; and (B) is authorized by, and in accordance with, State law; and (2) the possession or use of an experimental drug, biological product, or device— (A) that is described in subparagraphs (A) and (B) of paragraph (1); and (B) for which the patient has received a certification from a physician, who is in good standing with the physician’s certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options. (b) No liability or use of outcomes (1) No liability Notwithstanding any other provision of law, no liability shall lie against a producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental drug, biological product, or device for the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is in compliance, with subsection (a). (2) No use of outcomes Notwithstanding any other provision of law, the outcome of any production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that was done in compliance with subsection (a) shall not be used by a Federal agency reviewing the experimental drug, biological product, or device to delay or otherwise adversely impact review or approval of such experimental drug, biological product, or device. (c) Definitions In this section: (1) Biological product The term biological product has the meaning given to such term in section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). (2) Device; drug The terms device and drug have the meanings given to such terms in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). (3) Experimental drug, biological product, or device The term experimental drug, biological product, or device that— (A) has successfully completed a phase 1 clinical investigation