Thursday, February 20, 2014

Rockwell Compounding Pharmacy Loses License

RYE, N.Y. -- The licenses of a pharmacist and his specialty pharmacy have been suspended for compounding medicine without individual patient prescriptions, according to documents obtained by .
Steven J. Cosentino is also charged with failing to alert patients who were at risk of using contaminated medicine.
The state Board of Regents took the disciplinary actions in January against Cosentino and Rockwell Compounding Associates of Rye.
Neither Cosentino, who was licensed in 1978, nor his company, licensed in 2004, held registrations as a manufacturer or wholesaler, which are required to produce medicine in bulk.
Compounding is the creation of a pharmaceutical product tailored to individual patients. It can be done in a variety of ways, such as changing medication from a solid pill to a liquid, avoiding ingredients to which the patients may be allergic, or by creating exact doses.
According to the disciplinary report, Cosentino "committed professional misconduct of practicing pharmacy beyond its authorized scope" and "unlawfully compounded and distributed Avastin (used for retinal treatment of eye disease) in bulk for 'office use' without specific patient prescription."
Until January, Rockwell held licenses in 39 states.
"On Sep. 25, 2013, Rockwell compounded a batch of Avastin from 100 mg vials. This batch consisted of 1.25 mg syringes of Avastin," reads the report. "Rockwell sold to the Delaware Eye Institute in Del., 60 syringes of the Avastin it had compounded without having received individual prescriptions for specific patients."
The same batch was sent to Eagle Analytical Services to test the sterility of samples of the medications that Rockwell compounds.
In October, Eagle submitted a report to Rockwell saying the sample had failed a "sterility test," and Cosentino and Rockwell failed to notify physicians, facilities or the 312 patients who had received the contaminated batch of Avastin, according to the disciplinary report.
The report notes that there are instances throughout the country in which the injection of contaminated Avastin into the eye has "led to the brain infection of a patient, another patient lost vision, and many other patients developed severe eye infections."
"Notice of this contamination â?¦ would have enabled patients to avoid any future use," Regent Harry Phillips III of Hartsdale said in the report. "Under all these circumstances, the public health, safety or welfare imperatively requires the emergency action of the summary suspension."
This is not the first time Cosentino has been disciplined for "unlawful manufacture" and for selling "drugs to physicians who are not the ultimate user for whom said drugs were intended."
In 2002, he received a censure and reprimand, was fined $7,500, and was placed on probation for a year.
Cosentino's attorney, Jan Ira Gellis, could not be reached for comment.
Calls to the Rockwell office were greeted by a message which said, in part, "Due to recent severe weather and local power outages, our clean rooms are temporarily out of order. We are doing our best at restoring power and thoroughly cleaning them to ensure patient safety."
In October 2012, the U.S. Centers for Disease Control and Prevention traced the outbreak of fungal meningitis to steroid shots from a Framingham, Mass., compounding pharmacy. The outbreak led the state to revoke the license for the New England Compounding Center.

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