Final answer:
The FDA conducts a thorough risk assessment and approval process for drugs, known as a New Drug Application, to ensure they are safe and effective for human administration. Once approved, drugs are monitored for long-term safety through pharmacovigilance, and practitioners must have valid credentials to prescribe them.
Step-by-step explanation:
To determine whether a drug is deemed to be suitable for administration to humans, an acceptable risk assessment must be conducted by regulatory bodies, such as the Food and Drug Administration (FDA). Specifically, the FDA's Center for Drug Evaluation and Research sets requirements that vary depending on whether the product is a new drug, a generic drug, or an over-the-counter drug. New drugs undergo a rigorous evaluation process known as a New Drug Application (NDA), where the safety and effectiveness of the drug are thoroughly tested.
After a drug is approved, continuous monitoring, or pharmacovigilance, is essential to assess long-term safety and how the drug affects different subgroups of patients. This ongoing evaluation is crucial as a much larger patient population starts using the drug compared to the initial clinical trials.
It's important to note that the FDA's approval indicates that the drug is "safe and effective when used as directed." However, practitioners must also comply with additional regulations, such as possessing a valid DEA number, to prescribe these drugs to patients.