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Comprehensive Guide to FDA's OTC Drug Approval Process

Explore FDA's Food and Drug Administration (FDA) program for approving over-the-counter (OTC) drugs. Learn about regulations, safety monitoring, drug recalls, and FDA MedGuides for high-risk medications. Access the FDA website and research assigned drugs.

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Comprehensive Guide to FDA's OTC Drug Approval Process

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  1. CASTRO VALLEY ADULT AND CAREER EDUCATIONCMA 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

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

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

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

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