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Capitol Connections, November 17, 2014
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November 17, 2014

In This Issue

1. GAO Releases Report on Compounded Drugs

 

2. Election Results: A Look from Washington on What's in Store

 

3. Pharmacist Buddy Carter Elected to Congress!

 

4. IACP Board of Directors Voting Ballot to Open December 1st

 

5. USP Partners with IACP to Provide Members with the USP Compounding Compendium

 

6. California: Outsourcing Facilities Must be Registered as Pharmacies to Compound or Dispense Within or Into the State

 

7. Texas State Board of Pharmacy Votes Against Class I Pharmacy

 

8. USciences Presents Service Award to the Malmbergs

 

9. Corporate Partner Spotlight: Frier Levitt LLC

 

10. IACP Welcomes Corporate Partner CSI Specialty Group


Capitol Connections is a biweekly newsletter for IACP Members Only.

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



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Happy Thanksgiving!

 

The IACP offices will be closed Thursday and Friday, November 27th & 28th in observance of the Thanksgiving holiday.

 

IACP wishes a peaceful and happy Thanksgiving to you and your families. Please email us at iacpinfo@iacprx.org if you need to reach us.

 


GAO Releases Report on Compounded Drugs

Earlier this fall, the International Academy of Compounding Pharmacists (IACP) participated in the U.S. Government Accountability Office’s (GAO) data collection process. The GAO recommendation? The GAO recommended clarifying the policy so that it is clear to providers. Medicare, Medicaid, and private health insurers have varying payment practices for compounded drugs, depending upon whether compounded drugs and their ingredients can be identified on health insurance claims, and Medicare's Part B payment policy for these drugs is unclear.

 

Click here to read more, access the complete GAO report, and IACP's response to the report.


Election Results: A Look from Washington on What’s in Store

 

by Cynthia E. Blankenship, Esq., IACP Vice President of Government Affairs

Most of the elections are over, and the political ads have for most of us living outside of the eight undecided races have ceased – but what does the result of the election mean for compounding pharmacists? This article will explore what changes will occur when the new Congress reconvenes, the timeframe under which the current Congress is working during Lame Duck, and what all that could mean for compounding pharmacists.

 

Current Congress

The current Congress will be concluding its business during the Lame Duck Session that stretches from November 12th until the new, 114th Congress convenes on January 3rd.

The current Senate/House convenes on November 12, 2014 with the House set to vote on five pieces of legislation, and the Senate expected to start discussion on the Administration’s nominations. The Republican Party is expected to have its leadership elections for both the House and Senate on November 13th. The House Democrats are expected to host their leadership elections on November 18th.

Please click here to read more.


Pharmacist Buddy Carter Elected to U.S. Congress!


 

Congratulations Buddy Carter on becoming the only pharmacist currently elected to Congress, recently winning Georgia's first Congressional District.

"IACP raised more than $25,000 to support Pharmacist Carter's campaign at the 2014 Compounders on Capitol Hill event," says IACP President Pat Stephens, PharmD. "We are proud to have a fellow colleague who thoroughly understands patient healthcare needs serving in Congress!"

“There’s a legacy of great leadership and representation in this district that I take very seriously,” Carter said. “I’m ready — put me in coach, I’m ready to get to Washington and help get this country headed in the right direction.”

Please click here to read more in the Savannah Morning News.


IACP Board of Directors Voting Ballot to Open December 1st

IACP Members: Mark your calendars for Monday, December 1st, opening day for the 2015 IACP Board of Directors Voting Ballot.The ballot will remain open for two weeks, closing at midnight on Monday, December 15, 2014. All current IACP members will receive the voting ballot by direct email.

Your vote is vitally important!! Please take time to cast your opinion for the future of your IACP Board and organization.

 

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


USP Partners with IACP to Provide Members with the USP Compounding Compendium

 

A new publication designed to provide easy access to quality related standards for compounded medicines is now available from the U.S. Pharmacopeial Convention (USP).

The USP Compounding Compendium offers compounding practitioners convenient access to all compounding-related general chapters from the United States Pharmacopeia–National Formulary (USP–NF), USP’s official compendia that are enforceable under Federal law in the United States.


“USP has a deep historic connection to the practice of pharmacy, stretching back to the very beginning of our origination nearly 200 years ago when practitioners regularly prepared medicines as-needed,” noted USP Chief Executive Officer Ronald T. Piervincenzi, PhD. “Our founders, most of whom practiced and taught medicine and/or pharmacy, promoted quality standards as a tool to advance their profession and improve public health, and USP’s commitment to those core ideals continues today.”

Please click here to view USP's press release.

IACP Members: USP has partnered with the International Academy of Compounding Pharmacists (IACP) to enable members to purchase the USP Compounding Compendium directly through the IACP's website. Click here to order!


IACP Member Town Hall: Save the Date! December 4, 2014

 

Save the Date for IACP's Member Town Hall on Thursday, December 4th at 3:00 pm EST – 2:00 pm CST – 1:00 pm MST – 12:00 pm PST.

 

Special Guests: PCCA's Aaron Lopez and Stephan Beek who will provide the latest updates on the Protect My Compounds initiative.

A blast fax with call-in information will be coming soon.

 


California: Outsourcing Facilities Must be Registered as Pharmacies to Compound or Dispense Within or Into the State

We understand that facilities currently or previously licensed as pharmacies have been informed or have come to believe that federal licensure as an “outsourcing facility” under Section 503B (21 U.S.C. § 353b) of the federal Food Drug and Cosmetic Act (FDCA) to perform sterile compounding may exempt or except them from the requirement of licensure with the California State Board of Pharmacy that is otherwise a prerequisite to pharmacy activities including compounding or dispensing dangerous drugs within or into California.

 

This is not correct. As has been made clear at previous quarterly Board meetings, California statutory requirements that any person or entity wishing to compound or dispense dangerous drugs within or into California must be licensed in California as a (resident or non-resident) pharmacy remain in effect. (See Calif. Bus. & Prof. Code, §§ 4037, 4110, 4112.)

 

Please click here to read more.


Texas State Board of Pharmacy Votes Against Class I Pharmacy

In a unanimous vote, the Texas State Board of Pharmacy voted on November 4th against the Class I Pharmacy License Concerning a New Class of Pharmacy Located in a Physician's Office with Limited Dispensing.

After reviewing the proposed rules, the Board felt no one would ever apply for the license as the rules are written. It was also noted, that State Senator Charles Schwertner (R-D5), Senate Health and Human Services Chairman, was strongly opposed to the new proposed license and questioned the Board's authority on this issue.

Please click here for more.


FDA Update:



FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections

 

The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections. Click here for more.

 

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.

 


USciences Presents Service Award to the Malmbergs

USciences President Dr. Helen Giles-Gee is pictured above with USciences Service Award recipient Lucy Malmberg P'72.

Congratulations to IACP Board Member Lucy Malmberg, RPh, FACA, FACVP, Wedgewood Pharmacy in Swedesboro, N.J. Lucy and her late husband George Malmberg,RPh, FACA, FACVP, were presented with their alma mater University of Sciences's prestigious Service Award.

 

University of the Sciences presented its second USciences Service Award to the Malmbergs at a dinner ceremony on Friday, Nov. 7, 2014. This Service Award is an annual honor intended to recognize an individual or organization who has demonstrated outstanding service to the University, the broad community, and the disciplines, professions, and emergent entrepreneurial outcomes of healthcare and science.

 

 


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:

 

My state board was in my pharmacy, indicating that I was illegally compounding chloral hydrate. The board said that it was removed from the market, and is therefore illegal. My understanding was that if a drug is discontinued for business reasons, and not for efficacy, then it's still allowed to be compounded. Is that correct?

Answer:

 

You are correct in that chloral hydrate is a discontinued drug. It was not "removed from the market" for safety or efficacy reasons but rather that the manufacturer no longer wished to supply it. In fact, the FDA issued a request for comments on a revised/updated list of "do not compound" drugs on July 2, 2014. That has not yet been fully instituted; but, as you can see from the attached, there are no references to chloral hydrate on this list.

As a controlled substance, of course, you would still need to comply with the requirements of receiving a patient specific prescription prior to compounding or dispensing.

 

FDA Do Not Compound List

IACP Members: As soon as the new "Do Not Compound" list is official, IACP will alert our members.


Corporate Partner Spotlight: Frier Levitt LLC

 

Frier Levitt LLC is a healthcare boutique law firm. We provide comprehensive legal services to healthcare providers, including Compounding and Specialty Pharmacies, Outsourcing Facilities, chemical manufacturers, PSAOs, GPOs, physicians, large physician group practices, ACOs, laboratories, surgery and imaging centers and other healthcare related businesses. We advise clients on the recently passed Drug Quality and Security Act (H.R. 3204).

 

Click here to read more.


Don't Delay! Register Today and Save! Advance Discount Deadline is December 15, 2014

 

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.

 

Click here for more!


ACA, IACP, ACVP Educational Conference Graphic Toolkit Now Available!

This is an opportunity to let your patient and prescriber communities know that you will be attending the Educational Conference this year! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees, Corporate Partners and Exhibiting Companies are all encouraged to promote their support by using the Graphic Toolkit. The Educational Conference Graphic Toolkit includes a logo/web banner, Facebook Cover Image, “I’m Attending” e-mail signature as well as full page, ¼-page, and ½-page print ads.

Share that you’re attending! Click here to download the Graphic Toolkit.


The 2015 Educational Conference Student Writing Competition Application Deadline is Approaching!

Application Deadline is December 1, 2014

 

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.

 

Click here to read more!


IACP Welcomes State Pharmacy Association Affiliate: Texas Pharmacy Association

IACP is strategically working with State Pharmacy Associations to form a united pharmacy compounding community nationwide. With the support of our State Affiliates, IACP is able to return added benefits to you including ongoing updates on legislative and regulatory news happening in your state as well as additional tools and resources that can improve your practice.

IACP encourages all IACP members to support their state pharmacy association as they are partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

 

To learn more about Texas Pharmacy Association, please visit www.texaspharmacy.org.


Managing Risk in Today’s Society: Examining Compliance, High Risk Issues and Liability – IACP’s December Webinar

This one-hour webinar explores how to identify and manage risks associated with compounding pharmacy practice. Attendees will learn how to navigate the risk management process with a four step approach. By discussing specific claims against pharmacists, attendees will be exposed to techniques allowing them to decrease these risks and learn how to handle problems their practice might face.

 

Click here for more information, and to register!


IACP Welcomes New Corporate Partner: CSI Specialty Group

 

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 CSI Specialty Group, please visit www.csigroup.net.


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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