They will not affect other feed-use medications such as ionophores, coccidia, other parasite- and insect-control drugs or reproductive-control medications.
VFD regulations will not apply to antibiotics used by injection, tablet, bolus or water.
The following are some common questions related to the VFD rules, which go into effect in December 2016.
Why has the FDA developed the VFD?
The driving force is the concern for antibiotic resistance associated with daily antibiotic use in animal feeds. Over a decade ago, the decision was made to move toward removing all antibiotic use in livestock that was associated with growth or feed efficiency – or long-term use, more than 21 consecutive days that allowed extended time for bacteria to develop resistance.
The VFD concept became the option for allowing vital feed antibiotic use in livestock for protection of their health and well-being. Antibiotics approved for use under the VFD regulations will be for “prevention,” “treatment” or “control” of specific bacterial diseases.
What is the VFD regulation target?
Antibiotics used in livestock feed and minerals will be the only drugs affected – and then only the antibiotics considered “medically important to humans.” Ionophores are antibiotics not important to humans and will not be affected.
Additionally, no other drugs, such as parasite-control, insect-control or reproduction-control feed additives will be affected.
What exactly is meant by drug use for ‘prevention,’ ‘treatment’ or ‘control’ in the VFD regulation?
- “Prevention of disease” with a VFD can be approved when a known disease risk is present and the VFD antibiotic can be administered to prevent animal infections.
None of the animals in the group are exhibiting clinical signs of disease but disease is likely to occur if the drug is not administered.
- “Treatment of disease” with a VFD antibiotic can be approved when animals exhibit disease signs.
- “Control of disease” with a VFD antibiotic can be approved to decrease the spread of disease when a percentage of the animals in the group have exhibited disease signs and the clinically sick are being individually treated.
What is a VFD?
A Veterinary Feed Directive (VFD) is a written order (paper or electronic) by a licensed veterinarian in the course of their practice approving the use of a VFD medication. The difference between a VFD and a veterinary prescription is:
A VFD isn’t governed by a state’s “board of pharmacy,” which simplifies the inventory control, dispensing and required records. VFD regulations do not apply to injectable antibiotics.
What does it mean for veterinarians?
Veterinarians will become responsible for all feed use of antibiotics considered by the FDA as medically important to humans. The following list outlines many of the specific tasks that will be required of licensed veterinarians to issue a VFD for cattle farm or ranch clients.
- Veterinarians must be licensed in the state in which the cattle reside.
- Must have a proper veterinary-client-patient relationship with the cattle operation
- Must prepare and sign the VFD supplying all the required information
- The VFD they authorize must comply with all conditions of approved use.
- Must include required information if the VFD drug is to be used in combination with other VFD drugs
- Must restrict or allow the VFD drug in combination with one or more approved over-the-counter feed medication
- Must assign the approved VFD expiration date and the “drug withdrawal time” following approved duration of the VFD use
- Can indicate if a “generic” VFD drug can be substituted for the “pioneer” VFD drug
- Must develop a mixer “flushing” or “clean-out” protocol to prevent a VFD drug from contamination of subsequent mixed feeds
- Must provide the feed distributor or mill (if other than “on-farm” mixing) a copy of the VFD, which can be transmitted by fax, email or electronic; however, the distributor must receive hard copy of the “VFD order” from vet within five working days.
- Must provide the client (cattle operation) a copy of the VFD. If the “client” is also the “mill,” they also receive the “mill” copy.
- Must keep original VFD for two years (two-year retention is also required for the client and feed distributor copies.)
- Must provide VFD orders for inspection and copying by the FDA upon request
- Some VFD medication will allow disease diagnosing by trained non-veterinary cattle caretakers.
- For VFD medications that allow this, the veterinarian must develop training for the non-veterinary caretakers, provide documented training and have a copy of the training outline or materials on file in the cattle operations office.
Next issue: Explaining the Veterinary- Client-Patient Relationship (VCPR)
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Dee Griffin
- Veterinarian, Professor
- Great Plains Veterinary Education Center - University of Nebraska
- Email Dee Griffin