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.
(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.
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.
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).
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 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) 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. ELDU VFD for MUMS CPG 615.115 (page 8 has the description of the ELDU written recommendation and the VFD “special instructions”)