The Food and Drug Administration (FDA) has reportedly begun focusing its investigative efforts on compounding pharmacies at “high risk” for microbiological contamination. Some 30 facilities have been targeted for the proactive inspections, which will continue for two months. According to an agency spokesperson, “The recent tragic fungal meningitis outbreak has shed a harsh and important light on this area for us.” In the past, FDA conducted such inspections only when complaints came to its attention; its new initiative has reportedly revealed conditions at compounding pharmacies in Arkansas, Florida, Illinois, and Mississippi raising red flags and thus requiring drug testing. To the extent that FDA lacks authority to close facilities that make drugs only in response to patient prescriptions, it will refer its findings to state regulators. See Bloomberg Businessweek, March 1, 2013.
In a related development, lobbyists are apparently calling on Congress to draft legislation that would stop compounding pharmacies from mass producing “knockoff” drugs for people and their pets at a cost to commercial drug makers of millions in annual profits. Other stakeholders are opposed to any legislation that would limit pharmacies to dispensing patient-specific prescriptions only; veterinary groups, for example, argue that such restrictions would interfere with their ability to stockpile vital drugs and result in increased pet deaths at their clinics. Hospitals are evidently concerned that new FDA oversight does not exacerbate an already existing problem with drug shortages. According to a news source, the Senate Health, Education, Labor and Pensions Committee is preparing draft legislation to regulate compounders and expects to circulate it to stakeholders as early as March. A House committee is investigating whether lax FDA oversight contributed to the illnesses and deaths linked to the tainted steroids sold by a compounding pharmacy in Massachusetts. See The Washington Post, March 2, 2013.