By Larry K. Houck –
The Drug Enforcement Administration (“DEA”) published its long awaited notice of proposed rulemaking to implement the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”). 77 Fed. Reg. 75,784 (Dec. 21, 2012). Interested persons should submit electronic comments on or before February 19, 2013. Written comments must be postmarked on or before that date.
Congress enacted the Disposal Act on October 12, 2010. Prior to enactment, the Controlled Substances Act (“CSA”) and DEA regulations provided few options to ultimate users (e.g., patients) who wanted to dispose of unused, unwanted, or expired controlled substances. Individuals were limited to destroying the substances themselves, surrendering the drugs to law enforcement agencies or seeking assistance from the local DEA office. These restrictions invariably led to increased potential diversion or misuse from drugs being thrown away in trash receptacles or accumulating in household medicine cabinets.
The Disposal Act and DEA’s proposed regulations seek to establish controlled substance diversion prevention parameters that will encourage public and private entities to develop methods for collecting and destroying controlled substances that are secure, convenient, and responsible. A second goal is to decrease the amount of controlled substances released into the environment, especially into water and sewage systems. DEA believes that the new regulations will reduce the supply of unused controlled substances in households thereby reducing the risk of diversion or harm.
The proposed regulations contain sweeping changes that reorganize and consolidate existing requirements for disposal of controlled substances, including the role of reverse distributors. The proposed regulations also expand the entities to whom ultimate users may deliver unused, unwanted, or expired controlled substances for disposal, and the methods by which the controlled substances may be collected. Authorized entities may voluntarily administer any of the authorized collection methods but are not required to do so.
Disposal by Ultimate Users. DEA is proposing three voluntary disposal options for ultimate users: take-back events, mail-back programs and collection receptacles. Individuals entitled to dispose of deceased patients’ property will also be authorized to dispose of the controlled substances by utilizing the three options.
DEA is proposing to continue to authorize federal, state, tribal, and local law enforcement agencies, independently or in partnership with private entities or community groups, to hold take-back events and administer mail-back programs. DEA also proposes to permit manufacturers, distributors, reverse distributors, and retail pharmacies to obtain DEA authorization to receive controlled substances from ultimate users or long term care facilities for the purpose of destruction. DEA registrant may become “collectors” and would be authorized to conduct mail-back programs. However, mail-back programs must provide specific mail-back packages to the public at no cost or for a fee, and collectors conducting mail-back programs must utilize an on-site method of destruction. Collectors must also comply with specific security and recordkeeping requirements. (new § 1317.50)
The proposed regulations would authorize law enforcement agencies to maintain collection receptacles at that their physical location and would authorize collectors to maintain collection receptacles at their registered locations. Retail pharmacies that are authorized collectors may maintain collection receptacles at long term care facilities (“LTCFs”). LTCFs are permitted to dispose of controlled substances on behalf of ultimate users who reside or have resided at that LTCF only through a collection receptacle maintained by a retail pharmacy at that LTCF.
DEA also proposes to allow all controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances. Collectors would be restricted from individually counting or inventorying controlled substances that they collect.
Disposal by Registrants and Reverse Distributors. DEA is proposing to delete 21 C.F.R. § 1307.21, the existing regulation on registrant disposal, and incorporate requirements on disposal procedures, recordkeeping and security in a new part 1317. DEA proposes to modify existing DEA Form 41, “Registrants Inventory of Drugs Surrendered”, for documenting the destruction of controlled substances among registrants and to account for registrant destruction of controlled substances collected from ultimate users and other non-registrants.
DEA is also proposing to revise regulations for reverse distributors. Reverse distributors acquire controlled substances from other registrants and may also be authorized as collectors, so they accumulate greater quantities of controlled substances for destruction than other registrants. DEA proposes to revise definitions related to reverse distribution and add new acquisition procedures, recordkeeping and security requirements.
DEA is proposing to delete the existing regulation on return and recall (21 C.F.R. § 1307.12) and incorporate requirements into a new part 1317.10. The new regulations would clarify which registrants are authorized to handle returns and recalls and enhance recordkeeping and ordering requirements.
Methods of Destruction. DEA is proposing a “non-retrievable” standard of destruction for persons who destroy controlled substances. DEA will not require a particular method of destruction, so long as the controlled substance is rendered “non-retrievable.” This standard will allow public and private entities to develop a variety of destruction methods that are “secure, convenient, and responsible, consistent with preventing the diversion of such substances.”
We anticipate focusing on specific elements of DEA’s proposed rulemaking in future blog posts.