Section 1 Short title
This Act may be cited as the “Gluten in Medicine Disclosure Act of 2013”.
Gluten in Medicine Disclosure Act of 2013
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require the label of drugs intended for human use to contain a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient.
Sec. 2 Labeling of source of human drug ingredients constituting or derived from a grain or starch-containing ingredient
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:
“(bb) If it is a drug—
“(1) that is intended for human use;
“(2) that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient; and
“(3) whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.”
Applicability— Section 502(bb) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, shall apply beginning on the sooner of—
a date to be determined by the Secretary of Health and Human Services; and
the date that is 2 years after the date of the enactment of this Act.