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Capitol Connections Archive [March 7, 2014] [3.7.14]
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IACP Issues Nominations for FDA's Request for Bulk Drug Substances for Both 503A & 503B Facilities

IACP Submits FDA Pharmacy Advisory Committee Nominations

From the IACP AdvanCE Self-Paced Library: Don't Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists

Corporate Partner Spotlight: Fagron, Inc.

Looking for Live Law CE?  Join Pharmacy Law Expert Deborah A. Pearce, JD During a Pharmacy Law Update at CCH



Events & Education

Overcoming USP <797> Common Non-Compliance Issues Webinar - March 18

Registration is now open for March’s live webinar titled Overcoming USP <797> Common Non-Compliance Issues for Sterile Compounding presented by Kenneth S. Latta, RPh, BS Pharm, FIACP on Tuesday, March 18, 2014 from 1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT).

In this one-hour webinar, attendees will learn top non-compliance barriers to USP <797> standards, what it takes to meet these standards, and what resources should be used to overcome these barriers.

This program is made possible through an unrestricted educational grant-in-aid from MEDISCA.

This educational content is created and copyrighted by MEDISCA NETWORK.

Visit for more information. If you are unable to attend the live webinar, this program will be converted to the self-paced library 24-48 hours after it is recorded.

Save the Date!

For more information about the 2014 IACP AdvanCE live webinars, please click here.

  • Practicing Evidence Based Medicine: From IRB Approval to Bench Research
  • Being a Successful Advocate
  • “Constructive Delivery” and the Controlled Substances Act
  • Building a Compounding Practice: Lessons Learned
  • Essentials of Non-Sterile Compounding
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 and 2013, 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 and 1163
  • Cease and Desist Letters
  • Stark Law & the False Claims Act
  • Marketing and Sales
  • Legislative & Drug Updates
  • CMS and Reimbursement
  • Third-Party 
  • Media and Public Relations
  • Patient Safety Organizations


March 7, 2014  

IACP Issues Nominations for FDA's Request for Bulk Drug Substances - for Both 503A & 503B Facilities

Your Academy was the first pharmacy association to submit comments to the U.S. Food and Drug Administration (FDA) under the recently enacted Drug Quality and Security Act for Active Pharmaceutical Ingredients (APIs) commonly used by compounding pharmacists to ensure the appropriate treatment of patients.

“The compounding community is working diligently to ensure that the FDA has all the information the agency needs to move forward with the implementation of the Drug Quality and Security Act,” said Pat Stephens, PharmD, IACP President.  “We identified our list of bulk drug substances through a poll of our membership, as well as a review of the latest scientific and medical literature related to compounding pharmacy. Additionally, we are indebted to the IACP Foundation for its tireless work in helping identify as much information about each bulk ingredient as possible through the medical and scientific literature.”

Click here to access IACP's letters and bulk drug lists regarding 503A and 503B IACP submitted to FDA.

IACP Issues Press Release Announcing Submission to FDA of its 2,403-Bulk Drug Substances List

This week, IACP issued a press release on its efforts to seek FDA approval on a 2,403-bulk drug substances list for both 503A and 503B. Click here to read the IACP press release. IACP is working to Protect, Promote and Advance Pharmacy Compounding! 

IACP to Submit Nominations to FDA's Pharmacy Compounding Advisory Committee

On Monday, January 13th, the FDA published its request for nominations for the Pharmacy Compounding Advisory Committee (as required by the Drug Quality and Security Act). FDA is requesting nominations for 12 voting members, 1 voting consumer representative (consumer organizations will be participating in the selection of this individual), and 2 nonvoting industry representatives. Nominations for voting members are due March 14, 2014. Individuals can also self-nominate for the positions. The FDA included the following criteria for voting members:

"Persons nominated for membership must have adequately diversified research and/or experience appropriate to the work of the Committee in such fields as pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties. These members will include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations. The specialized training and experience necessary to qualify the nominee as an expert suitable for appointment is subject to review, but may include experience in medical practice, pharmacy practice, teaching, research, and/or public service relevant to the field of activity of the Committee."

Based on your peers' recommendations, IACP has developed a list of nominations. Click here to view the list.

IACP Joins Coalition of Pharmacy Associations Seeking Expanded Reimbursement for Pharmacist Services

This week, IACP joined a coalition of pharmacy associations seeking reimbursement for expanded pharmacist associations. IACP along with the American Association of Colleges of Pharmacy (AACP); American Society of Consultant Pharmacists (ASCP); American Pharmacists Association (APhA); American Society of Health-System Pharmacists (ASHP); National Alliance of State Pharmacy Associations (NASPA); National Association of Chain Drug Stores (NACDS); and the National Community Pharmacists Association (NCPA) sent a letter to Marilyn B. Tavenner, Administrator of the Centers for Medicare & Medicaid Services (CMS).

"The undersigned organizations write today to express our support for the Medication Management (MTM) expansion provision in the Proposed Rule and to express our thanks to CMS for recognizing the important role pharmacist-led MTM plays in improving patient outcomes. Collectively, our organizations represent over 100,000 pharmacists across the full spectrum of practice settings. Because the Proposed Rule includes changes like the MTM expansion, which is a fundamental, much-needed reform that will greatly benefit Medicare beneficiaries, we encourage CMS to move forward with this component of the Proposed Rule."

Click here to read the entire letter.

Access the Latest State Updates with IACP's Compounders Stateside!

Click here for the latest edition of IACP's Compounders Stateside. IACP currently is tracking and monitoring 57 pieces of state legislation that will directly impact our members and compounding pharmacies. That's only 7 short of last year's 64 bills.

IACP’s Compounders StateSide is a one-stop resource for state legislative and regulatory updates and the latest happenings with state Boards of Pharmacy. Visit our homepage for the latest Compounders Stateside updates,

From the IACP AdvanCE Self-Paced Library: Don't Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists

Glaxo Smith Kline -- $3 billion. Abbott -- $1.6 billion. J&J -- $2 billion. Those are the penalties just three drug companies have paid for violating the federal False Claims Act. Did you know that what got them into trouble was making claims about their drugs to prescribers for unapproved uses? But when many pharmacists hear the word “claims,” they believe the False Claims Act has to do with marketing. It doesn’t. It covers every single transaction between a provider of goods and services paid for by the federal government. That’s “claims” as in filing a claim for money. So, if you bill Medicaid or Medicare, the VA, or the Federal Employees Prescription Benefit Program, you are just as liable for violations of the False Claims Act as a major manufacturer. Unless you have a billion dollars or so just lying around, this is a must-attend webinar to protect yourself and your business from making costly mistakes.

Because any allegation of potential overbilling to a federal funded prescription or health benefit program – Medicaid, Medicare, TriCare, the Veterans Administration, the Federal Employees Health Plan – can be gravely serious, IACP offers members a self-paced webinar, Don’t Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists. The Stark Law (also called the Anti-Kickback Law) and the False Claims Act impact every pharmacy that fills a prescription and bills a federally funded program and also any pharmacy who has a sales or marketing person generating compounded prescriptions which also result in a billing for physician services to those programs. To view this invaluable self-paced webinar, please click here. 

Corporate Partner Spotlight: Fagron, Inc.

Fagron, Inc. provides pharmacists in the United States with high quality products and solutions. Fagron continuously introduces innovative products, based on research done in our own R&D center. We work together with our customers, universities, physicians, and other care providers to provide optimized compounding solutions. We continuously perform studies on our products, dedicated to providing you the best quality possible. Fagron supports customers by offering complimentary professional support. Our staff of experienced pharmacists and technicians provide technical assistance and answers to any and all questions.

Fagron, Inc. is part of the Fagron Group, the global market leader in pharmaceutical compounding, and is headquartered in the Netherlands. Fagron is active in 30 countries and employs over 160 pharmacists worldwide. For more information, please visit

Corporate Partner Spotlight: The NasoNeb® Nasal Nebulizer from MedInvent, LLC

Establish a NasoNeb Sinus Program and provide new treatment options to the multitude of sinus sufferers while creating a new revenue line for your compounding pharmacy.

The NasoNeb® Nasal Nebulizer delivers a high concentration of medication, with broad intranasal drug deposition and high intranasal drug retention. NasoNeb-delivered therapy is supported by peer-reviewed clinical data, including positive outcomes in a randomized, double-blinded, placebo-controlled study.

Broad intranasal deposition: The NasoNeb Nasal Nebulizer has been clinically-shown to deliver a high concentration of medication to all areas of the nasal and paranasal sinus cavities in pre- and post-operative patients*.

Click here to read the entire article.


IACP Welcomes New Corporate Partner: Polsinelli PC

The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with more than 3,600 IACP affiliates who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support these corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

To learn more about Polsinelli PC, please visit  

Looking for Live Law CE?  Join Pharmacy Law Expert Deborah A. Pearce, JD During a Pharmacy Law Update at CCH

The 20th Annual Compounders on Capitol Hill (CCH) will be held May 17-20, 2014 at the Crystal Gateway Marriott in Arlington, Virginia. With an expected 400 total attendees in 2014, CCH 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.

Session Highlight

As a renowned pharmacy law expert and long-time consultant to IACP, Deborah A. Pearce J.D., will be present, What's Going on Legislatively, Judicially, and by way of Enforcement? A Pharmacy Law Update, from 10:30 a.m. to 12:00 p.m. on Monday, May 19.  Most pharmacists rely upon their professional associations or their Board of Pharmacy to keep them informed and up-to-date about changes in practice acts at the federal and state levels. But did you know that the judicial branch – the court system – also affects pharmacy law? Over the past year, there have been some interesting legal challenges pertaining to pharmacy and pharmaceuticals which directly affect your daily practice. This session will provide an easy-to-understand overview of the key court decisions as well as some of the upcoming cases you need to know about in order to protect your practice and your business.  This session has been approved for 1.5 contact hours (0.15 CEUs) of Live Pharmacy Law.  The IACP 2014 Compounders on Capitol Hill has been approved for 14 contact hours (1.4 CEUs) and attendees may acquire up to 11 contact hours (1.1 CEUs) of continuing education credit.

At the conclusion of this educational session, the pharmacist and technician attendee will be able to:

  • Discuss FDA inspection authority in light of Medical Center Pharmacy v. Holder.
  • Discuss potential new legislation at the federal level.
  • Discuss trends among the states in regard to compounding pharmacies.

Presented by: Deborah A. Pearce, JD, Deborah A. Pearce, LLC (Attorney)
Program type: Knowledge-Based

Start planning now! Reserve your hotel room on or before Monday, April 21, 2014 to receive the IACP group rate. Register to attend the conference before March 24, 2014 and take advantage of advance discount prices.To learn more about CCH, visit





20th Annual Compounders on Capitol Hill
May 17-20, 2014
Crystal Gateway Marriott
Arlington, Virginia  

Thank you to Our Exhibitors and Meeting Sponsors!

We would like to thank the following exhibitors for their commitment to Compounders on Capitol Hill: AirClean Systems; Analytical Research Laboratories (ARL); Associates Of Cape Cod, Inc.; ATS Labs; Attix Pharmaceuticals; B&B Pharmaceuticals, Inc.; Blesstia Pharmaceutical; Campbell University-Pharmaceutical Education and Research Center; Diversified Pharmaceutical Ingredients, LLC (DPI); DYNALABS; Eagle Analytical Services; EXAKT Technologies, Inc.; Fagron; Feras Capital, LLC; Freedom Pharmaceuticals, Inc.; Frier Levitt LLC; Fuji Health Science, Inc.; Health Engineering Systems (HES); Humco Compounding; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc; KUNESA LLC; Letco Medical; Live Oak Bank; Medi-Dose, Inc./EPS, Inc.; MEDISCA; National Community Pharmacists Association (NCPA); Pharmacy Compounding Accreditation Board (PCAB); PCCA; Pure Encapsulations; RXinsider; RX TaxPros; RxCoop, LLC; Storey Marketing; Tacit Almonds, LLC; TeleManager Technologies; U.S. Pharmacopeial Convention (USP); Wellness Works; ZRT Laboratory.

We would like to thank the following meeting sponsors for their support of Compounders on Capitol Hill: American College of Apothecaries (ACA) (Continuing Education Provider); Attix Pharmaceuticals (First Timer Program); B&B Pharmaceuticals, Inc. (Meeting Tote Bag); Fagron (Meeting Syllabus); Freedom Pharmaceuticals, Inc. (Meeting Brochure/Commemorative Travel Mugs); Humco Compounding (Education Session/Door Drop Bag Insert); International Medical Industries, Inc (Door Drop Bag Insert); Letco Medical (Welcome Reception Honoring IACP fellows/Education Session/CCH Lapel Pin); MEDISCA (Meeting T-shirt); Microtest Laboratories, Inc. (Education Sessions (2)); PCCA (Hotel Room Keys/Name Badge Holder/Education Sessions (2)/Exhibitor and Monday Continental Breakfast & Lunch Sponsor); ProPharma Group (Door Drop Bag Insert);Tacit Almonds, LLC (Relaxation Station); Torrey Hills Technologies, LLC (Education Sessions (2)); Topi-CLICK Topical Dosing Applicator (Conference Notepad/Pen Combo).

We would like to thank the following individual and pharmacy meeting sponsors for their support of Compounders on Capitol Hill:  Judicial Sponsor: Eddie Glover, PD, US Compounding, Conway, AR; John Herr, RPh, FIACP, Town & Country Compounding, Ridgewood, NJ; Stan Reeves, PharmD, F & F Drugs, Demopolis, AL; Contributor Sponsors: Eyad Alsabbagh, Dr, Biomed Specialty Pharmacy, West Chester, OH; Kevin Borg, President/CEO, PharmD, FIACP, FACA, Potter's House Apothecary, Peoria, AZ; Steve Hoyt, RPh, Owner, San Ysidro Pharmacy, Santa Barbara, CA; Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health, Indianapolis, IN; Baylor Rice, RPh, FIACP, South Compounding River Pharmacy, Richmond, VA; Tiffany Turner, Freedom Pharmaceuticals, Broken Arrow, OK; Doug Yoch, PharmD, Stanley Specialty Pharmacy, Charlotte, NC.

To learn more about the exhibitors and meeting sponsors, click here

Only Two Weeks Left to Register for the Scottsdale, AZ Regional Education Meeting!

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.  We hope you’ll join us for an evening of compounding pharmacy law education, Q&A, and networking with your local compounders! For more information, please visit

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 affect you and your practice. Attendees will receive 2.0 contact hours (.20 CEUs) of ACPE-approved LIVE LAW continuing education credit.  

"The program was presented in an organized, easy to follow manner inviting conversation and open discussions throughout the evening. The speaker was knowledgeable and engaging." - Attendee at Chicago, Ill. Regional Education Meeting

"David's experience in dealing with Congress and State Boards of Pharmacies made this session very informative and helpful in understanding the impact of past and future legislative actions."  - Attendee at Austin, Texas Regional Education Meeting

Scottsdale, Arizona – March 21, 2014
6:30 - 9:00 p.m.
FireSky Resort & Spa, Sun and Moon Meeting Rooms
4925 North Scottsdale Road, Scottsdale, AZ 85251
Click Here to View the Event Flyer for More Details!

Joint Registration with the 2014 Functional Medicine Conference: This meeting is held in conjunction with the 2014 Functional Medicine Conference presented by ZRT Lab and Storey Marketing, to be held March 21-23, 2014 at the FireSky Resort & Spa in Old Town Scottsdale, AZ. A discounted package rate with Friday’s Marketing Update and/or the 2014 Functional Medicine Conference is available. Please visit for more information and to register for the discounted package rates.

Registration for the IACP Regional Education Meeting in Scottsdale Only: $20 for IACP Members, $40 for Non-Members, and Free for Pharmacy Students


This program is made possible through an unrestricted educational grant-in-aid from Storey Marketing. 

Would You Like to Sponsor or Host an IACP Regional Education Meeting in Your City?

If you would like IACP to plan a Regional Education Meeting in your city, please email Michelle Greene Atkinson or call 281.933.8400. For more information on sponsorship, please click here. For more information on hosting, please click here. 

Save the Date! The ACA, IACP, ACVP Educational Conference Returns to Fort Lauderdale in 2015

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.

Educational Conference Graphic Toolkit Now Available!

Here’s an opportunity to let your patient and prescriber communities know that you will be attending the Educational Conference in 2015! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees and Corporate Partners 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 ¼-page and ½-page print ads.

To download the Educational Conference Toolkit, click here.

Learn More About Hardy Diagnostics in a Series of Videos

One of our 2014 Educational Conference Exhibitors, Hardy Diagnostics, has provided several videos to better acquaint you with their services.  Learn more about Hardy Diagnostics and how they can help you effectively manage and grow your business.
To learn more about the HardyVAL Low Risk Media Fill Test, Sartorius Sterisart Universal Pump Assembly, and more, click here to watch now.

IACP Calendar

IACP is your one-stop resource for all things compounding! CompounderCalendar provides a comprehensive listing of compounding events and continuing education programs. Click here to view IACP’s Upcoming Events.

IACP Career Center

Welcome to the IACP Career Center! Your destination for exciting job opportunities and the best resource for qualified candidates within the Industry. Click here to view the IACP Career Center.

Stay connected to IACP by joining our online communities!

In this Section


U.S. Representative Cory Gardner Visits Good Day Pharmacy

PCAB Accreditation

Check out IACP’s Scholarship Opportunities!

Pharmacy in the News



U.S. Representative Cory Gardner Visits Good Day Pharmacy

In February, Good Day Pharmacy (Loveland, Colo.) Chief Operations Officer, Vicki Einhellig, and Good Day Pharmacy Manager, Valerie Weatherington-Harris, met with U.S. Representative Cory Gardner to discuss healthcare issues both at the state level and nationally. Cory Gardner is the Republican U.S. Representative for Colorado’s 4th congressional district. It was a valuable hour for all parties, which resulted in dynamic dialogues that were enlightening for everyone involved. According to Good Day Pharmacy officials, Congressman Gardner and his staff representative, Maria Secrest, were extremely knowledgeable about specific pharmacy topics which made the meeting interactive and productive. Also in attendance was Independent Pharmacy Cooperative/RxPlus’s Brad Young

PCAB Accreditation

Congratulations to the following IACP Members for achieving PCAB Accreditation:  

Anderson Compounding Pharmacy; Bristol, TN; Cleve Anderson, DPh
Accreditation for Sterile & Non-Sterile Compounding

Clearspring Pharmacy Ltd.; Highlands Ranch, CO; Rachel Burns, PharmD
Initial Accreditation for Sterile & Non-Sterile Compounding

Essential Pharmacy Compounding; Omaha, NE; Kris Shubert, PharmD
Re-Accreditation for Sterile & Non-Sterile Compounding

Lone Oak Pharmacy & Compounding Shoppe; Paducah, KY; Michelle Lowe, RPh
Initial Accreditation for Sterile & Non-Sterile Compounding

Medimix Specialty Pharmacy; Jacksonville, FL; Lisa Horkan, PharmD
Initial Accreditation for Non-Sterile Compounding

Northmark Pharmacy; Blue Ash, OH; Deepali Chachare, RPh
Initial Accreditation for Sterile Compounding

Philly Pharmacy Inc DBA Medicine Shoppe 0635; New Philadelphia, OH; Brad White, RPh
Re-Accreditation for Non-Sterile Compounding

Check out IACP’s Scholarship Opportunities!

It’s that time of year again! Check out IACP’s Scholarship opportunities:

Pharmacy Students - Please keep in mind that you can enter one or both competitions!

Pharmacy in the News

Click here for the latest pharmacy headlines.  


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