FDA finds safety issues at specialty pharmacies

Published on NewsOK Modified: April 12, 2013 at 11:16 am •  Published: April 12, 2013
Advertisement
;

WASHINGTON (AP) — The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs.

The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions. The FDA said Thursday it issued inspection reports to all but one of the pharmacies citing unsanitary conditions and quality control problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation, and employees wearing non-sterile lab coats.

The agency generally issues such reports before taking formal action against companies. Inspectors visited pharmacies in 18 states, including Florida, Arizona, Colorado, Tennessee and New Jersey.

The wave of inspections comes in response to a deadly fungal meningitis outbreak linked to contaminated steroids from the New England Compounding Center, a Massachusetts pharmacy. The company's injections, mainly used to treat back pain, have been linked to 53 deaths and 733 illnesses since last summer.

Compounding pharmacies are supposed to mix customized prescriptions based on individual doctors' instructions. However, some pharmacies like the New England Compounding Center have grown into larger businesses, supplying bulk quantities of injectable drugs to hospitals across the country.

The FDA has stepped up its oversight of the pharmacies since the outbreak was identified in September, but agency officials say they have been slowed by the complex overlap of various state and federal laws that govern the industry. Pharmacies are licensed and overseen by state pharmacy boards, though the FDA sometimes intervenes when major safety issues arise.

Continue reading this story on the...