Dairy Topics

Veterinary Feed Directive

Starting in 2012, the FDA published a series of reports outlining changes for the use of medically important antimicrobials in the feed and water of food producing animals. With the publishing of the revised Veterinary Feed Directive the timeline is in place for the changes to take place and become effective January 1, 2017.

The following is a summarization of the related information and resources for these upcoming changes.

Relevant FDA Documents & Key Points

Guidance for Industry #209

The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (Link to document)

Summary:  Final guidance, recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs. 

Key Points:

Medically important antimicrobials

The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.


Further defines Medically Important Antimicrobials as outlined in GFI #152.


                      Medically Important

Non-Medically Important
















Requirement for veterinary oversight

The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.

Guidance for Industry #213

New Animal Drugs and New Animal Drug Combination Products Administer in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntary Aligning Product Use Conditions with GFI #209 (Link to document)

Summary: Final Guidance, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.  Effective January 1, 2017.

Key Points:

Guidance on labeling for pharmaceutical companies

Guidance for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of medically important antimicrobial drugs to remove production indications.


  • Voluntarily remove label indications for production uses:
    • “increased rate of weight gain”
    • “improved feed efficiency”
  • Remaining labels will be for therapeutic uses:
    • “treatment”
    • “control”
    • “prevention” 

Change in over-the-counter (OTC) status

Change the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight for medically important antimicrobial drugs


Products not affected

The new rules and changes only affect medically important antimicrobials.  There are a number of important products used and delivered through feed or water that will not be affected by the changes, including:


Non-Medically Important Antimicrobials

  • Bacitracin (Albac, BMD)
  • Bambermycin (Gainpro)


  • Amprolium (Corid)
  • Decoquinate (Deccox)


  • Monensin (Rumensin)
  • Laidlomycin (Cattlyst)
  • Lasalocid (Bovatec)


  • Fenbendazole (Safe-Guard)
  • Morantel (Rumatel)


  • Methoprene (Altosid)
  • Tetraclovinphos (Rabon)


  • Poloxalene (Bloat Guard)
  • Ractopamine (Optaflexx, Actogain)
  • Melengestrol Acetate (MGA)

Transitional labeling

Expect to see some transitional labeling before and after the Jan 1, 2107 date as the manufacturing process works the new labels into the production system. For example:


Source: https://mwi.naccvp.com/product/view/3690440

21 CFR Parts 514 and 558, Veterinary Feed Directive; Final Rule

 (Link to document)

Summary:  Final Rule, updates the existing VFD regulation.  Outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

Further details and resources can be found at:  http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

Key Points:

Definition of Veterinary Feed Directive (VFD)

Definition - A VFD is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that authorizes the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client’s animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the FDA. A VFD is also referred to as a VFD order.


Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455416.htm

Veterinary Feed Directive (VFD) vs. Prescription (Rx)

FDA approves drugs in these two separate regulatory categories for drugs that require veterinary supervision and oversight for their use. When the drug being approved is for use in or on animal feed (a medicated feed), FDA approves these drugs as a VFD drug. When the drug being approved is not for use in or on animal feed, the drug is approved as a prescription drug.


When the VFD drug category was created, the Act made it clear that VFD drugs are not prescription drugs. This category was created to provide veterinary supervision without invoking state pharmacy laws for prescription drugs that were unworkable for the distribution of medicated feed.


Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455416.htm

VFD and Rx Caution Statements

Prescription (Rx) products and Veterinary Feed Directive (VFD) drugs can be dispensed only by or upon the lawful written order of a licensed veterinarian.


  • Rx products must bear the legend:
    • "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."
  • Veterinary Feed Directive (VFD) drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement:
    • ‘‘Caution: Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian.’’

Source: http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm268128.htm#Classifying_RX_and_OTC_Animal_Drugs


Veterinary-Client-Patient-Relationship (VCPR)

Use of a VFD feed requires the professional supervision of a licensed veterinarian. 


The veterinarian-client-patient relationship (VCPR) is the basis of professional supervision. Veterinarians who issue a VFD order must practice veterinary medicine in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a VCPR as de?ned by the state. If applicable VCPR requirements as de?ned by such state do not include the key elements of a valid VCPR as de?ned by Federal law, the veterinarian must issue the VFD in the context of a valid VCPR as de?ned by the Federal law.


For a list of State vs. Federal VCPR requirement application see:  http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm


For resources on establishing a VCPR and associated documents see: http://cares.dairyknow.umn.edu/best-practices/drug-residues/

Veterinarians' Responsibilities

  • must be licensed to practice veterinary medicine;
  • must be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements;
  • must write VFD orders in the context of a valid client-patient-relationship (VCPR);
  • must issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug;
  • must prepare and sign a written VFD providing all required information;
  • may enter additional discretionary information to more specifically identify the animals to be treated/fed the VFD feed;
  • must include required information when a VFD drug is authorized for use in a drug combination that includes more than one VFD drug;
  • must restrict or allow the use of the VFD drug in combination with one or more OTC drug(s);
  • must provide the feed distributor with a copy of the VFD;
  • must provide the client with a copy of the VFD order;
  • must retain the original VFD for 2 years, and
  • must provide VFD orders for inspection and copying by FDA upon request.

USDA Brochure; VFD Requirements for Veterinarians

Information needed on VFD Forms

Required Information on a VFD Form / Order

  • veterinarian’s name, address, and telephone number;
  • client’s name, business or home address, and telephone number;
  • premises at which the animals speci?ed in the VFD are located;
  • date of VFD issuance;
  • expiration date of the VFD;
  • name of the VFD drug(s);
  • species and production class of animals to be fed the VFD feed;
  • approximate number of animals to be fed the VFD feed by the expiration date of the VFD;
  • indication for which the VFD is issued;
  • level of VFD drug in the feed and duration of use;
  • withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval;
  • number of reorders (re?lls) authorized, if permitted by the drug approval, conditional approval, or index listing;
  • statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”;
  • an affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6); and veterinarian’s electronic or written signature.


You may also see the following optional information on the VFD:

  • a more specific description of the location of the animals (for example, by site, pen, barn, stall, tank, or other descriptor the veterinarian deems appropriate);
  • the approximate age range of the animals;
  • the approximate weight range of the animals; and any other information the veterinarian deems appropriate to identify the animals at issue.


A lawful VFD has to be complete.


Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

Producer Responsibilities

As the client, a producer must:


  • Have a valid Veterinary-Client-Patient-Relationship (VCPR) with a licensed veterinarian in the state where the animals are located
  • Only feed animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) to animals based on a VFD issued by a licensed veterinarian;
  • Not feed a VFD feed or combination VFD feed to animals after the expiration date on the VFD;
  • Provide a copy of the VFD order to the feed distributor if the issuing veterinarian sends the distributor’s copy of the VFD through you, the client;
  • Maintain a copy of the VFD order for a minimum of 2 years
  • Provide VFD orders for inspection and copying by FDA upon request.


Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455413.htm

USDA Brochure: VFD Requirements for Producers

Distributor Responsibilities

Under VFD regulation, a "distributor" means any person who distributes a medicated feed containing a VFD drug to another person.


As a Distributor you must do the following:


  • file a one-time notice with FDA of intent to distribute VFD drugs;
  • notify FDA within 30 days of any change in ownership, business name, or business address;
  • fill a VFD order only if the VFD contains all required information;
  • ensure that the distributed animal feed containing the VFD drug or combination VFD drug complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug;
  • ensure all labeling and advertising prominently and conspicuously displays the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.";
  • retain VFD orders for two years from date of issuance;
  • retain records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years;
  • provide VFD orders for inspection and copying by FDA upon request;
  • retain records of VFD manufacturing for 1 year in accordance with 21 CFR part 225 and make such records available for inspection and copying by FDA upon request;
  • obtain, as the originating distributor (consignor), an acknowledgement letter from the receiving distributor (consignee) before the feed is shipped; and
  • retain a copy of each consignee distributor’s acknowledgement letter for 2 years.


All distributors of VFD feed must notify FDA before they distribute for the first time. A distributor must also notify FDA within 30 days of a change in ownership, business name, or business address.


Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455414.htm

USDA Brochure; VFD Requirements for Distributors

VFD Transmission

  • The veterinarian is required to issue a written (nonverbal) VFD
  • The veterinarian must send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or other electronic means.
  • If in hardcopy, the veterinarian is required to send the copy of the VFD to the distributor either directly or through the client.
  • Veterinarian must retain the original VFD in its original form (electronic or hardcopy) and must send a copy to the distributor and client.
    • Digital scan of a signed hardcopy is not recognized as a digital signature (must be part 11 compliant)
  • The veterinarian must keep the original VFD for two years (electronic or hardcopy).
  • All parties involved (veterinarian, client, distributor) must keep a copy of VFD for 2 years.
Other Key Points

Extralabel Use

“Extralabel use” is de?ned in FDA’s regulations as actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling.

Examples of Extralabel use of a feed medication:

  • Feeding the animals VFD feed for a duration of time that is different from the duration specified on the label,
  • Feeding VFD feed formulated with a drug level that is different from what is specified on the label
  • Feeding VFD feed to an animal species different than what is specified on the label

Extra-label use of VFD feed (or any other medicated feed) is not permitted.

The following Statement is required on all VFD forms: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”

Source: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455413.htm

"Concurrent Use" or "Combination Drugs"

Concurrent use or combination drugs are the use of more than one feed grade antibiotic (drug) at the same time.

Not all approved feed grade drugs are approved/labeled to be feed in combination.

The feeding of multiple feed grade drugs that are not an approved combination would be considered Extralabel use and not allowed under FDA regulations.

When issuing a VFD one of the requirements for the veterinarian is to allow or not allow approved combinations or other VFD or OTC feed grade drugs.

Veterinarians should work with manufactures on approved combination uses.


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Animal Care

Tail Hygiene

No matter why you may choose to dock tails on your farm, tail docking on dairies is a potential public relations issue for many producers and processors. Consider the following:

♦ The National Mastitis Council (NMC), American Veterinary Medical Association (AVMA) and American Association of Bovine Practitioners (AABP) all have position statements against tail docking.

♦ The National Dairy FARM Animal Care Program opposes the routine tail docking of dairy animals, except in the case of traumatic injury to an animal. This practice is recommended to be phased out by 2022.

♦ Both Nestle and Kraft have committed to rollout of programs which only purchase milk from producers who no longer dock tails on their farms. This is a consumer-driven trend that is likely to expand in coming years.

Alternatives to tail docking exist (switch trimming or clipping, facility modifications).  As the issue of tail docking continues to gain national and international attention, you may wish to decrease your risk of negative publicity by considering another method of tail hygiene.

Hygiene Materials


A comprehensive dehorning protocol should include:

♦ names and contact information of authorized dehorning personnel

♦ description of appropriate restraint

♦ description of appropriate method

♦ schedule for dehorning

♦ method of pain control

The schedule for dehorning should be frequent enough to ensure calves are dehorned before 8 weeks of age if cautery is used, or before 3 days if paste is used. Ideal pain control should include a local block at time of dehorning, in addition to post-procedure pain control such as an NSAID. The protocol should include pictures or diagrams, and translations should be available as needed for non-English speakers.

Dehorning Materials


A comprehensive euthanasia protocol should describe the names and contact information of people who are authorized to perform euthanasia, methods of appropriate restraint, the euthanasia method, how to confirm death, guidelines for proper carcass disposal, and guidelines for record-keeping. The protocol should also include pictures or diagrams, and translations should be available as needed for non-English speakers.

Euthanasia Materials

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Organic agriculture has increased by over 250 percent in the past decade. Dairy production is it’s second largest sector and the number of organically raised cows has increased from 38,000 to almost 250,000 between 2002 and 2011 (NASS, 2012). In the United States, accredited third party certifiers audit farmers to ensure that management practices meet the standards of the National Organic Program (NOP) of the USDA-AMS

The corner stone of organic farming is disease prevention and so the use of vaccines as well as mineral and vitamin supplementation are allowed. In contrast, antibiotics and hormones (exception Oxytocine) are generally prohibited in organic livestock production. The NOP lists all allowable synthetic treatments (§205.603 of the NOP) for organic livestock. (See below)

Ongoing research projects will provide additional information about best preventative management practices and curative approaches within the NOP and FDA guidelines.

Organic Therapies

This is a list of allowable synthetic substances from the National Organic Program. Please note that this list is not a veterinary-client relationship, veterinary advise or prescription. All therapies should only be used under veterinary guidance and after checking with the farm's organic certifier whether their use is permissible on that farm.


NOP Remarks


- disinfectant and sanitizer only, prohibited as a feed additive


- disinfectant only

Calcium hypochlorite

Chlorine dioxide

Sodium hypochlorite

- all chlorine materials allowed for disinfecting and sanitizing facilities and equipment. Residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.


- allowed for surgical procedures conducted by a veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness

Copper sulfate


Formic acid

- for use as a pesticide solely within honeybee hives



Peroxyacetic/peracetic acid

- for sanitizing facility and processing equipment

Phosphoric acid

- equipment cleaner, Provided, that no direct contact with organically managed livestock or land occurs


"Parasiticides—Prohibited in slaughter stock (ie., animals can never be organically sold meat after treatment), allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if the progeny will be sold as organic and must not be used during the lactation period for breeding stock." National Organic Program, 2015


Additional NOP Remark




- only for use by or on the lawful written order of a licensed veterinarian




- for control of internal parasites only


Pain Medication




Withdrawal Times









Aspirin (oral)



24 h


24 h




as local anesthetic


Epid.: 24h

SQ: 72h


Epid: 1d

SQ: 72h

Flunixin (Meglumine) I.V.


in accordance with approved labeling (Note: do not use IM or SQ!)



= 2 x FARAD

IV: 36h

IM: 72h


= 2x FARAD

IV: 4d

IM: 30d

SQ: 38d



only in emergency







only for reverse effect of sedation and analgesia by Xylazine














as local anesthetic





OTC: Over the counter medication.





Withdrawal Times













Atropine (Sulfate)




3d (single dose)1

6d (multiple doses)


14d (single dose)

28d(multiple doses

Biologics/ Vaccines









have to be without antibiotics







only for use in the manufacture of drugs used to treat organic livestock when the excipient is: Identified by the FDA as Generally Recognized as Safe; Approved by the FDA as a food additive; or Included in the FDA review and approval of a New Animal Drug Application or New Drug Application







in accordance with label

2x label


2x label











allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils





Hydrogen peroxide







Lime, hydrated


external pest control, not permitted to cauterize physical alterations or deodorize animal wastes





Magnesium hydroxide







Magnesium sulfate







DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calcium


for use only in organic poultry production at the following maximum levels of synthetic methionine per ton of feed: Laying and broiler chickens—2 pounds; turkeys and all other poultry—3 pounds





Mineral oil


topical use and as a lubricant







use in postparturition therapeutic applications







only be used for the emergency treatment of bloat





Sucrose octanoate esters


in accordance with approved labeling, feed additive





Trace minerals


used for enrichment or fortification when FDA approved







used for enrichment or fortification when FDA approved





1Haskell et al., 2005. JAVMA, Vol 226, No. 6:884-887


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