Question

You must submit a ______ within ____ days after a controlled substance diversion (internal or external) and notify the DEA within ____ hours.

Answer 1

Entities must report controlled substance diversions, typically within 15 days, and notify the DEA usually within 24 hours. For the FDA, sponsors must report serious and fatal adverse drug experiences within 15 days, and other events quarterly.

Step-by-step explanation:

When there is a controlled substance diversion, either internal or external, the responsible entities must submit an initial report within 15 days, and often they must notify appropriate regulatory agencies like the Drug Enforcement Administration (DEA) immediately or within a certain prescribed timeframe. For instance, sponsors are required to report to the FDA every patient adverse drug experience they learn of after New Drug Application (NDA) approval. Serious and fatal unexpected adverse drug events need to be reported within 15 days, and other types of events are reported on a quarterly basis. Furthermore, health professionals and consumers can voluntarily report adverse drug event reports through the FDA's MedWatch program, which are termed as "spontaneous reports".