Compounding pharmacies were only a fairly obscure $2 billion a year niche-industry regulated by state regulatory agencies until a recent outbreak of fungal meningitis caused by tainted pain relieving injections placed the industry firmly in the national spotlight.
Last year the outbreak killed 53 people, sickened over 720, and may have exposed as many as 14,000 patients to a relatively rare form of fungal meningitis.
Many were shocked to find out that, although compounding pharmacies make customized medications for doctors and medical institutions nationwide, the U.S. Food and Drug Administration (FDA) does not regulate the industry. Rather, the pharmacies are overseen by state agencies that rarely, if ever, communicate with each other. Each state has varying sets of rules with varying degrees of expertise and oversight powers when it comes to regulating compounding pharmacies.
According to a report issued by Congressman Ed Markey (D-MA), many of these state agencies don’t even know basic information such as which pharmacies are compounding drugs or how much medication they make.