Commercial Feed Regulatory Program - Blog

Medicated Feed Labeling: Common Issues

Proper labeling of medicated feed is crucial in ensuring the feed will be used in a manner that is safe and effective for its intended use. Medicated feed must only be formulated and labeled in a manner that the stated concentration of the drug, indication of use, intended animal, and directions for use align to provide the dosage of the drug consistent with the level specifically permitted by the approvals and listed in Code of Federal Regulations, Title 21 (21 CFR) Part 558.

Many new animal drugs have many different approved levels of use depending on the intended animal and intended purpose of the drug. Incorrect dosing of any drug, even at levels that are not illegal or toxic, may still result in the medicated feed being ineffective for its intended use, or cause negative effects on production.

The Safe Animal Feed Education (SAFE) Program has compiled a list of common medicated feed label mistakes to avoid:

  • The label is missing the term “MEDICATED” at the top.
  • The label is missing the specific indication of use as stated in the Code of Federal Regulations (CFR).
  • The label is missing specific limitations and/or warnings as specified in the CFR.
  • The stated indication of use on the label is consistent with an approval for one production class of animal (e.g., calves), while other statements on the label including the title, purpose statement, and directions for use indicate the feed is intended for a different class of animal (e.g., lactating dairy cattle).
  • The stated indications of use are for one CFR approval (e.g., prevention of coccidiosis), while the feeding directions provide for a dosage that aligns with a different approval (e.g., feed efficiency).
  • The stated indication of use and dosage do not align with any CFR approval for the intended species and class of animal (e.g., there is no approval for “increased rate of weight gain” for calves).
  • The label contains two sets of conflicting feeding directions.
  • The label does not clearly state an intended feeding rate and/or mixing rate of the feed. It only states generally the approved use level of the drug.

More information and examples are provided in the Safe Medicated Feed Label Guide.


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