ANIMAL HEALTH ADVISORY
How State Dairy Inspections Assess On-Farm Drugs
The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) regulates all prescription and over-the-counter (OTC) drug use on dairy operations. All drugs used in dairy cattle/dairy goats must be approved by the FDA. Inspectors for the Indiana State Board of Animal Health (BOAH), as part of a routine inspection, will verify drugs present on the farm comply with CVM requirements.
Dairy farm inspectors look for three things regarding drugs on dairy operations:
- Is it a drug?
- Is it approved for use in dairy cattle/dairy goats?
- Is it properly labeled and stored?
Is it a drug?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines the term “drug” as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”
If an article (product/preparation) makes such a claim, then it is a drug for the purposes of dairy enforcement (inspection) and requires a drug label. Many drugs come with an FDA-approved label or a veterinarian’s label as required by the FDA. Products not normally considered as a drug may be deemed a drug during inspection based on a claim made on the label. This frequently happens for products to treat mastitis.
Homeopathic Nutritional Supplements
The FDA regulates veterinary homeopathic drugs in the same way as other animal drugs. Item 15r of the Pasteurized Milk Ordinance (PMO) requires that homeopathic drugs found on dairy operations comply with the drug labeling and storage requirements.
Dairy farm inspectors follow the PMO standard for use of drugs on dairy operations. These standards are applied to all drug use on dairy operations.
Is it approved for use in dairy cattle/dairy goats?
Products used in dairy animals must be specifically approved for lactating cows or goats. A product commonly administered to a beef cow (for example, Gold Spike) may not necessarily be FDA-approved for dairy cattle. The manufacturers’ label is essential to this determination.
Is it properly labeled and stored?
All drugs should be stored in the way stated on the label, such as a refrigerator. During inspection, drugs not adequately separated by use (e.g., lactating versus dry cows) will be noted on the report.
Extra-label products need to comply with the PMO to include a specified number of days withholding on the label. When appropriate, withholding should state zero days and not “no”.
Producers and veterinarians must understand what is on the labels of the products being dispensed. Most drugs will not require any additional labeling because the existing label meets FDA requirements. Some drugs may require additional labeling because they are being dispensed to a dairy herd and need additional information to meet the labeling requirements for dairy cattle.
Dairy producers need to read the labels of products they use to treat disease and supplement the nutrition of their dairy animals. In coordination with a veterinarian, with whom they have a valid veterinarian/client/patient relationship (VCPR), producers need to be sure that all products have a label that meets the standards of the Pasteurized Milk Ordinance and the Center for Veterinary Medicine as outlined.
Inspection Scores and Drugs Dairy drugs
can have a direct impact on a farm’s inspection score. Here are some important reminders for dairy farmers to remember:
- Prohibited and unlabeled drugs on the dairy result in a five-point debit.
- Incomplete drug labels on the dairy result in a two-point debit.
- 100 is a perfect score. 90 is passing. 89 is failing. During an interstate milk rating, failing scores, on a weighted basis, may result in a temporary loss in the ability of an individual or group of farms to ship milk in interstate commerce.
For more information about Indiana’s dairy inspection program and the PMO, go online to: www.in.gov/boah/2492.htm.