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Compounding Disaster - July 2016 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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... I've told our [Investigations Branch] not to bother inspecting compounding pharmacies if we aren't going to act on the violations." Douglas Stearn, the director of the Division of Compliance Policy in FDA's Office of Enforcement, was also incensed. "Some of these com- pounders have serious sterility issues," he wrote in an e-mail, calling it a "central public health issue." FDA's legal team ultimately decided that it could enforce the criteria in section 503A of the 1997 law except in the Ninth Circuit. It finished up the new guidelines in fall 2012. Rich and famous While the FDA stewed, the Caddens and Conigliaros were living the good life. In 2005, Barry and Lisa built a $1.8 million home in Wrentham, Mass. Later they bought a beach home in North Kingston, R.I. Mr. Cadden bought a $90,000 boat in 2010 and a sporty red BMW M3 for $80,000 in 2011. In April 2012, the Caddens treated themselves to a $15,000 first-class vacation to San Diego's ritzy Hotel Del Coronado. Between 2010 and 2012, Mr. Cadden raked in $62 million from NECC and Ameridose, according to FBI testimony. In 2010, Greg bought a stunning 6-bedroom house in Southborough, Mass., complete with indoor swimming pool and tennis court, for $3.5 million. He and his wife, Cynthia, already owned a $2.35 million water- front property and another $700,000 property in Cape Cod. Later, Greg hosted a fundraising event at his mansion for Senator Scott Brown (R- J U L Y 2 0 1 6 • O U T PA T I E N TS U R G E R Y. N E T • 1 5 5 NECC was manufacturing drugs in volume, without individual prescriptions for individual patients — both violations of FDA policy.

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