< Back to H.R. 4972 (112th Congress, 2011–2013)

Text of the Gluten in Medicine Identification Act of 2012

This bill was introduced on April 27, 2012, in a previous session of Congress, but was not enacted. The text of the bill below is as of Apr 27, 2012 (Introduced).

Source: GPO

I

112th CONGRESS

2d Session

H. R. 4972

IN THE HOUSE OF REPRESENTATIVES

April 27, 2012

(for himself and Mrs. Lowey) introduced the following bill; which was referred to the Committee on Energy and Commerce

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.

1.

Short title

This Act may be cited as the Gluten in Medicine Identification Act of 2012.

2.

Labeling of source of human drug ingredients constituting or derived from a grain or starch-containing ingredient

(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:

(aa)

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.

.

(b)

Applicability

Section 502(aa) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, shall apply beginning on the sooner of—

(1)

a date to be determined by the Secretary of Health and Human Services; and

(2)

the date that is 2 years after the date of the enactment of this Act.