History of sterile compounding in U.S. hospitals: Learning from the tragic lessons of the past

History of sterile compounding in U.S. hospitals: Learning from the tragic lessons of the past

Senate should act efficiently on drug compounding bill

07/31/2013 | Washington Post (tiered subscription model), The

A Senate vote for legislation that would put some compounding pharmacies under the FDA's regulatory oversight would be a crucial step even if it's not yet clear how the House will act, according to this editorial. The bill's approval would show Congress is ready to help prevent events similar to last year's fungalmeningitis outbreak tied to the New England Compounding Center.

View Full Article in: Washington Post (tiered subscription model), The

Rep. Cummings and Tierney Release GAO Report on Drug Compounding

 

FOR IMMEDIATE RELEASE

Members Urge Action on Legislation to Protect Nation’s Drug Supply
 
Washington, DC (July 31, 2013)—Today, Rep. Elijah E. Cummings, the top Democrat on the House Committee on Oversight and Government Reform, and Rep. John Tierney, Ranking Member of the Subcommittee on National Security, Homeland Defense and Foreign Operations, released a report from the Government Accountability Office (GAO) on the oversight of pharmaceutical drug compounding.
 
Cumming and Tierney requested the report last year after a fungal meningitis outbreak from a contaminated compound drug led to more than 50 deaths and hundreds of illnesses.

You may read the full report on the Oversight Committee website by clicking here.

Congress should consider clarifying FDA's authority over compounding, GAO says--FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority.”

By Jessica Zigmond 

Posted: July 31, 2013 - 7:15 pm ET

Tags: Government Accountability Office (GAO), Pharmaceuticals, Regulation, Supply Chain, U.S. Food and Drug Administration (FDA)

Congress should think about clarifying the Food and Drug Administration's authority to oversee drug compounding, the Government Accountability Office concluded in a report released on Wednesday.

A deadly outbreak of fungal meningitis linked to contaminated compounded drugs in 2012 led to a series of federal hearings on Capitol Hill last fall. In those heated discussions, FDA Commissioner Dr. Margaret Hamburg implored lawmakers for more clarity on her agency's authority over compounding, a process in which a pharmacist combines, mixes or changes ingredients to create a drug that is tailored to an individual's needs.

Read more: Congress should consider clarifying FDA's authority over compounding, GAO says | Modern Healthcare http://www.modernhealthcare.com/article/20130731/NEWS/307319946#ixzz2agWCkXAQ 
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Follow up to The Thriving Compounding Pharmacy Industry In Tampa Bay Post

Thank you to Kenneth N. Woliner, M.D., A.B.F.M for the following information:

1.  Previous post entitled The Thriving Compounding Pharmacy Industry In Tampa Bay  is a press release.  It was put out by Father David, LLC d/b/a "Maxcare Pharmacy" (http://ww2.doh.state.fl.us/IRM00PRAES/PRASINDI.ASP?LicId=18803&ProfNBR=2205) in an effort to promote their compounding pharmacy directly to patients, not just to doctors.  Actually, they are using this press release to promote SPECIFICALLY TO PATIENTS, not doctors.  BTW, MaxCare Pharmacy's website is: http://www.maxcare-pharmacy.com/

 

FATHER DAVID, LLC
LICENSE NUMBER: PH25823	Printer Friendly Version
2.  The supervising pharmacist is Rita Shoukry, R.Ph.  She has only had a license since October 6, 2011.  Not exactly years and years of experience.  3.  Dr. Scott Gottleib has nothing to do with this pharmacy.  He might be surprised that they are using his name (and quotes from him, supposedly from a Forbes magazine article), as a way of promoting their pharmacy.  Shouldn't he be "paid" for being a spokesman for this company?  If I found out that a private company was using quotes from me in this manner, I would have my lawyer send them a "cease and desist" letter, telling them to stop, and to remunerate for the false use of my name.   4. Father David, LLC d/b/a MaxCare Pharmacy is actually owned by its supervising pharmacist.  This is RARE IN FLORIDA.  Florida is one a few states that doesn't prohibit unlicensed persons from owning medical clinics (such as the pain clinics that have been pumping out Oxycontin, Oxycodone, Xanax and Soma - creating addicts from Florida to Kentucky to Ohio ...; such as "Rejuvination Clinics" that pump out steroids (testosterone) and Human Growth Hormone (HGH) to Major League Baseball Players such as Alex Rodriguez and Ryan Braun; such as diet clinics that pump out HCG and Phentermine ... etc.    http://search.sunbiz.org/Inquiry/CorporationSearch/ConvertTiffToPDF?storagePath=COR%5C2011%5C1019%5C40461724.tif&documentNumber=L11000119630 5.  The reason why I bring up the "corporate practice of ____" (medicine, pharmacy, etc) - is that Florida is a hotbed for criminal activity because unlciensed businessmen (a.k.a. the mafia) will start these clinics and pharmacies as an easy way to do Medicare/Medicaid fraud, and/or prescribe/dispense drugs without medical justification.  Florida is the laughing-stock of the country. 6.  Regardless, this pharmacy wants to break into the compounding pharmacy business because it is so lucrative, and because regulation and enforcement is so lax.  Hopefully, the U.S. Congress will not water down the Senate Bill going through the sausage-making machine.  Hopefully, Florida's Legislature will pass stricter laws, but actually enforce the laws they have.  I'm not as hopeful for Florida doing its part.  We don't have a good track record, and there are so many probems I've uncovered at the Florida Department of Health's Bureau of Enforcement (that are not being addressed), that I feel that Florida will feed poisonous drugs to the nation for a long time to come (just look at Franck's Compounding Lab, Signature Pharmacy, etc.).