February 11, 2014
IACP First to Issue Comments on for FDA's Draft Guidance: Implementation of 503A & 503B
Your Academy was the first to submit comments to the FDA on its Draft Guidance regarding the implementation for both Section 503A and 503B of the Federal Food, Drug and Cosmetic Act.
IACP is ensuring that the voice of our pharmacy compounding members is heard!
IACP Comments to FDA for your Review
Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503A.
Please click here to view IACP's Comments on FDA's Draft Guidance on the Implementation of Section 503B.
Please click here for IACP's Comparison Chart of 503A and 503B - The Drug Quality and Security Act of 2013.
Complete List of Stakeholder Comments to the FDA
Please click here for a List of All Comments Submitted to the FDA.
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 continues to support increased communications between the States and FDA. However, we have strong reservations with FDA sending a letter to State stakeholders encouraging conducting business only with facilities registered as outsourcing facilities when FDA has not yet finalized guidance, restrictions, and quality standards for these 503B outsourcing facilities."
Click here to read letter to FDA Commissioner Hamburg. Please email IACP with any questions at email@example.com.
LAST CALL: 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:
"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."
If you have suggestions for possible voting member or nonvoting industry representative nominees, please email IACP at Iacpinfo@iacprx.org by this Friday, February 14, 2014. IACP will submit any and all interested members for consideration.
For complete information on the FDA’s steps in implementing the DQSA, please click here. For the announcement requesting nominations to the Pharmacy Compounding Advisory Committee, please click here.
WesternU College of Pharmacy Hosting Contemporary Compounding Intensive Certification Course
The Western University of Health Sciences College of Pharmacy in Pomona, Calif., is offering a Contemporary Compounding intensive CE certificate course (1.7 CEUs or 17 Contact Hours), April 11-13, 2014. Deadline to register is April 4, 2014. For more information, click here!
Infection Outbreak at Duke University Hospital Traced to In-House Compounding Facility
An outbreak of Burkholderia cepacia complex was linked to a contamination in the hospital's institutional compounding facility, according to a report in JAMA Internal Medicine.
Seven inpatients at Duke University Hospital in Durham, N.C., were infected with the bacteria over a seven-day period. Click here to read more.
Corporate Partner Spotlight: EXAKT Technologies, Inc.
EXAKT Technologies, Inc. is a leader in the distribution of high-quality compounding equipment throughout the United States and Canada.
EXAKT recently launched a new website for compounding pharmacies - EXAKTRX.com. Pharmacists will find a robust selection of ointment mills to fit their specific needs. But more than just product information, the site demonstrates what is happening in the gap and why it's important. New content about how to operate an ointment mill on different formulations and the care and feeding of a mill will be available soon.
At EXAKTRX.com, you'll learn about the new EXAKT 50 EC+ (Easy Clean), which is equipped with variable speed control, aluminum oxide rollers, and more motor torque. It's the next generation of the ECs. And it lets you easily remove the rollers for cleaning without giving up any of the precision or performance the EXAKT Classic 50 has delivered for more than 50 years. From basic to high-performance models, EXAKT has an ointment mill to support each stage of a growing pharmacy. With factory-trained technicians, we provide complete service for all our mills.
EXAKT ointment mills are used in more than 30,000 pharmacies worldwide. EXAKT mills are made exclusively of the finest materials and are manufactured according to strict standards. Ease of cleaning, maintenance, operation, and parts replacement are engineered into each EXAKT product. No compounding pharmacy is complete without an EXAKT ointment mill.
For more information, send a request to firstname.lastname@example.org.
The Third Annual ACA, IACP, ACVP Educational Conference was One for the Record Books!
Thank you to all who attended the ACA, IACP, ACVP Educational Conference February 5-8, 2014 at the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. The three-day conference drew 347 attendees from 38 states; seven from Canada and one from Puerto Rico. We thank you all for playing an active role in advancing your profession.
Offering 31.5 contact hours (3.15 CEUs) allowing attendees to acquire up to 14 contact hours (1.4 CEUs), the Educational Conference provided many meaningful hours of networking opportunities both during the meeting and on the oceanfront property of the Harbor Beach Marriott Resort & Spa. The program consisted of targeted sessions for pharmacists, technicians, marketing representatives, and open to pharmacy students on pharmacy law, the fundamental steps to successfully work with your local media; practice-based, compounding, and veterinary clinical and compounding, and much more.
Kicking off the first night, ACA & IACP Corporate Partner Fagron, Inc. sponsored the Welcome Reception, where Fagron’s Mark Kieren, Commercial Manager, welcomed everyone to the meeting as attendees from all three pharmacy organizations met for the first time!
This year, the conference hosted 85 First-timers. The First Timer Program allowed new members, students and first timers to connect with their Ambassador prior to the start of the meeting. We’d like to thank our Educational Conference Ambassadors for reaching out to these new members and helping them become better acquainted with ACA, IACP and ACVP!
On Thursday, February 6, the programming began with a general session combining all three organizations in I Didn’t Know, I Didn’t Know presented by keynote speaker David G. Miller, RPh, EVP& CEO of the International Academy of Compounding Pharmacists (IACP).
Congratulations New and Renewing Fellows
During the conference, the ACA, IACP, and ACVP Fellowship Awards Luncheon honored new Fellows, who have distinguished themselves for a variety of achievements in the pharmacy profession.
ACA inducted 19 Full Fellows: Eyad Alsabbagh (West Chester, Ohio); Mazen Baisa (Canton, Michigan); Sheldon Birch (Tooele, Utah); Kevin Borg (Peoria, Arizona); Christopher Cantwell (Salt Lake City, Utah); Michael Dandurand (Wichita, Kansas); Saad Dinno (Acton, Massachusetts); William Fixler (Chelsea, Alabama); Kynan Gibson (Salina, Kansas); Athena Kingston (Conway, Arkansas); Kenneth Latta (Hillsborough, North Carolina); Richard Moon (Frewsburg, New York); Nathan Pope (Austin, Texas); Joshua Rimany (Charlotte, North Carolina); Andy Ruiz (Austin, Texas); Linda Sarpong (Houston, Texas); Mary Spitzer (Wawa, Ontario Canada); Will Spitzer (Wawa, Ontario Canada); John Walczyk (Waltham, Massachusetts).
IACP welcomed five new Fellows: Tracy Christian, Premier Custom Pharmacy (Palm Beach Gardens, Florida); Cathy H. Huie, Brame Huie Pharmacy (North Wilkesboro, North Carolina); David Joseph, AnazaoHealth
Corporation (Tampa, Florida); Ken Latta, Gates Healthcare Associates (Middleton, Massachusetts); and Ken Speidel, Gates Healthcare Associates, (Middleton, Massachusetts).
ACVP honored three new Fellows: Jorge Reyes (Bayamon, Puerto Rico); Clara Brown (Santa Rosa, California); Henry “Skip” Lenz (Boca Raton, Florida).
On Friday, February 7, the festivities included several social events including the IACP COMP PAC Reception, welcoming the Honorable Ted Yoho, U.S. House of Representatives (R, FL-3) as the keynote speaker. This exclusive event allowed 33 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. All proceeds went to our goal of raising $200,000 and making COMP PAC one of the largest political action committees in pharmacy.
The ACA Foundation & the ACA/ACVP President’s Reception and Banquet
The highlight of the ACA/ACVP banquet is the celebration and installation of the ACA/ACVP Officers, as well as the presentation of the ACA Foundation Awards. The Foundation presented the Albert E. Rosica, Jr. Memorial Award, ACA Member of the Year Award, the ACA Research & Education Foundation Lifetime Achievement Award and the Victor H. Morgenroth, Jr. Memorial Award with more than 85 guests in attendance.
Later that evening, all attendees joined ACA, IACP, and ACVP for the Celebration Dessert Reception sponsored by ACA and IACP Corporate Partner Letco Medical. The casual reception brought all three pharmacy organizations together for a wonderful evening of fellowship over an array of delicious desserts and cocktails.
One special highlight that evening included Bill Peters, Senior Executive Vice President of Sales and General Manager of Letco Medical generously raffling off one complimentary registration to the 2015 Educational Conference. The raffle winner was Tom Hunt, RPh, Lindenwood Drug (St. Louis, Missouri).
ACA, IACP and ACVP would like to thank both the Educational Conference Poster Presentation participants for sharing their knowledge about unique case studies and research through poster presentations at the Educational Conference.
This year’s Poster Presentations were presented by: Loren M. Kirk, PharmD Candidate, East Tennessee State University (Primary Author) with Stacy D. Brown, Assistant Professor, East Tennessee State University (Co-Author); and Manuel Isherwood, Pharmacy Student, Wilkes University, Nesbitt College of Pharmacy (Primary Author) with Co-Authors: Eliza Daubert, Pharmacy Student, Wilkes University, Nesbitt College of Pharmacy; Christina Inteso, Pharmacy Student, Wilkes University, Nesbitt College of Pharmacy; Trey Tietz, Pharmacy Student, Wilkes University, Nesbitt College of Pharmacy; Arthur H. Kibbe, Faculty, Department of Pharmaceutical Sciences, Wilkes University, Nesbitt College of Pharmacy; Adam VanWert, Faculty, Department of Pharmaceutical Sciences, Wilkes University, Nesbitt College of Pharmacy. Click here to review the poster presentations.
Thank you to our Meeting Sponsors and Exhibitors!
A BIG thank you to our exhibitors and meeting sponsors: AirClean Systems; Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc; Attix Pharmaceuticals; B&B Pharmaceuticals, Inc; Blesstia Pharmaceutical; Charles River; Compounding Matters Academy; Digi-Trax Corporation; EXAKT Technologies, Inc; Fagron; Feras Capital, LLC; 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; Take Charge Pharmacist Obesity Education System; Televox; Topi-Click Topical Dosing Applicator.
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); Eddie Glover, PharmD, US Compounding (Conway, AR); Charles Leiter, PharmD, Leiter’s Compounding Pharmacy (San Jose, CA); Scott Popyk, RPh, MBA, FIACP, Health Dimensions (Farmington Hills, Michigan); William Stuart, RPh, Hartley Medical Center Pharmacy (Long Beach, CA); 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, FACA, 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); Martin B. Mintz, RPh, Northern Pharmacy & Medical Equipment (Baltimore, MD); Becca Mitchell, PharmD, FIACP, US Compounding (Conway, AR); Suzanne Rosenberg, PharmD, Community Compounding Pharmacy (Portland, OR); Andy Ruiz, PharmD, MSc, Stonegate Pharmacy (Austin, TX).
To learn more about the exhibitors and meeting sponsors, click here.
To see photos from the meeting, check out the Educational Conference Facebook Page here.
Thank you to all for making the Educational Conference a huge success! Stay tuned for details on the 2015 meeting.
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.
Share with your community that you’re attending CCH. NEW - Click here for a press release attendees can distribute to your local media, post to pharmacy website, and share among your social media pages!
What you can expect in 2014:
- We have a sold out exhibit hall awaiting you! Meet face-to-face with 40 leading companies that serve compounding pharmacies.
- 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) (Tentative Speaker) 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 www.iacprx.org/cch.
20th Annual Compounders on Capitol Hill
May 17-20, 2014
Crystal Gateway Marriott
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; American College of Apothecaries (ACA); 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; Compounders International Analytical Laboratory (CIAL); 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; MEDISCA; Medi-Dose, Inc./EPS, Inc.; PCCA; Pharmacy Compounding Accreditation Board (PCAB); Pure Encapsulations; RX TaxPros; RxCoop, LLC; RXinsider; Storey Marketing; TeleManager Technologies; Wellness Works; ZRT Laboratory.
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
“I would highly recommend it for all! It’s important to keep learning and doing our best in compounding! It was great to get together with fellow compounders and others. It was a big step in the right direction!” - Dean Jolley, RPh, Jolley's Compounding Pharmacy, Attendee at Salt Lake City, Utah 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 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.
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