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CPGM 7356.021 Drug Quality Reporting System (DQRS)
Important Note: FDA Form 3500A is used for mandatory reporting of adverse drug events. (e.g., 15 day reports for adverse event reporting covered by 21 CFR
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Controlled Substances Discrepancy Report: Form 5 (
Instructions: This form should be completed if a discrepancy or an incident occurred with a controlled substance that was purchased by the Registrant. See
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Medication Error /Incident Report Form
Reason for Report: Missed medication, wrong medication, etc. Give a detailed report as to how incident happened: Action Taken/Intervention:.
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