Which federal agency is responsible for regulating medication safety and labeling?

The Food and Drug Administration (FDA) is the federal agency responsible for regulating medication safety and labeling. This agency oversees the approval process for new medications, ensuring they are safe and effective for public use before they can be marketed. The FDA sets guidelines for how medications are manufactured, labeled, and tested, which includes establishing standards for safety and efficacy. This is crucial because proper labeling provides essential information to healthcare providers and patients, including indications, contraindications, potential side effects, and proper usage instructions.

Other agencies mentioned, including the Centers for Disease Control and Prevention, the National Institutes of Health, and the Substance Abuse and Mental Health Services Administration, have important roles in public health, research, and mental health services, but they do not have the direct authority to regulate medication safety and labeling. The CDC focuses on disease prevention and control, the NIH primarily conducts and funds medical research, and SAMHSA works to improve the quality and availability of substance use and mental health services. This distinction clarifies the FDA's unique role in ensuring that medications are safe and effectively communicated to both the healthcare profession and the public.