Pub. L. 112-144, tit. VII, sec. 703 (as amended)

IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT LISTING.

Year: 2026Length: 191 wordsOfficial source
SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT LISTING. Section 510(j) (21 U.S.C. 360(j)) is amended— (1) in paragraph (1)— (A) in subparagraph (C), by striking “; and” and inserting a semicolon; (B) in subparagraph (D), by striking the period at the end and inserting “; and”; and (C) by adding at the end the following: “(E) in the case of a drug contained in the applicable list, the name and place of business of each manufacturer of an excipient of the listed drug with which the person listing the drug conducts business, including all establishments used in the production of such excipient, the unique facility identifier of each such establishment, and a point of contact e-mail address for each such excipient manufacturer.” ; and (2) by adding at the end the following: “(4) The Secretary shall require persons subject to this subsection to use, for purposes of this subsection, the unique facility identifier systems specified under subsections (b)(3) and (i)(4) with respect to drugs. Such requirement shall not apply until the date that the identifier system under subsection (b)(3) or (i)(4), as applicable, is specified by the Secretary.” .
Pub. L. 112-144, tit. VII, sec. 703 (as amended): IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT LISTING. | Justis AI