Animal Feed

Medicated Feed Labeling and Manufacturing in Wisconsin 

Medicated feeds are regulated by the Wisconsin Department of Agriculture, Trade and Consumer Protection and by the United States Food and Drug Administration. 

Clear, accurate labeling is essential to protect animal and human health, because medicated feeds are no different from drugs administered orally or by injection. Over-medication can harm the animal and contaminate meat, milk, or eggs. Under-medication can create resistant microorganisms. Using a medication on one species that is meant for another can cause injury or death.

Medicated feed definition
Labeling requirements for medicated feeds
Custom-mixed medicated feed label templates
Current good manufacturing practices for medicated feeds
FDA regulations and guidance
Contact us for questions

Medicated feed definition

A medicated feed is a commercial animal feed that contains one or more drugs. A drug is anything meant to diagnose, cure, mitigate, treat or prevent disease, or anything other than a nutrient that is meant to affect the animal's body structure or function.

Medicated feeds may be:

  • Branded or "floor-stock" feeds, which are mixed and distributed by manufacturers or labelers using their own formula, for general distribution rather than an individual retail buyer.
  • Mill-formulated feeds, which are mixed by manufacturers or labelers using a formula they or their consultants prepare for a final retail buyer.
  • Custom-mixed feeds, which are mixed by manufacturers or labelers at the request of a final retail buyer who either provides one or more ingredients that make up a significant part of the feed, or who specifies the formula. It is not a custom-mixed feed if a consultant employed by the manufacturer or labeler develops the formula. It is a custom-mixed feed if the formula is developed by a consultant not employed by the manufacturer or employed by the buyer.
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    Labeling requirements for medicated feeds

    Like all commercial feeds, medicated feeds must be accompanied by a label. The label includes more than just the label on the container. It includes:

    • All written, printed, or graphic material attached to the feed container or to the invoice or delivery slip for the feed
    • Information on company websites
    • Brochures
    • Separate feeding instructions
    • Feed formulations or other material referring to the feed or feed ingredient

    The labeler assumes responsibility for the product, either by manufacturing or guaranteeing it, so the name and address listed on the label is considered the "guarantor" or labeler of the product.

    All commercial feeds have labeling requirements, regardless of whether they are medicated. These requirements are found in an administrative rule, ATCP 42. Read the general requirements

    Custom-mixed feeds have additional labeling requirements on top of the general requirements, regardless of whether they are medicated. Read the custom-mixed feed labeling requirements

    All medicated feeds have additional labeling requirements on top of the general requirements, and on top of the custom-mixed requirements if they are custom-mixed. Medicated feed labeling must contain:

    • The word "MEDICATED" printed directly after and below the product name
    • A statement that clearly explains the purpose of each drug in the feed
    • A statement of active drug ingredients, including the generic name (not the brand name)
    • Guaranteed amount of each active drug ingredient
    • Directions, including adequate instructions for further mixing or feeding to administer the approved level of the drug
    • All precautionary statements required for the drug or drug combination

    Read the complete requirements. 

    View an example of a branded/mill-formulated medicated feed label. (2 page PDF)

    View an example of a custom-mixed medicated feed label. (1 page PDF)

    Custom-mixed medicated feed label templates

    To help feed manufacturers provide custom-mixed medicated feed labels that meet requirements, we have developed a labeling program that uses spreadsheets to create template labels for commonly used drugs and drug combinations.  

    This program does not include all drugs and drug combinations. It is the feed manufacturer's responsibility to provide each customer with a label that complies with requirements every time the customer buys the feed, regardless of whether there is a template for the product.

    Using these spreadsheets to create custom medicate feed labels is subject to these terms and conditions.

    Instructions (1 page PDF)
    Templates for medicated cattle feeds
    Templates for medicated swine feeds
    Templates for medicated sheep and goat feeds
    Templates for medicated poultry feeds

    For more help in labeling medicated feeds, contact the drug manufacturer or drug ingredient supplier. Other resources:

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    FDA Regulations and Guidance

    The U.S. Food and Drug Administration regulates animal feeds at the federal level. The FDA reviews data submitted by drug manufacturers seeking approval for animal drugs, drugs levels, and drug combinations. 
     
    For information about approved drug uses, levels and combinations:
     
    FDA guidance for industry on medicated feeds:
    Guidance for Industry #72 - GMPs for Medicated Feed Manufacturers Not Required to Register and Be Licensed with FDA 
    Guidance for Industry #120 - Veterinary Feed Directive Regulations 
    Guidance for Industry #181 - Bluebird Medicated Feed Labeling
    Guidance for Industry #188 - Guidance for Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
    Guidance for Industry #200 - Small Entities Compliance Guide Designation of New Animal Drugs for Minor Uses/Minor Species
     

    Current Good Manufacturing Practices

    Current Good Manufacturing Practices (CGMP) are regulations developed the FDA and adopted by most states. They apply to all feed manufacturing, and all medicated feed and pet food manufacturers, labelers and distributors must follow them. Feed manufactured, packaged or held in violation of CGMPs is considered adulterated, making it illegal for distribution.
     
    You can find them in the Code of Federal Regulations Title 21, part 225. Wisconsin's CGMPs are contained in ATCP 42 of Wisconsin Administrative Code. 
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    Contact us for questions

    Feed specialist, 608-224-4539, datcpfeed@wi.gov