; (B) stored in compliance with the requirements of parts 210 and 211 of title 21, Code of Federal Regulations, or any successor regulation; and (C) any specific criteria agreed to by the Secretary and the manufacturer of the essential generic medicine using the active pharmaceutical ingredient or key starting material. (2) Requirements To the greatest extent practicable, in carrying out paragraph (1), the Secretary shall acquire active pharmaceutical ingredients and key starting materials in a manner that minimizes cost, minimizes vulnerability of the United States to severe shortages or disruptions for essential generic medicines, minimizes the impact of acquisition of such ingredients and materials to the marketplace, gives preference to domestic manufacturers, and encourages competition in the marketplace. (3) Drawdown of the Reserve (A) In general The Secretary may distribute active pharmaceutical ingredients and key starting materials in the Reserve in order to initiate conversion of active pharmaceutical ingredients and finished dosage form, in accordance with the Plan developed under subsection (b). (B) Deviations from plan In distributing active pharmaceutical ingredients and key starting materials under subparagraph (A), the Secretary, in consultation with the Commissioner of Food and Drugs and the Assistant Secretary for Preparedness and Response, may deviate from the Plan developed under subsection (b) only after certifying that the distribution from the Reserve is required in response to a significant drug supply interruption. (d) Consultation (1) In general In carrying out this section, the Secretary shall consult with— (A) the Commissioner of Food and Drugs, with respect to identifying essential generic medicines; (B) the Administrator of the Centers for Medicare & Medicaid Services, with respect to determining the volume of essential generic medicines needed domestically