Drug Enforcement Administration

Intro

The Drug Enforcement Administration (DEA) is the office in the Department of Justice that oversees enforcement of drug policy, including the Controlled Substances Act (CSA). The CSA gives the DEA the authority to enforce rules that dictate prescribing of controlled substances to patients. The CSA was designed to protect public health and safety by preventing diversion and improper use while upholding the legitimate use of controlled substances, focusing on community and ambulatory settings. The focus of ASCP interactions involve controlled drugs in long-term care facilities, drug reclassification, and prescription requirements for controlled drugs in long-term care settings.

In June 2016, ASCP sent a letter to the Policy Section at the DEA, asking for clarification on the use of electronic emergency kits (e-kits). ASCP’s letter focused on the 1980 DEA-issued guidance spelling out conditions under which e-kits can be placed in long-term care facilities (LTCFs).

In their response to ASCP’s letter, on November 30, 2016 the DEA notified ASCP that they accepted the Society’s recommendations to treat electronic e-kits the same as tackle-box style e-kits and both types fall under that 1980 guidance. Dispensing out of electronic or tackle-box style e-kits can only be done in emergency situations and still requires compliance with the Controlled Substances Act and DEA regulation regarding valid prescriptions.

On January 16, 2017, the DEA responded to ASCP's request for clarification on potential conflicts between the partial fill provision included in the Comprehensive Addiction and Recovery Act (CARA) and existing long-term care partial fill regulations. CARA allows partial filling of CII prescriptions in a community setting and requires the remainder of the prescription be filled within 30 days. Existing DEA regulations allow long-term care (LTC) pharmacies to partial fill for CII medications but have 60 days to fill the remainder of the prescription.

ASCP asked the DEA for clarification to ensure that the CARA provision does not supersede the existing regulations. In their response letter, linked below, the DEA concurred with ASCP's assessment that the CARA provision does not supersede the existing LTC regulations.

In April 2017, the DEA provided verbal guidance regarding the transfer of controlled substance prescriptions that have not been filled. NACDS followed-up with DEA asking for a written response, which they received October 2017. It is noteworthy that they made a pointed distinction between electronic prescriptions and all other formats.

On November 4, 2018, the DEA Section Chief for Policy, addressed the ASCP Annual Meeting on DEA Policy Issues relevant to our members, focusing on prescription and dispensing requirements applicable to emergency kits (e-kits). Some important Q&A that were addressed at the meeting are included in a one-page document.

On March 29, 2019, ASCP received a written response from the DEA clarifying that a multi-dose formulation of a controlled substance may be placed in an e-kit if the appropriate state agency or regulatory authority permits. The letter can be found here.

On May 20, 2019, the DEA also responded to the association’s requests for clarifications regarding prescription and dispensing requirements of the initial dose of a medication from an e-kit. The agency concluded that a pharmacy that has in its physical possession a prescription for a controlled substance, and has placed an e-kit in a LTCF, could instruct the LTCF staff to withdraw the initial dose of this prescription from that e-kit, with all subsequent doses not being dispensed from the e-kit but physically delivered to the LTCF by the retail pharmacy. However, such activity can only take place if the appropriate state authority (state licensing or regulatory board) has first promulgated rules authorizing such activity. That letter can be found here.

ASCP continues to engage the DEA on the issues of nurse agency and medication-assisted treatment (MAT) for substance use disorder. The association encourages the DEA to accept ASCP’s suggestions and issue an “in addition to” statement to the current guidelines surrounding nurse agency in the LTCF setting. If nurses in this setting could serve as the agents of prescribers for controlled substances, the improved communication process would help residents of LTCFs receive appropriate pain management in a timely manner.

Resources

ASCP
1240 N Pitt St, Suite 300, Alexandria, VA 22314
© 2016-2018 ASCP | Contact Us | Privacy Policy
ASCP Foundation | BCGP