Thursday, February 27, 2014

Over One Year After My Inquiry to FDA I received the Following Answer--Thought I would Share So Everyone Would Know the Answer and Understand the Process

Dear Ms. Richmond:

This is in response to your e-mail communication dated January 22, 2013, inquiring why a December 8, 2004, warning letter to Veterinary Enterprises of Tomorrow is not listed on the Pharmacy Compounding web page.  You also asked what other letters are not included on that page and where these letters are located on the FDA web site.

The Pharmacy Compounding web page (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm) includes information related to compounded human drug products.  The Veterinary Enterprises of Tomorrow warning letter concerns compounded veterinary drug products, and, therefore, is not included on the Pharmacy Compounding web page.

Warning letters issued by the Agency between 1996 and the present, including the 2004 letter to Veterinary Enterprises of Tomorrow, are available on the following webpage: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm.

We hope this responds to your inquiry.  Should you have additional questions or require additional information, please contact Compounding@fda.hhs.gov.

Sincerely,

Edisa L. Gozun, PharmD
Compounding and Pharmacy Practices Branch
Division of Prescription Drugs
Office of Unapproved Drugs and Labeling Compliance
OC, CDER, FDA

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