Massachusetts Pharmacy Technician License Practice Test

Which regulatory agency is responsible for initiating recalls on prescription drugs?

1. DEA

2. CDC

3. FDA

4. CMS

The correct answer is: FDA

The Food and Drug Administration (FDA) is the regulatory agency responsible for ensuring the safety and efficacy of prescription drugs, among other products. When there are concerns about a drug's safety, effectiveness, or quality, the FDA has the authority to initiate a recall. This can occur if adverse effects are reported, if there is contamination, or if the drug does not meet regulatory standards. The FDA closely monitors drug manufacturers and can take action to protect public health by recalling products that pose a risk to patients. This authority enables the agency to address potential health threats promptly. Other agencies mentioned, such as the Drug Enforcement Administration (DEA), focus more on the regulation of controlled substances and preventing drug abuse; the Centers for Disease Control and Prevention (CDC) primarily targets public health and safety issues such as disease control; and the Centers for Medicare and Medicaid Services (CMS) handles health insurance programs and does not have direct responsibility for drug recalls. Understanding the distinct roles of these agencies is crucial for recognizing why the FDA is the correct entity for initiating drug recalls.