Disposal of Controlled Substances

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

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

[Docket No. DEA-316]

RIN 1117-AB18

Disposal of Controlled Substances

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Final rule.

SUMMARY:

This rule governs the secure disposal of controlled substances by registrants and ultimate users. These regulations will implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances from ultimate users for the purpose of disposal, including: Take-back events, mail-back programs, and collection receptacle locations. These regulations contain specific language allowing law enforcement to voluntarily continue to conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations will allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs (NTPs), hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. This rule also reorganizes and consolidates previously existing regulations on disposal, including the role of reverse distributors.

DATES:

Effective Date:

This rule is effective October 9, 2014.

Compliance Date:

All Memoranda of Agreement (MOAs) and Memoranda of Understanding (MOUs) issued pursuant to current 21 CFR 1307.21 will not be effective after October 9, 2014. Registrants may consult § 1317.05(a)(5) for information on requesting new MOAs and MOUs for disposal of controlled substances.

FOR FURTHER INFORMATION CONTACT:

Imelda L. Paredes, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Outline

I. Executive Summary

A. Purpose of the Regulatory Action

B. Summary of the Major Provisions of the Regulatory Action

C. Summary of Changes in the Final Rule

II. Background and Legal Authority

III. Discussion of Comments

A. Support for the Proposed Rule (1 Issue)

B. Definitions and Terms (12 Issues)

C. Types of Entities That May Operate a Collection Program (9 Issues)

D. Locations Where Authorized Collectors May Maintain Collection Receptacles or Host Take-Back Events (1 Issue)

E. Registration Requirements for Authorized Collectors (5 Issues)

F. Law Enforcement (7 Issues)

G. Collection Receptacle Design, Inner Liners, Placement, and Security (24 Issues)

H. Mail-Back Programs (11 Issues)

I. Take-Back Events (6 Issues)

J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents and Mail-Back Package Contents (8 Issues)

K. Long-Term Care Facilities (LTCFs) (21 Issues)

L. Disposing on Behalf of Ultimate Users (Other than Residents of LTCFs) (3 Issues)

M. Registrant Return, Recall, and Transfer (3 Issues)

N. Destruction (19 Issues)

O. Economic Concerns (18 Issues)

P. Recordkeeping and Reporting (8 Issues)

Q. Hazardous Materials Transportation and Hazardous Waste Destruction (3 Issues)

R. Transporting Collected Substances (3 Issues)

S. Miscellaneous Comments (2 Issues)

IV. Regulatory Analyses

I. Executive Summary

A.

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 pharmaceutical controlled substances had limited disposal options. The Controlled Substances Act (CSA) only permitted ultimate users to destroy those substances themselves (e.g., by flushing or discarding), surrender them to law enforcement, or seek assistance from the United States Drug Enforcement Administration (DEA). These restrictions resulted in the accumulation of pharmaceutical controlled substances in household medicine cabinets that were available for abuse, misuse, diversion, and accidental ingestion.

The Disposal Act amended the CSA to authorize ultimate users to deliver their pharmaceutical 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), 828(b)(3). This final rule implements regulations that expand the entities to which ultimate users may transfer unused, unwanted, or expired pharmaceutical controlled substances for the purpose of disposal, as well as the methods by which such pharmaceutical controlled substances may be collected. Specified entities may voluntarily administer any of the authorized collection methods in accordance with these regulations.

B.

Summary of the Major Provisions of the Regulatory Action

The DEA is implementing new regulations for the disposal of pharmaceutical controlled substances by ultimate users in accordance with the Disposal Act. In drafting the implementing regulations, the DEA considered the public health and safety, ease and cost of program implementation, and participation by various communities. To this end, the 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 (i.e., ultimate users). The reverse distributor registration category, which is pertinent to the process of registrant disposal, was included in this comprehensive review. These regulations are incorporated into a new part 1317 on disposal. Definitions relating to the disposal of controlled substances are added to § 1300.05(b), including definitions for “employee,” “law enforcement officer,” “non-retrievable,” and “on-site” and definitions relating to controlled substances generally are revised or added to § 1300.01.

The goal of this new part on disposal, consistent with Congress's goal in the Disposal Act, is to set parameters for controlled substance diversion prevention that will encourage public and private entities to develop a variety of methods for collecting and destroying pharmaceutical controlled substances in a secure, convenient, and responsible manner. Also, consistent with the Disposal Act's goal to decrease the amount of pharmaceutical controlled substances introduced into the environment, particularly into the water, these regulations provide individuals with various additional options to dispose of their unwanted or unused pharmaceutical controlled substances beyond discarding or

flushing the substances. As a result of these regulations, the DEA hopes that the supply of unused pharmaceutical controlled substances in the home will decrease, thereby reducing the risk of diversion or harm.

Ultimate User Disposal

An ultimate user is defined by the CSA 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). This rule provides three voluntary options for ultimate user disposal: (1) Take-back events, (2) mail-back programs, and (3) collection receptacles. Individuals lawfully entitled to dispose of an ultimate user decedent's property are authorized to dispose of the ultimate user's pharmaceutical controlled substances by utilizing any of the three disposal options. All of the collection methods are voluntary and no person is required to establish or operate a disposal program. The rule also does not require ultimate users to utilize any of these three methods for disposal of controlled substances. Although the three methods of disposal allowed by this rule seek to help protect the environment and prevent controlled substances from being diverted to illicit uses, this rule does not prohibit ultimate users from using existing lawful methods.

The DEA regulations provide specific language that will continue to allow Federal, State, tribal, and local law enforcement to maintain collection receptacles at the law enforcement's physical location; and either independently or in partnership with private entities or community groups, to voluntarily hold take-back events and administer mail-back programs. 21 CFR 1317.35. Thus, ultimate users will continue to be able to surrender their unwanted pharmaceutical controlled substances to law enforcement.

The DEA is also authorizing certain registrants (manufacturers, distributors, reverse distributors, narcotic treatment programs (NTPs), hospitals/clinics with an on-site pharmacy, and retail pharmacies) to be “collectors,” with authorization to conduct mail-back programs. 21 CFR 1317.40 and 1317.70. All registrants that choose to establish mail-back programs must provide specific mail-back packages to the public, either at no cost or for a fee, 21 CFR 1317.70. Collectors that conduct mail-back programs must have and utilize an on-site method of destruction to destroy returned packages, 21 CFR 1317.05.

These DEA regulations authorize collectors to maintain collection receptacles at their registered location. 21 CFR 1317.40. Thus, ultimate users will be able to carry their unwanted pharmaceutical controlled substances to an authorized retail pharmacy or other authorized collector location and deposit those controlled substances in a secure container for disposal. Hospitals/clinics and retail pharmacies that are authorized to be collectors may also maintain collection receptacles at long-term care facilities (LTCFs). 21 CFR 1317.40. LTCFs may dispose of pharmaceutical controlled substances on behalf of an ultimate user who resides, or has resided, at that LTCF, 21 CFR 1317.80, through a collection receptacle that is maintained by an authorized hospital/clinic or retail pharmacy at that LTCF. 21 CFR 1317.40 and 1317.80.

With this rule, the DEA allows all pharmaceutical controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances, although such comingling is not required. 21CFR 1317.65, 1317.70, and 1317.75. Pharmaceutical controlled substances collected by collectors may not be individually counted or inventoried. 21 CFR 1317.75. This rule also imposes various registration, security, and recordkeeping requirements.

The DEA appreciates there is a cost to entities that choose voluntarily to provide these methods of collection and destruction. The DEA acknowledges 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 are expected to benefit the public by decreasing the supply of pharmaceutical controlled substances available for misuse, abuse, diversion, and accidental ingestion, and protect the environment from potentially harmful contaminants by providing alternate means of disposal for ultimate users. 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, mail-back program collectors may partner with third parties to make mail-back packages 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 mail-back packages.

DEA Registrant Disposal

The DEA has deleted the existing rule related to registrant disposal, 21 CFR 1307.21, and incorporated similar requirements on proper disposal procedure and security in a new part 1317 on disposal. These changes provide consistent disposal procedures for each registrant category, regardless of geographic location. In addition, the DEA has modified DEA Form 41 and is explicitly requiring that form to be used to record the destruction of controlled substances that remain in the closed system of distribution and also to account for registrant destruction of pharmaceutical controlled substances collected from ultimate users and other non-registrants pursuant to the Disposal Act. As stated in the NPRM, a controlled substance dispensed for immediate administration pursuant to an order for medication in an institutional setting remains under the custody and control of that registered institution even if the substance is not fully exhausted (

e.g.,

some of the substance remains in a vial, tube, transdermal patch, or syringe after administration but cannot or may not be further utilized, commonly referred to as “drug wastage” and “pharmaceutical wastage”). Such remaining substance must be properly recorded, stored, and destroyed in accordance with DEA regulations (

e.g.,

§ 1304.22(c)), and all applicable Federal, State, tribal, and local laws and regulations, although the destruction need not be recorded on a DEA Form 41.

Reverse Distributors

The DEA is providing regulations for entities that reverse distribute that are clear and consistent. Entities that reverse distribute are often the last registrant to possess controlled substances prior to destruction; however, the recordkeeping safeguards that exist when controlled substances are distributed between registrants are not present when these registrants destroy controlled substances. 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. The DEA is defining “reverse distribute;” revising the definition of “reverse distributor;” (21

CFR part 1300) outlining security (21 CFR part 1301), inventory, recordkeeping requirements, and other procedures that reverse distributors must follow to acquire controlled substances from registrants and to destroy such acquired substances. 21 CFR part 1304. The DEA also is clarifying that these security, inventory, and recordkeeping requirements apply to certain specified entities that reverse distribute but are not registered as reverse distributors.

See, e.g.,

21 CFR 1304.11(e)(3) (“each person registered or authorized to reverse distribute”). The DEA believes that these regulations will help all registrants that reverse distribute comply with the CSA in a manner that decreases the risk of the diversion of controlled substances during the disposal process.

Return and Recall

This rule removes the existing regulation on return and recall, 21 CFR 1307.12, and incorporates separate return and recall requirements for registrants and non-registrants into new §§ 1317.10 and 1317.85. This rule also imposes various recordkeeping requirements pertaining to controlled substances acquired for the purpose of return or recall in §§ 1304.22 and 1305.03. The DEA has simplified the requirements of § 1317.10(a) to more clearly describe the records that registrants must keep.

Methods of Destruction

Existing DEA regulations do not specify a standard to which controlled substances must be destroyed. With this final rule, the DEA is implementing a standard of destruction—non-retrievable—for registrants that destroy controlled substances, and procedures for the destruction of controlled substances. 21 CFR 1300.05 (“non-retrievable”), 1317.90, and 1317.95. The 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. Once a controlled substance is rendered “non-retrievable,” it is no longer subject to the requirements of the DEA regulations.

As explained above under “Compliance Date,” this final rule supersedes all existing MOAs and MOUs that registrants may have pursuant to § 1307.21, including MOAs and MOUs pertinent to storage of controlled substances. The DEA retains in the new part 1317 the ability for practitioners to request assistance from the local Special Agent in Charge (SAC) regarding the disposal of controlled substances. 21 CFR 1317.05. Practitioners may request a new MOA or MOU pursuant to the new § 1317.05(a)(5).

C.

Summary of the Changes in the Final Rule

The DEA carefully considered the 192 individually-submitted comments received in response to the Notice of Proposed Rulemaking (NPRM) on the Disposal of Controlled Substances.

1

77 FR 75784, Dec. 21, 2012. The comment period closed on February 19, 2013. The DEA is making a number of significant changes after thorough consideration of the issues raised by the comments and the potential diversion risks associated with these changes.

1

All of the comments submitted, except two comments, are available for public inspection online at

www.regulations.gov

. Two comments are not posted (at the commenters' request) in order to protect confidential business information.

In response to concerns regarding ultimate users' ability to have convenient disposal options, the DEA is vastly expanding those entities that may be authorized as collectors, expanding the authority of those collectors to maintain collection receptacles at LCTFs, and relaxing some of the proposed security requirements related to storage and destruction of controlled substances.

Authorized Collectors

In addition to manufacturers, distributors, reverse distributors, and retail pharmacies, the final rule also authorizes registered NTPs, as well as hospitals/clinics with an on-site pharmacy, to operate disposal programs. 21 CFR 1317.40. By permitting these additional registrant categories to be collectors, the DEA anticipates that ultimate users will now have even more locations where they can securely, safely, responsibly, and conveniently dispose of their unwanted pharmaceutical controlled substances.

In this final rule, the DEA is permitting those entities registered as NTPs to become authorized collectors to manage collection receptacles at their registered locations. As stated in the Disposal Act, “the nonmedical use of prescription drugs is a growing problem in the United States.” Multiple commenters, including a national organization that represents NTPs, recommended that the DEA include NTPs as authorized collectors. The DEA recognizes the valuable role that NTPs have in helping those seeking substance abuse treatment. After considering the importance of providing secure, convenient, and responsible disposal options for those ultimate users currently receiving treatment for narcotic substance abuse or entering a narcotic treatment program, and the benefits of allowing NTPs to provide the opportunity to patients to dispose of unused controlled substances, the DEA is permitting NTPs to be collectors with certain enhanced security controls. 21 CFR 1317.75.

Due to the nature of the healthcare provided, NTPs face unique security challenges and heightened diversion risks and, as such, the final rule requires NTPs to securely place and maintain collection receptacles in a room that does not contain any other controlled substances and is securely locked with controlled access. 21 CFR 1317.75. The DEA understands that this security measure will require employees of the NTP to accompany the patient to the collection receptacle to facilitate the patient's disposal.

See

21 CFR 1317.75. Additionally, as the Disposal Act and these regulations are intended to address the

prescription

drug abuse problem, NTPs and other collectors are not authorized to collect schedule I controlled substances.

E.g.,

21 CFR 1317.75. Collectors must be vigilant in ensuring that such illicit substances are not collected intentionally or inadvertently.

E.g.,

21 CFR 1317.70 and 1317.75.

After extensive review and careful deliberation, in this final rule, the DEA is also permitting registered hospitals/clinics with an on-site pharmacy to become authorized collectors to maintain collection receptacles inside their registered locations or at LTCFs, and to conduct mail-back programs. 21 CFR 1317.30, 1317.40, 1317.70, and 1317.80. In response to the NPRM, many commenters stated that collection receptacles located inside of hospitals would provide ultimate users with an opportunity to dispose of medication that may no longer be needed or may be expired. In determining whether to allow hospitals/clinics to become authorized collectors, the DEA carefully weighed the diversion risks with the convenience of authorizing such entities to be collectors. The DEA determined that the diversion risks require the DEA to limit those registered hospitals/clinics that may become collectors to those with on-site pharmacies, and also impose separate security conditions on the monitoring and location of collection receptacles inside hospitals/

clinics that become authorized collectors. 21 CFR 1317.75.

The DEA is requiring these additional security measures in order to help protect against the diversion of collected controlled substances because hospitals/clinics are generally much larger and are open to a much larger general population than the other registrants authorized to be collectors; and, as discussed in the NPRM, hospitals/clinics do not operate under the same business model or with similar theft and loss prevention procedures as the other registrants authorized to become collectors. For example, the general public typically enters retail pharmacies for short durations in order to conduct retail business and retail pharmacies generally have open, clearly observable common areas with little opportunity 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 for extended periods of time; they are much larger than retail pharmacies and many interactions occur behind closed doors without routine theft and loss prevention measures; and foot traffic generally is not routinely monitored for unlawful purposes. The DEA believes that limiting authorized collection activities to hospitals/clinics with an on-site pharmacy is necessary to help protect against diversion because these hospitals/clinics routinely handle a large volume of controlled substances that are dispensed to in-patients as well as to the public, and these entities are more experienced with security, theft and loss prevention procedures, and inventory, recordkeeping and reporting requirements than those hospitals/clinics without an on-site pharmacy.

For reasons discussed in the NPRM, this final rule generally requires that, when authorized collectors choose to install collection receptacles, those collection receptacles must be placed inside their registered locations in the immediate proximity of a designated area where controlled substances are stored and at which an employee is present. 21 CFR 1317.75;

see also

1317.05. The DEA recognizes that hospitals/clinics with an on-site pharmacy can be unique in their design and it may be more effective to install collection receptacles at various locations within the hospital/clinic, depending on factors such as security, convenience, and accessibility. As such, it would be challenging for authorized hospitals/clinics to adhere to the general rule to place collection receptacles in the immediate proximity of where controlled substances are stored and at which an employee is present. Accordingly, the DEA is requiring hospitals/clinics that are collectors to place collection receptacles in locations that are regularly monitored by employees. 21 CFR 1317.75. In addition, the DEA is prohibiting such collectors from placing collection receptacles in the proximity of any area where emergency or urgent care is provided. In the DEA's experience, the risk of diversion is particularly high in areas where emergency or urgent care is provided because of the often chaotic environment and the extended amounts of time persons spend in such areas.

This rule also makes clear that DEA registrants cannot use the collection receptacles to dispose of unused controlled substances in their inventory or stock. 21 CFR 1317.05 and 1317.75. Pharmaceutical controlled substances remain under the custody and control of the DEA registrant if they are dispensed by a practitioner for immediate administration at the practitioner's registered location (such as a hospital) pursuant to an order for medication. If that 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), then the DEA registrant is obligated to destroy the remaining, unusable controlled substances, and record the destruction in accordance with § 1304.22(c). The DEA registrant shall not place such remaining, unusable controlled substance in a collection receptacle as a means of disposal. Hospital/clinic staff must also not dispose of any controlled substances in inventory or stock in a collection receptacle.

The security requirements described above are the minimum required in order to detect and prevent diversion in the unique circumstances of NTPs and hospitals/clinics. These registrants should be vigilant in the execution of their responsibilities as registrants to ensure that collected controlled substances are not diverted to illicit use, and that they do not collect illicit substances. Finally, all registrants are reminded of the responsibility to report theft and significant loss of controlled substances within one business day of discovery.

Long-Term Care Facilities (LTCFs)

Significant changes are made in this final rule to help ensure that LTCFs have adequate disposal options. In addition to allowing retail pharmacies to manage and maintain collection receptacles at LTCFs, the DEA is also allowing hospitals/clinics with an on-site pharmacy to manage and maintain collection receptacles at LTCFs. The DEA hopes that expanding those authorized to collect at LTCFs will maximize disposal opportunities for LTCF residents.

In addition, the DEA is alleviating two security requirements proposed to apply to collection receptacles located at LTCFs. First, the DEA is permitting authorized hospitals/clinics and retail pharmacies to store inner liners that have been sealed upon removal from a collection receptacle at LTCFs in a securely locked, substantially constructed cabinet or a securely locked room with controlled access for up to three business days until the liners can be transferred for destruction. The DEA encourages collectors to schedule inner liner removals and installations to coincide with existing LTCF visits when possible, for example, arranging a routine system in which medication deliveries coincide with the removal and transfer of sealed inner liners for appropriate destruction, thereby making storage of sealed inner liners unnecessary. Collectors may not transfer sealed inner liners from LTCFs to their primary registered location (i.e., the hospital/clinic or retail pharmacy location). As echoed in the comments, the DEA remains concerned about the security risks of hospital/clinic and retail pharmacy employees transporting large quantities of collected substances, making them potential targets for drug seekers. Instead, collectors should deliver sealed inner liners to a reverse distributor or distributor's registered location by common or contract carrier pick-up or by reverse distributor or distributor pick-up at the LTCF, pursuant to § 1317.05(c)(2)(iv).

Second, the DEA relaxed the two-employee integrity requirement for inner liner installation, removal, storage, and transfer at LTCFs. Collectors will retain the option to authorize two of their own employees to install, remove, store, and transfer inner liners; however, the DEA is permitting collectors the option to designate a supervisor-level employee of the LTCF (

e.g.,

a charge nurse, supervisor, or similar employee) to install, remove, store, or transfer inner liners with only one employee of the collector.

The DEA modified the above security requirements (storage and two-person integrity) to provide flexibility sufficient to encourage authorized hospitals/clinics and retail pharmacies to collect at LTCFs, while ensuring the minimum protections required to prevent

diversion at LTCFs. The DEA hopes that the inclusion of certain hospitals/clinics as authorized to maintain collection receptacles at LTCFs, and the modifications described above will result in expanded safe and secure disposal options for LTCF residents. The DEA emphasizes that if LTCFs dispose of LTCF residents' controlled substances in collection receptacles, such activity must be in accordance with this regulation and all other applicable Federal, State, tribal and local laws and regulations, including environmental laws and regulations.

The DEA acknowledges that there may be some LTCFs that will not have a collection receptacle, and there will be instances where LTCF residents are incapable of disposing of their own unused or unwanted medication. As ultimate users, LTCF residents may use any of the disposal options afforded other ultimate users in this final rule (e.g., mail-back programs), in addition to the disposal options currently available to ultimate users (e.g., flushing or otherwise discarding) that will remain options even after this final rule is implemented. For example, an LTCF resident may request that LTCF personnel place the resident's unwanted medication in a mail-back package, seal the mail-back package, and deposit that package into the facility's outgoing mail system. 21 CFR 1317.70. LTCFs should be mindful however that the touchstone for this disposal method is the individual nature of the disposal activity; institutional facilities such as LTCFs should ensure that the individual patient is the disposer, and should be wary of establishing any protocols whereby the facility itself is engaging in collection activities. Simply providing the method of disposal (e.g., mail-back packages) does not implicate that concern.

Destruction

After careful and thorough consideration of comments received regarding the burdens associated with the proposed 14-day destruction requirement, the DEA is extending the time those registrants that reverse distribute have to destroy controlled substances to 30 days. 21 CFR 1317.15(d). The DEA anticipates that this extension will allow reverse distributors and distributors adequate time to collect and destroy controlled substances in a safe, convenient, and secure manner, while also preventing diversion and diversion opportunities.

Practitioner Physical Security

In this final rule, the DEA is not amending § 1301.75(b) pertaining to practitioner physical security and is instead adding a new paragraph (c) to clarify that practitioners shall only store sealed mail-back packages and inner liners containing collected substances at their registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access. The DEA has made corresponding changes to §§ 1317.05(c)(1)(ii) and (c)(2)(ii). Part of this requirement was included in the proposed rule; however, after careful consideration of a number of comments, the DEA believes that the proposed requirement did not provide sufficient controls to protect against diversion and was impracticable. Pharmacies and institutional practitioners cannot store sealed inner liners or returned mail-back packages by dispersing them throughout the stock of noncontrolled substances. 21 CFR 1301.75(b) and (c).

Other Changes to the Final Rule

In addition to the changes described above, the DEA determined that the rule, as proposed, required other modifications, as generally described below. The DEA is also implementing additional technical modifications that will not have a substantive effect on this rule (e.g., relocating some sections in proposed part 1317 to other sections within title 21 of the CFR, re-phrasing some sections from the proposed rule to be simpler, clearer and easier to understand, and eliminating redundancy).

In the general definitions section of the DEA regulations, the DEA is amending § 1300.01(b) to be clear that the definitions that generally apply to most other parts of chapter II of title 21 of the CFR also apply to part 1317. In response to a number of comments, in § 1300.01(b) the DEA is amending the definition of “reverse distributor” to clarify that a reverse distributor is a person registered with the DEA as a reverse distributor.

Definitions were moved from § 1317.02 to § 1300.05 to provide consistency within the CFR pertaining to definitions. The DEA adds § 1300.05 “Definitions relating to the disposal of controlled substances,” moves the terms “authorized employee,” “law enforcement officer,” and “non-retrievable” from part 1317 to § 1300.05(b), adds a definition of “on-site” to § 1300.05(b), and deletes the definitions of “for cause” and “inner liner” that were in proposed part 1317. The DEA also moves the definition of “collection” to § 1300.01(b). These changes are in response to comments or related to the movement of several other requirements from part 1317 to other parts, as discussed below.

In addition to moving them to § 1300.05(b), the DEA amends the definitions of “authorized employee” and “law enforcement officer.” The DEA is omitting the word “authorized” from the definition of “authorized employee,” and codifying the definition of “employee” in harmony with the general common law of agency. The DEA is modifying the definition of “law enforcement officer” in part 1317 to specifically include officers from law enforcement components of Federal agencies, and authorized police officers of the Veterans Health Administration and the Department of Defense. In addition, this rule clarifies who may qualify as a “law enforcement officer” for the purpose of disposal. The DEA is changing references to “law enforcement agencies” to “law enforcement” in order to include law enforcement components of Federal agencies.

Although the DEA defined “inner liner” in the NPRM, the final rule does not amend the CFR to add a definition for inner liner. As described below, inner liners used in the collection of controlled substances must meet the specifications outlined in § 1317.60. The DEA also is not amending the CFR to add a definition of “for cause,” and instead is providing an explanation of “for cause” as it relates to the sections to which it applies.

The DEA added a definition of “on-site” to § 1300.05(b) to clarify that “on-site” means “located on or at the physical premises of the registrant's registered location” for purposes of destruction and registration as a collector. Specifically, a controlled substance is destroyed “on-site” when destruction occurs on the physical premises of the destroying registrant's registered location, and a hospital/clinic has an “on-site” pharmacy when it has a pharmacy located on the physical premises of the registrant's registered location.

Text was added to the registration table in § 1301.13 to reflect that distributors, as a coincident activity to distribution, may acquire controlled substances from collectors for the purpose of destruction. The registration table was updated so that it would be consistent with the regulations in the final rule, which authorize distributors to destroy controlled substances acquired from collectors.

The DEA received a number of comments indicating confusion regarding the procedures a registrant must follow to modify their DEA registration to become a collector. In

order to clarify such requirements, the DEA is further revising § 1301.51. The additional revisions clarify the requirements by listing them independently of other types of registration modifications (e.g., change of name or address) and clearly indicating that any modifications may be made in writing by mail or online. 21 CFR part 1301. Also, the submission method has been modified from “letter” to “written request” to accurately encompass the various ways the modification request may be submitted (e.g., online), and the phrase “to be paid” was deleted from § 1301.51(c) for stylistic reasons. Similarly, the DEA is further revising § 1301.52 to clarify that any registrant who has been authorized as a collector and who desires to discontinue their collection of pharmaceutical controlled substances from ultimate users must notify the DEA.

The DEA is also streamlining certain registration and security procedures by moving certain requirements from part 1317, as proposed in the NPRM, to part 1301. Reverse distributor employee security requirements in proposed § 1317.20 were moved to § 1301.74(m) for ease of reference and consistency. Collector security requirements in proposed § 1317.45 were moved to § 1301.71(f) for clarity and consistency.

The DEA determined that inclusion of recordkeeping and reporting requirements in part 1317 may lead to confusion among registrants. As such, the DEA is moving all recordkeeping and reporting requirements from part 1317, as proposed in the NPRM, to part 1304—Records and Reports of DEA Registrants—in order to maintain consistency and consolidate all recordkeeping and reporting requirements into one part. In § 1304.03, “each” was changed to “every,” and “who” was changed to “that” for stylistic reasons. In § 1304.11(e)(2), the first sentence, pertaining to an exception for reverse distributors, was removed and incorporated into § 1304.11(e)(3) of the final rule to accurately reflect the type of registrants to which the section applies.

The DEA is expanding the locations where a collector may maintain records in § 1304.04(a)(3). The text in § 1304.21(a) was updated to specifically include inner liners and mail-back packages, which were inadvertently overlooked in the NPRM. 21 CFR § 1304.21(c) was updated to include the general recordkeeping requirements for collection activities as outlined in the final rule. The recordkeeping requirements for disposal of controlled substances in 21 CFR § 1307.21 were moved to § 1304.21(e) and amended to include recordkeeping procedures for destruction. The title and introductory text in § 1304.22 were updated to accurately reflect their contents. Additionally, § 1304.22 was modified to include recordkeeping requirements for collected controlled substances. The second sentence in both § 1304.25(a)(9) and § 1304.25(b)(9), which required compliance with part 1317 when destroying narcotic controlled substances, were removed as superfluous. All disposal and destruction activities are clearly delineated in part 1317. Also, various Automation of Reports and Consolidated Ordering System (ARCOS) requirements are removed from part 1317, as proposed in the NPRM, and are consolidated and moved to § 1304.33. In addition, the title of § 1304.33 has been changed to add clarity, and the acronym “ARCOS” is clearly spelled out. The formatting for § 1304.33(f) was modified for ease of understanding, and “who” was changed to “that” in two locations for consistency.

The DEA is also amending § 1305.03 to add a new paragraph (f) to clarify that collectors are exempt from order form requirements for pharmaceutical controlled substances collected through mail-back programs and collection receptacles for the purpose of disposal. The title of § 1307.11 no longer references reverse distributors and has been changed to “Distribution by dispenser to another practitioner” because reverse distributor activities were moved to part 1317.

As discussed in the preamble to the NPRM and as mentioned in proposed § 1317.100, the DEA clarifies in § 1304.21 of this final rule that, in addition to any other recordkeeping requirements, all registrants that destroy or cause the destruction of a controlled substance must maintain a record of that destruction on a DEA Form 41. This requirement had been discussed in the preamble to the proposed rule, and in proposed § 1317.100 the DEA stated “any registered person that destroys or causes the destruction of a controlled substance shall maintain a record of destruction on a form issued by DEA . . ..” The DEA has determined that this requirement to keep such records on DEA Form 41 should be explicitly stated in the regulatory text, and not just the preamble, for registrants to clearly understand the requirements to which they are bound. As stated above, this requirement to record destruction activities on the DEA Form 41 does not apply to drug wastage or pharmaceutical wastage which must be properly recorded, stored, and destroyed in accordance with DEA regulations, and all applicable Federal, State, tribal, and local laws and regulations. 21 CFR part 1304.

The DEA is modifying proposed § 1317.70 to address the procedures that a collector must follow when ceasing operation of a mail-back program. This modification requires such collector to make reasonable efforts to notify the public of their intent to cease mail-back collection activities. 21 CFR 1317.70. Such collector must also establish an agreement with another collector authorized to conduct a mail-back program to receive all remaining packages and arrange for the forwarding of such packages to the second collector's registered location. These procedures will ensure that another authorized entity will be responsible for receiving and destroying any mail-back packages that were disseminated but not received back by the collector prior to the time that they ceased operation of their mail-back program.

Finally, the DEA is modifying proposed § 1317.75 for two purposes. The first modification clarifies that collected controlled and non-controlled substances can be comingled, but are not required to be comingled. 21 CFR 1317.75. As previously discussed, the second modification to this section allows certain LTCF employees, as designated by the collector authorized to maintain a collection receptacle at that LTCF, to install, seal, remove, store, and transfer for destruction the inner liners of the collection receptacle along with an employee of the collector. 21 CFR 1317.80. This modification allows greater flexibility for collectors authorized to maintain collection receptacles at LTCFs.

II. Background and Legal Authority

The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, but are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. 21 U.S.C. 801-971. The 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 needs of the United States. 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 as list I or list II chemicals based on their use and importance to the manufacture of controlled substances. 21 U.S.C. 802(33)-(35).

The CSA establishes a closed system of distribution that requires the 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 pharmaceutical controlled substances is essential to preventing the diversion of these substances into the illicit market.

In order to maintain this closed system of distribution, persons who handle (manufacture, distribute, dispense, import, export, engage in research, or conduct instructional activities), or propose to handle, controlled substances and listed chemicals are required to register with the DEA at each principal place of business or professional practice. Persons registered with the 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 who possess controlled substances are required to register with the DEA. For example, a patient who receives a pharmaceutical controlled substance pursuant to a lawful prescription, i.e., an ultimate user, is not required to register with the DEA in order to receive and possess that substance. 21 U.S.C. 822(c)(3);

see also

21 U.S.C. 957(b)(1)(C).

2

The CSA defines an “ultimate user” as “a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.” 21 U.S.C. 802(27).

2

21 U.S.C. 822(c)(3) and 957(b)(1)(C) except “ultimate users” who possess substances for purposes referenced in 21 U.S.C. 802(25); however, “ultimate user” is defined in 21 U.S.C. 802(27).

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 pharmaceutical 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 pharmaceutical controlled substances, if they distribute (e.g., deliver or transfer) such substances without the appropriate registration, they are in violation of the CSA.

3

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

4

3

It is unlawful to knowingly or intentionally manufacture, distribute, dispense, or possess with the intent to manufacture, distribute, or dispense, a controlled substance without the appropriate registration. 21 U.S.C. 841(a).

4

The terms “disposal,” “dispose,” or “disposition” appear several times in the CSA and its implementing regulations, but are not defined. For example, in the CSA, see 21 U.S.C. 822(g); 824(f)-(g); 826(c), (e)-(f); 827(a)(3), (d)(1); 842(a)(7); 853(n); 880(a)(2); 881(e)(1); 958(d)(6); and in the CFR, see 21 CFR 1307.21(b) and 1304.22(a)(2)(ix). 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.” The 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 Final Rule, the DEA uses the terms “disposal” and “dispose” to generally refer 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, and destroy/destruction).

The Disposal Act, enacted on October 12, 2010, amended the CSA to allow an ultimate user to “deliver” a pharmaceutical controlled substance “to another person for the purpose of disposal” if the person receiving the substance is authorized to receive it 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 the DEA.

5

5

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

In addition to authorizing ultimate users to deliver their pharmaceutical controlled substances to another person for the purpose of disposal, the Disposal Act also authorizes any person lawfully entitled to dispose of an ultimate user decedent's property to deliver the ultimate user's pharmaceutical controlled substances to another person for the purpose of disposal if the ultimate user dies while in lawful possession of the substances. The Disposal Act also gives the DEA the ability, by regulation, to authorize LTCFs to dispose of pharmaceutical controlled substances on behalf of ultimate users who reside, or have resided, at the LTCF. Congress directed the 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.

III. Discussion of Comments

The DEA had received 192 comments on the NPRM when the comment period closed on February 19, 2013. These comments are summarized below, along with the DEA's responses.

A. Support for the Proposed Rule (1 Issue)

[1] Issue:

The DEA received 192 comments for this rulemaking during the 60-day comment period. The vast majority of the comments were overwhelmingly positive with the commenters agreeing that there should be more options for secure, convenient, and responsible disposal of controlled substances. Nineteen commenters supported the rule as written in the NPRM. Almost every other commenter supported the rule to some degree, although many commenters had concerns with the implementation of the specific disposal procedures described in the NPRM.

Response:

The DEA appreciates the support for this rulemaking and is privileged to implement regulations to allow for the collection and disposal of controlled substances in a secure, convenient, and responsible manner. The DEA considered all of the comments and ramifications of implementing proposed changes to the rule. In finalizing this rule, the DEA

considered public health and safety, ease and cost of program implementation, and participation by various communities.

B. Definitions and Terms

6

(12 Issues)

6

Definitions and terms specific to particular comment categories, such as “Law Enforcement” and “Long-Term Care Facilities (LTCFs),” are located in those specific sections.

[1] Issue:

Five commenters asked the DEA to define “ultimate user.”

Response:

An ultimate user is defined by the CSA 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.” This definition, codified at 21 U.S.C. 802(27), was not amended or otherwise modified by the Disposal Act.

[2] Issue:

Ten commenters asked the DEA to clarify the term “retail pharmacy” and to specify whether “closed-door pharmacies,” such as those that service LTCFs, “Federal pharmacies,” and other pharmacies that only provide services to a distinct population are considered retail pharmacies.

Response:

The intended meaning of “retail pharmacy” with regard to collectors was discussed in the NPRM but was not defined in the proposed rule itself. The DEA intends “retail pharmacy” to include any entity registered with the DEA as a retail pharmacy as opposed to those entities registered as a hospital/clinic. Depending on a variety of factors, including State authority and authorized business practices, some entities that dispense controlled substances may be registered with the DEA as either a retail pharmacy or a hospital/clinic. 21 CFR part 1301. In other words, pharmacies are not registered with the DEA as “Federal pharmacies,” “LTCF pharmacies,” or even “closed-door pharmacies.” All of these pharmacies may be registered as retail pharmacies provided they meet the requirements of 21 U.S.C. 822 and 823, and they may be authorized as collectors upon proper application. As previously discussed, the DEA is also allowing entities registered as hospitals/clinics with an on-site pharmacy to be collectors. 21 CFR 1317.40. Therefore, patients of pharmacies that dispense controlled substances pursuant to a hospital/clinic registration may benefit if the hospital/clinic opts to modify its registration to become a collector.

[3] Issue:

Approximately 10 commenters asked the DEA to expand the definition of “authorized employee.” These commenters expressed concern that the definition of “authorized employee” in the NPRM was too limited in scope, and would result in a burden on smaller-staffed pharmacies, as well as pharmacies that employ contract pharmacists and part-time employees. One commenter asked whether or not physician-owners will be considered authorized employees.

Response:

The DEA carefully considered the commenters' concerns and is modifying the proposed definition of “authorized employee.” 21 CFR § 1300.05(b). In this rule, the DEA is omitting the word “authorized” from the definition of “authorized employee” because the rule already specifies what conditions qualify employees to conduct certain disposal activities (i.e., authorized collectors may not employ, as an agent or employee who has access to or influence over collected substances, any person who has been convicted of a felony offense related to controlled substances or who has, 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). Also, the DEA is modifying the definition of “employee” by adopting the general common law of agency's definition of the term and moving the definition from proposed part 1317 to part 1300. As a result of these changes, part-time personnel and physician-owners may be considered “employees” for the purpose of disposal if they meet the relevant criteria.

Where Congress does not define “employee,” the DEA utilizes the common law to determine who is an “employee.” Under U.S. Supreme Court precedent, the factors relevant to determining whether a person is an “employee” under the common law include, but are not limited to: The hiring party's right to control the manner and means by which the product is accomplished; the skill required; the source of the instrumentalities and tools; the location of the work; the duration of the relationship between the parties; whether the hiring party has the right to assign additional projects to the hired party; the extent of the hired party's discretion over when and how long to work; the method of payment; the hired party's role in hiring and paying assistants; whether the work is part of the regular business of the hiring party; whether the hiring party is in business; the provision of employee benefits; and the tax treatment of the hired party.

See Nationwide Mut. Ins. Co. v. Darden,

503 U.S. 318, 323-24 (1992). Other applicable factors may be considered and no one factor is dispositive.

See id.

at 324.

After evaluating the relevant factors in the context of controlled substance security and diversion prevention, in the context of disposal, the following criteria will determine whether a person is an “employee” regardless of the number of hours per week the person works: Persons who are directly paid by the registrant; who are subject to direct oversight by the registrant; who are required, as a condition of employment, to follow the registrant's procedures and guidelines pertaining to the handling of controlled substances; who receive a performance rating or performance evaluation on a regular/routine basis from the registrant; who are subject to disciplinary action by the registrant; and who render services at the registrant's registered location. This definition is incorporated in the new § 1300.05, titled “Definitions Relating to the Disposal of Controlled Substances.” These criteria focus on the degree of management and control that a registrant has over the person, and thus, adherence to these criteria will directly impact the security of controlled substances within the registrant's custody and control. The DEA believes that these criteria are the minimum required to ensure controlled substances are accounted for and not diverted to illicit purposes. Under the definition, contract personnel who do not meet these criteria are not “employees” for the purposes of disposal.

[4] Issue:

One commenter stated that the proposed definition of “authorized employee” was too expansive, and that controlled substances should be handled only by individuals who hold a professional license.

Response:

The DEA carefully considered the diversion risks associated with allowing various types of persons to handle collected substances. The definition of “employee,” as stated in this final rule, will help reduce diversion risks while ensuring that authorized collectors have sufficient ability to safely and securely manage the collection of controlled substances. 21 CFR part 1300. Individuals who do not hold a professional license are considered “employees” if they meet the criteria as explained above.

[5] Issue:

Five commenters asked the DEA to define the term “common or contract carrier.”

Response:

The DEA declines to define this term for the purpose of this rule. The DEA's primary concern regarding common or contract carriers is not about how these terms are defined, but whether there is adequate security to

prevent diversion when controlled substances are being transported. As explained in § 1301.74(e), when shipping controlled substances, non-practitioner registrants are responsible for selecting common or contract carriers that provide adequate security to guard against in-transit losses. In addition, non-practitioner registrants are responsible for employing precautions (e.g., assuring that shipping containers do not indicate that contents are controlled substances) to guard against in-transit losses. Although these specific requirements apply to non-practitioners, all registrants (practitioners and non-practitioners) shall provide effective controls and procedures to guard against theft and diversion of controlled substances. 21 CFR part 1301.

[6] Issue:

One commenter suggested that the DEA modify the definition of “non-retrievable” to read: “means to

permanently

alter any controlled substance's physical and/or chemical state through

essentially

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.”

Response:

The DEA declines to modify the definition as suggested. Such a change would significantly weaken the non-retrievable standard to a state where controlled substances could easily be diverted. The permanent and irreversible alteration of controlled substances is the cornerstone of the non-retrievable standard.

[7] Issue:

Some commenters asked the DEA to clarify the meaning of the terms “regularly” and “practitioner” used in the proposed § 1317.05(a)(4).

Response:

“Practitioner” is defined in the CSA at 21 U.S.C. 802(21) 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.” The term “regularly” has its ordinary meaning, with no specific or technical implications. The DEA understands the ordinary meaning of “regularly” to generally be considered as being on a routine basis or at routine intervals.

[8] Issue:

One commenter suggested that the DEA distinguish reverse distributors who only collect controlled substances for the purpose of disposal from reverse distributors who also handle non-controlled substances and other waste products. This commenter suggested that the DEA lessen the requirements for those reverse distributors that only collect controlled substances for disposal.

Response:

The DEA does not distinguish between different “types” of reverse distributors. All reverse distributors receive controlled substances for the purpose of disposal—either through return to the manufacturer who accepts returns, or through destruction. 21 CFR part 1300. The regulations impose the minimum requirements for reverse distributors when handling controlled substances regardless of whether they also handle other substances. Therefore, there is no basis to relax the requirements for reverse distributors whose activities are limited solely to the collection of pharmaceutical controlled substances for the purpose of disposal.

[9] Issue:

One commenter asked the DEA to clarify the difference between “transfer” and “transport” as used in proposed § 1317.95.

Response:

These terms have their ordinary meaning. Generally, the DEA uses the term “transport” to refer to the physical movement of an item from one location to another while “transfer” is used to refer to conveying possession or control (actual or constructive) from one entity to another.

[10] Issue:

One commenter asked the DEA to clarify the phrase “causes the destruction” as it could be interpreted to mean any person involved in the process.

Response:

As previously discussed, proposed § 1317.100 is relocated in this final rule to § 1304.21(e). The DEA included the term “causes the destruction” to encompass such circumstances where a registrant does not itself destroy the controlled substance but is still responsible for the destruction; for example, when a registrant or a registrant's employee initiates the destruction process by engaging a third-party destruction facility that will perform the actual destruction pursuant to § 1317.95(c). This final rule clarifies this distinction in §§ 1317.95(c) and 1304.21(e).

[11] Issue:

One commenter stated that the rule should be clarified in use of the word “may” with regard to individual counting and inventorying of collected substances. The commenter indicated that the word seems open for interpretation.

Response:

The commenter is specifically referring to the NPRM statement “[c]ontrolled substances collected by collectors may not be individually counted or inventoried.” The DEA understands that this phrase may be misinterpreted to mean that authorized collectors are not required to count or inventory collected substances. To clarify, the DEA is modifying §§ 1317.60 and 1317.70 to clearly indicate that sealed inner liners and returned mail-back packages “shall not be opened, x-rayed, analyzed, or otherwise penetrated.” The DEA also modifies § 1317.75(c) to specify that this prohibition includes counting or inventorying collected substances prior to sealing and removing an inner liner that contains collected substances, as well as after the inner liner is sealed. The DEA discusses below the different requirements applying to law enforcement.

[12] Issue:

One commenter noted that the DEA used inconsistent time requirements throughout the proposed rule, such as “timely,” “prompt,” and “as soon as practicable, but no later than 14 days.” Additionally, several commenters requested clarification regarding the definition of the word “prompt” in the proposed rule, and commenters asked for clarification regarding how the DEA would determine whether an action is “prompt.” Commenters asked for guidance as to what time range the DEA would find reasonably acceptable.

Response:

The DEA's use of different time standards throughout the proposed rule was intentional as the different circumstances of each requirement warrant different standards. The various timing requirements are intended to be flexible enough to account for individual circumstances while also ensuring sufficient and adequate controls to prevent diversion and opportunities for diversion. The DEA considered imposing specific timelines (

e.g.,

three days, five days); however, the wide variety of business models and activities made it impossible in most circumstances to set a specific deadline that would prevent diversion and diversion opportunities. Additionally, violations of specific timelines would be

per se

violations of the regulations, whereas violations of the flexible “prompt” and “as soon as practicable” standards would be considered under each registrant's individual circumstances. The DEA's determination will be guided by whether the registrant has fulfilled its responsibility to provide effective controls and procedures to guard against theft and diversion. All controlled substances destined for destruction must be rendered non-retrievable in order to be destroyed in a manner

consistent with this rule. As such, a controlled substance will have been promptly destroyed if it is promptly rendered non-retrievable. 21 CFR 1317.95. “Timely” refers to actions that have a specific time period for compliance,

e.g.,

30 days. Therefore, in each instance in which the rule uses the word “timely” to refer to destruction requirements for reverse distributors, it refers to the specific time period (14 days in the proposed rule, 30 days in the final rule) in which reverse distributors are required to destroy controlled substances. 21 CFR 1317.15.

C. Types of Entities That May Operate a Collection Program (9 Issues)

[1] Issue:

Several commenters asked the DEA to retain the provision in the proposed rule to permit retail pharmacies to maintain collection receptacles. These commenters stated that retail pharmacies will provide a convenient option for ultimate users who desire to safely and securely dispose of their unused or unneeded controlled substances. Commenters also asked the DEA to retain the provision to permit retail pharmacies to manage collection receptacles at LTCFs.

Response:

The DEA appreciates the support for the provisions in the rule that permit retail pharmacies to manage collection receptacles at not only the primary registered location of the retail pharmacy, but also LTCFs. 21 CFR 1317.40 and 1317.80. The DEA believes that these two provisions will provide ultimate users and others with convenient options to safely and securely dispose of unused controlled substances. The DEA retained these provisions in the final rule.

[2] Issue:

Eighteen commenters asked the DEA to permit hospitals to become authorized collectors so that they may maintain collection receptacles. An additional two commenters asked the DEA to allow specialized hospitals and clinics to maintain collection receptacles. These commenters stated that collection receptacles located inside of hospitals would provide ultimate users with an opportunity to dispose of medication that may no longer be needed or may be expired.

Response:

The DEA selected methods for disposal that provide opportunities for ultimate users to securely, conveniently, and responsibly dispose of their unused, unwanted, and expired pharmaceutical controlled substances while also preventing diversion. As previously discussed, after extensive review and careful deliberation, the DEA is permitting certain registered hospitals/clinics to become authorized collectors. 21 CFR 1317.40. In order to counterbalance the diversion risks of allowing collection receptacles to be located inside hospitals/clinics, the DEA is only allowing those hospitals/clinics with on-site pharmacies to become collectors. The DEA is requiring these collectors to place collection receptacles in locations that are regularly monitored by employees, and is prohibiting these collectors from placing collection receptacles in the proximity of any area where emergency or urgent care is provided. 21 CFR 1317.75.

[3] Issue:

One commenter suggested that hospitals of a certain size be required to become authorized collectors.

Response:

The DEA is not requiring, nor is the DEA authorized to require, any entity to implement a collection program or maintain a collection receptacle. The Disposal Act explicitly states that the “regulations may not require any entity to establish or operate a delivery or disposal program.” 21 U.S.C. 822(g)(2).

[4] Issue:

It was requested that the DEA allow military treatment facility pharmacies (registered with the DEA as a hospital/clinic), and the Indian Health Service (IHS), including IHS pharmacies (IHS, Tribal, and Urban programs) to become authorized collectors. One commenter also suggested that the DEA permit collection receptacles in select areas of military installations, such as ambulatory care clinics and service member barracks.

Response:

As previously discussed, any registered hospital/clinic with an on-site pharmacy and any retail pharmacy may be authorized to be a collector. 21 CFR 1317.40. Ambulatory care clinics and service member barracks are generally not registrants. As discussed in the NPRM, the Disposal Act did not give the DEA authority to create new classes of registration solely for the purpose of conducting ultimate user disposal activities. The DEA is allowing hospitals/clinics with an on-site pharmacy and retail pharmacies to be responsible for and manage collection receptacles in non-registrant LTCFs because the Disposal Act acknowledged that LTCFs “face a distinct set of obstacles to the safe disposal of controlled substances due to the increased volume of controlled substances they handle.” 21 CFR 1317.80. LTCF residents generally have limited mobility; accordingly, this final rule authorizes LTCFs to dispose of controlled substances

on behalf of ultimate users who reside or have resided at the LTCF

. 21 CFR 1317.30. Furthermore, un-registered ambulatory care clinics and service member barracks generally lack adequate safeguards to ensure the security of collected pharmaceutical controlled substances; thus, allowing collection receptacles at such locations poses an unacceptable risk of diversion and threatens the public health and safety.

[5] Issue:

Eight commenters asked the DEA to permit non-registrants to collect non-controlled substances for the purpose of disposal.

Response:

The DEA's authority regarding drug disposal is specific to pharmaceutical controlled substances. Non-registrants may collect non-controlled substances pursuant to all applicable Federal, State, tribal, and local laws and regulations; however, all regulations and laws relevant to controlled substances will apply if controlled substances are collected, even inadvertently.

[6] Issue:

One commenter asked the DEA to permit LTCFs to become authorized collectors.

Response:

The DEA is without authority to permit LTCFs to become authorized collectors. As discussed in the NPRM, authorized collectors must first be registrants in order for the DEA to impose and enforce these regulations upon them. A majority of LTCFs do not have State authority with respect to controlled substances—a fundamental prerequisite to obtaining a DEA registration. The Disposal Act authorized the development of regulations to permit LTCFs to dispose of controlled substances on behalf of ultimate users who reside or have resided in their facilities. The DEA is permitting hospitals/clinics with an on-site pharmacy and retail pharmacies to become authorized collectors with authority to install and maintain collection receptacles at LTCFs, and declines to extend this authority to the LTCFs themselves. 21 CFR 1317.40.

[7] Issue:

Several commenters urged the DEA to create a new status that permits non-registrant organizations to become authorized collectors for the sole purpose of collecting controlled substances from ultimate users and others authorized to dispose of controlled substances on behalf of ultimate users. One commenter asked that the DEA allow non-profit, non-registrant organizations to register as authorized collectors with a reduced fee.

Response:

The DEA is not developing a new category of registrant specifically for collecting pharmaceutical controlled substances from ultimate users. Any entity that wishes to collect controlled substances from ultimate users must do so in accordance with this rule, which includes provisions for specified

existing registrant categories to modify their registration to become authorized as collectors. Any person not already registered with the DEA, wishing to become authorized as a collector must first satisfy all of the requirements for registration identified in the CSA and its implementing regulations. Non-registrant organizations may partner with law enforcement and with registrants that are collectors. 21 CFR 1317.65.

[8] Issue:

One commenter asked the DEA to clarify how a local government may register with the DEA to become an authorized collector.

Response:

As discussed above, the DEA is not creating a new registration category for the exclusive purpose of collecting controlled substances from ultimate users. Persons registered with the DEA as manufacturers, distributors, reverse distributors, NTPs, hospitals/clinics with an on-site pharmacy, or retail pharmacies may apply to modify their registration to become an authorized collector in the manner proscribed by this final rule. 21 CFR part 1301. Any person not already registered with the DEA, wishing to become authorized as a collector must first satisfy all of the requirements for registration identified in the CSA and its implementing regulations. These requirements include being authorized to handle controlled substances by the State in which the applicant is located unless exempt by statute or regulation. The DEA encourages entities that are not registrants to partner with authorized collectors or law enforcement. 21 CFR 1317.65. For example, local governments may partner with authorized mail-back collectors to provide mail-back packages to the public.

[9] Issue:

One commenter asked the DEA to clarify that no Federal or State government entity may require registrants to amend their DEA registration to become authorized collectors.

Response:

The Disposal Act specifically prohibits the DEA from requiring any entity to establish or operate a delivery or disposal program. 21 U.S.C. 822(g)(2). The prohibition does not extend to every Federal and State agency and the DEA does not have the authority to institute such a prohibition.

D. Locations Where Authorized Collectors May Maintain Collection Receptacles or Host Take-Back Events (1 Issue)

[1] Issue:

Six commenters asked the DEA to permit retail pharmacies to manage collection receptacles at establishments other than the retail pharmacy's registered location, such as community centers. Commenters stated other locations may be more convenient for ultimate users and would thus maximize participation. Two commenters asked the DEA to allow collection receptacles at unregistered locations such as permanent household hazardous waste collection sites.

Response:

The DEA acknowledges that in some locations, and under certain circumstances, alternative settings may be more convenient for ultimate users, but that is not the only consideration. The DEA believes that in order to adequately ensure the safety and welfare of the public, collection receptacles must be located inside the DEA-registered location of authorized collectors. 21 CFR part 1317.75. Authorized collectors, as registrants, are readily familiar with the security procedures and other requirements to handle controlled substances. Most publicly-accessible locations where controlled substances are not typically handled, such as community centers and hazardous waste collection sites, are not targets for theft in the same manner as those locations where pharmaceutical controlled substances are regularly handled. Thus, those locations are unlikely to be familiar with, or to have in place, the security controls necessary to ensure the security of collected substances and prevent diversion of controlled substances. However, law enforcement may continue to conduct take-back events, and other persons may partner with law enforcement to conduct such take-back events at various locations. 21 CFR 1317.65.

E. Registration Requirements for Authorized Collectors (5 Issues)

[1] Issue:

Several commenters asked the DEA to clarify whether or not registration modifications for authorized collectors may be conducted online.

Response:

Registration modifications may be conducted online. For the final rule, the DEA is modifying the text of § 1301.51 to clarify that online modifications are indeed permitted. Registrants may go to

www.DEAdiversion.usdoj.gov

to modify their registration when they start or stop collection activities.

[2] Issue:

Three commenters stated that it is overly burdensome to require authorized collectors to modify their registration each time they start or stop collection activities. These commenters asked that the DEA provide additional details regarding the registration modification process.

Response:

The DEA carefully reviewed the registration requirements and did not find indications to suggest that registration modifications will be overly burdensome. The rule requires that a registrant must apply to modify their DEA registration prior to initiating any collection activities. 21 CFR part 1301. Authorization as a collector is subject to renewal in the same manner as registration. The DEA will consider an authorized collector to be conducting collection activities until the registration is modified, revoked, surrendered, suspended, or otherwise terminated. If an authorized collector stops collection activities, he/she must modify his/her registration to indicate such. The requirement to modify a registration requires a simple written notification to the DEA. This written notification can be easily and quickly conducted online in a few minutes. 21 CFR part 1301. The registrant may go online and select the option to indicate that the registrant has ceased collecting. Registrants without ready access to the online notification method can easily and quickly communicate such information to the DEA in writing via the mail, which the DEA will process promptly upon receipt.

[3] Issue:

One commenter suggested that the DEA relax requirements for registration modifications regarding LTCF collection receptacles. This commenter was concerned that registration modifications may outpace the DEA's resources.

Response:

The DEA evaluated this request and determined that the registration requirements regarding LTCF collection receptacle management are necessary to ensure accountability and prevent diversion; the related procedures are the minimum necessary to ensure that authorized collectors maintain the receptacles in a manner that is consistent with the applicable regulations. 21 CFR part 1301.

[4] Issue:

One commenter asked the DEA to clarify whether or not an entity may apply for registration as a reverse distributor with the sole intent of providing destruction services for collected substances.

Response:

Any entity may apply for registration as a reverse distributor pursuant to and in accordance with 21 U.S.C. 822-823, and 21 CFR part 1301. Reverse distributors are not required to conduct all activities that they are authorized to perform.

[5] Issue:

Two commenters asked the DEA to clarify whether a destruction facility must be registered with the DEA.

Response:

Pursuant to this rule, a destruction facility is not required to register with the DEA simply because a

registrant utilizes that facility to destroy controlled substances in a manner consistent with this rule and all other applicable Federal, State, tribal, and local laws and regulations. At this time, the DEA does not believe it is appropriate to require these entities to be registered because the destroying registrant maintains possession and control of the substances (and therefore retains responsibility and accountability) until the substances are rendered non-retrievable. 21 CFR part 1301. All handling, monitoring, reporting, recordkeeping, and witnessing with regard to the destruction of pharmaceutical controlled substances must be performed by registrants or their employees. The DEA has omitted the language that was proposed for § 1317.15(c)(4) in order to prevent confusion.

F. Law Enforcement (7 Issues)

[1] Issue:

Several commenters asked the DEA to expand the definition of “law enforcement officer” to include law enforcement components of Federal agencies and civilian law enforcement officers.

Response:

The final rule definition is expanded from the proposed rule to specifically include officers of the law enforcement components of Federal agencies, and police officers of the Veterans Health Administration and the Department of Defense. The NPRM proposed a definition of “law enforcement officer” to include persons who are employees of a “law enforcement

agency

.” The DEA is modifying this definition in the final rule to specifically include employees of law enforcement

components

of Federal agencies. Any person who meets the criteria for “employee” and “law enforcement officer” outlined in the final rule will be a qualified officer for the purposes of disposal of pharmaceutical controlled substances, regardless of whether the person is considered a “civilian” law enforcement officer. 21 CFR part 1300.

[2] Issue:

Four commenters stated it would be overly burdensome to require law enforcement to have a collection receptacle that fits the specifications in the NPRM. These commenters stated that the collection receptacle would pose logistical issues, and that the volume of drugs collected would likely exceed the volume that the receptacle could contain. Commenters also noted that it is unnecessary to mandate that law enforcement utilize collection receptacles at take-back events.

Response:

Law enforcement are not required to have a collection receptacle that meets all of the specifications in the rule, and the text of the rule is amended to clarify that the specifications apply to authorized collectors and

not

law enforcement. The only suggested requirements for the physical construction of collection receptacles maintained by law enforcement are that they be securely placed and maintained at the law enforcement's physical location. 21 CFR 1317.35. Also, law enforcement are not required to utilize collection receptacles at take-back events. The text of the final rule states, “[e]ach take-back event should have at least one receptacle for the collection of permitted substances . . .” 21 CFR 1317.65. Thus, law enforcement should have some sort receptacle at take-back events.

[3] Issue:

Commenters expressed concern that law enforcement may not have the facilities to store the collected substances until they are shipped to a destruction facility.

Response:

The rule suggests that law enforcement store collected substances in a manner that is consistent with its standard procedures for storing illicit controlled substances. The language used in the text of the rule, “should,” is suggestive. Law enforcement are encouraged to follow the guidance in 21 CFR 1317.35; however, they are not required to do so. It should be noted that the requirements in 21 CFR 1317.65 pertaining to law enforcement presence at take-back events are mandated; however, the DEA only suggests procedures for the storage and transportation of pharmaceutical controlled substances collected at take-back events.

[4] Issue:

One commenter asked the DEA to permit entities other than law enforcement to conduct take-back events.

Response:

If an authorized collector or other entity wishes to conduct a take-back event, the event must be held in partnership with law enforcement, as provided in the rule. 21 CFR 1317.65. Take-back events are intended to be limited-duration events that may take place at an unregistered location that is easily accessible to the public, such as a community center or town center. Given the likelihood of publicity and low physical security at such locations, the DEA believes that it is imperative to ensure active law enforcement participation for the safety of the event participants and the community, as well as to help deter theft and diversion of pharmaceutical controlled substances.

[5] Issue:

Commenters urged the DEA to relax the “authorized employee” requirement for civilian law enforcement officers. These commenters stated that the DEA should treat civilian law enforcement officers as “authorized employees” for the purposes of this rule. They stated that these officers and employees currently assist with take-back events, and if they were no longer permitted to, there would be a staffing shortage to assist with take-back events. Additionally, several commenters encouraged the DEA to allow civilian law enforcement employees to handle collected substances if they meet the same requirements as an employee or handle the substances in a manner consistent with law enforcement protocols.

Response:

In the NPRM, “authorized employee” referred to those registrant personnel who would be permitted to directly participate in the disposal process. “Authorized employee” did not pertain to law enforcement officers or to take-back events. In the final rule the definition is modified, but it still only pertains to those persons who may be permitted to directly participate in the disposal process. 21 CFR part 1300. With respect to law enforcement and take-back events, as discussed above, any person who meets the criteria for “employee” and “law enforcement officer” outlined in the final rule will be a qualified officer for the purposes of disposal of pharmaceutical controlled substances, regardless of whether the person is considered a “civilian” law enforcement officer. The DEA declines to expand the law enforcement authority to specifically include civilian law enforcement employees. Only employed law enforcement officers, as defined by this final rule, may handle pharmaceutical controlled substances at take-back events. As discussed in the NPRM and previous responses to this issue, the DEA believes that this level of security is necessary to prevent theft and diversion and to ensure the safety of the public due to the highly publicized nature of take-back events and the fact that such events are likely to occur at locations with minimal security. The DEA does not believe that this requirement will hinder the success of take-back events. As previously discussed, only one law enforcement officer must oversee the take-back event, and at the discretion of the law enforcement agency or law enforcement component of a Federal agency, this officer may also be the law enforcement officer who maintains control and custody of the collected substances. 21 CFR 1317.65. There are no prohibitions against other persons assisting law enforcement officers conduct the take-back event.

[6] Issue:

One commenter asked the DEA to address what rights Military

Provost Marshal Officers have with respect to collecting controlled substances from ultimate users.

Response:

Under § 1317.35 of the new regulation, Federal law enforcement may continue to conduct take-back events and mail-back programs, and operate collection receptacles as further detailed in the regulation. If the Office of the Provost Marshal is considered “Federal law enforcement,” it would be eligible to conduct such collection activities. Federal law enforcement can, and in some cases must, appoint a law enforcement officer to oversee those activities. The appointed officer would then have the authority granted by his/her agency.

[7] Issue:

One commenter asked the DEA to clarify how law enforcement may transport and deliver collected substances to a destruction facility (i.e., whether they may ship such substances using a common carrier) and how law enforcement can comply with Department of Transportation (DOT) requirements when transporting substances that may contain hazardous materials.

Response:

The DEA has no expertise or authority to interpret or apply the DOT laws, regulations, or guidelines regarding transportation of pharmaceutical controlled substances that may constitute hazardous materials. As such, interested persons are encouraged to contact the DOT directly with their specific circumstances, and such persons can obtain more information at

www.phmsa.dot.gov/hazmat

. However, the DEA understands that the DOT's Hazardous Materials Regulations apply to entities that place hazardous materials in commercial transportation, and not government vehicles operated by government personnel solely for non-commercial purposes. If more detailed guidance is necessary, the DEA encourages law enforcement and other entities to consult the DOT for guidance on transporting collected substances that may contain hazardous materials. For additional commentary on hazardous material disposal please see comment section “Q.” entitled “Hazardous Materials Transportation and Hazardous Waste Destruction.”

G. Collection Receptacle Design, Inner Liners, Placement, and Security (24 Issues)

Clarification of Terms

[1] Issue:

One commenter noted that the DEA interchangeably used the terms “container” and “shell” when referring to the outer collection receptacle.

Response:

The DEA is modifying the final rule to consistently use the term “container” when referring to the outer portion of collection receptacles. This change is purely for stylistic consistency and makes no substantive change to the rule.

Collection Receptacle Design

[2] Issue:

The DEA specifically requested comments regarding the value of the use of a uniform symbol to be placed on collection receptacles. The DEA received 22 comments regarding the use of a uniform symbol. Five commenters supported the use of a uniform symbol, and 17 commenters opposed the use of a uniform symbol. One commenter suggested that the symbol be yellow. Four commenters noted that the use of such a symbol is unnecessary given the requirement to clearly mark and label the receptacles. Three commenters expressed concern that the use of such symbols would result in the receptacles becoming targets for diversion. One commenter was not opposed to the use of a uniform symbol but does not believe it is essential. One commenter indicated that the use of a uniform symbol should be contingent upon the location and security of the collection receptacle.

Response:

The DEA appreciates all of the comments submitted in response to this request. After careful consideration, the DEA declines to include a uniform symbol requirement in this final rule. However, the DEA may consider requiring a uniform symbol on collection receptacles after a sufficient time to observe the effects of the existing requirement to clearly mark and label collection receptacles.

[3] Issue:

Eleven commenters stated that any signage indicating what ultimate users may deposit into the collection receptacle should be in plain language. These commenters noted that most ultimate users cannot distinguish between controlled substances and non-controlled substances. Other commenters stated that no sign should be required at all, and others suggested the use of pictograms instead of words. Others raised concerns that signage will draw attention to the receptacles, thus increasing risk for theft and diversion.

Response:

The final rule does not require any specific language, design, or color choice for the display on the collection receptacle as long as the sign indicates that only schedules II-V controlled substances and non-controlled substances

are

acceptable. 21 CFR 1317.75. As explained above, comingling is permitted but not required. 21 CFR 1317.75. Plain language, pictograms, or a combination of the two, may be used, as long as it is clear that schedule I controlled substances, controlled substances not lawfully possessed by the ultimate user, and illicit or dangerous substances are not permitted to be placed in the container. The DEA believes that some notice regarding what substances may be disposed in collection receptacles is necessary in order to provide guidance to the public and to discourage the use of receptacles for disposing trash or other items. While the diversion risks presented by the requirement for signage is mitigated by physical security requirements (

e.g.,

that the receptacle be securely fastened to a permanent structure), authorized collectors should be mindful that the selected signage not transform the receptacle into a target for theft or diversion.

[4] Issue:

Four commenters suggested that the collection receptacle sign encourage ultimate users to remove medication from its container before placing the medication in the collection receptacle. Several of the commenters who had participated in authorized pharmaceutical controlled substance take-back programs noted that the packaging for medication is voluminous, and that including such packaging will be burdensome since it will necessitate changing inner liners more frequently.

Response:

The DEA appreciates these commenters' concerns. Although collectors may encourage ultimate users to remove substances from their containers before depositing them into a collection receptacle or mail-back package, the DEA declines to require it. The DEA has declined to mandate whether substances must be disposed of, with or without packaging, because such requirements would not necessarily affect security or increase the risks of diversion, and as such, should be left to the individual collectors and other relevant authorities who best know the needs and requirements of their programs and locations.

[5] Issue:

Other commenters indicated that some hazardous waste disposal regulations require the disposal of medication containers, which may not fit into the receptacles.

Response:

As discussed in the immediately preceding comment, the DEA is neither requiring nor prohibiting medication containers to be disposed of with pharmaceutical controlled substances. Moreover, there is no indication that the vast majority of medications will not fit into the “small opening” that the collection receptacles specifications require. For additional commentary on hazardous waste

disposal please see comment section “Q.”, entitled “Hazardous Materials Transportation and Hazardous Waste Destruction.”

[6] Issue:

The DEA received comments that the inner liner should be a large plastic tub or bucket within a receptacle that can be easily removed and the collected items either dumped into smaller containers or sorted before being secured into storage for disposal or prior to destruction.

Response:

The DEA carefully considered the specifications of both the inner liner and the outer container of the collection receptacle. To prevent diversion and protect the public health and safety, the DEA drafted this rule with the precisely considered objective of limiting the number of people who handle the collected substances. The DEA's extensive experiences in regulating and enforcing the closed system of distribution established by the CSA have demonstrated that a key factor in reducing diversion risk is limiting the handling of controlled substances. In the context of disposal, this means prohibiting the sorting of collected substances once they are deposited into a collection receptacle.

[7] Issue:

One commenter stated that the collection receptacle design specifications will require current collection programs for non-controlled substances to install new collection receptacles if those programs wish to additionally collect pharmaceutical controlled substances. This commenter stated that such installations will be burdensome and will discourage participation for these programs.

Response:

The DEA deeply appreciates the concern and activism of local communities and other groups currently conducting non-controlled substance drug take-back programs and their wish to expand collection activities to pharmaceutical controlled substances. Programs such as these are an important and vital component of the communities they serve. The DEA understands that publication of this final rule may necessitate the need for some programs to implement new procedures and install new equipment in order to additionally collect pharmaceutical controlled substances. The DEA has not established the new requirements lightly or without considerable deliberation as to its impacts on existing programs. However, the risk of diversion for non-controlled substances is relatively low compared to the much higher risk of diversion, and the corresponding and associated risks to public health and safety, for pharmaceutical controlled substances. The DEA has been charged by Congress with the enforcement of the controlled substance laws of the United States, and must ensure that pharmaceutical controlled substances are properly secured and not easily susceptible to theft or diversion. Accordingly, the collection receptacle design specifications outlined in § 1317.75 will be implemented as proposed.

[8] Issue:

A commenter asked the DEA to permit the use of similar receptacles that may already exist and were designed for the deposit and storage of medical waste.

Response:

The DEA is not prohibiting the use of collection receptacles that currently exist on the market as long as such receptacles meet all of the design specifications outlined in § 1317.75 of this rule.

[9] Issue:

Five commenters stated that the requirement for a collection receptacle to be fastened to a permanent structure is burdensome. Several commenters pointed out that many pharmacies do not own the property that is their DEA-registered location, and such fixtures and installments are prohibited. One commenter pointed out that this requirement would be particularly burdensome for small, rural pharmacies. Another commenter asked if the requirement applies if the collection receptacle is located in a locked room, inaccessible to the public.

Response:

The DEA appreciates the willingness of pharmacies to aid in the societal goal of helping to combat unauthorized access to and abuse of pharmaceutical controlled substances. The DEA understands that there may be logistical concerns for some retail pharmacies that wish to maintain a collection receptacle at their registered location. However, the DEA believes that permanently-secured, fixed containers are the minimum required to prevent diversion and theft of collected substances. The requirement that collection receptacles be securely fastened to a permanent structure applies to all authorized collectors' collection receptacles, no matter the location of the registrant. 21 CFR 1317.75. Although the final rule does not expressly prohibit collection receptacles from being placed in a locked room that is inaccessible to the public, the final rule does mandate that collection receptacles at authorized collectors' registered locations must be accessible to ultimate users, and others authorized to dispose of controlled substances on behalf of ultimate users, as they are the only people who may deposit pharmaceutical controlled substances into a collection receptacle (e.g., ultimate users cannot transfer pharmaceutical controlled substances to pharmacy staff). 21 CFR 1317.30. The DEA encourages retail pharmacies leasing their commercial space to work with their landlords to allow for the installation of collection receptacles under the conditions established by this rule.

[10] Issue:

Nine commenters stated that requiring an outer container with an inner liner is unnecessary and burdensome. These commenters proposed that the collection receptacle be designed in such a way that it can be returned to the reverse distributor as a complete unit.

Response:

The DEA appreciates the value in utilizing temporarily secured containers that can be sealed and shipped for destruction; however, the DEA believes that such systems present an unreasonable risk of diversion because, even when secured, such containers can be relatively easily removed when compared to a securely fastened and locked outer container. Relatedly, the DEA is requiring that collection receptacles be “substantially constructed,” which is intended to ensure that the construction is such that unauthorized access to the contents of the receptacle is not easily obtained. 21 CFR 1317.75. Accordingly, the DEA is requiring that collection receptacles have a substantially-constructed outer container and removable inner liners. 21 CFR 1317.60 and 1317.75.

[11] Issue:

Three commenters stated that the collection receptacle should not be required to have a traditional lock, but that its opening be designed so that that the contents cannot be removed.

Response:

In implementing the Disposal Act to provide secure and responsible disposal methods for pharmaceutical controlled substances by ultimate users, the DEA must ensure that collected substances are properly secured and not easily susceptible to theft or diversion. The requirements pertaining to collection receptacles were carefully considered and designed to limit the handling of the controlled substances, from ultimate user to destruction. These considerations dictated the size of the opening. However, the NPRM and the final rule allow for flexibility regarding a traditional lock, and require that “the small opening in the outer container of the collection receptacle shall be locked

or made otherwise inaccessible to the public

when an employee is not present (e.g., when the pharmacy is closed).” 21 CFR 1317.75(f).

[12] Issue:

One commenter suggested that the DEA conduct a national pilot program prior to implementation of the final rule to ensure that collection

receptacle requirements are feasible and effective.

Response:

The DEA believes that the need to implement this rule in order to allow secure convenient options for disposal outweighs the delay and limited benefit that may be obtained by implementing any pilot programs or other testing or research. Through various outreach efforts, including the public meeting the DEA held in January 2011, comments from industry, and information obtained from pilot programs, the DEA believes that it has effectively researched and analyzed the various aspects of this rule. Also, the DEA believes that implementation of this rule is important to helping reduce the amount of unwanted pharmaceutical controlled substances available for theft, diversion, and accidental ingestion.

[13] Issue:

One commenter asked the DEA to allow a Special Agent in Charge (SAC) to approve container and inner liner designs.

Response:

As discussed in the NPRM, the DEA determined that the elimination of individual SAC approval for various aspects of disposal or destruction is necessary in order to ensure clear and consistent requirements throughout the United States, thus reducing the potential for confusion regarding requirements for ultimate users and authorized collectors. Specific approval of individual collection receptacles and inner liner designs is not required. All collection receptacles and inner liner designs must meet the specifications outlined in this final rule. 21 CFR 1317.60 and 1317.75.

[14] Issue:

One commenter suggested that national pharmacy organizations educate the public on proper disposal methods and various disposal options. This commenter suggested that such organizations post information online and disseminate leaflets at retail establishments.

Response:

With regard to patient information regarding disposal, the DEA is not requiring any entity to educate the public on proper disposal methods and their various disposal options. However, the DEA anticipates that many entities will voluntarily choose to do so. The DEA applauds and encourages voluntary, educational outreach to the public on issues related to the abuse potential and proper disposal of pharmaceutical controlled substances, whether it be through law enforcement, community groups, or professional organizations.

Collection Receptacle Inner Liners

[15] Issue:

Several commenters asked for clarification regarding inner liner tracking requirements. Specifically, commenters asked how unique identification numbers should be assigned, how tracking systems are to be implemented, and what entity will be responsible for placing identification numbers on inner liners. One commenter suggested that the DEA regulate the manufacture of inner liners or require that inner liners be sequentially numbered.

Response:

The rule outlines the design requirements and the recordkeeping requirements for inner liners. The purpose of a unique identification number is to provide for complete and accurate records that can be inventoried to ensure that each liner is accounted for from receipt, to installation, removal, storage, transfer, and destruction. 21 CFR part 1304. The unique identification numbers therefore must be unique to the individual collector. 21 CFR 1317.60. The DEA does not intend to require any particular method for assigning such numbers and is modifying the text of proposed § 1317.60(e) by indicating that only inner liners must bear a permanent, unique identification number. The company manufacturing the inner liners may assign the numbers. The DEA does not have authority to directly regulate the manufacturers of the inner liners.

[16] Issue:

One commenter suggested that the inner liner be clear so that it can be visually inspected for non-compliant items.

Response:

Due to associated increased risks for diversion, the DEA determined that the contents of the inner liners must not be viewable once the inner liner is sealed. 21 CFR 1317.60. The DEA appreciates the concerns regarding certain non-compliant items being placed in collection receptacles; however, for reasons discussed in previous comments, no one is permitted to handle the contents of inner liners. 21 CFR 1317.75. The DEA would like to point out that the text of the rule does not prohibit items from being observed

prior

to being placed in the collection receptacle, which could be an effective way to ensure that such non-compliant items are not placed in the collection receptacle.

[17] Issue:

Several commenters indicated that the requirement to store sealed inner liners in the same manner as schedule II controlled substances will be overly burdensome and will reduce the amount of space available for storing schedule II inventory at retail pharmacies. These commenters suggested that the DEA allow the authorized collector to transfer collected substances in inner liners to a secure warehouse facility for storage until they can be picked up or shipped.

Response:

The DEA appreciates these concerns but declines to permit authorized collectors to transfer collected substances to warehouse facilities for storage. Filled inner liners must be stored only at primary registered locations (and at LTCFs in accordance with § 1317.80(c)) and may not be transported to off-site warehouses. The basis for this requirement is that the risk of diversion increases each time inner liners change hands or are transported. However, as previously discussed, this final rule expands the NPRM requirement and authorizes practitioners to store collected substances at their registered location in either a securely locked, substantially constructed cabinet or a securely locked room with controlled access. 21 CFR 1317.05.

[18] Issue:

Four commenters stated that the DEA should permit schedule I controlled substances to be disposed of via collection receptacles, mail-back packages, or take-back events.

Response:

The Disposal Act addresses the issue of unused prescription drugs, and it allows the DEA to provide ultimate users with a secure and responsible method to dispose of pharmaceutical controlled substances. This rule does not address the disposal of illicit controlled substances,

e.g.,

those substances controlled in schedule I of the CSA. Schedule I controlled substances, by definition, have no accepted medical use in treatment in the United States, and may not be lawfully prescribed or otherwise distributed to any person. In fact, any transfer of a schedule I controlled substance by an ultimate user is a violation of the CSA, unless the ultimate user is participating in an investigational use of drugs pursuant to 21 U.S.C. 355(i) and 360b(j), and the delivery is conducted in accordance with 21 CFR 1317.85.

Collection Receptacle Placement and Safety

[19] Issue:

Ten commenters expressed concern regarding security in retail pharmacies with collection receptacles. Several commenters asked the DEA to provide guidance for proper security measures. One commenter asked for clarification on an authorized collector's liability should a receptacle become subject to diversion or if improper substances are deposited.

Response:

The DEA appreciates the concerns of the commenters and has carefully considered the risks and benefits associated with collection receptacles located in authorized retail pharmacies. The DEA's rationale for

allowing collection at authorized retail pharmacies was described in the NPRM. As previously noted, the DEA is not requiring any pharmacy to provide a collection receptacle. Each registrant is free to weigh the risks and benefits in determining whether or not to seek status as an authorized collector. The DEA proposed the rule with the security requirement for permanently-secured, fixed containers based on a determination that this was the minimum required to help reduce the risk of diversion and theft of pharmaceutical controlled substances. 21 CFR 1317.75. At retail pharmacies, the location of collection receptacles within the immediate proximity of a designated area where controlled substances are stored and at which an employee is present is anticipated to provide an additional layer of security due to the increased visibility of the receptacles. 21 CFR 1317.75. While potential violations of the CSA and its implementing regulations are investigated and assessed independently, this final rule imposes the minimum required procedures to prevent and detect diversion. Even so, each authorized collector's circumstances are unique. All registrants should be mindful of their responsibility to provide effective controls and procedures to guard against theft and diversion under 21 CFR 1301.71(a), and their duty to report thefts and significant losses of controlled substances under 21 CFR 1301.74 and 1301.76.

[20] Issue:

One commenter suggested that the inner liners be nondescript and free of any markings that would indicate their contents. This commenter was concerned that any markings on the inner liners would increase diversion risks and make them potential targets for drug seekers.

Response:

The DEA appreciates the commenter's concern for potential diversion risks that inner liners might pose, and made the determination to require them only after careful consideration of the associated risks and benefits of their use, and alternatives to their use. The DEA is requiring the size of the inner liner to be clearly marked on the outside of the liner, and for the inner liner to bear a unique identification number in order to help ensure accountability, and to identify and prevent diversion. 21 CFR 1317.60. Given the totality of information reviewed, the DEA concluded that a requirement for the contents to be non-viewable once the inner liner is sealed will help reduce diversion risks and deter drug seekers.

[21] Issue:

One commenter stated that requiring contents of the inner liner to be non-viewable could lead to diversion as staff could record controlled substances as being disposed of without actually placing them into the receptacle.

Response:

The rule prohibits authorized collectors' staff from handling collected substances, even for the purpose of depositing them into the collection receptacle. Ultimate users, and those who are authorized to handle controlled substances on behalf of ultimate users for the purpose of disposal, are the only persons who may deposit pharmaceutical controlled substances into a collection receptacle. 21 CFR 1317.30. Therefore, the DEA does not envision a circumstance where pharmaceutical controlled substances might be recorded as having been disposed of, but were in actuality diverted as a result of pharmacy staff never having placed the substances into the collection receptacle.

[22] Issue:

One commenter indicated that the use of an inner liner that is removable and sealable immediately upon removal without emptying or touching the contents is impractical because the contents may spill or fall out and then must be handled.

Response:

The DEA carefully considered the design and security requirements for inner liners and determined that the collection receptacle option will help to minimize the risk of diversion while ensuring safety and convenience for ultimate users and collectors. As discussed in the NPRM, inner liners that allow opportunities for collectors to sort or otherwise handle the collected substances would decrease security and increase the risk of diversion. The DEA does not believe that overfill or spillage from the inner liners will be a concern as the requirement that inner liners fit within the outer container of the collection receptacle is designed to prevent such occurrences. However, security requirements, such as the presence of two employees to remove or supervise the removal of an inner liner, help reduce the risk of theft and diversion if such instances do occur. 21 CFR 1304.22, 1317.60, and 1317.75. If spillage occurs, a registrant's responsibility to provide effective controls and procedures to guard against theft and diversion of controlled substances would require the registrant to take corrective action to prevent spillage from recurring.

[23] Issue:

Several commenters asked the DEA to identify the maximum allowable capacity for a receptacle and the maximum duration that controlled substances may be stored in the receptacle.

Response:

There is no maximum or minimum capacity for collection receptacles at this time. Although there is no maximum duration that the collected substances may remain in the collection receptacle at this time, authorized collectors are reminded of their responsibility to provide effective controls and procedures to guard against theft and diversion, 21 CFR 1301.71(a), and their duty to report thefts and significant losses of controlled substances under 21 CFR 1301.74 and 1301.76.

[24] Issue:

Several commenters asked the DEA to allow “disposal companies,” distributors, and reverse distributors to manage and maintain collection receptacles at the registered locations of authorized collector retail pharmacies and at LTCFs on behalf of the authorized collector retail pharmacies. These commenters also asked if such entities may establish a fee system for such services.

Response:

Distributors and reverse distributors will not be permitted to manage or maintain collection receptacles at retail pharmacies or LTCFs. 21 CFR 1317.40 and 1317.80. The DEA determined that no entities other than retail pharmacies and hospitals/clinics with an on-site pharmacy will be permitted to manage collection receptacles at LTCFs. 21 CFR 1317.40 and 1317.80. As discussed in the NPRM, this rule establishes a checked system of transfers where each registrant who handles collected substances serves as a source of verification for the other registrants that handle the same substances, thus ensuring that the collected substances reach their intended destination with accountability and a reduced risk of diversion. In order to maintain this system, all collected substances must be handled in the manner described in this rule, including the requirement that the handling of a collection receptacle inner liner be restricted to employees of the authorized collector as provided, with the limited exception for LTCFs. 21 CFR 1317.80. Such requirements ensure that persons handling collected substances during the disposal process are accountable to their employer, and the number of entities handling the collected substances is reduced while also providing a secure system of checks that increases the level of accountability.

H. Mail-Back Programs (11 Issues)

[1] Issue:

Thirteen commenters stated that the on-site destruction requirement for mail-back programs is severely

limiting due to the limited number of commercial incinerators. These commenters urged the DEA to allow collectors to receive mail-back packages whether or not they have a means of on-site destruction. Several commenters also asked the DEA to allow collectors to use a third party to destroy mail-back packages.

Response:

As discussed in the NPRM, an on-site method of destruction for mail-back packages is the minimum necessary to prevent diversion of controlled substances destined for destruction. 21 CFR 1317.05. Importantly, an on-site method of destruction reduces the accumulation of controlled substances in a single location, and minimizes the transfer of controlled substances between various locations. This is intended to help minimize the risk of diversion. For each of the three methods of ultimate user disposal included in this rule, the DEA has attempted to minimize the number of entities that handle the collected substances in order to minimize the risk of diversion, which increases each time a controlled substance is transferred to a new person. It is emphasized that authorized collectors may partner with reverse distributors and other authorized registrants with on-site methods of destruction to promote mail-back programs, e.g., empty mail-back packages may be disseminated at hospitals/clinics and retail pharmacies and mailed back to a reverse distributor with an on-site method of destruction.

[2] Issue:

One commenter strongly supports the requirement that authorized collectors who conduct a mail-back program use an on-site method of destruction; however, other commenters expressed concern that the requirement would discourage authorized collectors from conducting mail-back programs. Several commenters noted that very few destruction facilities currently exist and there was concern that such facilities do not have proper security to handle controlled substances.

Response:

As indicated in the previous response, mail-back programs have the potential to provide a secure and responsible means of disposal without geographical restriction within the United States. As such, the existence of a small number of appropriate destruction sites should not impact ultimate users' ability to participate or the potential for mail-back programs to develop. In other words, a single destruction site can support many different mail-back programs and an unlimited number of mail-back packages may be provided to ultimate users at various locations throughout the United States to be mailed back to a single destruction site. Also, as discussed in the NPRM, the DEA hopes that the rule will encourage innovation and expansion of destruction methods beyond incineration so that additional entities may provide destruction services for mail-back programs in the future.

[3] Issue:

A few commenters expressed concern that no entities will undertake the implementation of a mail-back program because of the related expense, noting that the requirement that mail-back packages be pre-addressed with pre-paid postage will be very costly. A commenter also asked the DEA to clarify whether unregistered retail pharmacies working with a registered authorized collector would be permitted to make mail-back packages available to patients.

Response:

As discussed in the NPRM, authorized collectors who conduct mail-back programs are encouraged to collaborate to operate mail-back programs by partnering with other entities to assist with the dissemination of mail-back packages to ultimate users, in order to minimize costs. Additionally, pre-paid postage will ensure that the package is not returned to sender, which will help reduce its handling and therefore, the diversion risks. Pre-addressed envelopes will help ensure that the package is delivered to the authorized location.

[4] Issue:

One commenter asked the DEA to clarify whether there are specific testing requirements in regard to the packaging standards (e.g., water/spill proof, tear resistant, sealable, etc.). One commenter asked the DEA to clarify the distinction between packages damaged as part of normal transport and packages damaged by other means, such as tampering.

Response:

The DEA is not requiring specific testing requirements to ensure packages meet the standards provided in § 1317.70 (e.g., water/spill proof, tear resistant, sealable, etc.). However, the packages must be consistent with these standards. Collectors authorized to receive mail-back packages must make a determination based on the facts and circumstances as to whether or not an apparently damaged package became so through normal transportation or through tampering or other intentional means.

[5] Issue:

Commenters expressed concern that the requirement for mail-back collectors to issue mail-back packages with unique identification numbers is burdensome and does not seem to provide any useful information since ultimate users are not required to notify collectors that they have mailed a package, and it is likely that many packages will not be used. Five commenters asked the DEA to explicitly state that authorized collectors who conduct mail-back programs will not be responsible for reconciling mail-back packages that were never returned.

Response:

The DEA believes that recording the unique identification numbers of mail-back packages in accordance with § 1317.70 is a reasonable recordkeeping requirement designed to help identify and prevent diversion; this information can aid investigations and is useful for that purpose alone. The DEA recognizes that disseminated packages may go unused, and this alone should not form the basis for unreasonable scrutiny of authorized collectors. Additionally, at this time, authorized collectors are not responsible for tracking mail-back packages that were disseminated but never returned.

[6] Issue:

One commenter disagreed with the DEA's assessment that mail-back programs are more susceptible to diversion and therefore require stricter controls.

Response:

The DEA carefully considered the diversion risks in mail-back programs. Based on the DEA's experience, the DEA believes that the risks of diversion associated with mail-back programs are great because of necessary actions including the handling of the packages, mail sorting, and mail delivery by non-registrants. The DEA believes that the security measures established by this rule are the minimum required to reduce the risk of diversion inherent to mail-back programs.

[7] Issue:

One commenter expressed concern that mail-back packages would be subject to greater risks of diversion in rural areas.

Response:

The DEA appreciates the commenter's concern. The DEA has considered the diversion risks for mail-back programs, including packages originating in rural areas. It may be true that mail-back packages originating in some rural areas may be subject to an increased risk of diversion due to fewer people being able to readily witness theft from a mailbox. However, it may also be true that risks of diversion from mail-back programs might be lower in rural areas due to less traffic (pedestrian, vehicular, or equine), resulting in fewer opportunities for tampering with or theft of mail-back packages. Regardless, the DEA believes that the relative risks of diversion of mail-back packages in rural areas are mitigated by the required security procedures and are outweighed by the benefits of providing ultimate users a means to dispose of unused, unwanted,

or expired pharmaceutical controlled substances.

[8] Issue:

The United States Postal Service (USPS) has raised a number of issues relating specifically to the mail-back program, and also to the disposal regulations in general. The USPS asked the DEA to make several changes to the terminology used in the proposed rule, so that the DEA regulations will be consistent with standard USPS products and services. The USPS also requested that the DEA clarify that all registrants must comply with USPS laws and regulations, including applicable USPS requirements for packaging and mailing pharmaceuticals.

The USPS asked the DEA to consistently refer to “mail-back packages” as “mailing packages” rather than “mailers” as the USPS refers to “mailers” as persons or entities entering a mailing. The USPS also asked the DEA to remove any references to “business reply mail” that are inconsistent with the USPS's use of the term. The USPS asked that proposed § 1317.85 specify that ultimate users may return recalled controlled substances to the manufacturer or other authorized registrant by U.S. Mail. The USPS also asked the DEA to clarify that inner liners are requirements for collection receptacles—not mail-back packages.

The USPS also requested that the DEA state that collectors operating a mail-back program must exclusively use the United States Postal Service. The USPS also asked the DEA to make all references to “mail system” in the preamble refer exclusively to the United States Postal Service. The USPS asked that they not be prohibited from transporting controlled substances to a reverse distributor on behalf of law enforcement, especially in light of the fact that law enforcement may operate mail-back programs.

Response:

The DEA appreciates the time taken by the USPS to review the proposed rule and submit thoughtful comments with their concerns and suggestions. In addition, the DEA acknowledges that the USPS understands these regulations and has experience responsibly handling controlled substances. The DEA is modifying some of the terminology that was used in the NPRM, per the USPS's concerns and suggestions. Rather than use the term “mailing packages,” all references to “mailers” are changed to “mail-back packages.” The DEA believes this will better avoid the confusion regarding “mailers” being defined as persons or entities that enter a “mailing.” The reference to “business reply mail” is also removed. The DEA declines to specify that “mail” or “mail system” refers exclusively to the USPS; however, the USPS is a shipping option.

Additionally, in § 1317.85, ultimate users still have the options to return a recalled controlled substance as is currently allowed under § 1307.12 of the existing regulations. The text of the rule clearly states that all persons and entities must comply with applicable Federal laws and regulations, which includes USPS laws and regulations. Also, inner liners are requirements for collection receptacles—not mail-back packages. The mail-back package specifications are outlined in § 1317.70.

While the USPS asked that the text of the regulation specifically state that mail-back packages may be sent via the U.S. Postal Service as well as by common or contract carrier, the DEA declines to make this change. The DEA considers the USPS to be a common or contract carrier for purposes of the CSA.

[9] Issue:

One commenter asked the DEA to clarify whether the regulation that requires mail-back programs to include only mail-back packages mailed from within the United States will preclude USPS-serviced mail-back programs in any of the areas in which it operates (e.g., the Caribbean District, other territories such as Guam, and United States military installations).

Response:

The term “import” means “any bringing in or introduction of” a controlled substance into any area. Pursuant to 21 U.S.C. 952, it is unlawful to import controlled substances into the customs territory of the United States (the 50 States, the District of Columbia, and Puerto Rico), except under specific circumstances not relevant to ultimate user disposal. Thus, an ultimate user located outside of the customs territory of the United States is not permitted to send a mail-back package into the customs territory of the United States.

[10] Issue:

One commenter asked the DEA to clarify whether authorized collectors operating mail-back programs may use carrier services that allow packages to be held at a carrier facility until the packages can be picked up.

Response:

Although some changes to business operations may need to occur in order for an authorized collector to effectively establish and maintain a mail-back program, the requirements established by this rule are the minimum required to detect and prevent diversion. As described in this rule, mail-back packages must be pre-addressed to the authorized mail-back location with the on-site destruction method, and thus, the packages must be delivered to the authorized mail-back location rather than picked up by the collector. 21 CFR 1317.70. The pre-addressed delivery location must be capable of receiving such deliveries on a regular basis without interruption. Otherwise, the opportunities for diversion increase as the packages are delayed or stored during transit.

[11] Issue:

One commenter suggested that the DEA establish a national mail-back program.

Response:

This rule authorizes certain collectors to conduct mail-back programs. 21 CFR 1317.40 and 1317.70. There is no limitation regarding the geographic coverage of mail-back programs within the United States if the programs comply with all applicable Federal, State, tribal, and local laws and regulations. At this time, the DEA does not have the resources to operate a national mail-back program.

I. Take-Back Events (6 Issues)

[1] Issue:

One commenter indicated it would be difficult for ultimate users to participate in take-back events, particularly in rural areas.

Response:

The DEA has attempted to expand the variety of disposal options while also ensuring secure and responsible drug disposal, and the DEA anticipates that the expansion to include certain hospitals/clinics to become authorized as collectors will provide more disposal options for ultimate users, including those in rural areas. Additionally, the DEA encourages those persons living in rural areas who are unable to utilize a collection receptacle or attend a take-back event to dispose of unwanted pharmaceutical controlled substances in the same manner in which the pharmaceutical controlled substances were received, i.e., if the substances were delivered by a mail-order pharmacy, the DEA encourages the pharmacy to include a mail-back package for safe disposal; or, if the substances were dispensed at a pharmacy, the DEA encourages pharmacies to have a collection receptacle available for safe disposal. Nonetheless, the DEA recognizes that some ultimate users may not have convenient access to any of the disposal options available in this rule. Until the availability of these disposal options increases, ultimate users who wish to dispose of unwanted pharmaceutical controlled substances may continue to dispose of them in manners consistent with all applicable Federal, State, tribal, and local laws and regulations. The DEA's Office of Diversion Control Web site provides information regarding safe disposal of pharmaceutical controlled substances, including guidance from the FDA and the EPA. Ultimate users can find this information at

www.DEAdiversion.usdoj.gov

.

[2] Issue:

Several people asked the DEA to clarify the role of law enforcement at take-back events. One commenter asked the DEA to relax the two-employee requirement for law enforcement officers handling collected substances. Another commenter stated that law enforcement officer supervision, rather than direct participation, should suffice.

Response:

Law enforcement must appoint at least one law enforcement officer employed by the agency to oversee collection at the take-back event. 21 CFR 1317.65. “Oversee” has its common, everyday meaning: To supervise, manage, watch over, and direct in an official capacity. The direct participation this rule mandates is that a law enforcement officer must maintain custody and control of the collected substances from the time they are collected to the point in time that they are securely transferred, stored, or destroyed. 21 CFR 1317.65. This rule does not require two law enforcement officers to be present at take-back events; however, law enforcement may determine that two or more law enforcement officers are necessary at a particular take-back event due to safety and security concerns. In the alternative, law enforcement may determine that the same law enforcement officer may oversee the take back event and also maintain custody and control 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, storage, or destruction has occurred, as outlined in § 1317.65(b). Although the participation of law enforcement is required at take-back events, the DEA is not requiring law enforcement to hold or participate in take-back events. As discussed in the NPRM, law enforcement must determine how often available resources allow them to hold take-back events.

[3] Issue:

A few commenters requested that the DEA allow other authorized collectors, such as retail pharmacies and reverse distributors, to become authorized to hold take-back events. One commenter stated that law enforcement officers' presence should be optional if there is a collection receptacle at the event that meets the specifications in the rule.

Response:

If an authorized collector or other entity wishes to conduct a take-back event, the event must be held in partnership with law enforcement. 21 CFR 1317.65. Take-back events are intended to be limited-duration events that may take place at an unsecure location that is easily accessible to the public, such as a community center or town center. Given the likelihood of publicity and limited physical security at such locations, the DEA believes that it is important to ensure active law enforcement participation for the safety of the event participants and the community. The DEA believes that active law enforcement participation will help deter theft and reduce diversion risks. The presence of a collection receptacle at a take-back event does not preclude the need for law enforcement presence at the collection site because the publicity for the event increases the receptacle's visibility for drug seekers, thus increasing diversion risks.

[4] Issue:

A number of entities expressed concern that the implementation of this rule will result in the cessation of DEA-sponsored national take-back events. These commenters felt that take-back events will be too costly for communities and law enforcement, and commenters suggested that the DEA continue take-back events and provide a transition plan from the national take-back events until implementation of the rule.

Response:

The DEA-sponsored national take-back events were initiated as a means of providing safe and convenient disposal of pharmaceutical controlled substances by ultimate users until alternative options could be implemented. The DEA is committed to continuing national take-back events until the effective date of this final rule. The DEA believes that implementation of disposal methods is best tailored to local communities by local communities. The DEA encourages public and private partnerships to optimize the expanded disposal options in a cost-efficient manner.

[5] Issue:

One commenter expressed concern that existing take-back events would likely be unable to continue under this rule. This commenter was concerned that the prohibition of sorting would cause a burden since non-controlled substances and packaging could not be sorted from controlled substances. This commenter stated that it will be overly burdensome for programs to handle all collected substances as schedule II controlled substances.

Response:

The DEA does not intend for this rule to require changes to existing non-controlled substance take-back programs. The security measures required by this rule are the minimum necessary to ensure a safe and secure means of disposal of pharmaceutical controlled substances. It should be noted however, that law enforcement are not required to follow the physical security requirements for handling, sorting, or storing collected controlled substances. 21 CFR 1317.35. The physical security requirements applicable to law enforcement in the final rule at §§ 1317.35 and 1317.65 state that law enforcement “should” take certain measures; and that law enforcement “shall” appoint a law enforcement officer to oversee a take-back event and law enforcement officers “shall” maintain custody and control of the collected substances. Additionally, this rule provides a number of previously unavailable means of ultimate user disposal that are likely to decrease the frequency of and need for community take-back events. The DEA would like to clarify that comingling of controlled and non-controlled substances is permitted, but not required, and co-sponsors of take-back events may specify that only controlled substances will be accepted. Another method to alleviate the burdens would be to provide a separate receptacle for non-controlled substances at the take-back event. Additionally, as discussed in response to previous comments, this rule does not require that collected substances be in their original packaging, and law enforcement may discourage or prohibit ultimate users from disposing of original packaging into the collection receptacle for controlled substances at take back-events.

[6] Issue:

One commenter indicated that municipalities and other organizations should be permitted to “take the lead” in organizing and conducting take-back events in conjunction with, and in the presence of, law enforcement. Other commenters raised concerns that such events conducted in partnership with local government and community groups would no longer be allowed, and that the requirements would prevent controlled substance take-back events from being held concurrently with other take-back events, such as for the disposal of hazardous waste and non-controlled substances.

Response:

The rule permits any entity to partner with law enforcement to hold a pharmaceutical controlled substances take-back event. 21 CFR 1317.65(a). Municipalities or other organizations may partner with law enforcement as long as such events are conducted in accordance with all applicable laws and regulations pertaining to the disposal of pharmaceutical controlled substances. The DEA emphasizes that take-back events are intended to be one-time or periodic events held in a community center or other convenient and accessible location, and that there is no

prohibition against holding such events in conjunction with events for the disposal of other substances, such as hazardous waste or non-controlled pharmaceuticals.

J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents and Mail-Back Package Contents (8 Issues)

[1] Issue:

One commenter adamantly stated that collected substances should not be sorted under any circumstances. This commenter expressed concerns about diversion risks and the brokering of unused controlled substances.

Response:

The DEA agrees that the diversion risks of handling, sorting, or inventorying collected substances outweigh any perceived benefits. The DEA has carefully considered all of the various commenters' concerns on the prohibition of handling, sorting, and inventorying inner liner contents and mail-back package contents, and will retain these prohibitions. As provided in §§ 1317.60(c) and 1317.70(f), inner liners shall be sealed

immediately

upon removal from the permanent outer container; sealed inner liners and returned mail-back packages shall not be opened, x-rayed, analyzed, or otherwise penetrated. Accordingly, their contents shall not be sorted or inventoried subsequent to being placed into a collection receptacle or mail-back package. To clarify this, § 1317.75(c) was modified to add the prohibition against individually handling substances after they have been deposited into a collection receptacle. These specific security measures are designed to help prevent and reduce the opportunities for diversion (including the re-introduction of tainted pharmaceutical controlled substances into the stream of commerce).

[2] Issue:

Twenty-four commenters stated that pharmacists and other volunteers should be permitted to sort collected substances, particularly in the presence of law enforcement officers at take-back events. One commenter stated that the DEA should recognize the accountability, expertise, and experience of healthcare professionals, and the DEA should utilize these experts in an effort to broaden medication disposal efforts.

Response:

The DEA appreciates the valuable expertise and experience of healthcare professionals, including pharmacists. The DEA has carefully considered the comments in response to the NPRM, and the remarks at the January 2011 public meeting. The DEA believes that the disposal methods outlined in this rule will provide ultimate users and their authorized representatives with expanded options to safely and securely dispose of unwanted, unused, and expired pharmaceutical controlled substances. Pursuant to § 1317.65, law enforcement may continue to conduct take-back events when a law enforcement officer maintains control and custody of collected substances at take-back events and only the ultimate user transfers controlled substances to law enforcement control and custody. However, non-law enforcement personnel may assist the law enforcement officer, and the final rule does not prohibit healthcare professionals from voluntarily polling ultimate users about the substances they are discarding or from assisting ultimate users to separate pharmaceutical controlled substances from non-controlled substances during the disposal process, and inventorying the non-controlled substances.

Furthermore, nothing in this rule prohibits law enforcement from partnering with authorized collectors or other entities to inventory or sort substances that have been collected by law enforcement provided that the collected substances remain under the control and custody of law enforcement. This final rule in § 1317.65(b) requires that law enforcement maintain control and custody of the collected substances from the time the substances are collected until secure transfer, storage, and destruction has occurred. Therefore, if law enforcement opts to inventory or sort collected substances within their possession, law enforcement should provide adequate security to prevent diversion or theft of controlled substances within their possession and control as a result of, or during, inventorying or sorting.

[3] Issue:

Thirty-eight commenters stated that the DEA should permit collectors or certain non-registered persons to handle, sort, and inventory collected substances for data collection and research purposes. Many of these commenters urged the DEA to provide an exception to allow pharmacists and volunteers to inventory and sort controlled substances under the supervision of law enforcement officers. Numerous commenters stated that inventorying collected substances is crucial to determining a root cause analysis of medication waste. Others stated that such information could help guide prescribing practices and be used in educational settings. Several commenters stated that inventorying collected substances is necessary to determine outcome measures for grants for disposal programs. Also, several commenters stated that the DEA should provide an exception for Institutional Review Board-approved research projects.

Response:

The DEA understands and appreciates these comments. As discussed in the preceding response, law enforcement has the discretion to partner with other entities to conduct a take-back event pursuant to § 1317.65(a). There are no restrictions on how law enforcement handles the collected substances so long as they maintain control and custody of the substance. Accordingly, law enforcement may inventory and sort substances that law enforcement collects. The diversion-related concerns present when authorized registrants collect controlled substances from ultimate users is not present when law enforcement collects substances from ultimate users. Taking into account the totality of the various risks and benefits, the DEA believes that this final rule imposes the minimum necessary controls to allow a secure and responsible means by which ultimate users can dispose of pharmaceutical controlled substances. Relying on its experience, and as discussed in the NPRM, the DEA finds that any potential benefits of allowing authorized collectors or unregistered persons to independently inventory or sort controlled substances after receipt from the ultimate user do not outweigh the risks of diversion, except when the controlled substances remain in the control and custody of law enforcement, as mentioned in the previous response.

Data collection is not impossible under the rule even though collected substances cannot be sorted or inventoried after they have been deposited into a collection receptacle or received by a collector through a mail-back package (unless the collection is conducted by law enforcement and the substances are within the custody and control of law enforcement). For example, authorized collectors may seek information voluntarily from ultimate users regarding the substances the ultimate user is disposing. And, data such as the weight of the inner liners, the number of ultimate users attending a take-back event, and the number of mail-back packages received in relation to the number of packages disseminated, can be useful measures. The rule only prohibits authorized collectors from physically handling the substances, such as taking the substances from the ultimate user, or sorting substances after the ultimate user has deposited them into a receptacle or mail-back package. 21 CFR 1317.70 and 1317.75.

[4] Issue:

Twenty-two commenters stated that contents should be sorted to ensure adequate storage space. Several

commenters stated that packaging and pill bottles should be sorted since they are voluminous. Other commenters stated that non-controlled substances should be sorted from controlled substances.

Response:

Pursuant to §§ 1317.70(b) and 1317.75(b), comingling of controlled and non-controlled substances is permitted, but it is not required. In addition, this rule does not require pharmaceutical controlled substances collected from ultimate users to be collected and stored in the original packaging, and collectors may institute procedures to prevent inadvertently collecting packaging. Authorized collectors may address adequacy of space issues by choosing not to collect comingled pharmaceutical controlled substances and non-controlled substances, refusing to accept the original controlled substance packaging, or by increasing destruction frequencies. In addition, the DEA has expanded the available storage options for practitioners in this final rule by allowing practitioners to store sealed inner liners and returned mail-back packages in a securely locked room with controlled access. 21 CFR 1317.05.

[5] Issue:

A commenter noted that authorized collectors should have direct supervision over the substances that are placed into collection receptacles to prevent undesirable materials from being deposited into collection receptacles.

Response:

Each potential authorized collector must weigh all of the potential risks and benefits in deciding whether to implement and manage any ultimate user disposal program, including any necessary steps to prevent the unwanted collection of regulated hazardous waste or otherwise undesirable materials, in a manner consistent with this rule and all other applicable Federal, State, tribal, and local laws and regulations. Authorized collectors may view what ultimate users deposit into collection receptacles, and they may ask what substances are being deposited. Although the actual disposal of a pharmaceutical controlled substance into a collection receptacle must be performed by an ultimate user in accordance with § 1317.30, the authorized collector maintains ultimate control over that receptacle and should institute necessary measures to protect against the collection of unwanted substances so long as such measures are consistent with this rule and all other applicable Federal, State, tribal, and local laws and regulations.

[6] Issue:

Several commenters asked that the DEA permit pharmacy staff to deposit collected substances into collection receptacles. These commenters asked the DEA to consider situations where the pharmacy is completely blocked from the public (such as with a bullet-proof barrier).

Response:

For the reasons discussed in the NPRM and in previous comment responses, the DEA declines to allow pharmacy staff to handle pharmaceutical controlled substances collected from ultimate users. The registered location of any retail pharmacy that wishes to become an authorized collector must satisfy the specifications for collection receptacles and inner liners. 21 CFR 1317.60 and 1317.75. If a retail pharmacy desires to be an authorized collector, that pharmacy shall only allow ultimate users (and others authorized to dispose of controlled substances on behalf of ultimate users) to deposit the pharmaceutical controlled substances directly into the collection receptacles in accordance with § 1317.30. The requirements of the collection receptacles were carefully considered and designed to limit the number of hands that handled the pharmaceutical controlled substances in order to prevent diversion and diversion opportunities, as well as to prevent the re-introduction of tainted pharmaceutical controlled substances into the closed system of distribution.

[7] Issue:

Twenty commenters suggested that the DEA permit some sort of inspection for inner liner and mail-back package contents to ensure that unacceptable contents are removed, such as x-raying and scanning. These commenters were particularly concerned about mercury-containing thermometers, iodine-containing medications, medical sharps, compressed cylinders, and other hazardous waste. Other commenters expressed concern that by allowing comingling of substances in collection receptacles, employees may be subjected to hazardous conditions if unsafe or hazardous materials are deposited.

Response:

The DEA understands and appreciates these concerns of the commenters; however, the DEA has concluded that allowing inspection of inner liners and mail-back packages presents an unacceptable risk of diversion. These issues were closely reviewed prior to the NPRM and re-reviewed in association with these comments. Whether an authorized collector comingles ultimate users' pharmaceutical controlled substances with non-controlled substances is within the discretion of that authorized collector. This rule does not mandate comingling. 21 CFR 1317.75. Each potential authorized collector must weigh all of the potential risks and benefits in deciding whether to implement and manage any ultimate user disposal program, including any necessary steps to prevent the unwanted collection of regulated hazardous waste or otherwise undesirable materials, in a manner consistent with this rule and all other applicable Federal, State, tribal, and local laws and regulations. As discussed in response to previous comments, collectors may control the substances collected, and they may view substances before they are deposited into collection receptacles. For additional commentary on hazardous waste disposal, please see comment section “Q.”, entitled “Hazardous Materials Transportation and Hazardous Waste Destruction.”

[8] Issue:

Some commenters urged the DEA to require authorized collectors to provide clear instructions on what may and may not be placed in mail-back packages in order to reduce instances in which hazardous materials/waste may be inadvertently destroyed in a manner that is not consistent with environmental or other applicable laws or regulations due to the prohibition against opening or inspecting the contents of mail-back packages.

Response:

The rule includes a requirement for the collector to provide packages with instructions indicating what substances are permitted to be included in the package. 21 CFR 1317.70. The rule does not require specific language for such instructions, which must ultimately be determined by the collector in a manner consistent with the rule.

K. Long-Term Care Facilities (LTCFs) (21 Issues)

Definitions and Terms Specific to LTCFs

[1] Issue:

Commenters asked the DEA to clarify the meaning of “LTCF” with regard to assisted living facilities, hospice facilities, and residential care in private homes, as the meaning of LTCF often varies by State.

Response:

LTCF is defined at § 1300.01(b) and “means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.”

[2] Issue:

Commenters asked the DEA to clarify the meaning of “have resided” with regard to a LTCF's ability to dispose of controlled substances on behalf of residents.

Response:

The phrase “have resided,” is utilized in the Disposal Act, but was not defined by Congress. The DEA has

not determined a need to apply a technical definition for this phrase apart from its ordinary meaning. The DEA understands the ordinary meaning of “have resided” to be typically understood as persons who have died or otherwise recently departed a location without manifesting intent to return. Thus, for example, as discussed in response to issue [7] below, when a LTCF resident is transferred to another facility, the resident “has resided” at the LTCF, and the LTCF may dispose of the former resident's pharmaceutical controlled substances in an authorized collection receptacle. 21 CFR 1317.30.

Registration of Collection Receptacles at LTCFs

[3] Issue:

Commenters asked the DEA to clarify whether an authorized LTCF location where an authorized collector maintains a collection receptacle would be considered a “registered location” of the retail pharmacy.

Response:

The location of the collection receptacle is both a registered location and a controlled premise. It is a registered location of the authorized hospital/clinic or retail pharmacy because the authorized collector may only install and manage a collection receptacle at a LTCF pursuant to the authority granted by the DEA, and they are limited at that location to conducting only those activities that are specifically authorized and required under this rule as necessary to the installation and maintenance of that authorized collection receptacle. LTCFs with authorized collection receptacles are “controlled premises” pursuant to 21 U.S.C. 880(a) and 21 CFR 1316.02(c); accordingly, the DEA may enter LTCFs and conduct administrative inspections in furtherance of, and in carrying out, the responsibilities charged to the DEA by the CSA pursuant to 21 U.S.C. 880(b) and 21 CFR 1316.03.

Disposal Methods and Procedures at LTCFs

[4] Issue:

A commenter asked the DEA if LTCFs may use an on-site method of destruction. Three commenters specifically asked if LTCFs may continue their current drug disposal method of “sewering.” Other commenters asked the DEA to clarify how existing methods of disposal utilized by LTCFs will be impacted by this rule and to provide for an interim method of disposal for LTCFs.

Response:

Although the DEA appreciates the commenters' concerns, the DEA cannot comment on each potential method of disposal occurring at LTCFs prior to these regulations. The implementation of authorized disposal methods for ultimate users is strictly voluntary and, with the exception of law enforcement-sponsored programs, generally such programs have no lawful means of existence prior to the effective date of this rule. It is important to note that this rule provides additional options for disposal and does not prohibit any methods currently used by LTCFs that are consistent with Federal, State, tribal, and local laws and regulations. For example, LTCFs are not prohibited by this final rule from destroying patients' unwanted pharmaceutical controlled substances at the LTCF, on behalf of th

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