Notice: Prescription Drug List (PDL): Ibuprofen
Notice to the reader:The online consultation is now closed.
October 2, 2015
Our file number: 15-110631-19
The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to switch certain uses of Ibuprofen to non-prescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific assessment of this switch against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations.
The proposed wording of the new listing on the Human List is:
Drugs containing the following: Ibuprofen or its salts
Qualifier: except: (a) An oral dosage form that provides 400 milligrams or less per dosage unit; or (b) A modified-release oral dosage form that provides 600 milligrams or less per dosage unit.
Effective Date: to be determined
Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is an analgesic, antipyretic, and anti-inflammatory medication. The exemption for the 200 and 400 milligram dosage has been in place since 2002 and has been safely used in the non-prescription setting. Pharmacokinetic comparison of one 600 milligram modified-release with the 200 milligram strength given once every four hours demonstrated an equivalent extent of absorption over the 12 hours. From this study it was concluded that the safety profile for the 600 milligram formulation would be the same as the 200 milligram for the intended use. Actual use studies indicated that consumers were able to correctly use the product according to label directions.
Comments on this proposed change to the Prescription Drug List should be provided to Health Canada in writing, preferably in electronic format, within 75 days from the date of this notice.
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.
Please send your comments to:
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
If all comments not in favour of this switch 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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