TWO FIRMS WARNED FOR COMPOUNDING 'COPIES' OF FDA-APPROVED DRUGS

The FDA warned two firms for compounding drugs that it said are "essentially copies" of commercially available, approved products without any documented reason. The companies also produced excessive amounts of the products, taking them beyond the realm of traditional pharmacy compounding, according to the agency.

During inspections Oct. 428, 2005, an investigator found that Wedgewood Village Pharmacy was engaged in the large-scale manufacturing of unapproved human and animal drugs, the Oct. 31 warning letter said.

The letter cited 20 Wedgewood Village products that it said are "essentially copies" of commercially available products. The firm does not document a medical need for patients who need these versions, the letter added.

The agency cited Pharmacy Creations as well, saying that the company was making 11 drug products that are copies of commercially available FDA-approved products. The company admitted it did not have documentation of a medical need for its versions of those products, the letter said.

In addition, Pharmacy Creations produces polidocanol, which is not contained in any FDA-approved product, and adenosine-5-monophosphate, which was removed from the market in 1973 because it was found to be neither safe nor effective, the agency said.

The warning letters can be viewed at www.fda.gov/foi/warning_letters/g6167d.pdf (http://www.fda.gov/foi/warning_letters/g6167d.pdf) and www.fda.gov/foi/warning_letters/g6168d.pdf (http://www.fda.gov/foi/warning_letters/g6168d.pdf).