Legal Issues Relating to the Disposal of Dispensed Controlled Substances

Congressional research reportOct 19, 2010

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Legal Issues Relating to the Disposal of

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances

Summary

According to the White House Office of National Drug Control Policy, the intentional use of

prescription drugs for non-medical purposes is the fastest-growing drug problem in the country

and the second-most common form of illicit drug abuse among teenagers in the United States,

behind marijuana use. Young adults and teenagers may find their parents’ prescription drugs in

unsecured medicine cabinets or other obvious locations in the home, or they may retrieve expired

or unwanted medication from the trash. It is believed that properly disposing of unwanted

medications would help prevent prescription drug abuse by reducing the accessibility and

availability of such drugs. Yet throwing prescription medications into the trash or flushing them

down the toilet may not be environmentally desirable. In response, many local communities and

states have implemented pharmaceutical disposal programs (often referred to as drug “take-back”

programs) that collect unused and unwanted medications from patients for incineration or other

method of destruction that complies with federal and state laws and regulations, including those

relating to public health and the environment.

Prescription drugs may be categorized as either controlled substance medication or noncontrolled substance medication. Pharmaceutical controlled substances, such as narcotic pain

relievers OxyContin® and Vicodin®, are among the most commonly abused prescription drugs.

However, community take-back programs usually only accept non-controlled substance

medication, in compliance with the federal Controlled Substances Act. This statute

comprehensively governs all distributions of controlled substances, and it currently does not

allow for a patient to transfer a controlled substance to another entity for any purpose, including

disposal of the drug. (Federal regulations provide a limited exception to this general prohibition—

local law enforcement may obtain a waiver from the federal Drug Enforcement Administration to

collect unused controlled substances from patients and destroy them.) As a consequence, patients

seeking to reduce the amount of unwanted controlled substances in their possession have few

alternative disposal options beyond discarding or flushing them.

The 111th Congress has considered legislation that would create a legal framework governing

disposal of controlled substances that have been dispensed to patients. On October 12, 2010,

President Obama signed the Secure and Responsible Drug Disposal Act of 2010 (S. 3397) into

law (P.L. 111-273). P.L. 111-273 amends the Controlled Substances Act to allow a patient to

deliver controlled substances to an entity that is authorized by federal law to dispose of them,

providing that such disposal occurs in accordance with regulations issued by the Attorney General

to prevent diversion of controlled substances. The Attorney General is required, in developing

those regulations, to take into consideration the public health and safety, as well as the ease and

cost of drug disposal program implementation and participation by various communities. Also,

P.L. 111-273 gives the Attorney General discretion to issue regulations that authorize long-term

care facilities to dispose of controlled substances on behalf of patients who reside in those

facilities.

Other related bills in the 111th Congress include the Safe Drug Disposal Act of 2010 (H.R. 5809),

the Safe Drug Disposal Act of 2009 (H.R. 1191, S. 1336), the Secure and Responsible Drug

Disposal Act of 2009 (H.R. 1359, S. 1292), and the Safe Prescription Drug Disposal and

Education Act (H.R. 5925).

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances

Contents

Introduction...................................................................................................................................... 1

Current Federal Guidelines on Proper Disposal of Prescription Drugs ........................................... 2

Overview of the Controlled Substances Act .................................................................................... 5

Prescriptions for Controlled Substances .................................................................................... 5

CSA Regulatory Scheme ........................................................................................................... 6

CSA Civil and Criminal Penalties ............................................................................................. 7

Disposal of Controlled Substances .................................................................................................. 9

Disposal By DEA Registrants.................................................................................................... 9

Disposal By Ultimate Users ...................................................................................................... 9

Legislation in the 111th Congress ................................................................................................... 11

Secure and Responsible Drug Disposal Act of 2010 ............................................................... 12

Other Related Bills .................................................................................................................. 13

Contacts

Author Contact Information........................................................................................................... 15

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Introduction

Prescription drug abuse1 is the second-most common form of illicit drug abuse among teenagers

in the United States, trailing only marijuana use.2 The director of the White House Office of

National Drug Control Policy (ONDCP), R. Gil Kerlikowske, has called prescription drug abuse

“the fastest-growing drug problem in the United States” and “a serious public health concern.”3

Controlled substances, such as the narcotic pain relievers OxyContin® and Vicodin®, are among

the most often abused prescription drugs.4 Young adults and teenagers may have easy access to

prescription drugs via their parents’ medicine cabinets, from their friends or relatives, or they may

retrieve expired or unwanted medication from the trash.5 A possible approach to addressing the

prescription drug abuse problem is to reduce the availability of such drugs by patients disposing

of unwanted medications that have been accumulating in their homes.6 Yet throwing prescription

medications into the trash, flushing them down the toilet, or pouring them down a sink or drain—

such that they end up in solid waste landfills or wastewater treatment systems—may have

undesirable environmental consequences.7 As Director Kerlikowske testified before Congress,

These drugs are dispensed for legitimate purposes and too often, the public’s perception is

that they are safe for uses other than those for which they are prescribed. We must change

public perception so the societal norm shifts to one where unused or expired medications are

disposed of in a timely, safe, and environmentally responsible manner. We envision a future

where disposal of these medications is second-nature to most Americans, in much the same

way as proper and responsible recycling of aluminum cans has become. Creating a method of

disposal of expired or unused prescription drugs is essential to public health, public safety,

and the environment.8

In this report, prescription drug abuse is defined as the “use of prescription medications without medical supervision

for the intentional purpose of getting high, or for some reason other than what the medication was intended.” White

House Office of National Drug Control Policy, Teens and Prescription Drug, February 2007, at 8, available at

http://www.theantidrug.com/pdfs/TEENS_AND_PRESCRIPTION_DRUGS.pdf.

ONDCP, Prescription Drug Abuse Prevention, at http://www.whitehousedrugpolicy.gov/drugfact/

prescr_drg_abuse.html; see also Substance Abuse and Mental Health Services Administration, Results from the

2007National Survey on Drug Use and Health: National Findings, available at http://www.oas.samhsa.gov/NSDUH/

2k7NSDUH/2k7results.cfm.

Drug Waste and Disposal: When Prescriptions Become Poison: Hearing Before the Senate Special Comm. on Aging,

111th Cong., 2nd sess. (2010) (statement of Director Kerlikowske, at 1).

ONDCP, Prescription for Danger, A Report on the Troubling Trend of Prescription and Over-the-Counter Drug

Abuse Among the Nation’s Teens, January 2008, at 3, available at http://www.theantidrug.com/pdfs/

prescription_report.pdf.

Id. at 5.

155 CONG. REC. E386 (daily ed. February 25, 2009) (statement of Rep. Jay Inslee) (“Family medicine cabinets all

across America have turned into the drug dealers of today”).

The environmental effects of disposal of prescription drugs by flushing them down the toilet are beyond the scope of

this report. For information related to this issue, see CRS Report R40177, Environmental Exposure to Endocrine

Disruptors: What Are the Human Health Risks?, by (name redacted) and (name redacted), and Pharmaceuticals in

the Nation’s Water: Assessing Potential Risks and Actions to Address the Issue: Hearing Before the Subcomm. on

Transportation Safety, Infrastructure Security, and Water Quality of the S. Comm. on Environment and Public Works,

110th Cong., 2nd sess. (2008).

Drug Waste and Disposal: When Prescriptions Become Poison: Hearing Before the Senate Special Comm. on Aging,

111th Cong., 2nd sess. (2010) (statement of Director Kerlikowske, at 2-3).

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Some local and state government agencies and grassroots organizations have established drug

disposal programs (often referred to as pharmaceutical “take-back” programs) to facilitate the

collection of unused, unwanted, or expired medications for incineration or other method of

destruction that complies with federal and state laws and regulations, including those relating to

public health and the environment.9 There are several different types of take-back programs,

including the following: permanent locations where unused prescription drugs are collected;

special one-day events in which patients can drop off unwanted drugs at pharmacies or hazardous

waste collection sites; and mail-in/ship-back programs.10 One of the action items set forth in the

ONDCP’s 2010 National Drug Control Strategy calls for an increase in the creation and operation

of take-back programs in communities around the country to address the pharmaceutical abuse

problem.11

However, these take-back programs often exclude controlled substance medications because

federal law currently does not allow for a patient to deliver a controlled substance to another

entity for disposal purposes, unless local law enforcement has obtained a waiver from the federal

Drug Enforcement Administration (DEA) to take custody of the unused controlled substances

from patients and destroy them.12 As a consequence, those seeking to reduce the amount of

unwanted controlled substances in their households have few alternative disposal options beyond

discarding or flushing them.

Current Federal Guidelines on Proper Disposal of

Prescription Drugs

The ONDCP has issued the following recommendations regarding disposing of expired or unused

prescription medications in such a way that makes it difficult for the drugs to be easily

retrieved:13

For a survey of these programs, see Illinois-Indiana Sea Grant College Program, Unwanted Medicine Take-back

Programs: Case Studies, April 2, 2009, available at http://www.iisgcp.org/UnwantedMeds/toolkit/2.0CaseStudies.pdf.

Drug Waste and Disposal: When Prescriptions Become Poison: Hearing Before the Senate Special Comm. on Aging,

111th Cong., 2nd sess. (2010) (statement of Director Kerlikowske, at 6).

ONDCP, The 2010 National Drug Control Strategy, at 30-32, available at http://www.whitehousedrugpolicy.gov/

publications/policy/ndcs10/ndcs2010.pdf.

DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74

Fed. Reg. 3480, 3483 (January 21, 2009); Drug Waste and Disposal: When Prescriptions Become Poison: Hearing

Before the Senate Special Comm. on Aging, 111th Cong., 2nd sess. (2010) (statement of Director Kerlikowske, at 6).

ONDCP, Proper Disposal of Prescription Drugs, October 2009, available at http://www.whitehousedrugpolicy.gov/

publications/pdf/prescrip_disposal.pdf.

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Federal Guidelines for Proper Disposal of Prescription Drugs

•

Do not flush prescription drugs down the toilet or drain unless the label or

accompanying patient information specifically instructs the patient to do so.

•

To dispose of prescription drugs not labeled to be flushed, take advantage of

community pharmaceutical drug take-back programs or other programs, such as

household hazardous waste collection events, that collect drugs at a central

location for proper disposal. Call your city or county government’s household

trash and recycling service and ask if a drug take-back program is available in

your community.

•

In the event a drug take-back or collection program is not available:

1. Take the prescription drugs out of their original containers.

2. Mix drugs with an undesirable substance, such as used coffee grounds or

kitty litter.

3. Put this mixture into disposable containers with a lid, such as an empty

margarine tub, or into a sealable bag.

4. Conceal or remove any personal information, including the Rx number, on

the empty containers by covering it with black permanent marker or duct

tape, or by scratching it off.

5. Place the sealed container with the mixture, and the empty drug containers,

into the trash.

This consumer guidance was developed in collaboration with the U.S. Food and Drug

Administration (FDA).14 The FDA also maintains a list of less than 30 medicines that the agency

recommends patients flush down the sink or toilet if they wish to dispose of them, although the

agency is careful to note that “disposal by flushing is not recommended for the vast majority of

medicines.”15 The FDA warns that the particular medications on its list, if taken accidentally by

children, pets, or anyone for whom they were not prescribed, could cause harmful health effects

including breathing difficulties, heart problems, or even death. Thus, in the FDA’s view, flushing

serves not only to deter illegal drug abuse, but also to reduce the danger of unintentional use of

these medicines.16 In support of flushing certain medicines down the toilet or sink, the FDA has

addressed concerns over whether such action poses a risk to human health and the environment:

We are aware of recent reports that have noted trace amounts of medicines in the water

system. The majority of medicines found in the water system are a result of the body’s

natural routes of drug elimination (in urine or feces). Scientists, to date, have found no

evidence of harmful effects to human health from medicines in the environment.

Food and Drug Administration, How to Dispose of Unused Medicines, October 14, 2009, available at

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm.

Food and Drug Administration, Disposal by Flushing of Certain Unused Medicines: What You Should Know, August

2009, at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/

EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES.

Food and Drug Administration, How to Dispose of Unused Medicines, October 14, 2009, available at

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm.

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Disposal of these select, few medicines by flushing contributes only a small fraction of the

total amount medicine found in the water. FDA believes that any potential risk to people and

the environment from flushing this small, select list of medicines is outweighed by the real

possibility of life-threatening risks from accidental ingestion of these medicines.17

In addition to the ONDCP and FDA recommendations described above, a public-private

collaboration between the U.S. Fish and Wildlife Service, the American Pharmacists Association,

and the Pharmaceutical Research and Manufacturers of America has produced a national

campaign called “SMARxT DISPOSAL™,” to provide information regarding the safe disposal of

medication and to raise public awareness about the possible environmental impacts from

improper disposal of drugs.18 The advice disseminated under the SMARxT DISPOSAL™

campaign regarding unused medication disposal is substantially similar to that offered by the

ONDCP and FDA.19

While the federal guidelines encourage consumers to utilize community pharmaceutical drug

take-back programs, the current legal restrictions on collecting controlled substances necessarily

limit many programs. In January 2009, in response to the concerns raised about these

impediments, the DEA, an agency within the U.S. Department of Justice, requested public

comments in advance of a proposed rulemaking to permit the disposal of dispensed controlled

substances in a manner that is consistent with the federal Controlled Substances Act.20 As of the

date of this report, the DEA has not yet promulgated a regulation concerning this matter.21

However, the DEA has recently explained in testimony before Congress that it cannot move

forward with the regulatory proposal in the absence of legislation that provides the agency with

the necessary statutory authority to fully implement it.22

This report presents an overview of the Controlled Substances Act and its implementing

regulations that relate to patient disposal of unwanted prescription medication, as well as

describes legislation introduced in the 111th Congress that would amend federal law to provide for

more accessible methods of secure and environmentally responsible disposal of dispensed

controlled substances.

Food and Drug Administration, Disposal by Flushing of Certain Unused Medicines: What You Should Know, August

2009, at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/

EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES.

U.S. Fish & Wildlife Service, News Release: Medicine Disposal Partnership Will Encourage Public to Flush Less,

Crush More, March 17, 2008, available at http://www.fws.gov/news/newsreleases/showNews.cfm?newsId=

BD972725-A176-1841-9F1266DD535BE6B1; see also the public awareness campaign’s website at

http://www.smarxtdisposal.net/.

However, one member of Congress has asserted that the information and advice that federal government agencies

have offered to citizens regarding disposal of unused medication is inconsistent and confusing. See Drug Waste and

Disposal: When Prescriptions Become Poison: Hearing Before the Senate Special Comm. on Aging, 111th Cong., 2nd

sess. (2010) (opening statement of Senator Herb Kohl) (“Contradicting guidelines put forth by the DEA, FDA, EPA,

and U.S. Fish and Wildlife Service need to be reconciled.”).

DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74

Fed. Reg. 3480 (January 21, 2009).

For information regarding the status of this rule, see http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=

201004&RIN=1117-AB18.

Drug Waste and Disposal: When Prescriptions Become Poison: Hearing Before the Senate Special Comm. on Aging,

111th Cong., 2nd sess. (2010) (statement of Joseph T. Rannazzisi, DEA, at 5).

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances

Overview of the Controlled Substances Act

The vast majority of prescription drugs are not controlled substances23 and therefore are not

regulated under the Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly

referred to as the Controlled Substances Act (CSA).24 However, some prescription drugs—in

particular those most susceptible to abuse such as narcotics and opiates that are often used in the

treatment of pain25—come within the purview of the CSA because they have a greater potential

for abuse than other prescription drugs and may lead to physical and psychological dependence.

Enacted in 1970, the CSA is designed to regulate and facilitate the use of controlled substances

for legitimate medical, scientific, research, and industrial purposes and to prevent these

substances from being diverted for illegal purposes. By delegation from the U.S. Attorney

General, the DEA is responsible for administering and enforcing the CSA and its implementing

regulations. 26

The CSA assigns various plants, drugs, and chemicals to one of five schedules, ranging from

Schedule I, which contains substances (such as heroin) that have no currently accepted medical

use in treatment and cannot be dispensed under a prescription, to Schedules II, III, IV, and V,

which include substances that have recognized medical uses and may be manufactured,

distributed, and used in accordance with the CSA.27 The order of the schedules reflects substances

that are progressively less dangerous and addictive. Schedule II narcotics include the drugs

morphine, codeine, and OxyContin®. Schedule III substances include Vicodin® and anabolic

steroids, while Schedule IV includes Xanax® and Valium®. Schedule V contains, among other

things, cough medicines that contain a limited amount of codeine (Robitussin AC®).28

Prescriptions for Controlled Substances

It is unlawful for any person to prescribe or dispense controlled substances without first

registering with the DEA Administrator.29 No controlled substance that is a prescription drug (as

determined under § 503(b) of the Federal Food, Drug, and Cosmetic Act) assigned to Schedules

II, III, IV, and V may be dispensed without a prescription.30 A prescription for a controlled

substance may be issued only for a “legitimate medical purpose” by a physician “acting in the

By one estimate, between 10%-11% of all drug prescriptions written in the United States are for pharmaceutical

controlled substances. Electronic Prescribing of Controlled Substances: Addressing Health Care and Law Enforcement

Priorities: Hearing Before the S. Comm. on the Judiciary, 110th Cong. (2007) (statement of Joseph T. Rannazzisi,

DEA).

The Federal Food, Drug, and Cosmetic Act, enforced by the Food and Drug Administration, governs the safety and

efficacy of all kinds of prescription medications (controlled and non-controlled substances), including the approval,

manufacturing, and distribution of such drugs.

Generation Rx: The Abuse of Prescription and Over-the-Counter Drugs: Hearing Before the S. Comm. On the

Judiciary, 110th Cong. (2008) (statement of Dr. Leonard J. Paulozzi, Centers for Disease Control and Prevention).

21 U.S.C. § 871(a); 28 C.F.R. § 0.100(b).

See 21 U.S.C. § 812. The list of controlled substances may be found in 21 C.F.R. § 1308.11-15.

U.S. DEP’T OF JUSTICE, DEA, PRACTITIONER’S MANUAL (2006 ed.), at 5-6.

21 U.S.C. §§ 822, 841(a)(1).

21 U.S.C. § 829.

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usual course of his professional practice.”31 The CSA authorizes the DEA Administrator to

suspend or revoke a physician’s prescription privileges upon a finding that the physician has

“committed such acts as would render his registration ... inconsistent with the public interest.”32

In determining the public interest, the DEA Administrator is required to consider the following

factors:33

•

the recommendation of the appropriate state licensing board or professional

disciplinary authority;

•

the applicant’s experience in dispensing, or conducting research with respect to

controlled substances;

•

the applicant’s conviction record under federal or state laws relating to the

manufacture, distribution, or dispensing of controlled substances;

•

compliance with applicable state, federal, or local laws relating to controlled

substances; and

•

such other conduct which may threaten the public health and safety.

CSA Regulatory Scheme

The regulatory structure of the CSA creates a “closed system” in which distribution of controlled

substances may lawfully occur among registered handlers.34 The CSA places several regulatory

requirements upon legitimate handlers of controlled substances, including registration, providing

effective security, recordkeeping, and reporting.35 Every person who manufactures, distributes,

dispenses, imports, or exports any controlled substance, or who proposes to engage in the

manufacture, distribution, dispensing, importation, or exportation of any controlled substance,

must obtain a registration issued by the DEA (unless exempt).36 Manufacturers and distributers of

controlled substances must register annually, and those who dispense controlled substances must

obtain registrations that may not be issued for less than one year or more than three years.37

Registrations specify the extent to which registrants are authorized to manufacture, possess,

distribute, or dispense controlled substances. All registrants must provide “effective controls and

procedures” to prevent the theft or diversion of the controlled substances in their possession.38 In

addition, the CSA imposes accountability requirements on all registered handlers of controlled

substances. Registrants must keep strict records and maintain inventories in compliance with

federal law and rules adopted by the relevant state.39 For example, a registrant must maintain a

complete and accurate record of each substance manufactured, received, sold, delivered, or

21 C.F.R. § 1306.04(a); United States v. Moore, 423 U.S. 122 (1975).

21 U.S.C. § 824(a)(4); 21 C.F.R. § 1301.36.

21 U.S.C. § 823(f).

DEA, Electronic Prescriptions for Controlled Substances, 73 Fed. Reg. 36722 (proposed June 27, 2008).

For more details about these requirements, see CRS Report RL34635, The Controlled Substances Act: Regulatory

Requirements, by (name redacted) and (name redacted).

21 U.S.C. § 822; 21 C.F.R. §§ 1301.22-1301.26 (exempting agents of registrants, certain military personnel, and law

enforcement officials from DEA registration requirements).

21 U.S.C. § 822(a).

21 C.F.R. § 1301.71.

21 U.S.C. § 827.

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otherwise disposed of by the registrant.40 Registrants must also complete and submit to the DEA

periodic reports of every sale, delivery, or other disposal of any controlled substance.41

The DEA has described the movement of a controlled substance from manufacture to the patient

as follows:

[A] controlled substance, after being manufactured by a DEA-registered manufacturer, may

be transferred to a DEA-registered distributor for subsequent distribution to a DEAregistered retail pharmacy. After a DEA-registered practitioner, such as a physician or a

dentist, issues a prescription for a controlled substance to a patient (i.e., the ultimate user),

that patient can fill that prescription at a retail pharmacy to obtain that controlled substance.

In this system, the manufacturer, the distributor, the practitioner, and the retail pharmacy are

all required to be DEA registrants, or to be exempted from the requirement of registration, to

participate in the process.42

This “closed system” of distribution guarantees that a particular controlled substance is always

under the control of a DEA-registered person until it reaches the patient or is destroyed, and the

CSA’s regulatory requirements “ensure that all controlled substances are accounted for from their

creation until their dispensing or destruction.”43

CSA Civil and Criminal Penalties

For persons who lawfully handle controlled substances, failure to comply with the regulatory

requirements of the CSA may result in civil penalties involving fines.44 Examples of violations

include the distribution or dispensing of a controlled substance not authorized by the person’s

registration with the DEA, as well as the refusal or failure to make, keep, or furnish any record or

report required under the CSA. The CSA provides that violations of its regulatory requirements

generally do not constitute a crime,45 unless the violation was committed knowingly, in which

case imprisonment of up to one or two years is authorized.46

The CSA provides a variety of criminal sanctions for unlawful possession, manufacturing,

distribution, or importation of controlled substances. The CSA outlaws simple possession of

controlled substances regardless of intent, stating that, “It shall be unlawful for any person

knowingly or intentionally to possess a controlled substance.” 47 However, the CSA permits

patients to possess a controlled substance that “was obtained directly, or pursuant to a valid

prescription or order, from a practitioner, while acting in the course of his professional

practice.”48 Any person who violates the simple possession offense may be sentenced to a term of

21 U.S.C. § 827.

21 U.S.C. § 827(d).

DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74

Fed. Reg. 3480, 3481 (January 21, 2009).

DEA, Definition and Registration of Reverse Distributors, 70 Fed. Reg. 22591 (May 2, 2005).

21 U.S.C. § 842.

21 U.S.C. § 842(c)(3).

21 U.S.C. § 842(c)(2).

21 U.S.C. § 844(a).

Id.

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imprisonment of not more than one year, and fined a minimum of $1,000, or both.49 A second

violation raises the minimum fine to $2,500 and a minimum imprisonment term of 15 days with a

maximum of two years; a third offense carries a minimum fine of $5,000 and minimum

imprisonment for 90 days, with a maximum term of three years.50

The CSA also prohibits any person from knowingly or intentionally acquiring or obtaining

possession of a controlled substance by misrepresentation, fraud, forgery, deception, or

subterfuge.51 A violation of this section may result in a term of imprisonment of not more than

four years or a fine of up to $250,000, or both; second offenses involving this section increases

the maximum imprisonment term to eight years.52

The CSA broadly defines “distribution” to include virtually every transfer of possession.53

Dispensing a controlled substance means “to deliver a controlled substance to an ultimate user ...

by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering

of a controlled substance.”54 The term “deliver” means “the actual, constructive, or attempted

transfer of a controlled substance or a listed chemical, whether or not there exists an agency

relationship.”55 It is unlawful for any person knowingly or intentionally to distribute or dispense,

or to possess with intent to distribute or dispense, a controlled substance, except as authorized by

law.56 The criminal penalties for violating this prohibition on unlawful distribution of a controlled

substance vary depending on whether the individual is a first-time offender or a repeat offender,

the type of substance involved, and the quantity of the type of substance involved.57 For example,

a violation of § 841(a) by a first-time offender involving a schedule II substance such as codeine

is punishable by a term of imprisonment of up to 20 years and a fine of up to $1,000,000.58 For a

second offense, the fine increases to $2,000,000 and the maximum imprisonment term increases

to 30 years.

The penalties are increased for possession of flunitrazepam (a kind of date-rape drug known by its slang term

“roofie”) or a mixture or substance which contains cocaine base. See 21 U.S.C. § 844(a).

Id.

21 U.S.C. § 843(a)(3).

21 U.S.C. § 843(d)(1).

21 U.S.C. § 802(11) (“The term ‘distribute’ means to deliver (other than by administering or dispensing) a controlled

substance or a listed chemical.”).

21 U.S.C. § 802(10).

21 U.S.C. § 802(8).

21 U.S.C. § 841(a)(1).

For a complete list of criminal sanctions for all violations of the CSA, see CRS Report RL30722, Drug Offenses:

Maximum Fines and Terms of Imprisonment for Violation of the Federal Controlled Substances Act and Related Laws,

by (name redacted).

21 U.S.C. § 841(b)(1)(C).

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Disposal of Controlled Substances

Disposal By DEA Registrants

DEA registrants may need to dispose of controlled substances in their possession when they are

expired, damaged, contaminated, or otherwise unwanted. Under the CSA and DEA regulations,

there are three different options for registrants to dispose of controlled substances:59

1. The distributor or dispenser may return the controlled substance to the

pharmaceutical manufacturer who accepts returns of outdated or damaged

controlled substances.

2. The distributor, dispenser, or manufacturer may itself dispose of the

controlled substances under procedures specified by federal regulation, 21

C.F.R. § 1307.21.60

3. The distributor, dispenser, or manufacturer may transfer the controlled

substances to a “reverse distributor” to take custody of the controlled

substances for the purpose of returning them to the manufacturer or arranging

for their disposal.61

Disposal By Ultimate Users

While disposal of controlled substances by DEA registrants is governed by the federal regulations

described above (and also perhaps local, county, or state environmental and waste disposal laws),

disposal of controlled substances by patients is left to their discretion. The CSA and DEA

regulations are largely silent on the ways in which patients may discard controlled substances that

have been dispensed to them.

The CSA refers to an individual patient as an “ultimate user,” meaning “a person who has

lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a

member of his household or for an animal owned by him or by a member of his household.”62

Ultimate users are not required to register with the DEA63 because the controlled substances in

their possession “are no longer part of the closed system of distribution and are no longer subject

to DEA’s system of corresponding accountability.”64 Therefore, an individual patient may dispose

DEA, Definition and Registration of Reverse Distributors, 70 Fed. Reg. 22591, 22592 (May 2, 2005).

Under 21 C.F.R. § 1307.21, any person may request permission from DEA to dispose of controlled substances

without the need for a DEA or state government witness. If a registrant has a regular need to dispose of controlled

substances, the DEA may grant blanket authorization for such disposal; however, “DEA normally requires that the

registrant provide two designated responsible individuals to accompany the drugs to the disposal site and witness the

destruction.” DEA, Definition and Registration of Reverse Distributors, 70 Fed. Reg. 22591 (May 2, 2005).

A “reverse distributor” is a DEA-registered entity “who receives controlled substances acquired from another DEA

registrant for the purpose of—(1) returning unwanted, unusable, or outdated controlled substances to the manufacturer

or the manufacturer’s agent; or (2) where necessary, processing such substances or arranging for processing such

substances for disposal.” 21 C.F.R. 1300.01(b)(41).

21 U.S.C. § 802(27).

21 U.S.C. § 822(c)(3).

DEA, Definition and Registration of Reverse Distributors, 68 Fed. Reg. 41222, 41226 (proposed July 11, 2003).

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances

of a controlled substance prescription medication without prior approval from the DEA, or

without notifying any legal authority beforehand or afterwards.

However, DEA regulations do permit any person in possession of any controlled substance,

including both registrants and non-registrants, to request assistance with disposal of such

substance from the DEA Special Agents in Charge (SAC) of the area where the person is

located.65 An ultimate user who seeks the help of the DEA in disposing of a controlled substance

must submit a letter to the SAC that provides several pieces of information, including the

following: (1) the user’s name and address; (2) the name and quantity of the controlled substance

to be disposed of; (3) how the applicant obtained the substance (if known); and (4) the name,

address, and DEA registration number of the person who possessed the controlled substance

before the user (if known).66 Upon receipt of this letter, a SAC may authorize the ultimate user to

dispose of the controlled substance by one of the following methods: (1) by transfer to a DEA

registrant; (2) by delivery to a DEA agent or to the nearest DEA field office; (3) by destruction in

the presence of a DEA agent; or (4) by “such other means as the Special Agent in Charge may

determine to assure that the substance does not become available to unauthorized persons.”67 The

DEA has conceded that ultimate users have very rarely utilized this procedure that is available to

them.68

The DEA’s testimony offered in congressional hearings, the DEA’s website, and the agency’s

comments published in the Federal Register have all repeatedly asserted the DEA’s view that the

CSA prohibits consumers from returning unwanted or unused controlled substances to their

pharmacies or giving them to other DEA-registered entities for disposal purposes.69 The DEA has

stated that the CSA has no provisions that allow a DEA registrant (such as a pharmacy) to accept

and take custody of controlled substances from a non-registrant (individual patient).70 The DEA

has previously explained the following:

21 C.F.R. § 1307.21(a).

Id.

21 C.F.R. § 1307.21(b)(4).

DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74

Fed. Reg. 3480, 3483 (January 21, 2009).

See DEA, General Questions and Answers, available at http://www.deadiversion.usdoj.gov/faq/general.htm#rx-10

(“An individual patient may not return his/her unused controlled substance prescription medication to the pharmacy.”);

DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74

Fed. Reg. 3480, 3482 (January 21, 2009) (“[N]o provisions in the CSA or DEA regulations allow a DEA registrant to

routinely acquire controlled substances from a non-registrant (i.e. individual patient).”); Drug Waste and Disposal:

When Prescriptions Become Poison: Hearing Before the Senate Special Comm. on Aging, 111th Cong., 2nd sess. (2010)

(statement of Joseph T. Rannazzisi, DEA, at 3) (“The statute does not contemplate that ultimate users may need to

dispose of unused pharmaceutical controlled substances. Under current law, an ultimate user is not authorized to deliver

or distribute controlled substances for purposes of disposal. Any such distribution by an ultimate user, regardless of the

purpose, is illegal.”).

DEA, Office of Diversion Control, General Questions and Answers, available at http://www.deadiversion.usdoj.gov/

faq/general.htm#rx-10. However, an individual patient may return unused controlled substances to a pharmacy if the

controlled substance was dispensed in error or if the controlled substance medication is subject to an FDA-supervised

recall. Id.

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances

The Controlled Substances Act is unique among criminal laws in that it stipulates acts

pertaining to controlled substances that are permissible. That is, if the CSA does not

explicitly permit an action pertaining to a controlled substance, then by its lack of explicit

permissibility the act is prohibited.71

Not only does the CSA lack provisions that permit the transfer of a controlled substance between

non-registrants and DEA registrants, but the CSA expressly prohibits an ultimate user to engage

in “distribution” of a controlled substance.72 Because the CSA defines “distribute” to mean

“deliver ... a controlled substance”73 and further defines “deliver” to mean “the actual,

constructive, or attempted transfer of a controlled substance,”74 it is illegal for an ultimate user to

give a controlled substance to another person (whether DEA-registered or not) for disposal

purposes.75

Some state and community drug take-back programs accept controlled substances from patients

because they have been granted “temporary allowances” from the DEA to do so—such programs

involve the participation of law enforcement agencies that have sought authorization from the

SAC to directly receive the controlled substances from ultimate users for disposal purposes.76 In

the absence of such DEA approval, however, community pharmaceutical take-back programs are

not permitted to collect controlled substances from consumers. The DEA has acknowledged that

“[a]t this time, most U.S. communities do not offer programs to properly dispose of excess

controlled substances or waste medication. Many consumers keep the drugs in their possession

because they do not know how to dispose of them.”77

Legislation in the 111th Congress

As noted earlier, the DEA has asserted that legislation is required to provide the DEA with

statutory authority to “promulgate regulations that set forth a comprehensive framework for

communities and regulated entities to use as guides to establish secure disposal programs for

unused controlled substances.”78 Several bills have been introduced in the 111th Congress that

would change current law and make it easier for patients to dispose of unused controlled

DEA, Electronic Prescriptions for Controlled Substances, 73 Fed. Reg. 36722, 36724 (proposed June 27, 2008). See

also, e.g., 21 U.S.C. § 841(a) (“Except as authorized by this subchapter, it shall be unlawful for any person knowingly

or intentionally—(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or

dispense, a controlled substance; or (2) to create, distribute, or dispense, or possess with intent to distribute or dispense,

a counterfeit substance.”) (emphasis added).

21 U.S.C. § 841(a)(1) (“Except as authorized by this title, it shall be unlawful for any person knowingly or

intentionally to ... distribute ... a controlled substance”); DEA, Disposal of Controlled Substances by Persons Not

Registered With the Drug Enforcement Administration, 74 Fed. Reg. 3480, 3481 (January 21, 2009) (“[T]he CSA and

its implementing regulations do not contemplate a situation in which an ultimate user would distribute controlled

substances.”)

21 U.S.C. § 802(11).

21 U.S.C. § 802(8).

DEA, Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 74

Fed. Reg. 3480, 3481 (January 21, 2009).

Id.

Drug Waste and Disposal: When Prescriptions Become Poison: Hearing Before the Senate Special Comm. on Aging,

111th Cong., 2nd sess. (2010) (statement of Joseph T. Rannazzisi, DEA, at 5).

Id.

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances

substances by participating in drug take-back programs or delivering them to entities authorized

by law to dispose of them; Congress has passed one of these bills, the Secure and Responsible

Drug Disposal Act of 2010 (S. 3397).

Secure and Responsible Drug Disposal Act of 2010

Introduced on May 24, 2010, by Senator Klobuchar, S. 3397 amends the CSA to allow an

ultimate user—without being registered—to deliver controlled substances to an entity that is

authorized under the CSA to dispose of them, providing that such disposal occurs in accordance

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

Also, the bill grants the Attorney General discretion to promulgate regulations that authorize

long-term care facilities to dispose of controlled substances on behalf of ultimate users who reside

(or have resided) at the long-term care facilities. The DEA has observed that “[t]his provision is

necessary because nursing homes and other long-term care facilities sometimes gain possession

of controlled substances that are no longer needed by patients, but the CSA currently does not

allow such facilities, which are usually not registered under the Act, to deliver controlled

substances to others for the purposes of disposal.”79 The bill includes a congressional findings

section. Among other things, the findings observe that “[l]ong-term care facilities face a distinct

set of obstacles to the safe disposal of controlled substances due to the increased volume of

controlled substances they handle,” and that “[t]he goal of this Act is to encourage the Attorney

General to set controlled substance diversion prevention parameters that will allow public and

private entities to develop a variety of methods of collection and disposal of controlled substances

in a secure and responsible manner.”80 The DEA has offered its support for the Secure and

Responsible Drug Disposal Act, noting that the measure allows “ensuing regulations to be

implemented uniformly throughout the nation” and grants the DEA the flexibility to allow, by

regulation, “a wide variety of disposal methods that are consistent with effective controls against

diversion.”81

On July 29, 2010, the Senate Judiciary Committee approved S. 3397 after adopting an

amendment that directs the Attorney General, in developing regulations governing drug disposal,

to take into consideration the public health and safety, as well as the ease and cost of program

implementation and participation by various communities. The amendment specifies that such

regulations may not require any entity to establish or operate a delivery or disposal program. In

addition, the legislation contains a provision that allows “any person lawfully entitled to dispose

of a decedent’s property” to deliver that decedent’s controlled substances to authorized persons

for disposal purposes.82 The amendment also requests that the U.S. Sentencing Commission

review and, if appropriate, amend the Federal Sentencing Guidelines to provide increased

imprisonment penalties if a person is convicted of a drug offense involving drugs that were

obtained from a drug disposal process authorized under the act.83 The Senate passed S. 3397 on

August 3, 2010, by unanimous consent. The House passed the bill on September 29, 2010, after

Hearing on Pending Public Health Legislation: Hearing Before the House Comm. on Energy and Commerce,

Subcomm. on Health, 111th Cong , 2nd sess. (2010) (statement of Joseph T. Rannazzisi, DEA, at 7).

S. 3397, §2 (4)(D), (6).

Hearing on Pending Public Health Legislation: Hearing Before the House Comm. on Energy and Commerce,

Subcomm. on Health, 111th Cong , 2nd sess. (2010) (statement of Joseph T. Rannazzisi, DEA, at 7).

S. 3397, § 3 (as reported in the Senate), adding new 21 U.S.C. § 822(g)(3).

Id. §4 (as reported in the Senate).

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Legal Issues Relating to the Disposal of Dispensed Controlled Substances

making technical corrections to the findings section that, among other things, emphasize that one

of the goals of the act is to “reduce instances of diversion and introduction of some potentially

harmful substances into the environment.”84 Later that same day, the Senate passed the measure

as amended by the House. On October 12, 2010, President Obama signed S. 3397 into law (P.L.

111-273).

Other Related Bills

Representative Inslee introduced the Safe Drug Disposal Act of 2010 (H.R. 5809) on July 21,

2010. The House Energy and Commerce Committee, Subcommittee on Health held hearings and

a markup session on H.R. 5809 on July 22, 2010. The subcommittee approved the bill (with a

substitute amendment)85 by voice vote and referred the measure to the full committee for its

consideration. As amended, the legislation largely resembles the Secure and Responsible Drug

Disposal Act of 2010, although it does not contain a congressional findings section and the

section regarding the U.S. Sentencing Commission. However, it includes additional provisions

that are not found in S. 3397. H.R. 5809 includes a provision that would require the Attorney

General to allow long-term care facilities to deliver for disposal controlled substances on behalf

of ultimate users (unlike S. 3397, which states that the Attorney General may authorize this

activity). H.R. 5809 would direct the ONDCP Director, in consultation with the EPA

Administrator, to carry out public education and outreach campaigns to increase awareness of

lawful and safe disposal of prescription drugs.86 The legislation would require the Comptroller

General of the United States to collect data on disposal of controlled substances by ultimate users

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

accessibility of disposal programs.87 Finally, H.R. 5809 would direct the EPA Administrator to

conduct a study (and report to Congress the results of such study) that examines the

environmental impacts of disposal of controlled substances “through existing methods,” offer

recommendations on disposing controlled substances that take into consideration such impacts (as

well as the ease and cost of implementing drug take-back programs and participation in such

programs by various communities), and “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.”88 On July 28, 2010, the House

Energy and Commerce Committee approved the bill and ordered it to be reported. The House

passed H.R. 5809 on September 22, 2010.

Introduced on February 25, 2009, by Representative Inslee and on June 24, 2009, by Senator

Murray, the Safe Drug Disposal Act of 2009 (H.R. 1191, S. 1336) would amend the CSA to allow

states to operate drug disposal programs that accept from patients unwanted or unused controlled

substances without requiring the presence of law enforcement personnel.89 Specifically, the bill

would direct the Attorney General to promulgate regulations that describe five drug take-back

S. 3397 (as amended by the House), §2(6).

Amendment available at http://www.cq.com//displayamendment.do?docid=3707907&productId=1.

H.R. 5809, §3.

H.R. 5809, §4.

H.R. 5809, §5(a)(1)(C).

155 CONG. REC. E386 (daily ed. February 25, 2009) (statement of Rep. Jay Inslee) (“[T]he Controlled Substances

Act has inadvertently established a barrier between safe and unsafe disposal methods of unused or unwanted controlled

substances. Without amending this law, controlled substance abuse on our streets and prescription drug pollution of our

water ways will continue to rise.”).

Congressional Research Service

Legal Issues Relating to the Disposal of Dispensed Controlled Substances

program models from which states may choose and implement, to permit an ultimate user (or a

care taker)90 to dispose of unused or partially used controlled substances through delivery to a

designated facility. Beyond these five model state programs, the regulations must also allow

states to devise an alternative means of disposal that best suits the state and that receives the

approval of the Attorney General. The bill requires that any approved state drug disposal program

must, among other things, permit ultimate users to dispose of controlled substances through nonlaw-enforcement personnel and incorporate environmentally sound practices for disposal.

Furthermore, the bill would amend Section 505 of the Federal Food, Drug, and Cosmetic Act91

and Section 351 of the Public Health Service Act92 to require the Secretary of Health and Human

Services to ensure that the labeling for drugs or biological products does “not include any

recommendation or direction to dispose of the drug by means of a public or private wastewater

treatment system, such as by flushing down the toilet.”93 In testimony offered before Congress,

the DEA has expressed its concern about “the complexity of the regulatory scheme called for” in

the Safe Drug Disposal Act of 2009.94

Representative Shea-Porter introduced the Safe Prescription Drug Disposal and Education Act

(H.R. 5925) that would, among other things, allow the Attorney General to distribute federal grant

awards to eligible entities to facilitate the establishment and operation of prescription drug

disposal units (that must be clearly marked as a “prescription drug drop-off box”) at various

locations. The bill first provides an amendment to the CSA that would permit an ultimate user (or

an individual authorized to act on his behalf) to deliver, without being registered, a controlled

substance to another person for the purpose of disposal. In addition, the bill would allow “a

person to whom such controlled substance is being delivered may, without being registered,

receive such controlled substance for such purpose.”95 The Attorney General would be required to

determine the places where the prescription drug drop-off boxes may be located, subject to state

and local requirements related to waste or hazardous waste management and any regulations

issued by the Food and Drug Administration.96 Entities that would be eligible to apply for a

federal grant include a state, local government unit, nonprofit organization, Indian tribe,

corporation, and community coalition. The funds received under the grant would be available to

establish, maintain, and operate the drug disposal unit, as well as to hire a reverse distributor, a

waste or hazardous waste management organization, or other state or local government entity, to

collect the drugs that have been deposited in the drop-off boxes. H.R. 5925 would authorize to be

appropriated $5 million for each of fiscal years 2011 through 2014 to carry out the grant program.

Finally, the bill would direct the Director of National Drug Control Policy, in consultation with

the EPA Administrator, to carry out an education and outreach campaign to increase public

awareness of safe and lawful prescription drug disposal methods.

H.R. 1191 and S. 1336 define “care taker” to mean “a person responsible for taking care of one or more individuals

or animals, including through provision of controlled substances; and may include a physician or other health care

professional, a veterinarian, a long-term care facility, a nursing home, a hospital, a jail, or a school.” H.R. 1191, S.

1336, § 2(a).

21 U.S.C. § 355.

42 U.S.C. § 262.

H.R. 1191, S. 1336, §3(a).

Hearing on Pending Public Health Legislation: Hearing Before the House Comm. on Energy and Commerce,

Subcomm. on Health, 111th Cong , 2nd sess. (2010) (statement of of Joseph T. Rannazzisi, DEA, at 6-7).

H.R. 5925, §2(a) (adding new 21 U.S.C. § 822(g)(1)(B)).

Id. §2(b)(1).

Congressional Research Service

Legal Issues Relating to the Disposal of Dispensed Controlled Substances

Author Contact Information

(name redacted)

Legislative Attorney

[redacted]@crs.loc.gov, 7-....

Congressional Research Service

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