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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Publishes Labeling Rules for Animal Drugs

June 29, 1998

In the June 17, 1998, Federal Register, FDA published a final rule on the labeling of drugs for use in milk-producing animals. This rule removes the existing 96-hour withdrawal time limitation, eliminates the requirement to calculate and label on the basis of the number of 12-hour milking periods that have elapsed since treatment, and permits a milk-discard or withdrawal time to be calculated by elapsed hours since treatment. FDA is taking these actions to allow greater flexibility in the labeling of these drugs which will make it easier and more economical for sponsors to comply with the regulations.

The previous 96-hour limitation was based on FDA's perception that 96 hours constituted a maximum practical withdrawal time for the dairy industry. However, FDA now recognizes that a withdrawal time longer than 96 hours may be desirable and practical in certain circumstances. Removal of the 96-hour limitation will allow the possibility of a longer withdrawal time to be considered for milk-producing animals on a case-by-case basis depending on the use and safety of the drug.

Similarly, the 12-hour milking schedule was established to calculate the number of milkings that occur during the withdrawal period. The 12-hour milking interval was considered to be generally reflective of dairy practice when this regulation was published; however, alternative milking schedules, such as three times a day milking, are in common use in the dairy industry today. The new rules revise the regulation so that the length of the milk cycle is not specified, eliminating the reference to the milking interval as long as milk is discarded the assigned number of hours after the latest drug treatment.

Additional information about this rule is available in the Federal Register (Volume 63, Number 116, pp. 32978-32980) and from Dr. Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1620.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855