; and (C) by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly. 344. Preemption of State barriers to the substitution of biosimilar products No State, or any political subdivision thereof, may, under any circumstances, prohibit a pharmacy or pharmacist from dispensing, in place of a biological reference product, any biosimilar that the Food and Drug Administration has designated as an interchangeable product for that biological reference product. 345. Increasing pharmaceutical options to treat an unmet medical need Subsection (b) of section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ) is amended by adding at the end the following: (4) Unmet medical need For purposes of paragraph (1), a drug shall be deemed to address an unmet medical need for a disease or condition if fewer than 3 available drugs exist for the treatment of such disease or condition. . 346. Provisional approval of new human drugs (a) In general Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by adding at the end of the following: 524B. Provisional approval of new human drugs (a) Priority review and evaluation of applications (1) In general The Secretary shall establish a priority review system to evaluate applications submitted under this pathway for provisional approval within 90 days of receipt of a completed application. (2) Review of applications during epidemics and pandemics In the case of an epidemic or pandemic, including with respect to COVID–19, the Secretary shall accept and review various portions of an application submitted under the pathway under this section for provisional approval on a rolling basis, and the review of any part of an application so submitted shall be completed not later than 3 weeks after submission. (3) Other designations If a drug submitted for review under the pathway under this section is eligible for a special designation by the Secretary under this Act, including as