In This Issue
1. Fix DQSA Update
2. IACP Presents Member Dilemmas at FDLI Conference
3. OIG Top 10 Recommendations for HHS to Handle
4. Wall Street Journal Pharmalot Blog Examines Compounding Pharmacy Suit Against Express Scripts - Quotes IACP
5. USP Announces Revised <800> Chapter Available for Viewing
6. FDA Update
7. Fallout Continues for Massachusetts Boards
8. Boston Globe: $135 Million Deal Proposed in New England Compounding Pharmacy Bankruptcy Case
9. IACP's Winter 2014 CustomRx Connection Magazine Now Available!
10. Corporate Partner Spotlight: Shockwatch
Capitol Connections is a biweekly newsletter for IACP Members Only.
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Fixing the Drug Quality & Security Act
by IACP's Executive Vice President/CEO David G. Miller, RPh
When Congress enacted the Food and Drug Administration Modernization Act (FDAMA) in 1997, it created the first formal federal authority over the compounding of medications in the United States by adding section 503A to the Food, Drug and Cosmetic Act (FDCA). While that law remained on the books, court challenges to various section of the law essentially rendered 503A unenforceable in many states.
Then came the New England Compounding Center crisis in October 2012. For the next year, legislative debate, regulatory agency finger pointing and blame shifting, and continual cries from the media, to “do something” to prevent another such tragedy all culminated with the passage of the Drug Quality and Security Act of 2013 (DQSA). DQSA reaffirmed the original section 503A with only minor modifications, created a new section called 503B that established sterile drug outsourcing facilities, and formally codified the track-and-trace system to preserve the integrity of the United States drug supply system.
Please click here to read the entire article, appearing in the current issue of IACP's Compounding Matters Quarterly!
IACP Submits Comments to FDA on Electronic Drug Product Reporting
On Friday, the International Academy of Compounding Pharmacists (IACP) submitted comments on the Food & Drug Administration's (FDA) withdrawal of a proposed rule and publication of a proposed revised guidance entitled Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities as part of the agency’s implementation of the §503B of the Food, Drug and Cosmetic Act.
Please click here to view IACP's comments.
The FDA Pharmacy Compounding Advisory Committee Announces February Meetings
The notice for the Pharmacy Compounding Advisory Committee has been announced. It will occur on February, 23, 2015 from 8:30 am to 5 pm, with another occurring on February 24th from 8:15 to 3 pm. This meeting will be open to the public.
Click here to view the procedure for submitting public comments or testimony.
FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies
The U.S. Food and Drug Administration (FDA) has announced it will soon hold the first meeting of a new and influential advisory committee that is set to make recommendations about which drugs will not be allowed to be made by compounding pharmacies in the U.S.
The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC), was re-created under a piece of 2013 legislation known as the Drug Quality and Security Act (DQSA). The law, passed in the wake of a major drug safety scandal that left more than 60 people dead, sought to update the way in which FDA oversees and regulates pharmaceutical products made by compounding pharmacies.
Please click here to read more.
DEA Releases National Drug Threat Assessment Summary
The Drug Enforcement Administration (DEA) released the 2014 National Drug Threat Assessment Summary, an assessment of illicit and prescription drugs providing an update on national level drug issues facing the United States.
The report provides information on prescription drug monitoring programs and state legislation aimed at combatting pill mills. The DEA report also notes that heroin use and availability is increasing in the U.S., driven by users switching from prescription drugs to heroin. Marijuana remains the most commonly used drug, yet prescription drugs are still responsible for the most deaths. Pain management clinics are contributing to the availability of illicit pharmaceuticals in the U.S., and states are addressing this problem by establishing new legislation aimed at curbing the clinics and creating prescription drug monitoring programs.
Save Rx Access/IACP to the Defense Health Agency: Cover Compounded Medications Without Restriction
Patients and Physicians for Rx Access and the International Academy of Compounding Pharmacists (IACP), urged the Defense Health Agency last week to cover compounded medications without restriction under the TRICARE Health Plan, which provides healthcare benefits to more than 9.5 million uniformed service members, and their families.
In late 2014, the Department of Defense Pharmacy and Therapeutics (P&T) Committee recommended significant restrictions on ingredients commonly used in compounded formulations and a strict manual prior authorization process for prescribers and patients. In a win for patients and patient advocates, TRICARE's Beneficiary Advisory Panel (BAP) rejected the P&T Committee's unnecessarily restrictive and burdensome recommendations. Now faced with divergent committee recommendations, the final determination on the fate of compounded medication coverage for military heroes and families rests in the hands of the Director, TRICARE Management Activity.
Please click here to read more.
Please click here to read IACP's Position Statement: Coverage of Compounded Preparations Under Federally Funded Health Benefit Programs
Recording Available: IACP Member Town Hall
Did you miss IACP’s First Town Hall of the New Year, featuring
Special Guest – U.S. Pharmacopeial Convention (USP’s) Patricia C. Kienle, RPh, MPA, FASHP, Chair of USP’s Compounding with Hazardous Drugs Expert Panel: Update on the Proposed USP <800> Hazardous Drugs – Handling in Healthcare Settings?
Don't worry, we recorded it for you.
Go to the Members-only site, click on Member Resources, and then Town Hall Recording, January 14, 2015. Please email firstname.lastname@example.org with any questions.
IACP Launches Publications!
IACP is proud to announce the launch of its two new publications, Compounding Matters Quarterly and Pharmacy Marketing Quarterly!
Our inaugural issue of Compounding Matters Quarterly features a cover story on the Drug Quality and Security Act by IACP’s own Executive Vice President/CEO David G. Miller, RPh. Flip through the pages to see what our members, Andy Ruiz, PharmD, MSc, FACA, and Kate James, RPh, FIACP, are up to. Make the most of your upcoming Educational Conference experience with New York Times best selling author, Dave Kerpen’s article, 7 Simple Ways You Can Get More Out of Conferences.
In Pharmacy Marketing Quarterly you’ll find valuable information on how to win back lost customers from IACP Member Amanda Addington and metrics for your sales by IACP Member Whitney Larkin Gale. Be sure to read the transcribed interview with Jim Martin, RPh, about the American College of Apothecaries by Pharmacy Podcast founder Todd Eury. Plus much more!
Both magazines are available online and print copies will be mailed by weeks end. Please click here to view the magazines.
For feedback, comments or suggestions, please email Scot Maitland at Scot@IACPRx.org or Dagmar Anderson at Dagmar@IACPRx.com.
IACP Welcomes Two New Corporate Partners: Healthcare Solutions & Analysis and Onnit
The IACP Corporate Partner Program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 members who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support IACP’s 68 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.
To learn more about Onnit Labs, please visit www.onnit.com.
USP Announces Revised <800> Chapter 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.
USP Partners with IACP to Provide Members with the USP Compounding Compendium
A new publication designed to provide easy access to quality related standards for compounded medicines is now available from the U.S. Pharmacopeial Convention (USP).
The USP Compounding Compendium offers compounding practitioners convenient access to all compounding-related general chapters from the United States Pharmacopeia–National Formulary (USP–NF), USP’s official compendia that are enforceable under Federal law in the United States.
“USP has a deep historic connection to the practice of pharmacy, stretching back to the very beginning of our origination nearly 200 years ago when practitioners regularly prepared medicines as-needed,” noted USP Chief Executive Officer Ronald T. Piervincenzi, PhD. “Our founders, most of whom practiced and taught medicine and/or pharmacy, promoted quality standards as a tool to advance their profession and improve public health, and USP’s commitment to those core ideals continues today.”
Please click here to view USP's press release.
IACP Members: USP has partnered with the International Academy of Compounding Pharmacists (IACP) to enable members to purchase the USP Compounding Compendium directly through the IACP's website. Click here to order!
FDA Drug Shortage Report
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.
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Congratulations to IACP Member Gigi Davidson, RPh, DICVP, Director of Clinical Pharmacy Services at North Carolina State’s College of Veterinary Medicine, who has been named the recipient of the U.S. Pharmacopeial Convention's (USP) 2015 Beal Award for Distinguished Volunteer Service—the organization’s highest award. Click here to read more!
IACP Member Charlene Vernak, RPh, pharmacist/owner of Vernak Farms Country Store in Skaneateles, N.Y., is highlighted along with her husband in a Skaneateles Journal story, "True Country Store: Vernak Farms Country Store Finds Right Niche in Spafford Community." Click here to read more.
Healthway Pharmacy Celebrates 30 Years! IACP Member Mike Collins, RPh, FIACP, Healthway Compounding Pharmacy in Saginaw, Mich., are celebrating their 30th Anniversary. Click here to read more.
Recently Elected U.S. Congressman Buddy Carter of Georgia is highlighed in a Congressional Quarterly profile. Click here to read more.
IACP Corporate Partner Fagron launches its Fagron Academy, providing compounding and clinical training. Click here for more.
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.
I received a notice from ESI today at one of our pharmacies, indicating that we cannot contact patients and providers regarding therapies that we as pharmacist deem necessary are we not? Can we do so?
Absolutely… a pharmacist can discuss potential therapies with a patient. That's not what ESI appears to be addressing here. It's more about reaching out to individuals who are not already patients of the pharmacy. We've had reports of robocalls, mailings, etc. about "ask us how we can help with your pain" from so-called compounding pharmacies… some have been sales and marketing companies, not the pharmacies… which is solicitation when the patient has no prior existing relationship with the pharmacy.
In other words… talking to your patients is okay. Advertising in general is okay. Marketing is okay. What is considered solicitation is a direct promotion to a consumer that isn't your current patient who also happens to be an ESI beneficiary.
This section of their contract is also what ESI has used against some of the chains when they have engaged in "transfer your prescription and get a $25 gift card" marketing.
Corporate Partner Spotlight:ICA Health, LLC
Results are the Most Important Ingredients in Our Products!
Formulated by Dr. James L. Wilson
ICA Health, LLC has a special interest in helping compounding pharmacists use the most effective dietary supplements to complement and enhance compounded therapies, and learn to take advantage of the valuable role they can play in building a profitable pharmacy. For example, approximately 70% of compounding scripts are BHRT related, and many compounding pharmacists have confirmed that at least 50% of women who need BHRT also have some level of adrenal fatigue. Because the adrenal glands are an important source of hormones during perimenopause and the primary source after menopause, our adrenal support products are a natural adjunct to BHRT.
Our doctor-designed adrenal support protocol augments BHRT’s effectiveness but does not compete with it, and helps minimize or eliminate many signs and symptoms not controlled by BHRT. Another group seeking help from compounding pharmacists that can greatly benefit from proper adrenal support are low thyroid patients unresponsive to thyroid hormone therapy. Dietary supplements do not require a prescription so you have greater control and the ability to provide a more comprehensive therapeutic protocol–resulting in increased customer satisfaction while improving your bottom line.
Click here to read more.
Advance Discount Deadline is December 15, 2014
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!
Advocate: Why You Should Attend #EduCon2015!
Take advantage of the Educational Conference 2015 Justification Letter and explain to your supervisor all the benefits you’ll receive from attending the ACA, IACP, ACVP Educational Conference!
The justification letter template includes how the conference will make you a better employee and what you and the pharmacy can expect to receive from attending. Click here to access the Educational Conference 2015 Justification Letter.
ACA, IACP, ACVP Educational Conference Graphic Toolkit Now Available!
This is an opportunity to let your patient and prescriber communities know that you will be attending the Educational Conference this year! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees, Corporate Partners and Exhibiting Companies are all encouraged to promote their support by using the Graphic Toolkit. The Educational Conference Graphic Toolkit includes a logo/web banner, Facebook Cover Image, “I’m Attending” e-mail signature as well as full page, ¼-page, and ½-page print ads.
Share that you’re attending! Click here to download the Graphic Toolkit.
The 2015 Educational Conference E- brochure is Now Available!
Review the complete meeting agenda; learn what's new in 2015; why pharmacy students should attend, and much more!
Click here to download the 2015 Educational Conference E-brochure, sponsored by ACA & IACP Corporate Partner Humco Compounding. The Flipbook technology for the E-brochure was generously provided by RXinsider.
IACP Members: Don't Miss the Only Political Action Committee for Compounders
Please plan to join IACP's Executive Vice President & CEO David G. Miller, RPh, and Vice President of Government Affairs Cynthia E. Blankenship, Esq., at IACP’s COMP PAC Reception Friday, February 27, 2015 during the 2015 ACA, IACP, ACVP Educational Conference.
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.
When the 114th Congress takes its oath of office on January 3, IACP will already have three major legislative priorities in the works that directly address YOUR needs.
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!
Managing Risk in Today’s Society: Examining Compliance, High Risk Issues and Liability – IACP’s December Webinar
This one-hour webinar explores how to identify and manage risks associated with compounding pharmacy practice. Attendees will learn how to navigate the risk management process with a four step approach. By discussing specific claims against pharmacists, attendees will be exposed to techniques allowing them to decrease these risks and learn how to handle problems their practice might face.
Click here for more information, and to register!
Check out the IACP AdvanCE Self-Paced Library 24/7!
If you were unable to attend our live webinars, they have been added to the IACP AdvanCE self-paced online program line-up so that you can review at your convenience 24/7. Please click here to access the self-paced programs.
The IACP AdvanCE self-paced library features previous live programs, the United States Pharmacopeia (USP) requirements, recorded sessions from Compounders on Capitol Hill 2012-2014, recorded sessions from the ACA, IACP, ACVP Educational Conference 2013, and a wide-range of sessions from the Texas Pharmacy Association, Ohio Pharmacists Association, Arizona Pharmacy Association, and the American College of Apothecaries online libraries.
Webinar topics include:
•Standards of Practice
•USP 797, 795, & 1163
•Cease and Desist Letters
•Stark Law and the False Claims Act
•Marketing and Sales
•Legislative & Drug Updates
•CMS and Reimbursement
•Media and Public Relations
•Patient Safety Organizations