DEA Issues its Final Rule on Disposal of Controlled Substances
September 30, 2014 10:43 AM
On September 9, 2014 the Disposal of Controlled Substances Final Rule was printed in the Federal Register. The rule is effective October 9, 2014. This rule governs the secure disposal of controlled substances by registrants and ultimate users. These regulations will implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances from ultimate users for the purpose of disposal, including: Take-back events, mail-back programs, and collection receptacle locations. An ultimate user includes ‘‘a person who has lawfully obtained, and possesses, a controlled substance for his own use or for the use of a member of his household’’ (emphasis added) (21 U.S.C. 802(27)).
Accordingly, a member of the hospice patient’s household may dispose of the patient’s pharmaceutical controlled substances, but the home hospice or homecare provider cannot do so unless otherwise authorized by law - for example, under state law - to dispose of the decedent’s personal property and in cases where an ultimate user has given permission to the hospice to dispose of the medication.
The DEA encourages home hospice and other homecare providers to assist their patients, and their patients’ families, in disposing of pharmaceutical controlled substances in accordance with applicable regulations. While education is paramount, home healthcare agencies are also encouraged to partner with authorized collectors to promote or jointly conduct mail-back programs.
The Disposal Act provides that ‘‘if a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent’s property may deliver the controlled substance to another person for the purpose of disposal under the same conditions as provided’’ for ultimate users (21 U.S.C. 822(g)(4)), meaning that a member of the decedent’s household can give the medications to hospice staff for disposal if that staff person is legally authorized to receive it and dispose of it. Otherwise, home hospice and homecare personnel are not authorized to receive pharmaceutical controlled substances from ultimate users for the purpose of disposal.
The National Association for Home Care & Hospice (NAHC) cautions hospice and homecare providers to review their applicable state regulations as some states have rules governing the transport and disposal of controlled substances of ultimate users and to utilize these options. NAHC also alerts hospice and homecare providers that members of a decedent’s household or a patient (ultimate users) may bring unwanted controlled substances to the hospice or home care office for disposal but these office locations may not be acceptable as legal take-back or disposal sites. Again, please refer to state law in conjunction with the national Disposal of Controlled substances final rule.
Some hospices have asked about the disposal options for residents of a long term care facility (LTCF). The DEA provides options for the disposal of pharmaceutical controlled substances by a LTCF on behalf of a person who resides, or has resided, at the LTCF, regardless of whether or not that person is also receiving hospice care. The Disposal Act authorized the Attorney General to allow LTCFs to dispose of controlled substances on behalf of ultimate users who reside, or have resided, at the LTCF, in a manner determined by the Attorney General. Therefore, hospice and homecare staff should not be disposing of controlled substances for this population.