Bi-weekly Member Newsletter                                  October 6, 2017
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] .
Cynthia Blankenship ESQ. IACP Executive Vice President
IACP/About   

Member Initiatives: A Progress Report Card! 

Keep checking IACP's Executive Vice President (EVP) Cynthia Blankenship's  Member Initiatives  to 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's Call for Nominations for the Board of Directors are Open! 

Please send in  your Nomination ! IACP needs YOU! YOU are instrumental to the success of IACP and to compounding. Please consider joining the IACP Board of Directors, today! The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the membership.
 
This year, there are seven Board of Directors' seats including the position of IACP Vice President available.  Obtain  more detailed information, including candidate eligibility and term length for each board position, and a Nomination Form!
We Need You on an IACP Committee!

We are strengthening the IACP Committees to oversee everything within their jurisdiction and we need you! In order to keep you updated on this initiative, we developed a new Committee membership page with descriptions, mission and vision statements, and the reoccurring meetings dates and times of each Committee! Please take a look and let us know which Committee(s) you want to join! We would love to have you on the IACP Committee team!

Please take a look and let us know which Committee(s) you want to join! We would love to have you on the IACP Committee team!
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 Town Hall or meeting at your pharmacy! Next on Cynthia's travel plans: 
*IACP EVP Cynthia Blankenship has been appointed as the United States Pharmacopeia (USP) delegate representing IACP. The delegate is invited to attend t he USP five-year meeting in 2020 and the twice per year Compounding Expert Committee (CEC) meeting as an observer. 

Marisol Lopez, RPh, MPh
IACP Board Member
Hurricane Maria Resources

Hurricane Maria Resources: Hurricane Maria caused significant and long-term damage to Puerto Rico and the U.S. Virgin Islands. The majority of the region is still without power and now there are serious drug shortage concerns. 

IACP Board Member Marisol Lopez, RPh, MPh, University of Puerto Rico School of Pharmacy in Trujillo Alto, Puerto Rico, provides an update. Please check out  the IACP resources packet as well as Marisol's recommendations on how to help! 

Let's Keep the Momentum Going! 
Please Contribute to IACP's One Fund!

IACP Hosting Inaugural Fundraiser - President's Gala!
 

Let's Keep the Momentum Going! IACP has established a Fundraising Committee and is hosting the FIRST-EVER IACP FUNDRAISER! IACP will be hosting the inaugural IACP Fundraiser at the 2018 Educational Conference. All proceeds from the President's Gala will go to the IACP One Fund. The President's Gala will be the ONLY IACP Fundraiser all year, so please join us! Find more information about the President's Gala, including how to attend, how to sponsor, meal selection, and entertainment details here!

 

In addition, you can 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!
Newsroom

Member Alerts
  • USP is announcing the intent to postpone the official date of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. To protect patients and healthcare workers from potential harm, USP General Chapters <800> Hazardous Drugs - Handling in Healthcare Settings and <797> Pharmaceutical Compounding - Sterile Preparations are designed to provide comprehensive standards for all healthcare workers to help ensure the safe handling of hazardous drugs throughout the healthcare system, including in the practice of compounding. The intent of the USP Compounding Expert Committee is that these chapters be implemented at the same time. To honor this intention, the official date of USP General Chapter <800> will be postponed to align with the expected official date of USP General Chapter <797>. The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September/October 2018 for a second round of public comment. Both USP General Chapter <797> and USP General Chapter <800> are anticipated to become official on December 1, 2019. 
Congressman Morgan Griffith
News Story Features HR 2871 Sponsor Congressman Morgan Griffith (VA) 

Watch Broadcast Here. WDBJ-7 (Roanoke, VA) Griffith Compounding Bill Draws Criticism, September 22, 2017  
  • Excerpt: "Griffith's legislation would allow compounding pharmacies to prepare drugs for use in a doctor's office without requiring a prescription, written in advance for a specific individual.
  • He says that's needed, especially in rural areas, to make sure critical drugs are available on short notice.
  • Griffith says his proposal doesn't roll back the legislation that was passed after the meningitis outbreak. He says it responds to a change in an FDA rule that could cause problems for rural communities. "'And if we don't change things, what's going to happen is there's going to be an emergency situation in a rural area," Griffith said, "and we're going to have somebody who loses sight in one eye, or loses an eye because the drugs aren't there.'"
IACP/Compounding In the News

  • Officials with the FDA have issued a compounding risk alert concerning an adverse event associated with compounded triamcinolone, moxifloxacin, and vancomycin (TMV) for intraocular injection.
  • According to an "FDA in Brief" report, officials with the FDA received an adverse event report on August 14, 2017, from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV). On Sept. 28, 2017, the agency approved a supplemental new drug application that adds a subsection about HORV to the WARNINGS section of the prescribing information in the labeling of the FDA approved Vancomycin Injection, USP."
  • Last week, the FDA approved the addition of a severe vision loss warning in the FDA-approved labels of injectable vancomycin, but since labels for compounded drugs are not reviewed or approved by the FDA, this warning will not necessarily be included in the labels of compounded drugs with vancomycin for injection," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research said in a statement. "Therefore, health care providers administering eye injections of compounded drugs containing vancomycin for prophylaxis may not be immediately aware of this potentially blinding postoperative complication associated with its use. The FDA intends to use compounding risk alerts to communicate safety issues linked to compounded drugs to health care providers to help inform decisions about the medications they administer." 
FDA Releases Outsourcing Facility Product Report: FDA Commissioner Scott Gottlieb released an outsourcing facility product report that provides a list of the compounded drugs that pharmacies registered as outsourcing facilities (503Bs) have produced. FDA is making the list public "to help the medical community in their efforts to identify and access specific compounded drug products from facilities that are required to follow current good manufacturing practice standards."
  • The FDA Commissioner has also stated in a recent article that "FDA would release draft guidance in the next two months reflecting its intention to adjust its enforcement priorities [for outsourcing facilities] based on the size of registered compounders and the riskiness of their products." FDA views this upcoming draft "503B-lite" guidance as a potential incentive to get more pharmacies compounding under 503A to register as 503Bs.
  • WASHINGTON - When President Trump nominated Scott Gottlieb as the head of the Food and Drug Administration, he was quickly pegged by many as a conservative businessman who was cozy with the pharmaceutical industry.
  • Seven months later, he is attracting praise from some of President Trump's staunchest critics - including former Obama administration officials. He may also be in line to succeed his old boss, Tom Price, as secretary of health and human services.
  • "I think he's been a real bright spot in the administration," said Andy Slavitt, who headed the Centers for Medicare and Medicaid Service for two years under President Obama and who has been a harsh critic of the Trump administration.
IACP Weekly Roundup provides a new way to keep you up-to-date on IACP's Member Communications! We've heard your concerns about missing important IACP member alerts, so we are now sending a weekly IACP roundup that contains all IACP member communications sent throughout the week. It's a one stop shop for IACP member communication. Check out what news your Academy has been sending. 
Membership

Have you Completed IACP's Membership Survey?  IACP is seeking your input on our programs, services, products, and demographics about your practice. IACP values our members and your 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! IACP Members: Click here to complete the survey.  IACP will be keeping in touch with you and regularly engaging your opinions. And, most importantly - communicating back to you the changes we're making based on your opinions.



IACP  Extends Membership Drive! Sign Up your Staff for 25% off NEW IACP Memberships. Share this with Your Colleagues! Due to the incredible number of members to join IACP during the membership drive and the interest expressed, IACP has extended our membership drive! Thank you to all the new IACP members and to the current IACP members that have shared their testimonials about what value they receive from IACP. YOU made these efforts a success! Thank you for your membership! Use code CCH25, and click here to save! 
Advocacy


Federal Advocacy
  • IACP along with the DQSA Coalition hosted a Congressional Briefing at the Rayburn U.S. House of Representatives Office Building in Washington, D.C. The Objective: to continue educating on the vital need to support patient safety and access to life-saving medications. The panel urged Members of Congress to cosponsor HR 2871: The Preserving Patient Access to Compounded Medications Act of 2017, the bipartisan legislation introduced by Congressmen Morgan Griffith (VA) and Henry Cuellar (TX). The panel shared patients' stories, urged Congress to preserve patient access to vital compounded medications, and discussed the importance of implementing the Drug Quality & Security Act as Congress fully intended. We were thrilled to host Members of Congress, staff and Capitol Hill-based media reporters, and provided an HR 2871 briefing and information packet (background documents and supporting documents) to all attendees. More information here. IACP Members - you are encouraged to use these background & supporting documents as you educate your stakeholders on HR 2871!''' 
  • Your Efforts are Making a HUGE Difference! We Now Have 33 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. 
  • Continue to collect patients' stories and let us know if a patient would like to get involved! We need patient stories for our Congressional documents as well as any potential future hearing. Please let us know if you are willing to be the voice of your patients or whether you know of patients willing to provide quotes or speak on the record!
State Advocacy
  • NOW AVAILABLE! 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 we ekly 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.
  • California - California Council for the Advancement of Pharmacy Third Annual CE & Networking Event, Oct. 7 & 8, 2017.
  • Florida - IACP Submits Comments to Florida State Board of Pharmacy.
  • 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 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! 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].
IACP Events & Education


IACP Educational Conference
Sonesta Fort Lauderdale Beach
Fort Lauderdale, Fla
January 24-27, 2018! #EduCon2018

Registration is OPEN for IACP's Educational Conference!  Come join us to obtain CE by the Sea! Make plans to attend IACP's Educational Conference in Fort Lauderdale, Florida, January 24-27, 2018! Enjoy southern Florida's soothing coastal ambience at the gorgeous Sonesta Fort Lauderdale Beach with every hotel room providing a gorgeous ocean view! More details here!

NEW!  IACP's Presidents Annual Gala - IACP will be premiering our First Presidents Annual Gala during the Educational Conference on Friday, January 26, 2018 at 7:30 p.m. in the Infinity  Ballroom at the Sonesta Fort Lauderdale Beach. Meet the new IACP Executive Vice President Cynthia Blankenship, Esq., and witness the installation of the IACP Board of Directors Officers! Enjoy an exquisite three-course meal, with your choice of Seared Sirloin Steak with Zinfandel Shallot Reduction, Petit Filet with Herb Grilled Jumbo Shrimp, Grilled Salmon with a  Roasted Garlic-Lime Emulsion, or a delicious Vegetable Pad Thai. One complimentary drink ticket and live entertainment will be included with your Gala reservation. Tickets can be  purchased during registration. Corporate Members - Please contact IACP's Ashlyn Grant  for exciting sponsorship opportunities! 

We would like to thank ITL Consulting for their support of the 1st President's Annual Gala! Sponsorships Available, Click here! All proceeds from the Gala will go to IACP's One Fund!
Save the Date for #CCH2018!

June 23-26, 2018 
999 Ninth Street NW
Washington, DC 20001

The 24th Annual  Compounders on Capitol Hill (CCH) will be held June 23-26, 2018 at the Renaissance Washington DC Downtown Hotel! With more than 400 expected attendees,  Compounders on Capitol Hill brings together the top-level compounding pharmacists and technicians from across the country with the same goal - to protect pharmacy compounding.  

Network! Reconnect with friends and meet new colleagues  who share your passion and interest in protecting, promoting and advancing pharmacy compounding!
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.
IACP Foundation Update

IACP Foundation's Board of Directors 2018 Call for Nominations is Now Open! The IACP Foundation is looking for people interested in becoming more involved and actively working with rest of the IACP Foundation Board of Directors to advance the practice of pharmacy compounding through student interactions, educational and scientific programming, and research. The Bylaws of IACP Foundation set forth an open election process with nominations for candidates accepted directly from the community of pharmacists, pharmacy technicians, other healthcare professionals, patients, etc. More here! 

IACP Foundation Fund-the-Future now accepting applications for the 2018 IACP Educational Conference! It's that time of year again! Do you know a pharmacy student interested in learning more about independent pharmacy and compounding? Through the generosity of donors to our Fund-the-Future campaign the IACP Foundation is offering up to two (2) pharmacy students a travel grant to attend the International Academy of Compounding Pharmacists' (IACP) - Educational Conference on January 24-27, 2018 in Fort Lauderdale, Fla. All pharmacy student are encouraged to apply. More here!
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IACP| 281.933.8400 | [email protected] | iacprx.org
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