Classification of Investigational Drugs

Classification of Investigational Drugs

One simple classification, which can be adapted to any hospital research program, is to  categorize: 

1. Class A: Should contain all investigational use drugs that are in a preliminary experimental stage. The use of the drug in this category is usually restricted to the principal investigator. 

2. Class B: Should consist of investigational use drugs that have passed through the preliminary research stage. Usually, drugs in this category are supplied to the department of pharmacy by the principal investigator and are dispensed only upon his written prescription. 

3. Class C: Is limited to drugs approved or passed by the FDA for commercial distribution. Drugs in this category may be used within the hospital or its clinics if the physician complies with some specific procedures. 

4. Class D: Drugs are preparations that have been accepted for use in the hospital and are listed in the hospital formulary.  Another simple classification which can be adapted to any hospital pharmacy operation: 

a. General: An FDA-approved drug that is recommended as essential for good patient care with a well-established usage, once accepted may be prescribed by all members of the attending and house staff. 

b. Conditional: Certain drugs may be approved for a conditional period of trial. A drug approved by the FDA for general use, but which the Committee wishes to evaluate for a given period before final consideration, may be prescribed by all members of the attending and house staff.  

c. Investigational: Drugs that are not approved by the FDA for use other than under controlled clinical settings must be approved by the Research Advisory Committee. A  protocol for any study involving drugs must be submitted to the

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