Notice of Consultation: Prescription Drug List (PDL): Hydroquinone

February 1, 2017
Our file number: 17-101181-760

This Notice of Consultation provides an opportunity to comment on the proposal to add hydroquinone to the Prescription Drug List (PDL) when sold in a concentration greater than 2% in topical products. Only the Human part of the PDL is proposed to be revised. The proposed wording of the new listing is:

Drugs containing any of the following: Hydroquinone

Qualifier:: When sold in a concentration that provides more than 2.0% hydroquinone in preparations for topical use on the skin.

Effective Date: to be determined

Rationale:

Hydroquinone, or 1, 4 Benzenediol occurs naturally as a conjugate with beta-D-glucopyranoside in the leaves, bark and fruit of a number of plants, especially the ericaceous shrubs such as cranberry, cowberry, bearberry and blueberry. It has been detected at low levels in many different kinds of food and when ingested from these sources it poses little health risk. It is also contained in a number of cosmetics and natural health products.

Hydroquinone is mainly used as a skin lightener through melanocyte toxicity and inhibition of melanogenesis (production of skin pigment). Hydroquinone is absorbed through the skin and metabolized primarily to sulfate and glucuronide conjugates, which are excreted in the urine. Additional metabolites include benzoquinone, multiple glutathione conjugates, and N-acetyl cysteine conjugates.

In July 2008, a scientific assessment by Environment Canada and Health Canada determined that hydroquinone can cause cancer in laboratory animals. On the basis of the carcinogenicity - for which there may be a probability of harm at any level of exposure - as well as the potential for other harmful effects, Health Canada and Environment Canada have determined that the health risks of hydroquinone can be mitigated as a prescription drug.

Hydroquinone has also been added to Schedule 1 of the Canadian Environmental Protection Act (CEPA 1999). This addition was due to health concerns as assessed through the Government of Canada’s Chemicals Management Plan. To manage the risks to health, hydroquinone was added to the Cosmetic Ingredient Hotlist. As a result, hydroquinone can only be used in cosmetics as an oxidizing colouring agent for hair dyes, artificial nail systems and cyanoacrylate adhesive products in specified concentrations.

Currently, hydroquinone containing products for topical use are classified as Over-the-Counter (OTC). It is proposed that the following marketed products for topical use be switched from OTC to prescription at hydroquinone concentrations greater than 2%:

The following Drug Information Number (DIN) products will be affected by this switch:

02248851, 02248849, 02010593, 02242933, 02242934, 02319047, 02250063, 02243007, and 02324113.

The following Licensed Natural Health Products (LNHPD) will be affected by this switch:

02245719, 00632783, 00626724, 80040427, 80040470, 02249553, 02249545, 80038901, 80048450, 80048449, 80064165, 80068828, 80072697 and 80073531.

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.

Comments on this proposed change to the Prescription Drug List should be provided to Health Canada, preferably in electronic format, within 75 days from the date of this notice.

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

Telephone: 613-957-1058
Facsimile: 613-941-5035

If all comments not in favour of this change can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada’s intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.

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