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Capitol Connections November 21, 2012
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November 21, 2012

The International Academy of Compounding Pharmacists would like to wish you and your family a very Happy Thanksgiving. In observance of this holiday the IACP offices will be closed November 23 & 24, 2012. Offices will re-open on Monday, November 26, 2012.

Vote Today! 2013 IACP Board of Directors Election

The IACP 2013 Board of Directors election is now in progress. Elections close at 5 pm CST on November 30, 2012. As a current dues-paying IACP member, you are eligible to vote and determine who will be the new leaders of your Academy. Make your voice heard. Vote today!

Click here to cast your vote now!

IACP Participates in Senate Hearing on Meningitis Outbreak

Last week, the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing on “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.” David G. Miller, RPh, IACP Executive Vice President & CEO represented the organization as he testified during the hearing. Click here to view the Senate HELP Hearing.

Click here for a complete overview of the hearing, transcripts of witness testimonies and a link to the FDA's initial inspection report of Ameridose.

IACP Letter to FDA and Press Release Declaring FDA had Clear Authority

Yesterday, IACP sent a letter to Food & Drug Administration (FDA) Commissioner Margaret Hamburg, MD, requesting information on not only why the FDA failed to take prompt action against New England Compounding Center (NECC) but also directly challenging their claims that the administration does not have adequate regulatory authority to halt illegal drug manufacturing. Click here to view article in its entirety.

Legislation on Regulation of Pharmacy Compounding Introduced to the House - HR 6584

In the aftermath of the unfortunate events surrounding the fungal meningitis outbreak, legislators are revisiting plans to strengthen the oversight of compounding pharmacies, namely Congressman Edward J. Markey (D-MA). On October 9, 2012 Congressman Markey released a statement announcing plans to introduce new legislation.

H.R. 6584 – Verifying Authority and Legality In Drug Compounding Act of 2012 was introduced to the House of Representatives on November 2, 2012. Click here to view article in its entirety.

Protect your privilege to compound. Contribute to IACP’s Public Affairs Fund today!

IACP Members,

IACP’s Public Affairs campaign is not just about getting the word out about compounding. The autistic child that requires an uncommon dosage of a particular medication, the diabetic allergic to an ingredient in a manufactured drug and even the elephant being treated by a local veterinarian are the very essence of this campaign. The Academy also wants to ensure that the option for patients to choose personalized medication solutions remains accessible. Click here to view article in its entirety.

PCAB Accreditation - More Important Than Ever

With Boards of Pharmacy exploring the need for additional regulation of compounding pharmacies of all types, much discussion has centered on whether pharmacies engaged in sterile compounding should be accredited.  While there are several accrediting bodies in the marketplace, IACP is a founding member of the Pharmacy Compounding Accreditation Board (PCAB).  Unlike for-profit accreditors, PCAB was created as a non-profit entity specifically by the national professional pharmacy associations in collaboration with the United States Pharmacopeial Convention (USP) and the National Association of Boards of Pharmacy (NABP).  IACP members serve on both the PCAB Standards and Accreditation Committees and provide much needed "real life" input to the organization. Click here to view article in its entirety.

Update on U.S. vs. Franck’s Pharmacy Case

IACP has worked to keep members up-to-date on developments in the U.S. vs. Franck’s Lab, Inc. case in past issues of Capitol Connections and special Member Alerts. IACP also issued a press release in response to the Food & Drug Administration’s (FDA) subsequent appeal of the September 2011 U.S. District Court for the Middle District of Florida ruling in US vs. Franck’s Lab, Inc. Click here to view press release.

The Academy has learned that as a result of...Click here to view article in its entirety.

Hunton & Williams Sending Out Cease-and-Desist Letters…Again

Another bout of “cease and desist” letters are in circulation, the most recent from the DC law firm of Hunton & Williams threatening action against pharmacists compounding hyaluronidase.  Although the client or manufacturer they represent is not mentioned, the manufactured product Hylenex® is.

Different pharmacies have received the same letter and it begins with the following statement: 

  • Specifically, we understand that your compounding pharmacy may be actively marketing to physicians a compounded hyaluronidase product that is represented to be manufactured to USP standards. No USP reference standard for hyaluronidase has existed since 2005, making compounded hyaluronidase per USP impossible. More importantly, no shortage of FDA-approved  hyaluronidase products has existed since 2004, leaving no rationale for the compounding of unapproved active ingredients that have not been tested for patient safety.

Click here to view article in its entirety.

Legislative/Regulatory Update

In light of the unfortunate events tied to the recent meningitis outbreak, regulations and standards of practice compounders must adhere to are now being placed under the microscope by many. Several state Boards of Pharmacy are reviewing existing regulations and even considering potential new laws that will affect compounders. Several Boards are also "reinterpreting" existing regulations. IACP has developed a running list of states currently examining laws/regulations. Click here to view article in its entirety.

Media Coverage of Compounding & Meningitis Outbreak

Below is a compilation of print, radio and television news pieces on pharmacy compounding and the meningitis outbreak crisis.

FDA took 684 days to warn compounding center tied to meningitis - NBC News

Senate health chair wants new drug compound rules - Associated Press

States try to strengthen rules on drug compounders - The Boston Globe

State board says it can regulate compounding pharmacies - The Baltimore Sun

GOP lawmakers push FDA on documents for meningitis probe - The Hill

Chances to avert meningitis outbreak possibly missed - USA Today

Deaths Stir a Dispute on Powers of F.D.A. - The New York Times

Click here to view full list.

IACP Calendar

 

IACP is your one-stop resource for all things compounding! CompounderCalendar provides a comprehensive listing of compounding events and continuing education programs.

Click here to view IACP’s Upcoming Events.

 

 

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