Continued from page 1

However, NECC was licensed only to fill individual patients’ prescriptions, state officials said. Authorities said it may have been operating beyond its legal boundaries by shipping products for broad use around the country. Compounding pharmacies are more lightly regulated than pharmaceutical makers, and their products are not subject to Food and Drug Administration approval.

“The New England Compounding Center was masquerading as a compounding pharmacy so it could escape federal regulation when it was actually operating as a drug manufacturer,” said Rep. Edward Markey, D-Mass., who sits on the Energy and Commerce Committee, which has jurisdiction over the FDA.

Ameridose is regulated by the FDA, and in 2008 an FDA investigator found problems with its records, procedures and testing of drug products. Among the issues: Finished drug products were shipped before the company received results of a 14-day sterility test, according to Inspection Monitor, a trade newsletter that covers FDA inspections. Representatives of Ameridose and FDA did not return calls for comment.


Associated Press writers Holbrook Mohr in Jackson, Miss., Linda Johnson in Trenton, N.J., and Rodrique Ngowi in Boston contributed to this report.