Notice: Prescription Drug List (PDL): Triamcinolone acetonide

July 14, 2014
Our file number: 14-108609-889

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to exempt Triamcinolone acetonide. Health Canada has conducted a scientific review of Triamcinolone acetonide 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 remains unchanged from what was proposed in the March 17, 2014 Notice of Consultation, is:

Drugs containing any of the following
Adrenocortical hormones or their salts or derivatives

Including (but not limited to)
hydrocortisone, hydrocortisone acetate, hydrocortisone valerate, hydrocortisone sodium succinate, clobetasone butyrate, difluprednate and triamcinolone acetonide

Qualifier
(c)Triamcinolone acetonide in a nasal spray that delivers 55 microgram (mcg)/spray for those 12 years of age and older.

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 March 17, 2014. The 75 day consultation period which ended May 31, 2014 has been completed.

Only one comment was received and it was favourable.

This revision will be in 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-statut_d'ordonnance_des_drogues@hc-sc.gc.ca
Phone: 613-957-1058
Facsimile: 613-941-5035