!
It is critical to engage our Providers and Patients in Partnership for Personalized Prescriptions (P3)! Please ask them to share their stories on how compounded medications have made a difference in their lives. Their experiences on the vital importance of compounded medications are needed on Capitol Hill!
Please ASK YOUR Providers and Patients also to Support HR 2871! Provide your audiences with this Action Link, today.
Click Here for IACP's Patient Testimonial Handout!
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- To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards. A presentation held at the ASHP 2017 Midyear Clinical Meeting and Exhibition provided an overview of the key steps pharmacists should take to improve their compounding practices.
MEMBERSHIP
Membership Surveys
- IACP's Veterinary Compounding Survey has Closed. Thank you to all Members who have taken the survey! We greatly appreciate your incredible participation. Your Educational Committee developed a Vet Compounding Survey to make sure IACP is providing the resources you need. We will be making the results available soon.
Federal Advocacy
- Your Efforts are Making a Difference! We Now Have 41 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. Act, Today!
- AVAILABLE FROM IACP! 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!
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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.
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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!
Grassroots
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FDA Launches New Patient Engagement Collaborative, Call for Nominations - Nominations Due by January 29th
IACP Members: Encourage Your Patients to Get Involved - Make Their Voices Heard on FDA's New Site - Why Access is NEEDED to Compounded Medications!
The
Food & Drug Administration (FDA) is launching a
Patient Engagement Collaborative and has issued a Call for Nominations. According to the Agency, "FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA's regulatory decision-making processes. And we know that patients and other stakeholders agree with the agency's commitment to improving and increasing patient involvement in FDA matters. In fact, members of the patient and stakeholder communities commented in public feedback on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). Stakeholders recommended that the FDA create an outside group to provide input on patient engagement across the agency. We are pleased to announce that in response to that feedback and to accelerate the FDA's efforts in this area, today the FDA published a request for nominations to join the FDA's Patient Engagement Collaborative (PEC)."
Click
here
for more FDA information.
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- Grassroots Advocacy - Tell Your Patients and Providers to sign up for the Partnership for Personalized Prescriptions 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 527 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? Please email Dagmar Anderson Climo, VP of IACP Communications at [email protected].
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