Company halts animal-use drug compounding during talks with government
posted June 18, 2010
A Florida laboratory has stopped compounding drugs for animal use and will allow federal inspectors to visit the business during negotiations over a pending court complaint.
Franck's Compounding Lab of Ocala, Fla., voluntarily stopped compounding and shipping animal-use drugs starting just before midnight May 17, according to a report company attorneys filed with federal court authorities. The voluntary suspension will last at least 30 days, and it does not affect the company's business as it relates to human-use pharmaceuticals.
Food and Drug Administration officials filed a complaint in April accusing Franck's officials of producing and selling unapproved and adulterated animal-use drugs and seeking an injunction that would ban the company and its CEO, Paul W. Franck, from compounding animal drugs from bulk ingredients. Company officials said they had acted within the law and they would fight the complaint.
In the complaint, the FDA cites its Compliance Policy Guide in stating that it considers animal drugs compounded from bulk substances or from unapproved drugs to be adulterated and illegal.
The FDA filed the complaint against Franck's in the U.S. District Court for the Middle District of Florida.
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