By:  Michelle Arnold, DVM (UKVDL)               Printable Version

The Food and Drug Administration (FDA) has issued a Judicious Use Guidance For Industry regarding the appropriate use of antibiotics in feed.  There are essentially two important principles that will change the way all livestock producers will obtain feeds containing antibiotics.  The first principle limits “medically important antimicrobial drugs” to uses in animals that are considered “necessary for assuring animal health”.  These uses include the treatment, control, and prevention of disease but do not include improved weight gain or feed efficiency.  The second principle states that the use of medically important antimicrobials will have veterinary oversight.  This will be accomplished by changing previously labeled over-the counter (OTC) drugs used in feeds to Veterinary Feed Directive (VFD) drugs. All feed labels are set to change by December 1, 2016 and guidelines for producers are to take effect January 2017. 

VFD drugs are defined by FDA as “drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian”.  Beginning January 2017, for a producer to obtain a feed or mineral containing a VFD drug (for example-neomycin in medicated milk replacer or medicated heifer feeds with chlortetracycline), a veterinarian must write a VFD order (similar to a prescription) for the distributor to fill according to the drug label.  The rule was finalized on June 3, 2015 and may be found at:  https://www.federalregister.gov/articles/2015/06/03/2015-13393/veterinary-feed-directive

The Veterinary Feed Directive (VFD) final rule requires veterinarians to issue all VFDs within the context of a veterinarian-client-patient-relationship (VCPR). What does that mean?  Basically the veterinarian assumes responsibility for making decisions regarding health problems in the herd; the veterinarian is familiar with the farming operation either by conducting patient examinations or visits to the facility; and the veterinarian will provide any necessary follow-up evaluation and emergency care. A licensed veterinarian can issue a VFD if the order is for animals under his or her “supervision or oversight” and is in the course of his or her professional practice. The only commonly used medically important antimicrobials with current feed labels approved for non-lactating cattle are chlortetracycline, neomycin, oxytetracycline, virginiamycin, and sulfamethazine.  The term “non-lactating” generally applies only to dairy bulls, dairy calves, and replacement heifers.  Labels should be read carefully because some products are not approved for non-ruminating calves, veal calves and female dairy cattle 20 months of age and older.  There are no FDA-approved drugs for feed additive use in lactating cattle. Antimicrobials not considered medically important so will not require a VFD include monensin (Rumensin®), lasolocid (Bovatec®), bacitracin (Baciferm), amprolium (Corid®), and decoquinate (Deccox®).  The veterinarian is required to keep the original VFD (in hardcopy or electronically) and the distributor and producer must also keep a copy of the VFD (in hardcopy or electronically) for 2 years.  Verbal communication of a VFD is not allowed.  

What information goes on the VFD form?

  1. Veterinarian’s name, address, and phone number [License number is not required];
  2. Client’s name, address, and phone number;
  3. Premises/Location where animals specified in the VFD are located;
  4. Species and production class of animals to be fed the VFD feed;
  5. The approximate number of animals to be fed the VFD feed by the expiration date of the VFD;
  6. 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.
  7. Name of VFD drug (pioneer or generic) and the indication for which the VFD is issued;
  8. Level of drug in the feed and duration of use;
  9. Withdrawal time;
  10. Any special instructions and caution statements;
  11. Number of refills (reorders) permitted by the drug’s approval regulation and only if the label explicitly permits them;Currently, there are no approved VFD drugs that allow refills or reorders.
  12. The following statement :  “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.”
  13. An affirmation of intent to combine VFD drugs with other drugs (for example, if using Rumensin (monensin) in the VFD feed, must include this information).
  14. Veterinarian’s electronic or written signature
  15. The veterinarian may enter more information on the VFD to more specifically identify the animals authorized to be fed the VFD feed if desired. 

Why is veterinary oversight necessary?  Developing strategies for reducing antimicrobial resistance is critically important for protecting both public and animal health. Based on the available scientific evidence, FDA believes the use of antimicrobial drugs in feed should involve the scientific and clinical training of a licensed veterinarian. However, it is important to remember that VFD drugs used in any fashion different than stated on the label (drug level, species, or indications for use) is strictly prohibited by law for veterinarians and producers alike.