Notice: Prescription Drug List (PDL): Human and Veterinary Antimicrobials
December 15, 2017
Our file number: 17-113103-789
This follows the July 5, 2017 Notice of Consultation regarding the amendment of 14 antimicrobial active ingredients or their salts or derivatives from non-prescription to prescription on the Veterinary Prescription Drug List (PDL). These amendments include adding antimicrobial classes, listing certain antimicrobials as derivatives rather than as antibiotic classes, and deleting qualifiers that are no longer necessary. Additionally, the Human PDL will be amended to specifically list the derivatives of Erythromycin and Lincomycin, and to delete the Erythromycin derivative, Tulathromycin, which is only used in veterinary medicine. The revised listings are provided in the tables below.
Consultation summary:
The proposal to amend the PDL with regard to Veterinary and Human Antimicrobials was communicated through a Notice of Consultation posted on Health Canada’s website on July 5, 2017. The 75 day consultation period ended on September 18, 2017.
Two comments were received supporting the amendments. One comment highlighted the economic and accessibility impacts of the changes, and one comment suggested further revisions on the existing veterinary PDL.
Rationale:
- Products for Human Use:
As noted in the Notice of Consultation, the proposed changes to the “Products for Human Use” part of the PDL are to correct inaccuracies (See Table 1a and 1b).
- Products for Veterinary Use:
As noted in the Notice of Consultation, the proposed changes to the “Products for Veterinary Use” part of the PDL are to strengthen veterinary oversight and promote the prudent use of medically-important antimicrobials in animals (See Table 2a-2d).
- Products for Human and Veterinary Use
In addition to the revisions proposed in the Notice of Consultation, two additional revisions to the PDL will occur. Specifically, for both the human and veterinary listings, a Carbapenem category will be added and the individually listed carbapenems will be removed (See Table 1c and 2e).
In addition, multiple ingredients will be included in the Cephalosporins category of the human and veterinary listings under the “Including (but not limited to)” section (See Tables 1d and 2f). Several ingredients belonging to this category that were approved for veterinary use in recent years and previously for human use, were not included as specific examples; they are now being included in both lists for clarity purposes. These products are already sold under prescription status and are labelled as such.
Table 1: Products for Human Use
The proposed amendments to the Products for Human Use part of the PDL are depicted below.
The following table depicts the ingredients that are being moved from the "Drugs containing any of the following" column to the "Including (but not limited to)" column since they are derivatives of an ingredient in the Human Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Deletion of:
|
Not applicable | Not applicable |
Erythromycin or its salts or derivatives | Addition of:
|
Not applicable |
Deletion of:
|
Not applicable | Not applicable |
Lincomycin or its salts or derivatives | Addition of:
|
Not applicable |
The following table depicts the ingredient that is being removed from the Human Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Erythromycin or its salts or derivatives | Deletion of:
|
Not applicable |
The following table depicts the ingredients that are being moved from the "Drugs containing any of the following" column to the "Including (but not limited to)" column since they belong to the Carbapenem category, which is being added to the Human Listing:
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Deletion of:
|
Doripenem |
Not applicable |
Carbapenem or its salts or derivatives | Addition of:
|
Not applicable |
The following table depicts the ingredients being added to the "including (but not limited to)" column of an already existing category in the Human Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Cephalosporin C or its salts or derivatives or analogs | Addition of:
|
Not applicable |
Table 2: Products for Veterinary Use
The proposed amendments to the Products for Veterinary Use part of the PDL are depicted below.
The following table depicts the ingredients that are being moved from the "Drugs containing any of the following" to the "Including (but not limited to)" column since they are derivatives of an ingredient listed in the Veterinary Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Deletion of:
|
Not applicable | Not applicable |
Addition of:
|
Addition of:
|
Not applicable |
Deletion of:
|
Not applicable | Not applicable |
Addition of:
|
Addition of:
|
Not applicable |
Deletion of:
|
Not applicable | Not applicable |
Change from: Tylosin or its salts Change to: Tylosin or its salts or derivatives |
Addition of:
|
Not applicable |
The following table depicts the deletion of the qualifiers from the ingredient Tilmicosin and for the Tylosin listing in the Veterinary Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Tylosin or its salts or its derivatives | Tilmicosin | Deletion of:
|
Tylosin or its salts or its derivatives | Not applicable | Deletion of:
|
The following table depicts the addition of derivatives under the column "Including but not limited to" of the Veterinary Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Penicillin or its salts or derivatives | Additions of:
|
Not applicable |
Tylosin or its salts or its derivatives | Addition of:
|
Not applicable |
The following table depicts additions of antibiotics and derivatives to both the columns "Drugs containing any of the following" and "Including (but not limited to)" of the Veterinary Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Addition of:
|
Not applicable | Not applicable |
Addition of:
|
Not applicable | Not applicable |
Addition of:
|
Addition of:
|
Not applicable |
Addition of:
|
Not applicable | Not applicable |
Addition of:
|
Not applicable | Not applicable |
Addition of:
|
Addition of:
|
Not applicable |
Addition of:
|
Addition of:
|
Not applicable |
Addition of:
|
Not applicable | Not applicable |
Addition of:
|
Not applicable | Not applicable |
Addition of:
|
Not applicable | Not applicable |
Addition of:
|
Addition of:
|
Not applicable |
Addition of:
|
Not applicable | Not applicable |
The following table depicts the ingredients that are being moved from the “Drugs containing any of the following” column to the “Including (but not limited to)” column since they belong to the Carbapenem category, which is being added to the Veterinary Listing:
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Deletion of:
|
Doripenem |
Not applicable |
Carbapenem or its salts or derivatives | Addition of:
|
Not applicable |
The following table depicts the ingredients being added to the "including (but not limited to)" column of an already existing category in the Veterinary Listing.
Drugs containing any of the following: | Including (but not limited to) | Qualifier |
---|---|---|
Cephalosporin C or its salts or derivatives or analogs | Addition of:
|
Not applicable |
Next steps:
These revisions will come into effect on December 1, 2018 through a Notice of Amendment posted on the Health Canada website.
However, beginning early 2018, some changes to products on the market will become apparent during the transition period between old and new labels. Health Canada is working with relevant stakeholders for a smooth transition period.
Health Canada has communicated with impacted market authorization holders about filing submissions with the Veterinary Drugs Directorate to address the above-noted changes to the PDL through revisions to their products’ labeling.
Health Canada encourages pharmacists, practitioners, and the public to consult the drug product database for drug status in cases of uncertainty.
Should you have any questions on this update to the Prescription Drug List, please contact:
Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9
Email: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca
Telephone: 343-998-9304
Fax: 613-941-1812
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