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Capitol Connection, July 25, 2014
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July 25, 2014  

House Letters Sent to FDA - Awaiting FDA Reply

 

Thank you to all IACP Members who participated in the Academy's Action Alert 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. Final signatures were gathered for both of these letters and, they have been sent to the Food & Drug Administration (FDA). At this point, we are awaiting FDA's reply. 

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

Click here to view the final Congressman Bilirakis 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. 
 

United States Government Accountability Office (GAO) Report on Prescription Drugs: Comparison of DOD, Medicaid, and Medicare Part D Retail Reimbursement Prices

GAO-14-578 - SUMMARY

The Government Accountability Office (GAO) recently released a report comparing prescription drug retail reimbursement prices paid by DOD, Medicaid, and Medicare Part D. Click here to read the entire GAO report. Click here to read IACP's summary of the report. 
 

Georgia State Senator Buddy Carter Wins 1st Congressional District Runoff

State Senator Buddy Carter, a Georgia community pharmacist and member of the National Community Pharmacists Association (NCPA), prevailed in a runoff election Tuesday, July 22 to become the Republican nominee in the Peach State’s 1st Congressional District. Click here to read more.

IACP Launches Partnership for Personalized Prescriptions Advocacy Group and Website!

IACP’s new compounding advocacy society, Partnership for Personalized Prescriptions (P3), brings together more than 150,000 patients and practitioners, providing them with a forum to share their support and passion for compounding. Importantly, P3 members are provided with the tools to advocate on their own behalf. P3 also provides an ongoing educational resource for those interested in pharmacy compounding and its value for patients and the practitioners who serve them. A compounding pharmacist locator service is provided so that patients, physicians, veterinarians and nurses can conveniently find compounders in their area. Click here to read more about P3.

Hundreds of Patients and Patient Advocates Form New Coalition to Fight Major Cuts in Prescription Coverage

In less than a month, more than 150 pharmacists, doctors, nurses, patients, patient advocacy organizations, and other advocates have banded together to form a coalition named Patients and Physicians for Rx Access. The coalition was formed to stop or reverse unprecedented cuts in prescription coverage by pharmacy benefit managers and some insurance plans. The cuts will directly impact millions of patients who rely on compounded medicines to address an array of medical conditions that are not satisfied by commercially available medications. This loss of coverage will force patients to pay out-of-pocket the full cost of their custom-formulated medications. Due to the financial burden placed on these patients, many will be forced to forego a compounded medication altogether, thus forcing physicians to prescribe less effective treatments. Click here to read more.

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 regarding Makena.

Question: Can I compound Makena?

Answer: That's really a question of "can I compound a commercially available product?"  Answer is yes given certain circumstances AND establishing some internal SOPs for documentation purposes.

The new guidance documents from the FDA aren't particularly different from the previous guidance and the existing language in 503A for compounding an "essential copy" of a commercially available product.  In other words, compounding 17-P can still be done so long as certain conditions are met, most importantly that the prescriber makes a decision based on clinical/medical need for an individual patient.

We have recommended to members to establish an SOP in their pharmacy whenever a request to compound an "essential copy" is received.  This might help:

  1. Upon receipt of a request or prescription for an "essential copy", the pharmacy contacts the prescriber and documents date/time of the call.
  2. The pharmacy informs the  prescriber that a commercially available version of the medication is available (document that).
  3. The pharmacy informs the prescriber that a compounded version can be prepared if in his/her determination of "medical need" that is in the best interests of the patient (document that conversation and response).
  4. Remind prescriber to document that in the patient's records as the prescriber is considered equally responsible for selecting the compound over the commercial product (document that).
  5. Upon dispensing to the patient, inform the patient that while a manufactured version of the medicine is commerically available, the prescriber has specifically determined that a compound is in the patient's medical interests. (a standard flyer comes in handy here).

Doing that for all similar situations helps document and demonstrate compliance with the intent of 503A that compounders are not engaged in bulk manufacture of duplicates of manufactured drugs. 

Corporate Partner Spotlight: MEDISCA

In only 20 years, MEDISCA has developed a solid reputation as an innovative and entrepreneurial company in the pharmaceutical compounding industry. We are dedicated to providing the highest quality products and supplies, unparalleled service and competitive pricing to our clients located in both the North American and Australian compounding industries. Together with our partner and educational arm MEDISCA NETWORK, we offer a full complement of products, services and educational courses that cater to the healthcare community as a whole.

MEDISCA’s mission is to provide the compounding industry pharmaceutical ingredients (APIs), including controlled substances, bases, excipients, equipment and devices at highly competitive prices coupled with exceptional service. As an FDA registered establishment, quality is the responsibility of everyone at MEDISCA. As a result, we have recently begun to implement a new quality management system which will support MEDISCA in exceeding industry regulatory requirements for years to come. Our passion for quality extends to all of our facilities.

Click here to read the entire Corporate Partner Spotlight.

Save the Date!  Registration will open Monday, August 4, 2014 for the ACA, IACP, ACVP Educational Conference February 25-28, 2015 in Fort Lauderdale, Florida

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! 

Pharmacy Students – Get Recognized!  Participate in the Educational Conference Spring 2015 Student Writing Competition

Essay Topic: Discuss the importance of being involved in a professional association as you’re starting your career. Click here to get the full details!

Meet the 2015 Exhibitors

The Educational Conference Exhibitor Experience has expanded to 28 exhibiting companies. Discover how you can work with them before you arrive. To learn more about MEDISCA and their services to help you effectively manage and grow your business, check out the video below. Make sure to stop by their booth when visiting the Exhibit Hall. For more videos from the Educational Conference exhibiting companies, visit our YouTube page at http://bit.ly/1p7zTAF.  Subscribe to the Educational Conference YouTube page as new videos will be added frequently.   

IACP Welcomes New Corporate Partner:  PCE Investment Bankers

The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with more than 3,600 IACP affiliates who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support these corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

To learn more about PCE Investment Bankers, please visit www.pcecompanies.com.  

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!

The Compounders on Capitol Hill State of the Academy Now Available

The State of the Academy recording from Compounders on Capitol Hill 2014 is now available. Please click here to view.  

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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