|Capitol Connections, January 23, 2014|
January 23, 2014
A Message from IACP President Pat Stephens, PharmD
There is no doubt, that 2013 has proven to be one of the most challenging, interesting and stressful years for our profession. With tragedy though, comes progress. I believe the list of IACP accomplishments achieved with Immediate Past President Wade Siefert's, RPh, leadership in 2013 is testimony to that. Despite a year spent much in crisis mode, your Academy Board and Staff still managed to pull off some incredible feats this year.
As we begin 2014, I would like to help navigate the new landscape of compounding now that HR 3204 has become law. I firmly believe that we as compounders have an opportunity before us to show the FDA that we have always and will continue to work to improve industry quality. If given the clear and right set of rules then we are more than capable of following them. USP 797 or cGMP. We now have the beginnings of some definitive information on what 503a pharmacies and 503b outsourcers are to operate under.
I believe very strongly that we need to continue to work and strongly lobby for compounders and patients rights. Now more than ever, our membership needs to be more actively involved with the Academy as well as in our state boards and associations. We each need to reach out to our fellow compounding colleagues, and ask if they are members of IACP. If they're not, encourage them to pick up the phone and call IACP. All of our collective voices are a powerful tool!
As I begin my IACP presidency, I am so very proud to be a part of this extraordinary organization. I look forward to serving our membership by furthering our mission of Protecting, Promoting and Advancing our rights to compound. Want to help us? Email email@example.com and get involved, today.
IACP and 2013 - A Year in Review
IACP Issues Comments on FDA's Draft Guidance: Implementation of 503A & 503B
This week, your Academy was the first pharmacy association to submit comments to the FDA on its Draft Guidance regarding the implementation of Section 503A and 503B of the Federal Food, Drug and Cosmetic Act.
Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503A.
IACP is Making Sure the FDA Plays by the Rules Congress Established
IACP also sent a letter to FDA Commissioner Margaret A. Hamburg, MD, expressing our specific concerns regarding what we believe is the premature nature of FDA's communication to stakeholders and State Boards, promoting conducting business with only 503B registered facilities.
IACP Members Submit Nominations for API Review
The Drug Quality and Security Act's reaffirmation of 503A of the Food Drug and Cosmetic Act places certain limitations on the use of bulk ingredients for compounding. Any API (Active Pharmaceutical Ingredient) must satisfy one of the following three requirements:
On December 4, 2013, the FDA issued a request to the professional practice community to identify bulk ingredients that don't meet the first two criteria, please click here. IACP members, responding to our request for recommendations from previous newsletters, have identified more than 170 APIs regularly used for preparing patient prescriptions. The preliminary list, click here, will be screened and IACP plans to prepare a dossier on each medication to submit on behalf of the compounding community. As those dossiers are prepared, we will be posting the information so that individual members may also submit these drugs to the FDA for consideration.
What's the next step? Once the lists of APIs have been submitted, the FDA's Pharmacy Compounding Advisory Committee will review and give a recommendation to the Secretary as to whether that particular bulk ingredient should or should not be used in compounding. The Secretary may or may not accept that recommendation and will subsequently publish the bulk ingredients deemed acceptable.
ACTION ITEM: Request for Nominations to the 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 nonvoting industry representatives and the voting consumer representative are due February 12, 2014. 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:
FDA Communicates how State Boards of Pharmacy Should Report to the Agency
According to FDA - the following will provide enhanced communication with states.
IACP's David Miller Interviewed by FDA Week
Excerpt from interview -
"David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacists, expects the drug compounding marketplace will evolve as a result of the new law and that legal challenges similar to those that stalled FDA enforcement in the 1990s will re-emerge.
The FDA Modernization Act of 1997 created manufacturing exemptions for compounding pharmacists that met certain requirements, including not advertising, but the law was challenged in the courts. The Supreme Court eventually struck down an advertising prohibition for violating the First Amendment, but the high court did not rule on the severability of that provision, thus hindering FDA's implementation of the entire law. Last year's Drug Quality and Security Act (DQSA) reinstates provisions for traditional compounding pharmacists in the 1997 law without the advertising ban and adds a new section outlining requirements for a category of outsourcing facilities -- large scale compounders under federal oversight.
One lingering question has been office-use compounding, which is allowed by some state laws. But industry has been reading early FDA indications as requiring patient prescriptions for any type of anticipatory compounding, which sets up a potential conflict with state laws that let physicians obtain compounded drugs for use in their practice. Miller said this could tee up a legal case of federal versus state oversight.
FDA is developing a memorandum of understanding that interested states can sign to limit interstate shipments of compounded drugs. This document will give insight into FDA's thinking about relationships with states, said Allan Coukell, senior director of drugs and medical devices at Pew Charitable Trusts. Further, it could indicate how the agency would like to see traditional pharmacy compounding requirements enforced and go into office use compounding, he said.
The agency must work with the National Association of Boards of Pharmacy to develop the MOU, but Miller argues that there are other drug compounders such as veterinarians and podiatrists that are not covered by boards of pharmacy on the state level that will not be included. Further, under the new law, outsourcing facilities do not have to be a pharmacy, opening up the possibility that other firms will shift into this new category, he said."
CMS Releases First Batch of 2014 Enrollment Data
The Centers for Medicare & Medicaid Services (CMS) has just released the first batch of 2014 enrollment data for Medicare Part D Prescription Drug Plans (PDPs). These close-to-final numbers provide an initial look at the "winners and losers." Click here to read more.
IACP Members: Participate in your Academy's Bylaw Ratification Vote
The IACP Bylaws Committee finalized updates to the Academy’s bylaws in December 2013. Approved by the Board of Directors, it is now your opportunity to be on the governance side of your association by voting in the bylaws ratification.
IACP Seeking Volunteer for District V Board Seat
IACP recently held its 2014 Board of Directors Elections. Click here to view IACP's 2014 Board of Directors.
IACP is still seeking volunteers to serve the open board of directors seat in District V (Louisiana, Texas, Oklahoma, New Mexico). Please send your input to IACP at firstname.lastname@example.org. Your commitment and dedication to the Academy is much appreciated.
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 two-year goal is to raise $2 million by January 31, 2015 and we are almost halfway there since our campaign launched in July.
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.
Please click here for a donation form to make your commitment to your profession, patients and association.
Corporate Partner Spotlight: Diversified Pharmaceutical Ingredients’ (DPI)
Diversified Pharmaceutical Ingredients’ (DPI) mission is to supply your pharmacy with outstanding service and pharmacy driven solutions through dedication, speed of execution, and wisdom. We distribute only the finest active pharmaceutical ingredients and excipients available. Each chemical is meticulously tested by an independent analytical laboratory, to ensure the consistency and quality we command. Our procedures are a proven and practical option for your compounding pharmacy.
We offer ready made compounding bases that include both creams and lotions. They are designed for use in hormone therapy replacement, cosmeceuticals, pain management, antinausea and veterinary compounding. With pharmacist approved performance these bases are sure to benefit your patient's experience at a proven value.
DPI is your alternative for high quality compounding chemicals offered at very competitive prices. Call or email us today for a quote on your most commonly used API’s at 1-877-842-4716 or email@example.com.
Educational Conference Poster Presentations
Connect and network with fellow colleagues.
Through the generosity of donors of both the ACA Foundation and the IACP Foundation, the ACA/IACP/ACVP Educational Conference has granted two pharmacy students Loren M. Kirk, PharmD (East Tennessee State University) and Manuel Isherwood (Wilkes University) with a scholarship to present their Poster Presentations and attend the Educational Conference February 5-8, 2014 in Fort Lauderdale.
Title: High-performance liquid chromatographic method for a compounded vancomycin oral solution for application toward a beyond-use date determination.
Learn More about the Exhibiting Companies Ready to Meet with You at the Educational Conference!
Check out these short videos featuring the 2014 Educational Conference Exhibitors and Sponsors. These companies are anxious to meet with you and showcasing services that can improve your business. Watch now!
Be Prepared When you Arrive at the Educational Conference! Download the First Timer’s Guide Now!
An anticipated, 350 total attendees will convene in Fort Lauderdale, Florida in three weeks! We look forward to seeing many of you at the ACA, IACP, ACVP Educational Conference, February 5-8, 2014 in Fort Lauderdale, Florida at the Harbor Beach Marriott Resort & Spa. We know attending a conference for the first time can be overwhelming. To help you prepare for the Educational Conference, we’ve put together a comprehensive guide.
Download here the First Timer’s Guide to the Educational Conference sponsored by Take Charge Pharmacist Obesity Education System. The Flipbook technology for the First Timer’s Guide was generously provided by RXinsider.
Have you reserved your hotel room for the Educational Conference?
Reserve your hotel room by contacting Susan Decker, Director of Conferences by phone at (434) 989-5938 or firstname.lastname@example.org.
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; PCCA; Pharmacy Compounding Accreditation Board (PCAB); 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: AirClean Systems (Friday Continental Breakfast with Exhibitor Experience); Attix Pharmaceuticals (Meeting Syllabus Sponsor); B&B Pharmaceuticals, Inc (Name Badge Holder, Education Session Sponsor); Blesstia Pharmaceutical (Saturday Continental Breakfast with Exhibitor Experience); 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 (First Timer Program); Topi-Click Topical Dosing Applicators (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 Sponsors: 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 Sponsors: Jay Ashworth, BS Pharm, RPh, GE Nuclear (Dallas, TX); Lisa Ashworth, BS Pharm, RPh, Children's Medical Center of Dallas (Dallas, TX); David Carter, PharmD, Riggs Drugs, Inc. (Chetopa, KS); Saad Dinno, RPh, FIACP, Acton Pharmacy, Inc. (Acton, MA); Justin Dipisa, RPh, Century Pharmacy, LLC (Paramus, NJ); 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).
To learn more about the exhibitors and meeting sponsors click here.
Register to Attend IACP’s 20th Annual Compounders on Capitol Hill!
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.
What you can expect in 2014:
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 www.iacprx.org/cch.
20th Annual Compounders on Capitol Hill
Thank you to Our Exhibitors and Meeting Sponsors!
We would like to thank the following meeting sponsors for their support of Compounders on Capitol Hill: 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); PCCA (Exhibitor and Monday Continental Breakfast & Lunch Sponsor, Hotel Room Keys, Name Badge Holder, 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; Contributor Sponsors: Eyad Alsabbagh, Dr, Biomed Specialty Pharmacy, West Chester, OH; Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health, Indianapolis, IN.
To learn more about the exhibitors and meeting sponsors, click here.
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 www.iacprx.org/RegionalEducationMeetings.
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.
“This was an excellent CE and the speaker was amazing. His knowledge on the subject matter was on spot!!!" - Attendee at Foley, Ala. Regional Education Meeting
Scottsdale, Arizona – March 21, 2014
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 www.functionalmedconference.com 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 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!
Tell us how compounded pharmaceuticals have helped you, someone you know, or how you have helped someone as a practicing compounding pharmacist. Help us protect your continued access to pharmacy compounding!
Share the P3 community and the value and necessity of personalized prescriptions with your friends.