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Capitol Connections, June 19, 2015
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June 19, 2015

In This Issue

1. 406 Attendees Convene in Washington, for the 21st Annual Compounders on Capitol Hill

 

2. Senator Vitter Introduces Legislation: SB 1406

 

3. FDA Extends Deadline for Comments on MOU

 

4. IACP Participates in FDA's PCAC Meetings This Week

 

5. FDA Update

 

6. IACP Member Q&A

 

7. Corporate Partner Spotlight: Letco Medical

 

8. IACP Welcomes Corporate Partner: Cleanroom Connection Inc.

 

9. Save the Date for CCH 2016! June 11-14, 2016

 

10. Register Today for The Compound Conference 2015!



Capitol Connections is a biweekly newsletter for IACP Members Only.

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



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

406 Attendees Convene in Washington, D.C. for the 21st Annual Compounders on Capitol Hill


 

The United Voice of Compounders Is Heard!

A special thanks to all the IACP members who participated either in person at Compounders on Capitol Hill, held, June 6-9, 2015 at the Renaissance Washington DC Downtown Hotel, or via our Virtual Hill Day -- your efforts made a HUGE impact. And a fast one as well. One of our key messages to Senators and Congressmen was that the U.S. Food and Drug Administration (FDA's) interpretation of the Drug Quality & Security Act (DQSA) appears to ignore Congressional intent. Despite repeated invitations from IACP to speak with our CCH conference attendees, everyone at the FDA was again "unavailable" this year to attend and talk to those most impacted by the agency's activities... and that was noticed by Congress.

“Compounding pharmacists went to Washington to speak with their Senator and Congressional representatives about several issues that directly affect their patients,” says IACP President Dale Coker, RPh, FIACP. “We were particularly interested in discussing the Drug Quality and Security Act (DQSA) with our respective representation to ensure access to pharmacy compounding continues. We also emphasized the need for increased communications between the States and FDA as this legislation continues to go into effect.”

Please click here to view more, including the 2015 CCH Asks, Senator Vitter's SB 1406, Hill Day Stats and the CCH 2015 Photo Gallery!


Senator Vitter Introduces Legislation: SB 1406

IACP is pleased to announce that U.S. Senator David Vitter (R-La.) has introduced legislation to protect and expand access to life-saving compounded medications. The IACP-led DQSA coalition has worked diligently with the Senator's office to ensure that patient access to compounded medications continues.

 

From Senator Vitter's press release - "Compounded medications are used to treat patients with unique medical conditions that make them resistant to standard medications, such as pediatric cancer patients. Vitter’s legislation, the Saving Access to Compounded Medications for Special Needs Patients Act, would ensure that patients have access to the custom medications they need"

“Compounded medications often go to the most vulnerable patients, like cancer patients and children with special needs. Our children’s health and safety need to be our very top priority, and Louisiana families shouldn’t have to drive to Texas to get life-saving medications,” Vitter said. “FDA overreach is jeopardizing access to these medications, and my legislation would make sure patients and families can get the medicines they need as quickly as possible.”


Please click here to read more.


FDA Extends Deadline for Comments on MOU

The Food and Drug Administration (FDA) is extending the comment period in the notice of availability that originally appeared in the Federal Register of February 19, 2015 until July 20, 2015. The Agency is extending the comment period both for the draft standard Memorandum of Understanding (MOU) and for information collection issues under the PRA for 30 days, until July 20, 2015. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying resolution of these important issues.

Please click here for additional information.

 

Background

 

The U.S. Food & Drug Administration (FDA) has established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets. So, while IACP and compounders can submit comments on the draft guidance documents that are directly related to repackaging, adverse event reporting, and the Memorandum of Understanding there has been no place where physicians, patients, pharmacists and others can voice our concerns about office-use.

If office-use is important to your practice or your prescriber clientele, this public docket is the perfect place to file your comments about how the FDA is ignoring Congressional intent and disregarding state laws and regulations permitting office-use.

 

Last week, IACP filed comments on the FDA Guidance Document with the Agency. Please click the below links to view IACP's comments.


FDA's "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities"

"Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act"

"Repackaging of Biologics"

 

Letter from Congress

Click here to view a Congressional letter regarding the repackaging of biologics.

FDA Public Docket


IACP Members! Click here to access the FDA Public Docket, which includes comment submission instructions.

Make your voice heard! Let the FDA know of your concerns on the recent compounding implementation plan.

IACP Summary on FDA Four Draft Guidance Document

Please click here to view.


IACP Participates in FDA's PCAC Meetings This Week

IACP representatives David Miller, CEO/EVP and Cynthia Blankenship, VP Government Affairs, participated this week in the FDA's Pharmacy Compounding Advisory Committee meeting held in White Oak, Maryland.

The PCAC voted to add four additional drugs to the "do not compound" list that have been withdrawn or removed from the market for safety concerns or lack of efficacy. They are:

Acetaminophen: all drug products containing more than 325mg of acetainophen per dosage unit

Aprotinin: all drug products containing aprotinin

Ondansetron HCl: all IV drug products containing greater than a 16mg, single dose of odansetron

Bromocriptine Mesylate: all drug products containing bromocriptine mesylate for prevention of physiological lactation

These four will be in addition to the 26 medications voted on by the PCAC at their first meeting in February 2015. Although the Committee has voted to add these medications to the existing list, that will not become formal until accepted by the Secretary of Health and Human Services and published in the Federal Register. IACP will alert its members when the updated list goes into effect.

 

PCAC also considered four Active Pharmaceutical Ingredients (APIs) which do not have a USP/NF monograph or are not a component of a current or previously approved FDA manufactured drug product. Under 503A, compounding using bulk ingredients that lack monograph or approval status is permitted once the FDA and the Secretary of Health and Human Services consider submitted drugs and those are reviewed and decided upon by the FDA PCAC. The Committee did not consider any bulk ingredients for 503B outsourcing facilities; their decision today is only for traditional compounders.

Please click here to read more.



FDA Update

 

FDA Drug Shortage App


FDA Launches Drug Shortage App

 

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.

 

 


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:

I’ve given my compounded preparation a proprietary brand name. Is that permitted?

 

Answer:

 

It depends upon your state’s law and regulations.

Some states prohibit the use of “coded” or “secret” formulas on prescriptions. Using a “brand name” for a compounded preparation which you promote to prescribers may unintentionally result in invalid prescriptions. Check with the state Board(s) of Pharmacy in which you are licensed to determine if the use of a proprietary brand name, for which ingredients and composition are not publicly available, would be considered a violation of any regulations or rules.


Corporate Partner Spotlight: Letco Medical


 

"Take a look at Letco NOW"

 

Our change for the better #1/New & Innovative Products

 

At Letco Medical we know that staying ahead of regulations and compliance is only half the challenge -- we also need to make every effort to help our customers sell. Our new line of bases-enhanced scar care, wound care, anhydrous, salt durable - are in demand and immediately available. Our new MinneMold is the industry's first child deterrent troche mold. We're also ready with new suspension and syrup vehicles, and new Topi-CLICK colors, sizes, and dispensing options. Plus, new PharmaRamTM II provides you with the ultimate in advanced mixing technology. These are just a few examples.

 

Please take a look at what Letco Medical's new commitment can do for you. We've updated our look, with easier to recognize purple branding that you'll find on everything from communications to product containers. We want to make sure you quickly see us for who we are, and that's the best partner you've ever had.

Please click here to learn more about Letco Medical.


IACP Welcomes Corporate Partner: Cleanroom Connection Inc.


 

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 73 Corporate Partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

 

To learn more about Cleanroom Connection Inc., please visit www.CleanroomConnection.com.

 


Save the Date for CCH 2016! June 11-14, 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 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.

 

More details to come!


IACP Regional Education Meeting Heading to Chicago, IL and Denver, CO!

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. Listen to David G. Miller, RPh, IACP’s Executive Vice President & CEO as he presents Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today.

 

Click here for more information!


Register Today for the Compound Conference 2015!

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.

 

We would like to thank the following exhibitors for their commitment to the Compound Conference: Analytical Research Laboratories (ARL); ASI; Associate of Cape Cod, Inc.; Biomerieux; Cleanroom Design LLC; Letco Medical; MEDISCA; P&C Pharma; PCCA; Pharmacists Mutual Companies; Rx30 Pharmacy System; Storey Marketing; Topi-CLICK; Topi-Pump.


We would like to thank the following meeting sponsor for their support of The Compound Conference: Letco Medical (Refreshment break with Exhibitors).

There are exhibitor and sponsor opportunities still available!

 

Click here to download the Exhibitor Prospectus.

 

Click here for more information on The Compound Conference.


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