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I. Purpose

This policy deals with food products derived from livestock that are legally considered adulterated due to their use in research. It also defines procedures for preventing inadvertent adulteration of animals that receive substances for clinical care under the direction of a veterinarian. Residues can also be created by research endeavors by feeding non-AAFCO (Association of American Feed Control Officials) approved feedstuffs and would be included under this policy.

II. Scope

This policy applies to all food producing livestock used in Montana State University’s agricultural teaching and research programs.

III. Substances used in the clinical care of livestock

  1. Background: FDA approved compounds for clinical use fall into two categories:
    1. Compounds that are used strictly as labeled, with manufactureer-recommended withdrawal times followed. 
    2. Compounds that are considered extra-label and must meet the following criteria to be administered to food-producing animals while still allowing those animals to enter the food suppl:
      1. Must be administered by or on the lawful written or oral order of a licensed veterinarian with in the context of a valid VCPR.
      2. Extra-label use is limited to circumstances when the health of an animal is threatened or suffering or death may result from failure to treat. Extra-label use is not permitted to enhance production. 
      3. There is no approved animal drug that is labeled for such use and that contains the same active ingredient in the required dosage form and concentration, except where a veterinarian finds, within the context of a valid VCPR, that the approved animal drug is clinically ineffective for its intended use. 
      4. Before prescribing or dispensing an approved animal drug or approved human drug for an extra-label use in food animals, the veterinarian must take appropriate measures to ensure that assigned time frames for withdrawal are met and no illegal drug residues occour in any food producing animal subjected to extra-label treatment.
  2. Compounds NOT permitted in food producing animals
    1. Under the Animal Medicinal Drug Use Clarification Act (AMDUCA) provisions the Food and Drug Administration (FDA) has the right to prohibit extra-label uses of certain drugs in animals. 
    2. The list can be found in Section 530.41 of Title 21 of the Code of Federal Regulations. 
  3. Compounds that ARE permitted in food producing animals
    1. Drugs with known meat and milk withdrawal: Veterinary Drugs and other FDA-prescribed withdrawal period for agricultural animals.
    2. Any veterinary drug or other FDA-approved compound that includes an FDA-prescribed withdrawal period for agricultural animals: 
      1. Such compounds must have been manufactured utilizing Good Manufacturing Practices. 
      2. Such products must be administered as labeled to not fall under extra-label use category and AMDUCA.
      3. Any drugs used with food-producing agricultural animals must follow laabeled withdrawal times for milk or meat that are species-specific.
    3. Any pharmaceutical-grade drug prescribed by a veterinarian under the Animal Medicinal Drug Use Clarification Act (AMDUCA)
      1. AMDUCA permits veterinarians to prescribe extra-label uses of certain approved new animal drugs and approved human drugs for animal use under certain conditions. Under AMDUCA and its regulations published at Title 21, Code of Federal Regulations, Part 530, any extra-label use of an approved new animal or human drug must be by or on the lawful order of a veterinarian within the context of a veterinarian-client-patient relationship.
      2. The consulting veterinarian will provide the published withdrawal times for pharmaceuticals utilized in this manner. These compounds can be administered only under the direct orders of a licensed
    4. FARAD
      1. FARAD can be used as a resource to guide withdrawal time recommendations on a case-by-case basis for compounds administered to animals. A withdrawal time prescribed by FARAD does not automatically indicate an animal is unadulterated or cleared to be used for food production.
        1. The FARAD website: farad.org.
        2. Data from FARAD regarding any compounds administered to agricultural animals in teaching or research protocols should be available and maximum withdrawal period after administration of these compounds will be documented and shared with Program Veterinarian and facility manager.
    5. Substances used in research investigation involving livestock
      1. Animals prohibited from slaughter:
        1. Any agricultural animal treated with recombinant protein, non-FDA approved vaccine adjuvant or any experimental substance, where residue clearance cannot be predicted or avoided, will not be allowed to enter the food chain, and must be euthanized upon final disposition.
      2. Animals that may be sent to slaughter:
        1. Animals that receive experimental substances as part of an approved MSU AACUC protocol must be approved for slaughter by the USDA Food Safety and Inspection Service (FSIS) in writing.
      3. Animals sold/returned to original owner with uncertain disposition:
        1. Circumstances may arise where the party receiving animals from the university cannot identify what their final disposition will ultimately In this case, the transfer or sale of the animals cannot be done unless a signed, written agreement is in place whereby the university discloses the animals use in research, and the receiving party agrees to indemnify the university from the impact of the research activity on the future use of the animals.

Note: “While there are currently no United States markets for horse meat, international markets still exist. No MSU-owned horse shall be directly sold or transferred to any entity known to deal in these markets.”

 

AACUC Approval Date: 10/21/2025

Review Date:  10/21/2025

Issue Date:  10/31/2025