Senate committee passes drug compounding bill

Posted in Drug & Medical Devices on May 23, 2013

5/23/2013

 The U.S. Senate has approved legislation aimed at increasing federal oversight for companies that prepare and sell compound drugs.  One such company, the New England Compounding Center (NECC) was found to have shipped contaminated steroids that killed 55 people and sickened 686 others last fall.

According to The Washington Post, the new bill, approved by the Senate’s Health, Education, Labor and Pension Committee, “would create a new category of FDA oversight that would apply to a part of the industry that has grown rapidly over the past two decades, from small corner pharmacies into businesses that operate like large-scale manufacturers.”

Traditional compounding is a process in which medicines are combined or altered to change the dosing or form to address specific patient needs. However, many of these companies often ship drugs in advance of, or without a prescription for national use.  These drugs are not FDA approved.  Instead, they are currently regulated by states.

Today, in a hearing before the House Committee on Energy and Commerce, Joe Harmison of the National Community Pharmacists Association (NCPA) made the following statement.

“[B]efore expanding federal authority it is imperative that Congress look at whether current laws and regulations are being properly enforced. NCPA urges the Committee to preserve the authority of state Boards of Pharmacy over compounding by defining any new category with FDA oversight in a very limited and narrowly targeted manner. In addition, any legislation must not be used to facilitate a broad expansion of FDA power over the historically state-regulated practice of pharmaceutical compounding.”

Several consumer advocacy groups have voiced concerns about the bill, specifically that compound companies would not be held to the same rigorous standards as traditional pharmaceutical companies.  Also, the Senate bill leaves out medications taken in pill form as well as exempting compounders that only sell in one state.