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Capitol Connections Archive [December 13, 2013] [12.13.13]
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In this Issue 

IACP Needs Your Input!

FDA Releases Draft Guidance Documents (CPGs) for Comment

IACP Launches $2 Million Campaign to Fund Vital Legislative, Public Relations & Advocacy Efforts

USP: Fight the Fakes Campaign 

Corporate Partner Spotlight: ATS Labs 

Join Your Colleagues for CE by the Sea!

Registration Opens Next Week to IACP’s 20th Annual Compounders on Capitol Hill!


Events & Education

Endotoxin Testing and Environmental Monitoring Webinar – January 22

Registration is now open for the next IACP AdvanCE Webinar Endotoxin Testing and Environmental Monitoring for Your Pharmacy, presented by William A. Stuart, RPh, Hartley Medical Center Pharmacy, Inc. on Wednesday, January 22, 2014 from 1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT). 

As the demand for compounded medications has increased and in light of recent tragic events, the pharmaceutical sterile compounding profession requires a greater understanding of quality assurance testing. This presentation will educate individuals about sterile compounding principles of bacterial endotoxin testing and environmental monitoring. Attendees will gain technological knowledge about how to implement the highest quality compound preparations for their patients.



This program is made possible through an unrestricted educational grant-in-aid from Associates of Cape Cod, Inc.

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!

Please save the date for the following 2014 IACP AdvanCE live webinars from 1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT):

Click here to review the full schedule of live webinars!

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:

  • FDA Inspections
  • DEA Inspections
  • USP 797, 795 and 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



December 13, 2013

IACP Wishes You a Happy Holiday Season!

Happy Holidays from the IACP staff to you! Wishing you a joyous and peaceful holiday with your family and friends! In observance, the IACP office will be closed Wednesday, December 24th through Wednesday, January 1st! We will return to the office on Thursday, January 2nd. Please email iacpinfo@iacprx if you need to reach us.

IACP Needs Your Input!

As covered in our Town Hall teleconference and in the story below, several regulations and requests for input were issued by the FDA on December 4. One of the most critical is the agency's request for a list of drugs for which APIs (Active Pharmaceutical Ingredients) are necessary for compounding preparations. As provided for within 503(a), a pharmacist or physician may compound medications for individual patients using an API only if that drug has a USP monograph, is a component of an FDA approved drug, or appears on a list of APIs reviewed and approved by the FDA's Pharmacy Compounding Advisory Committee and accepted by the Secretary of Health and Human Services.

IACP is assembling a list of APIs used regularly in compounding for which no USP monograph exists or is part of an FDA approved drug to submit on behalf of our members. We need your assistance in identifying as many of these as possible. 

Please submit the following information for each API you use that falls into this category to us at no later than January 15, 2014:

  • Name of the API including the chemical name and common name
  • Chemical grade, strength, quality and purity of the API
  • Form of the API (powder, liquid, etc.)
  • Whether a monograph in an ex-US pharmacopeia exists such as the British Pharmacopeia
  • Common compounded dosage forms, strengths and route of administration for which the API is used
  • Clinical data, studies, papers, references, etc. on how the compounded version of the API is used
  • Stability data for the compounded preparations

The Academy will compile a formal dossier on each of these medicines you help identify for submission to the agency in time for its March 4, 2014 comment deadline.

FDA Releases Draft Guidance Documents (CPGs) for Comment - IACP Members Please Submit Your Input!

The US Food and Drug Administration (FDA) today released its draft guidance documents (CPGs) for the new 503(b) and 503(a) sections of the Drug Quality and Security Act. 

Click here to review 503(b) section (Discusses how registration will be handled)

Click here to review 503(a) section (Please note page 5 and start at line 155) 

Both of these documents are open for comment and input to the FDA by February 4, 2014. IACP currently is reviewing and will be compiling our formal submission to the FDA.

ACTION ITEM: IACP strongly encourages all members to review these documents and submit comments on how these drafts may affect your business and your practice. Additionally, you should circulate these to physicians and other prescribers with whom you work so that they are informed of the pending changes as well. The electronic address for submitting comments to the FDA is including in each of the 503(b) and 503(a) documents.

Please email IACP with any questions or CPG input at

FDA HR 3204 Stakeholder Conference Recording Available

If you'd like to listen to the FDA Pharmacy Compounding Stakeholder Conference held on Tuesday, December 3, 2013, a replay of the teleconference will be available for the next 30 days, by calling 1-203-369-3325<tel:1-203-369-3325>, or for international callers, 1-800-723-6769<tel:1-800-723-6769>. 

Click here for a transcript of the question & answer transcript from this FDA teleconference.

Did You Miss the IACP HR 3204 Town Hall? Recording Now Available!

IACP Members! No worries if you missed the Wednesday, December 4th, HR 3204 Town Hall: The Drug Quality and Security Act has passed the House and Senate. What does this mean for you, today? What does this mean for your practice, tomorrow? 
Please visit our Members-only site, select Members Resources, and then select Town Hall Teleconference Recordings. Please email with any questions at

IACP Launches $2 Million Campaign to Fund Vital Legislative, Public Relations & Advocacy Efforts

IACP has developed a Preserve your Patients’ Access Fund to raise continued support for critical legislative, public affairs and advocacy activity to help preserve our profession and your patients’ access to the customized medication they depend upon. Our goal is to raise $2 million by January 31, 2014.

We need your financial contributions to protect our beloved pharmacy compounding profession. This is not a short-term situation that will likely see us crossing any goal lines soon. We need your help to maintain and continue what will be a long-term effort.

Please donate to the only association that is solely dedicated to the profession of pharmacy compounding today with a contribution to IACP’s Preserve your Patients’ Access Fund. Help IACP continue to Protect, Promote & Advance Pharmacy Compounding.

Click here to read more about IACP's efforts.

Please click here for a donation form to make your commitment to your profession, patients and association.

USP: Fight the Fakes Campaign 

Counterfeit and substandard medicines have reached global health crisis proportions, and present a real danger to all of us.  In a concerted effort to help protect people from fake medicines, the United States Pharmacopeial Convention (USP) is joining other global health organizations, including two USP Member organizations (International Council of Nurses and International Federation of Pharmaceutical Manufacturers and Associations), in a campaign to raise awareness and mobilize strategic partners to address this growing problem.

Fight the Fakes encourages organizations and individuals around the world to help spread the word about this vital public health issue.  Fake medicines put patients and the public at risk, offering potentially dangerous products that can increase resistance to real treatments or cause further illness, disability or even death.  Everyone is encouraged to join the campaign and help spread the word about the dangers of fake medicines.

As a leader in the fight against counterfeit and substandard medicines, USP is actively involved in a series of ongoing initiatives to help ensure the quality of medicines.  Since 1992, USP has worked to implement programs in more than 35 countries.  For example: 

USP is pleased to join the international Fight the Fakes campaign, and encourages anyone concerned about this global issue to join us. 

Are you Receiving "Media" Calls from Leading Edge?

Everyone's heard the old adage, "If it sounds too good to be true, then it probably is?" Such is the case with a "media" outfit which is contacting many of our members, offering them a wonderful editorial opportunity on their Leading Edge Show hosted by Jimmy Johnson (former Dallas Cowboys Coach). What the TV producer does not tell you right away is that is a paid placement (pay-to-play). Please be aware that this is a show aired on public access, and the thousands of dollars required to participate is probably not your best use of your marketing dollars. Please email IACP's Dagmar Climo if you have further questions.

Corporate Partner Spotlight: ATS Labs


No two compounding pharmacies face the same disinfection challenges.

USP <797> compliance requires a formal, verified cleaning and disinfection plan to minimize microbial contamination introduced into the clean room environment by pharmacy staff and the inanimate instruments they use. Scheduled disinfection of the anteroom and compounding area should be based on the classification of the room and area surfaces.

Compounding pharmacies with validated disinfection programs: 

  • Understand the effectiveness of their site-specific disinfectant products and disinfection processes.
  • Can correct and control clean room environment contamination.
  • Have the confidence—and necessary documentation—to stand up to FDA facility audits.

ATS Labs tailors disinfection validations around each compounding pharmacy’s unique processes, surfaces and disinfectant products. We qualify site-specific disinfection practices for compounding pharmacies, as we do for traditional pharmaceutical manufacturers, thereby mitigating potential contamination issues. Furthermore, per FDA guidance, we offer genotypic microbial and fungal identification services to support environmental monitoring activities, ultimately validating your disinfection practices.

  • Disinfection Qualification Testing
  • Expert Disinfectant Product Knowledge
  • Rigorous Regulatory Compliance
  • Site-Specific Environmental Isolates
  • Protocols Tailored For Your Unique Facility/Process

To discuss whether a disinfection qualification is appropriate for your compounding pharmacy, please contact:

Dave Rottjakob
Director, Business Development
ATS Labs

IACP Welcomes New Employee

IACP welcomes Ashlyn Grant as the Events and Education Assistant. This December, Ashlyn is slated to graduate from the University of Houston – University Park with a Bachelor of Science in Community Health and minor in Nutrition. During her senior year, Ashlyn held an internship with Oyster Creek Elementary under the supervision of the school nurse.  She worked on health and wellness initiatives and organized a walk for the school.  

In her new role at IACP, Ashlyn assists with the coordination of both Compounders on Capitol Hill and the Educational Conference as well as the IACP Corporate Partner program. Please join us in welcoming Ashlyn to the IACP team!  

Join your Colleagues for CE by the Sea!  

Connect and network with fellow colleagues.

Follow us! 

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 5-8, 2014 at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. The Educational Conference offers superior education and networking opportunities for pharmacists, technicians, marketing representatives, and pharmacy students.

Review the complete meeting agenda; learn what's new in 2014; why pharmacy students should attend, and much more! Click here to download the 2014 Educational Conference e-brochure, sponsored by ACA & IACP Corporate Partner Humco Compounding. The Flipbook technology for the e-brochure was generously provided by RXinsider. For all the latest meeting details, visit

Register before December 15, 2013 and be automatically entered to win a $25 Amazon gift card, provided by the Educational Conference Media Sponsor Tacit Almonds, LLC.  Just in time for your holiday shopping!  On Monday, December 16, the winner will be draw and contacted directly.

Science and Practice Poster Presentation Showcase – Deadline Extended

The deadline for submission of abstracts has been extended to December 31, 2013. To download the Poster Presentation Application and Scholarship Application, visit

Have you reserved your hotel room for the Educational Conference?

The Harbor Beach Marriott Resort & Spa is filling up quickly.  To ensure you receive a hotel room that can accommodate your schedule, reserve your hotel room by contacting Susan Decker, Director of Conferences by phone at (434) 989-5938 or

Registration closes Friday, January 10, 2013.  For the latest conference news, visit 

Educational Conference
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida

Thank you to Our Exhibitors and Meeting Sponsors!

We would like to thank the following exhibitors for their commitment to the Educational Conference: Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc; Attix Pharmaceuticals; Charles River; Compounding Matters Academy; Digi-Trax Corporation; EXAKT Technologies, Inc; Fagron; Freedom Pharmaceuticals, Inc; Hardy Diagnostics; Humco Compounding; ICA Health, LLC; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc; KUNESA LLC; Letco Medical; Live Oak Bank; MEDISCA; Pharmacy Compounding Accreditation Board (PCAB); PCCA; RX TaxPros; Storey Marketing; Tacit Almonds, LLC; Televox; Topi-Click Topical Dosing Applicator.

We would like to thank the following meeting sponsors for their support of the Educational Conference: Attix Pharmaceuticals (Meeting Syllabus Sponsor); B&B Pharmaceuticals, Inc (Name Badge Holder, Education Session Sponsor); Blesstia Pharmaceutical (Saturday Continental Breakfast with Exhibitor Experience Sponsor); Fagron (Welcome Reception, Education Session Sponsor); Feras Capital, LLC (Thursday Continental Breakfast with Exhibitor Experience); Freedom Pharmaceuticals, Inc. (Meeting Tote Bag, Conference Pen, Education Session Sponsor); Humco Compounding (Meeting e-Brochure, Fellowship Luncheon, Education Session Sponsor); Letco Medical (Celebration Dessert Reception, ACA/ACVP & IACP AdvanCE Education Sponsor); MEDISCA (Meeting T-Shirt Sponsor); PCCA (Hotel Room Key, Thursday Mid-Day Break with Exhibitor Experience, Education Session Sponsor); Tacit Almonds, LLC (Media Sponsor); Take Charge Pharmacist Obesity Education System (First Timer Program); Topi-Click Topical Dosing Applicator (Friday Lunch with Exhibitor Experience Sponsor).

We would like to thank the following individual and pharmacy meeting sponsors for their support of the Educational Conference:  Bronze Sponsor: Robert Anniharico, RPh, The Compounding Facility (Staten Island, NY); Charles Leiter, PharmD, Leiter’s Compounding Pharmacy (San Jose, CA); Eddie Glover, PharmD, US Compounding (Conway, AR); Contributor Sponsor: Johannes Heine, MBA, KUNESA LLC (Coral Gables, FL); Lucy Malmberg, RPh, CEO, Wedgewood Village Pharmacy, Inc. (Swedesboro, NJ); Arthur Margolis, RPh, America's Compounding Center (Newton, MA); Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health (Indianapolis, IN); Becca Mitchell, PharmD, FIACP, US Compounding (Conway, AR); Andy Ruiz, PharmD, MSc, Stonegate Pharmacy (Austin, TX); David Carter, PharmD, Riggs Drugs, Inc. (Chetopa, KS); Justin Dipisa, RPh, Century Pharmacy, LLC (Paramus, NJ); Saad Dino, RPh FIACP, Acton Pharmacy Inc. (Acton, MA).

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

Registration Opens Next Week to IACP’s 20th Annual Compounders on Capitol Hill!

Mark your calendar!  Registration opens on Tuesday, December 17 for IACP’s 20th Annual Compounders on Capitol Hill (CCH) 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.

What you can expect in 2014:

  • Hear from experts during in-depth Continuing Education sessions on legislative and regulatory issues at the state and federal level affecting pharmacy compounding.
  • A bargain hotel group rate at $159 – that’s half the price from previous years!
  • Join us on the Hill!  Be an advocate for compounding during in-person Capitol Hill meetings with your state representatives.
  • Socialize and support the IACP Foundation during compounding pharmacy’s biggest party of the year – 10th Annual Rx Mixer Presents The Roaring Twenties: The Compounding Age on Sunday, May 18, 2014.  To learn more about the Rx Mixer, click here.
  • On Monday, May 19, the COMP PAC Dinner and Fundraiser is an exclusive opportunity to hob-nob with the powerful movers and shakers of Washington, D.C. The COMP PAC will host the Honorable Jerry Moran, United States Senate (R-KS) as the keynote speaker for the COMP PAC Dinner.
  • Network! Reconnect with old friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding! 

Start planning now! Reserve your hotel room on or before Monday, April 21, 2014 to receive the IACP group rate. To learn more about CCH, visit 


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

IACP Welcomes New Corporate Partner

The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 3,600 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding.  We encourage all IACP members to support these corporate partners that are instrumental in our joint effort to protect and grow this vital part of quality health care. Thank you for your continued support of pharmacy compounding!

Gates Healthcare Associates

CCH State of the Academy Videos from 2012 and 2013

The State of the Academy videos from Compounders on Capitol Hill 2012 and 2013 are available for viewing in the IACP Member Center, under the Member Information tab. Listen to IACP’s Executive Vice President/CEO David G. Miller, RPh, IACP Board President Wade Siefert, RPh, Preckshot Professional Pharmacy, and IACP Past President Scott Karolchyk, MS, RPh, FIACP, Pharmacy Creations give an overview of the Academy’s accomplishments throughout the year and plans for the upcoming year. Click here to login to the IACP Member Center and watch now!

IACP Regional Education Meeting Headed to Scottsdale, Arizona! 

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.  

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.

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

Check out IACP's Scholarship Opportunities!

IACP Members: Cast your Board of Directors Vote by December 15, 2013

IACP 2014 Class of Fellows Deadline Approaching!

Members in the News

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 all these competitions! 

Last Call! Cast your Board of Directors Vote by December 15, 2013!

Please take a moment to cast your vote for Vice-President, Treasurer, At-Large and District Representative (if applicable). All current dues-paying IACP members are eligible to vote in the election. Make your voice heard.  Vote today for the next leaders of your association!

The 2014 election is being conducted electronically on IACP's secure Web site. You must be logged into the IACP Member Center to vote in the election. Click on the link below to log in and cast your vote. All votes must be submitted no later than midnight CST on December 15, 2013. Full election results will be announced in January.

As always, please call the IACP office if you need assistance: (281) 933-8400.

Click here to cast your vote! 

IACP 2014 Class of Fellows Deadline Approaching!

The deadline is quickly approaching to apply for the 2014 class of Fellows! The IACP Fellowship Program offers members who have been compounding for at least three years the opportunity to be distinguished in their communities as specialists in the art and skill of pharmacy compounding. To learn more or to apply, visit our Fellowship website here.

Applications are due by December 20th, 2013. Approved Fellows will be inducted at IACP’s 2014 Educational Conference being held February 5-8, 2013 in Ft. Lauderdale, Florida. Please direct any questions to Lindsey Turnau,

Members in the News

Most of us know IACP Member Kim Tenreiro, RPh as compounding pharmacist/owner of The Pharmacy Shop in Canandaigua, N.Y. Did you also know that Kim is a Theatre Board Member/Actor, and has portrayed Scrooge, Bob Cratchit, Tiny Tim and every other character in a one-man performance of A Christmas Carol for the past five years? Read more here!

IACP Board Member David J. Miller, RPh, PhD, FIACP, Keystone Pharmacy in Grand Rapids, Mich., is featured in this Michigan Biz article on how pharmacies have become more than just a place to fill prescriptions, and have evolved instead into an accessible, one-stop center in the delivery of basic health care services.

"We are by far the most accessible health care professional,” said David Miller, a pharmacist and owner of Keystone Pharmacy in Grand Rapids that recently launched a nutrition consulting division. “You can’t just walk in and see your physician. You can see us.” Read more at







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