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POLICY
From the Therapeutic Products Programme

Factors for listing drugs in Schedule F

Issued: December 6, 1989
Re-posted: August 9, 1999
891206.EXT

Schedule F to the Food and Drug Regulations is a listing of chemical entities or classes of drugs which, with exceptions, are required by regulation to be sold under prescription. The following are the factors used by the Programme to determine whether this level of control over the sale of these drugs is appropriate.

Drugs will be listed in Schedule F if:

1. individualized instructions and/or direct practitioner supervision, adjunctive therapy with scheduled drugs or routine laboratory monitoring are required;
   
   
2. there is a narrow margin of safety between the therapeutic and toxic doses, especially in populations such as geriatrics, children and pregnant or nursing mothers;
   
   
3. there are potential or known undesirable or severe side effects at normal therapeutic dosage levels;
   
   
4. they are known by experimental data to induce toxicity in animals but have not been in clinical use long enough to establish the pattern or frequency of long-term toxic effects in humans;
   
   
5. they are used in treatment of a serious disease easily misdiagnosed by the public;
   
   
6. their use may mask other ailments;
   
   
7. they have contributed to, or are likely to contribute to, the development of resistant strains of micro-organisms in humans;
   
   
8. they possess a dependence or abuse potential that is likely to lead to harmful non-medical use;
   
   
9. they possess a high level of risk relative to expected benefits; or
   
   
10. they have a therapeutic effect based on recently elucidated pharmacological concepts, the consequences of which have not been established.
    
    

Exceptions will be considered for drugs which:

1. are required to be readily available under emergency circumstances where it is not practical to obtain a prescription (such as adrenalin in insect bite kits);
   
   
2. are rarely used without a practitioner's supervision, and where the need for free availability outweighs the need for protection under Schedule F (such as insulin and nitroglycerin); or
   
   
3. have potential to produce dangerous interactions with other drugs or food constituents but effective labelling can minimize the risk.