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FDA appeals compounding ruling
New Orleans - Federal regulators want the U.S. Court of Appeals for the Fifth Circuit to overturn a trial court's ruling that limits the Food and Drug Administration's (FDA) jurisdiction over the production of some compounded drugs.
NEW ORLEANS — Federal regulators want the U.S. Court of Appeals for the Fifth Circuit to overturn a trial court's ruling that limits the Food and Drug Administration's (FDA) jurisdiction over the production of some compounded drugs.
The appeal, filed Dec. 1, is the latest move by FDA, which has sent warning letters to two animal-health and seven human-health compounding companies since a U.S. District Court ruled Aug. 30 that compounding from bulk ingredients does not violate the Federal Food, Drug and Cosmetic Act (FDCA), as asserted by the regulatory agency.
FDA has long maintained that compounding from bulk substances constitutes manufacturing and is subject to the agency's oversight. Yet the 26-page decision exempts compounding drugs in "reasonable quantities" with receipt of a valid prescription from a licensed practitioner.
The trial court decision is valid only in the Western Texas district. The appeals ruling will cover Louisiana, Texas and Mississippi. Any challenge would go to the U.S. Supreme Court.
In the meantime, Wedgewood Pharmacy and Pharmacy Creations, both animal-health compounders in New Jersey, received letters from FDA Oct. 31 that were not scheduled to post on the agency's Web site until Dec. 19 due to "resource issues" within the Freedom of Information Office.
A six-page letter to Wedgewood notes a month-long inspection in October 2005 uncovered "serious" FDCA violations. It accuses Wedgewood of manufacturing new animal drugs that are not recognized by "qualified experts as safe and effective" for their labeled uses. The letter references its Compounding Policy Guide (CPG), which acts as internal document that directs inspectors, and alleges Wedgewood makes "copies of commercially available products," including enrofloxacin, pyimethamine/sulfadiazine, cyclosporine ophthalmic, altrenogest, flunixin meglumine and ketoprofen, among others.
The lawsuit asks Wedgewood to respond to the letter and correct the alleged violations. FDA officials did not return DVM Newsmagazine's comment requests. Linda Grassie, director of FDA's Center for Veterinary Medicine communications staff, says she has "serious doubts" about agency officials speaking publicly on the issue.
Wedgewood President George Malmberg contends the company operates within legal limits. Last month, the agency granted Wedgewood an extension to respond to its warning letter.
"This is a disagreement FDA has with our entire profession. This is the first warning letter we've received in the 26 years we've been doing business, and its allegations are unproven," he says.