Sildenafil

The current prescribing information for Revatio identifies sildenafil as the active drug, labels the product “Rx only,” and indicates it for pulmonary arterial hypertension in adults. Under § 503(b) of the Federal Food, Drug, and Cosmetic Act, a human drug limited by its approved application to professional supervision may be dispensed only by prescription.

Canada's federal Prescription Drug List for human use lists sildenafil or its salts as a prescription drug, with an effective date of 19 December 2013. Under section C.01.041 of the Food and Drug Regulations, a prescription drug may be sold only by a person authorized under provincial law to dispense it, pursuant to a received verbal or written prescription, or under the exception in section C.01.043. These federal provisions regulate sale and dispensing and do not create a general prohibition on ordinary possession; provincial law determines who may dispense prescription drugs. Health Canada's Drug Product Database classifies marketed human sildenafil citrate tablets, including VIAGRA, as PRESCRIPTION.