; or (B) a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death. (b) Alternative pathway for eligible patients with a terminal illness (1) In general Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 502(f), 503(b)(4), and subsections (a) and (i) of section 505 of this Act, and section 351(a) of the Public Health Service Act so long as the conditions specified in paragraphs (2), (3), and (4) are met with respect to the provision of such investigational drugs. (2) Compliance with certain regulations The conditions specified in this paragraph, with respect to an eligible investigational drug referred to in paragraph (1), are that— (A) the eligible investigational drug is labeled in accordance with section 312.6 of title 21, Code of Federal Regulations (or any successor regulations)