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. 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. 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®). 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. 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.