Final answer:
In California, dispensed Schedule II, III, and IV controlled substances must be reported to CURES within one working day. Additionally, pharmaceutical companies must report serious adverse drug events to the FDA within 15 days and other events quarterly.
Step-by-step explanation:
In the state of California, the Controlled Substance Utilization Review and Evaluation System (CURES) requires that all Schedule II, III, and IV controlled substances dispensed are reported. Health care providers must report these dispensed controlled substances to CURES within one working day after the medication is released to the patient or their representative. This is in accordance with California state law to improve patient safety, reduce substance abuse and enhance the ability to detect prescription drug fraud.
It's also essential for pharmaceutical companies to report any adverse drug event to the FDA following New Drug Application (NDA) approval. Serious and unexpected adverse events must be reported within 15 days, while other types of events need to be reported on a quarterly basis. These events are important for collecting data on the safety and efficacy of medications once they are in use by the public.