Report: NECC operated on manufacturing scale, failed in quality

The initial report from the Massachusetts Board of Registration in Pharmacy discovered what is already pretty clear by now. It shows that New England Compounding Center (NECC) was operating like a small drug manufacturing plant but without following the strict quality and safety oversight that would come if it had been treated like a manufacturer and regularly inspected by the FDA. The findings boost those who think that is what needs to happen.

A federal criminal investigation has been launched into the Framingham-based company, whose steroid products have been tied to an outbreak of a rare meningitis, CNN reported. The illness has killed 23 people and infected more than 300, numbers that change daily.

In its report issued late Tuesday, the pharmacy board found that "NECC distributed large batches of compounded sterile products directly to facilities apparently for general use rather than requiring a prescription for an individual patient." Its state license was only supposed to allow for prescription-specific compounding, although it has been operating on a much larger scale for years without state officials interceding.

Among quality problems, the probe that found the drug manufacturer released two of the recalled lots of methylprednisolone acetate (PF) 80 mg/ml before getting results of quality tests.

Proper sterilization procedures were not followed, and an inspection found dirty ventilation hoods, filthy floor mats and water standing on the floor next to a clean room. It also discovered black particles in some of the recovered vials of medication.

A congressional committee has already launched its own probe, a move that may lead to some new legislation to put large-scale compounding under federal purview. In part, the congressional inquiry is to hold the FDA accountable given that it did an inspection and issued a warning letter to the operation in 2006 after receiving a complaint about NECC's repackaging of the cancer drug Avastin.

The letter raised quality and health concerns, but the FDA apparently never returned to the facility, saying that the operation was under state jurisdiction. State regulators also found issues with the plant and made it agree to outside inspections from a consulting firm but didn't prevent it from operating on the scale that has now raised concerns. The steroid believed to be responsible for the outbreak was distributed in 23 states and administered to more than 14,000 patients.

- here's the state pharmacy board report
- get more from Reuters
- read this report from CNN

Related Articles:
Congressional committee wants answers on NECC's scale
Compounder tied to meningitis deaths sold large quantities
Outbreak probe broadens as first patient sues compounding pharmacy
Should FDA get more power over compounding pharmacies?

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