Notice: Prescription Drug List (PDL): Human and Veterinary Antimicrobials

November 30, 2018
Our file number: 18-118591-617

The purpose of this Notice of Amendment is to notify that Health Canada has amended 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 has been amended to specifically list the derivatives of Erythromycin and Lincomycin, and to delete the Erythromycin derivative, Tulathromycin, which is only used in veterinary medicine. These amendments are effective as of December 1, 2018.

The revised listings are provided in the tables below.

Rationale:

Products for Human Use:

As noted in the Notice of Intent to Amend, the 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 Intent to Amend, the 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, there are two additional revisions to the PDL. Specifically, for both the human and veterinary listings, a Carbapenem category is added and the individually listed carbapenems were removed (See Table 1c and 2e).

In addition, multiple ingredients are 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 in recent years approved for veterinary use and previously for human use, were not included as specific examples; they are now 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 amendments to the Products for Human Use part of the PDL are depicted below.

Table 1(a)

The following table depicts the ingredients that have been 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. Please note that an empty entry means that the columns do not apply for that ingredient:

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
Erythromycin or its salts or derivatives	Addition of: Azithromycin Clarithromycin Telithromycin
Deletion of: Clindamycin or its salts or derivatives
Lincomycin or its salts or derivatives	Addition of: Clindamycin

Table 1(b)

The following table depicts the ingredient that has been removed from the "including (but not limited to)" column of the Erythromycin or its salts or derivatives listing:

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Erythromycin or its salts or derivatives	Deletion of: Tulathromycin

Table 1(c)

The following table depicts the ingredients that have been 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 has been added to the 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
Addition of: Carbapenem salts or derivatives	Addition of: Doripenem Ertapenem Imipenem Meropenem

Table 1(d)

The following table depicts the ingredients that have been added to the "including (but not limited to)" column of an already existing category:

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

Table 2: Products for Veterinary Use

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

Table 2(a)

The following table depicts the ingredients that have been moved from the "Drugs containing any of the following" to the "Including (but not limited to)" column since they are derivatives of an ingredient:

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
Addition of: Erythromycin or its salts or derivatives	Addition of: Azithromycin Gamithromycin Telithromycin Tulathromycin
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
Addition of: Penicillin or its salts or derivatives	Addition of: Amoxicillin Ampicillin Azlocillin Benzathine penicillin Carbenicillin Cloxacillin Hetacillin Methicillin Mezlocillin Nafcillin Ticarcillin
Deletion of: Tildipirosin Tilmicosin
Change from: Tylosin or its salts Change to: Tylosin or its salts or derivatives	Addition of: Tildipirosin, Tilmicosin

Table 2(b)

The following table depicts the qualifiers that have been removed from the ingredient Tilmicosin and for the Tylosin listing to better reflect the new Tylosin entry as depicted in Table 2(a):

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Tylosin or its salts or its derivatives	Tildipirosin, Tilmicosin	Deletion of: except when sold in premix form
Tylosin or its salts or its derivatives	Tildipirosin, Tilmicosin	Deletion of: when sold for the treatment of chronic colitis in dogs

Table 2(c)

The following table depicts the derivatives that have been added under the column "Including but not limited to":

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Penicillin or its salts or derivatives	Additions of: Dicloxacillin Penicillin G (benzyl penicillin) Procaine penicillin G
Tylosin or its salts or its derivatives	Addition of: Tylvalosin

Table 2(d)

The following table depicts the antibiotics and derivatives that have been added to the columns "Drugs containing any of the following" and "Including (but not limited to)":

Drugs containing any of the following:	Including (but not limited to)	Qualifier
Addition of: Apramycin or its salts
Addition of: Bacitracin or its salts or derivatives
Addition of: Lincomycin or its salts or derivatives	Addition of: Clindamycin
Addition of: Neomycin or its salts or derivatives
Addition of: Spectinomycin or its salts or derivatives
Addition of: Streptomycin or its salts or derivatives	Addition of: Dihydrostreptomycin
Addition of: Sulphonamide salts or derivatives	Addition of: Sulfadiazine Sulfadoxine Sulfaguanidine Sulfamerazine Sulfamethazine Sulfanilamide Sulfapyridine Sulfaquinoxaline Sulfathiazole
Addition of: Tetracycline or its salts or derivatives
Addition of: Chlortetracycline or its salts
Addition of: Oxytetracycline or its salts
Addition of: Tiamulin or its salts	Addition of: Tiamulin fumarate
Addition of: Virginiamycin or its salts or derivatives

Table 2(e)

The following table depicts the ingredients that have been 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 has been added to the 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
Addition of: Carbapenem salts or derivatives	Addition of: Doripenem Ertapenem Imipenem Meropenem

Table 2(f)

The following table depicts the ingredients that have been added to the "including (but not limited to)" column of an already existing category:

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 Cefovecin Ceftiofur Ceftriaxone Ceftobiprole

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