proposed amendment to the food and drug regulations notice of intent project no. 1651 schedule f 5 pages available in english and french the purpose of this notice of intent noi is to provide an opportunity for comment on the proposal to amend the current listings in part i of schedule f to the food and drug regulations for four medicinal ingredients to retain prescription status for specific strengths uses routes of administration or dosages while providing exemptions that would allow non-prescription status. since the coming into force of the natural health products regulations in 2004 all naturally sourced substances meeting the definition of a natural health product are governed by these regulations. however products containing substances listed in schedule f to the food and drug regulations are explicitly excluded from the natural health products regulations. health canada has undertaken a review of the naturally sourced medicinal ingredients listed in schedule f. as part of this undertaking the departments drug schedule status committee the committee has reviewed science assessments for 11 naturally sourced medicinal ingredients and has recommended that these medicinal ingredients could be regulated in whole or in part as non-prescription natural health products under the natural health products regulations. four of these eleven medicinal ingredients are presented in this project. this proposed amendment would allow manufacturers to apply for market authorization for products containing the proposed exempted strengths uses routes of administration or dosages of the following four medicinal ingredients as natural health products pursuant to the natural health products regulations. description of the medicinal ingredients dopamine and its salts the current listing for dopamine and its salts would be revised to retain prescription status for injectable parenteral forms of dopamine and its salts. all other dosage forms and routes of administration at any strength and for any use would be exempt from prescription status. dopamine is inactive in the body when administered orally. therefore there are no oral drug products containing dopamine on the market in canada. revising the prescription status of dopamine would mitigate issues with the licensing of orally administered natural health products with ingredients that might naturally contain trace amounts of dopamine. dopamine is administered by intravenous injection to treat kidney failure septic shock and acute heart failure resulting from a heart attack. it works by increasing blood pressure heart rate and force of heart contraction and by causing constriction of blood vessels. administration of dopamine by injection requires direct supervision by a practitioner and can cause serious adverse effects in the therapeutic dosage range. retaining prescription status for injectable forms of dopamine and its salts is therefore recommended. gold and its salts the current listing for gold and its salts would be revised to retain prescription status for injectable parenteral forms of gold and its salts and derivatives. the revised listing would be worded so that it would not change the status of auranofin an orally administered gold derivative that is listed separately in schedule f. gold and its salts and derivatives in any other dosage form or route of administration at any strength and for any use would be exempt from prescription status. gold is naturally occurring in trace amounts in nature so it is appropriate to add qualifiers to the listing on schedule f to avoid unintentionally subjecting products containing trace amounts of gold to prescription requirements where it is not necessary. as prescription drugs gold compounds are administered parenterally by injection to treat rheumatoid arthritis in patients for whom other treatments have been unsuccessful. gold compounds administered by the parenteral route can have undesirable side effects at normal therapeutic dosage levels and require direct practitioner supervision and routine laboratory monitoring. lovastatin the current listing for lovastatin would be revised to retain prescription status for all strengths and dosage forms except when lovastatin is sold in oral dosage form that provides less than 1.0 mg per dosage unit or per daily dose. oral dosage forms containing less than 1.0 mg of lovastatin would be exempt from prescription status. the proposed exemption for less than 1.0 mg is only 10 of the lowest therapeutic dose of 10 mg of lovastatin. this would allow red yeast rice products containing only trace amounts of lovastatin to be marketed as natural health products in canada. red yeast rice is derived from yeast grown on rice and is used as food in some asian countries. it contains several substances including lovastatin known to reduce cholesterol. as a prescription drug lovastatin is available in canada and is used to treat high cholesterol and is usually given in an initial dose of 10 to 20 mg daily increased if necessary over a period of time to 80 mg daily to achieve target cholesterol levels. uracil and its salts the current listing for uracil and its salts would be revised to retain prescription status for uracil and its salts when sold for the treatment of cancer. uracil and its salts for other uses at any strength dosage form or route of administration would be exempt from prescription status. uracil is found in all living organisms so its listing in schedule f without qualifiers is inappropriate. uracil has been used as a prescription drug in conjunction with other anti-cancer drugs to enhance antitumour activity and to reduce adverse effects. however this therapeutic use is not currently in practice in canada. if uracil were used in the treatment of cancer it would require the supervision of a practitioner and laboratory monitoring. 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.