How could this have happened? According to an article posted this morning on industry news site PharmPro,
The betting money seems to be on dirty conditions, faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees.
The drug at the center of the investigation is made without preservative, meaning there’s no alcohol or other solution in it to kill germs such as a fungus. So it’s very important that it be made under highly sterile conditions. …
“I don’t see it as appropriate for a community pharmacy to do a batch of something preservative-free in numbers in the thousands” of doses, said Lou Diorio, a New Jersey-based consultant to compounding pharmacies. Diorio, who has no connection to the investigation or the company, said it is harder to keep everything sterile when working with large amounts.
FDA’s Office of Criminal Investigations raided the New England Compounding Center (NECC)’s Massachusetts facility yesterday and seized all drug products that remained in the facility. The agency has expressed concerns about the sterility of NECC’s products and has expanded its advisory to healthcare providers.
Also yesterday, US Congressional Representative Edward Markey, D-MA, asked the Department of Justice to investigate whether NECC violated DEA regulations. Although NECC was not registered with DEA as a manufacturer or supplier of controlled substances, its product list appears to include almost 1000 separate formulations of drugs that are subject to DEA oversight. US Senator Richard Blumenthal, D-CT, also called for a criminal investigation in a letter to US Attorney General Eric Holder.
Meanwhile, the House Energy and Commerce Committee – whose jurisdiction includes the Department of Health and Human Services – requested that FDA hand over all documentation at has on NECC, going back to 2004. FDA has until October 31st to respond. Last week, the E&C Committee sent a similar letter to the Massachusetts Board of Pharmacy and also asked NECC to provide a briefing (which was to happen no later than today; stay tuned).