Should Compounding Pharmacies Be Required to Follow FDA Safety Regulations?

Posted by Salvatore J. Zambri, founding member and partner

 

The International Academy of Compounding Pharmacies has traditionally fought against FDA oversight for compounding pharmacies and has argued that state pharmacy board registration and control was sufficient. Under the current laws, pharmacies must register with and are licensed by the state boards of pharmacy, not the FDA.  For drug manufacturers, FDA registration is required and their products must have FDA approval.  

Following a recent investigative research article by the Washington Post about the lack of safety regulation for compounding pharmacies, the executive vice president of the organization now endorses, "FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms."  As the FDA commissioner argued before Congress several months ago, "non-traditional" compounders need a special category for stepped-up enforcements, but left open recommending whether the FDA or state pharmacy boards should be responsible for the enforcement. 

This new position by the International Academy of Compounding Pharmacies seems to acknowledge the need for more control by the FDA. Creation of a way to regulate "non-traditional" drug manufacturing is currently being debated on Capitol Hill. Compounding firms frequently use non-FDA-approved drugs as key ingredients and many of their drugs are not dispensed in pill form, creating a difficult regulation scenario. According to Sarah Sellers, executive director of the Center for Pharmaceutical Safety, her concern is that a new enforcement system would be set up for compounders that assumes they are using FDA-approved ingredients. “When people use FDA-approved ingredients, built into that are good manufacturing practices. But there is an entire group of compounding pharmacies that are not using FDA-approved drugs. I’m concerned they will end up creating a ‘good manufacturing practices light.' ”

As I posted previously, the safety problems with compounding pharmacies have been known for years. Finding a way to police the industry effectively is important for patient safety.

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 About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2013 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers in both medical malpractice and personal injury law, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2013)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

 

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