Final answer:
The time limit to report dispensing of a controlled substance varies depending on the type of adverse drug event. Unexpected serious or fatal events must be reported within 15 days, while other events are reported quarterly.
Step-by-step explanation:
According to FDA regulations, the time limit to report the dispensing of a controlled substance depends on the type of adverse drug event.
If the event is an unexpected serious or fatal adverse drug event, the sponsor must report it to the FDA within 15 days. On the other hand, for other adverse drug events, the reporting should be done on a quarterly basis.
The FDA also receives spontaneous reports of adverse drug events through its MedWatch program, which rely on voluntary reporting from consumers and health professionals.