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Capitol Connections, September 29, 2015
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September 29, 2015

In This Issue

1. Take Action! Stop FDA's Misguided Vet Guidance

 

2. FDA Inspections Accelerate

 

3. Revisions to USP <797> Announced

 

4. GAO Report on Veterinary Compounding Released

 

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

 

6. IACP & Industry News

 

7. MEDISCA Contributes $50,000 to IACP's One Fund!

 

8.Corporate Partner Spotlight: International Filter Products

 

9. IACP Members in the News

 

10. Registration Opens 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.

 

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Take Action! Stop FDA’s Misguided Vet Guidance

 



 

At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter, please click here to view, 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.

 

How to Take Action!

Please click here to read the entire article.

 

Also learn how you can have your respective congressional contacts sign onto Congressmen Salmon and Schrader's letter to the FDA.


FDA Inspections Accelerate

In the past week, more than a dozen IACP members reported that FDA representatives are inspecting their pharmacy practice. While these practices are engaged in sterile compounding, the FDA also is inspecting all non-sterile compounding activities as well.

 

Even though a pharmacy may be in full compliance with its state pharmacy practice act, the agency continues to interpret the compounding of any medication for office-use as a violation of section 503A of the federal Food Drug and Cosmetic Act.

Please click here to read more, including information on IACP's October 6th webinar, FDA Inspections for Compounders: The Impact of DQSA.


Revisions to USP <797> Announced


 

On Friday, September 25, the United States Pharmacopeial Convention (USP) released an advance copy of its proposed revisions to General Chapter <797> - Pharmaceutical Compounding – Sterile Preparations.

 

The Compounding Expert Committee has been reviewing this chapter since 2010 with an eye towards clarifying and incorporating input from the compounding community. This will represent the first time in seven years that USP has announced an update to <797>.

Please click here to read more, including when comments to the USP are due.


GAO Report on Veterinary Compounding Released

 

One of the requirements included within the Drug Quality & Security Act of 2013 was for the Government Accountability Office (GAO) to conduct analysis of animal compounding with specific focus on the extent to which that practice occurs, FDA's approach to regulating compounded animal drugs, and the benefits and risks of drug compounding for animals.

 

The report was released yesterday and is entitled: DRUG COMPOUNDING FOR ANIMALS: FDA Could Improve Oversight with Better Information and Guidance (GAO 15-671). IACP staff were interviewed at length last summer on pharmacists' services, issues and concerns with veterinary compounding and our input was included in the GAO report.

 

Please click here to read more, as well as access the full GAO report.

IACP Foundation Board of Directors Call for Nominations is Now Open

 

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.

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


IACP in the News

Bloomberg BNA Q&A: IACP CEO David Miller

 

P&T Community: Two Draft FDA Guidance Documents Stir Controversy

 

Pharmacy Times: Pharmacists Commend Lawmaker's Opposition to Tricare Cuts

 

Fox News: What Every Patient Should Know Before Giving Their Child Prescription Meds

 

Industry News

 

APhA News: Key Changes to Part D for 2016

 

DVM 360: FDA Warns Pet Owners, Veterinarians of NSAID Toxicity from Use of Topical Flurbiprofen

 

Stars and Stripes: Military Update|DOD Resists Hill Push to Roll Back Compound Drug Rules

 

Roll Call: Congress Speaks - Tricare's Sweeping Action Hurts Veterans|Commentary

 

RAPS: Final Rule Allows FDA to Destroy Some Drugs Denied Entry into US

 


MEDISCA Contributes $50,000 to IACP's One Fund!


 

In a press release last Friday, MEDISCA announced that it is contributing $50,000 to IACP's One Fund Campaign.


"The practice of pharmacy compounding is one that has transformed considerably over the years. Through the efforts of the International Academy of Compounding Pharmacists (IACP), the industry has benefited from a number of innovative programs and research initiatives, with the ultimate goal focused on the continuous advancement of patient care.

 

MEDISCA recognizes the importance of the IACP and recently has made a donation of $50,000 to the well-established organization."

 

Please click here to read MEDISCA's entire press announcement.

 

On behalf of the entire IACP Board, Membership and Staff - thank you MEDISCA - for this very generous contribution to IACP. Your support is greatly appreciated.


 

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.

 

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.


Corporate Partner Spotlight: International Filter Products

 

International Filter Products Engineers and products have been serving the needs of the Pharmaceutical, Biotechnology, and Medical communities for over 30 years with world class technical support and products.

 

We are a stocking distributor making it possible to ship your products needs within 24 hours. Our technical staff consistently provides technical support and products that are well suited and cost effective for each user’s individual needs.

 

Our inventory includes filter, medical tubing, Bio-Bags, filter capsules, and filter disc capsules. We offer eight capsule configurations with seven media selections, and multiple inlet/outlet options.

 

Please click here to read more!


IACP Members in the News

 

Congressman Scott DesJarlais Visits Medical Center Compounding Pharmacy

 

Pharmacist Donny Ahlberg, DPh, Medical Center Compounding Pharmacy in Cleveland, Tenn., discusses the Drug Quality & Security Act and office use with a supportive U.S. Congressman Scott DesJarlais (R-Tenn) during a recent visit at the pharmacy. Congressman DesJarlais also signed onto the Congressman Carter letter to Tricare.

 

Vic's Family Pharmacy Moves to New Home

 

Vic's Family Pharmacy owned by Victor Allen, RPh has moved to a new facility in Nampa, Idaho. Please click here to read the news story.

 

Diamondback Drugs, National Veterinary Compounding Pharmacy, Launches New Website


Michael Blaire, RPh and his staff at Diamondback Drugs in Scottsdale, Ariz., have launched a new interactive website. Please click here for more information.

 

Fusion Specialty Pharmacy Increases Custom Compounding

 

"Compounded medications are on the rise," states Koby Taylor, PharmD, Pharmacist for Fusion Specialty Pharmacy in Santa Clara, Utah"By providing compounding services, we can provide customized medications to meet the prescription needs of all of our customers." 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.

 

IACP Launches Newly Updated Frequently Asked Questions

 

In today's issue, IACP is pleased to provide an updated Frequently Asked Questions document, a compilation of the many member questions we receive on a daily basis!

 

Please click here to view!

 

IACP will update this FAQ on a quarterly basis. If you don't see your question, please email us at iacpinfo@iacprx.org.



IACP Provides You with Educational Resources on How to Work with Third Parties

IACP has several self-paced, on-demand CE offerings on how to work with third parties. Check our our expanding library below:

 

CMS and Reimbursement for Medicaid/Medicare Prescription Drugs

Third Party – Part 1 Private

Don’t Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists

Contracting and Audit Considerations for Compounding Pharmacy

Medicare Part B: Documentation Requirements and 2013 Update

CMS and Reimbursement for Medicaid/Medicare Prescription Drugs

Hot Button Issues on the PBMs Radar Screen

Please contact IACP with any questions at iacpinfo@iacprx.org.


Registration Opens 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 Loews Coronado Bay Resort.

 

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

 

Please click here for more information!


IACP Foundation News


 

Apply Now for a Student Pharmacist Travel Grant for the 2016 Educational Conference

 

The American College of Apothecaries (ACA), International Academy of Compounding Pharmacists (IACP) and American College of Veterinary Pharmacists (ACVP) Foundations are offering up to four (4) pharmacy students a travel grant to attend the 2016 Educational Conference, February 24-27, 2016, in San Diego, CA.

What’s Available?

 

Travel grants, up to $2,500 each, will cover the following expenses:
•Meeting registration for one student to attend 2016 Educational Conference – $ 300
•Special event(s) – $ 200
•Four (4) nights of hotel accommodations – $ 1,100
•Funds to cover meals and travel not covered by registration and incidentals – $ 900 (paid after attendance)


Get an Application Here!

 

Please click here for more information and to access an application.

 

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.


Tune into IACP Podcasts #18 and #19!

 

Podcast #18 - The Washington State Court Ruling on the Pharmacist Conscience Clause and The Stocking of Plan B

 

Podcast #19 - FDA Guidance on 503B Facilities

 

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

 


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!


Marketing Research for Compounding Pharmacies

 

Daniel Faintuch, MBA
Lee Silsby Compounding Pharmacy
Thursday, October 22, 2015
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00MT)

 

Success in business (compounding pharmacies included) is dependent on understanding the target consumer, whether it is a patient or practitioner. The design and application of market research allows one to uncover the thoughts, reasons, behaviors and opinions of the parties you interact with, allowing the pharmacy to address those aspects more effectively.

At the conclusion of this program, the attendee will be able to:

Describe the risk pharmacy owners face when processing sensitive customer data.
• Discuss the financial and brand impact of a data breach.
• List the best practices/measures to take to avoid a data breach.
• Prepare a crisis management plan in the event of a breach.

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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