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Capitol Connections May 29, 2014
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May 29, 2014  

400 Attendees Convene in Washington, D.C. for the 20th Annual Compounders on Capitol Hill

The United Voice of Compounders Is Heard!

A special thanks to all the IACP members who participated either in person at Compounders on Capitol Hill, held, May 17-20, 2014 in Washington, D.C., or via our Virtual Hill Day -- your efforts made a HUGE impact. And a fast one as well. One of our key messages to Senators and Congressmen was that the U.S. Food and Drug Administration (FDA's) interpretation of the 2013 Drug Quality & Security Act (DQSA) appears to ignore Congressional intent. Despite repeated invitations from IACP to speak with our CCH conference attendees, everyone at the FDA was "unavailable" to attend and talk to those most impacted by the agency's activities... and that was noticed by Congress.

U.S. Senator Lamar Alexander (R-Tenn.) announced that, at his request, the Senate Appropriations Committee is directing the FDA to meet with doctors, patients, and pharmacists to discuss their concerns about implementation of the compounding legislation passed into law in November 2013.

“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak. If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.” – Lamar Alexander

Click here to read the U.S. Senate HELP Press Release.

IACP and its legislative team have worked tirelessly for the past several months emphasizing that FDA should be implementing DQSA according to congressional intent. This issue was the primary basis of our CCH 2014 Asks. Click here to review these Asks.

As covered in a Pink Sheet (subscription required) article from this week, there currently is an unenviable dilemma for pharmacists: whether to follow FDA regulations or those of their state.

"The International Academy of Compounding Pharmacists argues that FDA is not following the congressional intent of the Drug Quality and Security Act (DQSA), which was that office use regulation should be left to the states. Academy executive VP and CEO David Miller said the group wants FDA and/or Congress to clarify the office use issue as well as write other necessary regulations so pharmacists can operate under DQSA.

“'It is much more cloudy, muddy, messed up, uncertain, unclear, than we had, even from the compounding professionals’ standpoint, originally anticipated,' Miller said May 19 during a media briefing. Guidance may be coming, but it is unclear how the agency would address the office use issue.'"

Congressman Marino Introduces HR 4709 as a Complete Substitute for What was HR 4069


In order to generate bipartisan support, Congressman Thomas Marino (R, PA-10), has introduced HR 4709 as a complete substitute for what was HR 4069 (both are entitled the Ensuring Patient Access to Effective Drug Enforcement Act). HR 4069 essentially "disappears" now and 4709 is the primary legislation. Click here to read more.

IACP Nominations Open for 2014 Elections

IACP officially opened the nomination process for the 2014 election at last week’s Compounders on Capitol Hill annual convention. The Bylaws of IACP set forth an open election process with nominations accepted directly from membership.

An IACP member may nominate him/herself or another IACP member by July 15, 2014 by submitting their name, the position for which their nomination is being submitted, and the individual’s biosketch or resume to Wade Siefert, RPh, Chairman of the IACP Nominations Committee at iacpinfo@iacprx.org. The Nominations Committee will review all nominees’ qualifications and submit a formal slate to the IACP Board of Directors for its approval at the Board’s fall 2014 meeting. The approved slate will then be sent forward to the membership for an open election in November. Elected Board members will take office on January 1, 2015. Click here to read more. 

USP Proposed General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings

The United States Pharmacopeia (USP) currently is seeking public review and comment on its proposed Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. Click here to download this chapter with line numbers

All stakeholders are encouraged to submit comments with corresponding line numbers to CompoundingSL@usp.org. Comments are due by July 31, 2014. 

IACP is preparing its comments to the USP, and will share with IACP members as soon as available. Please click here to view why it's important to submit comments. Please email IACP with questions at iacpinfo@iacprx.org.  

FDA Offers Drug & Device Regulations Conference

The FDA is offering an opportunity to interact with Agency experts to learn about drug & device regulations. The conference is free of charge, and will be held June 16-17, 2014, at the Hyatt Regency near the San Francisco Airport.
Click here for more information.

FDA Releases Nominee Names for Nonvoting Industry Representative

As part of the Drug Quality & Security Act, the FDA is required to form a Pharmacy Compounding Advisory Committee. Although the members of the Committee -- of which 24 individuals were nominated by IACP -- have not yet been named, the agency did release the names of the nominees for the non-voting industry representative on Wednesday, May 28, 2014. The practitioner community is now responsible with selecting one individual from this list and submit that name to the FDA by July 28, 2014. IACP will be working with the nominating organizations to set a discussion date to come to an agreement on the single representative. 

Click here for the list of non-voting industry representative nominees to date.
Click here for FDA's instruction memo for the process of selecting one from the list.

Corporate Partner Spotlight: Fuji Health Science, Inc.

Fuji Health Science, Inc., offers F-MeltR, a ready-to-use ODT/chewable base. The Tablets that Melt in the Mouth.

  • Innovative Excipient Matrix for Orally Disintegrating Tablets (ODTs):
  • Ready to Use
  • Directly compressible via tablet press
  • Tablets disintegrate in the mouth without water
  • Excellent mouth feel

Click here for more information!

IACP Starts Strategic Plan for the Future of Compounding

Under the leadership of President-elect Dale Coker, IACP will begin a multi-month strategic planning initiative beginning this coming summer. In addition to representatives from the current Board of Directors, your Academy is looking for interested volunteers to participate in helping shape the future of the organization and develop key objectives for the compounding practitioner community. "Having members of the organization help in this process, including those who've never been on a Committee or even attended an IACP program, will assure that our planning is multi-dimensional and brings in perspectives that our Board may not have," said Coker. 

Any current IACP member may submit their name and contact information to
iacpinfo@iacprx.org for consideration by June 15, 2014. IACP's Executive Committee and Board will select from the submitted names at their upcoming Board teleconference on June 19 and the selected individuals will be contacted.

IACP Welcomes New Corporate Partner

The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 3,600 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding.  We encourage all IACP members to support these corporate partners that are instrumental in our joint effort to protect and grow this vital part of quality health care. Thank you for your continued support of pharmacy compounding!

New Rules Regarding Reporting of CEUs to the CPE Monitor Data Base

Effective May 1, 2014 all ACPE-accredited providers have 60 days after the CPE activity participation date to upload the participant credit into CPE Monitor.  The provider must upload the participant information 60 days from the date the participant completed the CPE activity.  This applies to all CPE activities:  live, internet-based, and home-study articles.
 
Please click here for more information!

Registration will open August of 2014. Save the date! The ACA, IACP, ACVP Educational Conference returns to Fort Lauderdale in 2015

Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 25-28, 2015, at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.

Click here for more details!

Reserve your hotel room now and receive the advance discount!

Start planning now!  Book your hotel room at the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. The deadline to receive the hotel group rate is on or before 6:00 p.m. (EST) on Friday, January 23, 2015. 

IACP Regional Education Meeting Heading to Newark, NJ; Atlanta, GA; and Dallas, TX

 

The IACP Regional Education Meeting brings 2.0 contact hours (.20 CEUs) of live pharmacy law continuing education credit to pharmacists and technicians all across the United States.  Listen to David G. Miller, RPh, IACP’s Executive Vice President & CEO as he presents, Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today. Click here for more information!

IACP Calendar

IACP is your one-stop resource for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs. Click here to view IACP’s Upcoming Events.

IACP Career Center

Welcome to the IACP Career Center! Your destination for exciting job opportunities and the best resource for qualified candidates within the Industry. Click here to view the IACP Career Center.

 

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