Clarifying provisions; labeling requirement

Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is amended— (1) by striking subsection (b)(3)(B) and the matter following such subsection and inserting the following: (B) such drug product is labeled as follows: This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration.; and (2) in subsection (b)(1)(A)(i)(I) by striking National Formulary monograph and inserting National Formulary drug or dietary supplement monograph.