IACP News Roundup - May 25, 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.


ABOUT

Member-Driven Initiatives

IACP is committed to making sure you are kept up to date on all the member-driven initiatives that we are working on and the latest in industry news.  


Interim Executive Vice President (EVP) Announced: Gary McCrory, RPh, CCN
Gary McCrory, RPh, CCN, IACP Interim EVP

IACP is pleased to announce that Gary McCrory has accepted the Interim EVP role.  Cynthia Blankenship's last day with IACP was Friday, May 4, 2018.  After much thought, Cynthia believed it was necessary to resign to do what is best for her family after her father's passing.  On behalf of the IACP Executive Committee, Board of Directors and Staff, we thank Cynthia for her years of dedication and contributions to IACP.  We want to thank Gary for his years of service to IACP as a member, as a Board Member, Past-President and former Chairman of IACP and with his support this will guarantee a smooth transition in leadership while the Search Committee and Board work together during this time.

IACP's Search Committee is being led by IACP Board Member, Jeffery Bray.  The Search Committee is conducting a thorough search and we want to thank the committee for their time and effort.

IACP's Government Affairs will continue to be led by David Pore of Hance Scarbrough LLP, and he continues to do outstanding work on behalf of IACP.  He will be leading the DQSA Coalition, which is making amazing headway in the area of patient access to compounded medications.

Thank you for your ongoing membership and support!  Together, we can accomplish great things for our compounding profession, and for patient access.




Check out the video from Congressman Griffith
 explaining why 
YOU NEED to be at CCH this year!


CLICK HERE to register for #CCH2018

Click here to learn more about Congressman Griffith and 
to attend the COMP PAC Lunch Fundraiser.


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!


Member Initiatives

IACP Initiatives - Storm the Hill at CCH!

The following states will be represented at this year's 24th Annual Compounders on Capitol Hill (CCH) by your fellow IACP Members.


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!

We need 300+ pharmacists at #CCH2018.  H.R. 2871 is gaining momentum and support, but we need more Representatives to back the bill and Senators to sponsor a companion bill. It will take all of us to make this happen. Our POWER comes from our face-to-face visits - where members of Congress see and hear directly from constituents in their own districts about how
H.R. 2871 will impact their communities.  No one can tell a pharmacy's story - and patients' stories - like YOU . So, the more CCH attendees we have, the more districts we represent and the more legislators we can reach. 

Simply put:  WE NEED YOU ON THE HILL!

Top 10 Reasons to Attend #CCH2018!

 
Rooms at the Renaissance Washington D.C. Downtown Hotel 
are SOLD OUT!!
Please visit one of the surrounding properties listed below.

Marriott Marquise Washington D.C. - 0.2 miles from the meeting hotel
 
Hampton Inn Washington-Downtown-Convention Center - 0.3 miles from the meeting hotel



Registration for Compounders on Capitol Hill is  OPEN!

Compounders on Capitol Hill  (CCH) brings together the top-level compounding pharmacists and technicians from across the country with the same goal - to protect pharmacy compounding.  Network and  Reconnect  with old friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!

The 24th Annual Compounders on Capitol Hill will be held June 23-26, 2018 at the Renaissance Washington DC Downtown Hotel. With more than 400 expected attendees in 2018.



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NEWSROOM


IACP submitted comments on Thursday, May 24th to FDA regarding the Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use Under Section 503.   IACP encourages members to submit their own comments.  The deadline is Friday, May 25, 2018.  

To view IACP's comments click HERE.  

To submit your own comments click HERE.

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. To read more click HERE.

FDA finalizes outsourcing facility guidance
The US Food and Drug Administration (FDA) on Thursday finalized guidance to help outsourcing facilities register with FDA.

FDA said it received 19 comments on the draft. "In response to received comments, FDA made certain changes," the agency  said . "In particular, FDA revised the guidance to provide for a compounder seeking to operate under section 503A of the FD&C Act (21 U.S.C. 353a) to be located next to an outsourcing facility provided that there is complete segregation between the outsourcing facility and the 503A compounder."  Click HERE to read more.
FDA said it received 19 comments on the draft. "In response to received comments, FDA made certain changes," the agency 
said. "In particular, FDA revised the guidance to provide for a compounder seeking to operate under section 503A of the FD&C Act (21 U.S.C. 353a) to be located next to an outsourcing facility provided that there is complete segregation between the outsourcing facility and the 503A compounder."  Click  HERE  to read more.

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.


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.

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IACP Member Alerts
  • Meet IACP's Board Members - Part Three - April 19, 2018
  • Don't miss the IACP COMP PAC Events during CCH! - April 18, 2018
  • IACP AdvanCE Webinar Program - Register TODAY! - April 18, 2018
  • Meet IACP's Board Members - Part Two - April 17, 2018
  • IACP Reveals TWO More NEW Membership Categories - Educational/Institutional and
    Pharmacy Tech Student  - April 16, 2018
  • IACP Member Alert - NIOSH List Revision - Comment Deadline 4/16/18 - April 13, 2018
  • Meet IACP's Board Members - Part One - April 12, 2018
  • Congressman Morgan Griffith to Present at #CCH2018 - April 12, 2018
  • Attend CCH for FREE - April 11, 2018
  • IACP Committee Chairs Part Six - April 11, 2018
  • IACP Video Competition - April 9, 2018
  • IACP Progress Report - April 5, 2018
  • IACP COMP PAC Newsletter - April 3, 2018

    •  
    IACP Member Newsletter

    Members News

    Carrollwood Compounding Center and Pharmacy announced May 14, 2018 that it has launched ASTDrops.com to assist patients with Dry Eye and Sjogren's Syndrome. ASTDrops.com provides education, information, and prescription fulfillment services for  Autologous Serum Tears and  Antibiotic Eye Drops. Affiliations with specific physicians and labs will allow ASTDrops.com to provide prescription fulfillment services across the state of Florida.


    Members of Senator Orrin Hatch's office tour MedQuest Pharmacy

    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.


    INDUSTRY NEWS



    • A new package of legislation introduced in Congress would bar legal clauses that limit pharmacists from alerting patients to the cheapest way to pay for their prescriptions at the pharmacy counter.
    • The bipartisan bills would bar an insurer or pharmacy benefit manager from restricting a pharmacist's ability to disclose when a customer's prescription would cost less if they paid the cash price, rather than the amount of their health insurance copay.
    • The legislation was prompted by the practice of "clawbacks." That's when a patient's copay - often set by the pharmacy benefit manager - is more expensive than the total cost of the drug. The difference in cost is then "clawed back" by the insurer or pharmacy benefit manager.
    PBM transparency, DIR fees are top priorities for pharmacists on Capitol Hill
    https://www.specialtypharmacytimes.com/news/pbm-transparency-dir-fees-top-priorities-forpharmacists-on-capitol-hill 
    • Researchers at Oregon State University have made a key advance in the fight against drug resistance, crafting a compound that genetically neutralizes a widespread bacterial pathogen's ability to thwart antibiotics.
    • The findings are important because antibiotic resistance is a growing global threat, with the percentage of isolates with multidrug resistance on the rise for many bacteria.
    NEWSROOM
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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>.




         Schedule & Links for Compounding Standards
     
    Click the links for access where the respective information will be posted 
     
     
     
    <795> *
    Pharmaceutical Compounding -  Nonsterile Preparations
    <797> *
    Pharmaceutical Compounding -  Sterile Preparations
    Pre-Posted on the USP Website for Public Comment**
    Published in thePharmacopeial Forum
    Open Microphone Session
     
    Registration will open 
     
     
    March 15, 2018
     
     
    August 5, 2018
    Public Comment Period will close
     
    Intended Publication DateUSP - NF
     
    Anticipated Official Date
    December 1, 2019
    December 1, 2019
     
    *   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.



    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.

    Read more here!
       

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    ADVOCACY
    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.
    • 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!    
    • 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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    IACP COMP PAC


    Save the Date for TWO  Compounders on Capitol Hill   
    IACP COMP PAC Events!

    COMP PAC Lunch with Congressman Morgan Griffith -  NEW in 2018
    COMP PAC Dinner with Congressman Buddy Carter


    IACP COMP PAC offers the rare and incredible opportunity to meet with Members of Congress one-on-one to share your and your patients' stories. We have heard your request for more opportunities to meet Members of Congress in this rare, small setting, and your COMP PAC is answering the call by having more PAC events than ever at #CCH2018!

     

    COMP PAC LUNCH with Congressman Morgan Griffith   
    -   
    NEW in 2018

    IACP COMP PAC Lunch Fundraiser for Congressman Morgan Griffith!
    You don't want to miss the NEW IACP COMP PAC Lunch Fundraiser at CCH for Congressman Morgan Griffith and your opportunity to meet a true pharmacy champion and share your and your patients' stories! You won't want to miss this NEW PAC event!

    Please click here to access the registration form for this amazing opportunity with Congressman Morgan Griffith.





    COMP PAC DINNER with Congressman Buddy Carter

    Make plans now to attend the  COMP PAC Dinner and Fundraiser with Congressman Buddy Carter  to be held during IACP's 
    Compounders on Capitol Hill, on Monday, June 25
          th, 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! 

    Please click here to access the contribution form for this vitally important COMP PAC Dinner  with Congressman Buddy Carter and Fundraiser!

    To buy your IACP CCH COMP PAC Dinner and Fundraiser Tickets, click here or contact Ashlyn at [email protected].


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    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 535 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! If you missed the Congressional Hearing on the implementation of the DQSA, these stories were highlighted as to why patient access to compounded medications needs to be preserved. These stories are vital to share with Congress and essential in our mission of preserving patient access. It's easy to tell patients how to share their stories! You can send them here to Share their Stories and the rest is taken care of to ensure their voice is heard by Congress! How have compounded medications helped your community? Please email IACP Communications at [email protected].
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    IACP Foundation


    14th Annual Rx Mixer: Aloha State of Mind

    The ONLY IACP Foundation fundraiser of the year and helps support the Foundation's invaluable mission! This fun Party with a Purpose is being held Sunday, June 24, 2018 from 6:30 p.m. - 11:00 p.m. The 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.
     
    This event ensures a night to remember and an awesome opportunity to relax and party all night with your colleagues. Join us in paradise and come relax with your colleagues and friends.  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!
     
    Join us in paradise and
    Party with a Purpose by registering  here.


    To donate, sponsor, or volunteer please contact Jennifer at [email protected].