Bi-weekly Member Newsletter                                             December 15, 2017
Keep up-to-date with the latest legislative and regulatory news. Visit IACP's websiteArchived  Capitol Connections  newsletters here. Send your suggestions and questions to  iacpinfo@iacprx.org .
IACP/ABOUT


Wishing you and yours a very Merry Christmas and Happy Hanukkah! Upcoming IACP Holiday Schedule: IACP will be closed Monday, December 25th through Tuesday, January 2nd. Please email us at iacpinfo@iacprx.org if you need to reach us! 
Let's Keep the Momentum Going - Please 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!

Thank you to the following sponsors for their support of the 1st President's Annual Gala:
DoseLogix/Topi-CLICK (Bar Sponsor); Letco Medical (Entertainment Sponsor, Table Sponsor);  My USP 800 (Additional Gala Drink Tickets);  PCCA (Table Sponsor). 

Thank you, IACP Member and Past IACP President Eldon Armstrong, RPh, FIACP, Sandlapper Consultant Pharmacists, Chapin, SC; and IACP Member Joseph Rossetti, RPh, Boulevard Pharmaceutical Compounding Center, Worcester, Mass., for your individual sponsorship of the 1st President's Annual Gala! 

Find more information about the President's Gala, including how to attend/purchase tickets, how to sponsor, meal selection, and entertainment details here! All proceeds from the President's Gala will go to the IAC P One Fund.
IACP Executive Vice President Cynthia Blankenship ESQ. 
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  iacpinfo@iacprx.org .
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 the USP five-year meeting in 2020 and the twice per year Compounding Expert Committee (CEC) meeting as an observer. 

IACP's 2018 Board of Directors Election Closes Tonight at Midnight! 

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. All ballots must be cast by Friday, December 15th! Results will be announced the end of December. More information and vote here!

All ballots must be cast by Midnight on Friday, December 15th! Results will be announced the end of December.
Thank You to ALL who have Joined IACP Committees!

IACP is a success because of  YOU ! Please take a moment and look at what IACP Committees are doing and let us know if you would like to join a Committee. We would love to have YOU on an IACP Committee. 
In addition, in response to your feedback on the Membership Survey, the IACP Board
has responded by creating new Committees and one new Committee Subgroup. 
  • IACP 503B Committee - IACP is establishing a 503B Outsourcing Facility Committee. If you are interested in serving on this committee, please email Jennifer Petska at jennifer@iacprx.org.
  • IACP International Committee - For the first time in history, IACP is undertaking a massive State and International expansion. We are thrilled to be working with the State Pharmacy Associations to expand IACP state involvement, state tracking, and comments in response to state regulations and legislation. IACP also is thrilled to be working with our International members to expand IACP presence internationally.  In order to further this expansion and ensure International Members are receiving the information they need, the IACP Board of Directors has launched an International Committee. Please let us know if you want to serve on this Committee!  We are so excited to work with our International members and expand the IACP International presence!
  • Infrastructure Review Subgroup - This subgroup will serve as a function of the IACP Strategic Planning Committee and is open to all IACP members who have an expertise in IT or infrastructure review. IACP is looking at all of our internal processes to ensure we are employing members' dues and donations in the best manner, and to make sure we are operating as efficiently as possible. In order to do so, the IACP Board has created an Infrastructure Review Subgroup which will review internal IACP processes to help us select new future operational processes. If you have a background in IT or reviewing internal processes, or have experienced this process yourself, please consider joining this Subgroup! We would love to have your insight!

 IACP President Baylor Rice and President-
Elect Erik Tosh
REGISTER TODAY 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 attend IACP'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!
Let's Keep the Momentum Going! 
Please Contribute to IACP's One Fund!
Newsroom

IACP Member Alerts

FDA Guidance: Regulations in Disguise? 

The FDA's over-reliance on guidance documents is undercutting traditional notice-and-comment rulemaking and hurting industry, one advocacy group warns. The Washington Legal Foundation, a free-market advocacy group and think tank, is charging that the Food and Drug Administration is leaning too heavily on guidance documents in lieu of regulations, causing excessive burdens on affected industries. The group said in total the FDA has released more than 2,000 guidance documents and draft documents, far too many for industry to keep track, and noted that such documents aren't subject to judicial review.
"The reason for this trend is obvious: formal rulemaking can be quite cumbersome, and FDA would prefer, when possible, to avoid the time and expense involved," the group wrote to the FDA in response to a  comment request
William Garvin, a Washington-based life sciences attorney at Buchanan Ingersoll & Rooney PC, told Bloomberg Law Monday that the FDA might be pushing guidance-based requirements too far. "It gives the agency flexibility to change their position if the situation changes," he said. "So in general the use of guidances is an important tool for FDA that can be subject to abuse."
The next big thing in pharmacy supply chain: Blockchain
 
 
"Big black box called PBMs" draws attention from lawmakers trying to solve drug prices https://www.statnews.com/2017/12/13/pbms-lawmakers-drug-prices/ 

 
  • FDA announced the launch of a new tool that will give healthcare providers direct and timely access to critical updates about antibiotics and antifungal drugs. A new website will provide information about when bacterial or fungal infections are likely to respond to a specific drug. According to FDA, "This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria." Physicians use antimicrobial susceptibility testing to help select an appropriate antibacterial or antifungal drug to treat a patient's infection. The tests use criteria, known as "breakpoints," that help determine whether a specific bacteria or fungi is susceptible to antibacterial or antifungal drugs. However since bacteria and fungi change over time, the breakpoints need to be updated.
  • Previously, each drug manufacturer updated its drug labeling with new breakpoint information, which FDA reviewed and approved on a case-by-case basis. Under the new approach, FDA can simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently through a dedicated FDA website that will list FDA-recognized breakpoints. Companies that disagree with the recognized standard can submit data to support alternative breakpoints, FDA noted. Drug companies will have to update their labeling to reference the FDA webpage containing the breakpoint information-but will no longer have to continuously update their labeling with new breakpoint information, which should make "the process more efficient and more timely." The agency is also issuing guidance on how companies should update their labeling on breakpoints to point to the information online generated by FDA.

 

IACP Weekly Roundup


IACP Weekly Roundup provides a new way to keep you up-to-date on IACP's Member Communications! We know you're busy, so we are making sure you don't miss a beat by rounding up all the IACP news that goes out to members in one location to make it easier for you to never miss any news on compounding!  Check out what news your Academy has been sending. 
IACP/Compounding In the News
IACP Board Member Shawn Hodges, PharmD

IACP Board Member Shawn Hodges, PharmD, is quoted in an APhA - American Pharmacists Association Pharmacy Today article on drug shortages. "Currently, the Food & Drug Administration (FDA) and Congress disagree on the ability of compounding pharmacies to provide compounded medications during the ongoing drug shortage situation, said Shawn Hodges, PharmD, International Academy of Compounding Pharmacists board member.

"The FDA actions in implementing the Drug Quality and Security Act (DQSA) contrary to Congressional intent have decreased patient access and further impeded the ability of compounding pharmacists to effectively compound medications for providers and health systems to be administered to patients." The practice is often termed "office-use." Hodges explained that before FDA implemented the DQSA, many states authorized the practice of traditional state-licensed pharmacists to provide compounded medications to health care providers and facilities for administration to patients."  Read the entire article here .
Membership

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.

New Membership Processes Coming Soon!  We want to make sure that your membership dues are utilized to provide you with all the resources you need! As such, we are revamping some of our membership processes such as going digital for new membership packets and renewals. You may have received a fax blast describing the new renewal process. If you have not received, you can find it HERE. Please take a moment to review these exciting and most cost-effective changes! We will continue to fax and email renewals. In addition, when the new website launches, new members will be directed to a new member packet with videos from IACP Board of Directors, tutorials, and all the latest compounding information! Just more ways we are making sure your membership dues are used to provide the resources that you need. 
In addition, IACP is collecting demographics from our membership in order to better 
serve and protect the art of compounding! The data collected will enhance IACP's focus on current and potential concerns on the local and national levels.
Advocacy


Federal Advocacy
  • 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 HUGE 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. 
  • 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!
RECAP In Case You Missed It: IACP  attended the Food & Drug Administration's (FDA) Pharmacy Compounding Advisory Committee Meeting  on November 20-21, 2017 in White Oak, Maryland.  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 also 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 iacpinfo@iacprx.org with any questions.
State Advocacy
  • The California State Board of Pharmacy has issued emergency rules addressing beyond use dating and non-sterile compound drug preparations. The Board finds that there is a significant adverse impact to patients related to the current requirements for establishing beyond use dates (BUDs) for non-sterile compounded drug preparations. "Each day that the board's existing regulations are in place, there is a significant risk that patients will be deprived access to needed medications. In addition, the board finds that it is necessary to clarify the requirements to extend the BUDs for sterile compounded drug preparations in order to allow for the BUDs of non-sterile to be emended." Read IACP's Member Alert here.
  • The New Jersey Board of Pharmacy voted at its Board Meeting yesterday to delay implementation of USP Chapter <800> until December 2019. The Board had planned to implement the original effective date of July 2018 - despite USP's delay of 800. Please click here to view the Agenda. Please view IACP's Member Alert on this Board Meeting here.
  • 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 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 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 - The International Academy of Compounding Pharmacists (IACP) submitted comments this week 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, § 39G. Please read IACP's comments to Massachusetts State Board of Registration in Pharmacy. Thanks to all IACP Members who acted on our member alert and sent their own comments!
  • 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.  
  • Check out IACP's 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.
  • 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 WebsitePatient 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 525 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 dagmar@iacprx.org.
IACP Events & Education


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

ROOM BLOCK ALMOST FULL! Advanced Hotel Discount ends December 24, 2017

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 !

Click here for a Educational Conference Schedule Sneak Peek!

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

Thank you to the following sponsors for their support of the  1st President's Annual Gala:
DoseLogix/Topi-CLICK (Bar Sponsor); Letco Medical (Entertainment Sponsor, Table Sponsor);  My USP 800  (Additional Gala Drink Tickets);  PCCA  (Table Sponsor). 

Thank you, IACP Member and Past IACP President Eldon Armstrong, RPh, FIACP, Sandlapper Consultant Pharmacists, Chapin, SC; and IACP Member Joseph Rossetti, RPh, Boulevard Pharmaceutical Compounding Center, Worcester, Mass., for your individual sponsorship of the 1st President's Annual Gala! And thank you to all members who have purchased Gala tickets! 

Find more information about the President's Gala, including how to attend/purchase tickets, how to sponsor, meal selection, and entertainment details hereAll proceeds from the President's Gala will go to the IACP One Fund.
Registration NOW OPEN for IACP's 24th Annual Compounders on Capitol Hill!

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!

Register Here! Reserve Your Hotel Room Here!
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.

Corporate Member Spotlight: MEDISCA


Get ready for the most impactful event of 2018!

MEDISCA, proud sponsor of the World Congress of Compounding (WCC), invites you to join us at the event that will elevate your compounding business to the next level.

Our Commitment to you:
  • Learn valuable insights from industry experts
  • Develop strategies to effectively grow your business
  • Enjoy networking opportunities with global professionals 
Register before December 31st, 2017 and benefit from our Early Bird Special.

Visit the WCC website for more information.

 
Proudly sponsored by MEDISCA, MEDISCA Network, and LP3 Network.
 
North America
+1.866.833.5318
International
+01.011.514.788.5694
Like us on Facebook  Follow us on Twitter
 


IACP Corporate Member Announcement


IACP Corporate Members - we are working to reveal a new structure for Corporate Members to make sure you know how appreciated you are! Thank you to all Corporate Members who completed IACP's recent Corporate Member survey! Your feedback will help us to ensure we're providing the resources you need and the opportunity to effectively assist IACP members! We will be sharing your feedback soon!
IACP Affiliate News 




ACHC/PCAB  Joins Forces with Rxinsider on New
 Video Series

Our desire to connect with the providers we serve today and those we hope to serve in the future, made the decision to collaborate with IACP Affiliate RXinsider an easy one! RXinsider is a publishing and technology company offering fresh and relevant multimedia publications to the pharmacy and healthcare markets. 

With video projected to claim more than 80% of all web traffic by 2019*, ACHC and PCAB decided to leverage RXinsider's Thought Leader Video Series as an engaging platform to deliver the reasons why ACHC is best positioned to be the total accreditation solution for pharmacies.

The video series is segmented into clips that address 12 questions we believe are on the minds of pharmacies in need of accreditation, boards of pharmacy, payors/PBMs and manufacturers. CEO Jose Domingos, PCAB's Jon Pritchett, and National Account Manager, Roy Bigler, provide their thoughts on important questions like:
  • Why do managed care organizations prefer ACHC?
  • How is PCAB promoting safe practices in compounding?
  • How do Distinctions set your pharmacy apart from the competition?
Since 59% of company decision makers would rather watch a video than read an article or blog post*, these short clips will allow us to educate pharmacies and industry stakeholders about ACHC and our programs in a dynamic and more personal format. 


New USP Activities/Resources: Safe Handling of Hazardous Drugs <800>
 

Coming soon... in 2018
  • Know your exposure: Awareness campaign
  • HazRx™ Mobile App:  At the point of practice tool to identify HDs and take measures to help decrease risk associated with handling hazardous drugs. 

IACP Affiliate Rxinsider

Check out IACP's Affiliate RXinsider's  20 Ways  Winter  Hospital Edition



Need CE ASAP?  

If you need CE credit, check out IACP AdvanCE's on-demand library. The library houses over 100 programs over various pharmacy topics. Please click here to access the self-paced programs.

Featured Webinar Programs:
IACP| 281.933.8400 | iacpinfo@iacprx.org | iacprx.org
STAY CONNECTED:

(C) IACP 2017