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Vol. 77 Friday,No. 246 December 21, 2012

Part V

Department of Justice

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304 et al.Disposal of Controlled Substances; Proposed Rule

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75784 Federal Register / Vol. 77, No. 246/ Friday, December 21, 2012/ Proposed Rules

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

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

[Docket No. DEA316]

RIN 1117AB18

Disposal of Controlled Substances

AGENCY: Drug EnforcementAdministration (DEA), Department of

Justice.ACTION: Notice of proposed rulemaking.

SUMMARY: This rule proposesrequirements to govern the securedisposal of controlled substances by

both DEA registrants and ultimate users.These regulations would implement theSecure and Responsible Drug DisposalAct of 2010 (Pub. L. 111273) byexpanding the options available to

collect controlled substances fromultimate users for purposes of disposalto include: Take-back events, mail-backprograms, and collection receptaclelocations. These proposed regulationscontain specific language to continue toallow law enforcement agencies tovoluntarily conduct take-back events,administer mail-back programs, andmaintain collection receptacles. Theseregulations propose to allow authorizedmanufacturers, distributors, reversedistributors, and retail pharmacies tovoluntarily administer mail-backprograms and maintain collectionreceptacles. In addition, this proposedrule expands the authority of authorizedretail pharmacies to voluntarilymaintain collection receptacles at longterm care facilities. This proposed rulealso reorganizes and consolidatesexisting regulations on disposal,including the role of reversedistributors.

DATES: Electronic comments must besubmitted and written comments must

be postmarked on or before February 19,2013. Commenters should be aware thatthe electronic Federal DocketManagement System will not acceptcomments after midnight Eastern Timeon the last day of the comment period.ADDRESSES: To ensure proper handlingof comments, please reference DocketNo. DEA316 on all electronic andwritten correspondence. DEAencourages all comments be submittedelectronically through http://www.regulations.govusing theelectronic comment form provided onthat site. An electronic copy of thisdocument is also available at the http://www.regulations.govWeb site for easyreference. Paper comments that

duplicate the electronic submission arenot necessary as all commentssubmitted to http://www.regulations.govwill be posted for public review and arepart of the official docket record. Shouldyou, however, wish to submit writtencomments via regular or express mail,they should be sent to the DrugEnforcement Administration, Attention:

DEA Office of Diversion Control (OD/DX), 8701 Morrissette Drive,Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT:JohnW. Partridge, Executive Assistant, Officeof Diversion Control, Drug EnforcementAdministration; Mailing Address: 8701Morrissette Drive, Springfield, Virginia22152; Telephone: (202) 3074654.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all commentsreceived are considered part of thepublic record and are made available for

public inspection online at http://www.regulations.govand in the DEAspublic docket. Such informationincludes personal identifyinginformation (such as your name,address, etc.) voluntarily submitted bythe commenter.

If you would like to submit personalidentifying information (such as yourname, address, etc.) as part of yourcomment, but do not want it to beposted online or made available in thepublic docket, you must include thephrase PERSONAL IDENTIFYINGINFORMATION in the first paragraph

of your comment. You must also placeall the personal identifying informationyou do not want posted online or madeavailable in the public docket in the firstparagraph of your comment and identifywhat information you want redacted.

If you would like to submitconfidential business information aspart of your comment, but do not wantit to be posted online or made availablein the public docket, you must includethe phrase CONFIDENTIAL BUSINESSINFORMATION in the first paragraphof your comment. You must alsoprominently identify confidential

business information to be redactedwithin the comment. If a comment hasso much confidential businessinformation that it cannot be effectivelyredacted, all or part of that commentmay not be posted online or madeavailable in the public docket.

Personal identifying information andconfidential business informationidentified and located as set forth abovewill be redacted, and the comment, inredacted form, will be posted online andplaced in the DEAs public docket file.Please note that the Freedom of

Information Act applies to all commentsreceived. If you wish to inspect theagencys public docket file in person byappointment, please see the FORFURTHER INFORMATION paragraph.

Outline

I. Executive SummaryA. Purpose of the Regulatory Action

B. Summary of the Major Provisions of theRegulatory ActionII. Background

A. Legal AuthorityB. History of Disposal of Controlled

SubstancesC. Existing DEA Regulations

III. Prescription Drug Abuse EpidemicIV. Scope of Proposed RuleV. Proposed Disposal Act Implementing

RegulationsA. Disposal of Controlled Substance by

Ultimate UsersAuthorized PersonsB. Disposal of Controlled Substances by

Ultimate UsersAuthorized MethodsC. Disposal of Controlled Substances by

RegistrantsD. Return and RecallE. Methods of Destruction

VI. Miscellaneous ChangesVII. Regulatory Analyses

Executive Summary

Purpose of the Regulatory Action

On October 12, 2010, the Secure andResponsible Drug Disposal Act of 2010(Disposal Act) was enacted (Pub. L.111273, 124 Stat. 2858). Before theDisposal Act, ultimate users whowanted to dispose of unused, unwanted,or expired controlled substancepharmaceuticals had limited disposaloptions. The Controlled Substances Act

(CSA) only permitted ultimate users todestroy those substances themselves, forexample by flushing or discarding, or todispose of such substances bysurrendering them to law enforcementor by seeking assistance from the U.S.Drug Enforcement Administration(DEA). These restrictions resulted in theaccumulation of controlled substancesin household medicine cabinets thatwere available for abuse, misuse, andaccidental ingestion. The Disposal Actamended the CSA to authorize ultimateusers to deliver their controlledsubstances to another person for the

purpose of disposal in accordance withregulations promulgated by the AttorneyGeneral. 21 U.S.C. 822(g) and 828(b)(3).The Attorney General delegatedresponsibility for promulgating theDisposal Act implementing regulationsto DEA. These proposed regulationsexpand the entities to which ultimateusers may transfer unused, unwanted,or expired controlled substances for thepurpose of disposal, as well as themethods by which such controlledsubstances may be collected. Specifiedentities may voluntarily administer any

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75785Federal Register / Vol. 77, No. 246/ Friday, December 21, 2012/ Proposed Rules

of the authorized collection methods inaccordance with these proposedregulations.

Summary of the Major Provisions of theRegulatory Action

DEA is proposing new regulations forthe disposal of controlled substances byultimate users in accordance with the

Disposal Act. In drafting theimplementing regulations, DEAconsidered the public health and safety,ease and cost of programimplementation, and participation byvarious communities. To this end, DEAfound that in order to properly addressthe disposal of controlled substances byultimate users, it was necessary toconduct a comprehensive review ofDEA policies and regulations related toeach element of the disposal process,including the transfer, delivery,collection, destruction, return, andrecall of controlled substances, by both

registrants and non-registrants (e.g.,ultimate users). The reverse distributorregistration category, which is pertinentto the process of registrant disposal, wasincluded in this comprehensive review.These regulations will be incorporatedinto a new part 1317 on disposal.

The goal of this proposed new part ondisposal, consistent with Congresssgoal in passing the Disposal Act, is toset controlled substance diversionprevention parameters that willencourage public and private entities todevelop a variety of methods forcollecting and destroying controlled

substances in a secure, convenient, andresponsible manner. Also consistentwith Congresss goal in passing theDisposal Act to decrease the amount ofcontrolled substances introduced intothe environment, particularly into thewater, these regulations provideindividuals various additional optionsto dispose of their unwanted or unusedcontrolled substances beyonddiscarding or flushing the substances.As a result of these regulations, thesupply of unused controlled substancesin the home should decrease, therebyreducing the risk of unintentionaldiversion or harm.

Ultimate User Disposal

This rule proposes three voluntaryoptions for ultimate user disposal: (1)Take-back events, (2) mail-backprograms, and (3) collection receptacles.In addition to ultimate users,individuals lawfully entitled to disposeof ultimate user decedents property areauthorized to dispose of the ultimateusers substances by utilizing any of thethree options for disposal. All of theproposed collection methods are

voluntary and no person is required toestablish or operate a disposal program.

DEA proposes specific language thatwill continue to authorize federal, state,tribal, and local law enforcementagencies, either independently or inpartnership with private entities orcommunity groups, to voluntarily holdtake-back events and administer mail-

back programs. DEA also proposes toauthorize certain registrants(manufacturers, distributors, reversedistributors, and retail pharmacies) to becollectors, with authorization toconduct mail-back programs. All mail-

back programs must provide specificmail-back packages to the public, eitherat no cost or for a fee, and collectors thatconduct mail-back programs must haveand utilize an on-site method ofdestruction.

Finally, DEA proposes that lawenforcement agencies voluntarilymaintain collection receptacles at thatagencys physical location and toauthorize collectors to maintaincollection receptacles at their registeredlocation. Retail pharmacies that areauthorized to be collectors maymaintain collection receptacles at longterm care facilities (LTCFs). LTCFs arepermitted to dispose of controlledsubstances on behalf of an ultimate userthat resides or has resided at that LTCFonly through a collection receptacle thatis maintained by a retail pharmacy atthat LTCF.

DEA proposes to allow all controlledsubstances collected through take-backevents, mail-back programs, and

collection receptacles to be comingledwith non-controlled substances.Controlled substances collected bycollectors may not be individuallycounted or inventoried. In addition,DEA proposes various collectionsecurity and recordkeepingrequirements.

DEA appreciates that there is a cost tovoluntarily providing these methods ofcollection and destruction. DEA notesthat some state and localpharmaceutical disposal programsreceive funding and other support fromnumerous sources, including

conservation groups, local governments,state grants, and public and privatedonations. These expanded methods ofdisposal benefit the public bydecreasing the supply of controlledsubstances available for misuse, abuse,and accidental ingestion, and protectthe environment from potentiallyharmful contaminants. However, otheradvantages may accrue directly to thoseentities that opt to maintain a disposalprogram. For example, those authorizedregistrants that choose to maintaincollection receptacles may be enhanced

by the increased consumer presence attheir registered locations and thegoodwill that develops from providing avaluable community service. Inaddition, the proposed regulationspecifies that mail-back programcollectors may partner with third partiesto make mailers available to the public.Those authorized registrants that choose

to administer mail-back programs maygain from the opportunity to distributeto consumers promotional, educational,or other informational materials withthe mailers.

Registrant Disposal

DEA proposes to delete the existingrule related to registrant disposal, 21CFR 1307.21, and incorporate similarrequirements on proper disposalprocedure, security, and recordkeepingin a new part 1317 on disposal. DEAproposes these changes in order toprovide consistent disposal proceduresfor each registrant category, regardlessof geographic location. In addition, DEAproposes to modify existing DEA Form41 to record the destruction ofcontrolled substances that remain in theclosed system of distribution and toaccount for registrant destruction ofcontrolled substances collected fromultimate users and other non-registrantsoutside the closed system pursuant tothe Disposal Act.

Reverse Distributors

DEA proposes revised regulations forreverse distributors that are clear,consistent, and consolidated into one

part. Reverse distributors are often thelast registrant to possess controlledsubstances prior to destruction becausethey are at the end of the closed systemand the same recordkeeping safeguardsthat exist when controlled substancesare distributed between registrants arenot present. Because reverse distributorsroutinely acquire controlled substancesfor destruction from other registrantsand may also be authorized ascollectors, reverse distributorsaccumulate greater amounts ofcontrolled substances that are destinedfor destruction in comparison to otherregistrants. DEA believes that theproposed regulations will help reversedistributors comply with the ControlledSubstances Act in a manner thateffectively decreases the risk of thediversion of controlled substancesduring the disposal process. DEAproposes to revise the definition ofreverse distributor in addition toproposing new procedures that reversedistributors must follow to acquirecontrolled substances from registrantsand other security and recordkeepingrequirements.



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1The Attorney Generals delegation of authorityto DEA may be found at 28 CFR 0.100.

221 U.S.C. 822(c)(3) and 957(b)(1)(C) exceptultimate users who possess substances forpurposes referenced in 21 U.S.C. 802(25); however,ultimate user is defined in 21 U.S.C. 802(27).

3 It is unlawful to knowingly or intentionallymanufacture, distribute, dispense, or possess withthe intent to manufacture, distribute, or dispense,

a controlled substance without the appropriate

registration. 21 U.S.C. 841(a).4The terms disposal, dispose, or

disposition appear several times in the CSA andits implementing regulations, but these terms arenot defined. For example, in the CSA, see 21 U.S.C.822(g); 824(f) and (g); 826(c), (e), and (f); 827(a)(3)and (d)(1); 842(a)(7); 853(n); 880(a)(2); 881(e)(1);and 958(d)(6); and in the CFR, see 21 CFR1307.21(b). The term net disposal, however, isdefined at 21 CFR 1300.01(b). As used, the termsrefer to a variety of activities that ultimately resultin eliminating the availability of controlledsubstances for use. For example, within themeaning of the CSA, a controlled substance can bedisposed of by destruction, return, recall, sale, orthrough the manufacturing process. The DisposalAct allows an ultimate user to deliver a lawfullyobtained controlled substance to another personfor the purpose of disposal. DEA believes that the

ultimate user disposal authorized by the DisposalAct includes the transfer or delivery of controlledsubstances for purposes of destruction, return, andrecall. Such ultimate user activities are consistentwith the intent to remove unused, unwanted,tainted, and expired substances from householdsand out of the reach of children and teenagersthereby reducing the risk of diversion andprotecting the public health and safety. As used inthis Notice of Proposed Rulemaking, DEA uses theterms disposal and dispose to refer generallyto the wide range of activities that result incontrolled substances being unavailable for furtheruse. When necessary to specify a particular activitywithin the disposal process, the particular activityis identified, e.g., transfer, deliver, collect/collection, return, recall, destroy/destruction.

Return and Recall

DEA proposes to delete the existingrule on return and recall, 21 CFR1307.12, and incorporate into a new part1317 clarified and separate return andrecall requirements for registrants andnon-registrants.

Methods of Destruction

DEA proposes a standard ofdestructionnon-retrievableforpersons that intend to destroycontrolled substances. In particular,DEA is not requiring a particularmethod of destruction, so long as thedesired result is achieved. This standardis intended to allow public and privateentities to develop a variety ofdestruction methods that are secure,convenient, and responsible, consistentwith preventing the diversion of suchsubstances. Destruction of controlledsubstances must also meet all otherapplicable Federal, state, Tribal, and

local laws and regulations.Background

Legal Authority

The Drug EnforcementAdministration (DEA) implements andenforces Titles II and III of theComprehensive Drug Abuse Preventionand Control Act of 1970 and theControlled Substances Import andExport Act (21 U.S.C. 801971), asamended, and referred to as theControlled Substances Act (CSA).1 DEApublishes the implementing regulationsfor these statutes in Title 21 of the Code

of Federal Regulations (CFR), parts 1300to 1321. The CSA and its implementingregulations are designed to prevent,detect, and eliminate the diversion ofcontrolled substances and listedchemicals into the illicit market whileproviding for a sufficient supply ofcontrolled substances and listedchemicals for legitimate medical,scientific, research, and industrialpurposes. Controlled substances havethe potential for abuse and dependenceand are controlled to protect the publichealth and safety. To this end,controlled substances are classified into

one of five schedules based upon: Thepotential for abuse, currently acceptedmedical use, and the degree ofdependence if abused. 21 U.S.C. 812.Listed chemicals are separatelyclassified based on their use andimportance to the manufacture ofcontrolled substances (List I or List IIchemicals). 21 U.S.C. 802(33)(35).

The CSA establishes a closed systemof distribution that requires DEA to

monitor and control the manufacture,distribution, dispensing, import, andexport of controlled substances andlisted chemicals until they reach theirfinal lawful destination. The securedestruction of unused, recalled, tainted,expired, or otherwise unwantedcontrolled substances is essential topreventing the diversion of controlled

substances into the illicit market.In order to maintain this closed

system of distribution, persons thatmanufacture, distribute, dispense,import, export, or conduct research orchemical analysis with controlledsubstances and listed chemicals arerequired to register with DEA at eachprincipal place of business orprofessional practice. Persons registeredwith DEA are permitted to possesscontrolled substances and listedchemicals as authorized by theirregistration and must comply with theapplicable requirements associated with

their registration. 21 U.S.C. 822.Not all persons that possesscontrolled substances are required toregister with DEA. For example, apatient who receives a controlledsubstance pursuant to a lawfulprescription, also known as an ultimateuser, is not required to register withDEA in order to receive and possess thatcontrolled substance. 21 U.S.C.822(c)(3); see also 21 U.S.C.957(b)(1)(C).2 The CSA defines anultimate user as a person who haslawfully obtained, and who possesses, acontrolled substance for his own use orfor the use of a member of his

household or for an animal owned byhim or by a member of his household.21 U.S.C. 802(27).

While Congress envisioned a closedsystem of distribution that wouldcontrol a substance from itsmanufacture or import through thetraditional chain of distribution movingfrom registrant to registrant until itreached its final lawful use (e.g.,dispensed to the ultimate user, etc.), itdid not account for circumstances inwhich controlled substances werelawfully dispensed to and possessed byan ultimate user but not fully used.

Although ultimate users are exemptfrom CSA registration requirements forthe possession of controlled substances,if they distribute (i.e., deliver ortransfer) such controlled substanceswithout the appropriate registration,they are in violation of the CSA.3 Such

unlawful distribution includes thetransfer of controlled substances for thepurpose of disposal.4

On October 12, 2010, the Secure andResponsible Drug Disposal Act of 2010(Disposal Act) was enacted (Pub. L.111273, 124 Stat. 2858). The DisposalAct amended the CSA to allow anultimate user to deliver a controlled

substance to another person for thepurpose of disposal if the personreceiving the controlled substance isauthorized to receive that substance andthe disposal takes place in accordancewith regulations issued by the AttorneyGeneral to prevent the diversion ofcontrolled substances. 21 U.S.C.822(g)(1). The Attorney Generaldelegated responsibility forpromulgating the Disposal Actimplementing regulations to DEA.

In addition to authorizing ultimateusers to deliver their controlledsubstances to another person for thepurpose of disposal, the Disposal Actalso authorized any person lawfullyentitled to dispose of an ultimate userdecedents property to deliver theultimate users controlled substance toanother person for the purpose ofdisposal if the ultimate user dies whilein lawful possession of the controlledsubstance. The Disposal Act also gaveDEA the ability, by regulation, toauthorize long term care facilities(LTCFs) to dispose of controlledsubstances on behalf of ultimate userswho reside or have resided at the LTCF.



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5H.R. Rep. No. 911444 (1970), reprinted in 1970U.S.C.C.A.N. 4566, 45714572.

6 In 1973, the BNDD was abolished and all BNDDfunctions were transferred to DEA. ReorganizationPlan No. 2 of 1973, 38 FR 18380 (July 2, 1973).

7The procedures are found today in 21 CFR1307.21.

Congress directed DEA, in promulgatingthe Disposal Act implementingregulations, to consider the publichealth and safety, ease and cost ofprogram implementation, andparticipation by various communities.The implementing regulations may notrequire any person to establish oroperate a delivery or disposal program.

History of Disposal of ControlledSubstances

In 1970, Congress created the CSAafter consolidating more than 50 lawsrelated to the control of narcotics anddangerous drugs. The statute wasdesigned to improve theadministration and regulation of themanufacturing, distribution, anddispensing [and import/export] ofcontrolled substances by providing for aclosed system of drug distribution forlegitimate handlers of such drugs withcriminal penalties for transactionsoutside the legitimate chain.5 With theenactment of the CSA, the AttorneyGeneral delegated the responsibility forpromulgating the CSAs implementingregulations to DEAs predecessor, theBureau of Narcotics and DangerousDrugs (BNDD).6

BNDD recognized that to maintain theclosed system of distribution, secureavenues for the destruction of controlledsubstances were essential. Theimplementing regulations specificallyaddressed the issue of the disposal ofcontrolled substances (36 FR 7776,April 24, 1971). In particular, theimplementing regulations outlined a

process under which any personlawfully in possession of a controlledsubstance could distribute suchsubstance to the person from whom he/she obtained it or return it to themanufacturer or the manufacturersregistered agent, and created proceduresfor any person in possession of acontrolled substance, with instructionfrom DEA, to either deliver or transferthe substance to another for destruction,or to destroy that substance themselves.21 CFR 1307.12 and 1307.21. Theseprocedures have changed little since1971.

DEA Registrant DisposalReverseDistributors

Through the mid-1990s, DEAaccepted controlled substances fromregistrants for destruction or authorizedregistrants to destroy controlledsubstances pursuant to 21 CFR 1307.21.Manufacturers also accepted returns of

controlled substances from theircustomers as an additional service.Eventually, a group of brokers emergedwith the sole purpose to collectcontrolled substances from registrantsfor destruction pursuant to theprocedures outlined in DEAsregulations.7 Initially, this groupregistered with DEA as distributors and

called the services that they providedreverse distribution. At about thesame time, another group emergedcalled inventory control processors/auditors whose primary purpose wasto identify expired substances in aregistrants inventory and prepare themfor disposal by the registrant pursuant to21 CFR 1307.21, or return to the personfrom whom it was obtained or to themanufacturer. This group was notrequired to register with DEA in orderto conduct their activities because theydid not take possession of thesubstances. Any inventory control

processors/auditors that wanted to takepossession of controlled substanceswere required to register with DEA asdistributors. To reduce the risk ofdiversion from these activities, andensure accountability during thedisposal process, DEA and theregistered distributors entered intomemorandums of understanding(MOUs) that outlined acceptabledisposal procedures until permanentregulations were finalized.

Initially, DEA proposed to codifythese MOUs by issuing a Notice ofProposed Rulemaking to define and

register a new category of manufacturerregistration called disposers thatwould authorize those registrants toreceive controlled substances for theprimary purpose of destruction (60 FR43732, August 23, 1995). This rule wasnever finalized. In 2003, DEAreaddressed the issue of registrantdisposal in an Interim Final Rule (IFR)to define and register reversedistributors (68 FR 41222, July 11,2003). In 2005, DEA published a finalrule, thereby finalizing a new categoryof distributor registration calledreverse distributors (70 FR 22591,

May 2, 2005). The final rule authorizedreverse distributors to acquirecontrolled substances from DEAregistrants for the purpose of return tothe manufacturer or manufacturersagent or for processing those substancesfor disposal in accordance with 21 CFR1307.21. The final rule also codifiedsecurity, recordkeeping, reporting, andorder form requirements applicable toreverse distributors.

Non-Registrant Disposal

As discussed above, prior to passageof the Disposal Act, the CSA did notaddress the disposal of controlledsubstances by ultimate users. Congressenvisioned a closed system ofdistribution that would control asubstance from its manufacture or

import through the traditional chain ofdistribution moving from registrant toregistrant until it reached its final lawfuluse (e.g., dispensed to the ultimate user,etc.). The CSA did not, however,account for circumstances in whichcontrolled substances were lawfullydispensed to and possessed by anultimate user, but not fully used. To thisend, the CSA did not authorize theultimate user to transfer unwanted andunused controlled substances to anotherperson for the purpose of disposal.

Moreover, the CSA did not addressthe disposal of controlled substances bylong term care facilities (LTCFs). DEA

defines a LTCF as a nursing home,retirement care, mental care or otherfacility or institution which providesextended health care to residentpatients. 21 CFR 1300.01(b). Generally,controlled substances are prescribed bya LTCF residents physician anddispensed by the residents pharmacist;such controlled substances are owned

by the resident. This is in contrast withpatients in a hospital where controlledsubstances are dispensed dose by doseand remain under the possession andcontrol of the registered dispenser, thehospital. Accordingly, a LTCF may

secure its residents controlledsubstances for custodial purposes only.The controlled substances remain in thelawful possession of the resident, theultimate user. As with any otherultimate user, prior to the enactment ofthe Disposal Act, a LTCF resident inlawful possession of dispensedcontrolled substances could notdistribute those substances to anotherperson, even for the purpose of disposal.

In anticipation of the growing need ofultimate users and LTCFs to dispose ofunused and unwanted controlledsubstances, DEA published an Advance

Notice of Proposed Rulemaking tosolicit information on the disposal ofcontrolled substances by ultimate usersand LTCFs (74 FR 3480, January 21,2009). Subsequently, as discussedabove, on October 12, 2010, the Secureand Responsible Drug Disposal Act of2010 was enacted.

Existing DEA Regulations

Existing DEA regulations on thedisposal of controlled substances arecodified at 21 CFR 1307.12 and 1307.21.The process for returns is outlined in 21



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8The National Take-Back Days were held onSeptember 25, 2010, April 30, 2011, October 29,2011, April 28, 2012, and September 29, 2012.

9DEA registrants are not authorized to dispose ofcontrolled substances at these events; DEAregistrants must comply with the current DEAregulations regarding disposal of controlledsubstance stock/inventory.

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

11Partnership for a Drug-Free America andMetLife Foundation, 2009 Parents and TeensAttitude Tracking Study Report,March 2, 2010.

12Partnership for a Drug-Free America andMetLife Foundation, 2010 Partnership AttitudeTracking Study, April 6, 2011.

13The National Survey on Drug Use and Health(NSDUH) is an annual survey of the civilian, non-institutionalized, population of the United Statesaged twelve or older. The survey is conducted bythe Department of Health and Human ServicesOffice of Applied Studies, Substance Abuse andMental Health Services Administration (SAMHSA).

14Substance Abuse and Mental Health ServicesAdministration, Results from the 2010 NationalSurvey on Drug Use and Health: Volume I,Summary of National Findings, Office of AppliedStudies, 2011 (NSDUH Series H41, HHSPublication No. SMA 114658), http://www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf.

15Partnership for a Drug-Free America andMetLife Foundation, 2010 Partnership AttitudeTracking Study, April 6, 2011.

16Lloyd D. Johnson, Ph.D., et al, Monitoring theFuture National Results on Adolescent Drug Use:Overview of Key Findings, 2011, Institute for

CFR 1307.12 and permits any person inlawful possession of a controlledsubstance to distribute that substance,without being registered to distribute, tothe person from whom the substancewas obtained or to the manufacturer ormanufacturers registered agent.

The procedure governing the transferof controlled substances for disposal is

outlined in 21 CFR 1307.21. In theexisting regulations, any person inpossession of any controlled substancethat desires or is required to dispose ofsuch substance may request authorityand instructions for disposal from theDEA Special Agent in Charge (SAC) inthe region in which they are located.The SAC must authorize and instructapplicants to dispose in one of fourways, by: (1) Transfer to a DEAregistrant authorized to possess thesubstance; (2) delivery to an agent ofDEA or to the nearest DEA office; (3)destruction in the presence of an agent

of DEA or other authorized person; or(4) such other means that the SACdetermines to assure that the substancedoes not become available tounauthorized persons. 21 CFR1307.21(b).

Registrants requesting authority andinstructions from the SAC to dispose ofcontrolled substances must submit tothe SAC three copies of DEA Form 41listing the controlled substances that theregistrant would like to dispose. 21 CFR1307.21(a). Registrants required toregularly dispose of controlledsubstances may ask the SAC forauthorization to dispose of those

substances without prior approval fromDEA in each instance if the registrantagrees to keep records of disposal.Further, the SAC may place additionalconditions upon the ongoing approvalto dispose. 21 CFR 1307.21(c).

Reverse Distributors

DEA currently defines a reversedistributor as a registrant who receivescontrolled substances acquired fromanother DEA registrant for the purposeof(1) Returning unwanted, unusable,or outdated controlled substances to themanufacturer or the manufacturers

agent; or (2) Where necessary,processing such substances or arrangingfor processing such substances fordisposal. 21 CFR 1300.01(b). Reversedistributors are required to meet generalsecurity requirements, the securityrequirements applicable to non-practitioners, and specific inventory,recordkeeping, and reportingrequirements. DEA registrants areauthorized to distribute their lawfullypossessed controlled substances to aregistered reverse distributor to theextent authorized by their registration

and in conformity with the CSA and itsimplementing regulations. 21 U.S.C.822(b) and 958(g); See, e.g., 21 CFR1301.13(e) and 1307.11. Manufacturers,distributors, importers, andpractitioners are currently authorized todistribute their lawfully possessedcontrolled substances to a reversedistributor without prior authorization

from the SAC in the region they arelocated. 21 CFR 1301.13(e)(i), (ii), (viii)and 1307.11(a)(2).

Law Enforcement Agencies andUltimate User Take-Back Events

Until DEA finalizes the implementingregulations for the Disposal Act andexpanded options for disposal areavailable, ultimate users may not delivertheir lawfully obtained controlledsubstances to any other person for thepurpose of disposal other than bysurrender to law enforcement or underthe direction of the DEA Special Agent

in Charge in the area in which theperson is located. In the interim, DEAhas established National Take-BackDays.8 DEA organized these nationwideone day events as a collaborative effortwith state and local law enforcementagencies. The National Take-Back Daysprovide the public with a convenientand secure way to surrenderpharmaceutical controlled substances tolaw enforcement for destruction.9

Prescription Drug Abuse Epidemic

Before the Disposal Act, the CSA didnot address the disposal of controlledsubstances by ultimate users. To dispose

of their controlled substances, ultimateusers were permitted to destroy thesubstances themselves (e.g., mix thesubstances with coffee grounds, place ina plastic bag, and throw into the garbageor flush) or surrender the substances tolaw enforcement or DEA. There isconcern, however, that throwingcontrolled substances into the garbageor flushing them can contribute toharming the environment. Because thepublic has limited options for disposal,outdated and unwanted controlledsubstances often accumulate inmedicine cabinets, easily within reach

of children and teenagers. In passing theDisposal Act, Congress recognized thatthe secure disposal of controlledsubstances is important because of thesignificant prescription drug abuseproblem in the United States. The

Centers for Disease Control andPrevention declared prescription drugoverdoses an epidemic.10 Studies showthe adverse consequences associatedwith the substantially high levels ofabuse and misuse (non-medical use) ofprescription drugs.

The availability of outdated orunwanted prescription drugs is

problematic because there is a concernthat young people may perceiveprescription and/or over-the-counterdrugs as safer than illegal drugs

because of their intended, legitimatemedical use.11 This misperception may

be shared by parents. Over 20 percent ofparents believe that it is acceptable togive a teen a prescription drug that wasnot prescribed to them.12 The 2010National Survey on Drug Use andHealth (NSDUH)13 indicates that over 70percent of Americans twelve and olderwho used pain relievers non-medicallyin the previous year obtained the drugs

from a friend or relative.14

Anotherstudy found that more than 50 percentof teens obtained prescription drugsfrom their own familys medicinecabinet.15

The prevalence of controlledsubstance prescription drug abuseamong teenagers is right behind theirabuse of marijuana (to include organicmarijuana and synthetic cannabinoids).The 2011 Monitoring the Futuresurvey of teenagers found that 8.1percent of high school seniors reportednon-medical use of Vicodin (a brandname for Schedule III hydrocodonecombination products) in the past year,

and 4.9 percent reported non-medicaluse of OxyContin (a brand name forSchedule II oxycodone sustained releaseproducts) in the past year.16 This is

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Social Research, The University of Michigan,22012.

17Lloyd D. Johnston, Ph.D., et al, Monitoring theFuture National Results on Adolescent Drug Use:Overview of Key Findings, 2009,National Instituteof Drug Abuse, 2010 (NIH Publication No. 107583).

18Substance Abuse and Mental Health ServicesAdministration, Results from the 2010 NationalSurvey on Drug Use and Health: Volume I,Summary of National Findings, Office of AppliedStudies, 2011 (NSDUH Series H41, HHSPublication No. SMA 114658), http://www.oas.

samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf.19These estimates were similar to those from the

2009 survey but 13 percent higher than those fromthe 2008 survey.

20 Id.21Substance Abuse and Mental Health Services

Administration, 2010 National Survey on Drug Useand Health.

22U.S. Department of Health and HumanServices, Centers for Disease Control andPrevention, National Center for Injury Preventionand Control, Drug Poisoning Deaths in the UnitedStates, 19802008, December 2011.

23Behavioral Health Statistics and Quality,Highlights of the 2009 Drug Abuse WarningNetwork (DAWN) Findings on Drug-Related

Emergency Department Visits, The DAWN Report,December 28, 2010.

24 Id. at 4.25 Id. at 3.26DEA does not address the proper disposal of

listed chemicals by DEA registrants in thisrulemaking.

27Any previous waivers, MOUs, and MOAsissued in accordance with 21 CFR 1307.21 shall besuperseded by this rulemaking on the Disposal ofControlled Substances if and when it is finalized.

28

DEA proposes in 21 CFR 1301.76 to deletereference to 1307.12 and replace it with referenceto 21 CFR part 1317; in 21 CFR 1304.11(e) and theintroductory paragraph of 1304.22 to deletereference to 21 CFR 1307.12; in 21 CFR 1301.25(i),1301.52(c), and 1307.13 to delete reference to 21CFR 1307.21 and replace it with reference to 21CFR part 1317; in 21 CFR 1304.25(a)(9) and1304.25(b)(9) to delete reference to 21 CFR 1307.22and replace it with reference to 21 CFR part 1317;and in 21 CFR 1304.04(a) to add reference to 21CFR part 1317. DEA also proposes in 21 CFR1307.22 to delete reference to 21 CFR 1307.21, andreplace it with reference to 21 CFR part 1317. DEAproposes to revise the title of 21 CFR 1307.22 toDelivery of surrendered and forfeited controlledsubstances for clarity.

consistent with reports by high schoolstudents of increased non-medical useof painkillers in the past five years.17According to a 2009 survey by thePartnership at Drugfree.org, more than50 percent of teenagers (grades 912)

believe that prescription drugs are easierto obtain than illegal drugs.

Prescription drug abuse is the fastest

growing drug problem in the UnitedStates. Findings from the 2010 NSDUHestimate that 7.0 million persons agedtwelve or older used prescription-typepsychotherapeutic drugspainrelievers, anti-anxiety medications,stimulants, and sedativesnon-medically in the previous month.18 Thisrepresents 2.7 percent of the U.S.population.19 In 2010, 2 million personsaged twelve or older used pain relieversnon-medically for the first time.20 Onaverage, every day 2,046 12 to 17-year-olds abuse a prescription pain relieverfor the first time.21

Non-medical prescription drug use,particularly among young adults, ishaving a devastating effect on theUnited States. According to the Centersfor Disease Control and Prevention,poisoning deaths, which include drugoverdoses such as those fromprescription drugs, are the leading causeof injury death in the United States;nearly nine out of ten poisoning deathsare caused by drugs and more than 40%of those involve opioid analgesics.22According to SAMHSAs latest DrugAbuse Warning Network (DAWN) data,of the 4.6 million emergency

department visits in 2009 associatedwith drug use, about 1.2 million visitsinvolved the non-medical use ofpharmaceuticals.23 Emergency

department visits involving non-medical use of pharmaceuticals (misuseor abuse) almost doubled between 2004and 2009 from 627,291 in 2004 to1,244,679 visits in 2009 (a 98.4 percentincrease).24 About half of the 2009emergency department visits related tomisuse or abuse of pharmaceuticalsinvolved painkillers and more than one-

third involved drugs to treat insomniaand anxiety.25

Scope of Proposed Rule

In response to this growing problem,DEA is proposing new, expandedregulations for the disposal of controlledsubstances by ultimate users inaccordance with the Disposal Act. Theseregulations will provide ultimate userswith more options for disposal of theircontrolled substances so that thecontrolled substances will notaccumulate and be available for misuse,abuse, and accidental ingestion bychildren and the elderly. In drafting theimplementing regulations, DEAconsidered the public health and safety,ease and cost of programimplementation, and participation byvarious communities. To this end, DEAfound that in order to properly addressthe disposal of controlled substances byultimate users, it was necessary toconduct a comprehensive review ofDEA policies and regulations related toeach element of the disposal process,including the transfer, delivery,collection, destruction, return, andrecall of controlled substances, by bothregistrants and non-registrants (e.g.,

ultimate users).26 The reversedistributor registration category, whichis pertinent to the process of registrantdisposal, was included in thiscomprehensive review.

As discussed above, DEA currentlyregulates the disposal of controlledsubstances by registrants and otherpersons in accordance with 21 CFR1307.21 and regulates the returnsprocess through 21 CFR 1307.12. Theexisting disposal regulation gives DEASpecial Agents in Charge (SACs) thediscretion to authorize disposal in amanner that reduces the risk of

diversion from this activity on a case-by-case basis. These regulations havechanged little since the CSA wasenacted. While this approach iseffective, with the enactment of theDisposal Act and the increasing need forthe responsible disposal of controlled

substances by registrants and non-registrants alike, DEA believes that inorder to securely and effectively disposeof unwanted or unused controlledsubstances, consistent nationwidestandards on disposal are necessary. Asa result, DEA proposes to delete 21 CFR1307.12 on Distribution to supplier ormanufacturer and 21 CFR 1307.21 on

Disposal of controlled substances andpromulgate a new part 1317 that willexpand available disposal options,establish nationwide standards for thedisposal of controlled substances, andcomprehensively outline the processand procedure for the disposal ofcontrolled substances by registrants,ultimate users, and other non-registrantssuch as long term care facilities.27

The goal of this proposed new part ondisposal, consistent with Congresssgoal in passing the Disposal Act, is toset controlled substance diversionprevention parameters that will allow

public and private entities to develop avariety of methods for collecting anddestroying controlled substances in asecure, convenient, and responsiblemanner. DEA believes that the new parton disposal will provide registrants andnon-registrants alike clear andconsistent requirements for the disposalof controlled substances. It is intendedto maximize cost efficiency, voluntaryparticipation, and public accessibilitywhile simultaneously promoting thesecure and responsible disposal ofcontrolled substances in order toprevent diversion.

In accordance with the changes

described above, DEA proposes to deleteany reference to 21 CFR 1307.12 and1307.21 and replace it with a referenceto the new 21 CFR part 1317, whereappropriate.28 DEA also proposes torevise 21 CFR 1301.13(e)(1)(i) to deletereference to a disposer category ofregistration in the coincident activitycolumn for manufacturers. A disposercategory of registration was proposed byDEA in 1995, but was never finalized

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(60 FR 43732, August 23, 1995).Reference to a disposer category wasinadvertently included in a previousrulemaking (68 FR 58587, October 10,2003).

January 1920, 2011 Public Meeting

On January 19 and 20, 2011, DEAheld a well-attended public meeting to

receive information from interestedparties and the public and gather ideasfor drafting regulations for the newlyenacted Disposal Act. (The Notice ofMeeting was published in the FederalRegister on December 22, 2010, 75 FR80536.) This meeting provided anopportunity for all interested personsthe general public, including ultimateusers, parents, pharmacies, wastemanagement companies, long term careand pharmaceutical related industries,as well as federal, state, and localagencies, including law enforcementpersonnel, and othersto express their

views regarding safe and effectivemethods of disposal of controlledsubstances consistent with the CSA.Representatives of various industriesand organizations as well as federal,state, and local agencies madepresentations at the meeting and manysubmitted written comments prior to themeeting.

In drafting the Disposal Actimplementing regulations, DEAgathered information about disposalfrom the more than 70 writtencomments and 44 oral presentations thatwere submitted and transcribed from

the two day public meeting. Informationand experience resulting from pilotprojects around the United Statesinvolving mail-back programs, take-backevents, and collection receptacles forpharmaceuticals were shared andhelped inform this proposed rule.Representatives of law enforcementagencies provided information on theirexperience, existing procedures, andperspective, particularly with respect totake-back events as a method ofcollection. Representatives from DEAregistrant and other affected groups,such as pharmacies, reverse distributors,

and the waste management industry,provided insights on technology andexisting destruction procedures.Presentations by the EnvironmentalProtection Agency, the Food and DrugAdministration, the U.S. Postal Service,the U.S. Army, and state and localagencies provided information onrelevant federal, state, and local lawsand procedures pertaining to thedisposal and transportation ofcontrolled substances, particularlypharmaceuticals. DEA appreciated andconsidered all information provided at

or submitted in response to the Noticeof Meeting in drafting this NPRM.

Proposed Disposal Act ImplementingRegulations

Disposal of Controlled Substances byUltimate UsersAuthorized Persons

In accordance with the Disposal Act,

DEA proposes new regulations for thedisposal of controlled substances byultimate users and other non-registrantsin particular: (1) Personslawfully entitled to dispose of ultimateuser decedents property and (2) LTCFson behalf of ultimate users that reside orhave resided at that LTCF. In draftingthese proposed implementingregulations, DEA considered the publichealth and safety, ease and cost ofprogram implementation, andparticipation by various communities.To this end, DEA proposes three optionsfor ultimate users to dispose of

controlled substances: (1) Take-backevents; (2) mail-back programs; and (3)collection receptacle locations. Theseproposed options are voluntary and noperson is required to establish oroperate a disposal program, althoughany person who chooses to do so and isauthorized by DEA to do so must adhereto the final regulations.

DEA proposes to authorize ultimateusers and persons lawfully entitled todispose of an ultimate user decedentsproperty to deliver lawfully possessedcontrolled substances in Schedules II,III, IV, and V to law enforcement

agencies through take-back events, mail-back programs, and collectionreceptacles, and to authorized collectorsthrough mail-back programs andcollection receptacles. DEA is alsoproposing to authorize LTCFs, on behalfof an ultimate user that resides or hasresided at that LTCF, to deliver aresidents lawfully possessed controlledsubstances in Schedule II, III, IV, or Vto certain on-site collection receptaclesoperated by a registered retail pharmacythat is an authorized collector. Thecollection of Schedule I controlledsubstances is not permitted because,generally, ultimate users cannotlawfully possess Schedule I substancesunless they are participating in aninvestigational use of drugs pursuant to21 U.S.C. 355(i) and 360b(j). Forultimate users in lawful possession ofSchedule I substances forinvestigational use, DEA proposes thatthey follow the disposal procedures in21 CFR 1317.85(b). Furthermore, theproposed collection methods areintended for the collection anddestruction of lawfully possessedcontrolled substances, not as an avenue

for the disposal of substances that wereillegally obtained.

DEA proposes in sections 1317.651317.80 that controlled substancescollected from ultimate users and otherauthorized non-registrant persons may

be comingled with non-controlledsubstancesboth controlled and non-controlled substances may be collected

together so long as the requirementsoutlined for controlled substances arefollowed. Comingling reduces the risk ofdiversion and is practical, efficient, andeconomical. Members of the publiccannot easily identify the difference

between controlled and non-controlledsubstances. As collection pilot programsdemonstrate, the requirement thatcontrolled and non-controlledsubstances be collected separately isexpensive, time-consuming, andhampers the collection process. Inaddition, comingling controlledsubstances is another way to minimize

the risk of diversion of collectedcontrolled substances. For example,many pharmacies and institutionalpractitioners disperse controlledsubstances throughout the stock of non-controlled substances in order to deterthe theft or diversion of the controlledsubstances. See 21 CFR 1301.75(b).

DEA proposes in section 1317.30 thatfederal, state, tribal, and local lawenforcement agencies continue withauthority to collect ultimate usercontrolled substances, and that certainregistrants authorized by DEA to be acollector be authorized to collectcontrolled substances from ultimate

users, persons lawfully entitled todispose of ultimate user decedentsproperty, and, in some circumstances,long term care facilities. DEA isauthorizing certain registrant categoriesto be collectors so that DEA canensure sufficient physical securitycontrols are in place, therebyminimizing the risk of diversion.Registrants are subject to controlsrelated to their DEA registration. Thesepre-existing controls will protect againstthe diversion of controlled substances inthe process of ultimate user collection.

Possession for Disposal

Once a controlled substance islawfully dispensed to an ultimate user,the ultimate user is in possession of thatsubstance. Only the ultimate user orother authorized persons (i.e., personslawfully entitled to dispose of anultimate user decedents property and,in some cases, the LTCF where theultimate user resides or has resided)may dispose of such controlledsubstances in accordance with DEAsproposed ultimate user disposalregulations. In contrast, a controlled



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substance dispensed for immediateadministration pursuant to an order formedication in an institutional settingremains in the possession of thatregistered institution, even if thesubstance is not fully exhausted (e.g.,some of the substance remains in a vial,tube, or syringe after administration butcannot or may not be further utilized).

Such remaining substance must beproperly recorded, stored, anddestroyed in accordance with DEAregulations, and all applicable federal,state, tribal, and local laws andregulations. These same principleswould apply to hospice settings, whichmay be registered by DEA as aninstitutional practitioner or may beunregistered like many LTCFs.

Law Enforcement Agencies

DEA proposes specific language insection 1317.35 to continue to authorizelaw enforcement agencies, on a

voluntary basis, to collect controlledsubstances from ultimate users andpersons lawfully entitled to dispose ofan ultimate user decedents propertythrough: (1) Take-back events, (2) mail-

back programs, and (3) collectionreceptacles located at the lawenforcement agencys physical address.

DEA recommends that lawenforcement agencies electing toparticipate in ultimate user disposalmaintain any records of receipt orcollection in a manner that is consistentwith that agencys recordkeepingrequirements for illicit controlled

substance evidence handling and storeany controlled substances collected in amanner that reasonably prevents thediversion of controlled substances andis consistent with that agencys standardprocedures for storing illicit controlledsubstances. Destruction of controlledsubstances must be in accordance withapplicable federal, state, tribal, and locallaws and regulations. DEA recommendsthat law enforcement agencies also keepa record of any transfer of controlledsubstances to reverse distributors fordestruction; such records may assistDEA in ensuring that reverse

distributors are keeping proper recordsof those controlled substances theyacquire from law enforcement agenciesthat conduct ultimate user disposalactivities. DEA recognizes that lawenforcement agencies have existingprocedures regarding the handling,storage, or transfer for destruction ofcontrolled substances. These proposedrules do not require changes to thoseprocedures. DEA anticipates that thoseexisting procedures will provide thenecessary security to prevent thediversion of controlled substances.

DEA proposes that law enforcementagencies that choose to conduct mail-

back programs within their jurisdictionmust make available to ultimate userspackages described in proposed section1317.70. Such packages may, however,

be made available pursuant to apartnership or other agreement betweenthe law enforcement agency and another

person for the purpose of funding,dissemination, production, or othernon-collection activity meant tofacilitate the law enforcement agencysmail-back program. Such standards willhelp to alleviate the primary securityconcerns related to mail-back programs.As explained below, many suchconcerns exist regardless of thedestination of the mail-back packages;thus, security standards related to themail-back packages must be maintainedeven if the program is conducted by alaw enforcement agency. DEAemphasizes, however, that the authority

of law enforcement agencies to conductultimate user disposal programs is not amechanism by which registrants maycircumvent these proposed regulationsor any other applicable laws orregulations. Any person, group, or entitythat partners with a law enforcementagency to implement an ultimate userdisposal program must comply with allapplicable laws and regulations. Inspecific terms, any authorized collectorthat partners with a law enforcementagency to jointly conduct a collectionprogram must adhere to these proposedregulations and any other applicablelaws and regulations.

DEA appreciates that implementingsome of the proposed disposal methodsmay present challenges to some state,tribal, and local law enforcementagencies. When implementing any newcommunity service, all governmentagencies must balance availableresources against established priorities.DEA hopes that these regulations willprovide flexibility and opportunities forcommunities, interest groups,registrants, and law enforcementagencies to partner together to providecost effective, safe, and convenientmethods of ultimate user disposal. DEA

looks forward to receiving suggestionsfrom state, tribal, and local lawenforcement agencies concerning itsproposed regulations for the disposal ofcontrolled substances by lawenforcement agencies.

Collectors

DEA proposes in section 1300.01(b) todefine a collector as a registeredmanufacturer, distributor, reversedistributor, or retail pharmacy that isauthorized to receive a controlledsubstance for the purpose of destruction

from an ultimate user, person lawfullyentitled to dispose of an ultimate userdecedents property, or a long term carefacility on behalf of an ultimate userthat resides or has resided at thatfacility. In section 1317.40(a), DEAproposes that registered manufacturers,distributors, reverse distributors, andretail pharmacies may obtain

authorization from DEA to be acollector. No manufacturer, distributor,reverse distributor, or retail pharmacy isrequired to be a collector.

In proposing which DEA registrantscould become authorized collectors,DEA considered public health andsafety, diversion control, andconvenience and accessibility. Inparticular, DEA is proposing toauthorize registered retail pharmacies to

become collectors because suchregistrants are open to the public andhave theft and loss prevention measureswithin the pharmacy processing area as

well as outside the confines of theprescription processing and pick-uparea, which easily lends itself to securecollection receptacle placement. Retailpharmacy personnel also routinelyhandle controlled substances intendedfor the ultimate user in a public settingwhile keeping such substances secure,and they have experience cominglingcontrolled and non-controlledsubstances in the receipt and storageprocess. As public retail establishments,retail pharmacies generally haveexperience with the general public ascustomers and routinely implementtheft and loss prevention measures.

For the foregoing reasons, retailpharmacies co-located with hospitalsmay be authorized to maintaincollection receptacles in accordancewith these regulations. Registeredhospitals themselves, however, may not

be authorized as collectors. This shouldhave limited adverse impact on theability of hospital patients to participatein ultimate user disposal because DEA

believes many hospitals are co-locatedwith registered retail pharmacies as aconvenient service for outpatients. DEAproposes to restrict hospitals from beingauthorized collectors because they do

not generally operate under the samebusiness model or with similar theft andloss prevention procedures as retailpharmacies. For example, the generalpublic is expected to enter retailpharmacies for short durations in orderto conduct retail business. The physicallayout of retail pharmacies is designedfor open, clearly observable commonareas and practically no areas to concealan unlawful purpose. It would beunusual and suspicious for a person tospend an extended amount of time in aretail pharmacy without a known,



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29 In accordance with the Disposal Act, whichpermitted DEA to, by regulation, authorize LTCFsto dispose of controlled substances on behalf ofultimate users that reside or have resided at theLTCF (see 21 U.S.C. 822(g)(3)), DEA is alsoproposing to authorize the collection of controlledsubstances at those LTCFs for which a registeredretail pharmacy is authorized to maintain acollection receptacle (see discussion of LTCFsbelow).

specific purpose, triggering routine theftand loss prevention measures. Incontrast, hospitals are generally open24-hours per day and allow forunsupervised public access; they aremuch larger than retail pharmacies andmany interactions occur behind closeddoors without routine theft and lossprevention measures; and foot traffic is

not routinely monitored for unlawfulpurposes. These differences reduce theeffectiveness of the proposedregulations diversion controlmechanisms and substantially increasethe risk of diversion at hospitals ifhospitals were authorized as collectors.

The above discussed risks in allowinghospitals as collectors are not necessaryin light of the many other optionsavailable to ultimate users to dispose ofunwanted or unused controlledsubstances.

In addition to the increased risk ofdiversion at hospitals, there is a risk of

inadequate recordkeeping if hospitalsare permitted as collectors. Unlike retailpharmacies, registered hospitals do notdispense controlled substances toultimate users pursuant to legitimateprescriptions. Rather, registeredhospitals administer controlledsubstances to inpatients dose by dose,and the controlled substances remainwithin the possession and control of theregistered dispenser, the hospital. Assuch, registered hospitals may notdispose of controlled substances incollection receptacles, but must followthe revised regulations for registrant

destruction, and keep records of suchdestruction.DEA is also proposing to allow retail

pharmacies to operate collectionreceptacles in LTCFs under certaincircumstances, as discussed below,

becauseunlike hospitalsLTCFs facea distinct set of obstacles to the safedisposal of [ultimate user] controlledsubstances due to the increased volumeof controlled substances they handle.Pub. L. 111273, 2, 124 Stat. 2858. DEAis further proposing to authorizeregistered manufacturers, distributors,and reverse distributors to become

collectors because, although suchregistrants have registered locations thatgenerally are not open to the public,they do have heightened securityrequirements and are accustomed toreceiving, securing, and distributinglarge amounts of controlled substanceson a daily basis. DEA believes thatexpanding collector authorization tothese registrants will provide thenecessary convenience and accessibilityto the public while ensuring the publichealth and safety and minimizingpotential diversion.

To obtain authorization to be acollector, a manufacturer, distributor,reverse distributor, or retail pharmacymust apply for a modification to theirregistration in accordance with 21 CFR1301.51, which DEA is proposing torevise in order to reflect these changes.Upon DEA approval of this modificationin registration, each authorized

registrants DEA Certificate ofRegistration will specify that registrantsstatus as a collector and thelocation(s) approved for collection.Once approved to be a collector, theoption for renewal will be available toauthorized registrants when they renewtheir registration.

DEA proposes in section 1317.40(a)that if the registrant that is authorizedto collect ceases activities as a collector,such registrant must modify theirregistration in accordance with 21 CFR1301.51 to indicate that they no longercollect. In accordance with 21 CFR

1301.52, the registration of any personand any modifications, includingauthorization to be a collector,terminates if and when such persondies, ceases legal existence,discontinues business or professionalpractice, or surrenders a registration.Any registrant that ceases legalexistence or discontinues business orprofessional practice must notify theAdministrator promptly of such fact. 21CFR 1301.52(a). Additionally, aregistrants authorization to collect isdependent upon the registration statusof the manufacturer, distributor, reversedistributor, or retail pharmacy.

Accordingly, the expiration, revocation,suspension, or surrender of a DEAregistration will also result in the loss ofthe registrants authorization to be acollector.

DEA proposes in section 1317.40(c)that authorized collectors may conductthe following activities: (1) Receivemail-back packages from ultimate usersand persons lawfully entitled to disposeof an ultimate user decedents propertyif the collector has and utilizes an on-site method of destruction; (2) install,manage, and maintain collectionreceptacles at locations for which the

registrant is authorized to collect; and(3) promptly dispose of sealed innerliners and their contents as provided forin 1317.05(c)(2). DEA proposes insection 1317.40(b) that collection mayoccur only at the registered locations ofmanufacturers, distributors, reversedistributors, and retail pharmacies thatare authorized to collect at thoselocations and at long term care facilities(LTCFs) at which registered retailpharmacies are authorized to maintain acollection receptacle (see discussion onLTCFs below).

DEA proposes to authorize ascollectors those persons alreadyregistered as manufacturers,distributors, reverse distributors, andretail pharmacies because, as registrants,these persons are accountable, haveexperience handling large volumes ofcontrolled substances on a routine basis,and they are subject to controls related

to their DEA registration. These pre-existing controls also protect against thediversion of controlled substances in theprocess of ultimate user collection.Further, DEA believes that ultimate usercollection should occur at DEAregistered locations because thesepremises are subject to DEA inspection,security, and other controls.29 Suchrequirements ensure that propersecurity and other controls are in placeto minimize the risk of diversion fromthe collection of controlled substances.Finally, with the passage of the DisposalAct, Congress did not provide DEA the

authority to register persons specificallyfor the purpose of collecting anddisposing of controlled substances fromultimate users. DEA is thereforerestricted to operating within itspreviously existing statutory authoritywith regard to registration.

In section 1317.45, DEA proposes thatauthorized collectors employ as anagent or employee with access to orinfluence over controlled substancesacquired pursuant to their status as acollector, only those persons that havenever been convicted of any felonyoffense related to controlled substancesand have never, at any time, had an

application for registration with DEAdenied, had a DEA registration revokedor suspended, or surrendered a DEAregistration for cause. DEA is proposingsecurity requirements for collectors inorder to strengthen the accountability ofthe ultimate user collection process,which occurs outside the closed systemof distribution, by ensuring that onlythose employees that have met certainemployee screening requirements haveaccess to or influence over controlledsubstances collected from ultimateusers. This requirement is similar to theemployee screening requirements for

registered practitioners in 21 CFR1301.76, where there is also a high riskof diversion.

The information that collectors mustmaintain in their records is proposed in



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30The recordkeeping requirements differdepending on whether the records pertain to theregistrants inventory or stock, or the registrantsactivities as an authorized collector. Therequirements contained in the current regulationsare those imposed on registrants with regard to theirstock on hand (i.e., their inventory of controlledsubstances). Controlled substances collected fromultimate users are not part of a registrantsinventory and would not be counted as such.

31Reverse distributors or distributors may acquirecontrolled substances that have been collected bycollection receptacle at either an authorizedcollectors registered location or, pursuant tosections 1317.75(g) and 1317.80(d), at a long termcare facility for which a registered retail pharmacyis authorized to collect. See subsequent discussionfor more detail on reverse distributors.

32For clarity, DEA proposes in 21 CFR1304.11(e)(2) and 1304.22(b) to cross referencethese reverse distributor and distributorrecordkeeping requirements covered by 21 CFR1317.55.

section 1317.50. In accordance with theCSA, every DEA registrant must make a

biennial inventory and maintain, on acurrent basis, a complete and accuraterecord of each controlled substancemanufactured, received, sold, delivered,or otherwise disposed of. 21 U.S.C.827(a).30 These records must bemaintained separately from all other

records of the registrant or,alternatively, in the case of non-narcoticcontrolled substances, be in such a formthat required information is readilyretrievable from the ordinary businessrecords of the registrant. 21 U.S.C.827(b)(2). The records must be kept and

be available for at least two years forinspection and copying by officers oremployees of the Attorney General. 21U.S.C. 827(b)(3). DEA may promulgateregulations that specify the informationthat registrants are required to maintainin their records. 21 U.S.C. 827(b).

To this end, DEA is proposing

information that collectors must recordbased on the particular ultimate usercollection method utilized (i.e., mail-

back program or collection receptacle).The inner liners and mail-back packagesthat DEA proposes to be utilized in thecollection of ultimate user controlledsubstances are intended for the disposalof controlled substances. As a result,DEA is requiring that collectors make aninventory of all inner liners and mail-

back packages and maintain records onthe use and destruction of such linersand packages in order to properlyaccount for the disposal of controlledsubstances in accordance with the CSA.

Once sealed, inner liners and mail-backpackages shall not be opened, x-rayed,or otherwise penetrated and thesubstances contained in the inner linersand mail-back packages may not beindividually handled, counted,inventoried, or otherwise discerned.

DEA is also proposing in section1317.50 that collectors be exempt fromthe ARCOS requirements in 21 CFR1304.33 and the order formrequirements in 21 CFR part 1305 onlywhen they collect controlled substancesfrom ultimate users or other authorizednon-registrant persons. Such substances

are outside the closed system ofdistribution, and these tracking andaccountability mechanisms are designedfor substances within the closed systemof distribution.

Registered Reverse Distributors andDistributors

DEA appreciates that law enforcementagencies and authorized collectors maynot have the resources to destroycontrolled substances received fromultimate users. Such persons may usethe services of a registered reversedistributor for this purpose. DEAproposes in section 1317.55(a) toauthorize registered reverse distributorsto acquire for purposes of destructioncontrolled substances that have beencollected by: (1) Law enforcementagencies; and (2) authorized collectorsthrough collection receptacles. DEA alsoproposes in section 1317.55(b) toauthorize registered distributors, inaddition to registered reversedistributors, to acquire for purposes ofdestruction controlled substancescollected by authorized collectorsthrough collection receptacles.31 DEA isproposing in section 1317.55(c) that

registered reverse distributors andregistered distributors that choose toacquire such collected controlledsubstances from authorized collectorsdo so in the manner prescribed foracquiring registrants controlledsubstance inventory for purposes ofdisposal. This consistent procedure willhelp provide certainty in the disposalprocess, and help prevent errors duringthe acquisition process. Suchacquisitions may be made pursuant topick-up by the reverse distributor ordistributor at the registrants registeredor authorized collection location, by

delivery by common or contract carrierto the reverse distributors ordistributors registered location, or bydirect delivery from a non-practitionerto the reverse distributors ordistributors registered location.

DEA proposes that authorizedcollectors that conduct mail-backprograms must have and use an on-sitemethod of destruction, and, as a result,these collectors will not be authorizedto deliver or transfer those substances toa registered reverse distributor ordistributor. The requirement to destroyon-site would not apply to lawenforcement agencies that conduct mail-

back programs; law enforcementagencies may continue to transfer anycollected substance to an authorizedreverse distributor.

Registered reverse distributors anddistributors do not have to be

authorized collectors to acquirecollected controlled substances fromlaw enforcement agencies or authorizedcollectors. In such circumstances, thesubstances being acquired have already

been collected by law enforcementagencies and authorized collectors andshould already be securely sealed in aninner liner or mail-back package in

accordance with sections 1317.651317.80.

DEA also proposes in section1317.55(c) that those registered reversedistributors and distributors that acquirecontrolled substances from lawenforcement agencies and authorizedcollectors must destroy such controlledsubstances or securely transfer and storethe controlled substances utilizingapplicable procedures described insection 1317.15(c) until timelydestruction can occur. In addition,reverse distributors and distributorsmust destroy the controlled substances

as soon as practicable but no later thanfourteen calendar days of pick-up ordelivery, pursuant to proposed section1317.15(d). Consistent procedures forthe acquisition and disposal ofregistrant inventory and ultimate usercollected controlled substances willstreamline practices and help preventconfusion and error in the transfer,storage, and destruction processes. Anystorage of such substances at theregistered location of the reversedistributor or distributor must be in amanner consistent with the securityrequirements for Schedule II controlledsubstances. This is to minimize the risk

of diversion because inner liners andmail-back packages shall not be openedonce they are sealed and their contentswill not be known, and, as a result, suchliners and packages should be stored asthough each contains a Schedule IIcontrolled substance.

DEA also proposes in sections1317.55(d) and 1317.100 to require thatthese reverse distributors anddistributors keep records regarding thereceipt, storage, transfer, anddestruction of those controlledsubstances acquired from lawenforcement agencies and authorized

collectors.32

Such records will help toensure that the collected substances areaccounted for and properly destroyed.

Finally, DEA proposes in section1317.55(e) and (f) to exempt reversedistributors and distributors that acquirecollected controlled substances fromlaw enforcement agencies or authorizedcollectors from the ARCOS



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33DEA proposes in section 1317.02 to define lawenforcement officer for the purpose of 21 CFR part1317. In order to prevent the appearance that a thirdparty has access to or influence over controlledsubstances, for example by directly or indirectlyfunding law enforcement disposal activities, DEA isrequiring the law enforcement officer to be directlyemployed full time by a law enforcement agency,be under the direction and control of the federal,state, tribal, or local government, be acting in thecourse of their official duty, and be duly sworn andgiven the authority by the federal, state, tribal, orlocal government to: (1) Carry firearms; (2) executeand serve warrants; (3) make arrests withoutwarrant; and (4) make seizures of property.

requirements in 21 CFR 1304.33 and theorder form requirements in 21 CFR part1305, only when they acquire controlledsubstances that have been collectedfrom ultimate users by law enforcementagencies or authorized collectors. Suchsubstances are outside the closed systemof distribution, and these tracking andaccountability mechanisms are designed

for substances within the closed systemof distribution.

Disposal of Controlled Substances byUltimate UsersAuthorized Methods

Take-Back Events

The first method of collection thatDEA proposes, in section 1317.65, istake-back events. Ultimate users andpersons lawfully entitled to dispose ofan ultimate user decedents propertywould be authorized to utilize a take-

back event in accordance with 1317.65to dispose of their controlled substances

in Schedules II, III, IV, and V. Asmentioned above, DEA is proposingspecific language that will continue toauthorize law enforcement agencies toconduct take-back events. DEA believesthat take-back events should beconducted only by law enforcementagencies because such events are highlypublicized, are often held at easilyaccessible locations within acommunity, and do not have the samesecurity controls as permanentcollection locations. As such, take-backevents are more vulnerable to diversion.Although only law enforcementagencies would continue to beauthorized to conduct take-back events,DEA proposes in section 1317.65(a) thatprivate entities or community groupsmay continue to partner with lawenforcement to hold community take-

back events, thereby allowing for greatercommunity involvement, education,and outreach, while minimizing the riskof diversion.

Many of the provisions that DEAproposes in section 1317.65, withrespect to take-back events, arerecommendations (should instead ofshall) because DEA has no intent tochange existing law enforcementprocedures regarding the handling,storage, transfer, or destruction ofcontrolled substances. DEA is, however,proposing some requirements that lawenforcement agencies must follow inorder to hold a take-back event. Forexample, in section 1317.65(b), DEAproposes that any law enforcementagency that conducts a take-back eventshall appoint a law enforcement officer,who must be employed full time by theagency, to oversee the collection.Further, law enforcement officers

employed 33 and authorized by the lawenforcement agency conducting thetake-back event must maintain controland custody of the collected substancesfrom the time the substances arecollected from the ultimate user orperson authorized to dispose of theultimate user decedents property untilsecure transfer or destruction has

occurred. DEA believes that designatedlaw enforcement officers should berequired to maintain control andcustody of the controlled substances atall times in order to protect against theftand diversion.

Take-back events provide ultimateusers the opportunity to dispose ofSchedule II, III, IV, and V controlledsubstances, which they legally possess,at a designated place and time. DEAproposes in section 1317.65(c) that eachtake-back event should have at least onereceptacle for the collection ofpermitted substances. Although this is

only a recommendation for lawenforcement agencies that conduct take-back events, DEA believes that optimalsecurity and protection of public healthand safety can be achieved if controlledand non-controlled substances arecollected in a collection receptacle thatis securely locked and substantiallyconstructed with an outer shell andremovable inner liner.

DEA also proposes in section1317.65(e) that only an ultimate user orperson lawfully entitled to dispose of anultimate user decedents property maytransfer controlled substances to the lawenforcement agency during the take-

back event. No other person, such as atake-back event volunteer, may handleor touch the controlled substances atany time. DEA is proposing thisrequirement to limit the number ofhands through which the substancespass because the risk of diversionincreases each time a controlledsubstance is transferred to a new person.

Mail-Back Programs

The second method of collection thatDEA proposes, in section 1317.70, ismail-back programs. Ultimate users andpersons lawfully entitled to dispose ofan ultimate user decedents property are

authorized to utilize a mail-backprogram in accordance with 1317.70 todispose of their controlled substances inSchedules II, III, IV, and V. DEAproposes in section 1317.70(a) specificlanguage to continue to authorize lawenforcement agencies to voluntarilyconduct mail-back programs; and mail-

back programs may be conducted by

registered manufacturers, distributors,reverse distributors, or retail pharmaciesthat: (1) Are authorized as collectors;and (2) have and utilize an on-sitemethod of destruction at their registeredlocation. The security requirementsproposed with respect to the otherproposed collection methods (take-backevents and collection receptacles) areadequate to ensure that controlledsubstances are collected and maintainedin a manner that prevents diversionuntil transfer and destruction can occur.Designing regulations that ensure thesecurity of controlled substances in the

context of mail-back programs ischallenging because, unlike take-backevents and collection receptaclelocations, there is a third party whohandles the controlled substances asthey are transferred from the ultimateuser to the authorized collector in mail-

back programsthe mail system. Thisunique circumstance providesopportunities for diversion that do notexist with the other collection methods,thus requiring more stringent controlsthan the other methods. As a result,DEA proposes to allow mail-backprograms to be voluntarily conducted by

DEA registrants that are authorizedcollectors that have and utilize an on-site method of destruction and by lawenforcement agencies in order tominimize the transfer of controlledsubstances between various locations.This is intended to minimize the risk ofdiversion.

DEA also proposes in section1317.70(c) that any authorized collectoror law enforcement agency thatconducts a mail-back program mustproduce and provide specifiedpackages, either at no cost or for a fee,to ultimate users for the collection of

controlled substances through the mail,and may do so in partnership with thirdparties for convenience, funding, or anyother lawful purpose. One example ofsuch a partnership would be when anauthorized collector with an on-sitemethod of destruction (e.g., a DEA-registered reverse distributor) producesappropriate mail-back packages, andallows a third party business partnerthat is frequently accessed by the public(e.g., a retail pharmacy) to provide thesepackages to patronizing customers. Inthis circumstance, the registered reverse



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distributor would be responsible foroperating the mail-back program,including recordkeeping and security,and it must receive the mail-backpackages directly at its registeredlocation for on-site destruction. DEAproposes that packages used forcollection by mail-back must meetcertain specifications. The proposed

package requirements include onlythose specifications necessary to ensurethat controlled substances sent throughthe mail, outside of the closed system ofdistribution, can be tracked with a highdegree of confidence in their security.These requirements are intended toprotect public health and safety andprevent the diversion of controlledsubstances.

In particular, the packages areproposed to be postage paid (e.g.,

business reply), preaddressed to theauthorized mail-back location,nondescript, tamper-evident and tear-

resistant, among other things. This is toensure that the mailers are not delayedor diverted through address changes,theft, or because the package hasinadequate postage. Such mailers must

be addressed to the authorizedcollectors registered location with theon-site method of destruction or to thelaw enforcement agencys physicaladdress and cannot be addressed to anyother location, such as a post office box.

DEA is also proposing to require thateach package must have a uniqueidentification number so that eachpackage can be tracked. In an effort toincrease the ease of program

implementation and to enhance thesecurity of the mail-back option, DEA isalso proposing that each packageinclude instructions for the user thatindicate the process for mailing back thepackage, the permitted substances thatcan be sent, and notice that onlypackages provided by the authorizedcollector will be accepted fordestruction.

DEA considered requiring registrantsto establish a system that would allowultimate users to notify the collectorwhen the ultimate user mailed back apackage containing controlled

substances, similar to pilot projectsdescribed in the public hearing.However, the burden of requiring anotification system outweighed the

benefits of such a system, particularlywhen other security-enhancingmeasures are proposed. DEA believesthat the collector inventory andrecordkeeping requirementsthat acollector conducting a mail-backprogram must keep inventory of mailerscreated and record the uniqueidentification number of each mail-backpackage receivedcoupled with the

stringent package specificationsforexample the package must be postagepaid and preaddressedare

Documents

Drug Take-back Program 2012-30699