Notice - Prescription Drug List (PDL): Ibuprofen
February 5, 2016
Our file number: 16-101201-525
The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Ibuprofen to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific review of Ibuprofen against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which has not changed from what was proposed in the October 2, 2015 Notice of Consultation, is:
Drugs containing the following: Ibuprofen or its salts
- An oral dosage form that provides 400 milligrams or less per dosage unit; or
- A modified-release oral dosage form that provides 600 milligrams or less per dosage unit.
Effective Date: six months from date of this Notice
The proposal to amend the PDL was communicated to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations through a Notice of Consultation posted on Health Canada's website on October 2, 2015. The 75 day consultation period which ended December 16, 2015 has been completed.
There were no objections to this proposed switch only comments for clarity were received from two parties. The new modified release product will contain labelling consistent with the other ibuprofen products. This labelling will address the concerns raised about allergies, drug-drug interactions and increased risk of heart attack and stroke. Labelling also addresses concerns with the dosing frequency and duration of use, when and how to take the medication with respect to meals, and not to crush or chew the tablet. On December 6, 2015, the sponsor of the drug presented their request for nonprescription status to the National Drug Scheduling Advisory Committee (NDSAC) of the National Association of Regulatory Authorities (NAPRA). Meeting minutes are available on NAPRA's website. The committee expressed some concerns but tentatively recommended Schedule III status pending labelling revisions.
The amendment to allow the modified release formulation of ibuprofen nonprescription status will come into effect in six months from the date of this Notice through a Notice of Amendment posted on the Health Canada website.
Should you have any questions on this update to the Prescription Drug List, please contact:
Prescription Drug Status Committee
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
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