May 20, 2011
Food and Drug Regulations – Project # 1431 – Schedule F Amendment
The purpose of this Notice of Intent (NOI) is to provide an opportunity to comment on the revised proposal to amend Part I of Schedule F to the Food and Drug Regulations to add quinine, its salts and derivatives except in oral dosage form that provides 50 mg or less of quinine base per dosage unit or per daily dose. That means a prescription would be required for products for oral use containing more than 50 mg of quinine per dosage unit or per daily dose. A prescription would also be required for products containing quinine at any strength for any route of administration other than oral. Products for oral use containing 50 mg or less of quinine per dosage unit or per daily dose would be regulated under the Natural Health Products Regulations and would not require a prescription.
Quinine is a medicinal ingredient that was originally made from the bark of several species of the cinchona tree and was used for centuries as the primary treatment for malaria. The use of quinine as a malaria treatment declined over the years as new synthetic derivatives of the drug such as chloroquine and mefloquine were developed and used. However, with increasingly drug-resistant strains of malaria appearing, there has been renewed interest in the use of quinine to treat malaria. Quinine is now being used in combination with other drugs such as antibiotics to treat non-severe malaria infections caused by specific organisms that are resistant to other anti-malarial drugs.