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IACP Capitol Connections, October 29, 2015
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October 29, 2015

In This Issue

1. Busy Week for Compounding and FDA

 

2. Take Action: Step Up and Participate in Two Crucial IACP Action Alerts!

 

3. USP <797> Revisions – Impact on Sterile Compounders

 

4. NABP Supports Increasing Compounding Safety With Qualified Person Credentialing Program

 

5. IACP Foundation Board of Directors Call for Nominations is Now Open

 

6. Corporate Partner Spotlight: International Journal of Pharmaceutical Compounding

 

7. Thank You to our Generous One Fund Contributors!

 

8. IACP Members in the News

 

9. Educational Conference Registration is Now Open

 

10. #EduCon2016 Student Pharmacist Travel Grant



Capitol Connections is a biweekly newsletter for IACP Members Only.

Please email iacpinfo@iacprx.org with your editorial ideas and suggestions.

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Busy Week for Compounding and FDA


 

New Guidance Documents and New Lists

 

On Monday, the Food and Drug Administration (FDA) released two interim guidance documents to clarify how it intends to exercise enforcement discretion with both 503A traditional compounders - click here to view - and 503B outsourcing facilities - click here to view.

 

These guidance documents address the agency’s current position on what APIs can be used in preparing a compound when those bulk ingredients do not meet the Drug Quality and Security Act (DQSA) provisions that require the existence of either a USP monograph or that the API be a component of an FDA approved product.

Each of these guidance documents establish four lists. For both 503A and 503B, “List 1” shows a series of APIs which were nominated and accepted for review by the FDA’s Pharmacy Compounding Advisory Committee (PCAC). Although those reviews have not been completed, FDA is essentially permitting the use of these drugs in compounding until those reviews are finished and published on a formal list by the Secretary of Health and Human Services.

 

A second list, “List 2” shows those APIs which were nominated for review but which the agency deems unsafe at the present time. There is only one API on List 2 for 503A compounders – domperidone. No API appears on List 2 for 503B outsourcing facilities.

 

For both 503A and 503B, FDA has created a “List 3” of nominated drugs for which they did not receive sufficient background or information in order to present them to the PCAC for review.

 

Please click here to read more.


 

Take Action: Step Up and Participate in Two Crucial IACP Action Alerts!

Action Alert #1

 

Stop FDA's Misguided Veterinary Compounding Guidance

At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter (please click here to view the letter) demanding that the FDA withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances.

 

Led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR), the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine.

 

More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.

 

Click here to take action, it only takes a minute, and join 135 of your colleagues who already have sent their message to the Hill.

 

Our objective was to get at least 50 Congressional signatures on this by the end of October! With your help, the following Representatives have joined this effort!

 

Matt Salmon (R,AZ) - lead Republican
Kurt Schrader (D,OR) - lead Democrat
Patrick McHenry (R,NC)
Mark Pocan (D,WI)
Paul Gosar (R,AZ)
Dan Benishek (R,MI)
Peter DeFazio (D,OR
Ted Yoho (R,FL)
Joe Heck (R,NV)
Donald Norcross (D,NJ)
Krysten Sinema (D,AZ)
Ted Poe (R,TX)
Frank LoBiondo (R,NJ)
Pete Session (R,TX)

Congressmen Salmon and Schrader's offices have extended the deadline for their letter, and the opportunity for IACP members to secure additional co-signers, until next Friday, November 6.

 

Action Alert #2

 

Take Action! Ask your U.S. Senators to Support S.1406 Saving Access to Compounded Medications for Special Needs Patients Act.

 

Ask your Senators to preserve Office Use as Congress Intended in DQSA! To date, more than 525 members have sent their messages to the Hill on this very important issue. Please join us and send your messages. It only takes a minute!

 

Click here to take Action, Today!


 

In Case You Missed It: USP <797> Revisions – Impact on Sterile Compounders



 

 

After several years in the making, the USP Expert Committee on Compounding released and advanced preview of its proposed revisions to General Chapter <797> Pharmaceutical Compounding/Sterile Preparations at the end of September.

 

The revisions can be found by clicking here. When they are formally published on November 2, 2015, an open comment period will begin and run through January 31, 2016.

IACP already has reviewed the proposed revisions and its Legislative Committee has begun drafting comments on how these changes will affect sterile compounders in all types of pharmacy practice settings.

“One of our greatest concerns with the revised <797> standard is the elimination of a clinician’s ability to determine a beyond-use-date based upon the medical and scientific literature,” says David Miller, IACP executive vice president.

 

“Traditionally, USP has acknowledged that science evolves and that pharmacists have the ability to apply new information and incorporate that into their practices. By establishing specific limits on BUDs for sterile drugs using language similar to FDA guidelines, USP is inadvertently restricting professional decision making.”

 

Click here to read more.


 

NABP Supports Increasing Compounding Safety With Qualified Person Credentialing Program

With the goal of increasing compounding safety, CriticalPoint, LLC, has launched the Qualified Persons Credentialing Program (QPCP) for pharmacists at entities practicing compounding under sections 503A and 503B of the Drug Quality and Security Act (DQSA), Title I – Compounding Quality Act.

 

The National Association of Boards of Pharmacy (NABP) strongly believes that these pharmacists should be able to demonstrate knowledge, design sound compounding methodology, and develop effective quality systems in order to supervise such operations.

 

The Association is partnering with CriticalPoint to inform its member boards of pharmacy about the QPCP and how the program may assist the boards in establishing a formal and standardized system for evaluating, educating, and credentialing qualified persons for both 503A and 503B entities.

 

Please click here to read more.



 

IACP in the News

IACP's David G. Miller, RPh, Executive Vice President/CEO was interviewed by MassLive.com's Shira Schoenberg in the article Pharmacists See Patients Struggle as Insurers Limit Coverage for Compounded Drugs.

"Many of the payers started seeing a significant increase in what they were paying to compounded pharmacists, not because the price went up, but because the way we billed it changed," Miller said. "Over the last year, we've seen more third parties say we don't want to fix the system, we'll just stop paying for it."

Please click here to read the entire article which also features comments from IACP Members Ernie Gates and Andrew Stein.

 


 

Closing November 20th: IACP Foundation Board of Directors Call for Nominations

 

IACP Foundation’s 2015 Call for Nominations and the 2015 Election Cycle for the new March 1, 2016 – February 28, 2018 Board members is now open!

The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the community of pharmacists, pharmacy technicians, other healthcare professionals, patients, etc.

 

Nominations close on November 20, 2015.

Please click here for more information as well as a nomination form.



 

Corporate Partner Spotlight: International Journal of Pharmaceutical Compounding

 

 


 

The International Journal of Pharmaceutical Compounding (IJPC)®
Our Compounding Knowledge, Your Peace of Mind®

 

For almost 20 years IJPC and its associated products have provided compounding pharmacists with invaluable resources. Right now you can access articles and issues for immediate download at IJPC.com and formulas that are referenced with beyond-use dates and SOPs available on CompoundingToday.com.

 

Each issue of IJPC print/digital contains feature articles on relevant compounding topics, 2-4 peer reviewed scientific studies, ten formulations, series on the basics of nonsterile compounding and sterile compounding, quality assurance and much more. http://www.ijpc.com/Subscribe/

 

CompoundingToday.com is the world’s largest database for pharmaceutical compounding. It contains over 3,000 documented formulas, over 1,000 ‘Named” formulas, 350 cosmetic formulas, and more than 550 Standard Operating Procedures.

 

You can sign up for a free two-week trial and download some sample formulas at http://compoundingtoday.com/Register/

 

Please click here to read more.


 

Thank You to our Generous One Fund Contributors!


 

Help IACP reach our fundraising goal of $2 million dollars by the end of 2016. This funding allows us to continue our efforts to Fix DQSA and to be ready for the next challenge on the horizon. Through your generosity and support we are shaping the future of compounding.

 

Please click here to view our One Fund Contributors to date!

 

At Compounders on Capitol Hill this year, IACP President Dale Coker, RPh, FIACP, issued a personal challenge to our membership and Corporate Sponsors to donate to IACP’s One Fund.

 

Please click here to view IACP President Dale Coker's video message.

IACP Members and Corporate Partners: Please join us in our efforts to Protect, Preserve and Advance Pharmacy Compounding by making a donation to IACP’s One Fund fundraising campaign.


Please click here to donate online, or click here to access a One Fund donation form.

 

Please contact Jennifer Petska, BS, CPhT,IACP Director of Development & Membership, with questions about One Fund.


 

IACP Members in the News

 

Sienna Compounding Pharmacy Celebrates Grand Opening

 

Sienna Compounding Pharmacy owned by IACP Member Sulisa Chow, PharmD and Lori Markel, PharmD, opened August 18 at 9029 Hwy. 6, Ste. 190, Missouri City.

 

The pharmacy offers a wide variety of services to practitioners and patients, including prescription refills. The pharmacy compounds and sells medications for men, women, children and pets. It also sells dermatology prescriptions, vitamins and essential oils as well as offers hormone replacement therapy.

 

Lucy Malmberg/Wedgewood Pharmacy Receives Award for Excellence

 

Congratulations to IACP Board Member Lucy Malmberg, RPh, FACA, FACVP, Wedgewood Pharmacy in Swedesboro, NJ, for being presented the Annual Award for Excellence from the New Jersey Business & Industry Association!

 

Click here to read more.

 


 

 

ACA IACP ACVP Educational Conference Registration is Now Open!

 

 

Register, Today!

 

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 24-27, 2016, at the Loews Coronado Bay Resort located in San Diego, California.

 

Perched on its own 15-acre peninsula, Loews Coronado Bay Resort is a private oasis of tranquility with views of the shimmering bay waters and the San Diego skyline.

 

Learn More About the #EduCon2016 Exhibitors!

 

Visit our ACA, IACP, ACVP Educational Conference YouTube channel to checkout exclusive videos from our 2016 Educational Conference Exhibitors. Learn more about these exquisite companies and how you can improve your practice with their latest products and services!

This is destination education at its finest. We'll send you and your staff back to your practice energized, motivated and ready to conquer the world!

 

Please click here for more information and to register!


 

Act Today! #EduCon2016 Student Pharmacist Travel Grant Applications Due by October 31st


Calling All Students!

 

Are you interested in learning more about independent pharmacy and compounding?

 

 

The International Academy of Compounding Pharmacists (IACP), American College of Apothecaries (ACA) and American College of Veterinary Pharmacists (ACVP) Foundations are offering up to four (4) pharmacy students a travel grant to attend the joint 2016 Educational Conference, being held at the Loews Coronado Bay Resort, February 24-27, 2016, in beautiful San Diego, California.

 

Who Can Apply?

 

All student pharmacists are encouraged to compete.

 

What’s Available?

 

Travel grants, up to $2,500 each!

When Can I Apply?

 

Applications for the 2016 Educational Conference Travel Grant should be submitted no later than October 31, 2015.

 

Here's the Application

 

Student Pharmacist Travel Grant Application link here.

 

For More Information

 

Click here for more information. If you have any questions, contact ACAFoundation@acainfo.org or foundation@iacprx.org.

 



 

IACP Regional Education Meeting Heading to Action, MA; Richmond, VA & Houston, 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 Compounding Medicines: New Laws, New Regulations, New Questions an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today.

 

Please click here for more information and to register!

 


 

IACP Foundation News


 

 

IACP Foundation Seeking Grant Proposals

 


The IACP Foundation Research Committee is now seeking proposals for funding consideration. Please click here to read the Grant Request for Proposal, and submission guidelines. Please click here to read more about IACP's Grant Proposal program.

 

The Application Deadline is November 1, 2015. Grant Awards will be announced on December 15, 2015.

 

NEW! Announcing the Fall 2015 Student Writing Competition

 

Essay Theme: "How is the Drug Quality & Security Act Affecting the Future of Compounding?"

 

The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers by student pharmacists on a particular topic affecting pharmacy compounding. THREE winners will be selected by a review committee from the papers submitted. The winners of this writing competition will each receive a $500 cash prize. All student pharmacists are encouraged to compete.

 

The submission deadline is Monday, November 30, 2015. Please Click Here to obtain a Guidelines/Requirements document for essay submission.

 

For more information, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development.



 

Did You Miss the FDA Inspection Webinars? They're Available on Demand!

Office-Use + FDA = cGMP

 

That’s a heck of an equation! The Food and Drug Administration is directing its inspectors to find one… just one… instance of an office-use compound to justify allegations that a compounding pharmacist isn’t eligible for the exemptions provided for within section 503A of the Food, Drug and Cosmetic Act. And without those exemptions any compounder can then be held to Current Good Manufacturing Standards.

If you are a sterile compounder, understanding the approach and the areas which FDA inspectors are told to check is absolutely critical. For example, did you know that you are expected to validate and document the efficacy of your disinfectant? that you are supposed to audit your testing laboratory? That you must have SOPs to demonstrate assessments of the sterility of your containers and your container closures?

 

Webinars Available On Demand!

 

IACP recently hosted the webinar - FDA Inspections for Compounders: The Impact of DQSA. We had more than 100 participants. If you missed it, you can view in our Self-paced Webinars available through IACP AdvanCE. Click here to learn more!

 

Today, IACP hosted the second continuing education webcast on FDA inspection preparation focusing upon sterile compounding. This program will be available on demand in the next couple of days. Click here to access IACP's on demand AdvanCE library.

 


 

Mark your Calendars - 2016 CCH Exhibitor Prospectus will be Released November 2015!


 

 

The 22nd Annual Compounders on Capitol Hill (CCH) will be held June 11-14, 2016 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2016, 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.

 

Don’t miss the only pharmacy compounding event that takes our issues directly to Washington, D.C.’s doorstep.

 

CCH returns to Downtown Washington, D.C.! Conveniently situated in the Penn Quarter district, this premier location is surrounded by shops, a variety of dining options, the Spy Museum, Chinatown, the National Portrait Gallery, the Smithsonian American Art Museum, and world-famous National Mall monuments.

 

More details to come!


 

Need Additional CE Credit?

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

Featured Webinar Programs:


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