A firm planning a switch may request a meeting
What the document says“Any person planning to submit an application for an Rx-to-nonprescription switch may submit to the Secretary a written request for a meeting, for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application”
The Secretary may grant the meeting as appropriate, consistent with the established procedures for meetings and written responses, and each meeting has to be documented in minutes.
What the document actually says“Any person planning to submit an application for an Rx-to-nonprescription switch may submit to the Secretary a written request for a meeting, for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application”
A firm that plans to ask for a switch may ask for a meeting first. The meeting is to plan the request.
A switch means a drug moves from behind the counter to the shelf. The meeting is where the firm and the agency agree what proof is needed.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.