The Drug Enforcement Administration (DEA) recently issued proposed regulation for the secure disposal of controlled substances by DEA-authorized registrants and patients.
The goal of the proposal is to encourage the development of methods for public and private entities to collect and destroy controlled substances in a secure, convenient, and responsible manner, the administration said. Disposal protects the public by decreasing the supply of controlled substances available for misuse, abuse, and accidental ingestion by children and the elderly. Proper disposal also decreases the amount of potentially harmful contaminants that can enter into the environment, particularly the water, when individuals discard or flush their unwanted or unused prescriptions.
This regulation would implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options of collection to include take-back events, mail-back programs, and collection receptacle locations.
Federal, state, tribal, and local law enforcement agencies will continue to be allowed to voluntarily hold take-back events and administer mail-back programs. But the DEA is proposing the authorization of certain registrants (manufacturers, distributors, reverse distributors, and retail pharmacies) to be “collectors” as well, through mail-back programs. According to the proposal, “all mail-back programs must provide specific mail-back packages to the public, either at no cost or for a fee, and collectors must have and utilize an on-site method of destruction.”
The proposal also calls for collectors to maintain collection receptacles at their registered locations. It would allow authorized retail pharmacies to maintain receptacles at long-term care facilities, and the facilities could dispose of controlled substances on the behalf of their residents (or those who have resided at that specific location).
All collected controlled substances could be comingled with non-controlled substances. Controlled substances may not be individually counted or inventoried, however; instead, the DEA proposes various collection security and recordkeeping requirements.
Finally, the DEA proposes a standard of destruction for those who will be destroying controlled substances. No particular method is being required, just that it accomplishes the goal of non-retrievable destruction. This standard is intended to allow collectors to develop a variety of secure, convenient, and responsible destruction methods. The methods must also meet all other applicable laws and regulations.
Comments on the proposed regulation are due to the DEA by Feb. 19 and can be submitted electronically here. Written comments can be sent to Drug Enforcement Administration, Attention: DEA Office of Diversion Control (OD/DX), 8701 Morrissette Drive, Springfield, Virginia 22152