79–006 

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 


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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 reVerDate Nov 24 2008 06:57 Mar 25, 2009 Jkt 079006 PO 00000 Frm 00002 Fmt 6659 Sfmt 6602 E:\HR\OC\HR049.XXX HR049

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corded 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 HHSregistered 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. 


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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 2011 2012 2013 2014 2010– 

2014 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Estimated Authorization Level .......................................... 1 2 2 3 4 12 

Estimated Outlays ............................................................ 1 2 2 3 3 11 


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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 


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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 


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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 


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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. 

* * * * * * * 

Æ 


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