109 HR 5280 : Dextromethorphan Distribution Act of 2006 U.S. House of Representatives 2006-12-07 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II 109th CONGRESS 2d Session H. R. 5280 IN THE SENATE OF THE UNITED STATES December 7, 2006 Received 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 2006.

2.

Food and Drug Administration; restrictions on distribution of dextromethorphan

(a)

In general

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A the following:

503B.

Restrictions on distribution of dextromethorphan

(a)

In general

Not later than one year after the date of the enactment of the Dextromethorphan Distribution Act of 2006, the Secretary shall issue a final rule to prohibit the distribution of unfinished dextromethorphan to any person other than a person registered under section 510, subject to subsection (b). (b)

Further restrictions

Subsection (a) does not restrict the authority of the Secretary under section 201.122 of title 21, Code of Federal Regulations. (c)

Unfinished dextromethorphan

For purposes of this section, the term “unfinished dextromethorphan” means dextromethorphan that is not contained in a drug that is in finished dosage form.

. (b)

Enforcement

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following: (ii)The distribution of unfinished dextromethorphan in violation of regulations under section 503B. .

Passed the House of Representatives December 6, 2006. Karen L. Haas, Clerk.