Notice of intent to amend: Prescription Drug List (PDL): Epinephrine (Topical Solution)

• June 4, 2021
• Our file number: 21-110492-852

The purpose of this Notice of Intent to Amend is to announce 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 List will be updated. This addition will be effective 6 months after the posting of this notice.

The listing will read:

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)	6 months from the date of this notice

Rationale:

Health Canada received a drug submission for topical epinephrine that contains 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.

From August 12, 2019 to October 28, 2019 Health Canada held a consultation on the addition of Epinephrine and the associated qualifier presented above to the PDL. No comments were received.

This amendment will take effect six months from the date of this Notice of Intent to Amend. On that day, the PDL will be amended and a Notice of Amendment will be posted on the Health Canada website.

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 (FDR), and as such, will no longer be considered Natural Health Products (NHPs).

The following products will be affected:

• DIN 00155365
• NPN 00407658

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.

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

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