IACP News Roundup - November 10, 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.


Save the Date for IACP's Educational Conference!

WATCH   IACP President Baylor Rice, RPh, FIACP and  President-Elect Erik Tosh, BS, RPh, FIACP, FACA, as they urge you to Save the Date for I ACP's Educational Conference & Inaugural President's Gala, January 24-27, 2018 in Ft. Lauderdale, Fla!  #EduCon2018! More information and register  here! 

Please join us and your colleagues at the  Sonesta Fort Lauderdale Beach  for a jam-packed agenda filled with exciting educational sessions and connect with your colleagues during the President's Gala, receptions, and time with IACP exhibitors! The IACP exhibit hall is already sold out and the room block is filling up quickly, so please register now! We look forward to seeing you in Ft. Lauderdale!

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:


* 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 Nominations Now Closed
  • The nominations period for the IACP Board of Directors 2018-2020 election cycle has closed. Thank you for all the suggested candidates we received! The number of suggested candidates was tremendous and we are so grateful to have members as engaged and excited about the organization as you. IACP is a success because of YOU! Your work is what helps make us the great organization that we are. Read next steps and check out the suggested nominees here!
NEWSROOM

Member Alerts
Member Newsletter
Media

Politico - Pulse
  • FDA prioritizing critical pharmaceutical manufacturing facilities in Puerto Rico. The agency's working to prioritize the island's critical facilities - those that manufacture medical products sourced primarily or only in Puerto Rico - for consideration for earlier access to the island's rebuilt electrical grid, FDA Commissioner Scott Gottlieb said.
  • One reason for the push: To ensure critical medical products are available to U.S. patients. Puerto Rico produces $40 billion worth of pharmaceuticals for the U.S., more than any of the 50 states or any foreign country.
  • The FDA also is monitoring approximately 90 medical products to help prevent shortages, according to a new FDA analysis of the island's manufacturing sector. More than a month after Hurricane Maria ravaged Puerto Rico, 57 percent of the island is still without power, leaving many manufacturing plants to rely on generators for power
  • With the U.S. Pharmacopeial Convention (USP) General Chapter <800> launch date less than a year away, USP reset the start button to Dec. 1, 2019, stating it needs more time to align the official date of the hazardous drug handling measure with the anticipated official date of the next revision of Chapter <797>.
  • The new official date added 17 months to Chapter <800>'s previous compliance deadline, but compounding safety experts cautioned against viewing the postponement as a chance to delay the facility and workflow upgrades needed to meet the safe handling standards.
MEMBERSHIP

Membership Survey
  • IACP's Membership Survey has closed. Thank you to all participants! 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! Stay tuned for a comprehensive results report and how IACP will be implementing your ideas! 
Membership Drive
  • 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, IACP has extended our membership drive! Use code CCH25, and click here to save! 
ADVOCACY

Federal Advocacy
  • The International Academy of Compounding Pharmacists (IACP) is developing comments for submission to the Food & Drug Administration (FDA) for its upcoming Pharmacy Compounding Advisory Committee meeting being held on November 20-21, 2017. IACP Members: We NEED YOUR input as we write these comments! Please review the items up for PCAC vote - a) Do Not Compound List and b) the Active Pharmaceutical Ingredients (APIs) Positive List - and forward your comments to [email protected] by close of business TODAY so that we can include within our IACP comments draft. More information here.
     
  • The U.S. Food and Drug Administration is withdrawing draft Guidance for Industry (GFI) #230, "Compounding Animal Drugs from Bulk Drug Substances." According to FDA's announcement, it's withdrawing the draft Guidance for Industry (GFI) "in order to clarify the agency does not plan to finalize the current draft; but, instead intends to issue a new draft for public comment next year." More info here.
     
  • The  Food & Drug Administration (FDA) this week announced a  Pharmacy Compounding Advisory Committee (PCAC) meeting to occur on November 20-21, 2017 during the week of the Thanksgiving holiday.  PLEASE NOTE: The PCAC meeting will be open to the public, and you are encouraged to submit comments and attend the meeting. Please  click here  for more information including a statement from  IACP's Executive Vice President Cynthia Blankenship .  
  • 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
  • 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! 
  • Important Notice from the Ohio State Board of Pharmacy - Due to reports of critical drug shortages, the State of Ohio Board of Pharmacy has postponed the rescission of pharmacy compounding rules 4729-16-10 and 4729-16-07 of the Ohio Administrative Code to a date to be determined later. Read more here. 
  • Massachusetts State Board of Pharmacy Notice of Public Hearing - Notice is hereby given pursuant to M.G.L. c. 30A, § 2, that the Board of Registration in Pharmacy (Board) within the Department of Public Health (Department), will hold a public hearing on the Board's proposed new regulation at 247 CMR 17.00, Sterile Compounding. The proposed regulation sets standards for sterile compounding practice, as mandated by M.G.L. c. 112, § 39G. The public hearing will be held on Monday, November 13, 2017, at 10:00 am in Room 417A/B (4th Floor), 239 Causeway Street, Boston, Massachusetts 02114. Hearing testimony may be presented orally or in writing; a written copy of any oral testimony will be requested. More information including written testimony submission instructions here. IACP plans to provide written testimony for this hearing. 
  • NOW 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 524 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].