Final answer:
Prescription drug pedigree records must be maintained as per FDA regulations, which require reporting of serious and fatal adverse drug events within 15 days and other events quarterly, ensuring ongoing pharmacovigilance post-market approval for safety.
Step-by-step explanation:
The length of time that prescription drug pedigree records need to be maintained can vary depending on the regulations set by governing bodies such as the U.S. Food and Drug Administration (FDA). Generally, after a New Drug Application (NDA) approval, sponsors are required to monitor and report any adverse drug experiences to the FDA. The reporting of unexpected serious and fatal adverse drug events must be done within 15 days, while other events may be reported on a quarterly basis. Moreover, drugs must continue to be evaluated through pharmacovigilance systems even after approval to ensure long-term safety and effectiveness in different patient subgroups. This ongoing evaluation is necessary to meet post-market safety requirements and to ensure patient protection.