Saturday, November 17, 2012

Ohio Board of Pharmacy Summary Suspension of NECC in October


New England Compounding Center
Update
As many of you know from the Board’s recent e-mail
blast, the Board announced the summary suspension of the
Ohio Terminal Distributor of Dangerous Drugs license for

the New England Compounding Center (NECC) located
in Framingham, MA, effective October 9, 2012.  The
Board has participated in discussions with the Ohio Department of Health
(ODH) and the investigation conducted by the Centers for Disease Control
and Prevention and
the United States Food and Drug Administration (FDA)
concerning NECC’s contaminated methylprednisolone
acetate injections. To date, these products have resulted
in a fungal meningitis outbreak that has affected people
in 19 states and caused 28 deaths nationwide. Prior to the
issuance of the summary suspension, the Board found that
there was clear and convincing evidence that the continuation of NECC’s
professional practice in Ohio presented
a danger of immediate and serious harm to others.
The contaminated methylprednisolone acetate injections were
administered to 425 people in Ohio. All of
these patients have been notified by ODH and as of this
writing, 14 Ohio patients have tested positive for the
fungal meningitis infection. To date, there have been no
deaths in Ohio from this contamination. It appears that
four clinics in Ohio received the affected methylprednisolone product.
These clinics were located in Cincinnati,
Columbus, and Marion, OH. The Board is additionally
conducting its own investigation. Due to the amount of
product that has been shipped from NECC into Ohio,
there is federal concern that NECC was manufacturing
products, not compounding medications.

Source found here




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