Notice: Prescription Drug List (PDL): Hyoscine butylbromide

February 12, 2016
Our file number: 16-101454-524

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch injectable Hyoscine butylbromide to prescription status from ethical status for human use by adding it to the Human Prescription Drug List (PDL). Injectable Hyoscine butylbromide is already listed on the Veterinary Prescription Drug List. Health Canada has conducted a scientific review of Hyoscine butylbromide 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 16, 2015 Notice of Consultation, is:

Drugs containing the following: Hyoscine butylbromide

Qualifier: when recommended for parenteral use

Effective Date: six months from date of this Notice

Consultation summary:

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 16, 2015. The 75 day consultation period which ended December 30, 2015 has been completed.

Two comments were received on this proposal and both were positive. This revision to move only the injectable formulations and not the tablets to prescription status will come into effect 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
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9

Email: drug prescription status
Phone: 613-957-1058
Fax: 613-941-1812