Warning Letter

January 27, 2005
Pharmaceutical Technology

FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.

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 for mass-producing veterinary drugs from bulk active pharmaceutical ingredients.

The warning cited large-scale compounding of altrenogest, amikacin sulfate, dipyrone, flunixin belumine, ketoprofen, ivermectin, ompeprazole, phenylbutazone, and tripelemine hydrochoride, "among many others." As is typical in these warnings, the agency voiced concerns that Essential is compounding not for individual patients but for third-party resale, and that the compounded drugs duplicate approved products in dosage and concentration.