In This Issue
1. IACP Releases Summary on FDA's Four Guidance Documents and MOU
2. IACP Conveys Compounders' Concerns to The Wall Street Journal
3. IACP's Town Hall Recording Now Available
4.Update for Pharmacists Prescribing Part D Drugs
5. New State Legislation Tracker on Pharmacy Provider Status
6. Jennifer Petska Joins the IACP & IACP Foundation Staff!
7. USP Announces Revised <800> Chapter Available for Viewing
8. Corporate Partner Spotlight: CherylLeeMD® Sensitive Skin Care
9. #EduCon2015 Kicks Off 2.25.15!!!
10. CCH Registration is Open!
|Capitol Connections is a biweekly newsletter for IACP Members Only.
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IACP Releases Summary on FDA's Four Guidance Documents and MOU
On Friday, February 13, 2015, the Food and Drug Administration released four guidance documents that further explain the regulatory framework the agency intends to use in enforcing the Drug Quality and Security Act. These guidance documents, along with the draft Memorandum of Understanding between the FDA and state agencies for the oversight of interstate distribution of compounded preparations, are draft documents. The pharmacy profession as well as other stakeholders has 90 days to review and submit comments and questions.
IACP has prepared this summary for you that contains information on the four guidance documents, and the draft MOU.
While IACP will be preparing and filing formal comments on behalf of the members of the Academy, we strongly encourage you to read the draft guidance documents and consider how their contents may affect your patients and practice. You can share your concerns and comments via e-mail with IACP or you can submit those directly to the FDA by following the instructions on the first page of each guidance document.
Watch for additional information through IACP’s Capitol Connections newsletter, our email and FAX Member Alerts, our social media postings via Twitter and FaceBook. Be sure to continue visiting the Breaking News section of our website.
IACP Summary on FDA Four Draft Guidance Documents and MOU
Please click here to view.
IACP Conveys Compounders' Concerns to The Wall Street Journal
IACP weighed in on FDA's draft guidance documents and MOU in in a February 20th Wall Street Journal Pharmalot article, "Compound Pharmacies Complain FDA is Compounding Their Problems."
“There are some compounding pharmacies that are highly specialized in what they do, and they get patient referrals from all over the U.S.,” says a spokesman for the International Academy of Compounding Pharmacists, a trade group. “Why should they be limited at all if they are filling one prescription at a time in accordance with the regulations?”
Please click here to read the entire WSJ article.
IACP Summary on FDA Four Draft Guidance Documents and MOU
Please click here to view.
IACP's Town Hall Recording Now Available
At last week's Town Hall, IACP Leadership reviewed FDA’s Four Guidance Documents and MOU draft released on Feb. 13th, answering member questions, and detailing next steps.
Recording Available: The Town Hall Recording has been uploaded to the Members-only Site. Please click on the Member Resources icon, then select, Town Hall Teleconference Recording to access all Town Hall Recordings. Click here to access this Town Hall Recording - you will need to be logged in to view.
Update for Pharmacists Prescribing Part D Drugs
The Centers for Medicare & Medicaid Services (CMS) just released the following announcement regarding the Part D Prescriber Issue.
CMS values the role that pharmacists play in our health care system today. CMS is aware that in many states, pharmacists are allowed to write or modify prescriptions in certain circumstances. A CMS final rule published May 23, 2014, included a requirement that Medicare Part D plan sponsors and their Pharmacy Benefit Managers (PBMs) deny coverage for prescriptions written by prescribers who:
- Are not enrolled in Medicare in an approved status or
- Do not have a valid opt-out affidavit on file
However, the Medicare statute does not include pharmacists among the types of eligible professionals who can enroll in Medicare or opt out. CMS is considering various approaches for addressing pharmacists’ concerns with this enrollment requirement. Consistent with the Medicare statute and CMS requirements, pharmacists should not attempt to enroll in or opt out of Medicare. CMS will continue to update the pharmacist community on this issue.
New State Legislation Tracker on Pharmacy Provider Status
IACP Members: Check out the brand-new feature on our Compounders Stateside page. We've added a new State Legislation Tracker on Pharmacy Provider Status. Click here to view!
Jennifer Petska Joins the IACP & IACP Foundation Staff!
We're very pleased to announce that Jennifer L. Petska, CPhT, has joined IACP as the Director of Development & Membership, and also will manage IACP Foundation's Administration & Development roles.
Jennifer is responsible for IACP membership with goals to increase all levels of membership while maintaining retention with existing members. She coordinates with other IACP Events & Education and Communications & Publications staff to promote the visibility of IACP and the IACP Foundation.
Jennifer will interface with and provides support services to the IACP Foundation Board of Directors. In her new role, she will work with the Research Program Committee to coordinate and facilitate research initiatives and monitors grants. Jennifer also will work closely with the Education Committee on student programs including student essays and IACP Foundation Care Internships while being the liaison with the American Association of Colleges of Pharmacy. In addition, she is responsible for development and oversight of IACP Foundation fundraising, which includes events like the RxMixer, solicitations for fund development while identifying and cultivating short-term and long-term giving initiatives with key stakeholders.
As a Certified Pharmacy Technician, Jennifer understands that a commitment to quality and life-long learning is integral to the success of today’s compounders. She also has learned through her years of sales and service that networking and building relationships are key building blocks of growth. Welcome, Jennifer!
IACP Prepares Compounding Fact Sheet for Members
To help our members address questions from their patients, practitioners, media and others in their community, IACP has prepared a new Compounding Fact Sheet for your use.
It includes a compounding profession overview, message points in response to the NECC tragedy, current oversight info, and IACP concerns regarding DQSA. Please click here to access.
USP Announces Revised Chapter of the Proposed <800> Available for Viewing
The United States Pharmacopeial Convention (USP) announces that the revised chapter of the proposed <800> is now posted on the USP website. Please click here to review.
The chapter will still be proposed in the Pharmacopeial Forum 41(2) in Mar/April 2015. The comment period for this chapter will end on May 31st, 2015.
What's New on the FDA Drugs Site
Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
The FDA Drug Shortage Report
Please click here for the most recent Drug Shortage information.
Please send your news to email@example.com!
Congratulations to IACP President-elect Gary McCrory, RPh, CCN, for his news coverage in the El Paso Inc. Click here to read.
IACP Corporate Partner MEDISCA is hosting its annual SPCC Nationals, March 21-22, 2015 in Gainesville, Fla.! Please click here to view their 2014-2015 SPCC Nationals Booklet, highlighting their prestigious selection of guest speakers and judges.
IACP Member Q&A
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.
If the current draft FDA MOU goes forward please clarify how it would work for a pharmacy. For example, I’m a pharmacy in California shipping to Tennessee - who's MOU do I abide by California’s or Tennessee’s or both? What happens when the pharmacy’s home state has an MOU but the receiving state does not and vice versa?
IACP says “If a State does NOT enter into an MOU, the amount of compounded medications distributed interstate shall not exceed 5% of the total prescription orders dispensed or distributed by the pharmacy.”
FDA draft says “ (state) Has not entered into an MOU with FDA and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded human drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician (section 503A(b)(3)(B)(ii)). “
You will be obligated to follow the MOU signed by California as a California-based pharmacy. The MOU applies to the physical location of the pharmacy.
If California doesn't sign an MOU, you are limited to 5% interstate distribution.
If California does sign an MOU and Tennessee (for example) doesn't, the California MOU applies.
If California doesn't sign an MOU and Tennessee does, you are limited to 5%.
In other words, just because you have a permit in another state, their MOU status doesn't apply to you.
Now, having said that... we don't KNOW yet whether some states will try to limit in-state shipment of compounds by out-of-state pharmacies. Arizona has legislation pending on that very issue.
Corporate Partner Spotlight: CherylLeeMD® Sensitive Skin Care
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Click Here to learn more about the all New TrueLipids Compounding bases and more Business for You.
#EduCon2015 Kicks Off 2.25.15!!!
Connect and network with fellow colleagues. #EduCon2015
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 25-28, 2015, at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. Click here for more!
IACP Members: Don't Miss the Only Political Action Committee for Compounders
Plan to Join the ONLY pharmacist in Congress, Representative Buddy Carter (R-GA), our guest speaker at IACP’s COMP PAC Breakfast Saturday, February 28, 2015 during the 2015 ACA, IACP, ACVP Educational Conference. Congressman Carter will be sharing his insight and thoughts on the importance of bringing a united message on issues of importance to compounders and pharmacists to the Hill.
Why is a political action committee and COMP PAC important?
COMP PAC uses its funds to support those legislators that have demonstrated a commitment to compounding pharmacy and have expressed interest in advancing our legislative goals.
Please click here to read more!
CCH Registration is Open!
The 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2015, 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. Click here to read more!
Save the Date for Rx Mixer!
Lots of blue eye shadow, acid washed jeans with popped-up shirt collars, fingerless lace gloves, giant hair bows, and layers of beaded necklaces are totally tubular once again for Rewind: Back to the 80s— the theme for IACP Foundation’s 11th Annual Rx Mixer, a fundraising event to be held in conjunction with IACP’s 21st Annual Compounders on Capitol Hill (CCH), Sunday, June 7, 2015!
Travel back to the place where you uttered slang phrases like “gag me with a spoon,” “like, totally,” “gnarly,” “grody,” “grody to the max,” “rad,” “awesome,” or any combination of these words excessively. If your hairdresser couldn’t stop laughing long enough to actually give you the Flock of Seagulls haircut you wanted. And, if you still know all the dance moves to “Thriller.” You know you belong to the 80s.
Click here for more!
The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession. At the Compound Conference, attendees have an unprecedented opportunity to meet face-to-face with compounding pharmacists, technicians, and marketing representatives in their home state.
Offering a variety of Continuing Education sessions focused on understanding the essentials in building a compounding practice, the 2015 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA) and the International Academy of Compounding Pharmacists (IACP). Don’t miss this unique conference bringing together two leading pharmacy associations, August 15, 2015 at the Hilton Columbus at Easton in Columbus, Ohio.
Click here for more.
Marketing Research for Compounding Pharmacies: How to Identify Opportunities, Optimize Prices, and Maximize Patient Satisfaction
Success in business (compounding pharmacies included) is dependent on understanding the target consumer, whether it is a patient or practitioner. The design and application of market research allows one to uncover the thoughts, reasons, behaviors and opinions of the parties you interact with, allowing the pharmacy to address those aspects more effectively.
Click here for more information, and to register!
Need CE ASAP? Check out the IACP AdvanCE On-Demand Library!
If you need CE credit, check out IACP's 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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