Health Canada has announced updates to the Prescription Drug List (PDL) that affect both human and veterinary drugs. This amendment introduces four new medicinal ingredients that now require a prescription and revises the conditions under which benzoyl peroxide is considered prescription-only for human use. These changes are effective immediately as of the date of posting.
What Has Changed
The following medicinal ingredients have been added to the human and veterinary parts of the PDL:
- Artesunate or its salts
- Crovalimab
- Osilodrostat or its salts
- Quizartinib or its salts
In addition, the entry for benzoyl peroxide has been amended for human use. It is now considered prescription-only when present in concentrations greater than 5 percent, when combined with another medicinal ingredient, or when sold for the treatment of rosacea.
Why These Changes Were Made
Health Canada determines whether a drug should require a prescription based on criteria outlined in the Food and Drug Regulations. Following scientific review, it was determined that artesunate, crovalimab, osilodrostat, and quizartinib meet the criteria for prescription status because they require practitioner oversight for safe and effective use.
Similarly, the amendment to the benzoyl peroxide entry reflects its expanded use in treating rosacea. Epsolay, a benzoyl peroxide cream, is indicated specifically for inflammatory lesions of rosacea in adults, which necessitates prescription-only status.
Therapeutic Uses of the Newly Added Drugs
- Amivas-Artesunate (artesunate): Indicated for the initial treatment of severe malaria in both adult and pediatric patients.
- Piasky (crovalimab): Used in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and adolescents 13 years of age and older who weigh at least 40 kg.
- Isturisa (osilodrostat): Indicated for adults with Cushing’s disease who have persistent or recurrent hypercortisolism after pituitary surgery or for those who cannot undergo surgery.
- Vanflyta (quizartinib): Used in combination with standard chemotherapy for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive, followed by maintenance therapy.
What This Means for Industry and Healthcare Providers
With these changes, manufacturers, distributors, and healthcare providers must ensure compliance with the updated PDL. Products containing the listed ingredients now require a prescription and cannot be marketed or dispensed as non-prescription items. For benzoyl peroxide, non-prescription availability is restricted to concentrations of 5 percent or less, sold alone and not for the treatment of rosacea.
These updates reinforce Health Canada’s commitment to ensuring that products with significant safety considerations are used under medical supervision. Healthcare professionals should be aware of these changes to provide appropriate guidance to patients, while companies should review their product portfolios and labelling to confirm alignment with the amended PDL.
Final Remarks
Health Canada’s addition of artesunate, crovalimab, osilodrostat, and quizartinib to the Prescription Drug List, along with the revised conditions for benzoyl peroxide, highlights the ongoing effort to align drug availability with patient safety and therapeutic need. These decisions ensure that drugs requiring medical oversight remain accessible only through prescription, supporting both patient safety and regulatory compliance.
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FAQ
Which new drugs have been added to the Prescription Drug List?
Health Canada recently added four medications [artesunate (and its salts), crovalimab, osilodrostat (and its salts), and quizartinib (and its salts)] to the PDL, covering both human and veterinary use.
What is the updated status of benzoyl peroxide under the PDL?
The amendment now places benzoyl peroxide in the prescription-only category for human use when it is formulated in concentrations greater than 5 percent, when combined with another active medicinal ingredient, or when indicated for the treatment of rosacea. Lower concentration standalone products remain non-prescription
Why were these changes made to the PDL?
A scientific review in accordance with the Food and Drug Regulations confirmed that these newly added drugs meet criteria requiring prescription status. The revision regarding benzoyl peroxide reflects its intended therapeutic use for rosacea, which also requires medical oversight.
What are the clinical uses of the newly added drugs?
- Artesunate is used for initial treatment of severe malaria in adults and children.
- Crovalimab treats paroxysmal nocturnal hemoglobinuria (PNH) in patients aged 13 years and older who weigh at least 40 kg.
- Osilodrostat is indicated for adult patients with Cushing’s disease who cannot undergo, or have not responded to, pituitary surgery.
- Quizartinib is used in a multi-stage chemotherapy regimen for adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
What should industry and healthcare professionals do in response to these changes?
Manufacturers and distributors must ensure that products containing the newly listed drugs carry appropriate prescription-only labelling. Healthcare providers should be aware of the updated regulations, especially with benzoyl peroxide formulations now restricted in certain concentrations or therapeutic combinations. Compliance with the updated PDL is essential to maintain regulatory adherence.
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