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Massachusetts Orders 11 Pharmaceutical Companies to Shut Down

Over the past several months, the U.S. Department of Health of the state of Massachusetts inspected a series of pharmaceutical compounding plants after an outbreak of fungal meningitis. Yesterday, Massachusetts officials ordered the partial or complete closure of 11 pharmacies.

These surprise inspections are linked back to a meningitis outbreak that occurred late last year. On December 12, 2012, U.S. Food and Drug Administration (FDA) and the Center for Disease Control (CDC) announced an outbreak of meningitis at a compounding center in Massachusetts. The New England Compounding Center has since shut down.

Since then, Massachusetts officials have conducted a series of inspections on pharmaceutical compounding plants. 11 of the inspected pharmacies were required to partially or completely shut down because of varying degrees of violations.[1]

Pharmacies that have been closed are required to submit plans for corrective actions and then pass re-inspections before they can begin producing drugs again.

In the past, compounding pharmacies were not completely regulated by the FDA. Pharmacies generally fall under state law. On November 14, 2012, the FDA asked Congress to grant FDA more power to regulate compounding pharmacies. Congress has yet to make a final decision. Currently, U.S. food safety laws do not provide a clear definition of “compounding” which limits FDA’s “ability to build a case against compounding pharmacies that fail to meet basic safety standards.”[2]

If you have any question about drug establishment registration and listings requirements or any FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-244-0177.

 






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