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.

Table 1(a)
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:
  • Azithromycin or its salts or derivatives
  • Clarithromycin or its salts or derivatives
  • Gamithromycin
  • Telithromycin or its salts or derivatives
Not applicable Not applicable
Erythromycin or its salts or derivatives Addition of:
  • Azithromycin
  • Clarithromycin
  • Gamithromycin
  • Telithromycin
Not applicable
Deletion of:
  • Clindamycin or its salts or derivatives
Not applicable Not applicable
Lincomycin or its salts or derivatives Addition of:
  • Clindamycin
Not applicable
Table 1(b)
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:
  • Tulathromycin
Not applicable
Table 1(c)
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:
  • Ertapenem or its salts
  • Imipenem or its salts or derivatives
  • Meropenem or its salts or derivatives



Doripenem
Not applicable
Carbapenem or its salts or derivatives Addition of:
  • Doripenem
  • Ertapenem
  • Imipenem
  • Meropenem
Not applicable
Table 1(d)
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:
  • Cephalexin (cefalexin)
  • Cephapirin (cefapirin)
  • Cefaclor
  • Cefadroxil
  • Cefazolin
  • Cefoxitin
  • Cefixime
  • Cefotaxime
  • Ceftriaxone
  • Ceftobiprole
Not applicable

Table 2: Products for Veterinary Use

The proposed amendments to the Products for Veterinary Use part of the PDL are depicted below.

Table 2(a)
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:
  • Azithromycin or its salts or derivatives
  • Gamithromycin
  • Telithromycin or its salts or derivatives
  • Tulathromycin
Not applicable Not applicable
Addition of:
  • Erythromycin or its salts or derivatives
Addition of:
  • Azithromycin
  • Gamithromycin
  • Telithromycin
  • Tulathromycin
Not applicable
Deletion of:
  • Amoxicillin or its salts or derivatives
  • Ampicillin or its salts or derivatives
  • Azlocillin or its salts or derivatives
  • Benzathine penicillin or its salts or derivatives
  • Carbenicillin or its salts or derivatives
  • Cloxacillin or its salts or derivatives
  • Hetacillin or its salts or derivatives
  • Methicillin or its salts or derivatives
  • Mezlocillin or its salts or derivatives
  • Nafcillin or its salts or derivatives
  • Ticarcillin or its salts or derivatives
Not applicable Not applicable
Addition of:
  • Penicillin or its salts or derivatives
Addition of:
  • Amoxicillin
  • Ampicillin
  • Azlocillin
  • Benzathine penicillin
  • Carbenicillin
  • Cloxacillin
  • Hetacillin
  • Methicillin
  • Mezlocillin
  • Nafcillin
  • Ticarcillin
Not applicable
Deletion of:
  • Tildipirosin, Tilmicosin
Not applicable Not applicable

Change from: Tylosin or its salts

Change to: Tylosin or its salts or derivatives

Addition of:
  • Tildipirosin, Tilmicosin
Not applicable
Table 2(b)
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:
  • except when sold in premix form
Tylosin or its salts or its derivatives Not applicable Deletion of:
  • when sold for the treatment of chronic colitis in dogs
Table 2(c)
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:
  • Dicloxacillin
  • Penicillin G (benzylpenicillin)
  • Procaine penicillin G
Not applicable
Tylosin or its salts or its derivatives Addition of:
  • Tylvalosin
Not applicable
Table 2(d)
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:
  • Apramycin or its salts
Not applicable Not applicable
Addition of:
  • Bacitracin or its salts or derivatives
Not applicable Not applicable
Addition of:
  • Lincomycin or its salts or derivatives
Addition of:
  • Clindamycin
Not applicable
Addition of:
  • Neomycin or its salts or derivatives
Not applicable Not applicable
Addition of:
  • Spectinomycin or its salts or derivatives
Not applicable Not applicable
Addition of:
  • Streptomycin or its salts or derivatives
Addition of:
  • Dihydrostreptomycin
Not applicable
Addition of:
  • Sulphonamides or its salts or derivatives
Addition of:
  • Sulfadiazine
  • Sulfadoxine
  • Sulfaguanidine
  • Sulfamerazine
  • Sulfamethazine
  • Sulfanilamide
  • Sulfapyridine
  • Sulfaquinoxaline
  • Sulfathiazole
Not applicable
Addition of:
  • Tetracycline or its salts or derivatives
Not applicable Not applicable
Addition of:
  • Chlortetracycline or its salts
Not applicable Not applicable
Addition of:
  • Oxytetracycline or its salts
Not applicable Not applicable
Addition of:
  • Tiamulin or its salts
Addition of:
  • Tiamulin fumarate
Not applicable
Addition of:
  • Virginiamycin or its salts or derivatives
Not applicable Not applicable
Table 2(e)
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:
  • Ertapenem or its salts
  • Imipenem or its salts or derivatives
  • Meropenem or its salts or derivatives



Doripenem
Not applicable
Carbapenem or its salts or derivatives Addition of:
  • Doripenem
  • Ertapenem
  • Imipenem
  • Meropenem
Not applicable
Table 2(f)
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:
  • Cephalexin (cefalexin)
  • Cephapirin (cefapirin)
  • Cefovecin
  • Cefaclor
  • Cefadroxil
  • Cefazolin
  • Cefoxitin
  • Cefixime
  • Cefpodoxime proxetil
  • Cefprozil
  • Cefotaxime
  • Ceftiofur
  • Ceftriaxone
  • Ceftobiprole
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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