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111th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     111-49
======================================================================
 
               DEXTROMETHORPHAN DISTRIBUTION ACT OF 2009

                                _______
                                

 March 24, 2009.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Waxman, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1259]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1259) to amend the Federal Food, Drug, and 
Cosmetic Act with respect to the distribution of the drug 
dextromethorphan, and for other purposes, having considered the 
same, report favorably thereon without amendment and recommend 
that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Committee Consideration..........................................     2
Committee Votes..................................................     2
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Earmarks and Tax and Tariff Benefits.............................     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     6
Advisory Committee Statement.....................................     6
Constitutional Authority Statement...............................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     7

                          Purpose and Summary

    The purpose of H.R. 1259, the ``Dextromethorphan 
Distribution Act of 2009'', is to prohibit a person from: (1) 
possessing or receiving unfinished dextromethorphan (DXM) 
unless the person is registered with the Secretary of Health 
and Human Services (HHS) as a producer of a drug or device or 
otherwise registered, licensed, or approved under federal or 
state law to engage in specified pharmaceutical activities; or 
(2) distributing unfinished DXM to any person other than a 
registered person or person otherwise registered, licensed, or 
approved under federal or state law to engage in specified 
pharmaceutical activities.

                  Background and Need for Legislation

    Dextromethorphan is an over-the-counter (OTC) cough 
suppressant commonly found in more than 120 OTC cold 
medications either alone or in combination with other drugs 
such as analgesics, antihistamines, decongestants, or 
expectorants. When taken as directed, side effects are rarely 
observed.
    However, DXM is abused by individuals of all ages, and its 
abuse by teenagers and young adults is of particular concern. 
The typical clinical presentation of DXM intoxication involves 
hyperexcitability, lethargy, ataxia, slurred speech, sweating, 
and hypertension. Abuse of combination DXM products also causes 
health complications that result from other active ingredients, 
such as potential delayed liver damage from acetaminophen, and 
central nervous system and cardiovascular toxicity from 
antihistamines. The use of high doses of DXM in combination 
with alcohol or other drugs is particularly dangerous, and 
deaths have been reported. This abuse is fueled by DXM's 
widespread availability and extensive ``how to'' abuse 
information on various web sites. The sale of the powdered form 
of DXM over the Internet poses additional risks due to the 
uncertainty of composition and dose.
    The Food and Drug Administration (FDA) is particularly 
concerned about the abuse of dextromethorphan. In 2005, FDA 
issued an ``FDA Talk Paper'' warning against the abuse of DXM.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    The Committee on Energy and Commerce met in open markup 
session on Wednesday, March 4, 2009, and, pursuant to a motion 
by Mr. Waxman, agreed by unanimous consent to consider and 
approve H.R. 1259 and several other bills en bloc. H.R. 1259 
was ordered favorably reported to the House by a voice vote. No 
amendments were offered during full Committee consideration of 
H.R. 1259.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no recorded votes taken during consideration or 
ordering H.R. 1257 reported to the House.

                      Committee Oversight Findings

    Regarding clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the oversight findings of the 
Committee are reflected in this report.

         Statement of General Performance Goals and Objectives

    The purpose of H.R. 1259 is to restrict the distribution, 
possession, or receipt of the drug DXM to any person other than 
HHS-registered producers of drugs and devices, or persons 
registered, licensed, or approved under federal or state law to 
engage in specified pharmaceutical activities.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee adopts 
as its own the estimate of budget authority and revenues 
regarding H.R. 1259 prepared by the Director of the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974. The Committee finds that H.R. 
1259 would result in no new or increased entitlement authority 
or tax expenditures.

                  Earmarks and Tax and Tariff Benefits

    In compliance with clause 9 of rule XXI of the Rules of the 
House of Representatives, H.R. 1259 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                    Washington, DC, March 20, 2009.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1259, the 
Dextromethorphan Distribution Act of 2009.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 1259--Dextromethorphan Distribution Act of 2009

    Summary: H.R. 1259 would restrict the distribution, 
receipt, and possession of unfinished dextromethorphan to 
entities registered with the Secretary of Health and Human 
Services (HHS) or otherwise allowed under certain federal or 
state laws. It also would deem the product to be adulterated in 
circumstances that violate the new requirements. 
Dextromethorphan is an active ingredient commonly found in 
cough medications available over-the-counter and is subject to 
abuse by some individuals (particularly teenagers and young 
adults). ``Unfinished'' dextromethorphan generally refers to 
the bulk powdered form of the raw product.
    CBO estimates that implementing H.R. 1259 would cost $1 
million in 2010 and $11 million over the 2010-2014 period, 
assuming the appropriation of the necessary amounts. Enacting 
the bill could affect direct spending and revenues, but we 
estimate that any such effects would not be significant.
    Because those prosecuted and convicted of violating the 
bill's new requirements involving adulterated dextromethorphan 
could be subject to criminal fines, the federal government 
might collect additional fines if the legislation is enacted. 
Criminal fines are recorded as revenues, then deposited in the 
Crime Victims Fund and later spent. Such expenditures are 
classified as direct spending. CBO expects that any additional 
revenues and direct spending would not be significant because 
of the small number of cases likely to be affected.
    H.R. 1259 would impose a mandate on the private sector as 
defined in the Unfunded Mandates Reform Act (UMRA) by 
restricting the distribution, possession, and receipt of 
unfinished dextromethorphan to entities registered with the 
Secretary of HHS or otherwise allowed under certain federal or 
state laws. It would also be the duty of the person selling 
unfinished dextromethorphan to confirm that the buyer is 
legally allowed to make the purchase. CBO estimates that the 
aggregate cost of complying with those mandates would not 
exceed the threshold established by UMRA for private-sector 
mandates ($139 million in 2009, adjusted annually for 
inflation). The bill contains no intergovernmental mandates as 
defined in UMRA and would not affect the budgets of state, 
local, or tribal governments.
    Estimated cost to the Federal Government: The estimated 
cost of H.R. 1259 is shown in the following table. The costs of 
this legislation primarily fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                               By fiscal year, in millions of dollars--
                                                     -----------------------------------------------------------
                                                                                                          2010-
                                                        2010      2011      2012      2013      2014      2014
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated Authorization Level.......................         1         2         2         3         4        12
Estimated Outlays...................................         1         2         2         3         3        11
----------------------------------------------------------------------------------------------------------------

    Basis of estimate: For this estimate, CBO assumes that H.R. 
1259 will be enacted near the beginning of fiscal year 2010, 
that the necessary amounts will be appropriated each year, and 
that outlays will follow historical spending patterns for 
similar activities of the Food and Drug Administration (FDA). 
We estimate that implementing the bill would cost $11 million 
over the 2010-2014 period, assuming the appropriation of the 
necessary amounts. Enacting the legislation also could affect 
direct spending and revenues, but CBO estimates that any such 
effects would not be significant.

Spending subject to appropriation

    H.R. 1259 would restrict the possession, receipt, and 
distribution of unfinished dextromethorphan to entities 
registered with the Secretary of HHS or otherwise allowed under 
certain federal or state laws (with specific exceptions). It 
also would amend the Federal Food, Drug, and Cosmetic Act to 
deem unfinished dextromethorphan to be adulterated when it is 
possessed, received, or distributed in violation of the new 
restrictions established under the bill.
    CBO expects that FDA would be primarily responsible for 
administering the new registration requirements and related 
restrictions established under H.R. 1259. Following enactment, 
we expect that FDA would provide instruction to affected 
entities (such as chemical manufacturers) concerning how to 
comply with the bill's new requirements and that it would 
coordinate with other federal and state agencies that monitor 
or regulate dextromethorphan sales. We anticipate that ongoing 
administrative costs (mostly associated with enforcing the new 
requirements) would be roughly $2 million to $3 million 
annually. Based on information provided by FDA in 2007, 12 
additional agency staff (based on full-time equivalents) might 
be necessary to administer and enforce the bill's new 
requirements. However, CBO expects that staffing would build up 
to such levels over several years.

Direct spending and revenues

    Because those prosecuted and convicted of violating the 
bill's new requirements involving adulterated dextromethorphan 
could be subject to criminal fines, the federal government 
might collect additional fines if the legislation is enacted. 
Criminal fines are recorded as revenues, then deposited in the 
Crime Victims Fund and later spent. Such expenditures are 
classified as direct spending. CBO expects that any additional 
revenues and direct spending would not be significant because 
of the small number of cases likely to be affected.
    Estimated impact on the private sector: H.R. 1259 would 
impose a private-sector mandate, as defined in UMRA, by 
restricting the distribution, possession, and receipt of 
unfinished dextromethorphan to entities registered with the 
Secretary of HHS or otherwise allowed under certain federal or 
state laws. However, CBO believes the mandate would affect 
relatively few entities. Many of them would be exempt from 
registration, such as pharmacies and non-commercial research 
institutions, and others would have already registered to deal 
with other chemical products. H.R. 1259 would also impose a 
duty on the person selling unfinished dextromethorphan to 
confirm that the buyer is legally allowed to make the purchase. 
This verification process would require additional 
administrative work for sellers, but this cost would be 
negligible. CBO estimates that the direct cost of these 
mandates would be less than the annual threshold established in 
UMRA ($139 million in 2009, adjusted annually for inflation).
    Estimated impact on state, local, and tribal governments: 
The bill contains no intergovernmental mandates as defined in 
UMRA and would not affect the budgets of state, local, or 
tribal governments.
    Estimate prepared by: Federal costs: Julia Christensen; 
Impact on state, local, and tribal governments: Lisa Ramirez-
Branum; Impact on the private sector: Keisuke Nakagawa.
    Estimate approved by: Peter H. Fontaine, Assistant Director 
for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
states, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 establishes the short title of the Act as the 
``Dextromethorphan Distribution Act of 2009''.

Section 2. Restrictions on distribution of bulk dextromethorphan

    Section 2 amends section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.) to include unfinished DXM 
that is possessed, received, or distributed in violation of 
section 506D among the listing of adulterated drugs and 
devices. It further amends the Act by inserting a new section, 
506D, which restricts the possession, receipt, and distribution 
of DXM.

Section 506D. Restrictions on distribution of bulk dextromethorphan

    Section 506D prohibits a person from: (1) possessing or 
receiving unfinished DXM unless the person is registered with 
the Secretary of HHS as a producer of a drug or device or 
approved pursuant to a federal or state law to engage in 
specified pharmaceutical activities, or (2) distributing 
unfinished DXM to any person other than a person registered 
with the Secretary as a producer of a drug or device or 
approved pursuant to a federal or state law to engage in 
specified pharmaceutical activities. Section 2 excludes from 
such prohibitions common carriers that possess, receive, or 
distribute unfinished DXM between registered persons.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *


                      Chapter V--DRUGS AND DEVICES

                    Subchapter A--Drugs and Devices

                     ADULTERATED DRUGS AND DEVICES

  Sec. 501. A drug or device shall be deemed to be 
adulterated--
  (a) * * *

           *       *       *       *       *       *       *

  (j) If it is unfinished dextromethorphan and is possessed, 
received, or distributed in violation of section 506D.

           *       *       *       *       *       *       *


SEC. 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.

           *       *       *       *       *       *       *