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Capitol Connections June 27, 2014
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June 27, 2014  

IACP Offices Closed for 4th of July

The IACP offices will be closed on Friday, July 4th in observance of Independence Day. Wishing you and your family a happy and safe 4th of July! We will reopen on Monday, July 7th. Please email iacpinfo@iacprx.org if you need to reach us in the interim.

IACP Members Integral in Obtaining House Letter Signatures

 

Thank  you to all IACP Members who particpated in the Academy's Action Alert last week to obtain signatures for both Congressman Bilrakis and Congressmen Griffith, Green and DeGette's respective House letters. Holding FDA accountable for correct and appropriate implementation of the DQSA is IACP’s number one priority.   

Your efforts have been key in obtaining several signatures. The Bilirakis letter closed end of day, today. We will provide the final letter with signatures as soon as available.

Click here to view the final Congressmen Griffith, Green & DeGette letter with signatures. 

Background:

As part of this year’s Compounders on Capitol Hill, attendees visited House offices asking for support of a letter from Congressman Bilirakis (R-FL) to the Food and Drug Administration (FDA) that raised questions about the agency’s interpretation and implementation of the Drug Quality & Security Act. In addition to concerns about how the FDA views office-use dispensing in those states that permit it, repackaging of medications, the impact on patient access, and the promotion of 503B outsourcing facilities before the agency has completed the promulgation of regulations, Congressman Bilirakis and others signing onto the letter are specifically querying why the FDA appears to be ignoring specific Congressional intent. More and more House members are signing onto the letter and IACP expects it to be forwarded on to the FDA by the end of June. To see a copy of the Bilirakis letter, please click here. To view the IACP “Ask” document explaining it, click here.

A second letter from Congressmen Griffith (R-VA), Green (D-TX), and DeGette (D-CO) raising many of the same issues also was released. IACP worked with Congressman Griffith’s staff to advise House offices of the importance of signing on to this letter as well given that these leaders on the House Energy and Commerce Committee were directly involved in the 2013 hearings in which the FDA claimed that they did not have sufficient authority to take action against the New England Compounding Center even when the agency was aware of significant deficiencies and violations dating back to as early as 2005. Congressman Griffith had introduced HR 3089 in the summer of 2013 to clearly delineate the role and responsibility of the FDA in overseeing compounding without impinging on the authority of state Boards of Pharmacy. 

What Can You Expect from Congress the Remainder of the Year?

Cynthia Blankenship, Esq., IACP VP Government Affairs

One does not have to look very far here in Washington, DC to know that we are in an election year.  The upsets have already started to shake each party to the core leaving the entire legislative agenda in both the House and Senate in question.  With the shocking double-digit loss of House Majority Leader Eric Cantor in his Primary to a lesser known (and significantly less funded) Tea Party challenger, the Republican House was not only left scrambling to identify their new leadership, but also to determine what is “safe” to place on the legislative agenda for the months remaining before the election. Please click here to read more.

Join Coalition to Protect Patient Access to Compounded Medications

As you may have heard, in a series of surprise moves earlier this month, PBMs and insurance companies, including Express Scripts, Catamaran, Optum, United HealthCare, and BCBS of various states, announced that access to compounded medicines for thousands of people is in jeopardy. Unless employers and plan sponsors act swiftly to provide for continued coverage AND to hold PBMs and insurance companies responsible for truly managing the prescription benefit instead of arbitrarily slashing it, thousands of compounded prescription medicines will cease to be covered. Additionally, their actions will increase patients’ out-of-pocket costs for critical medications, while also limiting doctors’ ability to prescribe the medicines that are best for their patients.

In an effort to protect patient’s access to needed medications, the International Academy of Compounding Pharmacists (IACP) has joined a coalition consisting of individual patients, patient advocacy groups, pharmacists, physicians, pharmacies and healthcare organizations to raise the awareness of this issue. We need your help and invite you to join us in this all-important campaign. Together we must stand up to the PBMs’ and insurance companies’ efforts to limit access to these essential medicines. The PBMs and insurance companies are taking this unprecedented action without consulting patients, physicians, or pharmacists. Yet this plan will have tremendous impact on each.

Announcing Save Rx Access! 

Save Rx Access is a coalition of people and organizations working to save patients' access to compound medications. The voices of your pharmacy, patients, physicians, employer groups and elected representatives is critical to bringing awareness to these changes and protecting individualized compound therapy. IACP is proud to support Save Rx Access to help spread awareness of recent benefit changes restricting patients' access to compounded medications. This independent coalition is working diligently to protect your patient's right to specialized healthcare.


Below, we have provided the link to Save Rx Access' website where you will find the most up-to-date information. The website has support documents available to your patients with more being created and added daily. The documents include suggested letters for your patients to send their employers, as well as a template to send directly to the PBMs. Visit www.saverxaccess.org to join the Coalition.

 

Unite with us to ensure the coverage of compound prescriptions by taking advantage of the documents and resources provided by Save Rx Access. Patients should be treated based on their health, not their finances. Together as an industry, we can ensure that individualized patient care is not compromised.  Help spread the word by following Save Rx Access on Facebook and LinkedIn!

IACP Hosts USP Chapter <800> Town Hall - Recording Now Available

Did you miss IACP's Town Hall this week on USP Chapter <800>? You can still listen to the recording, which is now available in the Members-only site. Click here to access the IACP Town Hall recording. 

Additional Information:

Click here for background on USP 800 call for comments

Click here to access actual USP 800 draft

Click here for document from NIOSH of Hazardous Drugs (from 2012, most current)  

COMMENTS LAST CALL: 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.  

IACP Q&A

Every week, IACP members contact our offices for questions about practice, business, legislation and other issues.  Beginning with this issue of Capitol Connections, we'll highlight a question we've been asked that affects many of our members.  If you have a question you'd like answered, send that to iacpinfo@iacprx.org

This week's question comes from an IACP member in Pennsylvania regarding the Drug Quality & Security Act (DQSA).

Just read the Drug Topics article in which IACP was quoted regarding the implementation of the Drug Quality & Security Act and the specifics about the Memorandum of Understanding that will govern interstate distribution of compounded preparations. Could you verify that DQSA is 5% to an one particular state and not 5% to all other states?

The specific language in section 503A states:

(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.

Under the strictest interpretation that means that the maximum any pharmacy could distribute out-of-state -- whether that be to one state, five states, or 50 states -- would be equal to or less than 5 percent of their total prescription business.  It's not 5% of the total to Alabama, another 5% to Alaska, another 5% to Arizona, etc.  In other words, if you dispense and a distribute a total of 1,000 compounds per year, the most you could send from your Pennsylvania pharmacy to any other state would be 50. 

Corporate Partner Spotlight: Associates of Cape Cod, Inc.

Associates of Cape Cod, Inc. (ACC), a global biopharmaceutical company, was the first company licensed by the FDA to manufacture LAL for use as a quality control test for endotoxin in the pharmaceutical and medical device markets.  ACC manufacturers and sells LAL reagents, software and instrumentation and also provides a variety of LAL/endotoxin training workshops. ACC operates a Contract Test Laboratory which offers a variety of services including custom oven controls, method development and validation of methods for regulatory review.

(ACC) is pleased to introduce a new, FDA licensed version of our rapid endotoxin detection kit, Pyrosate®.  Pyrosate® is well suited for performing endotoxin assays in full compliance with the Bacterial Endotoxins Test, USP chapter <85>.  Pyrosate® has been developed as an easy-to-use Limulus Amebocyte Lysate (LAL) gel-clot test that enables rapid testing and does not require special laboratory supplies. The easy to follow, step-by-step illustrated instructions allow the user to set up assays within minutes. 

In addition to FDA licensure, the Pyrosate® Kit is now available in sensitivities of 0.03 EU/mL, 0.125 EU/mL and 0.25 EU/mL, in both 10 pack and 30 pack formats.  With the introduction of this licensed version, in addition to research and water testing, Pyrosate® is ideal for dialysis centers, compounding pharmacies, pharmaceutical and medical device companies.

You can find out more about our newly licensed Pyrosate® Kit by visiting our website at www.acciusa.com. If you have any questions or for additional information, please contact Vann Jones at vjones@acciusa.com.

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 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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