IACP News Roundup - December 8, 2017

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.



It's beginning to look more like Christmas!  Even at IACP's Missouri City,Texas office. Upcoming IACP Holiday Schedule: IACP will be closed Monday, December 25th through Tuesday, January 2nd. Please email us at [email protected] if you need to reach us! 

ABOUT

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:
Cynthia Blankenship,Esq.
IACP Executive Vice President

* 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
  • 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] .   
IACP Board of Directors Voting Open Until December 15th
  • Have You Voted, Yet? IACP's 2018 Board of Directors Election Will Close on Friday, December 15th!    A direct email distributed to all IACP Members with a voting ballot and candidate information. The IACP Board of Directors sets direction for the organization, serves as visionaries for the future of pharmacy compounding, and generates results. Board members contribute their time, energy and ideas to lead the organization forward and in turn, lead the compounding profession to greater success. Your vote is important to IACP as we elect individuals to lead our association into the future. More info and vote here!
    All ballots must be cast by Midnight on Friday, December 15th! Results will be announced the end of December. 
NEWSROOM

Member Alerts
Member Newsletter
Media

 
 


  • A new study may have veterinarians rethinking how they use compounded formulations of doxycycline, a common antimicrobial prescribed to treat numerous bacterial infections in animals.
  • Researchers from Kansas State University compared FDA-approved formulations of doxycycline with compounded doxycycline obtained from 3 national compounding pharmacies. They measured doxycycline content from all formulations 1 day after receipt and then again 3 weeks later.
  • Results showed that the compounded formulations of doxycycline lost potency within 21 days of receipt, with many dropping to sub-therapeutic content in that time, as defined by United States Pharmacopeia standards. The complete report was recently published in the Journal of the American Veterinary Medical Association.
  • "These study results have important ramifications for practicing veterinarians," said John Reddington, DVM, PhD, president and CEO of Morris Animal Foundation, which funded the study.
MEMBERSHIP

Membership Surveys
  • IACP's Veterinary Compounding Survey is Out! We have heard your suggestions through the Membership survey, and your Educational Committee has developed a Vet Compounding Survey to make sure IACP is providing the resources you need. Survey was emailed to all IACP Members. Please take a moment to fill out the survey by December 25, 2017! Take the survey here.
  • IACP's Membership Survey has closed. Thank you to all participants and your incredible feedback! We will use YOUR feedback to shape not only the direction of IACP, but also the resources IACP provides, our communications to you, and our events! We are currently in the process of reading every response that was sent in! Stay tuned for a comprehensive results report and how IACP will be implementing your ideas! 
Survey Feedback Sneak Peak! - You told us you wanted IACP to create more effective education & legislative platforms! IACP is working on this request. To facilitate this process, we'd like to begin by updating the demographics within your profile. It only takes a moment and will ensure that IACP always is representing your voice and providing the resources you need! Please log-in to the Members-Only site and update your profile. Once you have logged in, click "Manage Profile" on the right-hand rail, click on "Edit Bio" and answer the questions housed there. IACP has many ideas that we're working on in the future. It starts with knowing more about you!  

ADVOCACY

Federal Advocacy

In Case You Missed It - Pharmacy Compounding Advisory Committee (PCAC) Meeting Recap
IACP attended the Food & Drug Administration's (FDA) Pharmacy Compounding Advisory Committee Meeting this week on November 20-21, 2017 in White Oak, Maryland. Please see above IACP's summary of the first day's voting. Please click here to view a report that has voting results from the two-day meeting.

PLEASE NOTE: These votes are NOT final. FDA must release final guidance for this to be FINAL. These are the Committee's votes on FDA's recommendations for the API Positive List. 

Please note that IACP and other pharmacy organizations previously let Congress know that these meetings should be webcast to the public and a webcast was provided over the two-day meeting period.

Also, as IACP stated within its comments submitted to FDA for the PCAC meeting that you can read here, IACP is still very disappointed that while two PCAC members were allowed to participate via conference call for this meeting, FDA denied all stakeholder participation via conference calls even during the public meeting sections.

IACP will forward additional updates as we monitor the final disposition of these votes as they are presented to FDA. Please email IACP at [email protected] with any questions.

  • DQSA Coalition - Appropriations Update  - IACP Members: the Appropriations deadline is rapidly approaching! We are diligently working with the  DQSA Coalition  to ensure language is included in  FY 2019 Appropriations  that addresses our continuing concerns on how the  Food & Drug Administration (FDA)  has not implemented the  Drug Quality & Security Act (DQSA)  according to Congressional intent. We will keep our members updated on this process!  
  • API Category 3 List - IACP has heard your feedback from the Membership Survey regarding your concerns about the FDA API Category 3 list that is now being enforced during inspections. Your IACP Legislative Committee is working diligently to analyze the FDA API Category 3 list and will be working on a letter to FDA to address your concerns. Coming soon! 
  • Your Efforts are Making a Difference! We Now Have 40 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!
State Advocacy



 

 
  • IACP Submits Comments on Sterile Compounding Beyond Use Dating to California State Board of Pharmacy - IACP worked with the California Pharmacists Association to submit formal comments to the California State Board of Pharmacy today regarding Sterile Compounded Medications Beyond Use Dating. IACP applauds the California Pharmacists Association for their leadership role on this vital patient issue. 
Please click here to read IACP's comments.
Please click here to read California Pharmacists Associations comments.

IACP urges our members and corporate members also to submit their own comments to the state Board. You are welcome and urged to use our comments in submitting your own. Read more on how to submit your comments here.
  • IACP State Board of Pharmacy Member Alert - California, Florida, New Jersey and Washington - Click here to view IACP's comprehensive State Update on USP <800> and office use compounding. IACP is working to keep you in the know on what's going on in your states! 
  • IACP Submits Comments to Massachusetts State Board of Registration in Pharmacy on Sterile Compounding - IACP submitted comments to the Massachusetts State Board of Registration in Pharmacy. The Massachusetts Board of Registration in Pharmacy (Board) within the Department of Public Health (Department) held a public hearing on the Board's proposed new regulation on Sterile Compounding (247 CMR 17.00) on Monday, November 13th. The proposed regulation sets standards for sterile compounding practice, as mandated by M.G.L. c. 112, ยง 39G. Please read IACP's comments to the Massachusetts State Board of Registration in Pharmacy.

  • The DQSA Coalition, a broad cross-section of organizations representing varied healthcare providers, state pharmacy associations, pharmacists and patients, sent a letter to all state Boards of Pharmacy and Medicine, expressing continued concern regarding the Food & Drug Administration's (FDA) implementation of the Drug Quality & Security Act (DQSA) without following Congressional intent. The letter emphasized that FDA's actions consequently are affecting patient access to compounded medications, and causing mass confusion for the States, providers, patients, and pharmacists. Please click here to read more! 
States Respond to DQSA Coalitions Letter to State Boards of Pharmacy and Medicine!  Just a few days after sending, a dozen states have responded to the Coalitions Letter to State Boards of Pharmacy and Medicine to date including these states that have responded that the letter will be discussed during the next Board Meeting:  Georgia; Pennsylvania; New York; Indiana; and Washington .  
  • 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!  
  • 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.   
  • 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
  • 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 526 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].