Background
The Compendium of Medicating Ingredients Brochures (CMIB) is being updated on April 1, 2018, to support new Government of Canada policies and activities to reduce antimicrobial resistance. The three key changes are:
- removing growth promotion claims for medically-important antimicrobial drugs
- moving the following medications to the prescription drug list (PDL) so they require a prescription from a veterinarian instead of being sold over the counter. These medications are:
- bacitracin, lincomycin, neomycin, penicillin G, spectinomycin, sulphonamides, tetracycline-chlortetracycline-oxy tetracycline, tiamulin, tilmicosin, tylosin-tylvalosin, virginiamycin, or their salts or derivatives
- adding five medications to the CMIB so that, as of April 1, 2018, they only require a veterinary prescription before being sold. (Previously, they were approved for use in livestock feeds and listed on the PDL, and therefore required a veterinary prescription before being manufactured.) These medications are:
- avilamycin, emamectin benzoate, florfenicol, ormetoprim, trimethoprim
The format of the CMIB has also been improved:
- Four indexes have been added to search by active ingredient, brand name, species and company name.
- One of these new indexes also includes drug identification numbers (DIN).
- The medicating ingredient brochure (MIB) numbers have been eliminated and replaced with codes that are similar to those used in CFIA sampling programs.
Transition key dates to know
April 1, 2018: Publication of the new CMIB
- The new (2018) CMIB will be published on the CFIA website. The previous (2017) version of the CMIB will no longer be available on the CFIA website.
April 1 to November 30, 2018Footnote 1 (transition period): CFIA compliance activities
- During the transition period, feed manufacturers may decide whether to use the previous CMIB or the new version when manufacturing medicated feeds.
- Regardless, one of these CMIB must be used whenever on-label medicated feeds are manufactured during the transition period.
- CFIA inspectors will use the previous version of the CMIB to verify compliance for products manufactured before April 1, 2018.
- The new CMIB will be used to verify compliance for products manufactured after April 1, 2018.
- For feeds containing drugs that were over the counter, but moved to prescription status:
- Inspectors will remind facilities of the December 1, 2018 requirement to have a valid veterinary prescription before selling any feed containing these drugs.
- For products labelled with growth promotion claims that are no longer in the new CMIB or are missing information required by the new CMIB:
- Inspectors will note such instances and remind the facility of the requirements of the new CMIB and that effective December 1, 2018, the product would be subject to enforcement actions
- A corrective action request (CAR) will not be issued
- For feeds containing the five medications that have always been on the prescription drug list and subject to veterinary prescriptions:
- Inspection staff will verify that any floor-stocked product has been made and labelled in accordance with the new CMIB. Non-compliances will be subject to enforcement action.
- Inspection staff will verify that a valid veterinary script was available before the sale of any feed containing these five drugs. Observed deviations will be communicated to Health Canada.
December 1, 2018: CFIA compliance activities
- The transition period will be over and the changes will be in full force.
- Inspection staff will assess all medicated feeds against the requirements of the new CMIB.
- All labels on medicated feed must comply with the new CMIB, regardless of when the feed was manufactured. Medicated feeds manufactured before December 1, 2018, may be relabelled to comply with the new CMIB.
- For feeds containing drugs that were previously over the counter but moving to prescription status:
- Inspectors will verify that any floor-stocked product has been made and labelled in accordance with the new CMIB. Non-compliances will be subject to enforcement action.
- Inspectors will verify that a valid veterinary prescription was available before the sale of any feed containing these drugs. Observed deviations will be communicated to Health Canada.
- For products labelled with growth promotion claims that are not in the new CMIB or that are missing information required by the new CMIB:
- non-compliances will be subject to enforcement actions
- Products requiring drug identification numbers (DIN products) with old labels that have not expired cannot be sold (example, to producers or other feed manufacturers), but can be used in-house to manufacture medicated feeds. However, these feeds need to be manufactured and labelled in accordance with the new CMIB and not as specified on the old label.
Note: Sequencing Guide
The sequencing guide will still be valid and available for use by feed manufacturers. Modifications will be made to the document to align with updates to the CMIB.
For more information
Learn how the CFIA is contributing to the responsible use of medically important antimicrobials in animals.
Contact your local CFIA office for more information or if you have questions.