Drug regulations for the bovine practitioner (Proceedings)

Disclaimer: The author is not employed by any federal or state agency that enforces drug regulations. Therefore, the information presented below should be interpreted only as the author's opinion, and any questions regarding drug regulations should be referred to the appropriate government agency for clarification.

Who Regulates Veterinary Drugs?

The Food and Drug Administration Center for Veterinary Medicine (FDA CVM) approves drug labels. The Environmental Protection Agency approves pesticides and products used on premises. State Boards of Pharmacy regulate the practice of pharmacy and drug dispensing. State Boards of Veterinary Medicine regulate the practice of medicine. However, there is overlap in some cases; for example, some veterinary medical boards refine and narrow FDA CVM rules about prescriptions and record-keeping. Therefore, it can be difficult to determine the appropriate agency to contact with questions, so persistence is required.

Labeled vs. Extralabel Drug Use

A drug label typically includes any printed information about the drug, including the actual label on the bottle or box, the insert included in or attached to the packaging, and other information that a manufacturer provides with the drug. The FDA CVM website is one source of label information, on their "Animal Drugs @FDA" website. Many animal health companies also provide copies of drug inserts on their websites. These labels can be a great source of information about the drug, its use, warnings and precautions, efficacy data, and so on.

Extralabel use is defined as any use not included on a drug label. Extralabel use is regulated by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). Extralabel use may only occur when the health of the animal is threatened or suffering or death may result if the animal is not treated. Extralabel use is not permitted for production purposes, such as lactation induction.

AMDUCA outlines the following hierarchy for drug selection:

      (1) The first choice should be a product approved for the condition being treated which is effective as labeled

      (2) If (1) is not available, then a product approved for a food animal that may be used in an extralabel manner

      (3) If neither (1) nor (2) are available, a product approved in non-food animals or humans that may be used in an extralabel manner.

If no products exist that satisfy (1), (2) or (3), a compounded product may be permissible, and the compliance policy guide on compounding should be consulted (CPG 608.400; see website listed under "Recommended Websites" below).

In order to use drugs in an extralabel manner, the following must be present:

     • Valid veterinarian-client-patient relationship

     • Absence of labeled product with specific indication (or clinical inefficacy of a labeled product)

     • Specific labeling requirements

     • Specific records requirements (e.g., records of extralabel use and its reasons must be maintained for at least 2 years)

     • Assignment of an extended meat or milk withdrawal time

To comply with the assignment of an extended meat or milk withdrawal time, the Food Animal Residue Avoidance Databank is available to provide information to practitioners on extralabel uses and withdrawal time recommendations. Their contact information is listed under "Recommended Websites" below. Their resources are far greater and up-to-date than any practitioner could maintain, so their advice should be sought when extralabel use is contemplated. In addition, they publish FARAD Digests periodically in the Journal of the American Veterinary Medical Association, which contain useful information on specific drugs or drug groups.

While extralabel use is permitted under particular circumstance, extralabel use is not permitted under the following conditions:

     • By a lay person (i.e., on the order of)

     • In or on animal feed

     • If it results in a residue presenting a risk to public health

     • If it results in a residue above an established safe level or tolerance

AMDUCA does not allow for the extralabel use of drugs not approved in the US, drugs regulated by other agencies (such as EPA-labeled pesticides), and compounds used as drugs but which have no FDA-approved label (anything used to treat, prevent, diagnose or control a disease is a drug by definition). These products and compounds cannot therefore be legally used in an extralabel manner, at least not using the justification under AMDUCA.

Compounding

The FDA published a revision to their compliance policy guide about compounding in 2003. This document, while not legally binding, describes the agency's likely actions and priorities related to compounding. The FDA website can be accessed for the full text of the guide ("Recommended Websites" below). The main purpose of this guide is to prevent the use of bulk drugs in compounding, so that large scale compounding operations do not become unlicensed drug manufacturers. The guide also contains a list of bulk drug substances used as antidotes for compounding and subsequent use in animals to which the CVM would not ordinarily object including Ammonium molybdate, Ammonium tetrathiomolybdate, Ferric ferrocyanide, Methylene blue, Picrotoxin, Pilocarpine, Sodium nitrite, Sodium thiosulfate, and Tannic acid.

Compounding in general should be considered technically illegal, particularly if it is in bulk or not in response to a need for an individual patient. Compounding law is being actively reviewed currently, and actions against compounding pharmacies have been taken under certain circumstances.

Recommended Websites

FDA-CVM website: http://www.fda.gov/AnimalVeterinary/default.htm

FDA-CVM Compliance Policy Guide on Compounding: http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM200461.pdf

Food Animal Residue Avoidance Databank: http://www.farad.org

American Veterinary Medical Association Professional Resources: http://www.avma.org/resources/default.asp

American Veterinary Medical Association AMDUCA Flowchart: http://www.avma.org/reference/amduca/amduca1.asp

National Organic Program: http://www.ams.usda.gov/nop/indexIE.htm

Minor Species/Minor Use Program: http://www.nrsp-7.org/introduction.htm

Pasteurized Milk Ordinance: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MilkSafety/NationalConferenceonInterstateMilkShipmentsNCIMSModelDocuments/PasteurizedMilkOrdinance2007/default.htm

National Association of Boards of Pharmacy: http://www.nabp.net