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Capitol Connections December 4, 2014
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December 4, 2014

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.

Please email iacpinfo@iacprx.org with your editorial ideas and suggestions.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fix DQSA Update

 

The International Academy of Compounding Pharmacists (IACP) hosted another in a series of stakeholder meetings in Washington, D.C., on Tuesday, December 2nd, with several organizations and Congressional staff joining to discuss concerns stemming from FDA implementation of the Drug Quality & Security Act (DQSA).

Reports IACP Vice President Cynthia E. Blankenship, Esq., "Keeping the needs of pharmacy compounders in mind, we are working to: (1) maintain language protecting compounders within Congressional spending legislation; (2) get Congress/FDA to address drug access concerns through letters to Congress; and (3) Committee Hearings/Public Forums.

Please click here to read why IACP believes it's vitally important we FIX the Drug Quality & Security Act (DQSA)!

IACP will keep you informed of milestones as we are able. Please email iacpinfo@iacprx.org with questions.


IACP Presents Member Dilemmas at FDLI Conference

 

On Wednesday, December 3, 2014 IACP’s Executive Vice President David Miller was a guest presenter at the Food Drug Law Institute’s Conference on the Drug Quality and Security Act (DQSA). As part of a panel examining the impact of the DQSA’s implementation, Miller identified three major issues affecting 503A traditional compounders that make up the majority of IACP’s membership.

“Office-use, the ability to select APIs for the appropriate preparation of a compound, and the not-yet-release Memorandum of Understanding governing interstate shipment of compounded preparations are of significant concern to IACP’s pharmacists and technicians,” he began. “We have seen pharmacists placed in the unacceptable position of having to either comply with questionable interpretations of a law and turn patients away or risk regulatory action when we choose to do what we were trained to do as professionals – provide the right medication necessary to treat those that come to us for help.”

More than 75 lawyers and others participated in the FDLI conference. In addition to discussing the issues surrounding 503A and 503B, a representative of the FDA discussed the announced guidance documents for Title II of DQSA. That section deals with the track-and-trace provisions enacted by Congress to protect the integrity of the US drug supply system.

A copy of Miller’s slide presentation can be accessed here:

 

 


 

Recording: Today's IACP Member Town Hall

 

If you missed today's IACP Member Town Hall, don't worry, we recorded it for you!

Go to the Members-only site, click on Member Resources, and then Town Hall Recordings. The recording will be up tomorrow.


OIG Top 10 Recommendations for HHS to Tackle

The Office of Inspector General (OIG) released its Fiscal Year 2014 Top Management and Performance Challenges for the U.S. Department of Health & Human Services (HHS) where OIG details the top 10 challenges that it feels HHS faces and should address next year.

The complete report can be found here. Please note that #2 on the list is appropriate use of prescription drugs. We can be sure that in 2015, we’re going to see a big focus on fraud, waste, and abuse as well as reimbursement for prescription drugs.

Please email IACP with any questions, iacpinfo@iacprx.org.


Wall Street Journal Pharmalot Blog Examines Compounding Pharmacy Suit Against Express Scripts - Quotes IACP

IACP was mentioned in a Wall Street Journal Pharmalot blog, "Express Scripts is Sued by Compound Pharmacies for Denying Claims."

"Compound pharmacies, however, have been chafing over the law, which creates two classes of compounders – one that voluntarily chooses to register with the FDA and another that may decline to do so. The first group is subject to certain conditions, such as meeting good manufacturing practices, but the FDA hopes the requirements will give hospitals and physicians the confidence needed to purchase needed compounded medicines.

Recently, the International Academy of Compounding Pharmacists, a trade group, began lobbying Congress to alter the law and make “technical corrections.” In response, a group of trade groups for drug makers, along with the Pew Trust, wrote to the FDA to express support for the law in its existing form."

Please click here to read the entire story.

More on the Lawsuit

 

Three pharmacies are suing Express Scripts, Inc. for violations of federal regulations in a scheme to deny payments for compound pharmaceuticals. The suit alleges that thousands of patients are being impacted by the scheme.

The suit was brought in federal court in St. Louis on behalf of three compounding pharmacies, two based in Texas - Annie's Apothecary and Cypress Compounding Pharmacy, and one in Louisiana, Mason's Pharmacy. Express Scripts (ESI), based in St. Louis, is described as the largest U.S. claims administrator and fiduciary for health plan pharmacy claims.

According to the suit, Express Scripts has recently undertaken a scheme to reject all claims under health plans seeking payment for "compound" pharmaceuticals. These medicines are customized drugs made according to specific prescriptions written by doctors when there are no alternative medicines available that are either mass-produced or commercially made. Patients suffering from various conditions, diseases and injuries benefit from these medications every day, according to the suit.

Please click here to read more.


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 Update:

FDA Provides Clarity on Use of Estriol by Section 503A Compounding Pharmacies

The U.S. Food and Drug Administration (FDA) recently has provided limited additional information in an informal email on whether a pharmacy may use certain bulk drug substances in compounding. Specifically, the FDA has indicated that drug products containing Estriol may be compounded in accordance with Section 503A by a licensed pharmacist pursuant to a patient-specific prescription, based on the fact that Estriol is the subject of an applicable USP monograph.Click here for more.

FDA Approves Extended-release, Single-entity Hydrocodone Product with Abuse-deterrent Properties

FDA recently approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Click here for more.

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.


Fallout Continues for Massachusetts Boards

Last week, the Boston Globe’s investigative reporter Todd Wallack continued to delve into an area which may have led to lax oversight of the New England Compounding Center (NECC) by the Massachusetts Board of Pharmacy. According to the article, four Massachusetts health licensing boards conducted regular meetings without a quorum. That brings into question the legality of more than 450 votes on disciplinary proceedings, license and permit application decisions over a period of five years. Click here to read the entire Boston Globe article.

An internal audit by the Massachusetts Department of Public Health (DPH) and its findings mean those decisions could be challenged. Earlier this year, DPH offered 38 licensees who had received disciplinary actions taken by the pharmacy, physician assistants, dentistry and other Boards to have those actions revisited.

To further compound the issue, the Massachusetts Secretary of State reported that the DPH’s handling of public record requests is lacking as well with many instances identified where requests were simply ignored. Shortly after the crisis broke, IACP formally requested records from the Board of Pharmacy regarding their and the FDA’s inspections and investigations as well as the reasons for failing to timely implement a consent decree with NECC. That request, filed under the Freedom of Information Act, was never responded to by DPH.


Boston Globe: $135 Million Deal Proposed in New England Compounding Pharmacy Bankruptcy Case

The fund to compensate victims of a deadly 2012 meningitis outbreak linked to tainted drugs at a defunct Framingham pharmacy could increase by more than $35 million, lawyers involved in bankruptcy negotiations said Wednesday.

Under terms of a proposal filed Wednesday in federal bankruptcy court in Boston, at least $135 million will be available for distribution to people who have brought personal injury or death claims against New England Compounding, according to a statement from Paul D. Moore, the trustee of the pharmacy’s Chapter 11 bankruptcy filing, and lawyers advising the victims and their families.

Click here to read the entire Boston Globe story.


IACP's Winter 2014 CustomRx Connection Magazine Now Available!

 

IACP proudly shares the Winter 2014 edition of our CustomRx Connection Online Magazine. In this edition, you'll find a "New Reality" perspective from IACP's President Pat Stephens, PharmD, an inside look into Washington DC from IACP's Government Affairs Vice President Cynthia E. Blankenship, Esq., Marketing Must Haves from Lauren Onsa, why involvement in your state society is so important from IACP Member Alfonse Muto, PharmD, FIACP, and some recent validation study information from IACP Corporate Partner MEDISCA.

 

With this issue also come some big announcements about IACP's future publications. We're thrilled to announce that we're joining forces with Pharmacy Marketing Quarterly, and together look forward to bringing you a dynamic quarterly magazine that will be available both in print and online. So click below to read all about it!

 

Please click here to view the Winter 2014 CustomRx Connection magazine.

 

Your input is vital to the health of our publications! Please provide us with feedback, editorial ideas, photos and "What Works for You" tips! Please email your information to iacpinfo@iacprx.org.


Member News


IACP Member Whitney Larkin Gale reports that Congressman Phil Roe (TN-01) visited their pharmacy, ProCompounding in Johnson, Tenn., on November 24th. Congressman Roe toured ProCompounding's compounding and institutional pharmacy complex along with his Chief of Staff Matt Myers and Legislative Director, John Martin. Discussion included generic drug pricing issues and the compounding pharmacy legislation. Congressman Roe is a former practicing physician, and is very supportive of good pharmacy practice.

 

IACP Board Member Baylor Rice, RPh, FIACP, South River Compounding Pharmacy in Richmond, Va., is featured in Our Health Richmond. Click here to view the article. Click here to view the entire issue.

IACP Legislative Committee Member Doug Higgins, RPh, Doug's Compounding Pharmacy in Paxton, Illinois, explains in a CI Living interview how important personalized medications are to the patients who rely upon them. Click here to watch the interview.

 

 


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 iacpinfo@iacprx.org.

 

Question:

 

Does the Drug Quality and Security Act (DQSA) cover veterinary compounding? Can I compound for office use for my veterinarians?

 

Answer:

DQSA only addresses compounding for human patients. It does not cover veterinary compounding.

 

Question:

In that case, I can provide office use of a control to a veterinarian, is that correct?

 

Answer:

 

There is no such thing as an office-use prescription for a controlled substance for any person or animal. The Controlled Substances Act provides for the purchase of controlled substances from pharmacies using a medical order/invoice (Schedules III-V) or a Form 222 (Schedule II); those are not considered a prescription although many pharmacists and practitioners make the error of calling a medical order or invoice as a "prescription."


Corporate Partner Spotlight: Shockwatch

 

 

ShockWatch offers a complete range of cold chain solutions designed to help you understand the condition of temperature-sensitive products in transit and storage. Developed with industry regulations in mind, our recorders and indicators alert receivers to mishandling and help ensure compliance, safety, and quality of products we all use every day. Leading global pharmaceutical manufacturers and other companies depend on our solutions to determine product shelf life, protect their corporate reputations, and ensure customer satisfaction.

ShockWatch also offers real-time monitoring, temperature mapping and other cold chain services to provide detailed information about real-world conditions.

Contact ShockWatch
Phone 214-736-4580 | Toll-free 800-250-4074
www.shockwatch.com | buy.shockwatch.com | www.linkedin.com/company/shockwatch



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:

Endotoxin Testing
•Environmental Monitoring
•Standards of Practice
•FDA Inspections
•DEA Inspections
•USP 797, 795, & 1163
•Cease and Desist Letters
•Stark Law and the False Claims Act
•Marketing and Sales
•Legislative & Drug Updates
•CMS and Reimbursement
•Third-Party
•Media and Public Relations
•Patient Safety Organizations


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