United States of America. The Food and Drug Administration has amended the new animal drug regulations to remove the existing 96-hour withdrawal time limitation, eliminate the requirement to calculate and label on the basis of the number of 12-hour milking periods that have elapsed since treatment, and to permit a milk-discard or withdrawal time to be calculated by elapsed hours since treatment.

The agency has taken these actions to allow greater flexibility in the labelling of new animal drugs for use in milk-producing animals. The increased flexibility will make it easier and more economical for sponsors to comply with the regulations.

[See also Pharmaceuticals Newsletter No. 9, September 1996]

References: Federal Register 63(116): 32978-80 (1998).

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