Safety Issues at Compounding Pharmacies

Months after tainted steroid shots made by a Massachusetts pharmacy set off the worst drug disaster in decades by killing 53 people and sickening 680 others, federal inspectors have found dozens of potentially dangerous safety problems at 30 specialized pharmacies. 

According to an article published in The Washington Post, inspectors from the Food and Drug Administration discovered tears in gloves worn by technicians, rust and mold in “clean rooms” and inadequate microbial testing that raise the risk of lethal contamination. They also found black particles in vials of an injectable medicine at a Florida company.  

These specialized pharmacies, also called compounding pharmacies, were inspected between February and April, and marks the first time that the FDA targeted them. They focused on firms that produce high-risk sterile products.

According to the inspections, the compounders are failing to ensure safety of their products.  
 

The FDA has also inspected about a dozen other compounding pharmacies in response to complaints about drugs from state authorities. After the inspections, multiple firms have recalled their products and others have temporarily suspended making drugs.