Prescription Drug List (PDL): Multiple Additions

December 20, 2013

Our file number: 13-119778-430

Notice

The purpose of this Notice of Amendment is to notify the addition of more than 120 drugs on the Prescription Drug List (PDL). With coming into force of the regulations to establish the PDL (Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations)) on December 19, 2013, Health Canada is now revising, effective immediately, the PDL. The drug and supporting qualifier in italics are the additions to the PDL.

The following drugs have been added to both the Human and Veterinary lists as single medicinal ingredients:

The following drugs have been added to both the Human and Veterinary lists as medicinal ingredients along with their salts (for example, Aclidinium or its salts or Colesevelam or its salts and Colesevelam hydrochloride will appear in the including (but not limited to) column):

The following drugs have been added to both the Human and Veterinary lists as medicinal ingredients along with their derivatives (for example, Abiraterone or its derivatives):

The following drugs have been added to both the Human and Veterinary lists as medicinal ingredients along with their salts or derivatives (for example, Alitretinoin or its salts or derivatives):

The following drugs have been added to only the Human list:

The following drugs have been added to only the Veterinary list:

The following drugs are added to both lists with a qualifier:

The following drugs were previously captured under a general heading on both lists but are being added to the including (but not limited to) column:

Rationale:

A scientific review of these drugs against the former factors for listing drugs in Schedule F indicates they meet one or more of these factors and should only be available through a prescription.

While the drugs contained in this Notice were assessed against the factors for listing on Schedule F, future amendments to the PDL will be based on the criteria set out in C.01.040.3 of the Food and Drug Regulations. These criteria encompass and will now replace the Schedule F factors, which Health Canada has used for the past 20 years, when making decisions regarding prescription status. Additional information on how Health Canada now determines prescription

status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on these amendments to the Prescription Drug List please contact:

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: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.c

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2013-12-20