Wishing you a very peaceful and happy Hanukkah from IACP!
Almost five months ago, more than 3,000 concerned stakeholders submitted comments to the Food & Drug Administration (FDA) on the agency’s proposed Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration. That MOU, outlined within the Drug Quality & Security Act, is intended to define how the federal government and states will address the interstate distribution of compounded preparations. The proposed MOU, however, intertwined the definitions of “distribution” and “dispensing” in direct contradiction to Congressional intent.
“We have been told that a release of an amended MOU is imminent, that a document is in circulation already among Boards of Pharmacy, even that the MOU is already in effect. That’s not true… just rumors and speculation,” says David Miller, IACP Executive Vice President. “IACP continues to monitor the status of the MOU each day and until it is formally released and published in the Federal Register, as required by law, the MOU is still in a ‘watchful waiting’ mode.”
When and if an MOU is released, IACP will let all of its members know via a special Member Alert, our newsletter, and postings on our Breaking News section of the Academy’s website.
DQSA Coalition Meeting Scheduled
Next week, the coalition of stakeholders representing professional associations concerned about the FDA’s implementation of the Drug Quality & Security Act (DQSA) will hold its last meeting for 2015. Comprised of pharmacy and medical practitioner organizations, the coalition is working on the introduction of a House bill in early 2016 to clarify office-use, API product selection, the MOU, and other areas of concern identified by the FDA’s ongoing regulatory implementation of the legislation.
“One area we are focusing on collectively is educating state Boards of Pharmacy and Medicine about the unnecessary conflict which the FDA has created by ignoring state authority and existing laws and regulations which specifically address office-use compounding,” says David Pore of Arnold & Porter, the Washington DC firm with whom IACP contracts for lobbying support. “Although Congress specifically stated when DQSA was enacted that nothing in the legislation was intended to in any way interfere with the states’ abilities to regulate compounding pharmacy practice, the FDA is blatantly ignoring those instructions. The result is confusion about what a state can and cannot do.”
The Coalition continues to seek co-sponsorship and support on the Senate side for S. 1406, Saving Access to Compounded Medications for Special Needs Patients Act, introduced by Senator David Vitter (R-LA). This week will also be an important one as appropriations bills move forward within Congress to establish the spending budget for the coming fiscal year. The report language for the appropriations bills contain specific directives to FDA on its incorrect approach to enforcing office-use compounding as well as placing certain limits on the pending Memorandum of Understanding.
S. 1406 And Election Impact
Compounding champion and author of S. 1406, Senator David Vitter (R-LA) lost his bid to become the governor of Louisiana during a heavily contested run-off election held on November 21. Democratic state Representative John Bel Edwards defeated Vitter by a 56 to 44 margin despite polls last summer showing Vitter with a strong lead. While conceding defeat, Vitter also announced that he would not be running for an additional six-year term in the Senate when his current term expires at the end of 2016.
As the lead sponsor of Saving Access to Compounded Medications for Special Needs Patients Act, IACP and others will continue to support Senator Vitter’s efforts to legislatively address and correct conflicts between the Drug Quality & Security Act and the FDA’s regulatory implementation. “Even though Senator Vitter won’t be actively campaigning next year, his position as Senator for Louisiana means he remains an important voice in fighting for what’s right for compounding pharmacists and for their patients,” said IACP Legislative Committee Chair Erik Tosh, RPh.
“We’ll continue to work with his office to secure additional co-sponsors and champions and the calls and e-mails our members have sent to their Senators has kept our concerns front and center. That’s really appreciated and will be even more necessary as we move into the final year of the 114th Congress.”
NDAA Finally Passes
Just before Thanksgiving, a revised National Defense Authorization Act (NDAA) for 2016 was passed by Congress and signed by President Obama. Senate Bill 1356 replaced the original House version of the NDAA (H.R. 1735) vetoed by the President in late October because of the inclusion of an Overseas Contingency Operations (OCO) fund of nearly $38 billion; Obama and Democrats contended that the OCO skirted provisions within the Budget Control Act and would have allowed spending without proper oversight.
IACP had monitored the NDAA to watch for any attempt at reducing coverage for compounded medications to Tricare beneficiaries due to recent concerns about inappropriate marketing and billing that had captured national media attention.
No language affecting compounding was included in the final bill with the only mention of prescription drug coverage for military servicemen and their families focusing on maintaining current copayment levels.
IACP Board of Directors Election Ballot Coming Soon
Watch your inboxes later this week for the 2016 IACP Board of Directors Election Ballot!
The Board of Directors sets direction for the organization, serves as visionaries for the future of pharmacy compounding, and generates results. Board members contribute their time, energy and ideas to lead IACP forward and in turn, lead the compounding profession to greater success.
Thank you for taking the time to voting in the 2016 IACP Board of Directors Election. Your vote is important to IACP as we elect individuals to lead our association into the future.
IACP Wants You! Call for IACP 2016 Committee Volunteers
IACP invites members to volunteer to serve on a committee in 2016! Committee members provide an invaluable service to the Academy and its members by contributing to initiatives and projects that are essential to the continued advancement of pharmacy compounding.
By serving on a committee you are given the opportunity to network, contribute to your profession, assist IACP Board of Directors and staff and expand your leadership skills. Please note - you must be an IACP member in current standing to serve on an IACP Committee.
Click here to view IACP committees. Please email firstname.lastname@example.org for more information or to volunteer.
IACP Provides Educational Resources on How to Work with Third Parties
IACP has several self-paced, on-demand CE offerings on how to work with third parties. Check our our expanding library below:
CMS and Reimbursement for Medicaid/Medicare Prescription Drugs
Third Party – Part 1 Private
Don’t Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists
Contracting and Audit Considerations for Compounding Pharmacy
Medicare Part B: Documentation Requirements and 2013 Update
Hot Button Issues on the PBMs Radar Screen
Please contact IACP with questions at email@example.com.
Corporate Partner Spotlight: Analytical Research Laboratories
Analytical Research Laboratories (ARL) is a FDA registered and DEA licensed laboratory that has provided analytical and microbiological testing for compounding pharmacies and outsourcing facilities since 1998. Located at the University Research Park in Oklahoma City, ARL occupies approximately 20,000 square feet of laboratory and office space. Our dedicated team of scientists and experts with regulatory expertise continually deliver research and scientific solutions for the compounding industry.
Laboratory testing services most commonly provided for compounding pharmacies and outsourcing facilities include: sterility, method suitability, endotoxin, microbial identification, microbial limits, antimicrobial effectiveness, bioburden, media fill, potency determination, beyond use date studies, stability and compatibility studies, raw material/vendor qualification, drug diversion, and particulate matter.
cGMP and non-cGMP services are available depending on client request.
To request a quote for analytical and microbiology services, visit www.arlok.com or contact ARL at (800) 393-1595.
Thank You for Contributing to IACP's One Fund!
Help Us Reach $2 Million
Help IACP reach our fundraising goal of $2 million dollars by the end of 2016. This funding allows us to continue our efforts to Fix DQSA and to be ready for the next challenge on the horizon. Through your generosity and support we are shaping the future of compounding.
One Fund Contributors List
Please click here to view our One Fund Contributors to date!
IACP Members and Corporate Partners: Please join us in our efforts to Protect, Preserve and Advance Pharmacy Compounding by making a donation to IACP’s One Fund fundraising campaign.
Please click here to donate online, or click here to access a One Fund donation form.Please contact Jennifer Petska, BS, CPhT,IACP Director of Development & Membership, with questions about One Fund.
Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. In every issue of Capitol Connections, we'll highlight a question we've been asked that affects many of our members. If you have a question you'd like answered, please send to firstname.lastname@example.org.
Question: We had a strange call the other day. The woman said she worked with our wholesaler and needed to confirm our pharmacy's account number. Have others experienced this?
It has been reported that there may be a scammer targeting pharmacies. Here is what we have heard has been happening:
1. Phone call from someone claiming to work for a wholesaler and asks to verify the pharmacy’s wholesaler account number.
2. The scammer then uses the pharmacy’s account number to contact the wholesaler and order large quantities of diabetic supplies.
3. They call the pharmacy back, pretending again to be the wholesaler and says that the shipment of diabetic supplies was sent by mistake and that they will send a courier to pick up the order AND the invoices.
4. Someone shows up, posing as the wholesaler, and picks up the products.
Suggestions to protect your pharmacy:
• Remember that your real wholesaler knows your account number and other information – do not give this out over the phone.
• Make sure you have caller ID on your phone system so you can see who is calling you.
• If you receive one of these calls report it to the appropriate authorities
Corporate Partner News
Congrats to IACP Corporate Partner MEDISCA for receiving their ISO 9001:2008 Certification! More information by clicking here.
PCCA Institute's two-day compounding lab course introduces pharmacy students to unique dosage forms utilized by contemporary compounding pharmacists. Students will complete 11 compounds, focusing on dosage forms such as lollipops, lip balms, troches and transdermal delivery systems. Please click here for more information!
CCH Registration Now Open!
Click here to attend #CCH 2016!
The 22nd Annual Compounders on Capitol Hill (CCH) will be held June 11-14, 2016 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2016, Compounders on Capitol Hill 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.
•CCH returns to Downtown Washington, D.C.! Conveniently situated in the Penn Quarter district, this premier location is surrounded by shops, a variety of dining options, the Spy Museum, Chinatown, the National Portrait Gallery, the Smithsonian American Art Museum, and world-famous National Mall monuments.
•A bargain hotel group rate at $199 – that’s almost half the price from previous years!
•Hear from experts during in-depth Continuing Education sessions on legislative and regulatory issues at the state and federal level affecting pharmacy compounding.
•Expanded exhibit hall puts attendees face-to-face with 50 leading companies that serve compounding pharmacies.
•Stay for Hill Day! 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 – Rx Mixer on Sunday, June 12, 2016.
•On Monday, June 13, 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 a very high-profile influencer to talk face-to-face with our attendees about the future of health care.
Network! Reconnect with old friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!
June 11-14, 2016
Renaissance Washington, D.C.
999 Ninth Street NW
Washington, DC 20001
Exhibitor & Sponsorship Opportunities Available!
Click here to access the Online Commitment Form
Thank you to Our Exhibitors and Meeting Sponsors!
Accreditation Commission for Health Care (ACHC); AirClean Systems; American College of Apothecaries (ACA); Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc.; B&B Pharmaceuticals, Inc.; bioMerieux, Inc.; BiosRx, Inc.; Compounders International Analytical Laboratory (CIAL); DoseLogix; EXAKT Technologies, Inc.; Fagron, Inc.; Freedom Pharmaceuticals; Hardy Diagnostics; Health Engineering Systems; Humco Compounding; ICA Health; International Journal of Pharmaceutical Compounding; International Medical Industries, Inc. (IMI); Kunesa LLC; Letco Medical; LP3 Network; MEDISCA; PCCA; RxCoop, LLC; Storey Marketing; Topi-Pump; Torpac Capsules Inc.; Willow Birch Pharma.
We would like to thank the following meeting sponsors for their support of the Educational Conference: DoseLogix (Conference Pen/Notepad); Letco Medical (Hotel Room Keys, Welcome Reception, Education Session); MEDISCA (Name Badge Holder); PCCA (Meeting T-shirt, Meeting Tote Bags, Meeting Syllabus); Topi-Pump (Travel Mugs).
Save the Date: Rx Mixer Roundup Saddling Up for Research and Education!
The good guys in the white lab coats are riding to Rx Mixer Roundup - Saddling up for Research and Education! Join us as we gather for the IACP Foundation’s 12th Annual Rx Mixer, a fundraising event to be held at the Renaissance Washington DC on Sunday, June 12, 2016.
Event Co-Chairs, Erin Michael, MBA, CPhT and Richard Harwood, CPhT, with their Live Auction, Big Board and Reverse Card Draw Committees, plan to raise more than $205,000 through sponsorships and the auction to benefit the IACP Foundation! Since the first Rx Mixer was held in 2005, supporters of the pharmacy compounding profession generously have contributed more than $1.8 million to IACP's educational and research mission.
For more information about volunteering, donating an auction item, or becoming a sponsor, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development, or call the IACP office at 281/933-8400. To obtain a sponsorship or donation form, and to learn more about Rx Mixer please click here.
Your support and involvement is crucial in raising funds for the IACP Foundation. Click here to access the Rx Mixer Prospectus with corporate sponsorships, reserved seating, and donation opportunities.
To register online, please click here.
Yee-haw! It’s a Party with a Purpose! Now saddle up, Pardner. We’ll see you in June!
Advance Discount Deadline Ends Tuesday, December 15, 2015! Register Today!
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 24-27, 2016 at the Loews Coronado Bay Resort. Perched on its own 15-acre peninsula, Loews Coronado Bay is a private oasis of tranquility with views of the shimmering bay waters and the San Diego skyline.
What you can expect in 2016:
• Benefit from multiple education tracks; practice-based, compounding, and veterinary clinical and compounding.
• Earn up to 12.0 contact hours (1.2 CEUs) of continuing education credit including 3.0 contact hours (.3 CEUs) of LIVE Pharmacy Law.
• Early release on Friday, February 26 to enjoy dining out, snorkeling, water sports, and local shops.
• Local pharmacists, technicians, and marketers enjoy a special one-day Saturday rate. Network with your colleagues from across the country in your home state.
• In 2016, visit with exhibiting companies showcasing services that can improve your business.
By morning – experience a unique menu of CE programs merging the best of ACA, IACP and ACVP. Gain information and skills you can implement immediately to your pharmacy practice.
By afternoon – connect with your colleagues and enjoy an array of thrill-seeking water adventures, a luxurious Sea spa and dining overlooking shimmering bay waters and the San Diego skyline at the Loews Coronado Bay Resort in San Diego, California.
#EduCon2016 Social Activities:
Wednesday, February 24, 2016
Welcome Reception - Arrive in California ready to kick off the conference at the Welcome Reception. The education sessions begin on Thursday morning, so spend the Wednesday night relaxing and unwinding with your colleagues while enjoying cocktails and hor d’oeuvres, overlooking the San Diego Bay.
Thursday, February 25, 2016
Fellowship Luncheon - After a busy morning of education, come join your colleagues from all three organizations for lunch. You will be treated to a delicious meal and have a chance to welcome new Fellows as they are inducted, and you will be able to congratulate those members who have distinguished themselves for a variety of achievements in our profession. This is always a highlight of the conference. Please plan to attend!
Friday, February 26, 2016
IACP COMP PAC Reception - (IACP Members Only) (Ticketed Event-$250, includes 2 drink tickets)
Hors d’oeuvres and a selection of local wines will be served. All proceeds will go to our goal of making COMP PAC one of the largest political action committees in pharmacy. This exclusive event is limited to the first 50 people. You will be contacted for separate payment.
The ACA & ACVP Presidents’ Reception & Banquet (Ticketed Event - $195)
The highlight of the banquet is the celebration & installation of the ACA/ACVP Officers. You will be treated to a before dinner reception (includes 2 complimentary drink tickets) and a delicious dinner of Pan Roasted Salmon or Crusted Beef Tenderloin, Peppercorn Demi Horseradish-Potato Gratin, Chef’s Selection of Seasonal Vegetables & Hearts of Romaine with Parmesan Cheese. Plan to attend! This is a black tie optional affair.
Celebration Dessert Reception
Join ACA, IACP, and ACVP for this joint celebration bringing three leading pharmacy organizations together. After dinner, return to this casual reception for fellowship, an array of delicious desserts and cocktails. This evening dessert reception is open to all registered attendees.
Please click here for more information, to register and to make your hotel reservations!
Developing a Sustainable Cleaning, Sanitization and Disinfection Program - Don't Get Left Behind on the New FDA Guidelines
Chief Regulatory Affairs Officer & General Counsel
Regulatory Compliance Associates, Inc.
Tuesday, December 8, 2015
1:00 - 2:00 p.m. CST (2:00 ET/11:00 PT/12:00 MT)
Effective cleaning and sanitization programs are essential to ensure quality for drug compounders. In July of last year, the FDA issued new Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This guidance addresses cleaning, sanitization, disinfection and sterility for 503Bs. Because the guideline is still in the public comment phase of the regulatory process, now is the time to understand the requirements and ensure compliance for your facility.
At the conclusion of this program, the attendee will be able to:
• List the areas of the facility that need to be cleaned, sanitized, disinfected or sterilized.
• Develop compliant procedures for cleanroom cleaning and disinfecting as well as defined cleaning schedules.
• List the options for disinfecting agents and methods of application.
• Discuss the requirements for validation, documentation, and environmental monitoring.
• Explain how tips and case studies help outsourcing facilities demonstrate sustainable compliance.
Need Additional CE Credit?
If you need CE credit, check out IACP AdvanCE's on-demand library, which houses more than 100 programs on various pharmacy topics. Please click here to access the self-paced programs.
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