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Capitol Connections, August 17, 2015
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August 17, 2015

In This Issue

1. FDA Grants IACP Request for Extension on Veterinary Compounding GFI

 

2. Final Guidance Document on 503B Registration Released

 

3. First "The Compound Conference" A Success

4. IACP's Summer CAMP is in Session!

 

5. IACP Corporate Partner Spotlight: MEDISCA

 

6. IACP Welcomes New Corporate Partner: R. Donnelly and Associates, Inc.

 

7. IACP's Board Call for Nominations Ends on September 8

 

8. Support IACP's One Fund!

 

9. IACP Foundation 2015 Fall Grant Program: Request for Proposals

 

10. Save the Date! Registration Will Open October 5th for the ACA IACP ACVP Educational Conference!



Capitol Connections is a biweekly newsletter for IACP Members Only.

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



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA Grants IACP Request for Extension on Veterinary Compounding GFI

 

On July 27th, the International Academy of Compounding Pharmacists (IACP) requested a formal 90-day extension of the comment period for the Food & Drug Administration's (FDA) Guidance for Industry (GFI): Compounding Animal Drugs from Bulk Drug Substances from August 17, 2015 to November 2015.

In a letter sent to the FDA, David G. Miller, RPh, IACP Executive Vice President/CEO says, "IACP is gravely concerned with many issues within this GFI that create distinct conflicts with existing State-regulated pharmacy practice laws and regulations, that authorizes the preparation and distribution of veterinary medications by 503B outsourcing facilities without the necessary enabling statutory authority from Congress, and will have a detrimental impact on the availability of medications for use by veterinarians in the care and treatment of animals within their practices."

IACP is pleased to announce that the FDA has granted an extension for comments on Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry. FDA has extended the comment period by 90 days to November 16, 2015. Please click here to read FDA's announcement and instructions for submitting comments.

Official notice of FDA's comment extension appeared today, Monday, August 17th in the Federal Register. Click here to view.


Final Guidance Document on 503B Registration Released

FDA has released final guidance entitled, Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry. When released as a draft in February, the Guidance answered many outstanding questions as to what 503B outsourcing facilities can compound and what quality standard will be enforced for the compounding activities within a 503B outsourcing facility.

Click here to read the final guidance in its entirety.


Some key points found within the guidance include:
· All of the outsourcing facility’s compounded drugs must be compounded in accordance with cGMPs. This means that all drugs compounded within a 503B outsourcing facility must be compounded in accordance with cGMP requirements, and outsourcing facilities will be inspected by FDA on a risk-based schedule. The Guidance made clear that if you do not intend for all drugs compounded at your facility to be compounded in accordance with section 503B and comply with cGMP requirements, you should not register as an outsourcing facility under section 503B. "All" includes any patient specific compounded preparations dispensed in the same facility.
· The facility must be engaged in the compounding of sterile human drugs. The 503B must compound at least one sterile human drug in order to qualify for the registration.
· A 503B outsourcing facility may compound and distribute non-patient specific non-sterile drugs as well. Any non-sterile human drugs compounded by the facility must be prepared in accordance with cGMPs in order to be eligible for the exemptions from sections 505, 502(f)(1), and 582.
· A facility should NOT register as an outsourcing facility if the only activities conducted at the facility are repackaging, compounding non-sterile drugs, compounding animal drugs, or mixing, diluting, or repackaging biological products subject to licensure under section 351 of the PHS Act, because none of the products produced at the facility would qualify for the exemptions provided in section 503B. The guidance makes clear that the definition of compounding in section 503B(d)(1) does not include repackaging.


First "The Compound Conference" A Success

As part of his plans for the Academy, 2012 IACP President Scott Karolchyk, MS, RPh, FIACP, recognized that working with state pharmacy associations was essential to a successful compound pharmacy environment. Although much of that work has been behind-the-scenes -- including providing state associations with IACP newsletters and updates, access to our legislative and regulatory support, and signing co-marketing affiliation agreements -- this past weekend was the premiere of what promises to be a series of highly successful and well received regional conferences.

Called "The Compound Conference" and co-hosted with the Ohio Pharmacists Association (OPA) in Columbus, OH, the meeting specifically targeted pharmacists who were either thinking about providing or just starting to provide compound services in their community. With almost 100 attendees and more than 15 exhibitors, the educational seminars included updates on USP <800>, the Drug Quality and Security Act (DQSA), assessing testing and equipment needs, marketing and promotion, and a panel discussion by seasoned local compounders.

"This is the first and only instance of a national pharmacist association working directly with our state pharmacy association to bring important information right to our pharmacists' back yard," said OPA Executive Director Ernie Boyd, RPh, MBA. "Next year, we hope to expand this even more with IACP to include pharmacists from other states in the area as well as hospital and home infusion pharmacists who need information about USP <797> and sterile compounding."

"For next year, we're also looking at our state partners in California, New York, and Virginia/Maryland as possible sites," said IACP Executive Vice President David G. Miller, RPh. "Not only does this bring our organization to our members, it also helps expose pharmacists and technicians who aren't familiar with IACP to all the things we do to protect and preserve the unique services they provide to members."

 


IACP's Summer CAMP is in Session!

For the past six years, IACP's Summer CAMP (“Congressman At My Pharmacy”) campaign has brought legislators face-to-face with members to see first-hand what compounding pharmacy is all about and the impact you have on the business and health of your community.

This year, we want you to know how important it is to sponsor a Summer CAMP event at your pharmacy during the summer Congressional Recess. Timing couldn’t be better in 2015! Providing your Representative and Senator with an opportunity to meet your patients and their constituents increases the likelihood that they will want to spend time learning about compounding, your business, and the effects of the Drug Quality & Security Act.

IACP's Summer CAMP packet
contains everything you need to prepare and host a successful event. Follow the step-by-step instructions and do your part to put a face on compounding for federal legislators!

Please click here to view IACP's Summer CAMP packet!

 

Civic Center Pharmacy Successfully Uses IACP's CAMP!


 

IACP Member Mike Corrado, Marketing Consultant at Civic Center Pharmacy in Scottsdale, Ariz., just put IACP's CAMP packet to the test.

Adds Corrado, "The visit by David Bennett (shown left in photo), Legislative Aide for Senator John McCain, was a BIG success. David asked a ton of questions about what we do and how we do it. While he had some knowledge of compounding prior, I'm certain he left impressed with our attention to quality, what compounding means for patient care, and how FDA regulation threatens patient access to compounds and jobs here in Arizona.

Prior to leaving, David and I briefly discussed sponsorship of the Vitter Bill (S 1406), the "positives" and "Difficult To Compound" lists and the MOU and how they will restrict patient access to compounded medications. Lastly we asked that Senator McCain support reimbursement for Veterans on TriCare for compounded meds.

I have to tell you it was a BIG thrill and honor for our Pharmacy to show their stuff. It also validated that the time I spend at Compounders on Capitol Hill was impactful. Thank you, IACP!"


IACP Corporate Partner Spotlight: MEDISCA

 

Your Trusted Partner in Compounding

With over 25 years of experience, MEDISCA has developed a solid reputation as an innovative and entrepreneurial company in the pharmaceutical compounding industry. MEDISCA is a leading FDA-registered supplier of quality pharmacy compounding products and offers excellent service to the North American, Australian and other international markets. We are dedicated to providing our clients with the highest quality compounding products, such as:

• Active Pharmaceutical Ingredients (APIs)
• Fine Chemicals
• Bases
• Equipment & Devices
• Capsules
• Oils, Flavors and Colors
• Compounding Kits

Please click here to read more!



IACP Welcomes New Corporate Partner: R. Donnelly & Associates, Inc.


 

The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 members who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support IACP's 74 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

 

To learn more about R. Donnelly & Associates, Inc., please visit www.rda-group.net.



IACP Board Elections: Call for Nominations Deadline is September 8!

IACP’s 2015 Call for Nominations and the 2015 Election Cycle for the new 2016 Board members is now open! The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the membership. Nominations will close on Tuesday, September 8, 2015.

Interested candidates may be nominated or may be self-nominated to the IACP Nominating Committee chaired by IACP Immediate Past President Pat Stephens, PharmD. The IACP Board of Directors receives the Nominating Committee report at its October Board Meeting, approves the slate of candidates, and then all qualified IACP members are able to participate in the election process held each November. This year, there are four Board of Directors’ seats for which candidates are sought as well nominees for the position of IACP Vice President.

 

Please click here to read more about the nomination process.

 

Please click here to access the nomination form.

 


Support Your Future and Your Academy. Contribute to IACP's One Fund.


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.

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.

"IACP has a clear goal to be proactive rather than a reactive organization," says Coker. "To accomplish this, it requires capital. We need to replenish our reserves used in defending compounding in the wake of the NECC crisis of 2012. We need to build our war chest for the next coalition that will need to be formed. There are many issues on the horizon, with the Veterinary Compounding Compliance Policy Guide, third party reimbursement and third party credentialing to name a few. We need funding available to act NOW, not after a crisis sets in.

 

During CCH, we raised an additional $52,000 and $15,000 in future donations from members for a total of $87,000. To date we are at $413,000 which is about 21 percent of our goal with a quarter of our timeline already gone.

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.

 

Corporate Partner Topi-CLICK Donates $25,000 to IACP's One Fund Fundraising Campaign!

 

Corporate Partner Topi-CLICK heard our call and donated $25,000 to One Fund. Their generosity will help us reach our goal of $2 million dollars by the end of 2016.

 

Thank you, Topi-CLICK, for your ongoing generosity to the Academy. We greatly appreciated your support. On behalf of our Board and Members, thank you.

 

Please call Jennifer Petska with questions about One Fund.


Member Update!


 

Wedgewood Pharmacy Welcomes New Jersey Dignitaries

New Jersey dignitaries visit Wedgewood Pharmacy in Swedesboro, N.J. Shown (L-R) are New Jersey Senate President Stephen Sweeney; IACP Member Marcy Bliss, president, Wedgewood Pharmacy; Assemblyman Adam Taliaferro; IACP Board Member Lucy Malmberg, R.Ph., F.A.C.A., F.A.C.V.P., chief executive officer, Wedgewood Pharmacy; Assemblyman Adam Taliaferro; and IACP Member Anthony Grzib, R.Ph., director of pharmacy compliance and pharmacist-in-charge, Wedgewood Pharmacy.

 

Please click here to read more.


FDA Update

 

FDA Drug Shortage App

 

FDA Launches Drug Shortage App

 

What's New on the FDA Drugs Site

Drug Firm Annual Registration Status (updated)

Drug Firm Annual Registration Status Download File (updated)

The FDA Drug Shortage Report


Please click here for the most recent Drug Shortage information.

 

 


IACP Member Q&A

Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. In every 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, please send to iacpinfo@iacprx.org.

 

Question:

 

Bausch & Lomb has pulled their antipyrine and benzocaine ear drops. Can we continue compounding this for our physicians?

Answer:

 

Here's the thing. These ear drops are not FDA approved. They preceded the FDCA, never went through the approval process, and the FDA (after several decades) has begun going after the manufacturers for marketing and promoting them.

 

Please click here to read the FDA announcement from the beginning of July 2015.

What does this mean for compounders? A licensed pharmacist can still compound these on order of a prescriber for an individual patient. They were not "approved" as manufactured drugs -- that's what the issue was. No evidence of patient harm. Just not deemed "safe and effective."


Save the Date! Registration Will Open October 5th for the ACA IACP ACVP Educational Conference!

 

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 ocean front property, the Loews Coronado Bay Resort in San Diego, Calif.

 

Please click here to read more!


IACP Foundation 2015 Fall Grant Program: Request for Proposals


 

The IACP Foundation Research Committee is now seeking proposals for funding consideration. Please click here to read the Grant RFP, and submission guidelines.

 

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

 

Since 2015, IACP Foundation has awarded more than $275,000 in grants to academicians and practitioners. The IACP Foundation strongly believes pharmacy compounding research is vital to further exemplifying the role of pharmacy in personalized medicine.

 

For more information, please email Jennifer Petska.


IACP Podcast #16: David Miller Explains the Memorandum of Understanding

 

Please click here for a Podcast interview with special guest, David G. Miller, RPh, IACP EVP/CEO, who helps clarify what's in the FDA's Memorandum of Understanding.

 

For more information on IACP's Podcasts and Publications, please contact Scot Maitland.

 

The Latest Issues of IACP's Publication Are Available!

 

Summer Reading is here with the digital issues of Compounding Matters Quarterly and Pharmacy Marketing Quarterly. These issues are packed with great information from robotic thank you notes to the latest information affecting compounders who provide veterinary compounds. Read them at IACPRx.org/Publications today and be on the lookout for the print issues in your mailbox soon!

 

Get caught up on our past issues and read them online at IACPRx.org/Publications.

 

Have an idea for a story? What to share some feedback? Send us an email to Scot Maitland or give us a call on the IACPublications line 713-730-9043.

 


Save the Date for CCH 2016! June 11-14, 2016

 

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 2015, 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!


Save $100 on Freedom's 4th Annual Seminar and Attend the IACP Regional Education Meeting in Denver, CO!


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!


Hot Button Issues on the PBM Radar Screen with Bradley W. Howard, Atty. at Law

Bradley W. Howard, Attorney at Law
Brown and Fortunato, P.C.
Thursday, August 27, 2015
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00MT)

Pharmacies rely upon their participation in many different insurance programs. However, the PBMs that regulate pharmacy participation have taken a very aggressive stance against various business practices of pharmacies. This program will familiarize you with recent trends in PBM audits of pharmacies and better prepare you for the future.

At the conclusion of this program, the attendee will be able to:
•Describe recent trends in PBM audits of pharmacies.
•List pharmacy practices that PBMs will not tolerate.
•Describe the business arrangements that may lead to PBM scrutiny.

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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