[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5280 Introduced in House (IH)]








109th CONGRESS
  2d Session
                                H. R. 5280

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
   distribution of the drug dextromethorphan, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 3, 2006

  Mr. Upton (for himself and Mr. Larsen of Washington) 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 with respect to the 
   distribution of the drug dextromethorphan, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Dextromethorphan Distribution Act of 
2006''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Dextromethorphan is a safe and effective active 
        ingredient found in cough suppressant products sold over-the-
        counter in a variety of finished dosage forms, including 
        tablets, gel capsules, powders, and liquids.
            (2) The bulk powdered form of dextromethorphan is readily 
        available for purchase through various commercial channels.
            (3) Individuals, including teenagers in particular, are 
        attempting to get high by taking much larger than recommended 
        doses of dextromethorphan.
            (4) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
        et seq.) and the regulations of the Food and Drug 
        Administration govern the sale of products containing 
        dextromethorphan, the distribution of certain noncontrolled 
        drugs of abuse, and the sale, purchase, trade, and distribution 
        of drug products in general.
            (5) One critical step that should be taken to help combat 
        the abuse of dextromethorphan is to strengthen the Federal 
        controls over the distribution of dextromethorphan in bulk.

SEC. 3. FOOD AND DRUG ADMINISTRATION; RESTRICTIONS ON DISTRIBUTION OF 
              UNFINISHED ACTIVE INGREDIENTS.

    (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:

``SEC. 503B. RESTRICTIONS ON DISTRIBUTION OF UNFINISHED ACTIVE 
              INGREDIENTS.

    ``(a) In General.--If the Secretary determines that the 
distribution of an unfinished active ingredient should be restricted 
for the protection of the public health, the Secretary may by 
regulation prohibit the distribution of the ingredient to any person 
other than a person registered under section 510, subject to 
subsections (b) and (c).
    ``(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) Dextromethorphan.--Not later than 180 days after the date of 
the enactment of the Dextromethorphan Distribution Act of 2006, the 
Secretary shall issue a final rule under subsection (a) establishing 
restrictions on the distribution of dextromethorphan.
    ``(d) Unfinished Active Ingredient.--For purposes of this section, 
the term `unfinished', with respect to an active ingredient, means an 
active ingredient that--
            ``(1) is one of the ingredients in a drug that is not in 
        finished dosage form; or
            ``(2) is the sole ingredient of a drug that is not 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:
    ``(hh) The distribution of an unfinished active ingredient in 
violation of regulations under section 503B.''.
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