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NYS Food Safety & Drug Residue Avoidance Education

Drug usage on farms is a growing concern and regulations are swiftly changing. Through a cooperative agreement with FDA, New York State is offering talks around the state to discuss what food animal veterinarians need to know to protect themselves, their practices and their clients.

Sections

  1. Program Information
  2. Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
  3. Veterinary-Client-Patient-Relationship (VCPR)
  4. Veterinary Feed Directive (VFD)

Residue Prevention Systems

Welcome to the Food Safety and Drug Residue Avoidance Education Program

This program is a New York State education program funded through a grant from the Food and Drug Administration (FDA) to help farms with their drug use management. The program consists of a voluntary, educational, on-farm visit with a NYS field veterinarian to review the farm’s drug use management and recordkeeping which includes review of the food animal drug regulations; a risk assessment of the farm’s practices; identifying priority areas for improvement; creating new strategies/safeguards to improve management and their recordkeeping system with the ultimate goal of reducing the chances of drug residues in milk and meat going into the food supply. It is strongly recommended that the farm’s herd veterinarian participate in this on-farm visit to help strengthen the Veterinary – Client – Patient Relationship (VCPR) and to encourage the herd veterinarian and farm to continue to work together on the farm’s drug use, training, culling decisions and recordkeeping. The herd veterinarian not only allows farms legal access to prescription and Veterinary Feed Directive drugs, but also helps identify the correct drug choices for farm specific issues, helps create proper drug use protocols and withdrawal specifications as well as identify areas of opportunity to reduce drug use with preventative measures. This program will compensate the herd veterinarian for their participation so there is no cost to the farm.

Participation in the New York State Cattle Health Assurance Program (NYSCHAP) is not required to participate in this education program.

Farms and veterinarians interested in more information can contact the program coordinator:

Dr. Melanie Hemenway
Email: melanie.hemenway@agriculture.ny.gov
Phone/text: 585-313-754

Best Management Practices for Drug Residue Avoidance

From Food Safety/Drug Residue Avoidance Module of NYSCHAP.

  1. The farm has a valid veterinarian-client-patient relationship (VCPR) in place:
    • A veterinarian regularly visits your herd and consults with you about animal management and health issues.
    • A veterinarian is readily available for follow-up in case of adverse reactions or failure of treatment.
    • The veterinarian and producer have established an approved drug list.
    • The veterinarian establishes and reviews antibiotic use protocols in conjunction with the producer/farm management team.
  2. Proper drug usage on the farm:
    • Only FDA – approved drugs are used to treat animals.
    • All drugs on the dairy have proper labeling with copies of drug inserts and/or product labeling being followed and available.
    • Only drugs that are approved and labeled for designated herd groups ie. lactating cattle, non lactating cattle (less than 20 months of age) or other herd groups (e.g. bob veal calves), are use in those herd groups, and only those herd groups.
    • Only a veterinarian can prescribe drugs in an “extra-label” manner.
    • A farm specific list of current over-the-counter and prescription drugs that can be used on the dairy has been developed.
    • Drug withholding times for milk and meat are followed and documented as such in written records.
    • Minimize the number of people administering drugs on the farm to prevent miscommunication.
  3. Recordkeeping:
    • A record system is maintained for all treated animals.
    • Treatments are recorded immediately after completion.
    • ALL treated livestock (regardless of age or use), are identified after treatment.
    • Treatment records are kept for at least two years (State or local regulations may require a longer record retention time).
    • Drug label and insert directions are followed and the following information is recorded:
      • Identity of animal(s) being treated
      • Route of administration
      • Dose of administered
      • Person(s) administering
      • Date of administration
      • Reason for administration
      • Drug administered
      • Meat and milk withhold times
      • Specific dates when meat and milk can be used for food
      • If a veterinarian prescribed/recommended administration
      • Find example of drug insert at http://www.drugs.com/vet/excede-sterile-suspension-for-cattle.html
    • Treatment records are reviewed with veterinarian and used to improve management of potential hazards and to reduce risk to milk quality.
  4. Drug/Chemical/Storage/Testing:
    • Drugs for Lactating and Non-Lactating animals are stored separately.
    • Drugs are NOT stored/held in the milk house.
    • Expired drugs are removed from inventory.
    • No prohibited drugs are kept on the farm, or used, on food producing animals. http://www.farad.org/eldu/prohibit.asp
    • Prescription products are labeled appropriately, including name and address of the prescribing veterinarian (with which the herd has a veterinary-client-patient relationship).
    • Any Veterinary Feed Directive (VFD) feeds on the dairy are stored in such a way that an accidental use cannot occur.
    • It is understood that extra label drug of VFD drugs in animal feed is prohibited.
    • A drug (including a bulk drug) may not be mixed with feed for any use or at a potency level not specifically permitted by FDA regulation (21 CFR Part 558), even if prescribed by a veterinarian.
    • Milk from dry-cow treated cows that freshen early is tested for residues prior to marketing.
    • Milk from newly purchased animals is tested before adding their milk to the bulk tank.
    • When a cow is treated in an extra-label manner, test the milk for residues.  When using bulk tank tests on individual cows, consult the manufacturer’s directions to ensure applicability.
    • Complete a premarket/slaughter checklist before any animal is sold to market to review treatments and withdrawal periods to assure she is clear of drugs.
  5. Training:
    • Recommendations from the veterinarian are reviewed with employees and/or family members.
    • Employees and/or family members receive regular training on the prevention of milk and meat residues.
    • Treatment records are checked before marketing animals.
    • Employees and/or family members are trained on protocol of handling treated animals ie. milking last, keeping their milk from saleable milk.

Precautions while administering drugs

When treating animals with any product that is given IM, SC, IV, or intramammary (IMM), take the following precautions:

  • Read product label and insert, and consult your veterinarian before administering drugs.
  • Use a clean injection site and use a sterile needle for all injections.
  • Use the label dosage and method of administration least likely to create a residue.
  • Discard milk from all four quarters even when treating only one quarter with an IMM infusion.
  • Milk treated cows last or use a segregated facility (divert milk from bulk tank or saleable milk).
  • Thoroughly wash all equipment (inflations, hoses, weigh jars, etc.) that has come in contact with milk from treated cows.
  • Make certain that any procedure used to divert milk from treated cows cannot accidentally send contaminated milk into the pipeline.
  • Keep medicated feeds separated from non-medicated feeds.
  • Ensure that calves fed antibiotic waste milk are not sent to slaughter until withdrawal times are met.
  • Train employees on proper injection site selection.

Records:

Producers should keep records on all animals treated with drugs for 2 years.  The record system should be easily accessible to everyone who works with the animals and made available to government agencies when requested. Records should be permanent so the veterinarian has a history to which he/she can refer to prescribe effective therapy and to serve as protection in case of regulatory follow-up. The producer needs to be able to show how all drugs purchased were used or disposed. The treatment record should contain, at a minimum, the following information:

  1. Treatment date
  2. Animal identification
  3. Dosage
  4. Route of administration and expected duration
  5. Withdrawal time for milk and meat
  6. Individual who administered the drug
  7. Drug used
  8. Duration of therapy

Veterinarians should maintain records of what they are selling to their clients as well as protocols created for the client.  This gives the veterinarian a history to which he/she can refer to prescribe effective therapy and to serve as protection in case of regulatory follow-upNYS Department of Education requires records be kept for 3 years. 

AMDUCA

The FDA requires veterinarians to maintain records for two years of all animals treated using extra-label drugs (21 CFR 530.5).   NYS Department of Education requires records be kept for 3 years.  http://www.op.nysed.gov/prof/vetmed/vetpgintro.htm 

VFD

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 per federal guidance, 3 years per NYS guidance.  VFD’s can be generated and handled electronically. More information on the veterinarian’s requirements for the VFD can be found at 21 CFR 558.6   

References

Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) permits veterinarians to prescribe extra-label uses of certain approved new animal drugs and approved human drugs for animals under certain conditions. Extra-label use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. Under AMDUCA and its implementing regulations published at Title 21, Code of Federal Regulations, Part 530 (21 CFR 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 (VCPR). Extra-label use must also comply with other provisions of 21 CFR 530. A list of drugs specifically prohibited from extra-label use appears in 21 CFR 530.41.

"Extra-label use" is defined as:

"Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses." (21 CFR 530.3(a))

Labeling of Drugs Prescribed for Extra-label Use

Any drug prescribed and dispensed for extra-label use by a veterinarian or dispensed by a pharmacist on the order of a veterinarian must bear or be accompanied by labeling information adequate to assure the safe and proper use of the drug. (21 CFR 530.12) At a minimum, such information shall include the following:

  1. The name and address of the prescribing veterinarian. If the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian.
  2. The established name of the drug (active ingredient), or, if formulated from more than one active ingredient, the established name of each ingredient.
  3. Any directions for use specified by the veterinarian (including class/species or identification of the animal(s) being treated; dosage, frequency, and route of administration; and the duration of therapy).
  4. Any cautionary statements.
  5. The veterinarian's specified withdrawal, withholding, or discard time(s) for meat, milk, eggs, or any food which might be derived from the treated animal(s).

Prohibitions under AMDUCA

Under the AMDUCA provisions, FDA has the authority to prohibit extra-label uses of certain drugs in animals.

FDA may prohibit the extra-label use of an approved animal drug or approved human drug or class of drugs in food-producing animals if FDA determines that:

  1. An acceptable analytical method needs to be established and such method has not been established or cannot be established; or
  2. The extra-label use of the drug or class of drugs presents a risk to the public health.


A prohibition may be a general ban on the extra-label use of the drug or class of drugs or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors. 21 CFR 530.21

FDA may prohibit the extra-label use of an animal or human drug in nonfood-producing animals if FDA determines that such extra-label use presents a risk to the public health. 21 CFR 530.30

A list of drugs, families of drugs, and substances prohibited for extra-label use in animals appears in 21 CFR 530.41.

References

Veterinary Client-Patient Relationship (VCPR)

New York State:

A valid VCPR is a prerequisite to offering veterinary service in NYS. Veterinarians who are licensed and practice in NYS follow VCPR guidelines outlined by New York’s Bureau of Veterinary Medicine, as follows (October 2015):

A VCPR exists when all of the following are satisfied:

  1. The veterinarian has assumed the responsibility for making medical judgments regarding the health of the patient with the assent of the owner of the animal or their duly authorized agent.
  2. The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient. This means that the veterinarian is personally acquainted with the keeping and care of the patient by virtue of:
    1. a timely examination of the patient by the veterinarian, or
    2. medically appropriate and timely visits by the veterinarian to the operation where the patient is managed, or
    3. medically appropriate and timely visits by the patient to the veterinary facility where the veterinarian is working.
  3. The veterinarian is readily available for follow-up evaluation and oversight of treatment and outcomes, or has arranged for appropriate continuing care and treatment.
  4. Patient records are maintained.

Federal

New York’s guidelines, and US-FDA’s definition of a valid VCPR are very similar in meaning, however, since New York’s VCPR is not written in law, for US FDA’s purposes (as applies to writing a VFD or administering or prescribing drugs under AMDUCA) NY veterinarians defer to US FDA’s definition, noted below:

  1. A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an)animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;
  2. There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and
  3. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

Veterinarians must meet the State definition of a valid VCPR, in conjunction with the US-FDA definition of a valid VCPR, in other words, if the State definition goes above and beyond the US-FDA definition both definitions must be followed.

VCPR Key Points

  1. A VCPR is an inherent part of practicing veterinary medicine. It is in effect every time a veterinarian works with a client.
  2. Because it is inherent in practicing veterinary medicine daily, there is no requirement for it to be written between the vet and their client.
  3. There is no definition of timely visits which gives the veterinarian the discretion of what appropriate time limits are for each of their clients.
  4. The VCPR should be discussed between vet and client - especially when it comes to drug usage. A client’s drug usage can become the responsibility of their veterinarian even if the veterinarian is not aware of where or how their client is purchasing or using drugs. The relationship includes that the veterinarian is familiar with their client’s operation – that would include drug usage.
  5. Written agreements, especially in regards to drug inventories and drug usage, between the veterinarian and their clients is highly advisable. This would clarify what is happening on the operation and create responsibility/accountability for drug usage. An example of such an agreement is NYSCHAP’s Veterinary-Client Best Management Drug Usage Agreement form.
  6. These written agreements are NOT a COMPLETE VCPR in and of themselves, but rather, a subset of expectations under the broader definition of a VCPR; it includes responsibility and expectations between parties, as well as, documentation that “….the client (the owner of the animal or animals or other caretaker)” has agreed to follow the instructions of the veterinarian (stated in 21 CFR 530.3(i) )of the US FDA VCPR definition.

Veterinary - Client Recommendations

  1. CREATE WRITTEN AGREEMENTS between the veterinarian and the client. Include expectations between the two parties, outlines what the veterinarian’s responsible is for the operation (i.e. management area, drug usage, etc.), the client agrees to follow the protocols and accepts the oversight put forth by that veterinarian.
  2. CREATE FARM DRUG LISTS AND TREATMENT PROTOCOLS by the veterinarian for the client. This will set up the client to use drugs appropriately. Employee training on drug usage, treatments are completed by the herd veterinarian. Signed confirmation by both parties is recommended on protocols, training and oversight.
  3. REQUIRE FARMS TO KEEP WRITTEN/ELECTRONIC TREATMENT RECORDS for all groups of animals. Included in these records are: Date, ID, person administering treatment, indication for treatment, drug used, dosage, route given, withhold information for meat and milk.
  4. IDENTIFY RISKS FOR DRUG RESIDUES by reviewing the farm’s drug handling and usage, treatment records, number of individuals administering treatments, communication of these individuals, culling decisions, identification of all animals that have been treated – don’t forget young stock, storage and accessibility of drugs especially VFD drugs. Refer to NYSCHAP’s Drug Residue Risk Assessment under Residue Prevention Systems.
  5. ONGOING COMMUNICATION between veterinarian and client regarding other veterinarians/consultants that may be working with the client and any drug use changes. Review of written treatment protocols, drug usage, and treatment records by the veterinarian on a regular basis.

Frequently asked questions about the VCPR:

Does the VCPR have to be in writing?

No, but it is considered a “best practice” to have a written understandings of drug usage signed by all of the involved parties and to have a Veterinarian of Record for farm operations. AABP has issued their recommended guidelines for establishing and maintaining a VCPR which is included in our resource section.

Does the VCPR mean the client can ONLY purchase drugs from the veterinarian?

No. The VCPR simply states that the client has agreed to follow the instructions of the veterinarian. It is not an exclusive contract for purchasing drugs.

Does the VCPR include drugs that my client purchases over-the-counter and uses without my knowledge?

No. However, it is a good practice to discuss with the client ALL medications including OTC drugs to avoid errors in dosing and residues.

I signed a VCPR with my veterinarian for a period of one year. Does this mean that I don’t need to consult with him/her before I administer a prescription drug?

It depends on the drug and circumstances. For example, if you have a written protocol for how and when a fresh cow is treated for metritis, and your veterinarian is familiar with and approves of this protocol, you may follow this protocol for the duration of the VCPR. However, if you are suddenly noticing an increased incidence of metritis or you wish to change the protocol, then you should consult with your veterinarian. Similarly, you may, for example, have calves that are treated for pneumonia with a certain antibiotic after being examined by your veterinarian. If a few months later, the calves are once again showing symptoms, or if a different age calf is affected, or the symptoms are more severe, then you should consult with your veterinarian.

What if the veterinarian sells or prescribes a particular drug to a client, and the client does not follow the veterinarian’s directions. Is the veterinarian liable?

Maybe. The VCPR specifically states that the client has agreed to follow the instructions of the veterinarian. The veterinarian must advise the client clearly on the proper usage of medications, if this does not happen, then responsibility may fall on the veterinarian. If instructions are clearly given to the client and the client fails to follow these instructions, he/she is violating the terms of the VCPR. To avoid misunderstandings, written and specific instructions for all medications must be provided.

References

Veterinary Feed Directive (VFD)

History:

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.

Frequently Asked Questions


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.

What drugs are affected by the VFD?

Affected Feed - Use Antimicrobials

Antimicrobial Class Specific Drugs Approved for use in Feed
Aminoglycosides Apramycin, Hygromycin B, Neomycin, Streptomycin
Diaminopyrimidines Ormetoprim
Lincosamides Lincomycin
Macrolides Erythromycin, Oleandomycin, Tylosin
Penicillins Penicillin
Streptogramins Virginiamycin
Sulfas Sulfadimethoxine, Sulfamerazine, Sulfamethazine, Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline


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
Lincosamides Lincomycin
Macrolides Carbomycin, Erythromycin, Tylosin
Penicillins Penicillin
Streptogramins Virginiamycin
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).

  • Ionophores (monensin, lasalocid, etc.)
  • Bacitracin (BMD, bacitracin zinc)
  • Bambermycins
  • Carbadox

Drugs that are not antimicrobials, for example:

  • Anthelmentics: Fenbendazole, Ivermectin
  • Beta agonists: Ractopamine, Zilpaterol
  • Coccidiostats: Clopidol, Decoquinate, Diclazuril

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:

  • Engage with the client to assume responsibility for making clinical judgment about patient health.
  • Have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed.
  • Provide for any necessary follow-up evaluation or care.

For this purpose, the VCPR does not mean the veterinarian is simply acquainted with the client and the client’s animals.

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:


Either
(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."

  • Veterinarian and client information
  • Premise information where the animals specified 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
  • Number of reorders authorized
  • Statement: “Use of feed containing this VFD drug in a manner other than as directed on the labeling is not permitted”
  • An affirmation of intent for combination VFD drugs as described in 21 CFR 558.6(b)(6):
  • Veterinarian's electronic or written signature

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 extra label 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., extra label 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 extra label uses. Extra label 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.

References

VFD - General Information

VFD - Information for Veterinarians

VFD - Information for producers

VFD - Guidance for industry

Industry Resources

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