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Capitol Connections, November 4, 2014
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November 4, 2014

In This Issue


1. IACP Leads DQSA Stakeholder Meeting

2. Did You Know IACP has 60 Corporate Partners?

3. IACP Participates in USP Expert Compounding Committee

4. Georgia: Out-of-State Pharmacies Required to Register

5. MEDISCA Announces the Launch of the 5th Annual Student Pharmacist Compounding Competition

6. IACP Member Q&A

7. Corporate Partner Spotlight: PennTech Machinery Corporation

8. 2015 Educational Conference Registration Now Open

9. CCH Registration Opens on December 1, 2014

10. IACP Welcomes Corporate Partner ITL Consulting, Inc.


Capitol Connections is a biweekly newsletter for IACP Members Only.

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



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

IACP Leads DQSA Stakeholder Meeting


The International Academy of Compounding Pharmacists (IACP) hosted a meeting and listening session in Washington, D.C., last Monday, October 27th, with several stakeholder groups and Congressional staff joining to discuss concerns stemming from FDA implementation of the Drug Quality & Security Act (DQSA).

"The meeting was very productive with many stakeholders agreeing to participate in future meetings and continue the discussions on preserving patient access to medications," says Pat Stephens, PharmD, IACP President. "IACP's primary objective is to ensure that patients continue to have access to the compounded, personalized medications they need."

Please click here to read why IACP believes it's vitally important we FIX the Drug Quality & Security Act (DQSA)!

Stay tuned for additional updates.


Did You Know IACP has 60 Corporate Partners?


Can we brag a little? Did you know that IACP now has 60 Corporate Partners? That's right. SIXTY. In fact, since the IACP Corporate Partner program was founded in 2006, it has grown by 106 percent.

The health of an association is often related to the company it keeps. IACP is very fortunate to have considerable corporate support - high-caliber organizations passionately committed to Protecting, Promoting & Advancing Pharmacy Compounding.

IACP's award-winning Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 Members.

How can you help? Help grow your profession by leading IACP to companies that are providing pharmacy compounding products, cleanroom or lab equipment, compliance training, legal counsel, etc. You may play a role in advancing your profession by asking your vendors to join the IACP Corporate Partner Program. Please email any vendor recommendations to Meridyth Moore.

The next time you speak to an IACP Corporate Partner, please thank them for supporting IACP and the pharmacy compounding profession!

Click here to view our Corporate Partner Website page.

Click here to read more about the Corporate Partner program/application.


IACP Participates in USP Expert Compounding Committee

The USP Expert Compounding Committee formally voted on Thursday, October 30, 2014, to retain the proposed general chapter on USP <800> with a number LESS than 1,000. It will become enforceable once formally adopted.

IACP members will have the opportunity to review and comment again when the next iteration is formally released with the modifications and changes made by the Committee; that will cascade out through the Pharmaceutical Forum shortly. There will be an extended comment period as was done with the initial draft. The Committee has NOT discussed/decided upon the implementation date or length of implementation time (e.g., more than the minimum six months) but it appears that's in abeyance until the next round of comments come through. Please email IACP with any questions.


Georgia: Out-of-State Pharmacies Required to Register

Until recently, only Georgia, Massachusetts and Pennsylvania did not require out-of-state pharmacies to register with their Boards of Pharmacy. Georgia passed legislation to establish non-resident permitting in April 2013 and final rules were adopted by the Georgia Board at its meeting on October 7, 2014. Forms and instructions for registering are now available at the Board's website.

Beginning on January 1, 2015, all pharmacies dispensing or delivering prescriptions into the state of Georgia must have a non-resident permit. The application requirements are included in the attached rules published by the Board. Compounding pharmacies that deliver office-use medications to Georgia practitioners must also provide a current inspection report from their home state Board of Pharmacy that includes verification that the pharmacy is in compliance with USP <795> for non-sterile compounding and USP <797> for sterile compounding.

Click here to read more.


MEDISCA Announces the Launch of the 5th Annual Student Pharmacist Compounding Competition!


IACP Corporate Partner MEDISCA has announced the launch of its fifth annual Student Pharmacist Compounding Competition (SPCC 15). MEDISCA is continuing its commitment to sponsor both the regional and national events. The fifth annual national event will once again be hosted by the University Of Florida College Of Pharmacy in Gainesville, Fla.

Click here to read MEDISCA's SPCC Press Release.

 


Members in the News!

“I like to compare it to making a cake that’s just right for each person," said Stephen P. Bernardi, a registered pharmacist and co-owner of Johnson Compounding & Wellness Center in Waltham.

IACP Member Stephen Bernardi, RPh, of Johnson Compounding & Wellness Center in Waltham, Mass, effectively shares the value of compounding in this Boston.com interview. Click here to read more!

 

 


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:

Will MOUs be state specific or the same for all states?

Answer:

There will be a standard MOU template submitted to all states that is under development by the FDA in conjunction with the National Association of Boards of Pharmacy. That template MOU has not been released.

Question:

Will State Boards have any input as to what they will or will not accept?

Answer:

That will be up to the processes specified within each state's laws and regulatory process.


Corporate Partner Spotlight: PennTech Machinery Corporation

PennTech Machinery Corporation was founded in 1992 as a manufacturer of vial washing and trayloading machines. Since that time, success in performance and reliability has led to an ever increasing and diverse product line, to include: vial washers, trayloaders, sterilization tunnels, filling/stopper inserting machines, automatic lyo loading machines, cappers and external washers. Today PennTech is the only company in the United States to manufacture complete aseptic vial processing lines.

Click here to read more.


2015 Educational Conference Registration Now Open

Connect and network with fellow colleagues. #EduCon2015

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.

On Thursday, February 26, 2015 the Educational Conference program kicks off with the Exhibitor Experience and Continental Breakfast followed by General Sessions accredited for both pharmacists and technicians. Earn up to 13.0 contact hours (1.3 CEUs) of continuing education credit including 5.0 contact hours (.5 CEUs) of LIVE Pharmacy Law. The program will feature dynamic speakers in thought-provoking sessions on hot topics including veterinary compounding oversight, specialty pharmacy, third party reimbursement, a review of the Drug Quality and Security Act, the advantages and disadvantages of the new drugs in the New Drug Update, Approved vs Unapproved Veterinary Drugs-Dispelling the Myths, and much more.

Thursday, February 26 General Sessions Include:

  • Veterinary Compounding Boot Camp: A Future Look at Veterinary Compounding Oversight, presented by Gigi Davidson, BSPharm, FSVHP, DICVP, NC State College of Veterinary Medicine; Ashley Shelton Morgan, DVM, American Veterinary Medical Association; Jane G. Owens, DVM, PhD, Dipl ACVP, Director-Food Animal Refinement, Elanco Animal Health
  • If It Sounds Too Good To Be True…How to Navigate Business Opportunities While Protecting Your Pharmacy, presented by Jonathan E. Levitt, Esq., Frier & Levitt, LLC; John E. Morrone, Esq., Frier & Levitt, LLC; Jesse C. Dresser, Esq., Frier & Levitt, LLC
  • Payor & Governmental Trends: An Update to Stay Ahead of the Curve, presented by Jonathan E. Levitt, Esq., Frier & Levitt, LLC; John E. Morrone, Esq., Frier & Levitt, LLC; Jesse C. Dresser, Esq., Frier & Levitt, LLC

Click here for more details!


Announcing the 2015 Educational Conference Student Writing Competition

Do you have a pharmacy intern? The ACA, IACP, ACVP Educational Conference announces the 2015 Educational Conference Student Writing Competition to recognize original papers on a particular topic affecting the future of independent community pharmacy practice. Two winners will be selected by a review committee from the papers submitted. Thanks to the generosity of donors of both the ACA Foundation and the IACP Foundation's Fund-the-Future program, the winners of this writing competition will each receive a travel stipend and scholarship to attend the Educational Conference February 25-28, 2015 in Fort Lauderdale, Florida. All pharmacy students are encouraged to compete.

Share this great opportunity with your pharmacy interns!

To download the 2015 Educational Conference Student Writing Competition Flyer Scholarship Application, please visit www.educationalconference.org/students.html.


CCH Registration Opens on December 1, 2014

The 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 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.

Why is CCH important to attend? “It is absolutely imperative that members participate in Compounders on Capitol Hill if we are to continue to validate and strengthen our industry of compounding pharmacy by educating our elected representatives in Congress on the importance of customized medication.”

Brenda Pavlic, CPhT, President-Elect, IACP Foundation Board of Directors, SaveWay Compounding Pharmacy, Newark, Del.

Why is CCH important to you? Email a brief statement to Ashlyn Grant.

Click here for more about CCH 2015!


IACP Welcomes Corporate Partner: ITL Consulting, 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 60 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

To learn more about ITL Consulting, Inc., please visit www.itlconsulting.net.

 


Compounding Pharmacies and the USP <71> Sterility Tests – IACP’s November Webinar

The compendial Sterility Test has a simple premise - test CSP for the presence of viable microorganisms. However, recent regulatory action has highlighted the difficulties in performing the test compliantly. This one-hour webinar will examine the now internationally-harmonized test in terms of its scope as a regulatory requirement and a scientific test method. The discussion will focus on the compendial Sterility Tests (and their Method Suitability requirements) and provide background needed to understand why a harmonized, if admittedly arbitrary, test is so widely required. The discussion will be summarized with a checklist of considerations to review when considering the outsourcing of this important test.

Click here for more information and to register.

 


Save the Date!

For more information about the IACP AdvanCE live webinars, please click here.

•Managing Risk in Today's Society: Examining Compliance, High Risk Issues, and Liabilities

 


 

Check out the IACP AdvanCE Self-Paced Library 24/7!

If you were unable to attend our live webinars, they have been added to the IACP AdvanCE self-paced online program line-up so that you can review at your convenience 24/7. Please click here to access the self-paced programs.

The IACP AdvanCE self-paced library features previous live programs, the United States Pharmacopeia (USP) requirements, recorded sessions from Compounders on Capitol Hill 2012-2014, recorded sessions from the ACA, IACP, ACVP Educational Conference 2013, and a wide-range of sessions from the Texas Pharmacy Association, Ohio Pharmacists Association, Arizona Pharmacy Association, and the American College of Apothecaries online libraries.

Webinar topics include:

•Endotoxin Testing
•Environmental Monitoring
•Standards of Practice
•FDA Inspections
•DEA Inspections
•USP 797, 795, & 1163
•Cease and Desist Letters
•Stark Law and the False Claims Act
•Marketing and Sales
•Legislative & Drug Updates
•CMS and Reimbursement
•Third-Party
•Media and Public Relations
•Patient Safety Organizations


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