April 12, 2013
FDA Commissioner Hamburg to Testify Tuesday at Subcommittee on Oversight and Investigations Hearing
The Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), has scheduled a hearing for Tuesday, April 16, 2013, at 10:00 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “A Continuing Investigation Into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented.” Food and Drug Administration Commissioner Margaret Hamburg will testify. Click here to read the Subcommittee's Press Release regarding this hearing.
More in the News:
Washington Post, April 11, 2013
Tennessean, April 11, 2013
Wall Street Journal, April 11, 2013
New York Times, April 12, 2013
Reuters, April 12, 2013
Rumors About AVMA Prohibiting Compounding?
There has been quite a bit of confusion about where the American Veterinary Medical Association (AVMA) is or is going as it relates to veterinary compounding. Much of that is due to conflicting information about proposed legislative language that the Animal Health Institute (AHI) has circulated and for which they are seeking AVMA's support. The AHI is the association for the pharmaceutical companies that manufacture veterinary medications.
AVMA always has accepted and educated its members that the Food and Drug Administration's (FDA) position prohibits the compounding of any animal drug from APIs (active pharmaceutical ingredients/bulk products). Their position is based upon the FDA regulations and the Veterinary Compounding Compliance Policy Guidance issued in 2003 by the Agency. As IACP members know, that CPG was issued on an emergency basis in 2003 by the agency without public input or comments. Since then, and despite three letters from Congress demanding action and a public announcement in 2004 that the CPG would be "reconsidered," the document remains unchanged.
While IACP and compounders continue to fight for veterinarians to prescribe medications prepared from APIs, the AVMA takes a very strict view to protect its members, and that is that the FDA prohibits the use of APIs for both major and minor non-food producing species.
The proposal from AHI which IACP has seen and reviewed would change the existing federal law to permit some compounding with APIs for animal use. However, while that might seem like a positive step forward, the manner in which AHI is recommending that be done is too restrictive and would have significant impact on the clinical care of animals as well as further confusing the "can we/can we not" dilemma which pharmacists and vets currently face. IACP continues to meet with AVMA's legislative team to discuss the pros and cons of the AHI proposal as well as the need for great clarity for all practitioners in whether or not APIs should or should not be used.
Part of the confusion is also due to a lack of understanding of the AVMA's policy development process. As with other associations, internal committees of members provide input on recommendations to their Board. The AVMA Board then adopts a policy which is then circulated back to the entire membership for input. The Board policy may change after that or may be discussed and voted upon through the association's House of Delegates process at their July 2013 meeting in Chicago. Rumors in the compounding community that an AVMA Board vote was 'imminent" and that a formal AVMA policy on the use of APIs or even the AHI proposal was occurring this month are unfounded and only served to create confusion among vets and pharmacists. The AVMA Board will not take this issue up until they meet formally in June.
Modern Healthcare: Risky Drug-Compounding Method Rarely Used, Survey Finds
According to a Modern Healthcare article that ran yesterday, the method for mixing drugs that led to 53 deaths in an outbreak of fungal meningitis in 20 states last fall is inherently risky, but seldom-used by hospitals.
The article reports that a new survey of U.S. hospitals by HHS' inspector generals' office finds that the drug-mixing technique—known as “nonsterile-to-sterile” drug compounding—was used for only 666 doses per year in larger hospitals, or less than 1% of the time. The less-risky “sterile-to-sterile” drug mixing method was used more than 200,000 times per year in larger hospitals. Only 25% of the hospitals used any nonsterile-to-sterile mixed drugs at all.
Click here to read the entire Modern Healthcare article.
Massachusetts Mulls New Rules for Compounding Pharmacies
State health officials want Massachusetts – where a deadly fungal meningitis outbreak originated – to lead the nation with new rules for compounding pharmacies.
On April 2, interim Public Health Commissioner Lauren Smith outlined Gov. Deval Patrick’s proposed legislation that would beef up inspections, require special licenses for sterile compounders, institute a system of fines for violations, and reduced the number of pharmacists serving on the state’s regulatory board.
Smith and others testified for more than three hours before the Legislature’s Joint Committee on Health Care, which held a public hearing on several bills filed in the wake of health and safety problems at the New England Compounding Center in Framingham, Mass. IACP representatives were in attendance at this hearing. Click here for a recap of the hearing.
Compounding Bill Passes in Tennessee
A Drug Compounding Bill with the support of the Tennessee Pharmacists Association and IACP's clarification of office use dispensing has passed with collaboration and input. Please click here to read more.
IACP to Participate on American Academy of Ophthalmology Panel
IACP's Sarah R. Dodge-Palmer – Vice President of Government Affairs, and IACP Member Charles Leiter, PharmD, Leiter's Compounding Pharmacy in San Jose, Calif., will serve on a panel today, April 12, 2013, at the American Academy of Ophthalmology’s Mid-Year Forum hearing on compounded pharmacies. Click here for more information on this panel.
Multi-State Licensure: A Reminder to all IACP Members
Does your pharmacy send compounded preparations to residents of other states? Does your pharmacy fill and dispense manufactured prescription drug products to patients who live out-of-state? Do you process and ship "office-use" prescriptions or sell prescription medications to prescribers in other states?
Only three states -- Georgia, Massachusetts, and Pennsylvania -- do not have non-resident pharmacy permit laws. All other state Boards of Pharmacy require non-resident pharmacies to obtain a permit to deliver prescription medications into their state as part of their responsibilities to protect their citizens. Unfortunately, many pharmacies who are close to the border of another state do not realize that they, too, may be required to have a non-resident pharmacy permit or license to mail or ship prescription medications to patients or prescribers.
Make it a priority today to review your licensure or permitting status in all the states to which you send medicines.
IACP Continues to Work with Media
IACP has spent the last several months engaged in a high volume of media interviews to help set the record straight about pharmacy compounding. Click here to view a list of all news coverage in which IACP has been involved from December 2012 through March 2013. Many of the links are to wire stories that the other publications on the list also covered.
This week, IACP's David G. Miller, RPh met one-on-one with the Associated Press, ABC News, CBS News and The Wall Street Journal to provide information and perspective on compounding and answer questions.This is one part of IACP’s strategy to ensure that our position and perspective are known by journalists covering compounding, and will be key to stories generated going forward.
Your Academy will continue to update you in IACP member communications, including: the IACP website/Breaking News; Capitol Connections member newsletter, CustomRx Connection online magazine, IACP Facebook, Twitter, Linkedin and IACP DConnection (our blog), to keep our members and other key stakeholders informed of our public relations activity.
Selecting an API Supplier – Did You Know?
Aside from the general business terms and conditions compounding pharmacists ordinarily review, for any new potential supplier of active pharmaceutical ingredients (APIs), you should always require the following:
1. Evidence of their current licensure as a wholesaler/distributor in the state in which you practice. That's required. Some suppliers do not do business in some states because they choose to be only regional.
2. Evidence of their status as a registrant with the Food and Drug Administration (FDA). Manufacturers, wholesalers, suppliers, distributors, importers, etc. must register with the FDA and be subject to regular inspections and compliance with laws and regulations. You can do some of that verification yourself by visiting FDA's website. Please send an email to email@example.com with any questions.
Alabama Pharmacy Association: 2013 Pharmacy Legislative Day
Alabama Members - Mark your calendars for April 18, 2013, in Montgomery, Ala, for the Alabama Pharmacy Association's (APA) Pharmacy Legislative Day. Legislators from all over the state will be attending, and we need every pharmacist and technician there to show that pharmacy WILL NOT be overlooked! Click here for more information. Please visit APA's website at www.aparx.org for more details or to register online.
Your Presence Is Needed at This Year’s Compounders on Capitol Hill!
The 19th Annual Compounders on Capitol Hill (CCH) will be held June 1-4, 2013 at the Crystal Gateway Marriott in Arlington, Va. Located only two miles from Ronald Reagan National Airport (DCA), the Crystal Gateway Marriott offers immediate lobby access to Washington, D.C.’s world-famous Metro system and a quick ride to all the museums, sights, restaurants, and even the Capital. Selecting a new hotel is part of a strategic plan to bring attendees and exhibitors much needed meeting space, a larger exhibit hall, discounted parking to encourage local compounders’ participation, and a considerably lower hotel group rate.
IACP Board President Wade Siefert, RPh, asks you to join him at CCH and explains why your presence is needed more than ever before! “Our profession is at a tipping point, and it requires all of us to be present and unified in Washington, D.C. in 2013.” Click here to hear a heartfelt message from President Siefert.
Make Plans to Stay for Hill Day and the Capitol Hill Debriefing and Closing Celebration
Make sure that all of your visits pay off by sharing your meetings and discussions with IACP’s Government Affairs team on Tuesday, June 4, 2013 from 3:00-6:00 p.m. held in bin 1700. Update us on your conversations, what follow-up needs to be done, and help “close the loop” to maximize your personal and IACP’s collective impact. This year, enjoy hors d’oeuvres and refreshments as you share your Hill stories and help celebrate another successful CCH event. And as a special treat to the weary walkers…don’t miss out on the shoulder and neck massages we have scheduled to get you back in shape for your last evening in Washington, D.C.!
The 2013 Compounders on Capitol Hill printed brochure edition and e-brochure is sponsored by IACP Corporate Partner Freedom Pharmaceuticals, Inc. The Flipbook technology for the e-brochure was generously provided by RXinsider. To review the 2013 Compounders on Capitol Hill e-brochure, click here.
Compounders on Capitol Hill
June 1-4, 2013
Crystal Gateway Marriott
1700 Jefferson Davis Highway
Arlington, VA 22202
IACP’s COMP PAC Dinner Hosts the Honorable Sam Farr, U.S. House of Representatives
Held in conjunction with Compounders on Capitol Hill, IACP’s COMP PAC Dinner will be on Monday, June 3, 2013 at Ruth’s Chris Steak House in Arlington, Va. This year’s COMP PAC Dinner is an exclusive opportunity to hob-nob with powerful movers and shakers of Washington, D.C. The COMP PAC will host the Honorable Sam Farr, U.S. House of Representatives (D, CA-17) to talk face-to-face with our attendees about the future of health care. All proceeds will go to our goal of making COMP PAC one of the largest political action committees in pharmacy.
Enjoy a delicious dinner with entrées such as Sizzlin’ Blue Crab Cakes and USDA Prime Ribeye accompanied by Fresh Asparagus with Hollandaise Sauce and Mashed Potatoes followed by a delectable dessert, chocolate sin cake. To review the complete menu, click here.
Space at the event will be limited so reserve your seat early and help COMP PAC achieve its goal of raising funds to use in supporting candidates who recognize the value of compounding pharmacists and the services they provide. Remember, COMP PAC is the only PAC exclusively representing the interests of the compounding profession.
Payment for the COMP PAC Dinner must be paid by individual personal check or personal credit card. Please join us for this special event! Be sure to indicate your interest in the COMP PAC Dinner when completing your Compounders on Capitol Hill online registration and the IACP Registrar will contact you for payment or click here.
Please click here to view the Honorable Sam Farr’s bio
COMP PAC Dinner and Fundraiser (IACP MEMBER EVENT)
Monday, June 3, 2013
Ruth’s Chris Steak House
2231 Crystal Drive, 11th Floor
Arlington, VA 22202
Cost: $1000 per person
Thank you to our CCH 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.; B&B Pharmaceuticals, Inc.; bioMérieux; Charles River Laboratory; Digi-Trax Corporation; DYNA Labs; Eagle Analytical Services; EMD Millipore; Exakt Technologies, Inc.; Fagron (formally Gallipot); Freedom Pharmaceuticals, Inc.; Humco Compounding; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc.; IsoTech Design; Letco Medical; Life File; Live Oak Bank; Mar Cor Purification; MEDISCA; PCAB; PCCA; Pharmacy Marketing Quarterly; RxCoop, LLC; RXinsider; Storey Marketing; TeleManager Technologies; Torpac Capsules; USP; and ZRT Laboratory, LLC.
We would like to thank the following meeting sponsors for their support of Compounders on Capitol Hill: American College of Apothecaries (Continuing Education Provider); B&B Pharmaceuticals (Meeting Tote Bag Sponsor, Education Session Sponsor); Fagron (formerly Gallipot) (Meeting Syllabus Sponsor); Freedom Pharmaceuticals, Inc. (Meeting Brochure Sponsor); Humco Compounding (Education Session Sponsor); Letco Medical (Welcome Reception Honoring IACP Fellows Sponsor, IACP AdvanCE Education Session Sponsor); MEDISCA (Meeting T-Shirt Sponsor); PCCA (Name Badge Holder Sponsor, Hotel Room Key Sponsor, Education Session Sponsor, State Breakfast/Hill Day Sponsor); Storey Marketing (Meeting App Sponsor); and Topi-Click Topical Dosing Applicator (Conference Pen Sponsor).
To learn more about the exhibitors and meeting sponsors, click here.
Reserve your hotel room online by clicking here.
Register to Attend CCH! Online Registration Closes Monday, April 29, 2013
IACP is Headed to Chicago on July 25, 2013!
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. You don’t want to miss this in-depth presentation on legislative and regulatory issues that affect you and your practice by IACP’s Executive Vice President and CEO David G. Miller, RPh.
The seminar is designed for any pharmacist, technician or pharmacy student currently involved in or interested in building their understanding about compounding pharmacy. Whether you’re a veteran compounder or just thinking about implementing this critical health service for your community, we hope you’ll join us for an evening of education and fellowship. For more information, please visit www.iacprx.org/RegionalEducationMeetings.
Prospective Cities in 2013 include:
- Chicago, Illinois – July 25, 2013
7:00 - 9:30 p.m.
Martin Avenue Pharmacy
1247 Rickert Drive, Naperville, Ilinois 60540
Registration opening shortly!
- Austin, Texas – August 2013
- Houston, Texas – August 2013
- Tulsa, Oklahoma – September 2013
- Salt Lake City, Utah – September 2013
Prospective Cities in 2014 include:
- Birmingham, Alabama
- Phoenix, Arizona
- Conway, Arkansas
- Boston, Massachusetts
- Raleigh, North Carolina
- Salt Lake City, Utah
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 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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