Interim Compliance Policy for feeds containing Chlortetracycline Hydrochloride (CTC) manufactured and labelled according to the Compendium of Medicating Ingredient Brochures (CMIB)
With the implementation of Health Canada's action plan on the Responsible Use of Medically Important Antimicrobials in Animals, all growth promotion claims and related directions for use for those drugs considered medically important antimicrobials (MIAs), including Chlortetracycline Hydrochloride (CTC), were no longer permitted. As a result, the drug manufacturers were required to amend their labels for these MIAs to omit any reference to a growth promotion purpose.
The Medicating Ingredient Brochure (MIB) for CTC has historically contained a distinct and separate claim at the approved level of 220 mg/kg for pre-starter and starter swine feeds. With the most recent version of the approved label for CTC, the drug manufacturer was compelled to exclude the individual aforementioned claim to comply with Health Canada's amended requirements for MIAs. While the 220 mg/kg level continues to be approved for pre-starter and starter swine feeds, the sole reference to this level in the newest version of the CMIB is incorporated within the existing claims for the approved levels of 55 mg/kg and 110 mg/kg under the heading: "Additional information to be added as notes to feed labels."
The absence of a distinct and separate claim in the CTC-MIB for the approved level of 220 mg/kg has caused uncertainty whether this continues to be considered "at a level…as set out in the Compendium of Medicating Ingredient Brochures…", thus meeting the requirements outlined in the section 14(b) of the Feeds Regulations.
As a result, the following interim compliance policy is in effect until the approved drug label can be officially amended and the CMIB updated to reflect the amendment(s).
The CFIA continues to be responsible for ensuring medicated feeds adhere to the manufacturing and labelling standards outlined in the CMIB. With respect to swine feeds for the pre-starter and starter growing stages that are medicated with CTC, 220 mg/kg remains an approved level and as such the feed label should continue to reflect the information contained in the MIB for this medicating ingredient, with the following interim amendments.
- The feed label must indicate either the approved claim statement found in Claim 1 (As an aid in prevention of bacterial enteritis (scours, bacterial diarrhea)) or the approved claim statement found in Claim 2 (As an aid in the treatment of bacterial enteritis (scours, bacterial diarrhea)). Combining the two claims is not permitted.
- The feed label must indicate the correct level of medicating ingredient (220 mg/kg) contained in the feed when required by the CMIB, that is, when declaring the level of medicating ingredient in the complete feed or within the wording of Warning statement #1.
- The directions for use indicated on the feed label must reflect that the feed is to be fed as the sole ration to swine up to and including 6 weeks of age. For example: "Feed this medicated feed as the sole ration during the period of early growth up to 6 weeks of age".
- The withdrawal time remains at 7 days, as indicated in Claims 1 and 2 of the MIB for CTC.
If you have any questions, please contact your local CFIA office.
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