Compounding Pharmacy Bill May Hinder Patient Safety

December 10, 2013 | Crandall & Pera Law
Compounding Pharmacy Bill May Hinder Patient Safety

A new bill passed by Congress regarding stricter regulations for compounding pharmacies may actually be doing less to keep patients safer, according to ABC News. 

The Drug Quality and Security Act was passed to prevent a repeat of what officials have called the "largest documented healthcare-related outbreak in the United States," when a New England Compounding Center made tainted steroid injections that killed 64 people and sickened about 700 others in a fungal outbreak in 20 states last year.

The bill would give large-scale compounding pharmacies the option to register with the Food and Drug Administration and adhere to stricter guidelines for testing and maintaining quality and sterility.

Opponents of the bill fear compounding pharmacies will not be treated like other drug manufacturers who have to adhere to mandatory guidelines because the bill does not require them. Supporters hope that compounding pharmacists will want to register with the FDA because doctors will prefer to use manufacturers perceived as safer.

"It makes no sense to have two different tiers of drug manufacturers -- one that has to meet all the manufacturing guidelines and one that only has to meet some of them," said Dr. Michael Carome, who directs the health research group at Public Citizen. "We believe in a level playing field." Read the full details here:

Compounding Pharmacy Bill Might Not Make Drugs Safer

Are compounding pharmacists safer? Should there be two sets of laws for the manufacture and sale of the same drugs? This article illustrates that the answers to these questions is not easy.

If you or a family member believe you have a medical malpractice case, contact Crandall & Pera Law today for a free case evaluation. Crandall & Pera Law is available to help answer your questions and guide you in determining your next steps.