As a condition of FDA’s recent supplemental approval for Pulmotil® (tilmicosin) in cattle, a veterinarian is required to issue a Veterinarian Feed Directive for the use of this new in-feed bovine respiratory disease therapy. As part of an ongoing series, Doug Hufstedler, PhD and Elanco technical consultant, explains what a VFD is, why it’s required, and how it impacts the veterinarian.
New feed-grade therapeutics are regulated by the FDA-CVM Veterinary Feed Directive. The VFD regulations were developed and implemented by the FDA in response to the Animal Drug Availability Act passed by Congress in 1996. The Act encourages continued development and approval for new feed grade therapeutics, while placing higher requirements for veterinarian oversight of their use to help ensure food safety. The judicious use of antimicrobials is important to all stakeholders in the food chain to help provide a safe and wholesome product to consumers. Several VFD drugs have been approved since the VFD regulations were established. These include Pulmotil for use in swine, Nuflor® (florfenicol) Premix for use in swine, Aquaflor® (florfenicol) for use in aquaculture and now Pulmotil for use in cattle.
What is the veterinarian’s overall role and responsibility for the VFD?
The VFD process requires a coordinated effort by the veterinarian, producer/client, feed advisor and feed supplier. The veterinarian initiates the process and is responsible for both approving the use of the VFD product by issuing a VFD order, and supervising the appropriate use of the product.
The most important starting point in the VFD process is the Veterinarian-Client-Patient-Relationship (VCPR). The veterinarian needs to have ongoing, direct involvement with the client. This ensures that when the VFD product label requirements are met, a VFD order can be implemented if the veterinarian believes the VFD drug is the most appropriate therapeutic solution for the group of cattle.
What is a VFD order?
The VFD order is a written document directing the use of the VFD drug by the client. As outlined by FDA in the Code of Federal Regulations (21 CFR 558.6) and summarized in Guidance for Industry #120, it includes information about the location and number of animals to be treated, the maximum amount of feed that can be fed and the drug level to be used. The primary requirements for a VFD include the following:
- Client (contact) information
- Veterinarian (contact) information
- Identification, number and location of cattle to be treated
- Special instructions directed by the veterinarian
- Feeding instructions, including amount of feed and drug level to provide, and withdrawal time
- Expiration date of the VFD
- Date of treatment, and, if different, date of issuing the VFD drug
- Name of drug and approved indications for use
- Veterinarian signature, license number and state
- The statement “Extra-label use, (i.e., use of this VFD feed in a manner other than as provided for in the VFD drug approval) is strictly prohibited.”
When can a VFD order be initiated?
A VFD order can be written and issued before the animals actually meet the conditions for product use required on the label. The drug cannot be administered until those label requirements are met, however. The VCPR is key to ensuring that all requirements are met before the VFD order is implemented. Once the VFD is written, copies are sent to both the client and the client-specified feed supplier of the VFD drug. The feed supplier must receive the original, signed copy of the VFD within five business days.
How do I determine the amount of feed and drug level for the VFD?
It is important to work with a client’s feed advisor and feed supplier to determine the amount of feed and drug level to include on the VFD. Knowing dry matter feed intakes is key in calculating the correct drug level to include.
Will Elanco be providing training and support tools to help me implement the VFD process?
Elanco will provide an extensive educational outreach program and support tools to help veterinarians, clients, feed advisors and feed suppliers understand the requirements and responsibilities for using Pulmotil in cattle under a VFD order.
When can I expect to hear more about VFD training opportunities?
Before bringing Pulmotil to market later this year, we have two important initiatives underway. First, we are conducting additional Pulmotil commercial trials in order to clearly understand and maximize Pulmotil’s value in a variety of commercial settings. We will also work closely with the veterinarian community to deliver VFD education and training opportunities that support the VFD process. Be sure to keep reading this newsletter throughout the year for more information about how to implement the VFD process, training opportunities and access to related support tools. We also encourage you to contact your Elanco technical consultant for additional information.
The label contains complete use information, including cautions and warnings. Always read, understand and follow the label and use directions.
Feeds containing tilmicosin must be withdrawn 28 days prior to slaughter.
For the control of Bovine Respiratory Disease (BRD) in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group: Feed continuously for a single, 14-day period at 568 to 757 g/ton of tilmicosin (100% DM basis) in a Type C medicated feed as the sole ration to provide 12.5 mg/kg of body weight/hd/d.
CAUTION: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian’s professional practice.
Nuflor and Aquaflor are property of Intervet International B.V. or affiliated companies or licensors.
Pulmotil® is a registered trademark of Elanco’s brand of tilmicosin.
© 2012 Elanco Animal Health.