31, 2018. (e) Safe and affordable drugs from approved countries Chapter VIII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 et seq.) is amended by adding at the end the following: 810. Importation by individuals of prescription drugs, and devices, from an approved country if manufacturers are charging an excessive price for comparable products in the United States (a) In general Notwithstanding any other provision of this Act, not later than 180 days after the date of enactment of this section, the Prescription Drug and Medical Device Price Review Board (in this section referred to as the Board ) shall promulgate regulations permitting individuals to safely import from an approved country into the United States prescription drugs, and devices, that are comparable to prescription drugs, and devices, for which the Board makes a final determination that the manufacturer is charging or has charged an excessive price in violation of section 5(a) of the Prescription Drug and Medical Device Price Review Board Act of 2018 . (b) Comparable defined For purposes of this section, the term comparable means— (1) with respect to a drug, having the same active ingredient or ingredients, route of administration, dosage form, and strength