Update on Unapproved Animal Health Products

February 17, 2010 — 

On October 28th the AASV published an article in the e-Letter regarding the use of unapproved animal health products in food producing animals (Are You Aware there are Unapproved Animal Health Products on the Market ). The article essentially advised veterinarians and producers that only products listed on the FDA's approved drug database, Animal Drugs@FDA, could legally be used in food producing animals in either a labeled or extra-label manner.

Following publication of this article, we received some inquiries regarding a couple of products being marketed for topical use that were not included in the FDA's database but which the manufacturers felt they had FDA "approval" to market. AASV contacted FDA directly to discuss the status of these specific products. Representatives of the FDA's Center for Veterinary Medicine reviewed the issue and basically reiterated their earlier position that only drugs listed in the FDA approved drug database, or approved human label drugs under AMDUCA, could be used for the topical treatment of wounds in food-producing animals.

AASV members can access a list of approved topical products on the AASV website. Take note, however, that of the 20 products, only the 2 trypsin-based products can be used in food-producing animals without veterinary prescription. The other products on the list could be prescribed by a licensed veterinarian on an extra-label basis assuming the criteria set forth under AMDUCA are met.

It is our understanding that at least one of the manufacturers has been in contact with FDA regarding having their product included in the list of approved products. We will update our database and let you know when additional products are added to the official approved products list.