IIB 111th CONGRESS 1st Session H. R. 1259 IN THE SENATE OF THE UNITED STATES April 1, 2009 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes.

1.

Short title

This Act may be cited as the Dextromethorphan Distribution Act of 2009.

2.

Restrictions on distribution of bulk dextromethorphan

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) is amended— (1)in section 501, by inserting at the end the following: (j)If it is unfinished dextromethorphan and is possessed, received, or distributed in violation of section 506D. ; and (2)by inserting after section 506C the following:

506D.

Restrictions on distribution of bulk dextromethorphan

(a)

Restrictions

No person shall— (1)possess or receive unfinished dextromethorphan, unless the person is registered under section 510 or otherwise registered, licensed, or approved pursuant to Federal or State law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients; or (2)distribute unfinished dextromethorphan to any person other than a person registered under section 510 or otherwise registered, licensed, or approved pursuant to Federal or State law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. (b)

Exception for common carriers

This section does not apply to a common carrier that possesses, receives, or distributes unfinished dextromethorphan for purposes of distributing such unfinished dextromethorphan between persons described in subsection (a) as registered, licensed, or approved. (c)

Definitions

In this section: (1)The term common carrier means any person that holds itself out to the general public as a provider for hire of the transportation by water, land, or air of merchandise, whether or not the person actually operates the vessel, vehicle, or aircraft by which the transportation is provided, between a port or place and a port or place in the United States. (2)The term unfinished dextromethorphan means dextromethorphan that is not contained in a drug that is in finished dosage form.

.

Passed the House of Representatives March 31, 2009. Lorraine C. Miller, Clerk.