proposed amendment to the food and drug regulations notice of intent project no. 1663 schedule f 4 pages available in english and french the purpose of this notice of intent noi is to provide an opportunity to comment on a proposal to add to part t of schedule f to the food and drug regulations pancrelipase pancreatin and pancreatic extracts where the strength per dosage unit exceeds 20 000 usp units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency. this would result in affected products being regulated as prescription drug products under the food and drug regulations. since pancrelipase pancreatin and pancreatic extracts meet the definition of a natural health product products sold for any other use or at a lower strength would continue to be regulated under the natural health products regulations. 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 t of schedule f lists ingredients that require a prescription for human use and for veterinary use. part u 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. description of the medicinal ingredient pancreatic enzymes are important for the adequate absorption of fat proteins and to a lesser extent carbohydrates from the diet. the failure of the pancreas to produce an adequate level of enzymes results in the inability to properly digest food otherwise known as pancreatic exocrine insufficiency pei . certain medical conditions can cause this lack of enzymes including cystic fibrosis chronic inflammation of the pancreas or blockage of the pancreatic ducts. a review of the available scientific literature on pancrelipase pancreatin and pancreatic extracts indicates that direct supervision by a practitioner and routine laboratory monitoring are required to determine and maintain the optimum dose as the response to these ingredients varies greatly from one patient to another. testing is needed to determine the level at which these ingredients are effective as there are potential health risks if the dose is excessive. pancrelipase pancreatin and pancreatic extracts have been known to cause undesirable side effects such as scarring of the large intestine which is commonly seen with excessive doses but has occurred at normal therapeutic dosage levels.