FDA’s Judicious Use Strategy
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
The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation
December 2013 – Drug companies were asked to voluntarily revise their product labels to remove claims of growth promotion and increased feed efficiency
October 2015 – VFD final rule goes into effect which applies to current VFD drugs
December 2016 – Target for changes in label changes from drug companies.
January 1, 2017 – Full implementation of VFD – that all medically important antimicrobials for use in or on feed require a VFD and for those used in drinking water to require an Rx.
What is the VFD rule?
The U.S. Food and Drug Administration placed into effect the Veterinary Feed Directive (VFD) October 1, 2015, an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health. The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes.
“The actions the FDA has taken to date represent important steps toward a fundamental change in how antimicrobials can be legally used in food-producing animals,” said Michael R. Taylor, FDA deputy commissioner for foods. “The VFD final rule takes another important step by facilitating veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while ensuring such oversight is conducted in accordance with nationally consistent principles.”
What effect does the VFD rule have on the use of feed grade antimicrobials?
Essentially the Veterinary Feed Directive (VFD) rule ends performance enhancement uses of feed grade antimicrobials. Some of the same products, however, are labeled for prevention or control of disease and the VFD rule places those applications under the control of a licensed veterinarian. According to FDA, medically important antibiotics are those that are of therapeutic importance in human medicine and there is a risk of microbial resistance development if they are used in an injudicious manner.
|Antimicrobial Class||Specific Drugs Approved for use in Feed|
|Aminoglycosides||Apramycin, Hygromycin B, Neomycin, Streptomycin|
|Macrolides||Erythromycin, Oleandomycin, Tylosin|
|Sulfas||Sulfadimethoxine, Sulfamerazine, Sulfamethazine, Sulfaquinoxaline|
The above antimicrobials will be voluntarily withdrawn or transitioned to VFD status by 1/2017.
Affected Water – Use Antimicrobials:
|Antimicrobial Class||Specific Drugs Approved for use in Water|
|Aminoglycosides||Apramycin, Gentamicin, Neomycin, Spectinomycin, Streptomycin|
|Macrolides||Carbomycin, Erythromycin, Tylosin|
|Sulfas||Sulfachloropyrazine, Sulfachlorpyridazine, Sulfadimethoxine, Sulfamerazine, Sulfamethazine, Sulfaquinoxaline|
|Tetracycline||Chlortetracycline, Oxytetracycline, Tetracycline|
Antimicrobials used in water will require a prescription from a licensed veterinarian.
Links for the drugs that will be transitioning from OTC to VFD status:
What drugs are not affected by the VFD?
Drugs that are not medically important (medically important antimicrobials are those that are of therapeutic importance in human medicine and there is a risk of microbial resistance development if they are used in an injudicious manner).
Drugs that are not antimicrobials, for example:
What are the responsibilities of the veterinarian?
It must be emphasized that a veterinarian can only legally authorize a VFD or prescription within the context of a veterinary-client-patient relationship (VCPR). New York State utilizes the Federal definition of a VCPR which basically means the veterinarian must:
For this purpose, the VCPR does not mean the veterinarian is simply acquainted with the client and the client’s animals.
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What are the responsibilities of the producer/client?
Producers can obtain and feed the VFD drugs to animals only after receiving a lawful VFD issued by a licensed veterinarian. The client is obligated to use the VFD feed as indicated on the VFD and as specified on the product’s label. The producer must also maintain a copy of the VFD order for a minimum of 3 years (NYS requires records be kept for 3 years, federal guidelines are 2 years); and provide VFD orders for inspection and copying by FDA upon request.
What information needs to be on the VFD?
Labels for VFD drugs will include a cautionary statement saying “Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian”. Information that is required on a VFD is:
(i) “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.” OR
(ii) “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.] OR
(iii) “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.”
The veterinarian cannot provide clients with VFD drugs without filing the VFD documents. Three copies of the VFD will be issued by the veterinarian: one for their own records, one for their client and one to the client’s VFD feed distributor. Recordkeeping for VFD can be either written or electronic and must be retained for 2 years. NYS Department of Education requires records of veterinarians be kept for 3 years. VFD’s can be generated and handled electronically.
What’s the difference between a written prescription and a VFD?
Although they share similarities, they are distinguished by the intended use of the drug for which they are being written. When the drug is for use in or on animal feed (a medicated feed), the FDA approves these drugs as a VFD drug. When the drug is not for use in or on animal feed, the drug is approved as a prescription drug. The VFD category was created to provide veterinary supervision without invoking state pharmacy laws for prescription drugs that were unworkable for the distribution of medicated feed.
Will I still be able to purchase over-the-counter (OTC) drugs for my livestock?
In the past, certain drugs used in animal feeds were approved as over-the counter (OTC) drugs. The VFD only applies to antibiotics that are fed to cattle, with the exception of ionophores (Rumensin®, Bovatec®). Although the ionophores are technically considered antibiotics, they are not used in or deemed medically important to humans and, therefore, aren’t covered in the new Guidances. The new rule does not apply to OTC drugs such as injectable penicillin.
For how long is a VFD valid?
The expiration date of the VFD must not exceed 6 months after the date of issuance. If the drug approval, conditional approval, or index listing expressly allows a reorder (refill) the veterinarian can authorize up to the permitted number of reorders. If a drug is silent on reorders (refills), then the veterinarian may not authorize a reorder (refill).
Can a veterinarian write a VFD order for extralabel use?
No. A veterinarian may only write a VFD order for drugs approved, conditionally approved, or indexed as VFD drugs by the FDA (21 U.S.C. 354); nor may he or she write a VFD order to be used other than as specified on the labeling for that drug (i.e., extralabel use is not permitted). For example, feeding the animals a VFD medicated feed for a duration of time that is different from the duration specified on the label, feeding a VFD formulated with a drug level that is different from what is specified on the label, or feeding a VFD to an animal species different than what is specified on the label would all be considered extralabel uses. Extralabel use of medicated feed, including medicated feed containing a VFD drug or a combination VFD drug, is not permitted.
What is the difference between an “expiration date” on the VFD and duration of use?
While the VFD expiration date defines the period of time for which the authorization to feed an animal feed containing a VFD drug is lawful, the duration of use determines the length of time, established as part of the approval, conditional approval, or index listing process, that the animal feed containing the VFD drug is allowed to be fed to the animals.
Can a producer feed a VFD feed past the VFD expiration date?
No. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD. If the duration of use has not been completed before the expiration date of the VFD, the client must request a new VFD be written by his/her veterinarian.
I have a VFD order that I would like to use to feed a VFD feed, but the order will expire before I can complete the duration of use on the order, what should I do?
You should contact your veterinarian to request a new VFD order. A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD.
VFD - General Information:
VFD - Information for Veterinarians:
VFD - Information for producers:
VFD - Guidance for industry: