|Capitol Connections CCH 2014 Report|
400 Attendees Convene in Washington, D.C. for the 20th Annual Compounders on Capitol Hill
The United Voice of Compounders Is Heard!
A special thanks to all the IACP members who participated either in person at Compounders on Capitol Hill, held, May 17-20, 2014 in Washington, D.C., or via our Virtual Hill Day -- your efforts made a HUGE impact. And a fast one as well. One of our key messages to Senators and Congressmen was that the U.S. Food and Drug Administration (FDA's) interpretation of the 2013 Drug Quality & Security Act (DQSA) appears to ignore Congressional intent. Despite repeated invitations from IACP to speak with our CCH conference attendees, everyone at the FDA was "unavailable" to attend and talk to those most impacted by the agency's activities... and that was noticed by Congress.
U.S. Senator Lamar Alexander (R-Tenn.) announced that, at his request, the Senate Appropriations Committee is directing the FDA to meet with doctors, patients, and pharmacists to discuss their concerns about implementation of the compounding legislation passed into law in November 2013.
“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak. If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.” – Lamar Alexander
Click here to read the U.S. Senate HELP Press Release.
IACP and its legislative team have worked tirelessly for the past several months emphasizing that FDA should be implementing DQSA according to congressional intent. This issue was the primary basis of our CCH 2014 Asks. Click here to review these Asks.
As covered in a Pink Sheet (subscription required) article from this week, there currently is an unenviable dilemma for pharmacists: whether to follow FDA regulations or those of their state.
"The International Academy of Compounding Pharmacists argues that FDA is not following the congressional intent of the Drug Quality and Security Act (DQSA), which was that office use regulation should be left to the states. Academy executive VP and CEO David Miller said the group wants FDA and/or Congress to clarify the office use issue as well as write other necessary regulations so pharmacists can operate under DQSA.
“'It is much more cloudy, muddy, messed up, uncertain, unclear, than we had, even from the compounding professionals’ standpoint, originally anticipated,' Miller said May 19 during a media briefing. Guidance may be coming, but it is unclear how the agency would address the office use issue.'"
Congressman Marino Introduces HR 4709 as a Complete Substitute for What was HR 4069
In order to generate bipartisan support, Congressman Thomas Marino (R, PA-10), has introduced HR 4709 as a complete substitute for what was HR 4069 (both are entitled the Ensuring Patient Access to Effective Drug Enforcement Act). HR 4069 essentially "disappears" now and 4709 is the primary legislation.
On Wednesday 28 May, the bill went to mark-up and an amendment is still planned to be added that specifically addresses our constructive transfer issue. That language appears as follows:
Amend HR 4709 by adding a new SECTION ___ and renumbering subsequent Sections accordingly.
SECTION ____ DISPENSING OF CONTROLLED SUBSTANCES
Section 102(10) of the Controlled Substances Act (21 U.S.C. 802(10)) is amended--
(1) by striking “The term `dispense' means to deliver” and inserting the following: “(A) The term `dispense' means--
“(i) to deliver”;
(2) by striking “such delivery.” and inserting the following: “such delivery; or
“(ii) to deliver a controlled substance by a pharmacy to a practitioner, pursuant to a patient-specific prescription of the practitioner, when the prescribing practitioner has determined that it is medically necessary for the controlled substance to be administered by the practitioner to the patient acting in the usual course of professional practice.”;
(3) by striking “The term `dispenser' means” and inserting the following:
“(B) The term `dispenser' means”; and
(4) by striking “to an ultimate user or research subject”.
Here's the formal announcement regarding the HR 4709 mark-up and the other bills under consideration.
Health Subcommittee Markup of H.R. 4631, H.R. 4299, H.R. 4709
Held Wednesday, May 28, 2014 - 2:00 p.m.
Background Documents and Information:
H.R. 4631, the Combating Autism Reauthorization Act
H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act
H.R. 4709, the Ensuring Patient Access to Effective Drug Enforcement Act
The Full Report from CCH 2014
Thank you for joining us at IACP’s 20th Annual Compounders on Capitol Hill, May 17-20, 2014! More than 691 community pharmacists, pharmacy technicians and pharmacy students either traveled to Washington, D.C., to meet with their federal House and Senate delegations in face-to-face meetings or sent in letters as part of the third annual Virtual Hill Day. Thank you for playing an active role in working to ensure the continued good health of our profession. The future of your practice, your patients’ wellbeing and your compounding profession depends in great part upon your participation at this important annual event. Thank you for going to D.C.!
IACP COMP PAC Dinner
On Monday, May 19, the IACP COMP PAC Dinner hosted the Honorable Morgan Griffith, U.S. House of Representatives (R, VA-09) as the keynote speaker. This exclusive event allowed nearly 30 members to have a candid and direct dialogue with the Congressman to talk about the future of health care and compounding as well as the current regulatory and legislative issues facing compounding pharmacies. The night raised $30,000, contributing to our yearly goal of $200,000 and making COMP PAC one of the largest political action committees in pharmacy.
Hill Day 2014 at a Glance
Once again this year, IACP worked with Soapbox Consulting, LLC, a D.C.-based company specializing in grassroots advocacy. Soapbox helped to schedule all of IACP’s Member Pharmacist Hill appointments and also conducted a “Being a Good Advocate for Compounding” session. This interactive session provided techniques to successfully convey our position and message to legislators.
The Stats to Date
Although all the debriefing documents are being summarized by our Washington D.C. team, the initial reports from CCH are impressive.
In addition to these scheduled meetings, state delegations also called on additional Congressional representatives while they were on the Hill.
States without representation/CCH attendees this year, Alaska, Connecticut, Hawaii, Montana, Vermont, W. Virginia.
We look forward to having your colleagues’ representation in these states next year! IACP’s David G. Miller, RPh, Executive Vice President, and Cynthia Blankenship, Esq., Vice President of Government Affairs, currently are reviewing all of our Hill Day Participants' congressional meeting evaluations and will publish a comprehensive report of action items in an upcoming edition of Capitol Connections.
A complete CCH 2014 photo gallery is now available. Click here to view.
And the winners are...
Congratulations to Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health (Mooresville, IN), who won a complimentary registration to the 2015 Compounders on Capitol Hill and one Rx Mixer Ticket.
Congratulations to James Bui, RPh, Community Compounding Pharmacy (Portland, OR), who won a complimentary registration to the 2015 Compounders on Capitol Hill at B&B Pharmaceuticals, Inc. Exhibit Booth Drawing.
Thank you to our Exhibitors and Meeting Sponsors!
We would like to thank the following exhibitors for their commitment to Compounders on Capitol Hill: Accreditation Commission for Health Care (ACHC); AirClean Systems; American College of Apothecaries (ACA); Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc.; ATS Labs; Attix Pharmaceuticals; B&B Pharmaceuticals, Inc.; bioMèrieux; Blesstia Pharmaceutical; Campbell University-Pharmaceutical Education and Research Center; DYNALABS; Eagle Analytical Services; EXAKT Technologies, Inc.; Fagron; 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 (IMI); 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); Analytical Research Laboratories (ARL) (Education Session); 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 Journal of Pharmaceutical Compounding (IJPC) (Education Session); International Medical Industries, Inc. (IMI) (Door Drop Bag Insert); Letco Medical (Welcome Reception Honoring IACP fellows/Education Session/CCH Lapel Pin); MEDISCA (Meeting T-shirt; Education Session); 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); RX TaxPros (Education Session); 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: Presidential Sponsor: Darby Brown, RPh, PIC, Brown's Compounding Center, Englewood, CO; Judicial Sponsor: Jeff Barton, RPh, Custom Dosing, P.C., Crown Point, IN; Greg Chase, RPh, Owner, Akina Pharmacy, Chantilly, VA; Joseph DiMatteo, RPh, CCN, ND, Medicine Shoppe Compounding Pharmacy, Oakmont, PA; Eddie Glover, PD, US Compounding, Conway, AR; John Herr, RPh, FIACP, Town & Country Compounding, Ridgewood, NJ; Bob Hoye, CRPh, FIACP, RPh, Hoye's Pharmacy, Tampa, FL; Alan Israel, RPh, Lee-Silsby Compounding Pharmacy, Cleveland Heights, OH; Rakesh Patel, WELLHealth Rx, Jacksonville, FL; Blake Powers, VP of Marketing, COO, QmedRx, Maitland, FL; Stan Reeves, PharmD, F & F Drugs, Demopolis, AL; David Smith, PharmD, FIACP, A & O Specialty Pharmacy, Salinas, CA; William Stuart, RPh, Hartley Medical Center Pharmacy, Long Beach, CA; Contributor Sponsors: Eyad Alsabbagh, Dr, Biomed Specialty Pharmacy, West Chester, OH; Joseph Bettinger, RPh, Hieber’s Pharmacy, Pittsburgh, PA; Barry Bilbro, RPh, Medicine Shoppe, Warner Robins, GA; Mike Boehmer, RPh, Director, Compound Pharmaceutical Technologies, Daphne, AL; Kevin Borg, President/CEO, PharmD, FIACP, FACA, Potter's House Apothecary, Peoria, AZ; Denise Burnham, RPh, Creative Compounds, Wilsonville, OR; Greg Chase, RPh, Owner, Akina Pharmacy, Chantilly, VA; David Creecy, RPh, Poquoson Pharmacy, Poquoson, VA; Nathan Damasius, Vyto’s Pharmacy, Hammond, IN; VJ Damasius, PharmD, Vyto’s Pharmacy, Hammond, IN; John Demars, RPh, Vet Med, Inc., Chapin, SC; Saad Dinno, RPh, FIACP, FACA, Acton Pharmacy, Acton, MA; Ken Elliott, Letco Medical, Decatur, AL; Donald K. Fellows, Jr., RPh, Central Rexall Drugs, Inc., Hammond, LA; Steve Hoyt, RPh, Owner, San Ysidro Pharmacy, Santa Barbara, CA; Brenda Jensen, CPhT, Compounding Consultants, LLC, Canton, SD; Richard Johnson, RPh, Owner, Compounding Specialists of Wyoming, Casper, WY; Joe Lorello, RPh, Principal, Apothecary by Design, Portland, ME; Bradley McCloskey, PharmD, University Compounding Pharmacy, Birmingham, MI; Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health, Indianapolis, IN; Harry Melnick, RPh, The Medicine Man Pharmacy, Houston, TX; Steve Moore, PharmD, Condo Pharmacy, Plattsburgh, NY; Aloysius Okei, RPh, Family Choice Pharmacy, New Carrollton, MD; Brenda Pavlic, CPhT, SaveWay Compounding, Newark, DE; Trey Phillips, PharmD, Summerton Drugs Compounding & Dispensary, Summerton, SC; Baylor Rice, RPh, FIACP, South Compounding River Pharmacy, Richmond, VA; B. Wade Scott, RPh, Scott’s Pharmacy, Macon, GA; Ascanio Serna, ASC Pharmacy Inc, Hialeah, FL; Greg Sutton, Sutton Family Pharmacy, Dalton, GA; Gener Tejero, RPh, Solutions Specialty Pharmacy, Las Vegas, NV; Tiffany Turner, Freedom Pharmaceuticals, Broken Arrow, OK; Charles W. Wilson Jr., RPh, Owner, Dunwoody Pharmacy, Dunwoody, GA; Doug Yoch, PharmD, Stanley Specialty Pharmacy, Charlotte, NC; Thomas Zieglar, RPh, Owner/PIC, Medicap Pharmacy, Ashburn, VA.
To learn more about the exhibitors and meeting sponsors, click here.
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