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IACP Capitol Connections, July 22, 2016
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July 22, 2016

In This Issue

READ

 

Today's Table of Contents

 

SUPPORT

 


 

CONNECT





CONTACT

 

Capitol Connections is a biweekly newsletter for IACP Members Only.

Have a story idea? Please email iacpinfo@iacprx.org with your editorial ideas and suggestions!

 

Find Capitol Connections Newsletter Archives here.


IN THIS ISSUE

 

FDA Announces Inspection Procedural Change.


IACP Files Comments for FDA’s Prescription Requirement Under Section 503A Guidance

 

GAO Releases Drug Shortages Report

 

IACP in the News

 

IACP Works to Educate Forbes Op-Ed Writer

 

IACP Members: We Need Your Help to Keep the Momentum Going in D.C.!

 

USP Compounding Compendium

 

IACP Member News

 

IACP Affiliate & Corporate Partner News

 

Corporate Partner

 

Spotlight: GRX Marketing

 

Mark Your Calendar for The Compound

Conference

 

IACP AdvanCE Live Webinars

 

Need CE?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA Announces Inspection Procedural Change


On July 12th, the Food & Drug Administration (FDA) posted a notice announcing a change in its procedure for inspections of certain human drug compounders, which will take effect on August 1, 2016. FDA has stated it's making this change in response to stakeholder input. Click here to view FDA's notice.

 

One of IACP's primary 2016 Compounders on Capitol Hill Asks (click here to view) challenged FDA's inspections of 503A compounding pharmacies using Current Good Manufacturing Standards (cGMPs) instead of under U.S. Pharmacopeial (USP) or other standards established by state pharmacy laws and regulations.

 

Please click here to read more including a statement from IACP.

 

 PLEASE NOTE: IACP along with other organizations within the DQSA Coalition are working on a response to the notice, asking the FDA for more clarity about certain changes with the inspection process. Once it is finalized, we will publish it to our membership.


IACP Files Comments for FDA’s Prescription Requirement Under Section 503A Guidance

On Monday, July 18th, IACP submitted comments to FDA regarding the Draft Guidance for Industry: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.

 

Please click here to view IACP's entire comments to FDA.

 

Thanks to those IACP Members who took time to submit comments! Click here to view FDA comment page – please note not all has been posted on the the site at this point.


GAO Releases Drug Shortages Report

The U.S. Government Accountability Office (GAO) this week released a report: Drug Shortages -Certain Factors Are Strongly Associated with This Persistent Public Health Challenge. Click here to read. IACP is reviewing and will report back to the membership.


IACP in the News

Inside Health Policy Asks IACP About FDA’s Inspection Change

 

IACP's John Voliva, RPh, Executive Vice President, is quoted in a July 15th Inside Health Policy article, "Reacting to Stakeholder Complaints...FDA to Cease Citing cGMP Violations for Traditional Pharmacists." Please click here to read. (Article reprinted with written permission from Inside Health Policy)

 

The Washington Post: "Fraud Concerns Grow as Spending on Handmade ‘Compounded’ Drugs Soars"

 

Please click here to read the The Washington Post article in which IACP is quoted. As happens sometimes with the media, our entire quote was not used.

 

Click here to view IACP’s entire statement provided to the Kaiser Health News reporter.


IACP Works to Educate Forbes Op-Ed Writer

Have you read the opinion piece by Henry I. Miller in Forbes? "Lax FDA Oversight Of 'Compounded Drugs' Is A Matter Of Life And Death." Read the article here.

 

Unfortunately what we have here is another example of uninformed and just plain inaccurate reporting. Mr. Miller states that pharmacy compounding is "unregulated," and “loopholes in the regulations that set the standards for a practice called ‘drug compounding’ have enabled dangerous products to injure and kill untold numbers of unsuspecting patients.”

 

IACP has sent a correction to Forbes and has submitted comments to the author in the article’s editorial commentary. We encourage our members to do the same. Click here to read the article. Scroll down to the bottom of the article and click, “Comment on this Story.”


IACP Members: We Need Your Help to Keep the Momentum Going in D.C.!

IACP is making real progress through our DQSA Coalition and your efforts in educating your respective congressional representatives. We have a lot more before us!

 

Please help us maintain the momentum by contributing to IACP’s One Fund. Your support enables us to serve you on the Hill! Click here to contribute.

Click to view IACP Member contributions!

 


USP Compounding Compendium

2016 USP Compounding Compendium with General Chapter <800> Available – Discount for IACP Members

 

The 2016 USP Compounding Compendium which includes General Chapter <800> is now available. The IACP Member price is $150, a $25 savings.

Please click here for more information or to purchase. USP Chapter <800> will become official on July 1, 2018.


IACP Member News


Congratulations to IACP Member Bill Mixon, RPh, FIACP, The Compounding Pharmacy, Hickory, N.C., who has been re-elected to the North Carolina Board of Pharmacy.

 

Thanks, Bill, for all you to do to represent pharmacy compounding!

IACP Member Joe Moose, RPh, Moose Pharmacies in Concord, N.C., has been named to the National Community Pharmacists Association's (NCPA) new Innovation Center Board.

 

Read more here. Congrats, Joe!


IACP Member John Hobbs, PharmD, Apothicare360 in Fort Myers, Fla., explains to the Business Observer why he is still investing in his pharmacy compounding practice. Read more here.



IACP Affiliate & Corporate Partner News

 

IACP Affiliate ACHC has upcoming workshops – please see the below links. All IACP members receive a $50 discount with the code WS50P!

 

USP <800> Compliance Workshop sponsored by PCAB

Infusion/Specialty Pharmacy Workshop

 

PCAB Sterile and Non-Sterile Compounding Workshop

DMEPOS Workshop

Be sure to download your free USP <800> Gap Analysis from IACP’s Corporate Partner International Journal of Pharmaceutical Compounding and CompoundingToday.com. Click here!


Corporate Partner Spotlight: GRX Marketing

 

GRX Marketing: IACP Corporate Partner Since 2015

 

GRX Marketing specializes in offering marketing services to independent pharmacies across the United States. Our program includes detailed marketing plan, custom designed in-store and out-of-store marketing materials, doctor detailing program, social media management, marketing consultation and more. Through this comprehensive approach, current patients and potential ones will see the same, consistent message in the various mediums available, thus increasing the probability of adding sales and new patients.

Please click here to read more about GRX Marketing.


Mark Your Calendars!

The 2016 Compound Conference will return to Columbus, Ohio on Sunday, October 9, 2016!

Exhibitor Prospectus Now Open - Booths Available!

Click here to access the Online Commitment Form

Attendee registration will be open on Monday, July 11th!

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 2016 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA), the International Academy of Compounding Pharmacists (IACP) and the Ohio Society of Health Pharmacists (OSHP). For more information, please click here.



Don’t miss these upcoming LIVE webinars!

2016 OSHA Training – Bloodborne Pathogens

Multiple webinars throughout the year - please click title for exact dates

 

Prioritizing USP <800>: Separating the ‘Musts’ from the ‘Shoulds’

Wednesday, August 10, 2016

12 pm - 1 pm CST


Need CE, ASAP?

If you need CE credit, check out IACP AdvanCE’s on-demand library. The library houses more than 100 programs with a variety of pharmacy topics. Please click here to access the self-paced programs.

 

Featured Webinar Programs:


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