Proper disposal of unused or expired controlled substance medications is an important public health initiative to help address the drug abuse epidemic. Until 2014, however, the DEA did not permit the return of controlled substances by a nonregistrant (e.g., patients, LTCFs) to a pharmacy for disposal. The basis for the DEA's opinion was that the law did not expressly permit this practice.

The agency recognized that its strict position on returns to a pharmacy conflict with its primary concern of reducing diversion and abuse as well as the concerns of many in society who want safe and responsible options for the disposal of controlled substances. To these ends, the agency issued an advance notice of rulemaking in January of 2009, seeking comments from stakeholders regarding what should be included in a regulation that would allow ultimate users and LTCFs to dispose of controlled substances (74 Fed. Reg. 3480). Subsequently, the DEA held a series of national take-back programs, starting in 2010, through local law enforcement agencies to facilitate the disposal of controlled substances and other medications.

However, in response to the prescription drug abuse epidemic, it was Congress that proposed a remedy to the problem by passing the Secure and Responsible Drug Disposal Act of 2010 (P.L. 111-273). This law permits an ultimate user (i.e., patient) who has lawfully obtained a controlled substance to deliver it to another person for disposal, if the person receiving the controlled substance is authorized to engage in disposal and the disposal takes place pursuant to regulations to be issued by the DEA. The law also directed the DEA to develop regulations authorizing LTCFs to dispose controlled substances on behalf of their residents.

The final DEA regulations implementing the Secure and Responsible Drug Disposal Act became effective on October 9, 2014 (79 Fed. Reg. 53520). The regulations expand options available to collect controlled substances from ultimate users, including: take-back events, mail-back programs, and collection receptacle locations. The new rules allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with on-site pharmacies, and retail pharmacies to collect pharmaceutical controlled substances from ultimate users by voluntarily administering mail-back programs and maintaining collection receptacles. In addition, the regulations allow authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at LTCFs.

Subsequently, the DEA added regulations defining "collection" and "collector." Collection is defined as:

Collector is defined as:

Thus, to become a collector, an eligible entity must register with the DEA. Retail pharmacies and hospitals/clinics with on-site pharmacies may modify their registrations to obtain authorization to be a collector. The voluntary registration as a collector requires compliance with additional DEA rules. For example, an authorized retail pharmacy or hospital/clinic with an on-site pharmacy maintaining collection receptables may only collect inside the registered location or at LTCFs, where the receptacles are maintained (21 CFR 1317.40(b),1317.75(d)); collection receptacles must meet design specifications and only be located in designated areas (21 CFR 1317.75(d)-(e)); and collectors maintaining receptables must use specific inner liners, keeping records regarding installation, removal, and transfer of liners (21 CFR 1317.60(a)-(c), 21 CFR 1304.22(f)(2)). Furthermore, controlled and noncontrolled substances may be collected together and be comingled (21 CFR 1317.75(b)); collectors can only allow ultimate users and other authorized nonregistrant persons in lawful possession of a controlled substance in schedule II, III, IV, or V to deposit such substances in a collection receptacle (21 CFR 1317.75(c)); and at no time may collectors count, sort, inventory, or individually handle any substances deposited into a collection receptable (21 CFR 1317.75(c)).

One can search for registered collectors at the DEA Drug Disposal Information website (https://www.deadiversion.usdoj.gov/drug_disposal/). This website also offers a variety of additional resources for healthcare providers and consumers regarding drug disposal. Similarly, the FDA offers guidelines to consumers for disposing of medications at https://www.fda.gov/consumers/consumer-updates/where-and-how-dispose-unused-medicines.

As mentioned earlier, the DEA has restrictions on nonregistrants transferring their controlled substances to registrants. When patients bring controlled substance medications from home to the hospital setting, and if the patient is admitted to the hospital, a concern comes up regarding the hospital taking possession from the ultimate user. The DEA has provided that when a patient is admitted to a hospital via an ambulance and has dispensed medications (including controlled substances) in their possession, and no family is present, the following options are available:

• If the treating practitioner determines that the controlled substance medication(s) brought by the patient should continue to be taken, the hospital could secure the controlled substances with the patient's effects in his or her hospital room (e.g., small safe or secured lock box). In this scenario, the hospital has not taken possession of the controlled substances and it would not be considered an unlawful distribution by the patient under 21 U.S.C. 841(a).

• If the treating practitioner determines that it is medically inappropriate for the patient to continue taking any controlled substance medication(s) brought to the hospital, or if the hospital has a policy not permitting patients to bring their dispensed medications into the hospital, the hospital has the following options:

  • If a member of the patient's household arrives at the hospital, the hospital can turn over the patient's medication(s) to them. This individual can then take the controlled medications back to the home and/or dispose of the medication(s) properly.

  • If a hospital is an authorized collector and has placed a collection receptacle at its registered location, a member of the patient's household may dispose of the patient's medication(s) in the hospital's collection receptacle.

  • If a hospital has empty mail-back packages (no modification of the hospital's DEA registration is required), the hospital may provide one or more of the mail-back packages to a member of the patient's household to place the medication(s) into the mail-back package(s) and seal the package(s) for mailing to the authorized DEA registered reverse distributor for disposal purposes.

  • If a member of the patient's household is not present, and there is no authorized person to dispose of the controlled substances (such as when controlled substances are abandoned and return to the ultimate user is not feasible), the hospital should contact local law enforcement or their local DEA Diversion Field Office for guidance on proper disposal procedures (79 FR 53546).

  • If the state where the hospital is located has a law or regulation authorizing a hospital to dispose of controlled substances that have been dispensed to a patient admitted to the hospital 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), a hospital may properly dispose of the abandoned controlled substance medications.