1. CASTRO VALLEY ADULT AND CAREER EDUCATION CMA PROGRAM FOOD AND DRUG ADMINISTRATION

2. FOOD AND DRUG ADMINISTRATION (FDA) A division of the Department of Health and Human Services of the Federal Government. FUNCTIONS: Approve new prescription drugs before they are marketed Monitor safety of drugs and devices on the market Approve and monitor Over the Counter (OTC) drugs Monitor food Safety Oversee drug or device recalls

4. FDA APPROVED OTC DRUGS MUST MEET FOLLOWING TESTS: 1.Benefits must outweigh risks 2.Potential for misuse and abuse should be low 3.Can be used to treat patient-diagnosed conditions 4.Can be adequately labeled 5.Health personnel not needed for safe and effective use 6.Drug is safe when used according to labeled directions

5. FDA MED-GUIDES *Provides patient information for high-risk drugs Includes: > Storage information > Potential drug interactions > Side effects > Warnings > Contra-indications

6. CLASS ASSIGNMENT 1.Obtain drug name to research 2.Go to FDA website: www.FDA.govwww.FDA.gov 3. Click on CDER section 4. Select assigned drug from drop-down menu 5. Answer questions on sheet for assigned drug