Synopsis
Since the tragedy that came to light in October 2012, when contaminated epidural steroid injections produced by NECC caused significant patient harm, including the deaths of 64 people, there has been a strong focus by the FDA and local state boards of pharmacy on ensuring strict regulatory compliance during sterile compounding. A likely contributory factor to the contamination appears to be the general disrepair of NECC’s physical plant and a lack of proper upkeep of the cleanrooms themselves, concerns that have received extensive government and media attention. In 2012, the FDA issued 47 Form 483s involving procedures for sterile drug products; in 2013, the number of Form 483s issued to pharmacies detailing objectionable conditions concerning procedures for sterile drug products that required correction surged to 76.
