DEA Final Rule on Controlled Substance Take-back

On Sept. 9, 2014, the Drug Enforcement Administration (DEA) released the final rule regarding the changes in the 2010 Secure and Responsible Drug Disposal Act (21 CFR Parts 1300, 1301, 1304, 1305, 1307 and 1317) regarding the take-back and disposal of controlled substances.

Patients are now able to bring all of their prescriptions, including controlled substances Schedules 2-5, to any pharmacy that is registered as a take-back location. Pharmacies will need to modify their current registration to allow for take-back [see 21 CFR 1301.51]. Additionally, authorized manufacturers, distributors, reverse distributors, narcotic treatment programs and hospitals/clinics with an on-site pharmacy may also administer mail-back programs and maintain collection receptacles.  The rule also expands the authority of authorized hospitals/clinics and retail pharmacies to maintain collection receptacles at long-term care (LTC) facilities.  Participation in these programs is voluntary.   

Under this new rule, there is no need for entities conducting medication take-back activities to separate legend drugs and Schedule 2-5 controlled substances. [21 CFR 1317.75 (b)] Any controlled substances that are collected should not be individually counted or inventoried. [21 CFR 1317.75 (c)] Schedule 1 controlled substances, controlled substances that are not lawfully possessed by the ultimate user, and other illicit or dangerous substances may not be collected utilizing general take-back methods. [21 CFR 1317.75 (e) (4)]

If at any point a “registrant” ceases to be a collector, they must notify the DEA in accordance with [21 CFR 1301.52 (f)]. This notice may be submitted online at www.DEAdiversion.usdoj.gov.

The rule did not change the way that drug/pharmaceutical waste generated through normal course of practice is disposed of. For example, if there is leftover morphine in a single-use vial that can no longer be utilized; it must still be disposed of in the original manner. It cannot be disposed of in a hospital/clinic/LTC facility drug take-back receptacle.

The federal rule takes effect on Oct. 9, 2014. The entire final rule, along with sections of the act that have been changed, can be found online at https://www.federalregister.gov/articles/2014/09/09/2014-20926/disposal-of-controlled-substances.