Food and Drug Regulations

C.01.606 No person shall sell an antibiotic preparation for the treatment of animals, other than an antibiotic preparation that is a new drug sold pursuant to section C.08.013, unless,

• (a) where the preparation is not to be used for lactating animals providing milk to be consumed as food, the inner and outer labels of the preparation carry a statement to that effect; or

• (b) where the preparation may be used for lactating animals providing milk to be consumed as food,

  • (i) there has been submitted, on request, to the Director, acceptable evidence to show the period of time, not exceeding 96 hours, that must elapse after the last treatment with the preparation in order that the milk from treated lactating animals will contain no residue of antibiotics that would cause injury to human health, and

  • (ii) the principal display panel of the outer label of the preparation, the inner label and the packaging insert, if any, describing the antibiotic preparation carry the warning “WARNING: MILK TAKEN FROM TREATED ANIMALS DURING TREATMENT AND WITHIN ... HOURS AFTER THE LATEST TREATMENT MUST NOT BE USED AS FOOD”, where the number of hours to be inserted is determined according to evidence submitted pursuant to subparagraph (i).