Antimicrobial Use and Stewardship

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Federal & State Policy

Livestock producers and veterinarians dedicate their lives and livelihood to the provision of high quality, safe and nutritious food for millions of Americans. Producers have a real passion and pride for their industry, from progressive ranch management and environmental sustainability, to on farm animal welfare and preventative health practices. Veterinarians have the indispensable role as stewards of animal health, animal welfare and public health. Veterinarians, livestock producers and processors follow a number of state and federal laws in order to ensure that they are producing safe and responsible food for consumers.

The following resources explain a few of the important laws related to antimicrobial drug use in livestock species that veterinarians and producers observe on a daily basis.

According to the Livestock: Use of Antimicrobial Drugs law (FAC § 14400 – 14408), a medically important antimicrobial drug (MIAD) can be used to treat, control the spread of, and, in some cases, prevent disease or infection in livestock under the professional oversight of a veterinarian. Veterinarians may authorize use of MIADs when necessary for the following:
(1) To treat a disease or infection.
(2) To control the spread of a disease or infection.
(3) In relation to surgery or a medical procedure.

MIADs may be used when, in the professional judgement of a licensed veterinarian, it is needed for prophylaxis to address an elevated risk of contraction of a particular disease or infection. MIADs cannot be administered in a regular pattern to prevent disease, unless they are necessary in relation to surgery or a medical procedure. MIADs may not be administered to a healthy animal continuously beyond therapeutic need or employed as an imprudent, habitual management practice.
Easy-to-read Flowchart explains what is a medically important drug. List of Drugs that went from over-the-counter to prescription status, effective January 1, 2018. Medically Important Antimicrobial Drugs subject to change in California (including the national VFD and water soluble drugs). Medically Important & Not Currently Medically Important Antimicrobial Drugs Listed in Table 1 on page 26 of the FDA 2016 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals.
In California, a VCPR is established when the client has authorized the licensed veterinarian to assume responsibility for making medical judgements and the need for medical treatment of the patient (including the prescription of antimicrobials) AND the veterinarian has agreed to assuming that responsibility and has communicated with the client an appropriate course of treatment.

For a valid VCPR, the veterinarian must be personally acquainted with the care of the animal(s) by way of an examination of the animal or by medically appropriate and timely visits to the premises where the animals are kept AND have enough knowledge of the animal(s) to give at least a general or preliminary diagnosis of the medical condition.
VCPR (16 CCR § 2032.1) California’s definition of a VCPR has been accepted by the FDA to fulfill the national requirements.
Effective January 1, 2018, a licensed veterinarian who renews his or her license shall complete a minimum of one credit hour of continuing education on the judicious use of medically important antimicrobial drugs every four years as part of his or her continuing education requirements.

An explanation of when the first unit of CE is required can be found at the Veterinary Medical Board’s website.
California VMB Approved CE Providers The California VMB requests that any provider that is not a statutorily recognized entity seek approval through the American Association of Veterinary State Boards (AAVSB) Registry of Approved CE (RACE).
In order to practice veterinary medicine in California a veterinarian must be licensed by the state of California. For information on how to acquire a CA Veterinary License, please visit the Veterinary Medical Board’s website. Veterinary Prescriptions (Rx) Details the required information on a written veterinary drug order and drug label per the Veterinary Practice Act. Veterinary Food-Animal Drug Retailers Minimum standards for drugs dispensed using a veterinarian’s prescription as is in the Board of Pharmacy Code (16 CCR § 1708.1). ELDU Drug Label As designated by the FDA (21 CFR § 530.12) ELDU Veterinary Records As designated by the FDA (21 CFR § 530.5)
VFD Overview Video VFD Video for the Veterinarian VFD Requirements for Producers FDA material that can be printed as a brochure VFD Requirements for the Veterinarian FDA material that can be printed as a brochure VFD Distributor Notification List Who plans to sell VFD feed VFD Order Common Format Q&A (Appendix A: Blank VFD in the recommended common format) ELDU VFD for MUMS CPG 615.115 (page 8 has the description of the ELDU written recommendation and the VFD “special instructions”) Blue Bird Labels FDA provides a list of all Type A medicated articles and labels proposed for manufactured Type B and Type C medicated feed with legal VFD drug combinations and feeding instructions.
Extralabel use refers to the use of an FDA approved drug in a manner that is not in accordance with the approved label directions.

Under the provisions of AMDUCA and its implementing regulations, the FDA recognizes the professional judgment of veterinarians, and permits the extralabel use of drugs by veterinarians with a valid VCPR under certain conditions following recordkeeping and labeling requirements. In food-producing animals, extralabel uses of antimicrobials must not be administered via feed (with an exception made for minor use/minor species), nor result in a residue that may present a risk to public health.

A substantially extended withdrawal period supported by appropriate scientific information (scientific literature, academia, or FARAD) must be established and followed. The client must maintain the identity of the animal treated, otherwise the entire group, herd or flock must follow the established withdrawal period.

Under the AMDUCA provisions, FDA has the right to prohibit extralabel uses of certain drugs in food animals if the extralabel use of the drug or class of drugs presents a risk to human health, including antimicrobial resistance.
AMDUCA permits licensed veterinarians with a valid VCPR to prescribe extralabel uses (ELDU) of certain approved new animal drugs and approved human drugs under certain conditions per regulations. AMDUCA Explanation ELDU Limitations, Prohibitions & Compounding Drugs Prohibited from ELDU An up to date list of ELDU prohibited drugs The Ins and Outs of Extra-Label Drug Use in Animals FDA Resource for Veterinarians FARAD ELDU Algorithm A decision tree analysis to identify if the general conditions required by AMDUCA for ELDU have been met, including the recordkeeping and labeling requirements. Food Animal Residue Avoidance Databank (FARAD) USDA NIFA program to provide current and accurate scientific information to veterinarians and thereby foster the production of safe animal-derived human foods.
“Minor use” drugs are for intended uses in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for diseases that occur infrequently or in limited geographic areas and in only a small number of animals annually.

“Minor species” are all animals other than humans that are not one of the major species. They include animals such as zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish, game birds, and honey bees among others.
MUMS act of 2004 The law is intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in the major animal species. ELDU of medicated feeds for Minor Use/Minor Species (MUMS) - CPG 615.115 According to the FDA, extra-label use of medicated feeds is illegal. This guide does not make extra-label use legal; it simply makes it less likely that action will be taken against veterinarians and producers who use medicated feeds approved for use in other species for therapeutic purposes in minor species under the conditions stated in the CPG. See Page 7 for the description of the ELDU written recommendation and the VFD “special instructions”.
Veterinarians working with organic livestock producers have a very important role and responsibilities when treating organic livestock. Veterinarians must know what options are allowable to treat organic livestock and how to best advise the owner in order to establish and maintain their organic status and certification. Food Animal Residue Avoidance and Depletion (FARAD) Organic Livestock Operations is a valuable resource for veterinarians on the allowable organic treatment options and considerations that must be made in order to ensure a safe food supply. In order to be marked as "Organic" in the United States, all domestic and imported livestock products must comply with Federal regulations. The detailed requirements of all organic and crop operations are published annually in the Code of Federal Regulations