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The 25-page report summarizes and quotes from FDA and state inspection reports and internal memos, though the committee declined to release the original documents.The report shows that after several years of problems, Food and Drug Administration officials in 2003 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations.But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.The congressional report also shows that in 2003 the FDA considered the company a pharmacy.That has put the Framingham, Mass.-based pharmacy at the center of congressional scrutiny and calls for greater regulation of compounding pharmacies, which make individualized medications for patients and have long operated in a legal gray area between state and federal laws.
The case ended without disciplinary action in 2006, when NECC agreed to a less stringent consent decree with the state.
Both patients were treated with antibiotics and eventually recovered, according to FDA documents cited by the committee.
When officials from the FDA and Massachusetts Board of Pharmacy visited NECC later in the month, Cadden said vials of the steroid returned by the hospital had tested negative for bacterial contamination.
Y., hospital who came down with symptoms of bacterial meningitis after receiving a different NECC injection.
The steroid, methylprednisolone acetate, is the same injectable linked to the current outbreak and is typically is used to treat back pain.