Compounding Pharmacy Report Reveals Limited Regulation | DC Metro Area Medical Malpractice Law Blog

Posted by Salvatore J. Zambri, founding member and partner

The push to regulate compounding pharmacies is beginning to gain more attention on the national front. According to a congressional report released on April 15, 2013, the state-by-state examination last fall into the safety issues surrounding the common practices among compounding pharmacies demonstrates that states do not adequately track, regulate or inspect these pharmacies, exposing patients to unsafe drugs, disease and death.

The Markey Report, “State of Disarray,” findings and conclusions:

• “State boards of pharmacy generally do not know which pharmacies engage in compounding, do not know whether pharmacies ship compounded drugs across state lines, and do not know which pharmacies manufacture large quantities of compounded drugs.
• Only thirteen state boards of pharmacy know which pharmacies are providing sterile compounding services and only five of these states have inspectors that are trained to identify problems with sterile compounding.
• States typically do not maintain pharmacy inspection records that enable them to identify systemic and repeated compounding pharmacy safety problems that originate either in-state or out-of-state.
• States are unable to effectively police compounding pharmacy activities in other states. Moreover, when issues arise with out-of-state pharmacies, states do not consistently inform the origination state or the FDA.
• Despite general increases in state board of pharmacy budgets, the number of pharmacy inspectors has remained consistently low. Furthermore, states usually do not distinguish between inspections of traditional and compounding pharmacies.”

Congressman Markey is among those who support legislation to give the Food and Drug Administration more authority over compounding pharmacies.  A scheduled hearing of a House Energy and Commerce subcommittee will be held on Tuesday, April 16, 2013 to focus on this issue.

I will continue to update our readers on this critical consumer issue as more attention is given to the safety problems of compounding pharmacies.

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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 [email protected] You may also reach him at 202-822-1899.