89–006 

111TH CONGRESS REPT. 111–618 " ! HOUSE OF REPRESENTATIVES 2d Session Part 1 

SAFE DRUG DISPOSAL ACT OF 2010 

SEPTEMBER 22, 2010.—Committed to the Committee of the Whole House on the 

State of the Union, and ordered printed 

Mr. WAXMAN, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 5809] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 5809) to amend the Controlled Substances Act to provide for take-back disposal of controlled substances in certain instances, 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 

Amendment .............................................................................................................. 1 

Purpose and Summary ............................................................................................ 3 

Background and Need for Legislation .................................................................... 3 

Committee Consideration ........................................................................................ 4 

Committee Votes ...................................................................................................... 5 

Committee Oversight Findings and Recommendations ........................................ 5 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 5 

Statement of General Performance Goals and Objectives .................................... 5 

Constitutional Authority Statement ...................................................................... 5 

Earmarks and Tax and Tariff Benefits .................................................................. 6 

Federal Advisory Committee Statement ................................................................ 6 

Applicability of Law to Legislative Branch ........................................................... 6 

Federal Mandates Statement ................................................................................. 6 

Committee Cost Estimate ....................................................................................... 6 

Congressional Budget Office Cost Estimate .......................................................... 6 

Section-by-Section Analysis of the Legislation ...................................................... 7 

Changes in Existing Law Made by the Bill, as Reported ..................................... 8 

AMENDMENT

The amendment is as follows: 


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Strike all after the enacting clause and insert the following: 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Safe Drug Disposal Act of 2010’’. 

SEC. 2. DELIVERY OF CONTROLLED SUBSTANCES BY ULTIMATE USERS FOR DISPOSAL. 

(a) REGULATORY AUTHORITY.—Section 302 of the Controlled Substances Act (21 

U.S.C. 822) is amended by adding at the end the following: 

‘‘(g)(1) An ultimate user who has lawfully obtained a controlled substance in accordance with this title may, without being registered, deliver the controlled substance to another person for the purpose of disposal of the controlled substance if— 

‘‘(A) the person receiving the controlled substance is authorized under this 

title to receive and dispose of the controlled substance; and 

‘‘(B) the delivery and disposal takes place in accordance with regulations 

issued by the Attorney General to prevent diversion of controlled substances. 

The regulations referred to in subparagraph (B) shall be consistent with the public 

health and safety. In developing such regulations, the Attorney General shall take 

into consideration the ease and cost of program implementation and participation 

by various communities. Such regulations may not require any entity to establish 

or operate a delivery or disposal program. 

‘‘(2) The Attorney General shall, by regulation, authorize long-term care facilities, 

as defined by the Attorney General by regulation, to deliver for disposal controlled 

substances on behalf of ultimate users in a manner that the Attorney General determines will provide effective controls against diversion and be consistent with the 

public health and safety. 

‘‘(3) If a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent’s property may deliver the controlled substance to another person for the purpose of disposal under 

the same conditions as provided in paragraph (1) for an ultimate user.’’. 

(b) CONFORMING AMENDMENT.—Section 308(b) of the Controlled Substances Act 

(21 U.S.C. 828(b)) is amended— 

(1) by striking the period at the end of paragraph (2) and inserting ‘‘; or’’; and 

(2) by adding at the end the following: 

‘‘(3) the delivery of such a substance for the purpose of disposal by an ultimate user, long-term care facility, or other person acting in accordance with section 302(g).’’. 

SEC. 3. PUBLIC EDUCATION CAMPAIGN. 

The Director of National Drug Control Policy, in consultation with the Administrator of the Environmental Protection Agency, shall carry out a public education 

and outreach campaign to increase awareness of how ultimate users may lawfully 

and safely dispose of prescription drugs, including controlled substances, through 

drug take-back programs and other appropriate means. 

SEC. 4. GAO REPORT. 

The Comptroller General of the United States shall— 

(1) collect data on the delivery, transfer, and disposal of controlled substances 

under section 302(g) of the Controlled Substances Act, as added by section 2; 

and 

(2) not later than 4 years after the date of the enactment of this Act, submit 

findings and recommendations to the Congress regarding use, effectiveness, and 

accessibility of disposal programs. 

SEC. 5. EPA STUDY OF ENVIRONMENTAL IMPACTS. 

(a) STUDY.—The Administrator of the Environmental Protection Agency (in this 

section referred to as the ‘‘Administrator’’) shall— 

(1) in consultation with relevant State and local officials and other sources of 

relevant technical expertise, conduct a study to— 

(A) examine the environmental impacts resulting from the ultimate disposal of controlled substances through existing methods; 

(B) taking into consideration such impacts, and the ease and cost of implementation of drug take-back programs and participation in such programs by various communities, formulate appropriate recommendations on 

the destruction or ultimate disposal of prescription drugs, including controlled substances; and 

(C) identify additional authority needed to carry out such recommendations if the Administrator determines that the Administrator’s existing 

legal authorities are insufficient to implement such recommendations; and 

(2) not later than 18 months after the date of the enactment of this Act, submit a report to the Congress on the results of such study. 


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1Office of National Drug Control Policy, The 2010 National Drug Control Strategy, p. 29 (online at www.whitehousedrugpolicy.gov/publications/policy/ndcs 10/ndcs2010.pdf). 2Substance Abuse and Mental Health Services Administration, Substance Abuse Treatment 

Admissions Involving Abuse of Pain Relievers: 1998–2008 (July 15, 2010) (online at 

oas.samhsa.gov/2k10/230/230PainRelvr2k10Web.pdf). 3 Centers for Disease Control and Prevention, Emergency Department Visits Involving Nonmedical Use of Selected Prescription Drugs—United States, 2004–2008 (June 18, 2010) (online 

at www.cdc.gov/mmwr/preview/mmwrhtml/mm5923al.htm). 4Substance Abuse and Mental Health Services Administration, Results from the 2008 National Survey on Drug Use and Health, p. 15–30 (online at www.oas.samhsa.gov/nsduh/ 

2k8nsduh/2k8Results.pdf). 

(b) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to affect 

the Administrator’s authority under other provisions of law. 

PURPOSE AND SUMMARY

H.R. 5809, the ‘‘Safe Drug Disposal Act of 2010’’, was introduced 

by Representatives Jay Inslee (D–WA), Lamar Smith (R–TX), Bart 

Stupak (D–MI), and James P. Moran (D–VA) on July 21, 2010. The 

bill was referred to the Committee on Energy and Commerce, and 

in addition to the Committee on the Judiciary. 

The legislation has two overriding goals: 

• To allow individuals, as well as long-term care facilities on behalf of their patients, to deliver unused prescription drugs to an appropriate person for disposal purposes, as determined by the Attorney General. • To enhance understanding of the environmental impacts of the 

disposal of unused medicines through existing methods. 

BACKGROUND AND NEED FOR LEGISLATION

The abuse of prescription medications is a growing public health 

concern in the United States. According to the 2010 National Drug 

Control Strategy released by the White House, prescription drug 

abuse is the fastest growing drug problem in the United States.1

Several recent studies underscore this point: • In a study released in July 2010, the Substance Abuse and 

Mental Health Services Administration (SAMHSA) found that between 1998 and 2008 there was a 400% increase in hospital admissions for those aged 12 and over reporting abuse of prescription 

pain relievers.2

• In a report published in June 2010, the Centers for Disease 

Control and Prevention (CDC) noted that emergency department 

visits associated with non-medical use of prescription controlled 

substances doubled between 2004 and 2008, reaching a million visits.3

• In a 2008 study, SAMHSA found that youth between the ages 

of 12 and 17 abuse prescription drugs more often than cocaine, heroin, and methamphetamine combined.4 It also showed that the 

scale of the problem is vast: more than six million Americans used 

a prescription medication for nonmedical purposes in a one-month 

period. The study further found that 70% of people who abuse prescription pain relievers obtained them from friends or relatives who 

had obtained them from a doctor. 

Drug take-back programs are one way to help address this growing and serious problem. As noted, a major factor in the increasing 

trend of prescription drug abuse is the availability of such drugs 

in the home. These programs provide a means by which patients 

can safely dispose of their unused medicines. Such programs also 


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5 Controlled substances are those substances listed in the schedules of the CSA and 21 CFR 

1308.11–1308.15, and generally include drugs that have a potential for abuse and physical and 

psychological dependence, such as narcotics, stimulants, depressants, anabolic steroids and 

hallucinogens. 6Drug Enforcement Administration, Testimony for the Special Committee on Aging Hearing 

on Drug Waste and Disposal: When Prescriptions Become Poison, Statement of Joseph T. 

Rannazzisi, p. 3 (June 30, 2010) (hereinafter, ‘‘DEA Testimony’’) (online at aging.senate.gov/ 

events/hr223gk.pdf). 7 Id. 

8 21 CFR 1300.01(b)(41). 

9DEA Testimony, supra note 6, at 5. 

decrease the amount of pharmaceuticals that might otherwise 

enter waterways via municipal waste water systems if such pharmaceuticals are flushed down the toilet. 

According to the Environmental Protection Agency, we know that 

pharmaceuticals have health effects at the therapeutic dose, but we 

do not know if there are effects to human health associated with 

long-term exposure to pharmaceuticals at much lower concentrations in drinking water. Some laboratory and other studies have 

demonstrated effects on fish and aquatic life of low-level exposure 

to pharmaceuticals. There are no known human health effects of 

low-level exposures to pharmaceuticals in drinking water in the 

general population, but EPA believes that more investigation is required to determine whether sensitive human populations (such as 

developing fetuses) are experiencing such effects. 

Under current law, the Controlled Substances Act (CSA) creates 

a barrier for many drug take-back programs. The CSA regulates 

controlled substances 5 through a closed registration system designed to prevent diversion.6 Under this system, any entity other 

than the ‘‘ultimate user’’ (i.e., the patient who is prescribed a controlled pharmaceutical) who receives or distributes a controlled 

substance must be registered with the Drug Enforcement Administration (DEA). In other words, although patients do not have to be 

registered with DEA in order to receive a controlled substance, 

they cannot lawfully deliver a controlled substance to another entity for any purpose, including disposal of the drug.7

Under current law as well, the only entities authorized to take 

possession of expired or otherwise unwanted controlled substances 

for the purpose of disposal are known as ‘‘reverse distributors.’’ 

Other registrants, such as pharmacies, may dispose of controlled 

substances already in their possession (for instance, if they are expired, damaged, or contaminated), but may not accept controlled 

substances from patients or any other person solely for the purpose 

of disposal.8

In January 2009, in response to growing concerns raised by individuals, interest groups, the healthcare industry, and the law enforcement community, DEA solicited public comments on the disposal of controlled substances dispensed to individual patients, as 

well as to long-term care facilities. Although DEA received numerous responses during the public comment period (which ended on 

March 23, 2009), the agency has stated it cannot move forward 

with a regulatory proposal in the absence of authorizing legislation.9

COMMITTEE CONSIDERATION

H.R. 5809, the ‘‘Safe Drug Disposal Act of 2010’’, was introduced 

by Representatives Inslee (D–WA), Smith (R–TX), Stupak (D–MI), 


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and Moran (D–VA) on July 21, 2010, and referred to the Committee on Energy and Commerce, and subsequently to the Subcommittee on Health on the same day. The Subcommittee on 

Health conducted a legislative hearing on the bill and afterwards 

met in open markup session to consider H.R. 5809 on July 22, 

2010. An amendment in the nature of a substitute (manager’s 

amendment) by Representative Stupak was adopted by a voice 

vote. Subsequently, H.R. 5809 was favorably forwarded to the full 

Committee, amended, by a voice vote. 

On July 28, 2010, the Committee on Energy and Commerce met 

in open markup session and considered H.R. 5809 as approved by 

the Subcommittee. An amendment in the nature of a substitute 

(manager’s amendment) offered by Representative Pallone (D–NJ) 

was adopted by a voice vote. Subsequently, the Committee ordered 

H.R. 5809 favorably reported to the House, amended, by a voice 

vote. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list each record vote on the motion 

to report legislation and amendments thereto. A motion by Mr. 

Waxman ordering H.R. 5809 reported to the House, amended, was 

approved by a voice vote. There were no record votes taken during 

consideration of this bill. 

COMMITTEE OVERSIGHT FINDINGS AND RECOMMENDATIONS

In compliance with clause 3(c)(1) of rule XIII and clause 2(b)(1) 

of rule X of the Rules of the House of Representatives, the oversight findings and recommendations of the Committee are reflected 

in the descriptive portions of this report, including the finding that 

drug take-back programs provide one means of addressing the 

growing and serious problem of prescription drug abuse. 

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 finds that H.R. 

5809 would result in no new budget authority, entitlement authority, or tax expenditures or revenues. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

In accordance with clause 3(c)(4) of rule XIII of the Rules of the 

House of Representatives, the performance goals and objectives of 

the Committee are reflected in the descriptive portions of this report, including the goal of facilitating the delivery of unused prescription drugs to appropriate persons for disposal purposes, and 

enhancing scientific understanding of the environmental impacts of 

the disposal of unused medicines through existing methods. 

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 auVerDate Mar 15 2010 01:08 Sep 24, 2010 Jkt 089006 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\HR618P1.XXX HR618P1

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thority for H.R. 5809 is provided under Article I, section 8, clauses 

3 and 18 of the Constitution of the United States. 

EARMARKS AND TAX AND TARIFF BENEFITS

H.R. 5809 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 of the Rules of the House of Representatives. 

FEDERAL ADVISORY COMMITTEE STATEMENT

The Committee finds that the legislation does not establish or 

authorize the establishment of an advisory committee within the 

definition of 5 U.S.C. App., section 5(b) of the Federal Advisory 

Committee Act. 

APPLICABILITY OF LAW TO THE LEGISLATIVE BRANCH

Section 102(b)(3) of Public Law 104–1 requires a description of 

the application of this bill to the legislative branch where the bill 

relates to terms and conditions of employment or access to public 

services and accommodations. H.R. 5809 contains no such provisions. 

FEDERAL MANDATES STATEMENT

Section 423 of the Congressional Budget and Impoundment Control Act of 1974 (as amended by section 101(a)(2) of the Unfunded 

Mandates Reform Act, P.L. 104–4) requires a statement on whether 

the provisions of the report include unfunded mandates. In compliance with this requirement the Committee adopts as its own the 

estimates of federal mandates prepared by the Director of the Congressional Budget Office. 

COMMITTEE COST ESTIMATE

Pursuant to clause 3(d)(2) of rule XIII of the Rules of the House 

of Representatives, the Committee adopts as its own the cost estimate of H.R. 5809 prepared by the Director of the Congressional 

Budget Office pursuant to section 402 of the Congressional Budget 

Act of 1974. 

CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

With respect to the requirements of clause (3)(c)(3) of rule XIII 

of the Rules of the House of Representatives and section 402 of the 

Congressional Budget Act of 1974, the Committee has received the 

following cost estimate for H.R. 5809 from the Director of the Congressional Budget Office: 

AUGUST 5, 2010. 

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. 5809, the Safe Drug Disposal Act of 2010. 


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If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Mark Grabowicz. 

Sincerely, 

DOUGLAS W. ELMENDORF. 

Enclosure. 

H.R. 5809—Safe Drug Disposal Act of 2010 

CBO estimates that implementing H.R. 5809 would cost about $2 

million in fiscal year 2011 and less than $500,000 annually over 

the 2012–2014 period, from appropriated amounts. The bill would 

not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. H.R. 5809 contains no intergovernmental or 

private-sector mandates as defined in the Unfunded Mandates Reform Act and would impose no costs on state, local, or tribal governments. 

H.R. 5809 would require the Department of Justice (DOJ) to authorize long-term care facilities (such as nursing homes) to arrange 

for the appropriate disposal of certain controlled substances. Based 

on information from DOJ, CBO estimates that implementing the 

bill would not significantly affect the department’s spending on 

drug control programs. 

In addition, H.R. 5809 would direct the Office of National Drug 

Control Policy to carry out a public outreach campaign relating to 

the safe disposal of prescription drugs. H.R. 5809 also would require the Environmental Protection Agency (EPA) to conduct a 

study on the environmental impacts of disposing of controlled substances and would require the Government Accountability Office 

(GAO), within four years of the date of enactment, to prepare a report on implementation of the bill’s provisions. 

Based on the costs of similar activities, CBO estimates that the 

public outreach campaign and the EPA study would cost about $1 

million each in 2011 and the GAO report would cost less than 

$500,000 annually over the 2011–2014 period, from appropriated 

funds. 

On August 3, 2010, CBO transmitted a cost estimate for S. 3397, 

the Secure and Responsible Drug Disposal Act of 2010, as reported 

by the Senate Committee on the Judiciary on July 29, 2010. The 

two bills are similar, but S. 3397 did not require a public outreach 

campaign or any reports and we estimated that its implementation 

would have no significant cost to the federal government. 

The CBO staff contact for this estimate is Mark Grabowicz. The 

estimate was approved by Theresa Gullo, Deputy Assistant Director for Budget Analysis. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section 1 designates that the short title may be cited as the ‘‘Safe 

Drug Disposal Act of 2010’’. 

Section 2. Delivery of controlled substances by ultimate users for 

disposal 

Section 2 amends the Controlled Substances Act to permit an ultimate user who has lawfully obtained a controlled substance and 

who is not registered with the DEA to deliver that controlled subVerDate Mar 15 2010 01:08 Sep 24, 2010 Jkt 089006 PO 00000 Frm 00007 Fmt 6659 Sfmt 6602 E:\HR\OC\HR618P1.XXX HR618P1

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stance to another person for the purpose of disposal if the person 

receiving the controlled substance is authorized to do so under the 

Act, and if the delivery and disposal takes place in accordance with 

regulations to be issued by the Attorney General to prevent diversion of controlled substances. In developing such regulations, the 

Attorney General is to consider both the ease and cost of program 

implementation and participation by various communities. The legislation prohibits the DEA from requiring any entity to establish a 

drug take back program. 

Section 2 also requires the Attorney General to issue regulations 

to authorize long-term care facilities to deliver for disposal controlled substances on behalf of ultimate users. 

In addition, Section 2 authorizes any person lawfully entitled to 

dispose of a decedent’s property to deliver controlled substances belonging to that decedent to another person for the purpose of disposal. 

Section 3. Public education campaign 

Section 3 requires the Director of National Drug Control Policy 

(ONDCP), in consultation with EPA, to carry out a public education 

and outreach campaign to increase awareness of drug take-back 

programs. 

Section 4. GAO report 

Section 4 requires the Comptroller General to submit a report to 

Congress on the delivery, transfer, and disposal of controlled substances under the Controlled Substances Act (as amended by the 

legislation) that includes findings and recommendations regarding 

the use, effectiveness, and accessibility of drug disposal programs. 

Section 5. EPA study of environmental impacts 

Section 5 requires the EPA administrator, in consultation with 

relevant state and local officials and other relevant experts, to conduct a study to: 

• Examine the environmental impacts from the final disposal of 

controlled substances through existing methods. 

• Consider the ease and cost of implementation of drug takeback programs, and participation in such programs by various communities. 

• Make recommendations on the appropriate ways to dispose of 

prescription drugs. 

• Identify additional authority needed to carry out such recommendations if the Administrator determines that existing legal 

authorities are insufficient to implement them. 

EPA is required to submit the results of the study to Congress 

within 18 months of the enactment of the legislation. 

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 (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 


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CONTROLLED SUBSTANCES ACT 

* * * * * * * 

TITLE II—CONTROL AND ENFORCEMENT 

* * * * * * * 

PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND

DISPENSERS OF CONTROLLED SUBSTANCES; PIPERIDINE REPORTING

* * * * * * * 

PERSONS REQUIRED TO REGISTER

SEC. 302. (a) * * * 

* * * * * * * 

(g)(1) An ultimate user who has lawfully obtained a controlled 

substance in accordance with this title may, without being registered, deliver the controlled substance to another person for the 

purpose of disposal of the controlled substance if— 

(A) the person receiving the controlled substance is authorized 

under this title to receive and dispose of the controlled substance; and 

(B) the delivery and disposal takes place in accordance with 

regulations issued by the Attorney General to prevent diversion 

of controlled substances. 

The regulations referred to in subparagraph (B) shall be consistent 

with the public health and safety. In developing such regulations, 

the Attorney General shall take into consideration the ease and cost 

of program implementation and participation by various communities. Such regulations may not require any entity to establish or 

operate a delivery or disposal program. 

(2) The Attorney General shall, by regulation, authorize long-term 

care facilities, as defined by the Attorney General by regulation, to 

deliver for disposal controlled substances on behalf of ultimate users 

in a manner that the Attorney General determines will provide effective controls against diversion and be consistent with the public 

health and safety. 

(3) If a person dies while lawfully in possession of a controlled 

substance for personal use, any person lawfully entitled to dispose 

of the decedent’s property may deliver the controlled substance to 

another person for the purpose of disposal under the same conditions as provided in paragraph (1) for an ultimate user. 

* * * * * * * 

ORDER FORMS

SEC. 308. (a) * * * 

(b) Nothing in subsection (a) shall apply to— 

(1) * * * 

(2) the delivery of such a substance to or by a common or 

contract carrier for carriage in the lawful and usual course of 

its business, or to or by a warehouseman for storage in the 

lawful and usual course of its business; but where such carriage or storage is in connection with the distribution by the 

owner of the substance to a third person, this paragraph shall 


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not relieve the distributor from compliance with subsection 

(a)ø.¿; or 

(3) the delivery of such a substance for the purpose of disposal 

by an ultimate user, long-term care facility, or other person acting in accordance with section 302(g). 

* * * * * * * 

Æ 


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