; or (B) in a country that is a member of the Organization for Economic Co-operation and Development. (2) The price charged by the manufacturer and the affiliate for the prescription drug or medical device in the United States and in any such country, as applicable. (3) The costs of the manufacturer and the affiliate to produce and market the prescription drug or medical device for sale in the United States and in any such country, as applicable. (b) Reporting by CBO The Director of the Congressional Budget Office shall submit an annual report to the Board on trends in the prices charged for prescription drugs and medical devices. 5. Prohibition against excessive price (a) Prohibition Beginning on the effective date of the regulation required by subsection (b), the manufacturer of a prescription drug or medical device shall not charge an excessive price, as determined pursuant to such regulation, for such drug or device. (b) Formula The Board shall by regulation prescribe a formula for determining whether the average manufacturer price of such drug or device over an annual quarter is an excessive price. (c) Determination of excessive price If the Board determines, on its own initiative or in response to a petition submitted under subsection (d), that the manufacturer of a prescription drug or medical device charges an excessive price for such drug or device in violation of subsection (a)— (1) the Board shall give the manufacturer— (A) notice of such violation; and (B) subject to subsection (d), a period to correct such violation