Notice of Amendment: Prescription Drug List (PDL): Epinephrine (topical solution)

• December 6, 2021
• Our file number: 21-120692-21

The purpose of this Notice of Amendment is to notify that Health Canada will add Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000) to the Prescription Drug List (PDL). Both the Human and the Veterinary parts of the PDL were revised. Health Canada conducted a scientific review of Epinephrine topical solution against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations.

The new listing is:

Drugs containing any of the following	Including (but not limited to)	Qualifier	Effective Date
Epinephrine or its salts	-	Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000)	December 6, 2021

Prior to this amendment, the ingredient "epinephrine" was not on the PDL in any form.

Rationale

As indicated in the Notice of Intent to Amend published in June 2021, Health Canada received a drug submission for topical epinephrine that contained sufficient information to demonstrate that topical epinephrine solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000) meets the PDL criteria outlined in section C.01.040.3 of the Food and Drug Regulations and that the PDL should be modified accordingly. It has been determined through the review of the submission that:

• Practitioner supervision is necessary for treatment and/or monitoring;
• The use of the drug requires complex or individualized instructions;
• Practitioner expertise is necessary to administer the drug or oversee the drug's administration;
• The drug has a narrow margin of safety; and
• Medication errors occurred with the use of topical epinephrine as an injectable.

As a result of this PDL amendment, products containing "Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000)" will be considered prescription drugs subject to the Food and Drug Regulations, and as such, will no longer be considered Natural Health Products. This amendment follows a 6-month delay from the posting of the Notice of Intent to Amend.

Additional information on how Health Canada 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 this amendment to the PDL, please contact:

Health Canada
Therapeutic Products Directorate
Office of Science

Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@hc-sc.gc.ca