Background The DEA, within the Department of Justice, is responsible for ensuring  the availability of controlled substances for legitimate uses while  preventing their diversion through its administration and enforcement of  the Controlled Substances Act and its implementing regulations. Under  the Controlled Substances Act, all persons or entities that manufacture,  distribute, or dispense controlled substances are required to register with  DEA, unless specifically exempted. DEA regulates these entities to limit  diversion and prevent abuse. For example, DEA regulates  pharmaceutical companies that manufacture controlled substances,  health care providers who prescribe them to patients, and pharmacies  that dispense them. In October 2010, the Disposal Act amended the Controlled Substances  Act to allow the public to deliver unused controlled substances to an entity  authorized by DEA to dispose of the substances. DEA was given  responsibility for promulgating the implementing regulations, and the  Disposal Act stipulated that the regulations should prevent diversion of  controlled substances while also taking into consideration public health  and safety, ease and cost of implementation, and participation by various  communities. In addition to disposal bins, DEA’s regulations describe two  other options for the public to transfer controlled substances for the  purpose of disposal: mail-back programs and take-back events. Law  enforcement agencies may use all three methods of drug disposal without  the need for authorization by DEA. The Disposal Act stipulates that the  regulations cannot require an entity to participate in or establish any of  the disposal options. Requirements for  Authorized Collectors of  Unused Prescription  Drugs To participate as authorized collectors of unused prescription drugs,  eligible entities—retail pharmacies, hospitals/clinics with an on-site  pharmacy, narcotic treatment programs, reverse distributors, distributors,  and drug manufacturers that are already authorized by DEA to handle  controlled substances—must modify their DEA registration. According to  DEA officials, such modification is free and simple to do. Eligible retail  pharmacies or hospitals/clinics that become authorized collectors are able  to install and maintain disposal bins in long-term care facilities in addition  to their own location. DEA’s website contains a public search feature to  identify authorized collectors located near a specific zip code or  address. Authorized collectors must install, manage, and maintain the disposal  bins following DEA regulations. For example, under DEA’s regulations for  maintaining the disposal bins,  the disposal bin must be securely fastened to a permanent structure,  securely locked, substantially constructed with a permanent outer  container and removable inner liner, and have a small opening that  allows contents to be added but not removed;  the bin must also prominently display a sign indicating which types of  substances are acceptable; users must dispose the unused prescriptions into the collection  receptacle themselves without handing them to staff at the  pharmacy;  the disposal bin must typically be located in an area where an  employee is present and near where controlled substances are  stored, and the bin must be made inaccessible to the public when an  employee is not present;  the inner liner of the disposal bin must meet certain requirements,  including being waterproof, tamper-evident, tear-resistant, opaque,  and having the size and identification number clearly labeled; and  the installation and removal of inner liners must be performed under  the supervision of at least two employees of the authorized collector. DEA regulations also require that all controlled substances collected in  the disposal bin’s inner liners must be destroyed in compliance with  applicable federal, state, and local laws and rendered non-retrievable.  According to DEA regulations, non-retrievable means that the physical  and chemical conditions of the controlled substance must be permanently  altered, thereby rendering the controlled substance unavailable and  unusable for all practical purposes. Authorized collectors are permitted to  destroy the inner liner on their premises if they have the capacity to do so.  If not, the inner liners can be transported to a separate location to be  destroyed. Typically, in this case, an authorized collector contracts with a  reverse distributor to periodically remove, transport, and destroy the inner  liners. DEA regulations require that two reverse distributor employees  transport the inner liners directly to the disposal location without any  unnecessary stops or stops of an extended duration. Authorized  collectors must document certain information, including inner liner  identification numbers and the dates that each liner is installed, removed,  and transferred for destruction. The authorized collectors must maintain  these records for 2 years. Figure 1 summarizes the steps involved in the  collection of unused prescription drugs. About 3 Percent of  Eligible Pharmacies  and Other Entities  Voluntarily Participate  as DEA-Authorized  Collectors of Unused  Prescription Drugs About 3 percent of pharmacies and other eligible entities have voluntarily  chosen to become DEA-authorized collectors of unused prescription  drugs, according to DEA data. As of April 2017, 2,233 of the 89,550 (2.49  percent) of eligible entities—which are already authorized by DEA to  handle controlled substances—had registered to use disposal bins to  collect unused prescription drugs. Most of the authorized collectors— about 81 percent—were pharmacies, followed by hospitals or clinics.  (See table 1). Narcotic treatment programs, reverse distributors, and  distributors made up approximately 1 percent of the authorized collectors. We also found that participation rates varied by state, though in most  states relatively few of the eligible entities had registered with DEA to  become authorized collectors of unused prescription drugs. In 44 states,  less than 5 percent of the eligible entities had registered. (See figure 2  and appendix I for more information on the participation rates of  authorized collectors in each state). As of April 2017, Connecticut,  Missouri, and Maine had the lowest participation rates, with 0.11, 0.22,  and 0.70 percent, respectively. In contrast, North Dakota had the  highest participation rate, with 32.0 percent of its pharmacies and other  eligible entities registered to be authorized collectors. The state with next  highest participation rate was Alaska, with 8.96 percent. In North Dakota,  the state’s Board of Pharmacy provides funding for authorized collectors  to purchase and maintain the disposal bins. According to a board official,  the board decided to fund these activities to increase participation rates  and plans to continue its funding indefinitely using revenue generated  from prescription drug licensing fees it collects. In addition, our analysis shows that about 82 percent of all authorized  collectors were located in urban areas as of April 2017. However, when  comparing the entities registered to be authorized collectors with the total  number of eligible entities, we found that a larger percentage of the  eligible entities in rural areas became authorized collectors compared  with those in urban areas (see table 2). The data we obtained on the number of eligible and participating  authorized collectors and their locations are the only available DEA data  on the use of disposal bins to collect unused prescription drugs.  According to DEA officials, the agency does not collect any other  information on the use of disposal bins, such as the extent to which the  bins are used, or the amount and types of prescription drugs deposited  into the bins. For example, to minimize the risk of diversion, DEA  regulations do not allow authorized collectors to open and inspect the  inner liners of the disposal bins, so information on their contents cannot  be collected. According to DEA officials, the agency is not responsible  for collecting information on the amount and types of prescription drugs  destroyed through the disposal bins. DEA officials told us that the agency  views its responsibility solely as giving pharmacies and other eligible  entities the opportunity to become authorized collectors. Though we do not have information on the extent to which individuals use  DEA’s prescription drug disposal bins, we were able to estimate that as of  April 2017, about half of the country’s population lived less than 5 miles  away from a pharmacy or other DEA-authorized entity offering a  prescription disposal bin. In 21 states, at least 50 percent of the state’s  population lived within 5 miles of a prescription disposal bin. (See   figure 3). While close to half of the nation’s population lived less than 5 miles from a  disposal bin as of April 2017, the availability of nearby disposal bins  varied significantly for people depending on whether they lived in an  urban or a rural area. Specifically, about 52 percent of the population in  urban areas lived less than 5 miles away from a disposal bin, compared  to about 13 percent of the population in rural areas. Furthermore, about  44 percent of the population in rural areas lived even further away—more  than 30 miles away from a disposal bin. An exception to this is North  Dakota, where about 86 percent of its urban population and about 64  percent of its rural population lived within 5 miles of a disposal bin. Stakeholders Cited  Cost and Other  Factors as Affecting  Decision to Become  DEA-Authorized  Collectors of Unused  Prescription Drugs According to officials from the 11 stakeholder organizations we  interviewed—which represent authorized collectors and long-term care  facilities—several factors may explain why relatively few pharmacies and  other eligible entities have chosen to become authorized collectors of  unused prescription drugs. These factors include the associated costs of  participating, uncertainty over proper implementation, and participation in  other, similar efforts for disposing of unused prescription drugs. Costs: Stakeholders said that the costs associated with purchasing,  installing, and managing the disposal bins is a factor that explains the  relatively low rate of participation. One stakeholder told us that many  eligible entities may decide that the benefit of participating does not  outweigh the costs associated with doing so. Specifically, stakeholders  told us that the major costs associated with participating include  the one-time cost of purchasing and installing a disposal bin;  the ongoing costs to train personnel to manage the bins; and  the cost of contracting with a reverse distributor to periodically dispose  of the bin’s inner liner and contents. Stakeholders gave varying examples of the specific costs associated with  these investments. For example, one stakeholder estimated the yearly  costs of maintaining a disposal bin ranged from $500 to $600 per  location; another stakeholder said that the cost is thousands of dollars per  location per year, but did not provide a specific estimate. These  stakeholders added that costs can increase if the disposal bins fill more  quickly and need to be emptied more often than expected. For their part, officials from the reverse distributor stakeholders we  interviewed cited incinerating hazardous waste, the availability of  incinerators, and the cost of personnel as factors that increase the cost of  their services for authorized collectors. One reverse distributor  stakeholder told us that there are not many incinerators available,  requiring them to travel long distances to incinerate collected waste. The  other reverse distributor stakeholder added that DEA’s requirement that a  second employee be present during the transportation and disposal  increases the cost of their services. While some stakeholders speculated that costs are a reason for low  participation, a few stakeholders told us that the benefits are worth the  costs. In fact, two stakeholders we spoke with told us that the benefit to  the communities was so important that they decided to provide funding to  retail pharmacies, alleviating an individual pharmacy’s concern about the  cost of installing and maintaining the disposal bins. We found that as of  April 2017, over a quarter of the 2,233 authorized collectors using  disposal bins received external funding to pay for the costs associated  with installing and maintaining the disposal bins. In addition, stakeholders  told us that some localities have enacted laws known as extended  producer responsibility ordinances, which require that pharmaceutical  manufacturers pay for certain costs associated with drug disposal. When  asked about the costs associated with operating disposal bins, DEA  officials told us that addressing cost issues with eligible participants falls  outside of their responsibilities. Uncertainty: Stakeholders also told us that uncertainty regarding how to  comply with aspects of DEA’s regulations for prescription drug disposal  bins affected their decisions to participate. One stakeholder added that  many eligible entities decide not to participate because uncertainties over  participation requirements could result in inadvertent non-compliance with  DEA’s regulations. As an example of their uncertainty over some of the requirements  governing the disposal bins, officials from both of the reverse distributor  stakeholders we interviewed cited DEA’s non-retrievable standard for  destruction of the inner liners of the bins. DEA requires that the method of  destruction be sufficient to render all controlled substances non- retrievable, meaning that the physical and chemical conditions of the  controlled substances must be permanently altered and unusable in order  to prevent diversion for illicit purposes. Both reverse distributor  stakeholders told us that they are uncertain about whether certain  disposal methods meet this standard, and they said that the agency has  not provided further guidance on how reverse distributors can meet this  requirement. DEA officials told us that the agency responds to questions  about whether a specific method of destruction meets the non-retrievable  standard by telling the registrant to test the remnants after destruction, to  see if any components of the controlled substance are still present. In its  summary of the regulations implementing the Disposal Act, DEA stated  that in order to allow for the development of various methods of  destruction, the agency did not require a specific method of destruction as  long as the desired result is achieved. However, DEA officials stated  that to their knowledge, incineration is the only method known to meet the  non-retrievable standard to date, but the officials hoped other methods  will be developed in the future. When asked about the guidance they provide to authorized collectors of  unused prescription drugs or those eligible to become authorized  collectors, DEA officials told us that they post frequently-asked questions  on their website, routinely answer questions from participants and others,  and give training presentations at conferences that include information on  the disposal bins. In our prior work, we found problems with DEA’s  communication and guidance to stakeholders. In 2015, we recommended  that DEA identify and implement cost-effective means for communicating  regularly with pharmacies and other entities authorized to handle  controlled substances. DEA agreed with the recommendation, and  officials told us that, starting in August 2017, these entities can subscribe  to DEA’s website to receive notifications when it is updated with new  guidance. Stakeholders also noted that some DEA requirements related to disposal  bins may conflict with other state and federal requirements governing the  transportation and disposal of hazardous waste, which includes some  controlled substances. For example, the two reverse distributor  stakeholders told us that some incinerator permits issued by states  require that hazardous waste be examined before incineration; however,  DEA requirements do not allow the contents of the liners to be examined,  even at the time of incineration. To address the incinerator permit  requirements, one reverse distributor told us that they use the  Environmental Protection Agency’s hazardous waste household  exemption, which treats the liners as household waste and thereby allows  incinerator facilities to destroy the liners without examining the contents or  violating their state permit. In addition, some stakeholders raised  concerns that DEA’s regulations may conflict with other federal  regulations. For instance, one stakeholder noted that they recently  learned that transporting the disposal bin’s inner liners could violate  Department of Transportation regulations. DEA officials told us that they  were aware of this, explaining that the conflict was between DEA’s  requirement that controlled substances be transported in liners and the  Department of Transportation’s requirement that this type of waste be  transported in sturdy containers. According to DEA officials, this conflict  has been resolved by the Department of Transportation allowing reverse  distributors to place the liners inside sturdy containers kept on trucks. Participation in or Availability of Similar Efforts: Stakeholders said  that some pharmacies and other eligible entities were already  participating in other, similar efforts that allow for the safe disposal of  controlled substances, and therefore they did not want to invest additional  resources into participating as authorized collectors using disposal bins.  For example, the Centers for Medicare & Medicaid Services has an  established process that long-term care facilities use to dispose of their  unused controlled substances. As a result, all of the long-term care  stakeholders told us that long-term care facilities may choose not to  partner with pharmacies interested in placing disposal bins within their  facilities because it adds significant cost and effort without any additional  benefit. Furthermore, pharmacy stakeholders noted that because of the  availability of other prescription drug collection efforts in their  communities, they did not think that maintaining a disposal bin at their  locations was needed. For example, two of the stakeholders explained  that local law enforcement precincts already had a similar type of disposal  bin in place to collect unused prescription drugs. DEA officials told us  that they were aware of other options for the public and entities such as  long-term care facilities that are not registered as authorized collectors to  dispose of controlled substances. The officials also indicated that the  availability of disposal options at law enforcement agencies contributes to  the low participation rates among pharmacies as authorized collectors of  unused prescription drugs. Agency Comments We provided a draft of this report to the Department of Justice for  comment. DEA, part of the Department of Justice, provided technical  comments, which we incorporated as appropriate. As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the Attorney General of  the United States and the Administrator of DEA. In addition, the report will  be available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or draperd@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix II. Appendix I: Entities Eligible to Register with  DEA to Become Authorized Collectors and  Participating Collectors, by State, April 2017 Number of authorized collectors  19 Number of authorized collectors  75 Appendix II: GAO Contact and Staff  Acknowledgments GAO Contact Staff  Acknowledgments In addition to the contact name above, Elizabeth H. Curda (Director), Will  Simerl (Assistant Director), Kathryn Richter (Analyst-In-Charge), Nick  Bartine, Giselle Hicks, Jessica Lin, and Emily Wilson made key  contributions to this report. Also contributing were Muriel Brown and  Krister Friday.
In 2015, 3.8 million Americans reported misusing prescription drugs within the last month, and deaths from prescription opioids have more than quadrupled since 1999. About half of the people who reported misusing prescription drugs in 2015 received them from a friend or relative. One way to help prevent this kind of diversion and potential misuse is by providing secure and convenient ways to dispose of unused, unneeded, or expired prescription medications. The Secure and Responsible Drug Disposal Act of 2010 authorizes pharmacies and other entities already authorized by DEA to handle controlled substances to also collect unused prescription drugs for disposal. In 2014, DEA finalized regulations for the implementation of the Act, establishing a voluntary process for eligible entities to become authorized collectors of unused prescription drugs using disposal bins. GAO was asked to review participation among authorized collectors that maintain disposal bins. In this report GAO describes (1) participation rates among entities eligible to collect unused prescription drugs and (2) factors that affect participation. GAO analyzed the most currently available DEA data from April 2017 on entities eligible to participate and those participating as authorized collectors. GAO also conducted interviews with DEA officials and a nongeneralizable sample of 11 stakeholder organizations selected to illustrate different types of authorized collectors and long-term care facilities. GAO is not making any recommendations. DEA provided technical comments, which GAO incorporated as appropriate. GAO found that about 3 percent of pharmacies and other entities eligible to collect unused prescription drugs for disposal have volunteered to do so. The Drug Enforcement Administration (DEA) authorizes these entities to dispose of unused drugs to help reduce their potential misuse. Analysis of DEA data shows that as of April 2017, 2,233 of the 89,550 (2.49 percent) eligible entities—that is, certain entities already authorized by DEA to handle controlled substances—had registered with DEA to use disposal bins to collect unused prescription drugs. Most—about 81 percent—of the authorized collectors were pharmacies, followed by hospitals or clinics. GAO also found that participation rates varied by state, though in 44 states less than 5 percent of the state's pharmacies and other eligible entities had registered to become authorized collectors. Stakeholders cited several factors that may explain why relatively few pharmacies and other eligible entities have registered with DEA as authorized collectors of unused drugs. Most notably, stakeholders representing authorized collectors told GAO that because participation is voluntary, the cost associated with maintaining a disposal bin—which includes purchasing and installing the bin according to DEA requirements and paying for the destruction of its contents—is an important factor to weigh against potential benefits. DEA noted that availability of disposal by law enforcement agencies also contributes to low participation.