An inspection campaign has been launched by federal regulators on large compounding pharmacies in reaction to the deadly outbreak of meningitis linked to tainted drugs from the New England Compounding Center (NECC).
Pressure from Congress and commercial drug makers has helped put this aggressive, surprise inspection in full force. The inspection began February 19th, and will continue over the next two months covering roughly 30 facilities that are considered “high risk”. According to records from the US Food and Drug Administration (FDA), these inspections have found 39 incidences of safety lapses. In the eleven states that have been inspected, four facilities have been cited for issues including contaminated drugs, medications with no expiration dates, and drug containers that were unsterile.
According to inspection reports released by the FDA, facilities in the states of Florida, Chicago, Arkansas and Mississippi were found with conditions that put their drugs at risk of microbiological contamination. The agency selected the pharmacies that they considered were at high risk, which was determined based on a potential for risk using adverse event reports turned into the FDA from historical inspection data, reports of quality problems and public information. State regulators are teaming up with the FDA to assist in conducting these inspections.
The surprise inspections are in response to the additional scrutiny on compounding pharmacies following the meningitis outbreak linked to a Massachusetts compounding pharmacy that shipped contaminated steroid shots to 23 states, resulting in 48 deaths and 666 sickened.
Typically, the agency will not inspect a pharmacy without receiving a complaint, however in light of the recent tragedy and the pressure placed on the FDA, they have taken it upon themselves to initiate these surprise inspections.
Source: Food and Drug Administration
Last Updated: 3/4/13; 11:40AM EST