proposed amendment to the food and drug regulations project no. 1627 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 three medicinal ingredients to part i of schedule f to the food and drug regulations. description of the medicinal ingredients 1. golimumab is a human monoclonal antibody that acts on the immune system and is used to treat adults with active forms of rheumatoid arthritis psoriatic arthritis inflammatory diseases of the joints and ankylosing spondylitis inflammatory disease of the spine . direct supervision by a practitioner is required during treatment and routine laboratory monitoring is required. golimumab may cause undesirable or severe side effects at normal therapeutic dosage levels. 2. lapatinib and its salts is an anti-cancer drug that is used to treat patients with her2 receptor positive breast cancer that is advanced or has spread to other parts of the body. direct supervision by a practitioner is required during treatment and routine laboratory monitoring is required. lapatinib and its salts may cause undesirable or severe side effects at normal therapeutic dosage levels. 3. vorinostat is an anti-cancer drug that is used to treat patients with advanced cutaneous t-cell lymphoma a cancer of the immune system in whom the disease has persisted become worse or returned following treatment with other drugs. individualized instructions and direct supervision by a practitioner are required during treatment and routine laboratory monitoring is required. vorinostat 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.