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Capitol Connections August 22, 2014
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August 22, 2014  

IACP Closed on Monday, September 1st for Labor Day

The IACP offices will be closed on Monday, September 1st, in observance of Labor Day. We will reopen on Tuesday, September 2, at 8 am. The next issue of IACP's Capitol Connections newsletter will distribute on Friday, September 5th. Please email if you need to reach IACP staff.

Ever wonder how Labor Day came to be? Labor Day in the United States is a holiday celebrated on the first Monday in September. It is a celebration of the American labor movement and is dedicated to the social and economic achievements of workers. It constitutes a yearly national tribute to the contributions workers have made to the strength, prosperity, and well-being of their country. The equivalent holiday in Canada, Labour Day, is also celebrated on the first Monday of September. In many other countries (more than 80 worldwide), "Labour Day" is synonymous with, or linked with, International Workers' Day, which occurs on May 1. Click here for more.

OIG Releases an Advisory Opinion on Specialty Pharmacies

The Office of the Inspector General (OIG) has released an Advisory Opinion holding that specialty pharmacies entering into contracts with retail pharmacies for referrals and to compensate retail pharmacies for providing other services to patients would violate the anti-kickback statute.

Please click here to read IACP's summary of this OIG opinion as well as the full OIG Advisory Opinion.

IACP Meets with the Government Accountability Office to discuss Animal Drug Compounding

At the request of the Government Accountability Office (GAO), IACP met with staff from the GAO on August 13th to discuss animal drug compounding. It is expected that the Agency will release a report based upon the Agency’s meetings and discussions with all opponents and proponents of compounding for animal use.  

The lengthy meeting centered around questions from GAO including the
U.S. Food & Drug Administration's (FDA’s) authority to oversee animal drug compounding; accreditation of veterinary pharmacies; safety and effectiveness of drug compounding for animal use; state regulatory practices regarding compounding for animal use; adverse events reporting and data available on such events; and drug approval process at FDA for animal drug compounding.  

As IACP previously reported, FDA stated within its annual Appropriations justification to Congress, that funds are needed by the Agency to develop guidance addressing animal compounding. With increased efforts by FDA to address animal compounding, IACP has worked with the
American Veterinary Medical Association (AVMA) to establish Veterinary Task Forces that will work to address any regulatory and/or legislative efforts to restrict animal compounding. IACP has met with AVMA and the AVMA Veterinary Task Force several times in the past months and looks forward to working with GAO, Congress, AVMA, and all stakeholders to provide insight into the benefit that animal compounding provides.

House Ways and Means Committee Solicits Comments from the Public on Released Draft Bill Addressing Medicare Fraud

House Ways and Means Subcommittee on Health Chairman Kevin Brady (R-TX) released a discussion draft addressing Medicare Fraud, Waste, and Abuse, the Protecting Integrity in Medicare Act of 2014 (PIMA). The draft legislation follows an April 2014 Ways and Means Health Subcommittee hearing with the Medicare Payment Advisory Commission (MedPAC) where MedPAC estimated that $44 billion of the $574 billion paid to providers under Medicare in 2012 was improperly paid claims or fraudulent activity.  

The House Ways and Means Subcommittee on Health is soliciting comments from stakeholders on the draft legislation. Comments on the discussion draft can be submitted by September 1, 2014 to

Click here for more information.  

FDA Update

The U.S. Food and Drug Administration (FDA) is hosting the Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation.

FDA requests input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics.
The meeting will be held near FDA’s main campus at College Park Marriott Hotel and Conference Center, 3501 University Blvd., East, Hyattsville, MD 20783, MD, on September 17, 2014, from 9:00am-5:00pm.
Submit electronic or written requests to make oral presentations by September 3, 2014 and presentation materials are due by September 9, 2014, to  Electronic or written comments will be accepted until October 13, 2014.
For more information and the latest events regarding GDUFA, please visit FDA's
Generic Drug User Fee Amendments of 2012 website. FDA will post meeting materials as they become available here. 

Number of Recalls Surges at FDA 

According to the Regulatory Affairs Professional Society (RAPS), the recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the U.S. Food and Drug Administration (FDA) late last month. 

DEA Announces New Certification Process for Providers of Electronic Prescriptions for Controlled Substances

The Drug Enforcement Administration (DEA) is announcing a new DEA-approved certification process for providers of Electronic Prescriptions for Controlled Substances (EPCS) applications. Certifying organizations with a certification process approved pursuant to 21 CFR 1311.300(e) are posted on DEAs Web site upon approval. Click here for more information.

HDMA to Hold Traceability Seminar in November

The Healthcare Distribution Management Association (HDMA) will host a Traceability Seminar, November 10-12, 2014, in Arlington, Va. According to HDMA, the enactment of national traceability legislation (Drug Quality and Security Act/H.R. 3204) replaces a 50-state patchwork of pedigree requirements with one national traceability framework, and represents one of the most significant legislative accomplishments for the distribution industry. With this new reality for the healthcare supply chain, HDMA is hosting a seminar presented by industry experts and government officials as the program shifts its focus to federal implementation over the next 10 years. Click here for more information.

In Case You Missed It - IACP Submits Comments to USP on Proposed General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings


IACP has submitted its comments to the United States Pharmacopeia (USP) on its proposed Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. Please click here to view IACP's comprehensive comments as well as those from several other organizations. IACP will update you with any developments on this Chapter.

Please email IACP with questions at    

540,000 Patients Lose Compounded Prescription Coverage says Patients and Physicians for Rx Access

According to Patients and Physicians for Rx Access, Express Scripts, the nation's largest pharmacy benefit manager, is offering "ambiguous and misleading reasons" for ending coverage of customized prescription medications for 540,000 individuals in order to conceal financial motives, a Patients and Physicians for Rx Access spokesperson said August 14. The organization is fighting to stop the unprecedented benefit cuts being made by Express Scripts and other pharmacy benefit managers.

"In July Express Scripts began sending form letters to more than a half-million patients nationwide, saying it will stop paying for their compounded medications on September 15," said Jay McEniry, executive director of Patients and Physicians for Rx Access. "Patients are sharing those letters with us. The letters are filled with misleading statements designed to confuse these patients while denying them access to important medications prescribed by their doctor."  Click here to read the entire press release. 

Contribute to IACP's One Fund - and Preserve Your Patients' Access to Customized Medications!

Compounding pharmacists have the privilege to advance the quality of patient care, helping those who are underserved, and saving lives – one patient at a time. IACP’s One Fund provides you with a simple, convenient and powerful way to ensure that IACP can preserve your privilege to compound. So that you can continue serving your patients and practitioners. Contribute to One Fund today, and become part of a unified effort to preserve patient access to customized medicines.

Click here to donate online!

IACP Launches Partnership for Personalized Prescriptions Advocacy Group and Website!

Share with your patients!  Has your employer recently received a letter from their Pharmacy Benefit Manager (PBM), stating that they would no longer cover your compounded prescriptions. Express Scripts (ESI) launched a program "Compound Management Solution," that would exclude coverage to the majority of compounded prescriptions, and began contacting its clients through sales force calls and a national webcast in June 2014. ESI's "solution" to a growing number of claims for compounded preparations is simple: they won't pay for them. Click here for more information, and what you can do about this!

IACP’s compounding advocacy society, Partnership for Personalized Prescriptions (P3), brings together more than 150,000 patients and practitioners, providing them with a forum to share their support and passion for compounding. Importantly, P3 members are provided with the tools to advocate on their own behalf. P3 also provides an ongoing educational resource for those interested in pharmacy compounding and its value for patients and the practitioners who serve them. A compounding pharmacist locator service is provided so that patients, physicians, veterinarians and nurses can conveniently find compounders in their area.

Please encourage your patients, practitioners and staff to join our P3 Facebook and Twitter pages! Click here to read more about P3. 


Every week, IACP members contact our offices for questions about practice, business, legislation and other issues.  Beginning with this 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, send that to

This week's question comes from an IACP member regarding
physicians administering IV's in-office

Question: Per the definition of compounding found in HR 3204, it would seem that ANY office that mixes several medications into an IV bag is in essence "compounding." Additionally, per the new Final Guidance for 503(a) Pharmacies, does this mean that ANY office (Naturopath, Oncology, Rheumatology, etc) that mixes IV's will have to be USP 797 compliant? Will they have to use a hood or glove box for mixing IV's in their offices?

Answer: Yes, under the definitions of the Drug Quality & Security Act, a traditional compounder includes physicians, dentists, nurse practitioners, and any other prescriber other than a veterinarian. The FDA has said and done little to explain how or if they will be carrying forth the enforcement of 503A for those practitioners -- that is a major concern and issue for IACP and one which we have taken to Congress for action.

What is unclear is whether or not individual states will enforce USP <797> against prescribers. In at least one state, Florida, physicians are actually EXEMPT from complying with USP <797>!  But you are correct. Any in-office compounding of an IV would fall under 503A. 

Corporate Partner Spotlight: ATS Labs

ATS Labs, Inc., announces the acquisition of MicroTest Labs, Inc. Majority owned by Ampersand Capital Partners, ATS Labs has acquired the assets of MicroTest Labs, Inc. (MTL) of Agawam, MA. The acquisition of MTL is the first step in the strategy of ATS to expand its microbiology and chemistry laboratory services platform to support the medical device and biopharmaceutical industries. The combined companies will soon be known as Accuratus Lab Services, a name that personifies the quality and accuracy of testing results and scientific solutions that support the antimicrobial, consumer product, medical device, and biopharmaceutical industries.

Click here to read ATS Labs' press release.

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.

Click here for more details!

New Location and Dates Announced for Compounders on Capitol Hill 2015

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.

Click here to read more!

Pharmacy Students – Get Recognized! Participate in the Educational Conference Spring 2015 Student Writing Competition

Essay Topic: Discuss the importance of being involved in a professional association as you’re starting your career.

The ACA, IACP, ACVP Educational Conference announces the Spring 2015 Student Writing Competition to recognize original papers on a particular topic affecting the future of independent pharmacy.  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 IACP Foundation, the winners of this writing competition will each receive a scholarship to attend the Educational Conference February 25-28, 2015 in Fort Lauderdale, Florida.  All pharmacy students are encouraged to compete.  

Click here to download the Spring 2015 Student Writing Competition Flyer.

Meet the 2015 Exhibitors

The Educational Conference Exhibitor Experience has expanded to 29 exhibiting companies. Discover how you can work with them before you arrive. To learn more about Topi-CLICK Topical Dosing Applicators and their services to help you effectively manage and grow your business, check out the video below. Make sure to stop by their booth when visiting the Exhibit Hall.  For more videos from the Educational Conference exhibiting companies, visit our YouTube page at Subscribe to the Educational Conference YouTube page as new videos will be added frequently.   

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