Answer: This question applies in the context where controlled substance prescription medications (schedules II-V) are considered "abandoned" as patients and/or visitors no longer possess the controlled substance because they left the controlled substance at a practitioner's registered location and they cannot be returned. In order to avoid such an "abandonment", practitioners may try to contact the patient or visitor who had left such medications at the practitioner's location in order for the patient or visitor to obtain the controlled substance medication and maintain possession. If practitioners successfully contact the patient or visitor, then they may return such medications to the proper owner in person upon verification that the owner is the ultimate user of the medication. The Controlled Substances Act defines "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). However, the remainder of this response addresses circumstances where such a return is not feasible and the controlled substance is considered abandoned.

As DEA explained in the preamble of the Final Rule titled "Disposal of Controlled Substances" (79 FR 53519, September 9, 2014), the DEA has limited authority regarding who may deliver pharmaceutical controlled substances for the purpose of disposal. Pursuant to the Secure and Responsible Drug Disposal Act of 2010, Congress granted DEA authority to authorize three groups of people to deliver controlled substances for the purpose of disposal.

• First, an ultimate user who has lawfully obtained a pharmaceutical controlled substance may deliver the substance to another person who is authorized to accept it for the purpose of disposal.
• Second, if a person dies while lawfully in possession of a pharmaceutical controlled substance, any person lawfully entitled to dispose of the decedent's property may deliver the substance to another person for the purpose of disposal. 21 CFR 1317.30.
• Third, long term care facilities may dispose of pharmaceutical controlled substances on behalf of ultimate users who reside or have resided at such facilities. 21 U.S.C. 822(g).

The DEA has no authority to expand the types of individuals and entities lawfully permitted to deliver pharmaceutical controlled substances for the purpose of disposal.

As such, DEA regulations do not permit practitioners to dispose of abandoned controlled substances, even if the ultimate user is a patient of the practitioner. Federal, state, and tribal laws may also prohibit such disposal. Therefore, when controlled substance prescription medications (schedules II-V) are abandoned by patients or visitors and return to them as the ultimate user is not feasible, DEA recommends that practitioners contact state, local, and tribal law enforcement or their local DEA office as soon as possible for guidance on proper disposal procedures. 79 FR 53546.

DEA notes that some hospitals/clinics, Narcotic Treatment Programs (NTPs), and other institutional practitioners operate in states that have passed laws or regulations authorizing the disposal of controlled substances that have been dispensed to an admitted patient and are considered abandoned (e.g., the patient left the controlled substance medications and they cannot be returned; or the patient is deceased and the state has authorized that the hospital can dispose of the decedent's personal property to include controlled substance medications). The hospitals/clinics, NTPs, and other institutional practitioners located in these states should dispose of the abandoned controlled substance medications in accordance with federal, state, local, and tribal laws and regulations pertaining to disposal of controlled substances. DEA defines "institutional practitioner" to mean a hospital or other person (other than an individual) licensed, registered, or otherwise permitted by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy. 21 CFR 1300.01.

Before handling any abandoned controlled substances, DEA registrants are advised to take every precaution to ensure the safety of their staff, patients, and visitors. Illicit counterfeit medications containing fentanyl, methamphetamine, or other potentially lethal substances, often look like legitimate prescription drugs. Because registrants cannot be sure of the contents of any abandoned medications, extreme care should be taken when handling them. When in doubt, registrants should contact local law enforcement or their local DEA office. EO-DEA238, DEA-DC-073, June 13, 2023

Answer: All DEA registrants, including DEA-registered authorized collectors, are required to notify the DEA Field Division Office in their area, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of the theft or loss; the registrant must also follow up on the written notification by subsequently filing a DEA Form 106 for the theft or significant loss. 21 CFR 1301.74(c); 21 CFR 1301.76(b). 21 CFR 1301.74(c)(1)-(6) and 1301.76(b)(1)-(6) also direct DEA registrants, including DEA authorized collectors, how they may determine whether a loss is significant. See also the Federal Register (FR) Final Rule published by DEA on September 12, 2005, titled Reports by Registrants of Theft or Significant Loss of Controlled Substances, 70 FR 47094.

If a sealed inner liner is stolen, lost, or missing from an authorized collector’s registered location (or authorized long-term care facility) before the sealed inner liner is picked up for destruction or destroyed on-site as allowed by 21 CFR 1317.05(c)(2), the authorized collector has the responsibility to both report the theft or loss as well as file a DEA Form 106 for the sealed inner liner. However, the authorized collector does not have the responsibility to file a DEA Form 106 for the actual contents of the liner because an inner liner’s contents are not allowed to be sorted or inventoried after being placed in a collection receptacle, and the sealed inner liner may not be opened once it is removed from the collection receptacle. See 21 CFR 1317.60(c); 1317.75(c).

Pursuant to 21 CFR 1317.40, DEA has authorized several types of registrants to be collectors after modifying their registration in accordance with 21 CFR 1301.51(b). Authorized collectors who are DEA registrants are designated as either non-practitioners (i.e., manufacturers, distributors, reverse distributors, and narcotic treatment programs), or practitioners (i.e., hospitals/clinics with an on-site pharmacy and retail pharmacies). 21 CFR 1317.05(c)(2)(iv)-(v). Here, non-practitioner collectors are responsible for filing a DEA Form 106 for the sealed inner liner as directed by 21 CFR 1301.74(c), and practitioner collectors are responsible for filing a DEA Form 106 for the sealed inner liner as directed by 21 CFR 1301.76(b). In addition, DEA-registered authorized collectors must also be in compliance with applicable State, local or tribal laws. EO-DEA122A, DEA-DC-058, September 15, 2022

Answer: All DEA registrants, including DEA-registered authorized collectors, are required to notify the DEA Field Division Office in their area, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of the theft or loss; the registrant must also follow up on the written notification by subsequently filing a DEA Form 106 for the theft or significant loss. 21 CFR 1301.74(c); 21 CFR 1301.76(b). 21 CFR 1301.74(c)(1)-(6) and 1301.76(b)(1)-(6) also direct DEA registrants, including DEA authorized collectors, how they may determine whether a loss is significant. See also the Federal Register (FR) Final Rule published by DEA on September 12, 2005, titled Reports by Registrants of Theft or Significant Loss of Controlled Substances, 70 FR 47094.

If a sealed inner liner is stolen, lost, or missing while in a common or contract carrier’s custody after a DEA-registered authorized collector requests pick-up, as allowed by 21 CFR 1317.05(c)(2), the authorized collector from whom the sealed inner liner was picked up still has the responsibility to both report the theft or loss as well as file a DEA Form 106 for the sealed inner liner, as all in-transit losses of controlled substances must be reported to DEA, not just significant losses. See 21 CFR 1301.74(c); see also 70 FR 47096. In the alternative, if a reverse distributor arranged for the pick-up of the sealed inner liner from the DEA-registered authorized collector (see 21 CFR 1317.15), using either the reverse distributor’s own employees or via a common or contract carrier hired by the reverse distributor, DEA considers the reverse distributor as having the responsibility to both report the theft or loss as well as file a DEA Form 106 for the sealed inner liner after the liner is picked up. See 21 CFR 1317.15(b), 1301.74(c). On the other hand, neither the authorized collector nor the reverse distributor has the responsibility to file a DEA Form 106 for the actual contents of the liner because an inner liner's contents are not allowed to be sorted or inventoried after being placed in a collection receptacle, and the sealed inner liner may not be opened once it is removed from the collection receptacle. See 21 CFR 1317.60(c); 1317.75(c). In addition, DEA-registered authorized collectors must also be in compliance with applicable State, local or tribal laws. EO-DEA122B, DEA-DC-059, September 15, 2022

Answer: Federal, State, tribal, or local law enforcement agencies may collect and dispose of controlled substances from ultimate users and other non-registrants as permitted by 21 CFR 1317.30 and 1317.35. Additionally, Federal, State, tribal, and local law enforcement agencies utilizing collection receptacles are exempt from the registration and reporting requirements otherwise imposed on DEA registrants. See 21 CFR 1301.24(a)-(b). Because the law enforcement agencies in this scenario are not registrants, they therefore would not be obligated to report thefts or significant losses of controlled substances to DEA, or file a DEA Form 106. See 21 CFR 1301.24(a)-(b); 21 CFR 1301.74(c); 21 CFR 1301.76(b). Such a law enforcement agency may nevertheless contact the DEA field office in its area if the law enforcement agency desires assistance with conducting its investigation if a theft or significant loss of a sealed inner liner occurs. EO-DEA122C, DEA-DC-060, September 15, 2022

Answer: DEA’s regulations on disposal do not specifically prohibit these scenarios. 21 CFR 1317.55(c) requires a reverse distributor to acquire collected substances (sealed inner liner) from DEA registrants authorized as collectors in accordance with 21 CFR 1317.15(b), which directs a reverse distributor to:

(1) Pick-up controlled substances from a registrant at the registrant's registered location or authorized collection site; or

(2) Receive controlled substances delivered by common or contract carrier or delivered directly by a non-practitioner registrant.

(i) Delivery to the reverse distributor by an authorized registrant directly or by common or contract carrier may only be made to the reverse distributor at the reverse distributor's registered location. Once en route, such deliveries may not be re-routed to any other location or person, regardless of registration status.

(ii) All controlled substance deliveries to a reverse distributor shall be personally received by an employee of the reverse distributor at the registered location.

If a non-practitioner registrant authorized as a collector directly delivers a sealed inner liner to a reverse distributor as mentioned above, 21 CFR 1317.95(b) requires, in part, that "the [controlled] substances shall be constantly moving towards their final location and unnecessary or unrelated stops and stops of an extended duration shall not occur." 21 CFR 1317.95(b)(1).

Although not mandated by the regulation, DEA suggested in the Federal Register in the Final Rule, Disposal of Controlled Substances 79 FR 53519, that because transportation to destruction facilities may occur over long distances, the collected substances (sealed inner liner) should be constantly moving towards their final destruction destination, and unnecessary or unrelated stops, and stops of an extended duration should not occur (see 79 FR 53555).

Outside of the above regulatory requirements, and the precatory language set forth in the Federal Register, DEA does not specify exactly how to transport a sealed inner liner from the DEA-registered authorized collector to a reverse distributor when utilizing a common courier for transport. DEA also explained in the above-referenced Final Rule that DEA’s primary concern regarding common or contract carriers was whether there is adequate security to prevent diversion when controlled substances are being transported. See 79 FR 53527-53528. Additionally, all registrants must provide effective controls and procedures to guard against theft and diversion of controlled substances. See 21 CFR 1301.71(a).

If a DEA-registered authorized collector or reverse distributor has specific questions or proposals regarding the physical security of the handling of controlled substances, including transportation plans involving a sealed inner liner, the collector or reverse distributor should forward and address such questions or proposals to the Special Agent in Charge in the region in which the proposal pertains, or to DEA’s Regulatory Section. See 21 CFR 1301.71(d). EO-DEA122D, DEA-DC-061, September 15, 2022

Answer: In accordance with 21 CFR 1317.15, 21 CFR 1317.55, and 21 CFR 1304.21(d), a reverse distributor acquires controlled substances (including sealed inner liners) when it picks up the controlled substances from a registrant at the registrant’s registered location or authorized collection site or from law enforcement, or when it receives the controlled substances delivered by common or contract carrier or delivered directly by a non-practitioner registrant or law enforcement.

Additionally, 21 CFR 1317.15(d) states, "A reverse distributor shall destroy or cause the destruction of any controlled substance received for the purpose of destruction no later than 30 calendar days after receipt." See 21 CFR 1317.05(c)(2)(iv)-(v) regarding authorized methods of sealed inner liner destruction. DEA reverse distributors are also reminded of their record keeping obligations with respect to sealed inner liners. See 21 CFR 1304.22(e)(4)-(5). EO-DEA122E, DEA-DC-062, September 15, 2022

Answer: While neither the Controlled Substances Act nor DEA’s regulations specifically address reporting the breakage and/or spillage of a controlled substance, on August 12, 2005, DEA published in the Federal Register (FR) a Final Rule, Reports by Registrants of Theft or Significant Loss of Controlled Substances, 70 FR 47094. In that rule, DEA remarked that previous guidance on the topic, given in a July 8, 2003 Notice of Proposed Rulemaking and Guidance Document, Reports by Registrants of Theft or Significant Loss of Controlled Substances, 68 FR 40576, was adequate and sufficiently clear: the witnessed breakage or spillage of a controlled substance does not constitute a loss of controlled substances because the registrant can account for the controlled substances; these types of incidents do not require notification to DEA. 70 FR 47096; see also 68 FR 40578. DEA also stated that registrants "should continue to employ common sense, good faith approaches to their reporting and recordkeeping obligations in the case of breakage and spillage." 70 FR 47096. DEA registrants are also reminded of their recordkeeping obligations with respect to controlled substances that are disposed of by destruction. See 21 CFR 1304.22(a)(2)(ix). EO-DEA144. DEA-DC-051, June 17, 2021

Answer: When a registrant dies, the DEA registration terminates and the inventory of controlled substances must be disposed of. Per 21 CFR 1301.52(a), a DEA registration terminates when a person dies, as well as when the business ceases legal existence, a business or professional practice is discontinued, or a registrant surrenders their registration. DEA regulations do not permit controlled substances in a registrant's inventory to be disposed of by way of drug take-back collection. See 21 CFR 1317.05, 1317.65. For individuals or entities handling a deceased registrant's affairs, local or State law enforcement should be contacted to assist in picking up controlled substances inventory for disposal. For uncommon situations, such as those involving the location of controlled substance inventories subsequent to a registrant death, local DEA Diversion offices can be contacted and consulted for guidance on next-steps. EO-DEA224, October 5, 2020

Answer: To comply with the DEA regulations when disposing of a controlled substance, registrants must use a method which renders the substance "non-retrievable" (21 CFR 1317.90(a)) and otherwise complies with relevant law and regulations. The term "non-retrievable" is defined in a results oriented manner as DEA requires the substance to be permanently rendered to an unusable state. 21 CFR 1300.05. The performance standard is that the method irreversibly renders the substance such that it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. Thus, regardless of whether the product claims to render controlled substances non-retrievable, to comply with the DEA regulations, a registrant that disposes of a controlled substance must use a product or method that actually does render the controlled substance non-retrievable within the meaning of the DEA regulations. Much like DEA does not evaluate, review, or approve the specific processes or methods utilized to produce, synthesize or propagate a controlled substance, DEA will not evaluate, review, or approve the processes or methods utilized to render a controlled substance "non-retrievable," as long as the desired result is achieved. EO-DEA178, October 5, 2020

Answer: Yes. An LTCF may dispose of controlled substances in schedules II-V on behalf of a resident or decedent of the facility who is or was in lawful possession of that controlled substance. 21 CFR 1317.30(b)(3). The controlled substances must be disposed of by transferring them into an authorized collection receptacle located at that LTCF within three business days after the permanent discontinuation of use as directed by the prescriber, or the resident’s transfer from that facility, or as a result of death. 21 CFR 1317.80. An LTCF must also ensure disposal is done in accordance with all applicable State, tribal and local controlled substance disposal laws and regulations. EO-DEA174, October 5, 2020

Answer: A registrant can transfer expired or unwanted controlled substances to a reverse distributor for final destruction; the reverse distributor will typically use incineration or a method that renders the controlled substance non-retrievable. A registrant also has the option of destroying controlled substances on-site at their registered location provided the destruction method meets the non-retrievable standard. Registrants who destroy their controlled substance inventory must document the destruction on a DEA Form 41 (see 21 CFR 1304.21(e). EO-DEA200, October 5, 2020

Answer: Not at this time. The controlled substances you are referring to are part of your inventory. The regulations enforced by DEA require that controlled substances, which are part of a DEA registrant’s inventory, be disposed of to the point of being non-retrievable. 21 CFR 1317.90(a). EO-DEA221, October 5, 2020