Labeling of drugs with an ingredient that is a major food allergen or is made from a gluten-containing grain

(a) Misbranding Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: (hh) If it is a drug— (1) that is intended for human use; (2) that contains an ingredient that is, or is derived directly or indirectly from— (A) a major food allergen; or (B) a gluten-containing grain (including wheat, barley, rye, and their crossbred hybrids); and (3) whose label fails— (A) to state that the drug contains such an ingredient; and (B) to identify each such ingredient and, as applicable, the type of gluten-containing grain.. (b) Applicability Section 502(hh) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on the earlier of— (1) a date to be determined by the Secretary of Health and Human Services; or (2) the date that is 2 years after the date of the enactment of this Act.