Product News and Recalls

Inspections shut down 11 Mass. pharmacies

State officials in Massachusetts have shut down 11 specialty pharmacies of the type responsible for last year’s deadly meningitis outbreak, following a series of surprise inspections.

According to a story in USA Today, inspectors looked in on 40 compounding pharmacies, which produce custom prescriptions in response to specific physician orders.

Compounding pharmacies aren’t subject to the same regulations as other pharmaceutical manufacturers.

That regulatory gap drew attention last year, when a Massachusetts pharmacy called the New England Compounding Center proved to the source of injectable steroid medication that spurred a fungal meningitis outbreak.

Meningitis is an inflammation of the tissue surrounding the spinal cord and brain. According to the U.S. Centers for Disease Control and Prevention, the outbreak traced to the NECC has killed 45 people and sickened nearly 700 throughout the country.

Inspectors later found unsanitary conditions at the NECC, which has since closed.

The USA Today story says 11 pharmacies shut down in the recent sweep must submit corrective plans, carry them out and pass another inspection before they can open again.

Among the problems found were improper procedures for sterile compounding, insufficient personnel training and environmental monitoring, improper storage and use of improper components.

According to the story, a congressional bill is in the works to step up federal oversight of the compounding pharmacy industry.

Lopez McHugh is investigating cases related to this outbreak. If you or a loved one had an injection and were diagnosed with meningitis, you should consult with a Lopez McHugh lawyer for a free consultation.

http://www.usatoday.com/story/news/nation/2013/02/06/meningitis-outbreak/1895155/