Notice - Prescription Drug List (PDL): Hydroquinone

October 1, 2018
Our file number: 18-110017-372

The purpose of this Notice of Amendment is to notify about the addition of  hydroquinone or its derivatives to the Prescription Drug List (PDL) for human use when sold in concentrations greater than 2% in topical products.

The new PDL listing is as follows:

Drugs containing any of the following:

Hydroquinone or its derivatives

Qualifier:

When sold in a concentration greater than 2% in preparations for topical use on the skin.

Effective Date:

June 30, 2019

Rationale:

A scientific assessment of hydroquinone was conducted by Environment and Climate Change Canada (previously Environment Canada) and a screening assessment of hydroquinone was conducted by Health Canada’s Healthy Environments and Consumer Safety Branch as part of the Chemicals Management Plan. Due to health concerns identified through the Chemical Management Plan, hydroquinone was added to Schedule 1 of the Canadian Environment Protection Act (CEPA, 1999).

All companies that intend to market their products containing hydroquinone at concentrations greater than 2% have filed submissions with Health Canada to comply with the regulatory requirements for prescription drugs. The coming-into-force date is delayed in order to complete the regulatory and scientific review of these products.

An Information Update has been published to remind Canadians about the possible risks to health associated with the use of high concentrations of hydroquinone, and that use of these products should remain limited and monitored by a healthcare professional.

Upon the coming into force of this PDL amendment, products containing greater than 2% hydroquinone in preparations for topical use on the skin for human use may only be sold if they have been issued a DIN and if they are sold pursuant to a prescription. We invite you to consult the aforementioned notices for additional information.

Should you have any questions on this update to the PDL, please contact:

• Prescription Drug Status Committee
  Health Canada
  Holland Cross, Tower B, 2nd Floor
  1600 Scott Street
  Address Locator 3102C3
  Ottawa, Ontario
  K1A 0K9
• Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca
• Telephone: 343-998-9304
• Fax: 613-941-1812