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Capitol Connections, April 6, 2015
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April 6, 2015

In This Issue

1. FDA Invites IACP to April 30th Compounding Stakeholder Meeting

 

2. FDA to Hold Public Hearing on Human Drug and Biological Products Labeled as Homeopathics

 

3. PAPCC Launches Media Campaign Promoting The Role of Pharmacists in Patient Care

 

4. All Dispensing Pharmacies Eligible to Request .Pharmacy Domain Names Until April 30th

 

5. IACP Provides You with the Latest State Updates

 

6. April 20th Deadline - Spring 2015 Student Writing Competition!

 

7. Comment Period Ends on May 31st for USP's Revised Chapter of the Proposed <800>

 

8. Corporate Partner Spotlight: Topi-Pump

 

9. CCH: Have You Registered, Yet?

 

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.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA Invites IACP to April 30th Compounding Stakeholder Meeting

 

The Food & Drug Administration (FDA) has invited IACP to participate in a Pharmacy Compounding stakeholder meeting on April 30, 2015 at the White Oak Campus in Silver Spring, Md.

 

In their invitation, FDA states, "As you may recall, we held a series of listening sessions with groups of interested stakeholders last year to discuss FDA’s efforts to implement the compounding provisions of the Drug Quality and Security Act, signed into law in November, 2013. We met with pharmacy and industry organizations, medical organizations, consumer groups, hospital organizations, insurers, animal drug organizations, and radiopharmaceutical organizations."

The FDA says it will hold at least six sessions this year: pharmacy and industry organizations; medical organizations; consumer and patient advocacy groups; hospital organizations and insurers; outsourcing facilities registered under section 503B; and radiopharmaceutical organizations."

Please note: The FDA will not be webcasting the sessions. Each organization will be provided the opportunity to make a statement of five minutes or less, depending upon how many people will be participating in each session. IACP will provide an update in an upcoming Capitol Connections member newsletter.

 

Please click here to view information about FDA meetings at the White Oak Campus.


FDA to Hold Public Hearing on Human Drug and Biological Products Labeled as Homeopathics

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, healthcare professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

 

Please click here to read more.

 


PAPCC Launches Media Campaign Promoting The Role of Pharmacists in Patient Care; Calls for Passage of S. 314/HR 592

IACP You Tube: Click here to listen to this story!

 

The Patient Access to Pharmacists’ Care Coalition (PAPCC) is launching a media campaign to promote the role of pharmacists in patient care and to call for passage of the Pharmacy and Medically Underserved Area Enhancement Act (S. 314/H.R. 592).

As part of the initiative, PAPCC will run both print and digital advertising in D.C. beltway media outlets over the course of the Congressional calendar. The initiative seeks to raise awareness about how pharmacists can specifically help seniors in areas of the country where access to care can be challenging.

 

IACP has played an active role in the PAPCC coalition, and has signed onto several advocacy letters to Congress.

Click here to view PAPCC's PowerPoint slide, featuring the first of a series of ads and a listing of the print media outlets in which the ad will run this week.


All Dispensing Pharmacies Eligible to Request .Pharmacy Domain Names Until April 30th

The National Association of Boards of Pharmacy® (NABP®) has begun accepting applications for .pharmacy domain names from all dispensing pharmacies. Since the .Pharmacy Top-Level Domain (TLD) Program was launched in 2014, the Association has approved about 275 .pharmacy domain names applied for or requested during prior limited registration periods. NABP launched the .pharmacy TLD to provide consumers around the world a means for easily identifying safe and legal online pharmacies and related resources.

The dispensing pharmacy limited registration period is the last limited application phase. Applications from dispensing pharmacies will be accepted through April 30, and approved pharmacies may begin to register their requested .pharmacy domains as early as that date. General availability, when any entity with a pharmacy or pharmacy-related website may apply and, if approved, register for a .pharmacy domain name, will begin on June 3, 2015.

Please click here to read more.


COMP PAC Event Invitation

IACP Members:

 

You are cordially invited to attend a reception in honor of Congressman Gene Green (TX-29), House Energy and Commerce Committee, and Ranking Member of the Subcomittee on Health, on Tuesday, April 7, 2015, 4:30 pm to 6:30 pm (CST) at 700 Louisiana Street, Suite 1600, Houston, TX 77002.

 

 For more information and to RSVP, please click here!

 


IACP Provides You with the Latest State Updates!

IACP Members: Check out the latest state news on IACP's Compounders Stateside page. We've also added a new State Legislation Tracker on Pharmacy Provider Status. Click here to view!

 

Additional Announcements:

 

IACP Texas Members, please click here for a Texas Pharmacy Association Advocacy Alert - "Oppose HB 1483 - the Physician Dispensing Bill"

 

2015 State Board of Pharmacy Meeting Schedule - please click here to view.


April 20th Deadline - Spring 2015 Student Writing Competition!

 

 

The Theme: "Should States Institute a 'Wet Lab' Examination as Part of the Pharmacist Licensing Process?"

The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers on a particular topic affecting pharmacy compounding. THREE winners will be selected by a review committee from the papers submitted. The winners of this writing competition will each receive a $500 cash prize. All pharmacy students are encouraged to compete.

Entries are due by Monday, April 20, 2015! Click here for more information.
Please email IACP Foundation's Jennifer Petska with any questions!

 


IACP Members: Have You Used the New Compounding Fact Sheet, Yet?

 

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.


Comment Period Ends on May 31st for USP's Revised Chapter of the Proposed <800>

 

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.


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.



Compounding/Member News


Please send your news to iacpinfo@iacprx.org!

Michael Collins, RPh, FIACP, President of Healthway Compounding Pharmacy in Saginaw and St. Charles, Mich., has been presented the Hank Fuhs Good Government Award by the Michigan Pharmacy Political Action Council. Please click here to read more!


Join Fagron Academy for Modern Pharmaceutical Compounding, a three-day (20 hour) application based course focusing
on the fundamentals and best practices of non-sterile pharmacy compounding. Click here for more 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:

We are looking at re-formatting our prescription label. On our current label we have included the FDA Toll-Free Number for Reporting Adverse Events. My recollection is that this notice is a standard of practice for compounded preparations. Could you clarify if this is a legal requirement, standard of practice, or if it only applies to medication guide.

Answer:

Including the FDA Adverse Event Reporting System (FAERS) telephone number or providing patients with information about the MedWatch program is NOT required by law at the federal level for 503A traditional compounders. It IS required for compounds prepared and distributed by 503B outsourcing facilities and there is a draft FDA compliance policy guideline in circulation for comment for those facilities... in other words, that's still "in the works."

We have not seen any standards of practice in USP <795> or <797> that mandate or require providing information for MedWatch on patient prescription labels.

Recommend that you confirm your State Board of Pharmacy regulations dealing with this as well.

 

You might want to consider creating an auxiliary label that includes this information as opposed to putting it on each and every label.


Corporate Partner Spotlight: Topi-Pump

 

Topi-Pump is an airless metered pump for dispensing compounded medications accurately and reliably. With a patented pouch design which allows for addition capabilities that piston and spiracle pumps cannot offer. The only truly airless system, which prevents drying and pollution of the medication.

Topi-Pumps are designed to be the most efficient, easy-to-use pumps and accessories in the pharmaceutical industry. They are manufactured in a certified ISO 9001 and ISO 13485 facility and tested to ensure quality. Topi-Pumps are perfect for topical hormones, pain management creams, dermatological compounds, and oral liquids. We offer six bottle sizes and four dosing options to meet the needs of any prescription regimen. We also offer optional accessories to make filling and dispensing even easier. Self-priming, UV protection above USP standards, PCAB compliant, and linked cap, are just some of the features that make it the best dispensing system. Contact us today to see how Topi-Pump can work for you. When accuracy matters, Topi-Pump.

 

To learn more about Topi-Pump, please click here for more information.

Topi-Pump Contact:

Alton Kelley
Topi-Pump
877-323-3376
www.topipump.com

 


CCH: Have You Registered, Yet?

 

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!


IACP Regional Education Meeting Heading to Boston, MA!

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. Click here for more.


Confused About What the Drug Quality & Security Act Really Means to You?

 

The Drug Quality and Security Act of 2013 (DQSA) has completely changed the regulatory landscape for compounders. With significant changes to §503A, the inclusion of a completely new §503B, and more than a dozen FDA guidance documents and requests for comments, understanding the basics of the law is something every compounder should know. Don’t miss this important four-part series, presented by David G. Miller, RPh, designed to educate attendees on this important bill.

 

Diving Into DQSA Webinar Series

Part 1: Getting Your Toes Wet – DQSA Basics
Tuesday, April 14, 2015
2:00 – 3:00 p.m. CST (3:00 ET / 12:00 PT / 1:00MT)


Part 2: Everybody Swim! What You Can And Can’t Do
Wednesday, April 15, 2015
2:00 – 3:00 p.m. CST (3:00 ET / 12:00 PT / 1:00MT)


Part 3: Getting in Deep – RX Repackaging
Tuesday, April 21, 2015
2:00 – 3:00 p.m. CST (3:00 ET / 12:00 PT / 1:00MT)


Part 4: The High Dive – Understanding the Draft MOU
Wednesday, April 22, 2015
2:00 – 3:00 p.m. CST (3:00 ET / 12:00 PT / 1:00MT)


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.

Featured Webinar Programs:



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