Fungal Menigitis Outbreak Fungal Menigitis Outbreak
U.S . Food and Drug Administration
– Questions and Answers on Fungal Meningitis Outbreak
Q1. What is FDA’s role in the investigation?
A1. FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. FDA has observed fungal contamination in a sealed vial of methylprednisolone acetate collected from NECC, and is in the process of conducting additional testing to confirm the species of the fungus.
Q2. Is New England Compounding Center still producing sterile injectable products?
A2. No. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012. NECC has also announced a voluntary recall of all of their products.
Q3. What should health care providers do to protect their patients from the threat of potential contamination?
A3. Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, we are advising you not to use it at this time. Please see the CDC website1 for additional information.
Q4. Are there other FDA approved epidural steroid injections that can be used?
A4. There are FDA approved versions of methylprednisolone acetate injection on the market, available with or without preservatives. The FDA-approved products are not approved for epidural administration.
Q5. Does FDA anticipate a shortage of epidural steroid injection drug supply ?
A5. No. FDA’s drug shortage office has confirmed that NECC’s voluntary shutdown will not affect the nationwide supply of methylprednisolone acetate.