Notice of consultation: Removing zuranolone from the Prescription Drug List (PDL)

February 9, 2026
Our file number: 26-100533-438

This Notice of Consultation provides an opportunity to comment on the proposal to remove “zuranolone or its salts” from both the Human and Veterinary parts of the Prescription Drug List  (PDL). The PDL is a list of medicinal ingredients that, when found in a drug, require a prescription under the Food and Drugs Act (FDA) scheme. It doesn't include medicinal ingredients that are listed on Schedules of the Controlled Drugs and Substances Act (CDSA).

Recently, Health Canada published in Canada Gazette, Part I its intent to:

• add zuranolone to Schedule IV to the CDSA
• regulate zuranolone as a targeted substance to permit its legitimate use^{Footnote 1}

Medicinal ingredients are removed from the PDL when they are scheduled under the CDSA scheme because the controls under the CDSA framework provide sufficient oversight for any therapeutic use.

Health Canada has authorized one zuranolone-containing drug under the Food and Drug Regulations, ZURZUVAE™. This product is indicated for the treatment of moderate or severe postpartum depression (PPD) in adults following childbirth, but it isn’t currently available on the Canadian market. As of the date of this notice, no health products containing zuranolone are being marketed in Canada.

If zuranolone is added to Schedule IV of the CDSA, unless authorized under its regulations or an exemption, it would be prohibited for zuranolone to be:

• sold, provided or administered
• imported
• exported
• produced
• possessed for the purpose of trafficking
• possessed for the purposes of exporting

A 70-day consultation period begins with the publication of Health Canada’s intent to add zuranolone to Schedule IV to the CDSA and also regulate it as a targeted substance to permit its legitimate use in Canada Gazette, Part I. During this period, interested members of the public, healthcare practitioners, healthcare professional associations, and any other interested stakeholders may submit comments about this consultation related to the proposed amendment to the PDL for Health Canada’s consideration.