Public-domain · open source
OpenJurist

Rx-to-nonprescription switch

Defined in 1 place of the United States Code.

For purposes of this paragraph, the term “Rx-to-nonprescription switch” means the approval of an application, or supplemental application, as applicable, submitted under this section by the holder of an approved application for a prescription drug seeking approval to market such drug as a nonprescription drug, including for—

(i) a full Rx-to-nonprescription switch, under which a drug previously approved for prescription use only is—

(I) approved for nonprescription use under the same conditions as applied to the drug when approved for prescription use; or

(II) approved for nonprescription use subject to one or more additional conditions for nonprescription use; and

(ii) a partial Rx-to-nonprescription switch, under which the drug is approved for nonprescription use only under certain conditions described in the approved labeling, while the drug otherwise remains approved for prescription use only.

Source