Who regulates over-the-counter medications?

Who regulates over-the-counter medications?

• A. Federal Trade Commission
• B. Drug Enforcement Administration
• C. Department of Health and Human Services
• D. Food and Drug Administration

Answer: (D)

The regulation of over-the-counter (OTC) medications falls under the jurisdiction of the Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety, efficacy, and quality of drugs and medications, including those available without a prescription. They oversee the approval process for OTC drugs, evaluating their labeling, advertising, and manufacturing processes to ensure that they meet established safety standards and can be used safely by consumers without the supervision of a healthcare professional. This regulatory framework includes determining what can be sold as an OTC medication, as well as managing how these medications are marketed to the public. By regulating OTC medications, the FDA helps protect consumers from ineffective or harmful products, ensuring that those available in the marketplace are appropriate for self-administration. In contrast, while the Federal Trade Commission (FTC) is involved in advertising practices to prevent deceptive marketing, it does not regulate drug safety or efficacy. The Drug Enforcement Administration (DEA) is focused on controlled substances and their distribution, whereas the Department of Health and Human Services (HHS) oversees a broader spectrum of health policy and welfare but does not specifically regulate the medications themselves. Hence, the FDA is the correct authority overseeing OTC medications.

The regulation of over-the-counter (OTC) medications falls under the jurisdiction of the Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety, efficacy, and quality of drugs and medications, including those available without a prescription. They oversee the approval process for OTC drugs, evaluating their labeling, advertising, and manufacturing processes to ensure that they meet established safety standards and can be used safely by consumers without the supervision of a healthcare professional.

This regulatory framework includes determining what can be sold as an OTC medication, as well as managing how these medications are marketed to the public. By regulating OTC medications, the FDA helps protect consumers from ineffective or harmful products, ensuring that those available in the marketplace are appropriate for self-administration.

In contrast, while the Federal Trade Commission (FTC) is involved in advertising practices to prevent deceptive marketing, it does not regulate drug safety or efficacy. The Drug Enforcement Administration (DEA) is focused on controlled substances and their distribution, whereas the Department of Health and Human Services (HHS) oversees a broader spectrum of health policy and welfare but does not specifically regulate the medications themselves. Hence, the FDA is the correct authority overseeing OTC medications.