United States: DEA Releases Final Rule On Disposal Of Controlled Substances

On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible Drug Disposal Act of 2010 (the "Disposal Act"), and according to the DEA, "generally expands the options available to collect controlled substances from ultimate users for the purpose of disposal."1 The Final Rule will go into effect on October 9, 2014, but affected entities and individuals may want to start preparing their policies and procedures now.

Background — The Disposal Act

The Disposal Act provides the legislative authority for the Final Rule. The Disposal Act was enacted in 2010 and was designed to address a gap in the Controlled Substances Act (the "CSA") concerning the disposal of controlled substances. Specifically, the CSA permitted only ultimate users2 of controlled substances to dispose of controlled substances in very limited ways. As noted by the DEA, this "resulted in the accumulation of pharmaceutical controlled substances in household medicine cabinets that were available for abuse, misuse, diversion, and accidental ingestion."3

The Disposal Act sought to remedy this problem by providing expanded alternatives for the disposal of controlled substances, including the ability to deliver controlled substances to another person for purposes of disposal. Thus, the goal of the Disposal Act—and of the Final Rule—"is to set parameters for controlled substance diversion prevention that will encourage public and private entities to develop a variety of methods for collecting and destroying pharmaceutical controlled substances in a secure, convenient, and responsible manner."4

Key Provisions of the Final Rule

Three New Voluntary Disposal Options

The Final Rule has several key provisions that generally provide ultimate users with three additional voluntary options for disposal of their controlled substances: (1) take-back events, (2) mail-back programs or (3) collection receptacles. It is not mandatory for ultimate users to use these three options, and ultimate users are not prohibited from using existing lawful methods for the disposal of controlled substances.5

  • Take-back Events.6 Ultimate users or persons entitled to dispose of an ultimate user decedent's property will be permitted to dispose of their lawfully possessed controlled substances listed in Schedules II-V during a take-back event. Law enforcement will be authorized to hold take-back events and may partner with any person to administer the take-back event. Take-back events are required to have at least one receptacle available for collecting controlled substances, and that receptacle should be securely locked, among other physical security requirements set forth in the regulations.
  • Mail-back Programs.7 Ultimate users or persons entitled to dispose of an ultimate user decedent's property will also be permitted to dispose of their lawfully possessed controlled substances listed in Schedules II-V through a mail-back program. In addition to law enforcement, collectors will also be authorized to administer mail-back programs.8 The law enforcement or collector that conducts the mail-back program is required to provide return packages (for free or for sale), and those packages have to meet certain physical security requirements set out in the regulations. Finally, the regulations permit only law enforcement officers or employees of the collector to handle packages received through the mail-back program.
  • Collection Receptacles.9 Finally, ultimate users or persons entitled to dispose of an ultimate user decedent's property will be permitted to dispose of their lawfully possessed controlled substances listed in Schedules II-V by depositing them in a collection receptacle. Again, law enforcement or collectors are authorized to manage and maintain collection receptacles to collect these controlled substances. The collection receptacles must be built to meet specific physical security requirements as set forth in the regulations, and the installation and removal of the liner into which the controlled substances are deposited must be supervised by at least two employees.

Certain Entities May Be "Collectors"

In addition to the three voluntary disposal options, the Final Rule authorizes certain DEA registrants to be "collectors,"10 including manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy or retail pharmacies. These "collectors" will have the ability to receive and destroy packages received through mail-back programs, and to maintain collection receptacles.

Collectors (and all other registrants) are required to maintain certain records and inventories, including for example, records of used and unused mail-back packages; and certain records about the installation and removal of receptacle liners placed in collection receptacles.11 Collectors are required to maintain similar records of their inventory of collected controlled substances.12

New Rules for Reverse Distributors

The Final Rule also addresses reverse distributors, with the goal of "providing regulations for entities that reverse distribute that are clear and consistent."13 It is important to note that these regulations will apply both to entities that are registered as reverse distributors and to non-registered entities that also reverse distribute.14 Reverse distributors will be permitted to acquire controlled substances by picking them up from a registrant or authorized collection site or receiving them from a non-practitioner registrant. Upon acquisition of the controlled substance, the reverse distributor must then store the controlled substance, deliver the controlled substance to a manufacturer/other registrant for return or recall, or destroy the controlled substance. As with collectors, reverse distributors are required to comply with certain recordkeeping requirements that are detailed in the Final Rule.15

New Standard for Method of Destruction

Lastly, the Final Rule establishes methods of destruction and destruction procedures. Specifically, the Final Rule requires all controlled substances to be destroyed in compliance with all applicable laws and rendered non-retrievable. "Non-retrievable" is defined in detail in the regulations, and it generally means that the controlled substance has been rendered "unavailable and unusable for all practical purposes."16 The Final Rule does not mandate a specific method of destruction; as long as the controlled substance has been rendered non-retrievable, it satisfies the requirements of the Final Rule.

The Final Rule also sets forth certain destruction procedures that must be used when controlled substances are transferred for destruction. For example, the Final Rule states that if controlled substances are transferred to a person registered/authorized to accept the controlled substances for purposes of destruction, then at least two employees of the transferor must load/unload the controlled substances or observe the loading/unloading of the controlled substances. This "two employee" rule also applies in numerous other situations, including observing the transfer of controlled substances to a destruction facility or witnessing the destruction of controlled substances.

Conclusion

The Final Rule contains comprehensive changes to the procedures for the disposal of controlled substances and presents opportunities for ultimate users and collectors. While the specific risks to new collectors remain unknown, entities contemplating registration as a collector should consider the costs and benefits of taking on that role.

If you have any questions about this Alert or would like more information, please contact Frederick (Rick) R. Ball, Elinor L. Hart, any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food group, or the attorney in the firm with whom you are regularly in contact.

Footnotes

1.Dep't of Justice, Drug Enforcement Admin., Disposal of Controlled Substances, 79 Fed. Reg. 53520 (Sept. 9, 2014).

2.An "ultimate user" is defined as a "person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household." 21 U.S.C. § 802(27).

3.Dep't of Justice, Drug Enforcement Admin., Disposal of Controlled Substances, 79 Fed. Reg. 53520 (Sept. 9, 2014).

4.Id.

5.Those methods include, for example, destruction of the controlled substances (e.g., flushing), surrendering the controlled substances to law enforcement or seeking assistance from the DEA in destroying the controlled substances.

6.F.R. § 1317.65.

7.F.R. § 1317.70.

8.However, ultimate users and persons lawfully entitled to dispose of controlled substances will not be required to provide personally identifiable information.

9.F.R. § 1317.75.

10.F.R. § 1317.40.

11.F.R. § 1304.22.

12.F.R. § 1304.04, § 1304.11.

13.Dep't of Justice, Drug Enforcement Admin., Disposal of Controlled Substances, 79 Fed. Reg. 53520, 53521 (Sept. 9, 2014).

14.F.R. § 1304.11.

15.Id.; see also 21 C.F.R. § 1304.22.

16.21 C.F.R. § 1300.05.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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