Notice of amendment: Correction to the Hetastarch entry on the Prescription Drug List

Date: April 1, 2025
Our file number: 25-102331-499

The purpose of this Notice of Amendment is to announce that Health Canada has revised the listing of "Hetastarch or its derivatives" on the Prescription Drug List (PDL). Note that both the human and veterinary parts of the PDL have been revised.

Rationale

Hetastarches, also known as hydroxyethyl starches (HES), are used in intravenous therapy for the treatment of hypovolemia (low blood volume). These solutions work by increasing the volume of blood plasma, thereby improving blood pressure and tissue perfusion. This amendment is the result of Health Canada's review of hydroxyethyl starches, used as plasma volume expanders, against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations (FDR).

Since 2013, only hetastarch had been listed on the PDL as "Hetastarch or its derivatives". Health Canada has amended the hetastarch listing on the PDL to capture all forms of hydroxyethyl starches.

A public consultation was not undertaken since this amendment is considered a correction and, therefore, access to these drug products will not be impacted. Marketed products containing hydroxyethyl starches used as plasma volume expanders will continue to be authorized as prescription drugs under the Food and Drug Regulations (FDR). As a result of this amendment, the Department remains internationally aligned with most regulators.

Next steps

This PDL amendment takes effect on the date of this notice.

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 regarding this notice, please contact:

Health Canada
Prescription Drug Status Committee
6th Floor Holland Cross – Tower B
Address locator: 3106C
1600 Scott Street
Ottawa ON K1A 0K9
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca