October 4, 2013
HR 3204 in Senate
Last Thursday, Chairman Fred Upton of the House Energy and Commerce Committee introduced a compromise bill (HR 3204) that combined compounding and “track and trace” bills in the House of Representatives. This new bill, markedly different from both the pending Senate 959 and the HR 3089 from Congressman Morgan Griffith’s office, moved quickly and was passed by voice vote on Saturday, 28 September.
The new legislation, now awaiting action in the Senate, does two things for compounders. First, it creates a “voluntary” registration for a new FDA-regulated entity called, an “outsourcing facility.” Those facilities would be businesses that wish to compound sterile medications and distribute or sell them without a patient-specific prescription. Second, it reaffirms the 1997 section 503(a) of the Food Drug & Cosmetic Act with the removal of a clause that had previously been determined to be unconstitutional by the US Supreme Court.
IACP opposes HR 3204 for several important reasons:
- The current language in 503(a) does not recognize “office-use” dispensing. That only continues the ambiguity and inherent conflicts between federal and state laws. Resolving that has been a top priority for IACP throughout all of our negotiations and work with both chambers of Congress.
- The new outsourcing facility does not have to be a pharmacy. That means that a non-pharmacy compounding facility is not subject to the laws and regulations of Boards of Pharmacy which IACP members are required to follow.
- Though an outsourcing facility is a “voluntary” registration, IACP has seen ample evidence that the FDA may continue its inspections and actions against pharmacies that provide sterile “office-use” medications. That so-called “choice” to register may not be a choice at all.
Click here to read IACP's Position Statement Regarding HR 3204.
IACP Seeks Solution to HR 3204 Problems
In addition to pursuing amendments from Senators to resolve the problems still contained in HR 3204, IACP is working with leadership and compounding supporters to:
- Demonstrate Congressional intent not to interfere with current office-use and repackaging practices by traditional compounders by securing a formal letter from Senators Harkin and Alexander to FDA Commissioner Hamburg.
- Insert a formal statement for the record on office-use and repackaging.
- Schedule a Congressional member meeting with the FDA to have their position and intended "enforcement discretion" activities explained.
- Request an expansion of the GAO report in the bill to assess the impact that traditional compounders have had on helping fill the drug shortage gap.
- Schedule hearings in 2014 and 2015 to review the FDA's actions on HR 3204 implementation.
- Introduce a bill clarifying 503(a) after enactment of HR 3204.
Compounders StateSide Update
The latest edition of IACP's Compounders StateSide is now available on our homepage. We're working to keep you updated on the evolving legislative news in your states. Please click here to read the most recent information.
Download the HR 3204 Town Hall Recording
Thank you to the 290 IACP Members who joined us on our October 1st Town Hall regarding HR 3204. If you could not attend, you can still access the Town Hall recording and listen at your convenience. Please visit IACP's Members-only site, and click on Member Resources, then Town Hall Recordings. If you have additional questions on the Town Hall content, please email us at firstname.lastname@example.org.
Letco Medical Issues Response Today on Current Legislation, “Drug Quality and Security Act” (HR3204)
Letco Medical is in favor of working toward clearly defined legislation that will help further the safety and continued access of compounded preparations as well as protect the American public. Letco Medical believes that the tragic events that occurred as a result of what occurred at the New England Compounding Center were preventable and have changed the face of compounding. It is essential that any legislation address the root cause of such events and should contain clear definitions to avoid creating more confusion.
Letco Medical applauds the efforts by the International Academy of Compounding Pharmacists (IACP) and Congressional staff to work toward crafting such a bill that addresses the original intent of patient safety and clear regulatory accountability surrounding compounded preparations and the facilities that provide them.
The IACP worked closely with Congressional staff to address potential issues in “Title I: Drug Compounding” of the current legislation, “Drug Quality and Security Act” (HR 3204). The IACP identified several key problems with “Title I-Drug Compounding” of the final bill HR 3204 and issued a letter of opposition addressing these gaps in the current language.
Click here to read more.
IACP Continues to Work with Major Media Outlets
The Wall Street Journal
IACP's David G. Miller, RPh, EVP/CEO quoted regarding the Compromise Compounding Bill in The Wall Street Journal article (9.28.13), "House Passes Bill Regulating Specialty Pharmacies: Effectiveness of Legislation Still Questioned." Read more here.
IACP is quoted in a Bloomberg Businessweek article (9.27.13) on the Compromise Compounding Bill, "A Confusing Attempt to Cure Compounding Pharmacies." Read more here.
"On Friday the International Academy of Compounding Pharmacists, the industry’s politically potent trade group, vowed to fight the proposed legislation. 'This bill, in its failure to recognize the very real problems in the draft legislation that we have identified over many meetings, will without question result in patients’ inability to obtain access to needed medications,' David Miller, the academy’s chief executive, said in an e-mailed statement. 'Although states have long had sufficient authority to regulate compounding, the bill grants the FDA sweeping, unprecedented authority in determining what pharmacies can compound.'”
IACP's David G. Miller, RPh, and IACP Board Member Pat Stephens, PharmD, Medi-Fare Drug & Home Health Center, Inc., in Blacksburg, S.C., worked with the NPR affiliate, WFAE, to explain how the current FDA inspections are using cGMP compliance standards that were not designed for compounding pharmacies.
Click here, to view and listen to the NPR broadcast, "FDA Inspections Put Compounding Pharmacies in Regulatory Gray Zone."
"Very few of the compounders inspected have met the FDA's manufacturer standards. That's no surprise to David Miller, the CEO of the International Academy of Compounding Pharmacists. 'The federal government has changed the rules and inspected with a different rule book, and then told them that they can't do business unless they follow rules that were never designed for a pharmacy in the first place,'" Miller said.
IACP is continuing to work with the media on behalf of its membership to Protect, Promote & Advance Pharmacy Compounding.
Media Trends: Continuing Stories on Compounding for Prison Executions
IACP Members: Please be aware that the media continues to explore the use of compounded drugs for prison executions.
Click here for Ohio Story
Click here of Texas Story
IACP does not take a stance on the use and/or purpose of any medication. That is the responsibility best managed by the individual pharmacist. We support the profession-wide acknowledgement of the rights of the individual pharmacist to engage in informed decision-making based up the professional judgement of the pharmacist, and the prescribing physician.
Please email IACP should you have any questions at email@example.com. If you receive calls from the media, IACP encourages you to direct these press inquiries directly to your Academy's PR Firm, David Ball, Ball Consulting Group This media assistance is part of your benefits as an IACP member.
David Ball, Ball Consulting Group, LLC
Corporate Partner Spotlight: EMD Millipore
Author: Karen Chronholm
Director Regional Marketing
EMD Millipore Corporation
290 Concord Road
Billerica, MA 01821 USA
Phone: +1 978-715-1748
Increasing Control in the Product Manufacturing Process with QC Microbiology Programs
While microbiological testing programs are an essential part of any compounding pharmacy’s operation, it can be challenging for an organization to define the optimal approach to testing. The United States Pharmacopeial Convention’s USP <797> Compounding-Sterile Preparations addresses testing and microbiological quality measures for sterile, compounded drugs conducted by US and Canadian facilities and provides guidelines for areas in which compounded sterile preparations are prepared, stored and dispensed. However, several US states do not have laws providing guidance for sterile compounding, and USP <797> guidelines were written to allow for flexibility, which can make it difficult when companies are trying to implement or maintain a microbiological testing and sampling program. Adding to the challenge is that regulations are likely to evolve in coming months and years in response to recent, well-publicized contamination events.
Microbiological testing and sampling programs are used to monitor and identify microbial contamination in raw and in-process materials, as well as non-sterile finished products. Independent of regulations, robust microbiological testing is crucial to preventing contamination and ensuring patient safety. In a stringent and evolving regulatory environment, a number of factors should be considered when establishing or updating existing QC microbiology programs.
Click here to read more.
The IACP Contributor List Continues to Grow! Thank you for Donating to your Profession's Future.
IACP is working to Protect, Promote & Advance Pharmacy Compounding. Please help IACP continue our ongoing legislative, regulatory and press efforts on issues including: S. 959, reimbursement, and preserving patients and practitioners' access to pharmacy compounds. With your help, IACP can continue to play an active role in protecting our profession.
Please click the Donate button above to access an IACP donation form. One-time sums, or monthly contributions are both available for your consideration. We greatly appreciate anything you can do to help support our efforts, and for being an IACP Member!
We Thank the IACP Members and Corporate Partners Contributing to the Academy!
Click here to view the entire list.
IACP’s Public Relations Firm Ball Consulting Group, LLC Presents Two Sessions on Implementing a Communications Plan for Your Compounding Pharmacy
Connect and network with fellow colleagues.
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.
Hear from a dynamic line-up of speakers in Continuing Education from three leading pharmacy organizations, multi-organization networking opportunities, and an exhibit hall showcasing companies dedicated to helping you grow your practice.
For the past year, IACP has worked with David A. Ball, MS, Ball Consulting Group, LLC to implement a strategic communications plan in light of the NECC crisis. Is your pharmacy prepared with a communications plan? Join David A. Ball, MS for Overcoming Perception through Public Relations on Thursday, February 6 from 9:00-10:00 a.m. This program will enable pharmacists to position their business for growth by enabling them to develop and then implement a marketing and communications plan. Pharmacists will learn how to use public relations and the media as a tool for making existing and prospective patients aware of their services. They will also learn how to confront head-on misperceptions about compounding pharmacists.
At the conclusion of this educational session, the pharmacist and technician attendee will be able to:
- Define three core elements of public relations.
- Discuss proven communication strategies for working with patients, physicians, and the public. Explain how to build relationships with the news media.
- Explain how to rebuild your pharmacy’s image.
Program Type: Knowledge-Based
Presented by: David A. Ball, MS, Ball Consulting Group, LLC
David A. Ball, MS Speaks on Preparing for and Withstanding a Crisis at Your Compounding Pharmacy
On the IACP track, David A. Ball, MS, Ball Consulting Group, LLC, will present a second session on Preparing for and Withstanding a Crisis at Your Compounding Pharmacy on Thursday, February 6, from 10:15-11:15 a.m. A crisis, such as contaminated medications, a medication error, employee larceny, or a natural disaster link an earthquake, flood, or fire can severely damage the reputation of a pharmacy and in some instances even lead to its closure. This program will enable participants to learn what they can do to prepare for and manage a crisis. It will feature IACP Member Charles Leiter, PharmD, who has done just that.
At the conclusion of this educational session, the pharmacist and technician attendee will be able to:
- Explain how to implement a crisis management plan.
- Identify how to organize a crisis management team.
- List three steps to undergo when implementing a crisis management plan.
- Explain how to reinvigorate your pharmacy in the aftermath of a crisis.
Program Type: Knowledge-Based
Presented by: David A. Ball, MS, Ball Consulting Group, LLC; Charles Leiter, PharmD, IACP Member, Leiter’s Compounding Pharmacy
This is destination education at its finest. Educational Conference attendees may acquire up to 14.0 contact hours (1.4 CEUs) of continuing education credit including 4.0 contact hours (.4 CEUs) of LIVE Pharmacy Law.
Advance discount deadline ends on or before December 3, 2013. For the latest conference news, visit www.EducationalConference.org.
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida
ACA, IACP, ACVP 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 this year! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees, Corporate Partners, and Exhibiting Companies 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. See examples below. To download the images in the Graphic Toolkit, click here.
We’ve also created several downloadable signs for you to print and take a picture with to show you're attending #EduCon2014. Let your creativity run wild in this picture! Don’t forget to use the meeting hashtag #EduCon2014 in your post! Tag us in your picture! Share on Facebook, Twitter, and Instagram. To download the images in the Graphic Toolkit, click here.
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, Inc.; 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 ); Freedom Pharmaceuticals, Inc. (Meeting Tote Bag, Conference Pen, Education Session Sponsor ); Humco Compounding (ACA/ACVP AND IACP Fellowship Luncheon Sponsor, Meeting E-Brochure Sponsor, Education Session Sponsor ); Letco Medical (Celebration Dessert Reception, ACA Education CEnter & 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 Pharmacy 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: Charles Leiter, PharmD, Leiter’s Compounding Pharmacy (San Jose, CA); Contributor Sponsor: Linda McElhiney, PharmD, RPh, FIACP,FACA, FASHP, Indiana University Health (Indianapolis, IN).
To learn more about the exhibitors and meeting sponsors click here.
Join IACP as we Celebrate 20 Years of 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.
In the next week, all IACP Members will receive a CCH Save the Date magnet/postcard with details on the conference. Be sure to check your mailbox and mark your calendar at the pharmacy!
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 Marketing Track for the non-marketer and marketer looking for innovative ideas. Reinvigorate your marketing strategies with the latest tools and resources; define short-term and long-term marketing strategies; and take away a comprehensive marketing plan you can implement directly into your practice.
- A bargain hotel group rate at $159 – that’s half the price from previous years!
Click here to read more!
Salt Lake City, UT Regional Education Meeting Recap
The IACP Regional Education Meeting in Salt Lake City, Utah on Thursday, September 26, 2013 hosted 75 pharmacists, technicians, marketing representatives, and pharmacy students for an evening of networking while enjoying pizza and refreshments provided by Utah Pharmacists Association (UPhA), a legislative and regulatory presentation by IACP’s David G. Miller, RPh, and Q&A with DOPL’s Compounding Task Force. A big thank you to our hosts: Roseman University of Health Sciences; IACP Member Dean Jolley, RPh, Jolley's Compounding Pharmacy; and Trip Hoffman, PharmD, University Pharmacy.
IACP Regional Education Meeting Headed to Tulsa, Okla; and Scottsdale, Ariz!
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 legislative and regulatory education, Q&A, and networking with your local compounders! For more information, please visit www.iacprx.org/RegionalEducationMeetings.
Title: 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.
Speaker: David G. Miller, RPh, IACP’s Executive Vice President & CEO
CE Credit: 2.0 contact hours (.20 CEUs) of ACPE-approved LIVE LAW continuing education credit; knowledge based
At the conclusion of this seminar, the pharmacist and technician attendee will be able to:
- Explain how compounders are regulated and enforced by the State Boards of Pharmacy, Food and Drug Administration (FDA), and Drug Enforcement Administration (DEA).
- List four different regulatory initiatives and two court cases that have defined FDA’s oversight to compounders.
- State what authority the FDA has when inspecting compounding pharmacies.
- Define “bulk ingredients” and the difference between “FDA-approved” products.
- Define “office use” and describe how compounding for office use differs from wholesaling.
- Describe key components of federal proposed legislation that may change the balance of existing federal and state authorities.
Tulsa, Oklahoma – November 9, 2013
5:00 - 7:30 p.m.
Hyatt Regency Tulsa, Diplomat Room, 2nd Floor
100 East 2nd Street, Tulsa, OK 74103
Click Here to View the Event Flyer for More Details!
This meeting is held in conjunction with Freedom’s November CPCSI training and the Freedom Pharmaceuticals 2nd Annual Seminar. For more information click here.
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
Save the date! Registration will open shortly.
Discounted registration fees: $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.
This meeting is held in conjunction with the 2014 Functional Medicine Seminar presented by ZRT and Storey Marketing, to be held March 21-23, 2014 at the FireSky Resort & Spa in Old Town Scottsdale, Ariz. More details coming soon!
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 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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