proposed amendment to the food and drug regulations project no. 1626 schedule f 5 pages available in english and french this notification announces the availability of a letter that provides an opportunity for comment on the proposal to add to part i of schedule f to the food and drug regulations collagenase when sold for debridement of severe burns and skin ulcers. health canada has conducted a scientific review of collagenase against a set of established and publicly available factors for listing drugs in schedule f. these factors include but are not limited to toxicity pharmacological properties and therapeutic uses of the medicinal ingredients. based on this assessment health canada is recommending the addition to schedule f of collagenase when sold for debridement of severe burns and skins ulcers. this would result in affected products being regulated as prescription drug products under the food and drug regulations. since collagenase meets the definition of a natural health product products sold for any other use would continue to be regulated under the natural health products regulations. description of the medicinal ingredient collagenase is an enzyme debriding agent that helps break down tissue in the body. collagenase is used to treat severe burns and skin ulcers by helping to remove dead skin and tissue in order to promote healing. individualized instructions and supervision by a practitioner are required for the treatment of these conditions with collagenase. the patient may also require additional treatment with scheduled drugs or routine laboratory monitoring. the degree of regulatory control afforded by schedule f prescription drug status coincides with the risk factors associated with this medicinal ingredient. oversight by a practitioner is necessary to ensure that appropriate risk benefit information is considered before the drug containing the medicinal ingredient is administered and that the drug therapy is properly monitored. sections c.01.041 to c.01.049 of the food and drug regulations control the sale of medicinal ingredients that are listed in schedule f. part i of schedule f lists ingredients that require a prescription for human use and for veterinary use. part ii of schedule f lists ingredients that require a prescription for human use but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.