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Capitol Connections, August 4, 2015
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August 4, 2015

In This Issue

1. Veterinary Compounding Guidance -- Your Help Needed!

 

2. FDA Announces Guidelines/Fees for 503Bs

 

3. DQSA Stakeholders Coalition Files Comments with FDA

 

4. IACP Requests FDA Comment Period Extension - Compounding Animal Drugs from Bulk Drug Substances

 

5. IACP's Summer CAMP is in Session!

 

6. USP Expert Committee for Compounding Appointed for 2015-2020

 

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

 

8. Corporate Partner Spotlight: Cleanroom Connection

 

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

 

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



Capitol Connections is a biweekly newsletter for IACP Members Only.

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



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Veterinary Compounding Guidance -- Your Help Needed!

 

The International Academy of Compounding Pharmacists (IACP) is hard at work in developing comments for our members to the Guidance for Industry #230, FDA's far reaching attempt to regulate veterinary compounding without clear Congressional direction. In addition to adding extensive new requirements for specific language that must appear on a prescription in order for it to be considered "valid" in the eyes of the agency, FDA has gone even further and permitted 503B outsourcing facilities to compound and distribute veterinary medications even though 503Bs were intended to provide sterile compounds for human patients.

 

Last week, the IACP Board formally requested an extension to the August 17, 2015 deadline for comments due to our concerns about the complexity and breadth of what it would mean to our members should this document move forward. In addition, a coalition of veterinary compounders secured the support of Congressmen Salmon (R-AZ) and Shrader (D-OR) to request a total withdrawal of the Guidance. Please click here to read the letter.

 

What can you do to help?

 

Contact your Congressman today and ask his or her office to co-sign this Guidance withdrawal request. Please email IACP with questions!


FDA Announces Guidelines/Fees for 503Bs

The Food & Drug Administration's (FDA) pace of releasing guidance and requirements for implementation of the Drug Quality and Security Act (DQSA) continues this week with the issuance of two specific documents directly related to outsourcing facilities.

 

On Monday August 3, 2015, the FDA released a revision to its Guidance document that outlines how 503B outsourcing facilities will collect and report adverse event data. This is in direct follow-up to the comments filed by IACP and others to the initial Guidance that was issued in February and which closed in May. Though the agency made several requested changes, there are still concerns that need to be addressed. Interested stakeholders have 30 days (until September 2, 2015) to respond to the proposed final document. For details on the document and the changes made, please click here.

 

Also announced at the same time was the fees to be paid by outsourcing facilities for the coming year. The permit fees and the inspection fees have both been increased. For qualified small businesses, the fee is now $15,610 and for non-small businesses the fee is $16,465. Reinspection fees are the same amount regardless of whether the 503B facility is a small business or not; that stands at a flat amount of $15,610.

 

As a reminder, all 503B outsourcing facility fees must be paid no later than December 10, 2015 in order for the materials to be reviewed by the agency and for the facility to remain registered in 2016.

 

For additional information, please click here.


DQSA Stakeholders Coalition Files Comments with FDA

The Drug Quality & Security Act (DQSA) Stakeholders Coalition led by the International Academy of Compounding Pharmacists submitted comments on Friday, July 31st to the Food & Drug Administration's (FDA) Compounding of Human Drug Products under the Federal Food, Drug and Cosmetic Act Public Docket.

 

Excerpt - "During the Pharmacy Stakeholders Listening Session held on April 30, 2015, as well as the listening session for physicians, ambulatory surgery centers, and others, FDA proposed several question to the attendees. To provide a comprehensive set of answers, the DQSA Coalition, a group of more than 20 professional organizations representing prescribers, pharmacist, physicians, ambulatory surgery centers, and patients -- has worked diligently to provide data, examples and responses to FDA's questions in order to aid in the implementation of the DQSA. As a Coalition, we understand and support the need to protect public health. However, we also urge FDA to fully consider the preservation of patient access to vital compounded medications."

 

Please click here to read the full commentary.

 

Please email IACP with any questions!


IACP Requests FDA Comment Period Extension - Compounding Animal Drugs from Bulk Drug Substances

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."

 

Please click here to read the entire IACP letter.


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!


USP Expert Committee for Compounding Appointed for 2015-2020

 

Committee Members

 

•Gigi S. Davidson, RPh, DICVP, Chair
•Lisa Ashworth, BS Pharm, RPh
•Gus Bassani, PharmD
•Ruth Ebiasah, PharmD
•Edmund J. Elder, Jr., PhD
•Ryan Forrey, PharmD, MS
•Deborah Houston, PharmD
•Brenda Jensen, MA
•Patricia C. Kienle, MPA
•William A. Mixon, MS
•John Musil, PharmD
•David Newton, PhD
•Alan Parr, PharmD, PhD
•Abby Roth
•Robert Shrewsbury, PhD
•Connie Rae Sullivan, BS Pharm
•James Wagner
•Brenda Yuzdepski, BS Pharm

 

Government Liaisons

 

•Jane Axelrad, JD
•Jonathan Bray, BS
•Ian DeVeau, PhD
•Edisa Gozun, PharmD
•Susie Homire, DVM
•John Metcalfe, PhD
•Erika Pfeiler, PhD
•Sara Rothman, PhD

 

USP Documentary Standards Staff

 

•Shawn Becker, MS, BSN
•Rick Schnatz, PharmD
•Jeanne Sun, PharmD

 

Primary Points of Contact

 

•Rick Schnatz, PharmD (rxs@usp.org)
•Jeanne Sun, PharmD (jhs@usp.org

Click here to read more about USP's Expert Committees.


Hospira Recalling 21 Million Units of Three Injectables

Hospira is voluntarily recalling a total of over 21 million units of three injectable products through three separate recalls.

 

The Lake Forest, Ill., drugmaker’s biggest culprit is the nonsteroidal anti-inflammatory drug ketorolac tromethamine injection, with 20.69 million single-dose vials being recalled because the calcium salt is crystalizing. The recall involves 64 lots, 10 of which — totaling more than 3.25 million vials — carry the Novaplus label, according to an FDA enforcement report.

 

The recall was initiated by Hospira on June 30 and affects product in the U.S., Puerto Rico, Guam, Canada and Singapore.

 

Please click here to read more.


IACP Board Elections: Call for Nominations

 

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!


 

IACP Member Janet Beard, RPh, co-owner of Harvest Drug in Wichita Falls, Texas, is the 2015 recipient of PCCA's Evelyn Timmons Advocacy Award. "Janet is passionate about providing customized medications to patients who depend on it, and she is a strong advocate for protecting the compounding industry in both her local community and on Capitol Hill," says, Aaron Lopez, PCCA Senior Director of Public Affairs.

 

Congrats, Janet!

 

Retail Merchandiser Spotlights Rye Beach Pharmacy

 

IACP Member Ken GiaQuinto, President of Rye Beach Pharmacy in Rye, New York, was recently featured in the publication, Retail Merchandiser for his long-term pharmacy practice and compounded medications.

 

"In business for more than 65 years, Rye Beach Pharmacy is a full-service, family owned pharmacy that has served its community since 1946. Today, the company is an independent pharmacy that specializes in patient counseling, compounded medications for humans and pets, Bio-identical Hormone Replacement Therapy (BHRT), nutritional supplements, natural health products, custom fitted stockings, homecare aids and customer service."

“We’ve been able to endure thanks to employees that care and go the extra mile, and our customers recognize and appreciate that,” President Ken GiaQuinto says."

 

Please click here to read the entire article.


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:

Is it mandatory to include the following verbiage on our prescription labels?

THIS MEDICINE WAS SPECIALLY COMPOUNDED IN OUR PHARMACY FOR YOU AT THE DIRECTION OF YOUR PRESCRIBER.

 

Answer:

No, there is no law mandating inclusion of this verbiage on your prescription label – either state or federal. Many pharmacists do however include this information to ensure their patients have written verification on the label - that it's a compounded medication.


Corporate Partner Spotlight: Cleanroom Connection


 

Cleanroom Connection is the leading compounding pharmacy cleanroom supplier that specializes in helping pharmacies achieve USP 797 and soon-to-be USP 800 compliance. Focusing on building long-term relationships with their customers, Cleanroom Connection works closely with each pharmacy to ensure they are using the proper cleaning supplies, cleanroom apparel and related products for their particular applications and clean room facility.

Working alongside PCAB, IACP, USP and even the FDA…Cleanroom Connection is fully up-to-date on all of the latest requirements, products and protocol that most pharmacies need to be in compliance with including cGMP and 503b.

Cleanroom Connection has a team of pioneer compounding pharmacists, pharmacy consultants and pharmacy cleanroom designers that are available to answer any technical questions you may have. Cleanroom Connection supplies over 1000 sterile compounding pharmacies with all of their cleanroom apparel, cleaning supplies, sterility testing products, disinfectants & cleaning chemicals as well as sterile compounding supplies. Our expert level technical support team is able to answer even the most technical questions. On-site consulting, training and compliance implementation packages are available.

Free samples are available on all of the products that Cleanroom Connection sells. Take advantage of our “Best Price or It’s Free Guarantee” and not only save money on all of your pharmacy supplies, but simplify your buying process by using Cleanroom Connection as your one-stop pharmacy cleanroom source.

To learn more visit the Cleanroom Connection website or call (800) 616-5319.


Register Today for The Compound Conference!

Don’t miss this unique conference bringing together two leading pharmacy associations, August 15, 2015 at the Hilton Columbus at Easton in Columbus, Ohio.

 

The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession. At the Compound Conference, attendees have an unprecedented opportunity to meet face-to-face with compounding pharmacists, technicians, and marketing representatives in their home state. Offering a variety of Continuing Education sessions focused on understanding the essentials in building a compounding practice, the 2015 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA) and the International Academy of Compounding Pharmacists (IACP).

Over the course of one day, attendees will experience unique continuing education programming including an overview of Trends and Growth in the Compounding Industry, Getting Started - Niche or All In?,Standards and Laws - USP/State/Federal, Testing and Equipment Resources, Marketing Your Compounding Practice, and innovative practice ideas in the Idea Exchange panel discussion from Ohio and IACP Members.

Join us for this unique conference to make a finished preparation that builds your business and practice.

 

Thank you to Our Exhibitors and Meeting Sponsors!

 

We would like to thank the following exhibitors for their commitment to the Compound Conference: Analytical Research Laboratories (ARL); ASI; Associates of Cape Cod, Inc.; Biomerieux; Cleanroom Design LLC; Humco Compounding; Letco Medical; MEDISCA; P&C Pharma; PCCA; Pharmacists Mutual Companies; Rx30 Pharmacy System; Steris; Storey Marketing; Topi-CLICK; Topi-Pump.

We would like to thank the following meeting sponsors for their support of the Compound Conference: Letco Medical (Refreshment break with Exhibitors).

There are exhibitor and sponsor opportunities still available! Click here to download the Exhibitor Prospectus.

 

The Compound Conference eBrochure

Click here or on the graphic above to view our Compound Conference eBrochure! View the program schedule, speaker line-up and hotel information.


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 #15: Jay McEniry & David Miller Discuss Tricare

 

Please click here for a Podcast interview with special guests, David G. Miller, RPh, IACP EVP/CEO, and Jay McEniry, Executive Director, Patients and Physicians for Rx Access (SaveRxAccess.org). The topic is Tricare, and the current issues facing compounding pharmacists and most importantly the patients they serve.

 

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

 

Next IACP Publication Issues Arriving Soon!

 

Our next issues of Compounding Matters Quarterly and Pharmacy Marketing Quarterly are coming out 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!


IACP Regional Education Meeting Heading to 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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