Expanded-access prescription drugs

(a) In general Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) is amended by adding at the end the following: (6) Expanded-access prescription drugs (A) Establishment of list The Secretary shall establish and maintain a list of expanded-access prescription drugs. (B) Designation The Secretary shall designate such expanded-access prescription drugs based on safety data, evidence of low risk, and suitability for assessment in a pharmacy or similar setting (such as certain antibiotics for minor infections, antivirals, hormonal therapies, and maintenance drugs for chronic conditions). (C) Dispensing and administering Notwithstanding paragraph (1), an expanded-access prescription drug may be dispensed and administered by a covered individual after conducting an appropriate patient assessment consistent with protocols to be issued by the Secretary. (D) Rulemaking Not later than 120 days after the date of enactment of this paragraph, the Secretary shall issue such regulations through notice-and-comment rulemaking as may be necessary to carry out this paragraph, including— (i) to establish and maintain the list under subparagraph (A); and (ii) to issue protocols under subparagraph (C). (E) Preemption (i) In general Except as provided in clause (ii), no State or political subdivision of a State may establish, enforce, or continue in effect with respect to an expanded-access prescription drug any provision of law or legal requirement, including with respect to licensure of a covered individual, that is different from, or is in conflict with, any requirement applicable under this paragraph. (ii) State opt-out authority The prohibition in clause (i) shall not apply in the case of a State (excluding a political subdivision thereof) that has in effect a law explicitly prohibiting or limiting the prescribing or dispensing of an expanded-access prescription drug by a covered individual. (F) Covered individual defined In this paragraph, the term covered individual means an individual who is licensed under applicable State law as— (i) a pharmacist; (ii) an advanced practice registered nurse; (iii) an advanced practice provider; (iv) a physician assistant; or (v) such other health care professional, as may be specified by the Secretary.. (b) Congressional report Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report on the implementation of, and State opt-outs under, paragraph (6) of section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) (as added by subsection (a)).