DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1304, 1305, 1307, 1317, and1321
[Docket No. DEA-316]
RIN 1117-AB18
Disposal of Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice of proposed rulemaking.
SUMMARY: This rule proposes requirements to govern the secure disposal of controlled substances by both DEA registrants and ultimate users. These regulations would implement the Secure and Responsible Drug Disposal Act of 2010 (Pub. L. 111-273) by expanding the options available to collect controlled substances from ultimate users for purposes of disposal to include: Take-back events, mail-back programs, and collection receptacle locations. These proposed regulations contain specific language to continue to allow law enforcement agencies to voluntarily conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations propose to allow authorized manufacturers, distributors, reverse distributors, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this proposed rule expands the authority of authorized retail pharmacies to voluntarily maintain collection receptacles at long term care facilities. This proposed rule also reorganizes and consolidates existing regulations on disposal, including the role of reverse distributors.
DATES: Electronic comments must be submitted and written comments must be postmarked on or before February 19, 2013. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period.
ADDRESSES: To ensure proper handling of comments, please reference "Docket No. DEA-316" on all electronic and written correspondence. DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov Web site for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to http://www.regulations.gov will be posted for public review and are part of the official docket record. Should you, however, wish to submit written comments via regular or express mail, they should be sent to the Drug Enforcement Administration, Attention: DEA Office of Diversion Control (OD/DX), 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the public record and are made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.
If you would like to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you would like to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase "CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.
Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in the DEA's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION paragraph.
Outline
I. Executive Summary
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> A. Purpose of the Regulatory Action
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> B. Summary of the Major Provisions of the Regulatory Action
II. Background
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> A. Legal Authority
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> B. History of Disposal of Controlled Substances
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> C. Existing DEA Regulations
III. Prescription Drug Abuse Epidemic
IV. Scope of Proposed Rule
V. Proposed Disposal Act Implementing Regulations
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> A. Disposal of Controlled Substance by Ultimate Users--Authorized Persons
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> B. Disposal of Controlled Substances by Ultimate Users--Authorized Methods
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> C. Disposal of Controlled Substances by Registrants
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> D. Return and Recall
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> E. Methods of Destruction
VI. Miscellaneous Changes
VII. Regulatory Analyses
Executive Summary
Purpose of the Regulatory Action
On October 12, 2010, the Secure and Responsible Drug Disposal Act of 2010 (Disposal Act) was enacted (Pub. L. 111-273, 124 Stat. 2858). Before the Disposal Act, ultimate users who wanted to dispose of unused, unwanted, or expired controlled substance pharmaceuticals had limited disposal options. The Controlled Substances Act (CSA) only permitted ultimate users to destroy those substances themselves, for example by flushing or discarding, or to dispose of such substances by surrendering them to law enforcement or by seeking assistance from the U.S. Drug Enforcement Administration (DEA). These restrictions resulted in the accumulation of controlled substances in household medicine cabinets that were available for abuse, misuse, and accidental ingestion. The Disposal Act amended the CSA to authorize ultimate users to deliver their controlled substances to another person for the purpose of disposal in accordance with regulations promulgated by the Attorney General. 21 U.S.C. 822(g) and828(b)(3). The Attorney General delegated responsibility for promulgating the Disposal Act implementing regulations to DEA. These proposed regulations expand the entities to which ultimate users may transfer unused, unwanted, or expired controlled substances for the purpose of disposal, as well as the methods by which such controlled substances may be collected. Specified entities may voluntarily administer any
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of the authorized collection methods in accordance with these proposed regulations.
Summary of the Major Provisions of the Regulatory Action
DEA is proposing new regulations for the disposal of controlled substances by ultimate users in accordance with the Disposal Act. In drafting the implementing regulations, DEA considered the public health and safety, ease and cost of program implementation, and participation by various communities. To this end, DEA found that in order to properly address the disposal of controlled substances by ultimate users, it was necessary to conduct a comprehensive review of DEA policies and regulations related to each element of the disposal process, including the transfer, delivery, collection, destruction, return, and recall of controlled substances, by both registrants and non-registrants (e.g., ultimate users). The reverse distributor registration category, which is pertinent to the process of registrant disposal, was included in this comprehensive review. These regulations will be incorporated into a new part 1317 on disposal.
The goal of this proposed new part on disposal, consistent with Congress's goal in passing the Disposal Act, is to set controlled substance diversion prevention parameters that will encourage public and private entities to develop a variety of methods for collecting and destroying controlled substances in a secure, convenient, and responsible manner. Also consistent with Congress's goal in passing the Disposal Act to decrease the amount of controlled substances introduced into the environment, particularly into the water, these regulations provide individuals various additional options to dispose of their unwanted or unused controlled substances beyond discarding or flushing the substances. As a result of these regulations, the supply of unused controlled substances in the home should decrease, thereby reducing the risk of unintentional diversion or harm.
Ultimate User Disposal
This rule proposes three voluntary options for ultimate user disposal: (1) Take-back events, (2) mail-back programs, and (3) collection receptacles. In addition to ultimate users, individuals lawfully entitled to dispose of ultimate user decedent's property are authorized to dispose of the ultimate user's substances by utilizing any of the three options for disposal. All of the proposed collection methods are voluntary and no person is required to establish or operate a disposal program.
DEA proposes specific language that will continue to authorize federal, state, tribal, and local law enforcement agencies, either independently or in partnership with private entities or community groups, to voluntarily hold take-back events and administer mail-back programs. DEA also proposes to authorize certain registrants (manufacturers, distributors, reverse distributors, and retail pharmacies) to be "collectors," with authorization to conduct mail- back programs. All mail-back programs must provide specific mail-back packages to the public, either at no cost or for a fee, and collectors that conduct mail-back programs must have and utilize an on-site method of destruction.
Finally, DEA proposes that law enforcement agencies voluntarily maintain collection receptacles at that agency's physical location and to authorize collectors to maintain collection receptacles at their registered location. Retail pharmacies that are authorized to be collectors may maintain collection receptacles at long term care facilities (LTCFs). LTCFs are permitted to dispose of controlled substances on behalf of an ultimate user that resides or has resided at that LTCF only through a collection receptacle that is maintained by a retail pharmacy at that LTCF.
DEA proposes to allow all controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances. Controlled substances collected by collectors may not be individually counted or inventoried. In addition, DEA proposes various collection security and recordkeeping requirements.
DEA appreciates that there is a cost to voluntarily providing these methods of collection and destruction. DEA notes that some state and local pharmaceutical disposal programs receive funding and other support from numerous sources, including conservation groups, local governments, state grants, and public and private donations. These expanded methods of disposal benefit the public by decreasing the supply of controlled substances available for misuse, abuse, and accidental ingestion, and protect the environment from potentially harmful contaminants. However, other advantages may accrue directly to those entities that opt to maintain a disposal program. For example, those authorized registrants that choose to maintain collection receptacles may be enhanced by the increased consumer presence at their registered locations and the goodwill that develops from providing a valuable community service. In addition, the proposed regulation specifies that mail-back program collectors may partner with third parties to make mailers available to the public. Those authorized registrants that choose to administer mail-back programs may gain from the opportunity to distribute to consumers promotional, educational, or other informational materials with the mailers.
Registrant Disposal
DEA proposes to delete the existing rule related to registrant disposal, 21 CFR 1307.21, and incorporate similar requirements on proper disposal procedure, security, and recordkeeping in a new part 1317 on disposal. DEA proposes these changes in order to provide consistent disposal procedures for each registrant category, regardless of geographic location. In addition, DEA proposes to modify existing DEA Form 41 to record the destruction of controlled substances that remain in the closed system of distribution and to account for registrant destruction of controlled substances collected from ultimate users and other non-registrants outside the closed system pursuant to the Disposal Act.
Reverse Distributors
DEA proposes revised regulations for reverse distributors that are clear, consistent, and consolidated into one part. Reverse distributors are often the last registrant to possess controlled substances prior to destruction because they are at the end of the closed system and the same recordkeeping safeguards that exist when controlled substances are distributed between registrants are not present. Because reverse distributors routinely acquire controlled substances for destruction from other registrants and may also be authorized as collectors, reverse distributors accumulate greater amounts of controlled substances that are destined for destruction in comparison to other registrants. DEA believes that the proposed regulations will help reverse distributors comply with the Controlled Substances Act in a manner that effectively decreases the risk of the diversion of controlled substances during the disposal process. DEA proposes to revise the definition of reverse distributor in addition to proposing new procedures that reverse distributors must follow to acquire controlled substances from registrants and other security and recordkeeping requirements.
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Return and Recall
DEA proposes to delete the existing rule on return and recall, 21 CFR 1307.12, and incorporate into a new part 1317 clarified and separate return and recall requirements for registrants and non- registrants.
Methods of Destruction
DEA proposes a standard of destruction--non-retrievable--for persons that intend to destroy controlled substances. In particular, DEA is not requiring a particular method of destruction, so long as the desired result is achieved. This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances. Destruction of controlled substances must also meet all other applicable Federal, state, Tribal, and local laws and regulations.
Background
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended, and referred to as the Controlled Substances Act (CSA).\1\ DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. To this end, controlled substances are classified into one of five schedules based upon: The potential for abuse, currently accepted medical use, and the degree of dependence if abused. 21 U.S.C. 812. Listed chemicals are separately classified based on their use and importance to the manufacture of controlled substances (List I or List II chemicals). 21 U.S.C. 802(33)-(35).
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> \1\ The Attorney General's delegation of authority to DEA may be found at 28 CFR 0.100.
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The CSA establishes a closed system of distribution that requires DEA to monitor and control the manufacture, distribution, dispensing, import, and export of controlled substances and listed chemicals until they reach their final lawful destination. The secure destruction of unused, recalled, tainted, expired, or otherwise unwanted controlled substances is essential to preventing the diversion of controlled substances into the illicit market.
In order to maintain this closed system of distribution, persons that manufacture, distribute, dispense, import, export, or conduct research or chemical analysis with controlled substances and listed chemicals are required to register with DEA at each principal place of business or professional practice. Persons registered with DEA are permitted to possess controlled substances and listed chemicals as authorized by their registration and must comply with the applicable requirements associated with their registration. 21 U.S.C. 822.
Not all persons that possess controlled substances are required to register with DEA. For example, a patient who receives a controlled substance pursuant to a lawful prescription, also known as an ultimate user, is not required to register with DEA in order to receive and possess that controlled substance. 21 U.S.C. 822(c)(3); see also 21 U.S.C. 957(b)(1)(C).\2\ The CSA defines an "ultimate user" as "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." 21 U.S.C. 802(27).
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\2\ 21 U.S.C. 822(c)(3) and 957(b)(1)(C) except "ultimate users" who possess substances for purposes referenced in 21 U.S.C. 802(25); however, "ultimate user" is defined in 21 U.S.C. 802(27).
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While Congress envisioned a closed system of distribution that would control a substance from its manufacture or import through the traditional chain of distribution moving from registrant to registrant until it reached its final lawful use (e.g., dispensed to the ultimate user, etc.), it did not account for circumstances in which controlled substances were lawfully dispensed to and possessed by an ultimate user but not fully used. Although ultimate users are exempt from CSA registration requirements for the possession of controlled substances, if they distribute (i.e., deliver or transfer) such controlled substances without the appropriate registration, they are in violation of the CSA.\3\ Such unlawful distribution includes the transfer of controlled substances for the purpose of disposal.\4\
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\3\ It is unlawful to knowingly or intentionally manufacture, distribute, dispense, or possess with the intent to manufacture, distribute, or dispense, a controlled substance without the appropriate registration. 21 U.S.C. 841(a).
\4\ The terms "disposal," "dispose," or "disposition" appear several times in the CSA and its implementing regulations, but these terms are not defined. For example, in the CSA, see21 U.S.C. 822(g); 824(f) and (g); 826(c), (e), and (f); 827(a)(3) and (d)(1); 842(a)(7); 853(n); 880(a)(2); 881(e)(1); and 958(d)(6); and in the CFR, see 21 CFR 1307.21(b). The term "net disposal," however, is defined at 21 CFR 1300.01(b). As used, the terms refer to a variety of activities that ultimately result in eliminating the availability of controlled substances for use. For example, within the meaning of the CSA, a controlled substance can be "disposed of" by destruction, return, recall, sale, or through the manufacturing process. The Disposal Act allows an ultimate user to deliver a lawfully obtained controlled substance to another person "for the purpose of disposal." DEA believes that the ultimate user disposal authorized by the Disposal Act includes the transfer or delivery of controlled substances for purposes of destruction, return, and recall. Such ultimate user activities are consistent with the intent to remove unused, unwanted, tainted, and expired substances from households and out of the reach of children and teenagers thereby reducing the risk of diversion and protecting the public health and safety. As used in this Notice of Proposed Rulemaking, DEA uses the terms "disposal" and "dispose" to refer generally to the wide range of activities that result in controlled substances being unavailable for further use. When necessary to specify a particular activity within the disposal process, the particular activity is identified, e.g., transfer, deliver, collect/ collection, return, recall, destroy/destruction.
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On October 12, 2010, the Secure and Responsible Drug Disposal Act of 2010 (Disposal Act) was enacted (Pub. L. 111-273, 124 Stat. 2858). The Disposal Act amended the CSA to allow an ultimate user to "deliver" a controlled substance "to another person for the purpose of disposal" if the person receiving the controlled substance is authorized to receive that substance and the disposal takes place in accordance with regulations issued by the Attorney General to prevent the diversion of controlled substances.21 U.S.C. 822(g)(1). The Attorney General delegated responsibility for promulgating the Disposal Act implementing regulations to DEA.
In addition to authorizing ultimate users to deliver their controlled substances to another person for the purpose of disposal, the Disposal Act also authorized any person lawfully entitled to dispose of an ultimate user decedent's property to deliver the ultimate user's controlled substance to another person for the purpose of disposal if the ultimate user dies while in lawful possession of the controlled substance. The Disposal Act also gave DEA the ability, by regulation, to authorize long term care facilities (LTCFs) to dispose of controlled substances on behalf of ultimate users who reside or have resided at the LTCF.
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Congress directed DEA, in promulgating the Disposal Act implementing regulations, to consider the public health and safety, ease and cost of program implementation, and participation by various communities. The implementing regulations may not require any person to establish or operate a delivery or disposal program.
History of Disposal of Controlled Substances
In 1970, Congress created the CSA after consolidating more than 50 laws related to the control of narcotics and dangerous drugs. The statute was "designed to improve the administration and regulation of the manufacturing, distribution, and dispensing [and import/export] of controlled substances by providing for a 'closed' system of drug distribution for legitimate handlers of such drugs" with criminal penalties for transactions outside the legitimate chain.\5\ With the enactment of the CSA, the Attorney General delegated the responsibility for promulgating the CSA's implementing regulations to DEA's predecessor, the Bureau of Narcotics and Dangerous Drugs (BNDD).\6\
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\5\ H.R. Rep. No. 91-1444 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4571-4572.
\6\ In 1973, the BNDD was abolished and all BNDD functions were transferred to DEA. Reorganization Plan No. 2 of 1973, 38 FR 18380 (July 2, 1973).
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BNDD recognized that to maintain the closed system of distribution, secure avenues for the destruction of controlled substances were essential. The implementing regulations specifically addressed the issue of the disposal of controlled substances (36 FR 7776, April 24, 1971). In particular, the implementing regulations outlined a process under which any person lawfully in possession of a controlled substance could distribute such substance to the person from whom he/she obtained it or return it to the manufacturer or the manufacturer's registered agent, and created procedures for any person in possession of a controlled substance, with instruction from DEA, to either deliver or transfer the substance to another for destruction, or to destroy that substance themselves. 21 CFR 1307.12 and 1307.21. These procedures have changed little since 1971.
DEA Registrant Disposal--Reverse Distributors
Through the mid-1990s, DEA accepted controlled substances from registrants for destruction or authorized registrants to destroy controlled substances pursuant to 21 CFR 1307.21. Manufacturers also accepted returns of controlled substances from their customers as an additional service. Eventually, a group of brokers emerged with the sole purpose to collect controlled substances from registrants for destruction pursuant to the procedures outlined in DEA's regulations.\7\ Initially, this group registered with DEA as distributors and called the services that they provided "reverse distribution." At about the same time, another group emerged called "inventory control processors/auditors" whose primary purpose was to identify expired substances in a registrant's inventory and prepare them for disposal by the registrant pursuant to 21 CFR 1307.21, or return to the person from whom it was obtained or to the manufacturer. This group was not required to register with DEA in order to conduct their activities because they did not take possession of the substances. Any inventory control processors/auditors that wanted to take possession of controlled substances were required to register with DEA as distributors. To reduce the risk of diversion from these activities, and ensure accountability during the disposal process, DEA and the registered distributors entered into memorandums of understanding (MOUs) that outlined acceptable disposal procedures until permanent regulations were finalized.
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\7\ The procedures are found today in 21 CFR 1307.21.
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Initially, DEA proposed to codify these MOUs by issuing a Notice of Proposed Rulemaking to define and register a new category of manufacturer registration called "disposers" that would authorize those registrants to receive controlled substances for the primary purpose of destruction (60 FR 43732, August 23, 1995). This rule was never finalized. In 2003, DEA readdressed the issue of registrant disposal in an Interim Final Rule (IFR) to define and register "reverse distributors" (68 FR 41222, July 11, 2003). In 2005, DEA published a final rule, thereby finalizing a new category of distributor registration called "reverse distributors" (70 FR 22591, May 2, 2005). The final rule authorized reverse distributors to acquire controlled substances from DEA registrants for the purpose of return to the manufacturer or manufacturer's agent or for processing those substances for disposal in accordance with 21 CFR 1307.21. The final rule also codified security, recordkeeping, reporting, and order form requirements applicable to reverse distributors.
Non-Registrant Disposal
As discussed above, prior to passage of the Disposal Act, the CSA did not address the disposal of controlled substances by ultimate users. Congress envisioned a closed system of distribution that would control a substance from its manufacture or import through the traditional chain of distribution moving from registrant to registrant until it reached its final lawful use (e.g., dispensed to the ultimate user, etc.). The CSA did not, however, account for circumstances in which controlled substances were lawfully dispensed to and possessed by an ultimate user, but not fully used. To this end, the CSA did not authorize the ultimate user to transfer unwanted and unused controlled substances to another person for the purpose of disposal.
Moreover, the CSA did not address the disposal of controlled substances by long term care facilities (LTCFs). DEA defines a LTCF as "a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients." 21 CFR 1300.01(b). Generally, controlled substances are prescribed by a LTCF resident's physician and dispensed by the resident's pharmacist; such controlled substances are owned by the resident. This is in contrast with patients in a hospital where controlled substances are dispensed dose by dose and remain under the possession and control of the registered dispenser, the hospital. Accordingly, a LTCF may secure its residents' controlled substances for custodial purposes only. The controlled substances remain in the lawful possession of the resident, the ultimate user. As with any other ultimate user, prior to the enactment of the Disposal Act, a LTCF resident in lawful possession of dispensed controlled substances could not distribute those substances to another person, even for the purpose of disposal.
In anticipation of the growing need of ultimate users and LTCFs to dispose of unused and unwanted controlled substances, DEA published an Advance Notice of Proposed Rulemaking to solicit information on the disposal of controlled substances by ultimate users and LTCFs (74 FR 3480, January 21, 2009). Subsequently, as discussed above, on October 12, 2010, the Secure and Responsible Drug Disposal Act of 2010 was enacted.
Existing DEA Regulations
Existing DEA regulations on the disposal of controlled substances are codified at 21 CFR 1307.12 and 1307.21. The process for returns is outlined in 21
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CFR 1307.12 and permits any person in lawful possession of a controlled substance to distribute that substance, without being registered to distribute, to the person from whom the substance was obtained or to the manufacturer or manufacturer's registered agent.
The procedure governing the transfer of controlled substances for disposal is outlined in 21 CFR 1307.21. In the existing regulations, any person in possession of any controlled substance that desires or is required to dispose of such substance may request authority and instructions for disposal from the DEA Special Agent in Charge (SAC) in the region in which they are located. The SAC must authorize and instruct applicants to dispose in one of four ways, by: (1) Transfer to a DEA registrant authorized to possess the substance; (2) delivery to an agent of DEA or to the nearest DEA office; (3) destruction in the presence of an agent of DEA or other authorized person; or (4) such other means that the SAC determines to assure that the substance does not become available to unauthorized persons. 21 CFR 1307.21(b).
Registrants requesting authority and instructions from the SAC to dispose of controlled substances must submit to the SAC three copies of DEA Form 41 listing the controlled substances that the registrant would like to dispose. 21 CFR 1307.21(a). Registrants required to regularly dispose of controlled substances may ask the SAC for authorization to dispose of those substances without prior approval from DEA in each instance if the registrant agrees to keep records of disposal. Further, the SAC may place additional conditions upon the ongoing approval to dispose. 21 CFR 1307.21(c).
Reverse Distributors
DEA currently defines a reverse distributor as "a registrant 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 CFR 1300.01(b). Reverse distributors are required to meet general security requirements, the security requirements applicable to non-practitioners, and specific inventory, recordkeeping, and reporting requirements. DEA registrants are authorized to distribute their lawfully possessed controlled substances to a registered reverse distributor to the extent authorized by their registration and in conformity with the CSA and its implementing regulations. 21 U.S.C. 822(b) and 958(g); See, e.g., 21 CFR 1301.13(e) and1307.11. Manufacturers, distributors, importers, and practitioners are currently authorized to distribute their lawfully possessed controlled substances to a reverse distributor without prior authorization from the SAC in the region they are located. 21 CFR 1301.13(e)(i), (ii), (viii) and 1307.11(a)(2).
Law Enforcement Agencies and Ultimate User Take-Back Events
Until DEA finalizes the implementing regulations for the Disposal Act and expanded options for disposal are available, ultimate users may not deliver their lawfully obtained controlled substances to any other person for the purpose of disposal other than by surrender to law enforcement or under the direction of the DEA Special Agent in Charge in the area in which the person is located. In the interim, DEA has established National Take-Back Days.\8\ DEA organized these nationwide one day events as a collaborative effort with state and local law enforcement agencies. The National Take-Back Days provide the public with a convenient and secure way to surrender pharmaceutical controlled substances to law enforcement for destruction.\9\
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\8\ The National Take-Back Days were held on September 25, 2010, April 30, 2011, October 29, 2011, April 28, 2012, and September 29, 2012.
\9\ DEA registrants are not authorized to dispose of controlled substances at these events; DEA registrants must comply with the current DEA regulations regarding disposal of controlled substance stock/inventory.
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Prescription Drug Abuse Epidemic
Before the Disposal Act, the CSA did not address the disposal of controlled substances by ultimate users. To dispose of their controlled substances, ultimate users were permitted to destroy the substances themselves (e.g., mix the substances with coffee grounds, place in a plastic bag, and throw into the garbage or flush) or surrender the substances to law enforcement or DEA. There is concern, however, that throwing controlled substances into the garbage or flushing them can contribute to harming the environment. Because the public has limited options for disposal, outdated and unwanted controlled substances often accumulate in medicine cabinets, easily within reach of children and teenagers. In passing the Disposal Act, Congress recognized that the secure disposal of controlled substances is important because of the significant prescription drug abuse problem in the United States. The Centers for Disease Control and Prevention declared prescription drug overdoses an epidemic.\10\ Studies show the adverse consequences associated with the substantially high levels of abuse and misuse (non- medical use) of prescription drugs.
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\10\ Centers for Disease Control and Prevention, "Morbidity and Mortality Weekly Report," Vol. 61, No. 1, at 10 (January 13, 2012).
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The availability of outdated or unwanted prescription drugs is problematic because there is a concern that young people may perceive prescription and/or over-the-counter drugs as "safer" than illegal drugs because of their intended, legitimate medical use.\11\ This misperception may be shared by parents. Over 20 percent of parents believe that it is acceptable to give a teen a prescription drug that was not prescribed to them.\12\ The 2010 National Survey on Drug Use and Health (NSDUH)\13\ indicates that over 70 percent of Americans twelve and older who used pain relievers non-medically in the previous year obtained the drugs from a friend or relative.\14\ Another study found that more than 50 percent of teens obtained prescription drugs from their own family's medicine cabinet.\15\
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\11\ Partnership for a Drug-Free America and MetLife Foundation, "2009 Parents and Teens Attitude Tracking Study Report," March 2, 2010.
\12\ Partnership for a Drug-Free America and MetLife Foundation, "2010 Partnership Attitude Tracking Study," April 6, 2011.
\13\ The National Survey on Drug Use and Health (NSDUH) is an annual survey of the civilian, non-institutionalized, population of the United States aged twelve or older. The survey is conducted by the Department of Health and Human Services Office of Applied Studies, Substance Abuse and Mental Health Services Administration (SAMHSA).
\14\ Substance Abuse and Mental Health Services Administration, "Results from the 2010 National Survey on Drug Use and Health: Volume I, Summary of National Findings," Office of Applied Studies, 2011 (NSDUH Series H-41, HHS Publication No. SMA 11-4658), http://www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf.
\15\ Partnership for a Drug-Free America and MetLife Foundation, "2010 Partnership Attitude Tracking Study," April 6, 2011.
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The prevalence of controlled substance prescription drug abuse among teenagers is right behind their abuse of marijuana (to include organic marijuana and synthetic cannabinoids). The 2011 "Monitoring the Future" survey of teenagers found that 8.1 percent of high school seniors reported non-medical use of Vicodin (a brand name for Schedule III hydrocodone combination products) in the past year, and 4.9 percent reported non-medical use of OxyContin (a brand name for Schedule II oxycodone sustained release products) in the past year.\16\ This is
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consistent with reports by high school students of increased non- medical use of painkillers in the past five years.\17\ According to a 2009 survey by the Partnership at Drugfree.org, more than 50 percent of teenagers (grades 9-12) believe that prescription drugs are easier to obtain than illegal drugs.
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\16\ Lloyd D. Johnson, Ph.D., et al, "Monitoring the Future National Results on Adolescent Drug Use: Overview of Key Findings, 2011," Institute for Social Research, The University of Michigan, 22012.
\17\ Lloyd D. Johnston, Ph.D., et al, "Monitoring the Future National Results on Adolescent Drug Use: Overview of Key Findings, 2009," National Institute of Drug Abuse, 2010 (NIH Publication No. 10-7583).
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Prescription drug abuse is the fastest growing drug problem in the United States. Findings from the 2010 NSDUH estimate that 7.0 million persons aged twelve or older used prescription-type psychotherapeutic drugs--pain relievers, anti-anxiety medications, stimulants, and sedatives--non-medically in the previous month.\18\ This represents 2.7 percent of the U.S. population.\19\ In 2010, 2 million persons aged twelve or older used pain relievers non-medically for the first time.\20\ On average, every day 2,046 12 to 17-year-olds abuse a prescription pain reliever for the first time.\21\
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\18\ Substance Abuse and Mental Health Services Administration, "Results from the 2010 National Survey on Drug Use and Health: Volume I, Summary of National Findings," Office of Applied Studies, 2011 (NSDUH Series H-41, HHS Publication No. SMA 11-4658), http://www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf.
\19\ These estimates were similar to those from the 2009 survey but 13 percent higher than those from the 2008 survey.
\20\ Id.
\21\ Substance Abuse and Mental Health Services Administration, 2010 National Survey on Drug Use and Health.
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Non-medical prescription drug use, particularly among young adults, is having a devastating effect on the United States. According to the Centers for Disease Control and Prevention, poisoning deaths, which include drug overdoses such as those from prescription drugs, are the leading cause of injury death in the United States; nearly nine out of ten poisoning deaths are caused by drugs and more than 40% of those involve opioid analgesics.\22\ According to SAMHSA's latest Drug Abuse Warning Network (DAWN) data, of the 4.6 million emergency department visits in 2009 associated with drug use, about 1.2 million visits involved the non-medical use of pharmaceuticals.\23\ Emergency department visits involving non-medical use of pharmaceuticals (misuse or abuse) almost doubled between 2004 and 2009 from 627,291 in 2004 to 1,244,679 visits in 2009 (a 98.4 percent increase).\24\ About half of the 2009 emergency department visits related to misuse or abuse of pharmaceuticals involved painkillers and more than one-third involved drugs to treat insomnia and anxiety.\25\
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\22\ U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, "Drug Poisoning Deaths in the United States, 1980-2008," December 2011.
\23\ Behavioral Health Statistics and Quality, "Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits," The DAWN Report, December 28, 2010.
\24\ Id. at 4.
\25\ Id. at 3.
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To continue with The Vice of The Vice President of The United States Tammy Dawn Perea of Dawn Report that Federal Food Drug and Cosmetic Act of President Franklin Roosevelt in Secretary Jodi Foster continue to full Rule in Counterban including Marijuana etc etc go to
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