If an outsourcing facility becomes aware that a patient has been harmed by a compounded product prepared by the facility, MedWatch reporting to the FDA must occur within how many days?

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Multiple Choice

If an outsourcing facility becomes aware that a patient has been harmed by a compounded product prepared by the facility, MedWatch reporting to the FDA must occur within how many days?

The key idea is the reporting deadline you must meet when an outsourcing facility learns that a patient was harmed by a product it compounded. For these facilities, MedWatch requires notifying the FDA within 15 calendar days of becoming aware of information about the harm. This 15-day window is designed to balance timely safety communication with enough time to gather preliminary facts, and it applies specifically to serious adverse events linked to the facility’s compounded products. It isn’t an immediate 24-hour or 72-hour rush, nor a 60-day delay—the regulatory trigger is awareness of the harm, and the 15-day period counts every calendar day.

The key idea is the reporting deadline you must meet when an outsourcing facility learns that a patient was harmed by a product it compounded. For these facilities, MedWatch requires notifying the FDA within 15 calendar days of becoming aware of information about the harm. This 15-day window is designed to balance timely safety communication with enough time to gather preliminary facts, and it applies specifically to serious adverse events linked to the facility’s compounded products. It isn’t an immediate 24-hour or 72-hour rush, nor a 60-day delay—the regulatory trigger is awareness of the harm, and the 15-day period counts every calendar day.

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