September 20, 2013
HR 3089: The Compounding Clarity Act
As reported in last week’s Capitol Connections, Representatives Morgan Griffith of Virginia (R-VA), Diana DeGette (D-CO) and Gene Green (D-TX) announced the filing of House Resolution 3089 called the "Compounding Clarity Act of 2013." A full text of the bill as it currently reads can be found here.
In comparison to similar legislation on the Senate side, HR 3089 focuses primarily on clarifying sections 503(a) of the Food Drug and Cosmetic Act rather than providing sweeping new authorities for the Food and Drug Administration to gain greater authority over traditional pharmacy compounding. Within the past few days, the National Community Pharmacists Association (NCPA) and the third-party PBM Express Scripts both issued formal letters of support for 3089.
“Even though we believe the House has a better understanding of the problems that lead up to the NECC tragedy last fall – particularly the failure of both state and federal agencies to take prompt action against a pharmacy that had violated the law – there are still several areas of concern for compounding pharmacists,” said IACP President Wade Siefert. “The IACP leadership met several times over the past few days and while we are generally supportive of the bill, we must resolve some specific areas that undoubtedly impact our ability to care for our patients.”
Click here for IACP's formal HR 3089 statement.
A few of the key points that IACP is watching carefully:
- “Anticipatory compounding”, an important issue for IACP, is included in the bill using essentially the same language that existed previously in 503(a). This includes that any anticipatory compounding must be done based upon a history of prescriptions generated within an established relationship between a physician/prescriber and a compounding pharmacists.
- Compounding must be conducted in compliance with USP <795> and USP <797> chapters. Those standards will apply to all professionals engaged in compounding regardless of location or practice type.
- The ability to compound using Active Pharmaceutical Ingredients (APIs) which previously appeared in 503(a) is retained. That requires that an API must have a USP/NF monograph, be a component of an FDA approved product, or appear on a list of approved APIs developed by the Secretary of Health and Human Services. Additionally, the requirement that all APIs must be obtained by an FDA registered supplier remains unchanged.
- New language would enable the FDA to add drugs to the existing “do not compound” list based upon their being “demonstrably difficult” to compound. IACP strongly objects to this new language because the bill does not include a definition of what constitutes “demonstrably difficult” nor does it adequately link that with a demonstrated lack of patient safety and efficacy.
- While pharmacies will be permitted to compound and provide preparations for “office use”, pharmacies may not act as wholesalers of compounded drugs. That is a new prohibition. For “office use”, a pharmacy would be responsible for obtaining the names of all patients to whom a medication was administered by the prescriber within seven days of administration. Additionally, no more than 5% of total prescriptions dispensed semi-annually may be sterile drug preparations distributed over state lines (interstate) as an office-use medication. IACP believes that this section in particular creates problems because the federal requirement may be in direct conflict with existing and evolving state laws on office-use sales and distribution.
- State Boards of Pharmacy and the FDA will be required to communicate with one another whenever an action is taken against a compounding pharmacy including warning letters, sanctions, or penalties. The FDA will be required to communicate with the state Board if it receives a complaint about a compounded medication or pharmacy. This section, lacking in the Senate version, is the direct result of the House Energy and Commerce Committee’s investigation into the NECC tragedy and the revelation that the FDA was very much aware of the problems at that pharmacy but failed repeatedly to interact adequately with the Massachusetts Board of Pharmacy.
- A new category of FDA licensure called an “outsourcing facility” would be created that applies to pharmacies or other businesses which compound and distribute more than 5% of their sterile medications for office-use over state lines. These new facilities would be subject to cGMP requirements. While this is similar to the “compounding manufacturer” concept in the Senate bill, what is still unclear is whether a pharmacy may remain a pharmacy and be an outsourcing facility as well. In the Senate version, a compounding manufacturer could NOT be a pharmacy and would have to be established as a separate business.
Join IACP for a Town Hall on HR 3089 Wednesday, September 25th
IACP Members: Save the date for Wednesday, September 25th, 11 am Pacific, 12 pm Mountain, 1 pm Central, 2 pm Eastern, for an important IACP Town Hall regarding House Resolution 3089. IACP's David G. Miller,RPh, Executive Vice President, and Sarah Dodge-Palmer, Vice President of Government Affairs, will walk you through the recently introduced HR 3089, “Compounding Clarity Act of 2013.” IACP will answer all of your questions and provide you with action steps for going forward.
A Blast Fax is being distributed today with all of the call-in numbers and information for this Town Hall. Please email firstname.lastname@example.org with your current fax number if you did not receive this blast fax.
The Town Hall will be recorded and will be available on the Members-only site. Please email your questions to email@example.com whether you can attend the live session or not, so we can address your questions at the Town Hall.
Have you seen the New “Poll” Claiming Strong Support for Effective FDA Regulation of Compounding Pharmacies?
This week, the “Working Group on Pharmaceutical Safety” released poll results they say indicate key findings from an “independent survey” of registered voters, claiming strong support for effective FDA regulation of compounding pharmacies.
The recently formed Working Group on Pharmaceutical Safety is led by Tommy Thompson, former Wisconsin governor and U.S. Secretary of Health and Human Services, and current chairman of TherapeuticsMD, a specialty pharmaceutical company as well as Sarah Sellers, self- proclaimed FDA expert and current KV Pharmaceutical employee (manufacturers of Makena (17-P)).
The Working Group’s key survey findings are:
- 87% say it is very important for their doctor to inform them if they prescribe non-FDA approved prescription drugs
- 83% say if their doctor would like to prescribe a drug for them that is not FDA-approved, it is very important for their doctor to tell them about FDA-approved alternatives, if one exists
- 77% are concerned that the FDA does not verify the safety, effectiveness, or manufacturing quality of compounded drugs
- 86% are concerned that not every prescription drug sold to patients in the United States has been reviewed and approved by the FDA
- 77% support legislation to give the FDA more authority to regulate compounding pharmacies and compounded drug
Click here to view the organization's press release.
Click here to view the entire survey.
The Survey Says…
All sounds pretty straight forward, right? Uhhh - not so much when you dive into the actual survey details. Click here to read the Rest of the Story.
IACP's Executive Vice President/CEO David Miller to Speak at CPhA's Annual Compounders Day
IACP's David G. Miller, RPh, Executive Vice President/CEO, will serve on a "Regulatory Update: Late Breaking Federal and State Update" Panel during the California Pharmacists Association's (CPhA) annual Compounders Day, which is being held, September 28-29, 2013, in Newport Beach, Calif. Click here for an event flyer!
IACP's Sarah Dodge-Palmer Spreading the Compounding Word at the 15th Clinical Applications for Age Management Medicine Conference
IACP's Sarah Dodge-Palmer, Vice President of Government Affairs, will be traveling to Las Vegas, Nev., to address attendees at the 15th Clinical Applications for Age Management Conference, being held October 31 - November 3, 2013. Sarah will present, "The 2012 NECC Meningitis Outbreak Tragedy: What Happened? What is Happening in Congress and the States Affecting Practitioners, Patients and Compounding Pharmacists?" Click here for an AMMG Conference brochure.
Corporate Partner Spotlight: Freedom Pharmaceuticals
One Day. Five Outstanding Speakers.
Join Freedom for our 2nd Annual Seminar on November 9, 2013 at the Hyatt Regency Hotel in Downtown Tulsa. The Annual Seminar will correspond with Freedom's November CPCSI training and the IACP Regional Education Meeting in Tulsa, Oklahoma. Topics will include: Pharmacy Inspection; Andropause; Using Marketing Representatives to Market Compound Prescriptions; Compounding Marketing Material; Compounding Legislative Updates; and much more.
Loyd V. Allen, Jr., PhD, RPh - International Journal of Pharmaceutical Compounding (IJPC)
David G. Miller, RPh - International Academy of Compounding Pharmacists (IACP)
Jonathan E. Levitt, Esq - Frier Levitt, LLC
Mazen Baisa, PharmD - Biomed Specialty Pharmacy
Harvey Mackay – Author of seven New York Times bestsellers
All ACPE-accredited lectures are knowledge based activities and continuing education credit will be awarded upon completion of the activity evaluation forms.
For more information about the Annual Seminar or CPCSI, or to register for the events, please visit our website at www.freedomrxinc.com.
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.
The ACA/IACP/ACVP Educational Conference Announces the Science and Practice Poster Presentation Showcase
Connect and network with fellow colleagues.
The ACA/IACP/ACVP Educational Conference invite all ACA, IACP and ACVP Members, pharmacy professors and pharmacy students/residents to participate in the Science and Practice Poster Presentation Showcase. 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.
Two Participating Pharmacy Student Scholarships Available
Through the generosity of donors of both the ACA Foundation and the IACP Foundation, the ACA/IACP/ACVP Educational Conference will be offering two pharmacy students a scholarship to attend the Educational Conference February 5-8, 2014 in Fort Lauderdale, Florida and participate in the Science and Practice Poster Presentation Showcase.
Two poster presentation scholarships will be awarded and are valued up to $2,500. The scholarship will cover the following expenses:
- Full registration for one pharmacy student to attend Educational Conference.
- Three nights of hotel accommodations at the host hotel
- Round–trip economy class airfare (up to $600 round-trip) for one person.
- Up to $250 in travel expenses for transportation, parking and meals not covered by registration.
The Educational Conference is the perfect venue for pharmacy students to network with 300 expected attendees – potentially a future employer. The Poster Presentation Showcase offers the opportunity for you to share your research on pharmacy related topics, be featured among the leaders in the pharmacy profession, and networking at this multi-organization conference. Add your ideas to the conversation!
All ACA, IACP and ACVP Members, pharmacy professors and pharmacy students/residents may participate in the Science and Practice Poster Presentation Showcase. Share your knowledge about unique case studies and research through poster presentations at the Educational Conference. The showcase offers the opportunity for accepted Poster Abstracts to be published in both the IACP electronic journal, CustomRx Connection and in ACA’s electronic publication, Voice of the Pharmacist. Additionally, abstracts will be submitted for consideration to the peer-reviewed International Journal of Pharmaceutical Compounding (IJPC).
The deadline for submission of abstracts is December 3, 2013. To download the Poster Presentation Application and Scholarship Application, visit www.EducationalConference.org/PosterPresentations.html.
Click here to book your hotel room at the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.
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
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; 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.; JMH, Inc; 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: 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 Pharmacist Obesity Education (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.
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida
IACP Welcomes New Corporate Partner
The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 3,600 pharmacists, technicians, students, and members of the compounding community. We encourage all IACP members to support these corporate partners that are instrumental in our joint effort to protect and grow this vital part of quality health care. Thank you for your continued support of pharmacy compounding!
IACP Regional Education Meeting in Salt Lake City, Utah; 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.
Salt Lake City, Utah – September 26, 2013
Only 6 Days Left to Register!
6:30 - 7:30 p.m. Check-in period with pizza & refreshments provided by UPhA
7:30 - 9:30 p.m. Educational Session
9:30 - 10:00 p.m. Q&A with David Miller and Department of Professional Licensing’s Compounding Task Force: Kavish Choudary, Christopher Cox, Kort Delost, Missy Duke, Trip Hoffman, Christine Jacobsen, Dean Jolley, Adam Jones, Wayne Jones, Dallas Moore, Jim Ruble, Evan Vickers, Angela Whitney, and Victoria Zippi
Roseman University of Health Sciences, P2 Classroom, 1st Floor
10920 S. River Front Parkway, South Jordan, UT 84095
Click here to view the event flyer for more details!
Thank you to the Utah Pharmacists Association (UPhA) for sponsoring the pizza & refreshments for this meeting.
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.
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.
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