iOn September 9, 2014, the U.S. Drug Enforcement Administration (DEA) published a rule pertaining to the secure disposal of controlled substances (the Rule), in large part to implement the Secure and Responsible Drug Disposal Act of 2010 ("Disposal Act"). The Rule broadens the range of permissible collection and disposal methods for unused, unwanted, or expired pharmaceutical controlled substances.
Background
Under the Controlled Substances Act (CSA), patients could only dispose of unused controlled substances themselves, or deliver them to a law enforcement official. The Disposal Act was enacted on October 12, 2010 in order to facilitate more convenient, secure, and environmentally responsible disposal options. The Disposal Act amended the CSA to authorize “ultimate users” to deliver their pharmaceutical controlled substances to a broader range of entities for the purpose of disposal in accordance with requirements to be promulgated by DEA. An ultimate user is 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). The Rule establishes the requirements envisioned by the Disposal Act and consolidates and revises existing rules on disposal in other contexts, such as transfers from DEA registrants to "reverse distributors."
Collection and Disposal Provisions
Collection of Controlled Substances
The Rule authorizes “collectors” to conduct mail-back collection programs and maintain collection receptacles at authorized collection locations. The Rule allows, on a voluntary basis, manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy and retail pharmacies to register with the DEA as “collectors.” 21 CFR §§1301.51 and 1317.40. In addition, hospitals/clinics with an on-site pharmacy and retail pharmacies are permitted to maintain collection receptacles at long-term care facilities. 21 CFR §1317.40(b)(2). These entities must submit a written request to the DEA Registration Unit in order to obtain authorization to act as a “collector.” 21 CFR §1301.51. They must also notify the DEA in writing when they intend to stop providing collection services. 21 CFR §1301.52.
In addition, in a continuation of current practice, Federal, State, tribal, or local law enforcement may voluntarily promote collection and disposal of controlled pharmaceutical substances from ultimate users through (1) take-back events, (2) mail-back programs, and (3) collection receptacles. 21 CFR §§1317.65, 1317.70, and 1317.75.
Security Controls and Collection Protocols
Under the Rule, only “ultimate users” or those entitled to dispose of their decedent property can transfer ownership of controlled substances to registered collectors or law enforcement. Hospitals, pharmacies, and other entities cannot dispose of their unwanted pharmaceuticals or controlled substances by adding them to materials collected from ultimate users. The Rule allows all pharmaceutical controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances. 21 CFR §§1317.65, 1317.70, and 1317.75.
Once deposited in a receptacle, pharmaceutical controlled substances cannot be individually counted, handled or sorted. At least two employees of the collector must perform or supervise installation and removal of the liners of all collection receptacles. 21 CFR §1317.75(g). Sealed mail-back packages and inner liners, prior to destruction, must be stored in a securely locked, substantially constructed cabinet or a securely locked room with controlled access. 21 CFR §§1317.05(c) and 1317.75(c).
All collection receptacles must meet certain requirements. They must be securely placed and maintained, securely locked, and substantially constructed. They must have a permanent outer container and removable inner liner, and they must be inside a collector’s registered location, authorized long-term care facility, or a law enforcement physical location. 21 CFR §1317.75. The inner liner must bear a permanent, unique identification number that allows it to be tracked, and must be sealed immediately upon removal from the outer container. 21 CFR §1317.60. The Rule requires detailed record-keeping by entities responsible for collection. 21 CFR §1304.22.
Reverse Distributors
The Rule also seeks to create a clear and consistent set of regulations for entities that are “reverse distributors.” To “reverse distribute” is to acquire controlled substances from another DEA registrant or law enforcement (rather than from an ultimate user) for the purpose of destruction or return to the registered manufacturer or an entity authorized to accept returns on a registered manufacturer’s behalf. Entities that engage in this activity must immediately store controlled substances upon receipt in a secure manner, as described above, at the reverse distributor’s location until the time of destruction or return to the registered manufacturer. 21 CFR §1317.15.
Disposal Requirements
All controlled substances collected under the Rule shall be destroyed in a manner compliant with all applicable Federal, State, tribal, and local laws and regulations. 21 CFR §1317.90. Destruction must render the substances “non-retrievable.” 21 CFR §1317.90. A controlled substance is “non-retrievable” when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. 21 CFR §1300.05. The rule does not specify a required disposal method. Any registered entity that destroys or causes destruction of a controlled substance must maintain a complete and accurate record of the destruction on a DEA Form 41. The record must include the signature of two employees who witnessed the destruction. 21 CFR §1304.21.
Implementation
The Rule becomes effective on Thursday, October 9th, 2014, thirty days after publication in the Federal Register.
