Within 14 days
Report the adverse reaction to the FDA.
[Question to BSAS: Licensees must report the reaction "in the form and manner required by the FDA." Should they report it through Medwatch?
(Relevant language: "Within 14 days of any adverse physical or psychological reaction to an opioid agonist medication, the licensee shall report this reaction to the Food and Drug Administration (FDA) in the form and manner required by the FDA."]
This is a DPH regulatory requirement to report the incident to FDA. From the FDA's perspective, you may be a "voluntary reporter."
Laws: 105 CMR §164.305