Compounding interest: a tragedy caused by contaminated steroids turned the spotlight on compounding pharmacies.

• Author: Hinkley, Kara Nett
• Position: COMPOUNDING PHARMACIES

At the end of last summer, doctors in several states became alarmed at the unusually high number of patients complaining of headaches, nausea, fever and inflammation around the spine. They all had one thing in common: recent steroid injections for back pain. Eventually, patients were diagnosed with fungal meningitis and other infections, and within six months, health officials in 23 states had documented 733 cases of the disease or infections related to it. The outbreak has claimed 53 lives and left scores of others facing a lifetime of chronic and debilitating health problems.

Ultimately, the problem was traced to unsanitary conditions at the New England Compounding Center in Framingham, Mass., maker of the steroid the victims had received earlier. When the U.S. Food and Drug Administration inspected the compounding center, it found 83 vials of the steroid that contained "greenish black foreign matter." The company, facing at least 400 lawsuits, has since filed for bankruptcy.

Compounding pharmacies make customized drugs for specific individuals who may be unable to use common forms. According to recent estimates, roughly 3,000 facilities practice sterile compounding and supply most of the injectable drugs in the United States.

States are responsible for regulating pharmacies and have set licensing and inspection requirements. But oversight of large compounding pharmacies that operate in and sell to several states can be problematic.

Seventeen states have based their laws and regulations on standards set by the U.S. Pharmacopeial Convention, also known as the USP, the organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements.

Recent State Action

Following the outbreak of fungal meningitis and other infections, state legislators began grappling with how best to regulate compounding pharmacies to prevent future tragedies without unfairly stifling the industry.

Lawmakers in 15 states have introduced 25 bills to address the often complex issue of regulatory authority. Virginia lawmakers were the first to enact an array of new regulations for compounded pharmaceuticals. "As a legislator and practicing pharmacist, I know that Virginia has an active pharmacy inspection program and has required compounding pharmacies to comply with USP standards for years," says Virginia Delegate Chris Jones (R). However, for Jones, it was important "to ensure Virginia can readily...