REGULATION OF CERTAIN PRODUCTS AS DRUGS.

SEC. 3621. REGULATION OF CERTAIN PRODUCTS AS DRUGS. Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) is amended by adding at the end the following:“(h)(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 201(g) and not a device under section 201(h). “(2) For purposes of this subsection:“(A) The term ‘contrast agent’ means an article that is intended for use in conjunction with a medical imaging device, and—“(i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or “(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid. “(B) The term ‘radioactive drug’ has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include—“(i) an implant or article similar to an implant; “(ii) an article that applies radiation from outside of the body; or “(iii) the radiation source of an article described in clause (i) or (ii). “(C) The term ‘OTC monograph drug’ has the meaning given such term in section 744L. “(3) Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 201(g)) if such product—“(A) is not described in paragraph (1); and “(B) meets the definition of a device under section 201(h), unless another provision of this Act otherwise indicates a different classification. “(4) The Secretary shall waive the application fee under sections 736 and 744B for applications for drugs that are—“(A) on the date of enactment of the Prescription Drug User Fee Amendments of 2022, legally marketed as devices; and “(B) deemed drugs pursuant to paragraph (1)” .136 STAT. 5878