A New Jersey pharmacy's parry of a FDA enforcement action may test the agency's power to regulate compounders -- makers of medicinal mixtures for special needs. In a cease-and-desist letter, the FDA accuses Wedgewood Village Pharmacy Inc. of violating federal law by manufacturing and selling "new drugs," not generally recognized as safe or effective for their labeled use. Wedgewood's counsel, Howard Hoffman, says the size and scope of production does not change the definition of compounding.
November 09, 2006 at 12:00 AM
1 minute read
The original version of this story was published on Law.Com
A New Jersey mail-order pharmacy’s parry of a Food and Drug Administration enforcement action may test the agency’s power to regulate compounders — makers of medicinal mixtures for special needs of human and animal consumers.
In a cease-and-desist letter, the FDA accuses Wedgewood Village Pharmacy Inc. of violating federal law by manufacturing and selling “new drugs” not generally recognized by experts as safe or effective for their labeled use.
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