proposed amendment to the food and drug regulations project no. 1624 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 proposed addition of four medicinal ingredients to part i of schedule f to the food and drug regulations. description of the medicinal ingredients 1. eculizumab is used to treat patients with paroxysmal nocturnal hemoglobinuria a rare disorder characterized by episodes of red blood cell destruction and blood in the urine occuring primarily at night. individualized instructions or direct supervision by a practitioner is required. the patient may also require routine laboratory monitoring. eculizumab may cause undesirable or severe side effects at normal therapeutic dosage levels. 2. olmesartan medoxomil is used to lower blood pressure in patients in whom the cause of high blood pressure is unknown. olmesartan medoxomil works by acting on the naturally occurring hormone in the body angiotensin ii which is actively involved in blood pressure. individualized instructions or direct supervision by a practitioner is required. the patient may also require routine laboratory monitoring. olmesartan medoxomil may cause undesirable or severe side effects at normal therapeutic dosage levels. 3. romiplostim is a protein used to treat low blood platelet counts in patients with immune thrombocytopenic purpura a disease in which the bodys immune system destroys platelets in the blood. individualized instructions or direct supervision by a practitioner is required. the patient may also require routine laboratory monitoring. romiplostim may cause undesirable or severe side effects at normal therapeutic dosage levels. 4. ustekinumab is used to treat patients with moderate to severe chronic plaque psoriasis. psoriasis is an autoimmune disease that causes scaly red patches called plaques on the skin. individualized instructions or direct supervision by a practitioner is required. the patient may also require routine laboratory monitoring. ustekinumab may cause undesirable or severe side effects at normal therapeutic dosage levels. the degree of regulatory control afforded by schedule f prescription drug status coincides with the risk factors associated with each 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. schedule f is a list of medicinal ingredients the sale of which is controlled under sections c.01.041 to c.01.049 of the food and drug regulations. 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.