Warning Letter

January 27, 2005
Pharmaceutical Technology

Warning Letter


In a 7 January warning letter,the US Food and Drug Administration's Kansas City district office(Lenexa, KS) cited Omaha's Essential Pharmacy Compounding formass-producing veterinary drugs from bulk active pharmaceuticalingredients. The warning cited large-scale compounding ofaltrenogest, amikacin sulfate, dipyrone, flunixin belumine, ketoprofen,ivermectin, ompeprazole, phenylbutazone, and tripelemine hydrochoride,"among many others."

As is typical in these warnings, the agency voicedconcerns that Essential is compounding not for individual patients butfor third-party resale, and that the compounded drugs duplicateapproved products in dosage and concentration.

–Douglas McCormick