CASTRO VALLEY ADULT AND CAREER EDUCATIONCMA PROGRAMFOOD AND DRUG ADMINISTRATION

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

FDA APPROVED OTC DRUGS MUST MEET FOLLOWING TESTS:

1. Benefits must outweigh risks2. Potential for misuse and abuse should be low3. Can be used to treat patient-diagnosed

conditions4. Can be adequately labeled5. Health personnel not needed for safe and

effective use6. Drug is safe when used according to labeled

directions

FDA MED-GUIDES

*Provides patient information for high-risk drugsIncludes:

> Storage information> Potential drug interactions> Side effects> Warnings> Contra-indications

CLASS ASSIGNMENT

1. Obtain drug name to research2. Go to FDA website: www.FDA.gov3. Click on CDER section4. Select assigned drug from drop-down menu5. Answer questions on sheet for assigned drug