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Capitol Connections Archive [August 26, 2013] [08.26.13]
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In this Issue

Member Alert: Letter Trifecta

Another FDA Salvo Against Compounding?

WSOCTV Ch 9 Interviews IACP Member Doug Yoch on How S. 959 Could Harm Patients

IACP Serves on International Committee

Corporate Partner Spotlight: Freedom Pharmaceuticals

Educational Conference Social Media Sites Launched!

Events & Education

Did You Miss the Latest IACP AdvanCE Live Webinar on Patient Safety Organizations? 

Tara Modisett, Executive Director, Alliance for Patient Medication Safety and Peggy Binzer, JD, Attorney, Polsinelli PC presented, Working with a Patient Safety Organization: Improve Quality and Reduce Legal Risk, on Thursday, August 22 at 1:00 pm CT (11:00 PT / 12:00 MT / 2:00 ET). In this one-hour webinar you will learn how to align your business strategies with the PSQIA’s objectives of improving quality, enhancing liability protections and reducing dispensing errors.

If you were unable to attend this live webinar or any previous live webinars, these webinars are converted to the self-paced library 24-48 hours after are recorded. Please click here to view IACP AdvanCE’s self-paced online webinars that are available today.
 

 

This program is made possible through an unrestricted educational grant-in-aid from Fagron.  

Were You Unable to Attend Compounders on Capitol Hill (CCH) 2013?

For the first time, a select few Continuing Education programs from IACP’s 2013 Compounders on Capitol Hill are now available in the IACP AdvanCE self-paced library. If you or members of your staff were unable to join us on-site, don’t feel left out! The IACP AdvanCE self-paced library makes obtaining unique CE convenient for pharmacists and technicians with busy schedules. Take this time to review these sessions and more in the IACP AdvanCE self-paced library, which continues to bring you up-to-date information on legislative, regulatory and practice topics in pharmacy compounding that can affect you and your practice. Click here to view the legislative and marketing CE courses from the conference that are available for immediate access.

Save the Date!

The next IACP AdvanCE live webinar, Regulatory Guidelines, Standards of Practice and Quality First Initiatives, is scheduled for November 13, 2013 from 1:00 – 2:00 pm CT (11:00 PT / 12:00 MT / 2:00 ET).

IACP AdvanCE Webinar Sponsorship

The IACP AdvanCE Webinar Sponsorship is a unique opportunity for your company as you will not only have exposure to live webinar attendees, but you also will receive future exposure and continued visibility when the live webinar is housed in the self-paced online webinar library. This is a great opportunity to support IACP and demonstrate to its members your commitment to their professional development. Sponsors may choose the webinar topic they’d like to sponsor when multiple live webinars are available. For a detailed listing of the benefits of the IACP AdvanCE Webinar Sponsorship, please click here.

If you would like to discuss the IACP AdvanCE Webinar Sponsorship in greater detail or for a listing of available webinar sponsorships, please email Michelle Atkinson
or call 281.933.8400.

To receive CE credit, you must submit your NABP e-Profile ID and birth date!

Pharmacists and pharmacy technicians are now required to submit their NABP e-Profile ID to receive credit for any ACPE-accredited CPE session. The new electronic system, CPE Monitor, will now track completed CPE credits online for pharmacists and pharmacy technicians. Please click here to register for your NABP e-Profile ID. You will be asked for your NABP e-Profile ID and date of birth during the registration process to receive CE credit.

It is the responsibility of the CPE attendee to provide their correct NABP e-Profile ID and birth date. If incorrect information is provided, the record will be rejected by CPE Monitor and the CPE credit will not be awarded.

Beginning January 1, 2013, a certificate of attendance is not sufficient to record your CE credit. All credits will be filed electronically on your behalf with NABP’s CPE Monitor.

If you requested Continuing Education credit during registration or at the completion of a program, your CPE credits will be uploaded to the CPE Monitor System within 60 days of completion. If you do not see CPE activity displayed for a session that you attended and it has been more than 60 days since you submitted the CPE to the provider, please contact your CPE provider. If you have any questions regarding IACP continuing education programs, please email
Michelle Atkinson or call the IACP office at (281) 933-8400.   

USP on Compounding Available from IACP!

IACP is proudly partnering with the United States Pharmacopeial Convention (USP) on their USP on Compounding : A Guide for the Compounding Practitioner, which includes all the compounding-related general chapters from the United States Pharmacopeia–National Formulary (USP–NF). Click here for more information.

 

August 26, 2013

Member Alert: Letter Trifecta

IACP is aware of the three letters currently circulating to our members - the Aptalis Pharma letter regarding RECTIV, the Arnall Golden Gregory letter regarding Mitosol, and the Express Scripts letter stating that compounded drugs using bulk chemicals will no longer be covered.

Click here for a copy of the Aptalis letter.

Click here for a copy of the Arnall Golden Gregory LLP (Mitosol) letter.

Click here for the Express Scripts letter. 

IACP will be sending all members an email and fax on how to handle these specific letters. In the meantime, please visit IACP's AdvanCE self-paced webinars on our website. Click here to access IACP's webinar, Sound & Fury: Responding to Manufacturers’ Cease & Desist Letters.

This webinar will answer your questions, “What should I do? Ignore it? Send it to my attorney? Comply with their request? Why did I get this in the first place? Who are these people anyway?” This program will help you understand what a “cease-and-desist” letter is, where it comes from, what it means, and what to do about it. Stay tuned for more information to come.

Another FDA Salvo Against Compounding?

Last week, the Food and Drug Administration issued a national statement  advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., located in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating.  According to the agency, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results.

Additionally, the FDA recommended that pharmacies not use this firm for sterility and other quality attributes at this time. Since that announcement, the agency has contacted many compounding pharmacies specifically requesting a recall of sterile medications tested by Front Range. Several IACP members have conducted additional in-house testing on their lots -- all showing and confirming that the Front Range results were aligned with their own.  

In a statement to its clients, Front Range Laboratories stated: "We are not in the business of manufacturing and do not conduct business with entities that manufacture finished drug products. We are not aware of a single client registered with the FDA as a drug manufacturer. Yet, during this recent inspection, our operations were inspected against the FDA's Current Good Manufacturing Practice (or cGMP) regulations which, by definition, do not legally apply to compounding pharmacies unless they are acting as manufacturers."

Front Range adds that:  "For over 10 years of operation, Front Range Laboratories has relied on state law (boards of pharmacy) and United States Pharmacopeia (USP) guidance when performing all of our testing. Specifically, the methods we use to assess sterility and other quality attribute testing are put forth by USP. Patient safety is an ongoing and primary concern within our industry, and Front Range Laboratories has always been extremely diligent in adhering to applicable guidelines as put forth by the organizations that govern the compounding pharmacy community. Our exceptional safety record is proof positive of our actions."

Once again, the FDA is applying a different rulebook to inspections, this time to laboratories that specifically service compounding pharmacies. Rather than inspecting pharmacies to USP standards, as required by many state laws and pharmacy practice acts, the FDA has issued inspection reports citing pharmacies' violations of cGMPs. Now the laboratories are being held accountable to cGMP standards. Front Range is not the first testing lab to have been inspected in the past few months.  And shortly, final regulations will be put in place to further enable the agency to halt the importation of APIs including those which are not components of FDA approved drugs.

To date, there has been no evidence whatsoever that a compounded preparation tested by Front Range failed to meet USP standards nor have any medications been deemed sterile that have in actuality found to be non-sterile. IACP members should continue to use the laboratory of their choice and raise any concerns about previous or ongoing inspections of those labs with the operators. 

Click here for the FDA alert.

IACP Members: If you have questions or concerns, please contact us at iacpinfo@iacprx.org, or call 281/933-8400.

WSOCTV Ch 9 Interviews IACP Member Doug Yoch on How S. 959 Could Harm Patients

Thank you to IACP Member Doug Yoch, PharmD, Stanley Apothecary in Charlotte, N.C., for educating his local media, WSOCTV Channel 9, on how S. 959 in its current form could negatively impact his patients, as well as the local economy.

Click here to view the WSOCTV print and broadcast story.

IACP Members: If you need assistance in telling your story to your local media, please contact IACP for help with message points and media training!

IACP Serves on International Committee

IACP’s Director of Membership, Lindsey Turnau, has been selected to serve on the American Society of Association Executive’s International Committee (ASAE). ASAE is the largest organization of staff that work for non-profit associations, like IACP. Because Lindsey is based internationally, this was a perfect match between what IACP has accomplished to date and our long term goal of growing the Academy globally.

Many of the issues that compounders face are the same, regardless of location. IACP hopes to find models and processes that will help our members here in the USA; but, also provide transfer of that knowledge back and forth across the globe. The ultimate goal is to have an enhanced information exchange between compounders internationally.

Lindsey says, “At my first meeting I realized that we are ahead of the curve as we have been committed to international pharmacy for many years. What many organizations are struggling with is how to have a greater global presence, while still keeping to their mission. On this committee, I’ll be able to share our strategy and also learn the most successful tactics already in place.” The two year term comes at a perfect time, as IACP is exploring more international opportunities and securing a more permanent place on the global scale. For more information, or to speak directly with IACP regarding our international outreaches, please contact Lindsey at Lindsey@iacprx.org.

Corporate Partner Spotlight: Freedom Pharmaceuticals

Great things come with Freedom!

Freedom Pharmaceuticals, Inc. specializes in the custom wholesale distribution of premium compounding chemicals – active pharmaceutical ingredients (APIs), excipients and pre-made bases – to independent compounding pharmacies throughout the United States. We are continually expanding our product offering based on our customer’s needs. Our team of experts has over 100 years of combined experience.

At Freedom, our goals are simple: supply your compounding pharmacy with the highest quality fine chemicals available and give your staff the personalized customer service necessary to operate successfully in this rapidly changing industry. Built on the belief that customer service and quality chemicals are paramount, Freedom Pharmaceuticals strives to meet the ever changing demand of independent compounding pharmacies and their patients. Our commitment to quality and exceptional
customer service is evident in all we do. At Freedom, we have our finger on the pulse of compounding and we help our customers remain on the forefront of this rapidly changing industry.

Upon becoming a Freedom customer, you will immediately experience the Freedom 5 Star Advantage:

  • Insurance/Third-Party Support, Guidance & Consulting
  • A True Custom Supplier
  • NO MEMBERSHIP FEES or Contractual Obligations
  • Competitive Pricing
  • First-Class Customer Service 

The Contributor List is Growing! 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.

New Staff Member Joins IACP

IACP is happy to announce Lauren Palliser as the Events & Education Assistant. Lauren is a recent graduate from the University of Louisiana at Lafayette with a Bachelor of Arts in Communication. During her senior year, Lauren held a Public Relations Internship at the Louisiana IceGators, a professional hockey league. While working for the IceGators, Lauren organized and carried out promotional events, wrote radio spots, worked with local media, and assisted in onsite event logistics. In her new role at IACP, Lauren assists with the coordination of both Compounders on Capitol Hill and the Educational Conference as well as the IACP Corporate Partner program. Please join us in welcoming Lauren to the IACP team!

Educational Conference Social Media Sites Launched! 

 

 

The ACA, IACP, ACVP Educational Conference is pleased to announce the launch of the Educational Conference 2014 social media sites, including Facebook, Twitter and Instagram. These social media sites are a great way for attendees to stay up-to-date on the latest information regarding meeting activities, view speaker videos, as well as connect and network with fellow colleagues. Stay tuned for exciting new updates including future announcements and contests. Remember to use #EduCon2014 when tagging posts or pictures! 

Advance discount deadline ends on or before December 3, 2013.  For the latest conference news, visit www.EducationalConference.org.

Educational Conference
February 5-8, 2014
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida 

The Educational Conference Goes to Fort Lauderdale, Florida, February 5-8, 2014

Registration Is Now Open!

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.

What you can expect in 2014:

  • Benefit from multiple education tracks; practice-based, compounding, and veterinary clinical and compounding.  
  • Learn the fundamental steps to successfully work with your local media.
  • Develop a Social Media campaign about your pharmacy and its role in the community.  
  • Leverage the latest tools and resources to implement a quality improvement plan in your pharmacy.
  • Hear what your peers are doing in the This Works for Me! sessions.
  • Tips for hiring and retaining good employees for a successful pharmacy.  
  • What’s New in Veterinary Pharmacy, and much more!
  • Visit with companies showcasing services that can improve your business.

Click here to read more! 

IACP Regional Education Meetings in Salt Lake City, Utah and Tulsa, Okla!

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
6:30 - 7:30 p.m.     Check-in period with pizza & refreshments
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!


 
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 will correspond with Freedom’s November CPCSI training and the Freedom Pharmaceuticals 2nd Annual Seminar. More information 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 Calendar

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. 

  

 Stay connected to IACP by joining our online communities!

                       

 

In this Section

IACP Members Receive Complimentary Specialty Pharmacy Times Subscription

IACP Fax Facts Keeps you Informed

Share your Knowledge - Become a Preceptor!

There is Still Time - Join the Be One Get One Membership Campaign 

Last Call for Nominations Approaching! 2014 IACP Board of Director Elections 

PCAB Update

IACP & Compounding in the News - A Report of the Year's Stories

IACP Members Receive Complimentary Specialty Pharmacy Times Subscription

IACP is proud to announce an affiliation with Specialty Pharmacy Times! Beginning this month, all IACP members began receiving a complimentary subscription to this innovative magazine along with a special IACP letter in the August 2013 issue, welcoming you to Specialty Pharmacy Times.

IACP is committed to bringing you the latest innovations and news from the world of specialty pharmacy practice. IACP is pleased to bring you this free subscription as part of a dynamic, education-based partnership between IACP and Specialty Pharmacy Times.

IACP will be working collaboratively with Specialty Pharmacy Times to share news, articles and insights from the pharmacy compounding profession. We invite our IACP members to send in news from your corner of the compounding world. Please email your patient stories and updates to iacpinfo@iacprx.org.

IACP Fax Facts Keeps you Informed!

IACP Fax Facts is a weekly fax to help keep you up-to-date on the quickly evolving legislative, state board and regulatory environment. Look for this fax every week, as IACP provides you with the latest news and information important to pharmacy compounding and your practice. Previous Fax Facts issues can be found in the IACP Members Only Site - Communications Tab.

Fax Facts is a hit!
We've heard from many members that they enjoy the short, pointed and timely messaging in IACP's Fax Facts! If you are not receiving IACP's fax, please email
iacpinfo@iacprx.org with your current fax number. Please also contact us with any questions on this information!

Share your Knowledge - Become a Preceptor!

Looking to help develop a young mind and expand the learning experience outside of the classroom? Become a preceptor today!

IACP has 1,500 student members who would love an opportunity to roll up their sleeves and learn from the best. Please sign up today at iacpinfo@iacprx.org.

IACP Student Members! Be sure to keep your eyes open for some upcoming scholarship opportunities coming your way! More details to follow.

There is Still Time! Join the Be One Get One Membership Campaign

We know how important a collective voice of compounding is and that NOW is the time to grow that voice. You can help by participating in the IACP Be One Get One Campaign. When it comes to spreading the word about the value of membership, no one does it better than YOU, a current member.

The campaign aims to grow IACP’s membership by recruiting from within our own members’ pharmacies. Ever thought of gifting your staff with a membership? Or encouraging them to join the only association that represents pharmacy compounders in the legislative & regulatory affairs arena? NOW is the time to do it!

This summer IACP is offering a discount for new memberships. Register at least one new staff pharmacist and one new technician and get BOTH first year membership fees for a discounted $300 with our 1+1=300 summer special! Click here for more information.

Click here for more information or to participate in IACP’s Be One Get One Campaign.

Last Call for Nominations Approaching!  2014 IACP Board of Directors Elections

IACP’s nominating process for the 2014 Board of Directors election cycle will close on September 6, 2013.

The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the membership.

Interested candidates may be nominated or may be self-nominated to the IACP Nominating Committee chaired by IACP Immediate Past President Scott Karolchyk, MS, RPh, FIACP. The IACP Board of Directors receives the Nominating Committee report at its October Board Meeting, approves the slate of candidates, and then all qualified IACP members are able to participate in the election process held each November.

This year, there are seven Board of Directors’ seats for which candidates are sought as well nominees for the position of IACP Vice President. Click here for more information.

PCAB Update

Congratulations to the following IACP Members who have achieved Pharmacy Compounding Accreditation Board (PCAB) Accreditation!  

Cherokee Custom Script, Canton, Ga., Dale Coker, RPh, (Re-accreditation for Sterile & Non-Sterile Compounding)

Dripping Springs Pharmacy, Dripping Springs, Texas, Kathryn Van Besien, PharmD (Initial Accrediation for Sterile & Non-Sterile Compounding)

Lamar Plaza Drug Store, Austin, Texas, Kathryn Van Besien, PharmD, (Initial Accreditation for Non-Sterile Compounding)

McCrory's Pharmacy, Inc., El Paso, Texas, Gary McCrory, RPh (Initial Accreditation for Sterile & Non-Sterile Compounding)

Wellness Pharmacy, Birmingham, Ala., Mary Ann Davis, RPh (Re-accreditation for Sterile & Non-Sterile Compounding)

For more information about PCAB, please visit www.pcab.org.

PCAB News Update - PCAB Technician Certification Requirement Change - Click here.

IACP & Compounding in the News - A Report of the Year's Stories

For more than a year, IACP has been working to help educate the media and rebuild the reputation of pharmacy compounding in the wake of the NECC tragedy. The results include nearly 400 articles in which IACP was either interviewed, quoted or mentioned. IACP is continuing to work with the media on a weekly basis.

Please email with any questions or if you need media assistance - iacpinfo@iacprx.org.

Click here for the media report with story links.


 

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