[House Report 110-377]
[From the U.S. Government Publishing Office]



110th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    110-377

======================================================================



 
               DEXTROMETHORPHAN DISTRIBUTION ACT OF 2007

                                _______
                                

October 15, 2007.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                        [To accompany H.R. 970]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 970) 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 with an amendment and recommend 
that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     1
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Committee Consideration..........................................     2
Committee Votes..................................................     3
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. 970, the Dextromethorphan Distribution 
Act of 2007, is to prohibit a person from: (1) possessing or 
receiving unfinished dextromethorphan unless the person is 
registered with the Secretary of Health and Human Services as a 
producer of a drug or device; or (2) distributing unfinished 
dextromethorphan to any person other than a registered person.

                  Background and Need for Legislation

    Dextromethorphan (DXM) 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 (e.g., acetaminophen), antihistamines (e.g., 
chlorpheniramine), decongestants (e.g., pseudoephedrine) and/or 
expectorants (e.g., guaifenesin). The typical antitussive adult 
dose is 15 or 30 mg taken 3 to 4 times daily. The anticoughing 
effects of DXM persist for 5 to 6 hours after oral 
administration. When taken as directed, side effects are rarely 
observed.
    DXM is abused by individuals of all ages, but its abuse by 
teenagers and young adults is of particular concern. 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.
    DXM abusers report a heightened sense of perceptual 
awareness, altered time perception, and visual hallucinations. 
The typical clinical presentation of DXM intoxication involves 
hyperexcitability, lethargy, ataxia, slurred speech, sweating, 
hypertension, and nystagmus. Abuse of combination DXM products 
also causes health complications--increased blood pressure from 
pseudoephedrine, potential delayed liver damage from 
acetaminophen, and central nervous system, cardiovascular, and 
anticholinergic toxicity from antihistamines--that result from 
other active ingredients. The use of high doses of DXM in 
combination with alcohol or other drugs is particularly 
dangerous and deaths have been reported.
    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. The 
agency is working with other health and law enforcement 
authorities to address this serious issue and to warn the 
public of potential harm, after five recently reported deaths 
of teenagers that may be associated with the consumption of 
powdered DXM sold in capsules.

                                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 Thursday, September 27, 2007, and ordered H.R. 970 
favorably reported to the House by a voice vote. No amendments 
were offered during full Committee consideration. Pursuant to a 
unanimous consent request by Mr. Dingell, a technical 
correction to the bill was made, which is shown in the text 
reported by the Committee.

                            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. 970 reported to the House. A motion by Mr. 
Dingell to order H.R. 970 favorably reported to the House was 
agreed to by a voice vote.

                      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. 970 is to restrict the distribution of 
the drug dextromethorphan to any person other than FDA-
registered producers of drugs and devices.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
970 would result in no new or increased budget authority, 
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. 970 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, October 12, 2007.
Hon. John D. Dingell,
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. 970, the 
Dextromethorphan Distribution Act of 2007.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                         Robert A. Sunshine
                                   (For Peter R. Orszag, Director).
    Enclosure.

H.R. 970--Dextromethorphan Distribution Act of 2007

    Summary: H.R. 970 would restrict the distribution, receipt, 
and possession of unfinished dextromethorphan to certain 
entities registered with the Secretary of Health and Human 
Services. 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. 970 would cost less 
than $500,000 in 2008 and about $11 million over the 2008-2012 
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. 970 would impose a mandate on the private sector as 
defined in the Unfunded Mandates Reform Act (UMRA) by requiring 
people receiving, possessing, or distributing unfinished 
dextromethorphan to register with the Secretary of Health and 
Human Services. It would also be the duty of the person selling 
unfinished dextromethorphan to confirm that the buyer is also 
registered or exempt from registration. CBO estimates that the 
aggregate cost of complying with those mandates would not 
exceed the threshold established by UMRA for private-sector 
mandates ($131 million in 2007, 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. 970 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--
                                 ---------------------------------------
                                   2008    2009    2010    2011    2012
------------------------------------------------------------------------
              CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated Authorization Level...       1       2       2       3       4
Estimated Outlays...............       *       2       2       3       4
------------------------------------------------------------------------
Note: * = less than $500,000.

    Basis of estimate: For this estimate, CBO assumes that H.R. 
970 will be enacted near the beginning of fiscal year 2008, 
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 about $11 
million over the 2008-2012 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. 970 would restrict the possession, receipt, and 
distribution of unfinished dextromethorphan to certain entities 
registered with the Secretary of Health and Human Services 
(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 registration 
requirements 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. 970. 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 might 
coordinate with other federal and state agencies that monitor 
or regulate dextromethorphan sales. We also anticipate that 
ongoing administrative costs (mostly associated with enforcing 
the new requirements) would be roughly $2 million to $4 million 
annually. Based on information provided by FDA, 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. Taken together, CBO 
estimates that such activities would cost less than $500,000 in 
2008 and about $11 million over the 2008-2012 period.

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.
    Intergovernmental and private-sector impact: H.R. 970 would 
impose a private-sector mandate, as defined in UMRA, on people 
that receive, possess, or distribute unfinished 
dextromethorphan by requiring them to register with the 
Secretary of Health and Human Services. CBO believes the 
mandate would affect relatively few people. 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. 970 would 
also impose a duty on the person selling unfinished 
dextromethorphan to confirm that the buyer is registered or 
exempt from registration. This verification process would 
require additional administrative work for sellers, such as 
chemical manufacturers, to confirm the buying party's 
registration, but this cost would be negligible. CBO estimates 
that the direct cost of these mandates would be less than the 
threshold of $131 million in 2007 adjusted for inflation.
    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: Keith J. Fontenot, Deputy Assistant 
Director for Health and Human Resources, Budget Analysis 
Division.

                       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 2007''.

Section 2. Restrictions on distribution of bulk dextromethorphan.

    Section 2 prohibits a person from: (1) possessing or 
receiving unfinished dextromethorphan unless the person is 
registered with the Secretary of Health and Human Services as a 
producer of a drug or device, or (2) distributing unfinished 
dextromethorphan to any person other than a registered person. 
Section 2 excludes from such prohibitions common carriers that 
possess, receive, or distribute unfinished dextromethorphan 
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
          (2) distribute unfinished dextromethorphan to any 
        person other than a person registered under section 
        510.
    (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 
registered under section 510.
    (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.

           *       *       *       *       *       *       *


                                  
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