A new challenge in the form of the FDA Animal Medicinal Drug Use Clarification Act is here. Among its many sets and subsets, it clearly defines the way in which antibiotics may be used in food animal management. Perhaps it is better said it clearly defines when antibiotics designated to be used in humans may not be used in the feed of animals.
These rules have as their basis the ever-rising concerns among physicians and other human health care professionals regarding the use of antibiotics in animal feed contributing to the number of so called super bugs which are resistant to many of the antibiotics in use today. All drugs used in livestock which might find their way into the human food chain are regulated by the FDA.
Effective Jan. 1, 2017 antibiotics used in livestock may be used only in those animals who are suffering from a disease amendable to antibiotics. All other usage is forbidden. Drugs used in the treatment of food producing animals must be obtained either by prescription or through a veterinary food directive (VFD) prescribed by a veterinarian. Producers are responsible for the proper use, administration and documentation of all prescription and VFD medications used in their animals. In order to be legal there must exist a valid veterinary-client relationship (VCPR). It is illegal for a veterinarian to dispense or write a prescription or VFD for any animal or herd of animals he/she has not personally seen. The VCPR is important for both parties because it establishes a type of agreement on the responsibility and care for the animals.
Certain criteria have to be met before a VCPR can be considered legal and one of the requirements is the attending veterinarian has assumed responsibility for making clinical judgments regarding the health of the animal/herd, established the need for medical treatment and the client has agreed to follow his/her directions. Another is that there is sufficient knowledge of the animals by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition. Further the veterinarian must be readily available for follow-up in the event of adverse reactions or failure of the initial course of treatment. This can exist only when there is a close relationship between the practitioner and the client by repeated visits.
Since the new regulations were put in force many veterinarians have been asked to circumvent the rules and issue prescriptions and VFDs to allow owners to illegally obtain antibiotics. Veterinarians do so at their own risk and they are asking regulatory personnel to intervene to take appropriate action against those who make such requests. As noted in a report by Greg Cima in the Journal of the American Veterinary Association (AVMA), for many years producers in the southwest have fed chlortetracycline (Aureomycin) in feed as an aid in the treatment of anaplasmosis, which is endemic in the region. These formulations have been developed by the growers and their nutritionists, but under the new regulations veterinary intervention is now required as they have oversight over all chlortetracycline administration. Despite the past illegal use of certain over the counter antimicrobials in the treatment of pink eye and hoof rot, now that veterinary intervention is mandated this practice is coming under greater scrutiny.
The Extension Service of Mississippi State University has developed a list of commonly asked questions relating to the new regulations. Some question whether certain supplements such as mineral supplements may contain antimicrobials and the only way to tell is to carefully read the label on the product. Some have questioned whether it is possible to obtain over-the-counter (OTC) injectable antibiotics and the answer is their use is not currently controlled. Injectables are rarely used on a scale as large as that.
It is interesting to note products, previously obtained OTC and commonly added to the drinking water, such as neomycin, certain sulfas and tetracyclines, now require a prescription. VFDs cannot be ordered over the phone — they must be hard copy. For the process to work smoothly a distributor must have on file with the FDA a letter of intent which states they are in compliance with all of the regulations which pertain to their operation and further have an acknowledgement letter from the drug manufacturer or feed manufacturer.
VFDs should have both an expiration period and a duration of use statement on it. The expiration date refers to how long a VDF is valid. It is determined by either the product label or by the attending veterinarian after evaluating the medical needs of the animals involved, but not to exceed six months. The duration of use refers to the amount of time an animal or group of animals should be fed a particular product. That will be determined by the labeled directions for the particular drug. A veterinarian can act as a distributor of VFD products as long as they have notified the FDA they intend to distribute VFD products. This notification letter establishes he/she as a VFD distributor and allows them to fill a VFD order and render them subject to all rules pertaining to VFD distributors.
The assumption is anything relating to government regulations will entail paperwork and so it is but not as bad as one might expect. All parties involved retain records for two years and have them readily available for FDA inspection upon request. VFD manufacturers must retain records for one year.
The following drugs read like a list of old friends — around for a long time and very reliable. Now in some situations to be managed in a somewhat different manner.
- Chlortetracycline (Aureromucin)
- Chlortetracycline/sulfamethazine (Aureo S)
- Chlortetracycline/sulfamethazine/penicillin (Aureomix 500)
- Hygromycin B (hygromix)
- Lincomycin (lincomix)
- Oxytetracycline (terramycin)
- Oxytetracycline/neomycin (Neo-Oxy)
- Tylocine (TylaN)
- Tylocin/sulfamethazine (Tylan Sulfa G)
- Virginiamycin (Stafac)
For some producers, these new regulations will require no adjustments in their feeding programs while for others some adjustments will have to be made.