Final answer:
A compounding pharmacy should report any patient adverse drug experiences to the FDA within 15 days for serious events, and quarterly for others, in addition to possibly reporting through the FDA's MedWatch program. Continuous monitoring post-approval is part of the pharmacovigilance system to ensure safety.
Step-by-step explanation:
If a compounding pharmacy needs to report an adverse effect, they should follow the guidelines set by the FDA, which include reviewing and reporting any patient adverse drug experience to the FDA. Serious and fatal adverse drug events must be reported within 15 days, and other events must be reported on a quarterly basis. Additionally, health professionals and consumers can voluntarily report adverse drug events directly to the FDA through the MedWatch program.
Continuous monitoring of the drug is essential even after NDA approval because as more patients use it, new information on long-term safety and effects on specific patient subgroups may emerge. This vigilant evaluation is part of a pharmacovigilance system that ensures ongoing patient safety. Moreover, postmarketing risk management may include Phase IV trials or other safety surveillance activities mandated by the FDA.