Drugs in Animal Feeds (Medicated Feeds)

Anyone who adds drugs to feed is subject to the Act. Just as each label claim for a new animal drug must be approved, a drug must be specifically approved for administration in animal feed. When the new animal drug application for use of the compound in animal feed is approved, a notice is published in the FEDERAL REGISTER [2]. The medicated feed must be labeled in accordance with the approved labeling.

A drug may only be mixed into feed for uses and at potency levels specifically permitted in the regulations (21 CFR Part 558.) The person or firm mixing a medicated feed containing a category II, Type A medicated article (21 CFR Part 558.4) must be registered with the FDA as a drug manufacturer and hold an approved medicated feed mill license.

It is a violation of the Act for drugs to be added for uses or at levels not specified in the regulations. Any individual authorizing the violation, as well as the individual illegally mixing the feed may be subject to regulatory action. Additionally, the feed itself may be subject to seizure. The agency will ordinarily allow off-label use of drugs in the feed of minor species provided certain conditions are met, including the involvement of a licensed veterinarian. Compliance Policy Guide 615.115 see (http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-115.html).