Veterinary Feed Directive (VFD) drugs are those intended for use in or on animal feed but are under the professional supervision of a licensed veterinarian. Soon, for a producer to obtain a feed or mineral Key Elements that Define a VCPR I. The veterinarian engages with the client to assume responsibility for making clinical judgments about patient health II. The veterinarian has sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed III. The veterinarian will provide for any necessary follow-up evaluation or care. containing a VFD drug (for example-chlortetracycline or “CTC”), a veterinarian must write a VFD order (similar to a prescription) for the feed mill or distributor to fill according to the drug label. Although the VFD requirements have been in effect since 2001, the FDA published a proposed rule in December 2013 described as a “user-friendly reorganization of the VFD rule” intended to improve the efficiency and practicality of veterinary oversight. The comment period ended on March 12, 2014 and the rule was finalized June 2, 2015. The FDA made several significant clarifications in the published final rule in areas that were highly debated. All guidelines are currently planned to take effect approximately December of 2016. The final rule may be found at: https://www.federalregister.gov/articles/2015/06/03/2015- 13393/veterinary-feed-directive

Clarifications in the Final Rule:

1. The Veterinary Feed Directive (VFD) final rule continues to require veterinarians to issue all VFDs within the context of a veterinarian-client-patient-relationship (VCPR), and specifies the key elements that define a VCPR. The final rule requires veterinarians to follow state-defined VCPR requirements; if FDA determines no appropriate state requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements (see Box). The agency will work with each state to review their VCPR requirements and determine if they are consistent with the federal standards.

2. Who can write a VFD order? As the regulation is written, a licensed veterinarian can issue a VFD if the following criteria are met:

a. The VFD order is for animals under his or her “supervision or oversight”;

b. In the course of his or her professional practice;

c. The veterinarian is in compliance with all applicable licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State (or Federal) guidelines. If a veterinarian issues a VFD without meeting these criteria, the State may take enforcement action and FDA may determine the resulting animal feed to be adulterated or misbranded. If the Federally defined valid VCPR standard is applicable and the veterinarian fails to comply, FDA may act to enforce compliance. The FDA did clarify that “licensed” means the veterinarian is licensed in the state in which the animals reside.

3. A few clarifications were made with the final rule to simplify the VFD order form including:

a. Veterinarian’s name, address, and phone number must be included but the Veterinary License number and state that issued it are no longer required;

b. Premises/Location where animals specified in the VFD are located; FDA clarified the definition of “location” as follows: Some groups of animals that are of similar age, weight range, etc., are managed in a similar manner, but may be housed in different physical locations. If a VFD is intended to authorize the use of a VFD feed in a group of animals that are located at more than one physical location, it is acceptable for a veterinarian to include multiple specified locations for that group of animals on the VFD. The veterinarian may write a VFD that covers animals in multiple locations to be fed the same VFD feed as long as it is supplied by a single feed manufacturer (distributor).

c. The approximate number of animals to be fed the VFD feed; The “approximate number of animals” is the potential or possible number of animals of the species and production class identified on the VFD that will be fed the VFD feed at the specified premises by the expiration date of the VFD.

d. Date the VFD order is issued and expiration date of order; The final rule allows the veterinarian to issue a VFD order authorizing access to the drug for up to 6 months except when the expiration is specified on the label.

e. Name of VFD drug (pioneer or generic)and the indication for which the VFD is issued;

f. Level of drug in the feed and duration of use; In the final rule, it is no longer necessary to calculate the total quantity of feed required.

g. Number of refills (reorders) permitted by the drug’s approval regulation and only if the label explicitly states refills are allowed. Currently, there are no approved VFD drugs that allow refills or reorders.

h. If desired, the veterinarian may, at his or her discretion, enter the following information on the VFD to more specifically identify the animals authorized to be treated/fed the VFD feed: (i) A more specific description of the location of animals (e.g., by pen, barn, or other descriptor that the veterinarian deems appropriate); (ii) The approximate age range of the animals; (iii) The approximate weight range of the animals; and (iv) Any other information the veterinarian deems appropriate to identify the animals specified in the VFD.

• Once completed, the veterinarian is required to keep the original VFD (in hardcopy or electronically) and the distributor and client must keep a copy of the VFD (in hardcopy or electronically) for two years. All involved parties must make the VFD and any other records specified in this section available for inspection and copying by FDA upon request.

• Verbal communication of a VFD is not allowed but electronic or hard copies of the order are acceptable.

4. FDA explained the difference between “expiration date” and “duration of use”. The “VFD expiration date” is the length of time a producer is authorized to legally feed the medicated feed.

- This period of time may be specified on the label of the VFD drug;

- If not specified, the veterinarian must specify an expiration date that does not exceed 6 months.

“Duration of use” limits the length of time that the animals can be fed the animal feed containing the VFD drug. This period of time is specified on the label of the VFD drug.

The best way to understand this difference is through an example. The currently approved VFD drug tilmicosin (Pulmotil®)allows a VFD expiration date of 45 days, but the duration of use (i.e., how long the drug is to be given to the animals) is limited to 21 days. This means the producer has a 45 day window to obtain the VFD feed and complete the 21 day course of therapy. Animals cannot legally be fed the VFD feed after the VFD expiration date.

5. Does FDA allow a “standing order”? The term “standing order” is not used in the regulatory text but refers to the situation in which a veterinarian issues a VFD for a drug with no label-defined expiration date; therefore, the veterinarian applies a VFD expiration date that does not exceed 6 months. In this situation, the veterinarian would use his or her medical judgment and knowledge of the operation to determine the need for the VFD drug and assign an expiration date. As a result, the client would have the VFD authorization in place and can quickly get the animal feed containing the VFD drug manufactured if and when the animals need treatment. This also allows clients with limited access to veterinarians to be able to receive a VFD and use it at a later date when it is needed.

6. What if you mix your own medicated feed? FDA does not intend to consider on-farm mixers to be distributors so no additional paperwork will be necessary once the VFD drug is obtained. The on-farm mixer must only be manufacturing VFD feed for use in their own animals on their own farm and should not be distributing feed to other persons without a VFD.

What is next? We are very early in the process of understanding how this law will be enforced and there are many more questions than good answers on how the purchase of previously over-the-counter products such as chlortetracycline (CTC) will be affected. FDA intends to use a phased enforcement strategy for implementation of this final rule as over-the-counter drugs become VFD drugs. FDA first intends to provide education and training for stakeholders subject to this final rule, such as veterinarians, clients (animal producers), feed mill distributors and other distributors. These education and training efforts are important for supporting effective implementation and compliance with the final rule. It is important to remember VFD drugs used in any fashion different than stated on the label (drug level, species, or indications for use) is prohibited by law for veterinarians and producers alike.