By Larry K. Houck & Andrew J. Hull –
Last week, the Drug Enforcement Administration (“DEA”) published its final rule implementing the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”). 79 Fed. Reg. 53,520 (Sept. 9, 2014). A post appeared here when DEA issued its notice of proposed rulemaking back in December 2012. DEA considered 192 comments in response to the notice of proposed rulemaking. The disposal regulations become effective October 9, 2014.
DEA’s final rule significantly expands the options available to ultimate users to dispose of their controlled substances. Prior to implementation of the final rule, ultimate users (e.g., patients) could only dispose of unused, unwanted and expired controlled substances by destroying the drugs themselves (e.g., by flushing), by surrendering the drugs to law enforcement agencies or by requesting assistance from DEA. As a result of these limited options, unused controlled substances accumulated in household medicine cabinets, creating a significant risk of diversion or accidental ingestion. The Disposal Act amended the Controlled Substances Act, requiring DEA to implement regulations permitting ultimate users to deliver the medication to third parties for disposal. The ultimate goal of the regulation is to decrease unused pharmaceutical controlled substances in households, thereby reducing the risk of diversion and harm. Some highlights of the new regulation include the following:
Ultimate Users. The final rule allows ultimate users to continue disposing their unused or outdated controlled substances through previously allowed methods (mentioned above), and creates three other options. Ultimate users may: (1) drop off the drugs at take-back events overseen by law enforcement agencies; (2) send the drugs to a law enforcement agency or authorized collector operating a mail-back program; or (3) drop the drugs at a collection receptacle maintained by a law enforcement agency or an authorized collector.
Law Enforcement Agencies. The rule specifically allows law enforcement agencies to conduct take-back and mail-back programs, and maintain collection receptacles at their physical location.
Registrants and Reverse Distributors. Manufacturers, distributors, reverse distributors, narcotic treatment programs (“NTPs”), hospitals and clinics with on-site pharmacies and retail pharmacies can modify their DEA registrations to become “collectors” (defined as registrants “authorized” to “receive a controlled substance for the purpose of destruction”). As authorized collectors, they may operate mail-back programs to receive and destroy schedule II-IV controlled substances received from ultimate users. To operate a mail-back program, they must make packages available to the ultimate user. Collectors operating mail-back programs must also destroy the drugs onsite. We anticipate that the on-site destruction requirement will deter many registrants from becoming authorized collectors via a mail-back program. Authorized collectors permitting take-backs on their premises may install, manage and maintain a collection receptacle for schedule II-IV controlled substances delivered by ultimate users. Controlled substances collected in this manner may be destroyed onsite or may be transferred to a reverse distributor. The final rule establishes new recordkeeping and safety requirements for registrants serving as authorized collectors.
Registered NTPs that become authorized collectors may maintain collection receptacles at their registered locations. The NTPs must maintain the collection receptacles in a securely locked room with limited access that contains no other controlled substances. Hospitals/clinics with on-site pharmacies, as well as retail pharmacies, that become authorized collectors can also maintain collection receptacles inside their registered locations or at long term care facilities. They may also conduct mail-back programs.
Controlled substances collected through take-back events, mail-back programs and collection receptacles may be comingled with non-controlled substances. Collectors cannot individually count or inventory the controlled substances they collect through collection receptacles.
DEA has modified DEA Form-41 (“Registrants Inventory of Drugs Surrendered”), to allow registrants who dispose of controlled substances to account for the destruction of collected controlled substances.
Reverse Distributors. The final rule clarifies the definition of “reverse distribute” and “reverse distributor,” as well as security, inventory and recordkeeping requirements applicable to all entities that reverse distribute controlled substances. Reverse distributors are now defined as “entities registered with the Administration as  reverse distributor[s]” (i.e., persons permitted to acquire controlled substances in order to return them to manufacturers or to destroy them). (Specified entities who reverse distribute are not just those registered as reverse distributors).
Destruction. DEA does not mandate that collectors use a particular destruction method so long as they render the controlled substances “non-retrievable.” DEA defines “non-retrievable” as “the condition or state…following a process that permanently alters that controlled substance’s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes.” Controlled substances rendered non-retrievable are no longer subject to regulation by DEA.
Costs/Benefits. DEA recognizes that collection and disposal of controlled substances is voluntary and costly. DEA notes that costs to collectors may be offset by potential benefits of providing these services, including “increased consumer presence” at the registered locations.
Caveats. Registrants considering voluntarily becoming authorized collectors must be aware of heightened recordkeeping and other responsibilities. The voluntary nature of authorized collector status does not obviate a registrant’s duty to comply with these heightened requirements, especially because the additional security and recordkeeping requirements relate to preventing diversion. See, e.g., Fred Samimi, M.D., 79 Fed. Reg. 18,698, 18,709-10 (Apr. 3, 2014). Second, registrants who take on the responsibility of destroying collected controlled substances should proceed with caution as they develop certain destruction methods. DEA specifically stated that it would not require registrants to use any particular method of destruction. DEA’s specific standard of “non-retrievable,” as well as its detailed definition of the same, must guide registrants in fulfilling their responsibilities. Registrants should be wary of not only the cost of destruction but also the risk of developing a method that DEA may later find does not meet DEA’s interpretation of “non-retrievable.”
Final Word. Registrants contemplating the merits of becoming collectors should consider the benefits to the community and themselves by assuming these additional responsibilities. The diversion and abuse of unused and outdated controlled substances is a significant problem, and DEA’s development of this disposal program as part of a congressional mandate, has the potential to address this issue. Registrants should not, however, accept these new, voluntary responsibilities without also considering the additional recordkeeping and security requirements – not to mention costs – associated with them.