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Capitol Connections, March 9, 2015
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March 9, 2015

In This Issue

1. IACP Members: Your Comments are Needed! FDA Reopens Docket on Compounding Documents


2. Drug Product Compounding Issues Addressed by FDA Panel


3. IACP Sets the Record Straight with USA Today and Pharmacy Times


4. Did You Miss IACP's Town Hall on FDA's Guidance Documents and MOU? Recording is Available!


5. New State Legislation Tracker on Pharmacy Provider Status


6. Announcing the Spring 2015 Student Writing Competition!


7. USP Announces Revised <800> Chapter Available for Viewing


8. Corporate Partner Spotlight: PennTech Machinery Corporation


9. CCH Registration is Open!


10. IACP Regional Education Meeting Heading to San Diego, CA!

Capitol Connections is a biweekly newsletter for IACP Members Only.

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IACP Members: Your Comments are Needed!

FDA Reopens Docket on Compounding Documents


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 So, while IACP and compounders can submit comments on the draft guidance documents that are directly related to repackaging, adverse event reporting, and the Memorandum of Understanding there has been no place where physicians,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.


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IACP Summary on FDA Four Draft Guidance Documents and MOU

Please click here to view.


Watch for additional information through IACP’s Capitol Connections newsletter, our email and FAX Member Alerts, our social media postings via Twitter and FaceBook. Be sure to continue visiting the Breaking News section of our website.

Drug Product Compounding Issues Addressed by FDA Panel

On February 23, 2015, FDA's Pharmacy Compounding Advisory Committee voted to add 25 drugs to the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act because, "they have been withdrawn or removed from the market as a result of their components having been determined to be unsafe or ineffective."


Please click here to read more.

IACP Sets the Record Straight with USA Today and Pharmacy Times

IACP take its mission of Protecting, Promoting & Advancing Pharmacy Compounding very seriously. In addition to our ongoing efforts of generating proactive compounding stories in the press, we also will take the time to correct erroneous information whenever we see it!


Please see two recent news stories in USA Today, and Pharmacy Times, that screamed for a response. IACP Members: We encourage you to provide IACP's responses to the respective publications to your patients and physicians who may be have questions or who are confused by these articles.

Media Stories and IACP Responses

Please click here to read the USA Today story.

Please click here to read IACP's response.

Please click here to read the Pharmacy Times story.

Please click here to read IACP's response.


Contact IACP!

Have you seen an article that needs IACP's response? Please email IACP's VP of Communications Dagmar Anderson at

Did You Miss IACP's Town Hall on FDA's Guidance Documents and MOU? Recording is Available!

At last month's Town Hall, IACP Leadership reviewed FDA’s Four Guidance Documents and MOU draft released on Feb. 13th, answering member questions, and detailing next steps.


IACP has received many, many questions regarding these proposed guidelines. We recorded the Town Hall and encourage you to listen at your convenience.


Recording Available: The Town Hall Recording has been uploaded to the Members-only Site. Please click on the Member Resources icon, then select,

Town Hall Teleconference Recording to access all Town Hall Recordings.


Click here to access this Town Hall Recording - you will need to be logged in to view.

New State Legislation Tracker on Pharmacy Provider Status

IACP Members: Check out the brand-new feature on our Compounders Stateside page. We've added a new State Legislation Tracker on Pharmacy Provider Status. Click here to view!

Announcing the 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.

USP Announces Revised Chapter of the Proposed <800> 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.

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!

Congratulations to IACP Board Member Teri Rolan, PharmD, PhC, for her news coverage in the Santa Fe New Mexican. Click here to read.


IACP Corporate Partner MEDISCA is hosting its annual SPCC Nationals, March 21-22, 2015 in Gainesville, Fla.! Please click here to view their 2014-2015 SPCC Nationals Booklet, highlighting their prestigious selection of guest speakers and judges.



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



Quick question on the Pharmacy Compounding Advisory Committee's (PCAC) "Do Not Compound" list. Cisapride and phenylpropanolamine, both on the list, are used for veterinary compounding. Is it still okay to have in pharmacy as long as marked, 'not for human use" or "for vet use only?"



Yes, that is correct. The "Do Not Compound" list is specifically for human prescription drugs. Bear in mind, however, that the list is not official until the final decision by the Secretary on the PCAC's recommendations. We expect that within the next few months.

Corporate Partner Spotlight: PennTech Machinery Corporation


Ensuring the safety and effectiveness of customized medications is a key priority of compounding pharmacists for protecting patients. However, there are still more than half of a million adverse medication-related events reported every single year to the FDA. This is estimated to be only 10% of all actual adverse events, according to estimates published by the FDA and Adverse Events, Inc.

As a result, federal and state regulators have greatly strengthened their oversight of compounding pharmacies and their methods of enforcement. It is vitally important, now more than ever for compounding pharmacies to evaluate their current processes.

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!

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 San Diego, CA!

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!

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.

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.

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