Notice: Prescription Drug List (PDL): Polymyxin B

June 19, 2015
Our file number: 15-107116-289

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to switch certain uses of Polymyxin B to prescription status for veterinary use by adding it to the Veterinary Prescription Drug List (PDL). Currently, Polymyxin B is listed on the Human List except for topical use or for local action in the oral cavity or nasal passage.

The proposed wording of the new listing on the Veterinary List is:

Drugs containing the following: Polymyxin B or its salts or derivatives

Including (but not limited to): not applicable

Qualifier: when sold in combination with other medicinal ingredients

Effective Date: to be determined

Rationale:

Polymyxins are considered to belong to a class of the last resort antibiotics (Category I -Very High Importance) for the treatment of serious multidrug-resistant bacterial infections in humans. Preserving the effectiveness of the polymyxin class is an important responsibility for drug regulators. Imprudent use of this class can lead to development of polymyxin resistance in bacteria of public health importance. With current knowledge on the importance of polymyxins in human medicine, there is a need to place polymyxin B (and its salts or derivatives) on the Veterinary Prescription Drug List to reinforce prudent use of this class of drugs.

Four veterinary drug identification number (DIN) products containing Polymyxin B with nonprescription status are potentially affected by this proposal. If this proposal is accepted these products will need to transition to prescription status. The products affected are DINs: 00813877, 00516414, 00517917 and 00755753.

Comments on this proposed change to the Prescription Drug List should be provided to Health Canada in writing, preferably in electronic format, within 75 days from the date of this notice.

Additional information on how Health Canada determines prescription status (or nonprescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Please send your comments to:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-1058
Facsimile: 613-941-6458
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

If all comments not in favour of this switch can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.