Disposal of Controlled Substances

Federal RegisterDec 21, 2012

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, 1305, 1307, 1317, and 1321

[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

A. Purpose of the Regulatory Action

B. Summary of the Major Provisions of the Regulatory Action

II. Background

A. Legal Authority

B. History of Disposal of Controlled Substances

C. Existing DEA Regulations

III. Prescription Drug Abuse Epidemic

IV. Scope of Proposed Rule

V. Proposed Disposal Act Implementing Regulations

A. Disposal of Controlled Substance by Ultimate Users—Authorized Persons

B. Disposal of Controlled Substances by Ultimate Users—Authorized Methods

C. Disposal of Controlled Substances by Registrants

D. Return and Recall

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) and 828(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

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.

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).

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).

The Attorney General's delegation of authority to DEA may be found at 28 CFR 0.100.

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).

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).

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).

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.

Such unlawful distribution includes the transfer of controlled substances for the purpose of disposal.

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).

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, see 21 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.

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.

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.

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).

H.R. Rep. No. 91-1444 (1970),

reprinted in

1970 U.S.C.C.A.N. 4566, 4571-4572.

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).

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.

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.

The procedures are found today in 21 CFR 1307.21.

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

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) and 1307.11. 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.

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.

The National Take-Back Days were held on September 25, 2010, April 30, 2011, October 29, 2011, April 28, 2012, and September 29, 2012.

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.

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.

Studies show the adverse consequences associated with the substantially high levels of abuse and misuse (non-medical use) of prescription drugs.

Centers for Disease Control and Prevention, “Morbidity and Mortality Weekly Report,” Vol. 61, No. 1, at 10 (January 13, 2012).

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.

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.

The 2010 National Survey on Drug Use and Health (NSDUH)

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.

Another study found that more than 50 percent of teens obtained prescription drugs from their own family's medicine cabinet.

Partnership for a Drug-Free America and MetLife Foundation,

“

2009 Parents and Teens Attitude Tracking Study Report,

”

March 2, 2010.

Partnership for a Drug-Free America and MetLife Foundation,

“

2010 Partnership Attitude Tracking Study,” April 6, 2011.

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).

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

Partnership for a Drug-Free America and MetLife Foundation,

“

2010 Partnership Attitude Tracking Study,” April 6, 2011.

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.

This is

consistent with reports by high school students of increased non-medical use of painkillers in the past five years.

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.

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.

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).

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.

This represents 2.7 percent of the U.S. population.

In 2010, 2 million persons aged twelve or older used pain relievers non-medically for the first time.

On average, every day 2,046 12 to 17-year-olds abuse a prescription pain reliever for the first time.

http://www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf.

These estimates were similar to those from the 2009 survey but 13 percent higher than those from the 2008 survey.

Id.

Substance Abuse and Mental Health Services Administration, 2010 National Survey on Drug Use and Health.

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.

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.

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).

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.

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.

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.

Id.

at 4.

Id.

at 3.

Scope of Proposed Rule

In response to this growing problem, DEA is proposing new, expanded regulations for the disposal of controlled substances by ultimate users in accordance with the Disposal Act. These regulations will provide ultimate users with more options for disposal of their controlled substances so that the controlled substances will not accumulate and be available for misuse, abuse, and accidental ingestion by children and the elderly. 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.

DEA does not address the proper disposal of listed chemicals by DEA registrants in this rulemaking.

As discussed above, DEA currently regulates the disposal of controlled substances by registrants and other persons in accordance with 21 CFR 1307.21 and regulates the returns process through 21 CFR 1307.12. The existing disposal regulation gives DEA Special Agents in Charge (SACs) the discretion to authorize disposal in a manner that reduces the risk of diversion from this activity on a case-by-case basis. These regulations have changed little since the CSA was enacted. While this approach is effective, with the enactment of the Disposal Act and the increasing need for the responsible disposal of controlled substances by registrants and non-registrants alike, DEA believes that in order to securely and effectively dispose of unwanted or unused controlled substances, consistent nationwide standards on disposal are necessary. As a result, DEA proposes to delete 21 CFR 1307.12 on “Distribution to supplier or manufacturer” and 21 CFR 1307.21 on “Disposal of controlled substances” and promulgate a new part 1317 that will expand available disposal options, establish nationwide standards for the disposal of controlled substances, and comprehensively outline the process and procedure for the disposal of controlled substances by registrants, ultimate users, and other non-registrants such as long term care facilities.

Any previous waivers, MOUs, and MOAs issued in accordance with 21 CFR 1307.21 shall be superseded by this rulemaking on the “Disposal of Controlled Substances” if and when it is finalized.

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 allow public and private entities to develop a variety of methods for collecting and destroying controlled substances in a secure, convenient, and responsible manner. DEA believes that the new part on disposal will provide registrants and non-registrants alike clear and consistent requirements for the disposal of controlled substances. It is intended to maximize cost efficiency, voluntary participation, and public accessibility while simultaneously promoting the secure and responsible disposal of controlled substances in order to prevent diversion.

In accordance with the changes described above, DEA proposes to delete any reference to 21 CFR 1307.12 and 1307.21 and replace it with a reference to the new 21 CFR part 1317, where appropriate.

(60 FR 43732, August 23, 1995). Reference to a disposer category was inadvertently included in a previous rulemaking (68 FR 58587, October 10, 2003).

DEA proposes in 21 CFR 1301.76 to delete reference to 1307.12 and replace it with reference to 21 CFR part 1317; in 21 CFR 1304.11(e) and the introductory paragraph of 1304.22 to delete reference to 21 CFR 1307.12; in 21 CFR 1301.25(i), 1301.52(c), and 1307.13 to delete reference to 21 CFR 1307.21 and replace it with reference to 21 CFR part 1317; in 21 CFR 1304.25(a)(9) and 1304.25(b)(9) to delete reference to 21 CFR 1307.22 and replace it with reference to 21 CFR part 1317; and in 21 CFR 1304.04(a) to add reference to 21 CFR part 1317. DEA also proposes in 21 CFR 1307.22 to delete reference to 21 CFR 1307.21, and replace it with reference to 21 CFR part 1317. DEA proposes to revise the title of 21 CFR 1307.22 to “Delivery of surrendered and forfeited controlled substances” for clarity.

January 19-20, 2011 Public Meeting

On January 19 and 20, 2011, DEA held a well-attended public meeting to receive information from interested parties and the public and gather ideas for drafting regulations for the newly enacted Disposal Act. (The Notice of Meeting was published in the

Federal Register

on December 22, 2010, 75 FR 80536.) This meeting provided an opportunity for all interested persons —the general public, including ultimate users, parents, pharmacies, waste management companies, long term care and pharmaceutical related industries, as well as federal, state, and local agencies, including law enforcement personnel, and others—to express their views regarding safe and effective methods of disposal of controlled substances consistent with the CSA. Representatives of various industries and organizations as well as federal, state, and local agencies made presentations at the meeting and many submitted written comments prior to the meeting.

In drafting the Disposal Act implementing regulations, DEA gathered information about disposal from the more than 70 written comments and 44 oral presentations that were submitted and transcribed from the two day public meeting. Information and experience resulting from pilot projects around the United States involving mail-back programs, take-back events, and collection receptacles for pharmaceuticals were shared and helped inform this proposed rule. Representatives of law enforcement agencies provided information on their experience, existing procedures, and perspective, particularly with respect to take-back events as a method of collection. Representatives from DEA registrant and other affected groups, such as pharmacies, reverse distributors, and the waste management industry, provided insights on technology and existing destruction procedures. Presentations by the Environmental Protection Agency, the Food and Drug Administration, the U.S. Postal Service, the U.S. Army, and state and local agencies provided information on relevant federal, state, and local laws and procedures pertaining to the disposal and transportation of controlled substances, particularly pharmaceuticals. DEA appreciated and considered all information provided at or submitted in response to the Notice of Meeting in drafting this NPRM.

Proposed Disposal Act Implementing Regulations

Disposal of Controlled Substances by Ultimate Users—Authorized Persons

In accordance with the Disposal Act, DEA proposes new regulations for the disposal of controlled substances by ultimate users and other non-registrants—in particular: (1) Persons lawfully entitled to dispose of ultimate user decedent's property and (2) LTCFs on behalf of ultimate users that reside or have resided at that LTCF. In drafting these proposed implementing regulations, DEA considered the public health and safety, ease and cost of program implementation, and participation by various communities. To this end, DEA proposes three options for ultimate users to dispose of controlled substances: (1) Take-back events; (2) mail-back programs; and (3) collection receptacle locations. These proposed options are voluntary and no person is required to establish or operate a disposal program, although any person who chooses to do so and is authorized by DEA to do so must adhere to the final regulations.

DEA proposes to authorize ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property to deliver lawfully possessed controlled substances in Schedules II, III, IV, and V to law enforcement agencies through take-back events, mail-back programs, and collection receptacles, and to authorized collectors through mail-back programs and collection receptacles. DEA is also proposing to authorize LTCFs, on behalf of an ultimate user that resides or has resided at that LTCF, to deliver a resident's lawfully possessed controlled substances in Schedule II, III, IV, or V to certain on-site collection receptacles operated by a registered retail pharmacy that is an authorized collector. The collection of Schedule I controlled substances is not permitted because, generally, ultimate users cannot lawfully possess Schedule I substances unless they are participating in an investigational use of drugs pursuant to 21 U.S.C. 355(i) and 360b(j). For ultimate users in lawful possession of Schedule I substances for investigational use, DEA proposes that they follow the disposal procedures in 21 CFR 1317.85(b). Furthermore, the proposed collection methods are intended for the collection and destruction of lawfully possessed controlled substances, not as an avenue for the disposal of substances that were illegally obtained.

DEA proposes in sections 1317.65—1317.80 that controlled substances collected from ultimate users and other authorized non-registrant persons may be comingled with non-controlled substances—both controlled and non-controlled substances may be collected together so long as the requirements outlined for controlled substances are followed. Comingling reduces the risk of diversion and is practical, efficient, and economical. Members of the public cannot easily identify the difference between controlled and non-controlled substances. As collection pilot programs demonstrate, the requirement that controlled and non-controlled substances be collected separately is expensive, time-consuming, and hampers the collection process. In addition, comingling controlled substances is another way to minimize the risk of diversion of collected controlled substances. For example, many pharmacies and institutional practitioners disperse controlled substances throughout the stock of non-controlled substances in order to deter the theft or diversion of the controlled substances. See 21 CFR 1301.75(b).

DEA proposes in section 1317.30 that federal, state, tribal, and local law enforcement agencies continue with authority to collect ultimate user controlled substances, and that certain registrants authorized by DEA to be a “collector” be authorized to collect controlled substances from ultimate users, persons lawfully entitled to dispose of ultimate user decedent's property, and, in some circumstances, long term care facilities. DEA is authorizing certain registrant categories to be “collectors” so that DEA can ensure sufficient physical security controls are in place, thereby minimizing the risk of diversion. Registrants are subject to controls related to their DEA registration. These pre-existing controls will protect against the diversion of controlled substances in the process of ultimate user collection.

Possession for Disposal

Once a controlled substance is lawfully dispensed to an ultimate user, the ultimate user is in possession of that substance. Only the ultimate user or other authorized persons (i.e., persons lawfully entitled to dispose of an ultimate user decedent's property and, in some cases, the LTCF where the ultimate user resides or has resided) may dispose of such controlled substances in accordance with DEA's proposed ultimate user disposal regulations. In contrast, a controlled

substance dispensed for immediate administration pursuant to an order for medication in an institutional setting remains in the possession of that registered institution, even if the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized). Such remaining substance must be properly recorded, stored, and destroyed in accordance with DEA regulations, and all applicable federal, state, tribal, and local laws and regulations. These same principles would apply to hospice settings, which may be registered by DEA as an institutional practitioner or may be unregistered like many LTCFs.

Law Enforcement Agencies

DEA proposes specific language in section 1317.35 to continue to authorize law enforcement agencies, on a voluntary basis, to collect controlled substances from ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property through: (1) Take-back events, (2) mail-back programs, and (3) collection receptacles located at the law enforcement agency's physical address.

DEA recommends that law enforcement agencies electing to participate in ultimate user disposal maintain any records of receipt or collection in a manner that is consistent with that agency's recordkeeping requirements for illicit controlled substance evidence handling and store any controlled substances collected in a manner that reasonably prevents the diversion of controlled substances and is consistent with that agency's standard procedures for storing illicit controlled substances. Destruction of controlled substances must be in accordance with applicable federal, state, tribal, and local laws and regulations. DEA recommends that law enforcement agencies also keep a record of any transfer of controlled substances to reverse distributors for destruction; such records may assist DEA in ensuring that reverse distributors are keeping proper records of those controlled substances they acquire from law enforcement agencies that conduct ultimate user disposal activities. DEA recognizes that law enforcement agencies have existing procedures regarding the handling, storage, or transfer for destruction of controlled substances. These proposed rules do not require changes to those procedures. DEA anticipates that those existing procedures will provide the necessary security to prevent the diversion of controlled substances.

DEA proposes that law enforcement agencies that choose to conduct mail-back programs within their jurisdiction must make available to ultimate users packages described in proposed section 1317.70. Such packages may, however, be made available pursuant to a partnership or other agreement between the law enforcement agency and another person for the purpose of funding, dissemination, production, or other non-collection activity meant to facilitate the law enforcement agency's mail-back program. Such standards will help to alleviate the primary security concerns related to mail-back programs. As explained below, many such concerns exist regardless of the destination of the mail-back packages; thus, security standards related to the mail-back packages must be maintained even if the program is conducted by a law enforcement agency. DEA emphasizes, however, that the authority of law enforcement agencies to conduct ultimate user disposal programs is not a mechanism by which registrants may circumvent these proposed regulations or any other applicable laws or regulations. Any person, group, or entity that partners with a law enforcement agency to implement an ultimate user disposal program must comply with all applicable laws and regulations. In specific terms, any authorized collector that partners with a law enforcement agency to jointly conduct a collection program must adhere to these proposed regulations and any other applicable laws and regulations.

DEA appreciates that implementing some of the proposed disposal methods may present challenges to some state, tribal, and local law enforcement agencies. When implementing any new community service, all government agencies must balance available resources against established priorities. DEA hopes that these regulations will provide flexibility and opportunities for communities, interest groups, registrants, and law enforcement agencies to partner together to provide cost effective, safe, and convenient methods of ultimate user disposal. DEA looks forward to receiving suggestions from state, tribal, and local law enforcement agencies concerning its proposed regulations for the disposal of controlled substances by law enforcement agencies.

Collectors

DEA proposes in section 1300.01(b) to define a “collector” as a registered manufacturer, distributor, reverse distributor, or retail pharmacy that is authorized to receive a controlled substance for the purpose of destruction from an ultimate user, person lawfully entitled to dispose of an ultimate user decedent's property, or a long term care facility on behalf of an ultimate user that resides or has resided at that facility. In section 1317.40(a), DEA proposes that registered manufacturers, distributors, reverse distributors, and retail pharmacies may obtain authorization from DEA to be a collector. No manufacturer, distributor, reverse distributor, or retail pharmacy is required to be a collector.

In proposing which DEA registrants could become authorized collectors, DEA considered public health and safety, diversion control, and convenience and accessibility. In particular, DEA is proposing to authorize registered retail pharmacies to become collectors because such registrants are open to the public and have theft and loss prevention measures within the pharmacy processing area as well as outside the confines of the prescription processing and pick-up area, which easily lends itself to secure collection receptacle placement. Retail pharmacy personnel also routinely handle controlled substances intended for the ultimate user in a public setting while keeping such substances secure, and they have experience comingling controlled and non-controlled substances in the receipt and storage process. As public retail establishments, retail pharmacies generally have experience with the general public as customers and routinely implement theft and loss prevention measures.

For the foregoing reasons, retail pharmacies co-located with hospitals may be authorized to maintain collection receptacles in accordance with these regulations. Registered hospitals themselves, however, may not be authorized as collectors. This should have limited adverse impact on the ability of hospital patients to participate in ultimate user disposal because DEA believes many hospitals are co-located with registered retail pharmacies as a convenient service for outpatients. DEA proposes to restrict hospitals from being authorized collectors because they do not generally operate under the same business model or with similar theft and loss prevention procedures as retail pharmacies. For example, the general public is expected to enter retail pharmacies for short durations in order to conduct retail business. The physical layout of retail pharmacies is designed for open, clearly observable common areas and practically no areas to conceal an unlawful purpose. It would be unusual and suspicious for a person to spend an extended amount of time in a retail pharmacy without a known,

specific purpose, triggering routine theft and loss prevention measures. In contrast, hospitals are generally open 24-hours per day and allow for unsupervised public access; they are much larger than retail pharmacies and many interactions occur behind closed doors without routine theft and loss prevention measures; and foot traffic is not routinely monitored for unlawful purposes. These differences reduce the effectiveness of the proposed regulation's diversion control mechanisms and substantially increase the risk of diversion at hospitals if hospitals were authorized as collectors.

The above discussed risks in allowing hospitals as collectors are not necessary in light of the many other options available to ultimate users to dispose of unwanted or unused controlled substances.

In addition to the increased risk of diversion at hospitals, there is a risk of inadequate recordkeeping if hospitals are permitted as collectors. Unlike retail pharmacies, registered hospitals do not dispense controlled substances to ultimate users pursuant to legitimate prescriptions. Rather, registered hospitals administer controlled substances to inpatients dose by dose, and the controlled substances remain within the possession and control of the registered dispenser, the hospital. As such, registered hospitals may not dispose of controlled substances in collection receptacles, but must follow the revised regulations for registrant destruction, and keep records of such destruction.

DEA is also proposing to allow retail pharmacies to operate collection receptacles in LTCFs under certain circumstances, as discussed below, because—unlike hospitals—LTCFs “face a distinct set of obstacles to the safe disposal of [ultimate user] controlled substances due to the increased volume of controlled substances they handle.” Pub. L. 111-273, 2, 124 Stat. 2858. DEA is further proposing to authorize registered manufacturers, distributors, and reverse distributors to become collectors because, although such registrants have registered locations that generally are not open to the public, they do have heightened security requirements and are accustomed to receiving, securing, and distributing large amounts of controlled substances on a daily basis. DEA believes that expanding collector authorization to these registrants will provide the necessary convenience and accessibility to the public while ensuring the public health and safety and minimizing potential diversion.

To obtain authorization to be a collector, a manufacturer, distributor, reverse distributor, or retail pharmacy must apply for a modification to their registration in accordance with 21 CFR 1301.51, which DEA is proposing to revise in order to reflect these changes. Upon DEA approval of this modification in registration, each authorized registrant's DEA Certificate of Registration will specify that registrant's status as a “collector” and the location(s) approved for collection. Once approved to be a collector, the option for renewal will be available to authorized registrants when they renew their registration.

DEA proposes in section 1317.40(a) that if the registrant that is authorized to collect ceases activities as a collector, such registrant must modify their registration in accordance with 21 CFR 1301.51 to indicate that they no longer collect. In accordance with 21 CFR 1301.52, the registration of any person and any modifications, including authorization to be a collector, terminates if and when such person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration. Any registrant that ceases legal existence or discontinues business or professional practice must notify the Administrator promptly of such fact. 21 CFR 1301.52(a). Additionally, a registrant's authorization to collect is dependent upon the registration status of the manufacturer, distributor, reverse distributor, or retail pharmacy. Accordingly, the expiration, revocation, suspension, or surrender of a DEA registration will also result in the loss of the registrant's authorization to be a collector.

DEA proposes in section 1317.40(c) that authorized collectors may conduct the following activities: (1) Receive mail-back packages from ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property if the collector has and utilizes an on-site method of destruction; (2) install, manage, and maintain collection receptacles at locations for which the registrant is authorized to collect; and (3) promptly dispose of sealed inner liners and their contents as provided for in § 1317.05(c)(2). DEA proposes in section 1317.40(b) that collection may occur only at the registered locations of manufacturers, distributors, reverse distributors, and retail pharmacies that are authorized to collect at those locations and at long term care facilities (LTCFs) at which registered retail pharmacies are authorized to maintain a collection receptacle (see discussion on LTCFs below).

DEA proposes to authorize as collectors those persons already registered as manufacturers, distributors, reverse distributors, and retail pharmacies because, as registrants, these persons are accountable, have experience handling large volumes of controlled substances on a routine basis, and they are subject to controls related to their DEA registration. These pre-existing controls also protect against the diversion of controlled substances in the process of ultimate user collection. Further, DEA believes that ultimate user collection should occur at DEA registered locations because these premises are subject to DEA inspection, security, and other controls.

Such requirements ensure that proper security and other controls are in place to minimize the risk of diversion from the collection of controlled substances. Finally, with the passage of the Disposal Act, Congress did not provide DEA the authority to register persons specifically for the purpose of collecting and disposing of controlled substances from ultimate users. DEA is therefore restricted to operating within its previously existing statutory authority with regard to registration.

In accordance with the Disposal Act, which permitted DEA to, by regulation, authorize LTCFs to dispose of controlled substances on behalf of ultimate users that reside or have resided at the LTCF (see 21 U.S.C. 822(g)(3)), DEA is also proposing to authorize the collection of controlled substances at those LTCFs for which a registered retail pharmacy is authorized to maintain a collection receptacle (see discussion of LTCFs below).

In section 1317.45, DEA proposes that authorized collectors employ as an agent or employee with access to or influence over controlled substances acquired pursuant to their status as a collector, only those persons that have never been convicted of any felony offense related to controlled substances and have never, at any time, had an application for registration with DEA denied, had a DEA registration revoked or suspended, or surrendered a DEA registration for cause. DEA is proposing security requirements for collectors in order to strengthen the accountability of the ultimate user collection process, which occurs outside the closed system of distribution, by ensuring that only those employees that have met certain employee screening requirements have access to or influence over controlled substances collected from ultimate users. This requirement is similar to the employee screening requirements for registered practitioners in 21 CFR 1301.76, where there is also a high risk of diversion.

The information that collectors must maintain in their records is proposed in

section 1317.50. In accordance with the CSA, every DEA registrant must make a biennial inventory and maintain, on a current basis, a complete and accurate record of each controlled substance manufactured, received, sold, delivered, or otherwise disposed of. 21 U.S.C. 827(a).

These records must be maintained separately from all other records of the registrant or, alternatively, in the case of non-narcotic controlled substances, be in such a form that required information is readily retrievable from the ordinary business records of the registrant. 21 U.S.C. 827(b)(2). The records must be kept and be available for at least two years for inspection and copying by officers or employees of the Attorney General. 21 U.S.C. 827(b)(3). DEA may promulgate regulations that specify the information that registrants are required to maintain in their records. 21 U.S.C. 827(b).

The recordkeeping requirements differ depending on whether the records pertain to the registrant's inventory or stock, or the registrant's activities as an authorized collector. The requirements contained in the current regulations are those imposed on registrants with regard to their stock on hand (i.e., their inventory of controlled substances). Controlled substances collected from ultimate users are not part of a registrant's inventory and would not be counted as such.

To this end, DEA is proposing information that collectors must record based on the particular ultimate user collection method utilized (i.e., mail-back program or collection receptacle). The inner liners and mail-back packages that DEA proposes to be utilized in the collection of ultimate user controlled substances are intended for the disposal of controlled substances. As a result, DEA is requiring that collectors make an inventory of all inner liners and mail-back packages and maintain records on the use and destruction of such liners and packages in order to properly account for the disposal of controlled substances in accordance with the CSA. Once sealed, inner liners and mail-back packages shall not be opened, x-rayed, or otherwise penetrated and the substances contained in the inner liners and mail-back packages may not be individually handled, counted, inventoried, or otherwise discerned.

DEA is also proposing in section 1317.50 that collectors be exempt from the ARCOS requirements in 21 CFR 1304.33 and the order form requirements in 21 CFR part 1305 only when they collect controlled substances from ultimate users or other authorized non-registrant persons. Such substances are outside the closed system of distribution, and these tracking and accountability mechanisms are designed for substances within the closed system of distribution.

Registered Reverse Distributors and Distributors

DEA appreciates that law enforcement agencies and authorized collectors may not have the resources to destroy controlled substances received from ultimate users. Such persons may use the services of a registered reverse distributor for this purpose. DEA proposes in section 1317.55(a) to authorize registered reverse distributors to acquire for purposes of destruction controlled substances that have been collected by: (1) Law enforcement agencies; and (2) authorized collectors through collection receptacles. DEA also proposes in section 1317.55(b) to authorize registered distributors, in addition to registered reverse distributors, to acquire for purposes of destruction controlled substances collected by authorized collectors through collection receptacles.

DEA is proposing in section 1317.55(c) that registered reverse distributors and registered distributors that choose to acquire such collected controlled substances from authorized collectors do so in the manner prescribed for acquiring registrants' controlled substance inventory for purposes of disposal. This consistent procedure will help provide certainty in the disposal process, and help prevent errors during the acquisition process. Such acquisitions may be made pursuant to pick-up by the reverse distributor or distributor at the registrant's registered or authorized collection location, by delivery by common or contract carrier to the reverse distributor's or distributor's registered location, or by direct delivery from a non-practitioner to the reverse distributor's or distributor's registered location.

Reverse distributors or distributors may acquire controlled substances that have been collected by collection receptacle at either an authorized collector's registered location or, pursuant to sections 1317.75(g) and 1317.80(d), at a long term care facility for which a registered retail pharmacy is authorized to collect. See subsequent discussion for more detail on reverse distributors.

DEA proposes that authorized collectors that conduct mail-back programs must have and use an on-site method of destruction, and, as a result, these collectors will not be authorized to deliver or transfer those substances to a registered reverse distributor or distributor. The requirement to destroy on-site would not apply to law enforcement agencies that conduct mail-back programs; law enforcement agencies may continue to transfer any collected substance to an authorized reverse distributor.

Registered reverse distributors and distributors do not have to be authorized collectors to acquire collected controlled substances from law enforcement agencies or authorized collectors. In such circumstances, the substances being acquired have already been collected by law enforcement agencies and authorized collectors and should already be securely sealed in an inner liner or mail-back package in accordance with sections 1317.65-1317.80.

DEA also proposes in section 1317.55(c) that those registered reverse distributors and distributors that acquire controlled substances from law enforcement agencies and authorized collectors must destroy such controlled substances or securely transfer and store the controlled substances utilizing applicable procedures described in section 1317.15(c) until timely destruction can occur. In addition, reverse distributors and distributors must destroy the controlled substances as soon as practicable but no later than fourteen calendar days of pick-up or delivery, pursuant to proposed section 1317.15(d). Consistent procedures for the acquisition and disposal of registrant inventory and ultimate user collected controlled substances will streamline practices and help prevent confusion and error in the transfer, storage, and destruction processes. Any storage of such substances at the registered location of the reverse distributor or distributor must be in a manner consistent with the security requirements for Schedule II controlled substances. This is to minimize the risk of diversion because inner liners and mail-back packages shall not be opened once they are sealed and their contents will not be known, and, as a result, such liners and packages should be stored as though each contains a Schedule II controlled substance.

DEA also proposes in sections 1317.55(d) and 1317.100 to require that these reverse distributors and distributors keep records regarding the receipt, storage, transfer, and destruction of those controlled substances acquired from law enforcement agencies and authorized collectors.

Such records will help to ensure that the collected substances are accounted for and properly destroyed.

For clarity, DEA proposes in 21 CFR 1304.11(e)(2) and 1304.22(b) to cross reference these reverse distributor and distributor recordkeeping requirements covered by 21 CFR 1317.55.

Finally, DEA proposes in section 1317.55(e) and (f) to exempt reverse distributors and distributors that acquire collected controlled substances from law enforcement agencies or authorized collectors from the ARCOS

requirements in 21 CFR 1304.33 and the order form requirements in 21 CFR part 1305, only when they acquire controlled substances that have been collected from ultimate users by law enforcement agencies or authorized collectors. Such substances are outside the closed system of distribution, and these tracking and accountability mechanisms are designed for substances within the closed system of distribution.

Disposal of Controlled Substances by Ultimate Users—Authorized Methods

Take-Back Events

The first method of collection that DEA proposes, in section 1317.65, is take-back events. Ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property would be authorized to utilize a take-back event in accordance with 1317.65 to dispose of their controlled substances in Schedules II, III, IV, and V. As mentioned above, DEA is proposing specific language that will continue to authorize law enforcement agencies to conduct take-back events. DEA believes that take-back events should be conducted only by law enforcement agencies because such events are highly publicized, are often held at easily accessible locations within a community, and do not have the same security controls as permanent collection locations. As such, take-back events are more vulnerable to diversion. Although only law enforcement agencies would continue to be authorized to conduct take-back events, DEA proposes in section 1317.65(a) that private entities or community groups may continue to partner with law enforcement to hold community take-back events, thereby allowing for greater community involvement, education, and outreach, while minimizing the risk of diversion.

Many of the provisions that DEA proposes in section 1317.65, with respect to take-back events, are recommendations (“should” instead of “shall”) because DEA has no intent to change existing law enforcement procedures regarding the handling, storage, transfer, or destruction of controlled substances. DEA is, however, proposing some requirements that law enforcement agencies must follow in order to hold a take-back event. For example, in section 1317.65(b), DEA proposes that any law enforcement agency that conducts a take-back event shall appoint a law enforcement officer, who must be employed full time by the agency, to oversee the collection. Further, law enforcement officers employed

and authorized by the law enforcement agency conducting the take-back event must maintain control and custody of the collected substances from the time the substances are collected from the ultimate user or person authorized to dispose of the ultimate user decedent's property until secure transfer or destruction has occurred. DEA believes that designated law enforcement officers should be required to maintain control and custody of the controlled substances at all times in order to protect against theft and diversion.

DEA proposes in section 1317.02 to define “law enforcement officer” for the purpose of 21 CFR part 1317. In order to prevent the appearance that a third party has access to or influence over controlled substances, for example by directly or indirectly funding law enforcement disposal activities, DEA is requiring the law enforcement officer to be directly employed full time by a law enforcement agency, be under the direction and control of the federal, state, tribal, or local government, be acting in the course of their official duty, and be duly sworn and given the authority by the federal, state, tribal, or local government to: (1) Carry firearms; (2) execute and serve warrants; (3) make arrests without warrant; and (4) make seizures of property.

Take-back events provide ultimate users the opportunity to dispose of Schedule II, III, IV, and V controlled substances, which they legally possess, at a designated place and time. DEA proposes in section 1317.65(c) that each take-back event should have at least one receptacle for the collection of permitted substances. Although this is only a recommendation for law enforcement agencies that conduct take-back events, DEA believes that optimal security and protection of public health and safety can be achieved if controlled and non-controlled substances are collected in a collection receptacle that is securely locked and substantially constructed with an outer shell and removable inner liner.

DEA also proposes in section 1317.65(e) that only an ultimate user or person lawfully entitled to dispose of an ultimate user decedent's property may transfer controlled substances to the law enforcement agency during the take-back event. No other person, such as a take-back event volunteer, may handle or touch the controlled substances at any time. DEA is proposing this requirement to limit the number of hands through which the substances pass because the risk of diversion increases each time a controlled substance is transferred to a new person.

Mail-Back Programs

The second method of collection that DEA proposes, in section 1317.70, is mail-back programs. Ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property are authorized to utilize a mail-back program in accordance with 1317.70 to dispose of their controlled substances in Schedules II, III, IV, and V. DEA proposes in section 1317.70(a) specific language to continue to authorize law enforcement agencies to voluntarily conduct mail-back programs; and mail-back programs may be conducted by registered manufacturers, distributors, reverse distributors, or retail pharmacies that: (1) Are authorized as collectors; and (2) have and utilize an on-site method of destruction at their registered location. The security requirements proposed with respect to the other proposed collection methods (take-back events and collection receptacles) are adequate to ensure that controlled substances are collected and maintained in a manner that prevents diversion until transfer and destruction can occur. Designing regulations that ensure the security of controlled substances in the context of mail-back programs is challenging because, unlike take-back events and collection receptacle locations, there is a third party who handles the controlled substances as they are transferred from the ultimate user to the authorized collector in mail-back programs—the mail system. This unique circumstance provides opportunities for diversion that do not exist with the other collection methods, thus requiring more stringent controls than the other methods. As a result, DEA proposes to allow mail-back programs to be voluntarily conducted by DEA registrants that are authorized collectors that have and utilize an on-site method of destruction and by law enforcement agencies in order to minimize the transfer of controlled substances between various locations. This is intended to minimize the risk of diversion.

DEA also proposes in section 1317.70(c) that any authorized collector or law enforcement agency that conducts a mail-back program must produce and provide specified packages, either at no cost or for a fee, to ultimate users for the collection of controlled substances through the mail, and may do so in partnership with third parties for convenience, funding, or any other lawful purpose. One example of such a partnership would be when an authorized collector with an on-site method of destruction (e.g., a DEA-registered reverse distributor) produces appropriate mail-back packages, and allows a third party business partner that is frequently accessed by the public (e.g., a retail pharmacy) to provide these packages to patronizing customers. In this circumstance, the registered reverse

distributor would be responsible for operating the mail-back program, including recordkeeping and security, and it must receive the mail-back packages directly at its registered location for on-site destruction. DEA proposes that packages used for collection by mail-back must meet certain specifications. The proposed package requirements include only those specifications necessary to ensure that controlled substances sent through the mail, outside of the closed system of distribution, can be tracked with a high degree of confidence in their security. These requirements are intended to protect public health and safety and prevent the diversion of controlled substances.

In particular, the packages are proposed to be postage paid (e.g., business reply), preaddressed to the authorized mail-back location, nondescript, tamper-evident and tear-resistant, among other things. This is to ensure that the mailers are not delayed or diverted through address changes, theft, or because the package has inadequate postage. Such mailers must be addressed to the authorized collector's registered location with the on-site method of destruction or to the law enforcement agency's physical address and cannot be addressed to any other location, such as a post office box.

DEA is also proposing to require that each package must have a unique identification number so that each package can be tracked. In an effort to increase the ease of program implementation and to enhance the security of the mail-back option, DEA is also proposing that each package include instructions for the user that indicate the process for mailing back the package, the permitted substances that can be sent, and notice that only packages provided by the authorized collector will be accepted for destruction.

DEA considered requiring registrants to establish a system that would allow ultimate users to notify the collector when the ultimate user mailed back a package containing controlled substances, similar to pilot projects described in the public hearing. However, the burden of requiring a notification system outweighed the benefits of such a system, particularly when other security-enhancing measures are proposed. DEA believes that the collector inventory and recordkeeping requirements—that a collector conducting a mail-back program must keep inventory of mailers created and record the unique identification number of each mail-back package received—coupled with the stringent package specifications—for example the package must be postage paid and preaddressed—are sufficient controls to help protect against diversion while minimizing the burden on ultimate users. However, while DEA is not proposing to require collectors to create and maintain a notification system, such a system is not prohibited by the proposed regulations. To ensure privacy, the proposed language of section 1317.70(d) specifies that the public cannot be required to provide any personally identifiable information when mailing back controlled substances to an authorized collector.

DEA proposes in section 1317.70(e) that the authorized collector shall accept for the purpose of on-site destruction only those packages that they made available, directly or in partnership with a third party, for the collection of controlled substances. This requirement is designed so that authorized collectors, who control the production of uniform mail-back packages that are both nondescript and not readily identified as containing controlled substances, can easily identify authorized packages and thereby increase the likelihood that they accept only those packages that they are authorized to accept.

If the authorized collector inadvertently and unknowingly accepts controlled substances from an ultimate user in a package that they did not make available for the collection of controlled substances, the authorized collector shall notify the DEA office in their area of the receipt of the package within three business days of receipt and store the package, in a manner consistent with the routine mail-back package storage requirements discussed below, until the collector receives further instructions from DEA.

The “three business day” requirement allows the registrant enough time to process the packages received while still ensuring that DEA is notified of the incident in a timely manner thus allowing further investigation if necessary. The requirements for postage paid and preaddressed packages are designed to reduce the likelihood that authorized collectors will receive unauthorized controlled substances via mail-back programs because the sender would have to address such package and pay for postage. Ultimate users will likely not engage in such inconveniences when postage paid and preaddressed mailers are available.

DEA proposes in section 1317.70(f) that law enforcement officers employed by the law enforcement agency and “authorized employees” of a collector be the only individuals permitted to handle packages collected through a mail-back program. Under the proposed definition in 1317.02(a), an “authorized employee” is a person directly employed by the registrant full time (i.e., not employed as a contractor or agent of a third party) and must not have been convicted of any felony offense related to controlled substances and not have had at any time an application for registration with DEA denied, had a DEA registration revoked or suspended, or surrendered a DEA registration for cause. These enhanced security requirements are proposed consistent with existing security screening procedures for employees of certain registrants and will strengthen the integrity of the mail-back process by ensuring that only trusted employees have access to or influence over controlled substances.

DEA proposes in section 1317.70(f) that upon receipt of a package through a mail-back program, an authorized collector shall not open the package, x-ray, analyze, or otherwise penetrate the package. DEA proposes in section 1317.05(c)(1) that the authorized collector must promptly destroy the package on-site or securely store the package until prompt on-site destruction or timely notification to DEA of receipt of an unauthorized package in accordance with 1317.70(e) can occur. DEA is proposing the flexible “prompt” destruction and secure storage standard for collectors rather than a specific time frame to ensure that controlled substances do not accumulate while pending destruction or secure storage and are destroyed in a prompt manner, thus reducing the opportunities for diversion, while still accounting for the individual circumstances of registrants that destroy controlled substances. If the authorized collector is a reverse distributor, however, such destruction must occur as soon as practicable but no later than fourteen calendar days of receipt in accordance with proposed section 1317.15(d), which is discussed below.

Mail-back programs provide a convenient means of disposal for ultimate users who may not otherwise have access to a safe method of disposal. Mail-back programs are valuable because they may be made available to a large number of ultimate users regardless of geographic location. Because this method of ultimate user disposal presents high risks of diversion, DEA has carefully weighed many options and proposes the outlined requirements. The proposed requirements may limit the number of persons authorized to conduct a mail-back program; however, a single

authorized mail-back program is capable of receiving packages from any location within the U.S.

The mail-back method of disposal for ultimate users is a valuable and convenient option, however, the high risk of diversion inherent to this method requires stringent controls, including post-collection tracking and accountability mechanisms, as well as on-site destruction by authorized collectors.

Mail-back programs are restricted to the receipt of mailers initiated within the U.S. in order to be consistent with the import requirements of the CSA as provided in Subchapter II of Chapter 13 of Title 21 of the U.S. Code (21 U.S.C. 951 et. seq.).

Collection Receptacles

The third voluntary method of collection that DEA proposes, in section 1317.75, is collection receptacles. DEA proposes specific language in section 1317.75(a) to continue authorization for any federal, state, tribal, or local law enforcement agency to maintain a collection receptacle at the law enforcement agency's physical location as well as to authorize any DEA registered manufacturer, distributor, reverse distributor, or retail pharmacy authorized as a collector to maintain a collection receptacle at their DEA registered location. Collection receptacles may be located at a collector's registered location (and certain authorized LTCFs, as discussed below) or at a law enforcement agency's physical location—they may not be placed at non-registered locations such as libraries or community centers. DEA is proposing collection receptacles be placed at registered locations to ensure that controlled substances are collected at those locations that have existing security controls in place, with the exception of LTCFs, thereby reducing the risk of diversion while still providing for a convenient option for ultimate user disposal.

Like take-back events and mail-back programs, DEA proposes in sections 1317.75(b) and (c) and 1317.80(a) that the only persons that may transfer controlled substances to the authorized collector's collection receptacle are the ultimate user, persons lawfully entitled to dispose of an ultimate user decedent's property, and, as discussed below, a LTCF on behalf of an ultimate user that resides or has resided at that LTCF when a collection receptacle is located at that LTCF. This requirement is proposed in order to limit the number of hands through which the substance passes because the risk of diversion increases each time a controlled substance is transferred to a new person.

The proposed collection receptacle requirements in section 1317.75(d) and (e) are intended to protect against diversion. In particular, DEA is proposing the minimum collection receptacle requirements necessary to protect against diversion while allowing flexibility. The collection receptacles used by authorized collectors must have a permanent outer container with a removable inner liner. The outer container must have an opening big enough to allow contents to be added to the inner liner, but small enough to prevent removal of the inner liner contents. The opening must be capable of being locked at times when an authorized employee is not present, unless the collection receptacle is located in a secured area of a long term care facility which is regularly monitored by LTCF personnel.

DEA defines an inner liner in section 1317.02 and proposes requirements for inner liners in section 1317.60. In particular, like the mail-back packages, the inner liner must be waterproof, tamper-evident, and tear-resistant. The inner liner must be removable and sealable immediately upon removal without emptying or touching the contents and the contents of the inner liner shall not be viewable from the outside when sealed. The size of the inner liner must be clearly marked on the outside of the liner, for example, be clearly marked “5 gallon” or “10 gallon.” Finally, the inner liner must bear a permanent, unique identification number that enables the liner to be tracked. DEA is proposing these inner liner requirements to ensure that controlled substances are collected and destroyed in an accountable, secure, and convenient way in order to both prevent the diversion of controlled substances and to protect public health and safety.

In an effort to increase the ease of program implementation, to increase the security of collection by collection receptacle and to remind the public that illicit substances shall not be collected, DEA is also proposing that the outer container prominently display a sign indicating that only non-controlled drugs and Schedule II, III, IV, or V controlled substances are acceptable for collection. DEA seeks comment on the value and utility of requiring that a specific, uniform symbol be placed on each collection receptacle.

DEA is also proposing other security measures, including the requirement that collection receptacles be securely fastened to a permanent structure such as a wall, floor, or immovable countertop so that they cannot be removed. At a registered location, the collection receptacle must be located within the immediate proximity of a designated area where controlled substances are stored and where an authorized employee is present. At a long term care facility, the collection receptacle must be located in a secured area monitored by personnel of that long term care facility. In addition, access to the inner liner is restricted to authorized employees. Containers secured in compliance with the proposed requirements are intended to deter and prevent theft and pilferage.

DEA proposes in section 1317.75(g) that the removal of the inner liner of the collection receptacle shall be performed by or under the supervision of at least two authorized employees of the authorized collector. To this end, a registered reverse distributor or distributor is permitted to remove and take the inner liner of the collection receptacle for destruction so long as the removal is performed under the supervision of at least two authorized employees of the authorized collector. In accordance with section 1317.05(c)(2), upon removal of the inner liner of the collection receptacle, the authorized collector shall promptly: (1) Destroy the inner liner and its contents; or (2) store the inner liner and its contents at the collector's registered location in a manner consistent with the security requirements for Schedule II controlled substances until prompt destruction can occur.

Authorized collectors who are registered practitioners

shall dispose of the sealed inner liners and their contents in one of the following ways: (1) Promptly destroy the sealed inner liners and their contents, using an on-site method of destruction in accordance with Subpart C of part 1317 of this chapter; (2) promptly deliver the sealed inner liners and their contents by common or contract carrier to the registered location of a reverse distributor or distributor for destruction, or by reverse distributor pick-up at the collector's registered or authorized location; or (3) request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located by submitting one copy of DEA Form 41 identifying what is to be disposed.

The basis for distinguishing between practitioners and non-practitioners when specifying disposal procedures is explained in detail below under the discussion of controlled substance inventory disposal, beginning on page 61.

Authorized collectors who are not registered practitioners

shall dispose of the sealed inner liners and their

contents in one of the following ways: (1) Promptly destroy the sealed inner liners and their contents, using an on-site method of destruction in accordance with Subpart C of part 1317 of this chapter; (2) promptly deliver the sealed inner liners and their contents by common or contract carrier to the registered location of a reverse distributor or distributor, or by reverse distributor pick-up at the collector's registered or authorized location; or (3) promptly transport the sealed inner liners and their contents by the collector's own means to the registered location of a reverse distributor or distributor, or to the location of destruction. DEA is proposing the flexible “prompt” destruction, transfer, and storage standard for collectors rather than a specific time frame to ensure that controlled substances do not accumulate while pending destruction, transfer, or storage, while still accounting for the individual circumstances of registrants that operate and maintain collection receptacles. If the authorized collector is a reverse distributor, however, such destruction must occur as soon as practicable but no later than fourteen calendar days of receipt in accordance with proposed section 1317.15(d), which is discussed below.

Long Term Care Facilities

The Disposal Act authorized the Attorney General to develop regulations to permit long term care facilities to dispose of controlled substances on behalf of ultimate users who reside or have resided at such facilities in a manner that provides effective controls against diversion and is consistent with public health and safety. As such, DEA proposes in section 1317.80 to allow collection receptacles to be placed at long term care facilities for the disposal of controlled substances in accordance with outlined requirements.

DEA is proposing that only a registered retail pharmacy that receives authorization to collect at a specific long term care facility may manage and maintain collection receptacles at that long term care facility and remove or supervise the removal of the inner liner of the collection receptacles at that long term care facility. Such registered retail pharmacies that desire to operate a collection receptacle at a long term care facility must apply to modify their registration in accordance with 21 CFR 1301.51 and include in their application for modification in registration the physical location of each long term care facility at which the registered pharmacy intends to operate a collection receptacle. If the retail pharmacy that is authorized to collect ceases activities as a collector, such registrant must modify their registration in accordance with 21 CFR 1301.51 to indicate that they no longer collect or have ceased collection at a particular physical location.

The requirements in 21 CFR 1301.52(a) related to the termination of registration also apply.

For the purposes of 21 U.S.C. 880(a), collection receptacles at long term care facilities maintained by a registered retail pharmacy authorized as a collector is a “controlled premise” of that registered retail pharmacy.

A registered retail pharmacy authorized to maintain a collection receptacle at a long term care facility shall comply with the proposed requirements in 21 CFR 1317.75 that govern collection receptacles. At a long term care facility, the collection receptacle must be located in a secured area monitored by personnel of that long term care facility. In addition, access to the inner liner is restricted to authorized employees of the registered retail pharmacy. Because an authorized employee must be employed full time by the registrant, employees of the long term care facility will not have access to the inner liner of the collection receptacle, unless they are also a full time employee of the registered retail pharmacy that maintains that collection receptacle. In addition, DEA is proposing that two authorized employees of the retail pharmacy must remove or supervise the removal of the inner liner from the collection receptacle. In an effort to increase security and control of controlled substances collected, no employee of the long term care facility will have access to or influence over the contents of the collection receptacle, except to deposit controlled substances into it.

DEA is proposing that long term care facilities be permitted to dispose of controlled substances in Schedules II through V on behalf of an ultimate user who resides or has resided at such long term care facility. As with all other collection methods, controlled and non-controlled substances may be comingled in the collection receptacle. DEA proposes that the long term care facility be required to transfer controlled substances into collection receptacles (on behalf of ultimate users who reside or have resided at the long term care facility) immediately, but no longer than three business days after it is determined that the ultimate user no longer needs or wants, or should discontinue use of the controlled substance. DEA proposes this requirement on the transfer of controlled substances at a long term care facility in an effort to prevent the accumulation of ultimate user controlled substances at long term care facilities. DEA believes that this requirement balances security concerns with the ease of long term care facility participation by allowing these facilities to determine whether it is appropriate for them to dispose on behalf of an ultimate user.

Pursuant to 21 U.S.C. 822(g)(3), DEA is proposing that a long term care facility must dispose of those controlled substances only by depositing the substances into an authorized collection receptacle at the long term care facility. The long term care facility is not permitted to deliver or transfer the controlled substances off-site. If the long term care facility does not have access to an on-site collection receptacle, they are not otherwise permitted to dispose of a controlled substance on behalf of an ultimate user. Rather, the ultimate user or persons lawfully entitled to dispose of ultimate user decedent's property should dispose of those controlled substances. See 21 U.S.C. 822(g)(1) and 822(g)(4).

Because ultimate user medications are concentrated in and often administered by long term care facilities, DEA considered proposing to authorize long term care facilities to dispose of controlled substances on behalf of an ultimate user through mail-back programs and through take-back events. However, the majority of such facilities are not registered by DEA to handle controlled substances, and, therefore, do not have in place physical security controls and other requirements that minimize the risk of diversion such as the obligation to maintain effective controls against diversion, report thefts and losses, and screen certain employees for controlled substance-related felony convictions. DEA believes that only authorized DEA registrants and law enforcement agencies should be authorized to collect controlled substances from ultimate users because they have in place the proper security and other controls to help guard against diversion. Because long term care facilities are typically not registered with DEA and face the unique challenge of disposing of controlled substances on behalf of an ultimate user, DEA is proposing an option for LTCFs that balances convenience with security.

The on-site collection receptacles will reduce the risk that controlled substances may be removed from the facilities by employees (e.g., to transport substances to a take-back event for disposal) who will not be subject to the same screening procedures as employees of authorized collectors, such as the requirement that authorized

employees who have access to or influence over controlled substances have no felony convictions related to controlled substances. Additionally, DEA believes that the mail-back option is not suitable because of the likelihood that long term care facilities may need to dispose of large quantities of controlled substances or dispose of controlled substances on a frequent basis. One security aspect of the mail-back method of disposal is the requirement that mailers be non-descript, so as not to be readily identifiable as containing controlled substances. If a large number of such mailers are consistently sent from an unregistered facility whose residents are likely to possess controlled substances, such as a long term care facility, that security measure loses much of its efficacy, thereby increasing the risk of diversion, and may even have the unintended effect of making a long term care facility's mailing system a target for diversion.

DEA is, therefore, proposing to only permit long term care facilities to use an on-site collection receptacle that is under the control of an authorized retail pharmacy registrant to dispose of controlled substances on behalf of an ultimate user. DEA believes that a secure on-site collection receptacle is the best method to protect against diversion and is consistent with public health and safety.

Although reverse distributors and other collectors conducting mail-back programs will likewise receive a large number of mailers, DEA does not anticipate that the same risk exists. Collectors authorized to conduct mail-back programs will be DEA registrants that already routinely receive controlled substances and have in place security controls. A long term care facility, however, is likely not a DEA registrant, does not already routinely send out controlled substances, and will not have in place the same types of security controls.

Although LTCFs may only dispose of their residents' controlled substances through collection receptacles at the LTCF, LTCF residents themselves may utilize any other disposal method available to ultimate users, including mail-back programs and take-back events. Care should be taken to ensure that LTCF residents' use of mail-back programs and take-back events does not result in the accumulation of controlled substances in a single location susceptible to internal or external diversion threats, as discussed above.

Additional Security Controls for the Collection of Controlled Substances Through Mail-Back Programs and Collection Receptacles

As discussed above, sealed mail-back packages and inner liners acquired by collectors and registered reverse distributors and distributors must be stored in a manner consistent with the physical security requirements for Schedule II controlled substances. Registered reverse distributors, distributors, and manufacturers authorized as collectors and that store mail-back packages and inner liners acquired from an ultimate user must follow the physical security controls for storing Schedule II controlled substances in accordance with 21 CFR 1301.72, which DEA proposes to revise. An authorized collector that is a retail pharmacy must follow the physical security controls for storing Schedule II controlled substances in accordance with 21 CFR 1301.75; however, such sealed mail-back packages and inner liners may not be dispersed through the practitioner's stock of non-controlled substances as described in 21 CFR 1301.75(b), which DEA proposes to revise. DEA understands that storing sealed mail-back packages and inner liners as though they are Schedule II controlled substances is a stringent requirement; however the majority of authorized collectors, as registrants, are likely to already have these storage capabilities in place. DEA is proposing these physical security requirements because Schedule II is the highest schedule of controlled substances that is lawfully permitted to be included in the mail-back packages and inner liners. Because mail-back packages and inner liners may not be opened and their contents will not be known, such packages and liners should be stored as though each package and liner contains a Schedule II controlled substance.

In the event of theft, pilferage, or loss, registrants must notify DEA, in accordance with 21 CFR 1301.76(b) and 1301.74(c). DEA considers any theft or loss from a collection receptacle or mail-back program to be a “significant loss” within the meaning of the regulation because such losses would be attributable to the unique activities involving the disposal of controlled substances. 21 CFR 1301.74(c)(3). Also, because the controlled substances collected cannot be individually handled or sorted, it must be assumed that the loss includes Schedule II controlled substances. 21 CFR 1301.74(c)(2) and 1301.76(b). Finally, collection receptacles and mail-back packages are likely candidates for diversion because these collection methods are highly publicized and accessible to the public, and, as a result, any theft or loss from these collection methods is considered significant. 21 CFR 1301.74(c)(5) and 1301.76(b)(5).

Tracking Controlled Substances Collected From Ultimate Users and Other Authorized Non-Registrants From Collection to Destruction

In accordance with the closed system and the statutory framework of the CSA, DEA must ensure that all controlled substances collected from ultimate users are properly and promptly secured, stored, and destroyed. DEA considered allowing authorized persons to count or otherwise inventory controlled substances collected from ultimate users. Any effort to count, identify, or otherwise inventory the contents of sealed packages or inner liners, however, would require individualized identification of the contents, increase the number of hands through which controlled substances pass, and require that the packages and inner liners remain opened and exposed for extended periods of time. These factors greatly increase the risk of diversion and, when combined with the increased costs associated with such efforts, outweigh the potential benefit.

As a result of these security and diversion prevention considerations, DEA is proposing a system of collection that requires the ultimate user or other authorized non-registrant person in lawful possession of a controlled substance to personally handle such substance at all times until it is safely and securely placed in an authorized mail-back package or in an appropriate collection receptacle at an authorized location or at a take-back event. Additionally, an authorized collector would be required to collect items only in a collection receptacle with an inner liner or in a mail-back package, both of which must be uniquely identifiable, sealable, waterproof, tamper-evident, and tear-resistant. No person may open or otherwise access any secured mail-back package or inner liner.

DEA is proposing that each inner liner and mail-back package provided by an authorized collector must have a unique identification number that enables the liner and package to be tracked. The authorized collector must record the unique identification number located on the inner liner or mail-back package so that it can be properly tracked from collection to destruction. Law enforcement agencies are encouraged, but not required, to implement similar recordkeeping and tracking procedures. DEA believes that the proposed recordkeeping and tracking system is the most effective and efficient way to ensure that those controlled substances collected from ultimate users and other authorized non-registrants are secure until destruction, and are actually

destroyed. DEA has proposed a rule that allows authorized collectors the flexibility to create a tracking system that is proportionate to the scope and method of their desired disposal program while also meeting the applicable security and control requirements proposed by DEA.

Disposal of Controlled Substances by Registrants

The procedures for the disposal of controlled substances by registrants are often determined on a case-by-case basis by the DEA Special Agent in Charge (SAC) in the area where the registrant is located. In many circumstances, the SAC has the discretion to determine how to authorize and instruct registrants to dispose of controlled substances, including how the substances may be destroyed. 21 CFR 1307.21(a) and (b).

DEA proposes to expand the inventory

disposal options available to registrants, delete the existing rule related to registrant disposal (21 CFR 1307.21), and incorporate similar requirements on proper disposal procedure, security, and recordkeeping into a new part 1317 on disposal. DEA is proposing these changes to ensure consistency in disposal procedures among registrant categories, regardless of geographic location. Such regulations will reduce the burden on registrants by eliminating the existing requirement for every registrant to contact the SAC in their area when they wish to destroy controlled substances. Also, the procedures and security and recordkeeping requirements that DEA proposes are intended to codify existing practice and to set singular and consistent procedures for DEA registrants in accordance with their authorized business activities while protecting the public health and safety and minimizing the risk of diversion.

“Inventory” means “all factory and branch stocks in finished form of a basic class of controlled substance manufactured or otherwise acquired by a registrant, whether in bulk, commercial containers, or contained in pharmaceutical preparations in the possession of the registrant (including stocks held by the registrant under separate registration as a manufacturer, importer, exporter, or distributor).” 21 CFR 1300.01(b).

Registration requirements and authorized activities vary depending on the type of controlled substance business activity in which a person is engaged. Accordingly, if a registrant desires to deliver controlled substances for any lawful purpose, the registrant must be authorized by his registration to conduct the delivery—the registrant must be authorized to engage in such conduct either as a business activity or coincident activity. This general rule also applies if a registrant desires to deliver controlled substances to an authorized person by transporting the substances itself and maintaining custody and control of the substances during transportation.

Pursuant to the Controlled Substances Act, registration to distribute conveys broad authority to deliver controlled substances for a lawful purpose. “Distribute” means to “deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term `distributor' means a person who so delivers a controlled substance or listed chemical.” 21 U.S.C. 802(11). Accordingly, registrants authorized to distribute controlled substances (e.g., non-practitioners such as manufacturers, distributors, and reverse distributors) may themselves deliver such substances to authorized persons for the purpose of disposal in accordance with applicable security and recordkeeping procedures. In contrast, the Controlled Substances Act narrows the authorization of practitioners

(e.g., physicians, pharmacies, and hospitals) to “dispense,” which means “to deliver a controlled substance

to an ultimate user

or research subject by, or

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

* * *” 21 U.S.C. 802(10) (emphasis added). Authorization to dispense does not include authorization to distribute and vice versa. See 21 U.S.C. 802(11) (specifically excluding “dispense” from the definition of “distribute”). As such, registration to dispense specifically conveys narrow authority to deliver a controlled substance

to an ultimate user pursuant to the lawful order of a practitioner.

Registrants who are only authorized to dispense controlled substances (e.g., practitioners) are therefore not authorized to deliver these substances themselves to any entity other than an ultimate user, even for the purpose of disposal. Instead, practitioners may only deliver these substances to authorized persons by common or contract carrier or by pick-up at the practitioner's registered location.

Defined by the CSA as “a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.” 21 U.S.C. 802(21). Under the CSA, “[t]he Attorney General shall register practitioners * * * to dispense, or conduct research with, controlled substances * * * .” 21 U.S.C. 823(f).

As discussed, non-practitioners (e.g., manufacturers, distributors, and reverse distributors) are not similarly limited in their authority to lawfully deliver controlled substances. DEA therefore proposes in section 1317.05(b) to allow non-practitioners to deliver (i.e., transfer) controlled substances themselves for the purpose of disposal provided that such substances are transported directly to the destruction location and accompanied by two authorized employees. This proposed requirement is consistent with existing practices by registered manufacturers, distributors, and reverse distributors when transporting and disposing of controlled substances. These non-practitioners generally follow these procedures (in addition to various other procedures) as a counter-measure against theft and diversion. DEA proposes these procedures, along with the procedures set forth at section 1317.95, as the minimum required to help ensure the physical security of highly pilferable controlled substances and as a deterrent to theft and diversion.

Consistent with the requirements of the Controlled Substances Act, DEA proposes in section 1317.05(b) to authorize non-practitioners to dispose of their controlled substance inventory in one of four ways: (1) Promptly destroy the substance using an on-site method of destruction in accordance with applicable federal, state, tribal, and local laws and regulations (as required by section 1317.90); (2) promptly deliver the substance to a registered reverse distributor at its registered location by common or contract carrier, or by reverse distributor pick-up; (3) for the purpose of return or recall, promptly deliver the substance by common or contract carrier or pick-up at the registrant's registered location to the person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls; or (4) promptly transport the substance by its own means to the registered location of a reverse distributor, the location of destruction, or the registered location of any person authorized to receive the substance for the purpose of return or recall.

As discussed, a practitioner's registration does not convey authority to distribute, deliver, or otherwise transfer controlled substances to any entity other than an ultimate user. Accordingly, DEA proposes in section 1317.05(a) to authorize practitioner registrants to dispose of their controlled substance inventory in one of four ways: (1) Promptly destroy the substance using an

on-site method of destruction in accordance with applicable federal, state, tribal, and local laws and regulations (as required by section 1317.90); (2) promptly deliver the substance to a reverse distributor at its registered location by common or contract carrier, or by reverse distributor pick-up;

; (3) for the purpose of return or recall, promptly deliver the substance to the registered person from whom the substance was obtained, the registered manufacturer of the substance, or another registrant authorized to accept returns or recalls by common or contract carrier or by pick-up at the registrant's registered location; or (4) request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located. DEA proposes to allow practitioner registrants to retain the existing ability to request assistance from the SAC in the area in which the practitioner is located to dispose of their controlled substances, similar to the existing provisions of section 1307.21, in order to expand the options available for practitioners to destroy controlled substances or cause controlled substances to be destroyed. DEA proposes that the SAC in the practitioner's area may authorize the practitioner to: Transfer the controlled substances to a person registered under the Act and authorized to transport and destroy the substance; deliver the substances to an agent of the DEA or the nearest DEA office; or destroy the substances in the presence of an agent of the DEA or other authorized person. In circumstances in which a practitioner regularly destroys controlled substances, the practitioner may do so on a regular basis upon instructions from the relevant SAC.

Current DEA regulations at 21 CFR 1307.11(a)(2) discuss practitioner distribution of controlled substances to a reverse distributor. DEA proposes to clarify that provision at the proposed section 1317.05. As such, DEA proposes to delete 21 CFR 1307.11(a)(2) to eliminate redundancy.

Registrants that destroy controlled substances must do so promptly, unless otherwise specified. DEA is proposing the flexible “prompt” destruction standard rather than a specific time frame for destruction to ensure that controlled substances do not accumulate while pending destruction and are destroyed in a timely manner, while still accounting for the individual circumstances of registrants that destroy controlled substances.

For all registrants that destroy controlled substances or cause controlled substances to be destroyed (e.g., by transferring the substance to an authorized reverse distributor or transporting the substance to an off-site, unregistered location for destruction), DEA proposes in section 1317.95 that such registrants be required to follow certain security procedures related to employees, transportation, loading and unloading, handling, and destruction. DEA is proposing enhanced security requirements in order to strengthen the integrity of the disposal process, which has been expanded to include more disposal options and eliminates the requirement of prior notice of destruction to DEA, by filing DEA Form 41 prior to destruction, in every instance except when practitioners seek disposal assistance pursuant to proposed section 1317.05(a)(4). When a DEA registrant that destroys or causes the destruction of controlled substances is the last registered person to possess such substances, the registrant must follow increased security measures at the point of destruction to ensure accountability and effectively minimize the risk of diversion.

For registrants that destroy controlled substances on-site, that maintain possession of controlled substances until they are rendered non-retrievable (e.g., when transporting substances to an unregistered location for destruction), or that transfer custody to an authorized person for disposal, DEA is proposing employee security requirements in section 1317.95 to ensure that only employees that have satisfied certain employee screening requirements are authorized to oversee the handling of controlled substances during the destruction process. Under the proposed definition in 1317.02(a), an “authorized employee” is a person directly employed by the registrant full time (i.e., not employed as a contractor or agent of a third party) who must not have been convicted of any felony offense related to controlled substances and not have had at any time an application for registration with DEA denied, had a DEA registration revoked or suspended, or surrendered a DEA registration for cause.

The proposed security measures include the requirement that two authorized employees load and unload (or observe the loading and unloading of) controlled substances during transfer of the substances to another registrant; and, if the substances are destroyed on a registrant's registered premises, two authorized employees shall personally witness the destruction and shall handle (or observe the handling of) the substance until it is rendered non-retrievable. This two-person integrity requirement is necessary because the destroying registrant is the last person authorized to handle the substance before destruction and this requirement will reduce the opportunity for diversion and help to ensure that the controlled substances are actually destroyed and not diverted to illicit use.

Additionally, DEA proposes in section 1317.100 that a registrant that destroys controlled substances or causes the destruction of controlled substances is required to maintain a record of the destruction in a form to be issued by DEA. This form will be DEA Form 41. At present, DEA Form 41 is used as a record of destruction by registrants. DEA is proposing to modify DEA Form 41 to act as the record of destruction, including the signature of the two authorized employees witnessing the destruction. In an effort to minimize the burden on registrants, and in accordance with the proposed comprehensive new part on disposal, registrants that destroy or cause the destruction of controlled substances and utilize DEA Form 41 will no longer be required to submit three copies of DEA Form 41 to the SAC in their area, except one copy shall be submitted by practitioners seeking assistance pursuant to section 1317.05(a). Rather, in accordance with the CSA, such registrants will be required to keep and make available that record, for at least two years, for inspection and copying by officers or employees of the United States authorized by the Attorney General. 21 U.S.C. 827. Furthermore, all methods of destruction must be conducted in accordance with all applicable federal, state, local, and tribal laws and regulations.

Reverse Distributors

Reverse distributors are a unique group of registrants whose primary function is to possess controlled substances for the purpose of destruction or return. In this regard, reverse distributors provide a valuable service to other registrants in the disposal process. In the distribution of controlled substances between registrants, each registrant serves as a check on the other and verifies whether the controlled substance has reached its lawful destination. This is accomplished through existing reporting, recordkeeping, and order form requirements. 21 U.S.C. 827-828; 21 CFR part 1304 and 21 CFR part 1305. However, a reverse distributor that acquires controlled substances from another registrant for destruction is the last person to possess such substance before destruction so there is no recipient to verify that the substance has been destroyed. Furthermore, reverse distributors accumulate greater amounts of controlled substances that are

destined for destruction in comparison to other registrants. This is because reverse distributors routinely acquire controlled substances for destruction from other registrants and may also be authorized as collectors. As a result, DEA is proposing security and recordkeeping requirements that apply specifically to a reverse distributor's unique function.

The existing regulations pertaining to reverse distributors are located in different parts of the CFR. DEA is proposing revised regulations for reverse distributors that are clear, consistent, and consolidated into one part.

DEA believes that these proposed regulations will help reverse distributors comply with the Controlled Substances Act in a manner that effectively decreases the risk of diversion of controlled substances during the disposal process.

While reverse distributor-specific regulations are consolidated into proposed new 21 CFR part 1317, registered reverse distributors will still be required to follow all other applicable regulations that fall outside 21 CFR part 1317.

DEA proposes to revise the definition of reverse distributor in section 1300.01(b). In the existing regulations, a reverse distributor is permitted to acquire controlled substances from other registrants for the purpose of return to the manufacturer or manufacturer's agent, or “to process for or arrange the processing for” disposal. DEA proposes to revise the definition of “reverse distributor” by first defining “reverse distribute” to mean “to acquire controlled substances from another DEA registrant or a law enforcement agency for the purpose of: (1) Return to the manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer's behalf, or (2) destruction.” A “reverse distributor” is a person who reverse distributes a controlled substance.

In the existing definition of reverse distributor, a reverse distributor is permitted to acquire controlled substances from other registrants for the purpose of return to the manufacturer or manufacturer's agent. DEA proposes revising the definition to authorize a reverse distributor to acquire controlled substances from another DEA registrant for the purpose of return to the manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer's behalf. This revision is proposed so that the reverse distribute definition is consistent with the proposed revisions to return and recall in sections 1317.05 and 1317.85 (discussed below). DEA believes that this new definition clearly and accurately reflects the proper role of a reverse distributor.

DEA proposes in section 1317.15(b) to authorize registered reverse distributors to acquire controlled substances from other registrants in one of two ways: (1) Pick-up the controlled substance from a registrant at the registrant's registered location (“pick-up”), or (2) receive the controlled substance from a registrant at the reverse distributor's registered location, delivered directly by a non-practitioner or by common or contract carrier (“delivery”). Once en route from a registrant's registered location to a reverse distributor's registered location, shipments or packages of controlled substances may not be re-routed to another person or location, even if that person or location is registered with DEA. DEA believes that re-routing shipments or packages destined for one registrant to another registrant substantially increases the likelihood of diversion.

DEA proposes in section 1317.15(c) that upon acquisition of a controlled substance from a registrant, a reverse distributor must either: (1) Immediately store the controlled substance at, or transfer the controlled substance to, the reverse distributor's registered location for secure storage until timely destruction or timely return to the registered manufacturer of the substance can occur, (2) immediately deliver the controlled substance to the manufacturer or manufacturer's agent, (3) timely destroy the controlled substance, or (4) immediately deliver the controlled substance to the place of destruction for timely destruction. The requirement for “immediate” transfer or delivery is intended to ensure that shipments or packages are continuously moving towards their ultimate, secure destination. Such continuous movement reduces the risk of diversion by limiting the opportunity for theft or loss. Consistent with 21 CFR 1301.12(b)(4) and the existing definition of “freight forwarding facility” in 21 CFR 1300.01(b), a reverse distributor may not operate freight forwarding facilities for purposes of transporting controlled substances. DEA proposes to clarify this by specifically excluding reverse distributors from the definition of “freight forwarding facility” in section 1300.01(b).

DEA is also proposing in section 1317.15(d) to require reverse distributors to destroy or cause the destruction of any controlled substances received for the purpose of destruction as soon as practicable but no later than within fourteen calendar days of pick-up or delivery. A reverse distributor that acquires a controlled substance for destruction is the last person to possess such substance before destruction and, therefore, must follow increased security measures. The “as soon as practicable but no later than fourteen calendar day” requirement is unique to reverse distributors—other registrants that destroy must do so promptly and do not have to follow a specific time limit—because the primary business activity of reverse distributors, unlike other registrants, is to acquire controlled substances for the purpose of destruction or return. As a result, reverse distributors generally accumulate greater amounts of controlled substances that are destined for destruction in comparison to other registrants. They are typically the last registrant to handle the controlled substance with no other registrant reporting and recording receipt of the substance as a check against diversion. The “as soon as practicable but no later than fourteen calendar day” requirement will ensure that reverse distributors destroy or cause the destruction of controlled substances in a timely manner while also enabling them sufficient time to prepare the necessary records required for destruction. In addition, the “as soon as practicable but no later than fourteen calendar day” requirement will reduce the risk of diversion by limiting the opportunity for theft or loss. This is necessary because, just as there is a greater risk of diversion when controlled substances are being transported for the purposes of destruction, there is a greater risk of diversion the longer a substance destined for destruction remains in storage awaiting destruction.

DEA is proposing to specify a maximum time limit for reverse distributors to destroy or cause the destruction of any controlled substance received for the purpose of destruction—as soon as practicable but no later than fourteen calendar days of receipt (pick-up or delivery). While DEA believes that the majority of reverse distributors already destroy or cause the destruction of controlled substances received for the purpose of destruction `as soon as practicable' but no later than fourteen calendar days of receipt, DEA recognizes that some may not. For the reverse distributors that do not currently meet this standard, this requirement may cause these reverse distributors to incur additional costs through more frequent transportation of controlled substances to the point of destruction and destruction of partial loads. For purposes of this proposal, DEA assumes that some reverse distributors may have

to adjust current business operations in order to comply with this new requirement, such as by restricting the receipt of deliveries to their registered location to specific days and/or amounts, or by changing pick-up routes to accommodate the requirement that any controlled substance received for the purpose of destruction be destroyed as soon as practicable but no later than fourteen calendar days of receipt.

DEA believes that the proposed “as soon as practicable but no later than fourteen calendar day” requirement is reasonable and will reduce the risks of diversion. However, DEA also acknowledges that there are assorted federal, state, and local transportation and environmental laws and regulations that reverse distributors must comply with in addition to those under the CSA and these proposed regulations. DEA also acknowledges that these proposed regulations may result in reverse distributors choosing to be responsible for much more controlled substances than they are currently responsible. Accordingly, DEA invites comments on the practicability of implementing the “as soon as practicable but no later than fourteen calendar day” requirement while also maintaining effective controls against diversion. Considering there are currently a limited number of registered reverse distributors with significant variations in current business practices across the United States, DEA seeks information regarding how the “as soon as practicable but no later than fourteen calendar day” destruction requirement would impact business practices, if at all, with specific focus on the potential long-term and short-term costs of implementing this requirement, and whether such costs would be offset by other measures. DEA also invites comment regarding the effects that shorter and longer time limits for destruction—specifically, as soon as practicable but no later than seven calendar days or thirty calendar days for destruction—would have on current business practices, including the physical security controls and operating procedures that would be implemented or modified in order to guard against theft and diversion, and the potential costs that may be incurred as a result of alternative time limits.

DEA is also proposing in section 1317.20 enhanced employee security requirements for reverse distributors. DEA proposes that reverse distributors be prohibited from employing, as an agent or employee who has access to or influence over controlled substances, any person that has ever been convicted of any felony offense related to controlled substances or has ever had an application for registration with DEA denied, had a DEA registration revoked or suspended, or surrendered a DEA registration for cause. DEA is proposing these enhanced security requirements for reverse distributors in order to strengthen the integrity of the disposal process by ensuring that only certain employees are authorized to have access to or influence over controlled substances. This requirement is similar to existing employee security requirements for registered practitioners in 21 CFR 1301.76(a), where there is a high risk of diversion and limited physical security requirements.

DEA is also proposing in 1317.25 to streamline and clarify recordkeeping requirements for registered reverse distributors that acquire controlled substances from other registrants so that they are consistent and accurately reflect reverse distributor authorized activities in compliance with the Controlled Substances Act. These requirements are separate from the recordkeeping requirements for reverse distributors that acquire controlled substances from law enforcement agencies and authorized collectors, as discussed above, in proposed section 1317.55.

First, the existing regulations require registered reverse distributors to record in an inventory, information regarding specific quantities of controlled substances that is different from the information required in continuing records. 21 CFR 1304.11(e)(3) and 1304.22(e). To reconcile this discrepancy, DEA proposes in sections 1317.25(b) and (c) that in both inventory and continuing records, a reverse distributor must record the quantity of a controlled substance in both finished and bulk form, and the quantity contained in a commercial container, carton, crate, drum, or other receptacle that has been opened.

Second, in accordance with the CSA, every DEA registrant must maintain, on a current basis, a complete and accurate record of each controlled substance manufactured, received, sold, delivered, or otherwise disposed of. 21 U.S.C. 827(a). These records must be maintained separately from all other records of the registrant or, alternatively, in the case of non-narcotic controlled substances, be in such a form that required information is readily retrievable from the ordinary business records of the registrant. 21 U.S.C. 827(b)(2). The records must be kept and be available for at least two years for inspection and copying by officers or employees of the Attorney General. 21 U.S.C. 827(b)(3). Under its statutory authority, DEA may promulgate regulations that specify the information that registrants are required to maintain in their records. 21 U.S.C. 827(b).

To this end, DEA proposes in section 1317.25(c) to require registered reverse distributors to: (1) Keep records regarding each controlled substance received from another registrant for the purpose of return to a manufacturer or, if designated, to another registrant authorized by the manufacturer to accept returns on the manufacturer's behalf, and (2) keep records regarding each controlled substance destroyed, including information pertaining to the receipt and destruction of the controlled substance. These records, similar to the current requirements in 21 CFR 1304.22(e) that DEA proposes to delete, are necessary for inspection to maintain the integrity of the closed system and to assist in the detection and prevention of diversion.

DEA proposes in section 1317.25(c)(4) that for all controlled substance records, reverse distributors will be required to maintain the record of receipt with the corresponding record of return or destruction. By maintaining all relevant records together, DEA will be able to account for each substance received by a reverse distributor from its acquisition to its disposition, whether by destruction or return to the manufacturer. DEA also emphasizes that each registrant must prepare and maintain separate and independent records in order to ensure accountability of each registrant, and the integrity of the closed system of distribution.

Return and Recall

DEA is proposing to delete the existing rule on return and recall, 21 CFR 1307.12, and to clarify and separate the role of registrants and non-registrants in the return and recall of controlled substances. This is because of the different circumstances surrounding registrant and ultimate user return and recall.

Return and Recall by Registrants

DEA proposes procedures for the return and recall of controlled substances by DEA registrants in sections 1317.05(a)(3), 1317.05(b)(3), and 1317.05(b)(4), and recordkeeping and order form requirements in a new section 1317.10, which are similar to the existing rule on return and recall in 21 CFR 1307.12. The proposed new sections, however, clarify which registrants are authorized to distribute and receive returns and recalls and clarifies the recordkeeping and order form requirements. DEA proposes in sections 1317.05(a)(3), 1317.05(b)(3), and 1317.05(b)(4) that registrants in

lawful possession of a controlled substance may return that substance for the purpose of return or recall to: (1) The registered person from whom it was obtained; (2) the registered manufacturer of the substance; or (3) another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf. The procedures governing return of the substance are determined by the returning registrant's authorization as a practitioner or non-practitioner, as discussed above. This is consistent with the intent of the Controlled Substances Act to prevent opportunities for diversion because the substances are being transferred within the closed system of distribution for the purpose of disposal (i.e., return or recall) without having left the closed system of distribution, and accountability is ensured by pertinent recordkeeping requirements.

DEA proposes in section 1317.10(a) information that must be maintained in the records of registrants returning controlled substances and registrants receiving returns. In addition, pursuant to proposed section 1317.10(b), DEA Form 222 must be used by each registrant that distributes a controlled substance in Schedule I or II for the purpose of return and recall in accordance with 21 CFR part 1305. The freight forwarding provision of the existing rule is also retained in section 1317.10(c).

Ultimate User Product Recall

DEA proposes in section 1317.85 procedures for the recall or return of controlled substances by ultimate users. Currently, DEA authorizes ultimate user distribution for the purpose of recall under existing 21 CFR 1307.12, but the language in this section is overly broad. The proposed section 1317.85(a) reduces ambiguity that exists under current regulations by specifying to whom an ultimate user is permitted to deliver their recalled controlled substance and by outlining consistent and clear requirements for registrants authorized to receive those recalled substances from ultimate users.

In particular, DEA proposes in section 1317.85(a) to authorize an ultimate user in lawful possession of a controlled substance in Schedules II, III, IV, or V to deliver the recalled controlled substance to the manufacturer of the substance or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf. In the event of a product recall, the manufacturer of the recalled controlled substance or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf is authorized to receive recalled controlled substances from an ultimate user and does not need to be an authorized collector to do so. This is because the necessary security and experience in handling controlled substances is already in place. Recalled controlled substances received by authorized registrants from ultimate users are re-entering the closed system of distribution and must be handled (stored, destroyed, etc.), unless otherwise specified, in accordance with procedures that the registrant is otherwise required to follow.

DEA proposes in 1317.85(a)(1) that registrants authorized to receive recalled controlled substances from ultimate users maintain a record of recalled controlled substances received from ultimate users. Those registrants, however, are exempted under section 1317.85(a)(2) from the requirements in 21 CFR part 1305 pertaining to DEA Form 222 for substances received from non-registrants. In accordance with the Disposal Act, the delivery of a Schedule II controlled substance for the purpose of disposal by an ultimate user, long-term care facility, or other person acting in accordance with the Disposal Act is exempt from order form requirements (i.e., an ultimate user or long-term care facility may transfer a Schedule II controlled substance to another person for the purpose of disposal without a written order of the person to whom such substance is transferred). 21 U.S.C. 828(b)(3). In other words, when an ultimate user delivers a recalled controlled substance to an authorized registrant for the purpose of disposal, in this case recall, such transactions are exempt from the requirements found in 21 CFR part 1305.

DEA is also proposing in section 1317.85(a)(3) that the authorized registrant report all recalled controlled substance acquisition transactions pursuant to 21 CFR 1304.33. Such registrants may report either each individual receipt or a single transaction that includes all recalled controlled substances of the same name and finished form (e.g., all 10-milligram tablets or all 5-milligram concentration per fluid ounce or milliliter) received from ultimate users.

Finally, DEA proposes in 1317.85(b) that an ultimate user that is participating in an investigational use of drugs pursuant to 21 U.S.C. 355(i) and 360b(j) and wishes to deliver any unused controlled substance received as part of that research to the registered dispenser from which it was obtained, may do so in accordance with regulations promulgated by the Secretary of Health and Human Services pursuant to 21 U.S.C. 355(i) and 360b(j).

Methods of Destruction

DEA is proposing a standard of destruction—non-retrievable—for persons that destroy or cause the destruction of controlled substances. Some examples of current technology that may achieve the non-retrievable standard are incineration and chemical digestion. Flushing and mixing controlled substances with coffee grounds or kitty litter are examples of existing methods of destruction that do not meet the non-retrievable standard. These examples are not exhaustive and DEA is not requiring, endorsing, authorizing, or recommending any particular method of destruction so long as the desired result is achieved and the method is compliant with all applicable federal, state, tribal, and local laws and regulations. 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. DEA is proposing a standard of destruction that provides communities the flexibility to tailor disposal options to meet their resources and needs and allows for advances in technology.

Non-Retrievable

Each controlled substance has its own inherent chemical and/or physical properties. Accordingly, the objective of “destruction” is to render the substance no longer susceptible to diversion for an illicit or non-medical use. DEA intends to provide maximum flexibility to allow for technological innovation and development in controlled substance destruction processes. As such, DEA solicits comments on the proposed requirement that all destruction processes be applied in such a manner that the controlled substances are rendered “non-retrievable.”

Any destruction method applied to a controlled substance must render it “non-retrievable.” The proposed definition of “non-retrievable” means to permanently alter any controlled substance's physical and/or chemical state through irreversible means in order to render that controlled substance unavailable and unusable for all practical purposes. This definition is not intended to require destruction beyond the state at which a controlled substance becomes unavailable, unusable and, subsequently, no longer available for diversion.

In the case of ultimate user disposal where most people are unable to differentiate between controlled and non-controlled substances and because cataloging or taking inventory of substances may be detrimental to efforts to prevent diversion, all of the proposed collection methods allow comingling of pharmaceuticals. As a result, this proposed rule would require a method of destruction sufficient to render all included controlled substances non-retrievable. Likewise, where the actual substances collected are unknown, but may reasonably include controlled substances, the proposed rule would require selection of a method of destruction sufficient to render non-retrievable any controlled substance likely to be present. Information received at the January 2011 public meeting held by DEA indicated that incineration in accordance with federal, state, and local law may be the currently most-used method of destruction to achieve this result. Even so, DEA is proposing a standard that allows flexibility so long as the desired result is achieved, thus allowing for technological innovation and development. Regardless of the destruction method, the destruction must be conducted in accordance with all federal, state, tribal, and local laws and regulations.

Environmental Considerations

In passing the Disposal Act to provide those individuals seeking to dispose of unwanted or unused controlled substances in their household with more disposal options beyond discarding or flushing the substances, Congress expected that there would be fewer such substances introduced into the environment, particularly into the water.

DEA also recognizes that the establishment of alternative, lawful means for disposing of unused or expired pharmaceutical controlled substances may alleviate some existing environmental concerns. For example, recent studies have reported on the presence of pharmaceutical chemicals in varying concentrations in water supplies. DEA is hopeful that the increased availability of methods for citizens to safely and securely dispose of unwanted prescription drugs will have a positive impact on reducing the introduction of chemical contaminants into the water supply. However, collection and destruction of unwanted and unused pharmaceuticals cannot and will not address water contamination that occurs from other means such as bodily elimination or excretion of such substances.

See Findings, Sec. 2, Secure and Responsible Drug Disposal Act of 2010.

The requirements of this proposed rule only govern compliance with the Controlled Substances Act. Any selected method of destruction of controlled substances meeting the requirements of this proposed rule must also comply with all applicable federal, state, and local laws and regulations applicable at the time of the destruction. Because of the broad range of such environmental and other laws and regulations, this proposed rule does not purport to address what laws may or may not be applicable in a particular circumstance now or at some future date.

As DEA and public and private entities introduce proposed options for disposal of controlled substances to the general public and in specific communities, it is anticipated that the environmental benefits of proper collection and destruction will be emphasized in the public education and publicity surrounding the disposal of unwanted or unused controlled substances. Public health and safety is protected and improved both in preventing diversion of controlled substances during a national epidemic of pharmaceutical drug abuse and in providing options for collection that result in secure and environmentally sound destruction consistent with federal, state, tribal, and local laws and regulations.

Miscellaneous Changes

In accordance with the changes described above, DEA proposes to delete any reference to 21 CFR 1307.12 and 1307.21 and replace it with a reference to the new 21 CFR part 1317, where appropriate.

DEA also proposes to revise 21 CFR 1301.13(e)(1)(i) to delete reference to a disposer category of registration in the coincident activity column for manufacturers. A disposer category of registration was proposed by DEA in 1995, but was never finalized (60 FR 43732, August 23, 1995). Reference to a disposer category was inadvertently included in a previous rulemaking (68 FR 58587, October 10, 2003).

DEA proposes in 21 CFR 1301.76 to delete reference to 1307.12 and replace it with reference to 21 CFR part 1317; in 21 CFR 1304.11(e) and the introductory paragraph of 1304.22 to delete reference to 21 CFR 1307.12; in 21 CFR 1301.25(i), 1301.52(c), and 1307.13 to delete reference to 21 CFR 1307.21 and replace it with reference to 21 CFR part 1317; in 21 CFR 1304.25(a)(9) and 1304.25(b)(9) to delete reference to 21 CFR 1307.22 and replace it with reference to 21 CFR part 1317; and in 21 CFR 1304.04(a) to add reference to 21 CFR part 1317. DEA also proposes in 21 CFR 1307.22 to delete reference to 21 CFR 1307.21, but not replace it with reference to 21 CFR part 1317. This revision to 21 CFR 1307.22 will allow existing practices for seizure and forfeiture to continue. DEA proposes to revise the title of 21 CFR 1307.22 to “Delivery of forfeited controlled substances” for clarity.

Regulatory Analyses

Regulatory Flexibility Act

Under the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601-612), federal agencies must evaluate the impact of rules on small entities and consider less burdensome alternatives. As discussed in the preceding sections of the regulatory preamble, DEA has considered numerous alternatives for each proposed requirement and method of collection and evaluated the impact of this proposed rule on small entities. DEA has concluded that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. An economic analysis of the Proposed Rule can be found in the rulemaking docket at

http://www.regulations.gov.

In developing this proposed rule, DEA considered several options for both registrant and non-registrant disposal and reverse distributor destruction requirements. DEA analyzed alternative methodology approaches keeping in mind its statutory obligations under the CSA. DEA considered three options for non-registrant disposal: (1) Single Collection, which would authorize non-registrants to utilize only one method of collection to dispose of their lawfully possessed controlled substances; (2) Open Collection, which would authorize any person to collect controlled substances from ultimate users for disposal, regardless of their status as a DEA registrant; and (3) Multiple Collection, which would authorize non-registrants to utilize more than one method of collection to transfer controlled substances for purposes of disposal to law enforcement agencies and certain DEA registrants. In addition, DEA considered two options fo

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