Definitions

Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71(9)(A)) is amended— (1) in clause (v), by striking; or and inserting a semicolon; (2) in clause (vi)— (A) by striking addition and inserting the addition; and (B) by striking the period and inserting; or; and (3) by adding at the end the following: (vii) the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is— (I) established by a national or international standards development organization; and (II) recognized by the Secretary through a process described in guidance for industry, initially published in July 2023, or any successor guidance, publicly available on the agency website, which addresses voluntary consensus standards for pharmaceutical quality..

Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71(9)(A)) is amended— (1) in clause (v), by striking; or and inserting a semicolon; (2) in clause (vi)— (A) by striking addition and inserting the addition; and (B) by striking the period and inserting; or; and (3) by adding at the end the following: (vii) the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is— (I) established by a national or international standards development organization; and (II) recognized by the Secretary through a process described in guidance for industry, initially published in July 2023, or any successor guidance, publicly available on the website of the Food and Drug Administration, which addresses voluntary consensus standards for pharmaceutical quality..