Legal Issues Relating to the Disposal of Dispensed Controlled Substances
Released: 2010-10-19T00:00:00

Introduction

Prescription drug abuse is the second-most common form of illicit drug abuse among teenagers in the United States, trailing only marijuana use. 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." Controlled substances, such as the narcotic pain relievers OxyContin® and Vicodin®, are among the most often abused prescription drugs. 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. 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. 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. 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.

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. 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. 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.

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. 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:

This consumer guidance was developed in collaboration with the U.S. Food and Drug Administration (FDA). 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." 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. 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.

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.

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. The advice disseminated under the SMARxT DISPOSAL™ campaign regarding unused medication disposal is substantially similar to that offered by the ONDCP and FDA.

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

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 111 th Congress that would amend federal law to provide for more accessible methods of secure and environmentally responsible disposal of dispensed controlled substances.

Overview of the Controlled Substances Act

The vast majority of prescription drugs are not controlled substances 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). However, some prescription drugs—in particular those most susceptible to abuse such as narcotics and opiates that are often used in the treatment of pain —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.

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. 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®).

Prescriptions for Controlled Substances

It is unlawful for any person to prescribe or dispense controlled substances without first registering with the DEA Administrator. 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. A prescription for a controlled substance may be issued only for a "legitimate medical purpose" by a physician "acting in the usual course of his professional practice." 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." In determining the public interest, the DEA Administrator is required to consider the following factors:

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. The CSA places several regulatory requirements upon legitimate handlers of controlled substances, including registration, providing effective security, recordkeeping, and reporting. 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). 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. 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. 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. For example, a registrant must maintain a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of by the registrant. Registrants must also complete and submit to the DEA periodic reports of every sale, delivery, or other disposal of any controlled substance.

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 DEA- registered 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.

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."

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. 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, unless the violation was committed knowingly , in which case imprisonment of up to one or two years is authorized.

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." 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." Any person who violates the simple possession offense may be sentenced to a term of imprisonment of not more than one year, and fined a minimum of $1,000, or both. 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.

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. 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.

The CSA broadly defines "distribution" to include virtually every transfer of possession. 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." 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." 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. 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. 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. For a second offense, the fine increases to $2,000,000 and the maximum imprisonment term increases to 30 years.

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:

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. 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.

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." Ultimate users are not required to register with the DEA 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." Therefore, an individual patient may dispose 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. 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). 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." The DEA has conceded that ultimate users have very rarely utilized this procedure that is available to them.

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. 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). The DEA has previously explained the following:

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.

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. Because the CSA defines "distribute" to mean "deliver ... a controlled substance" and further defines "deliver" to mean "the actual, constructive, or attempted transfer of a controlled substance," it is illegal for an ultimate user to give a controlled substance to another person (whether DEA-registered or not) for disposal purposes.

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. 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."

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." Several bills have been introduced in the 111 th Congress that would change current law and make it easier for patients to dispose of unused controlled 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." 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." 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."

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. 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. The Senate passed S. 3397 on August 3, 2010, by unanimous consent. The House passed the bill on September 29, 2010, after 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." 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) 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. 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. 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." 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. Specifically, the bill would direct the Attorney General to promulgate regulations that describe five drug take-back program models from which states may choose and implement, to permit an ultimate user (or a care taker) 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 non-law-enforcement personnel and incorporate environmentally sound practices for disposal. Furthermore, the bill would amend Section 505 of the Federal Food, Drug, and Cosmetic Act and Section 351 of the Public Health Service Act 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." 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.

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." 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. 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.