Certification of Pharmacy Technicians (ExCPT) Practice Exam

Which government agency regulates investigational medications?

1. FDA

2. DEA

3. CPSC

4. USP

The correct answer is: FDA

The Food and Drug Administration (FDA) is the government agency responsible for regulating investigational medications. Its primary role includes ensuring that new drugs and biological products are safe and effective before they can be marketed to the public. This is achieved through a rigorous process that involves clinical trials, which are conducted to evaluate the safety and efficacy of investigational drugs. The FDA oversees these trials, provides guidelines for their conduct, and reviews the resulting data to make informed decisions about whether a drug should be approved for wider use. The other agencies mentioned have distinct roles that do not pertain specifically to investigational medications. The Drug Enforcement Administration (DEA) focuses on the regulation of controlled substances and their distribution but does not oversee investigational new drugs. The Consumer Product Safety Commission (CPSC) deals with consumer products safety and regulations, while the United States Pharmacopeia (USP) sets standards for the quality of medicines but does not regulate their investigational status or clinical trials. Thus, the FDA is uniquely positioned to oversee and regulate investigational medications as part of its mission to protect public health.