This week, the Drug Enforcement Administration (DEA) greatly expanded the number of entities that may take back controlled substances from individuals lawfully in possession of such drugs. The DEA rule implements a 2010 law that aims to reduce abuse, misuse, diversion, and accidental ingestion of controlled substances stored in home medicine cabinets. Individuals with unused, unwanted, or expired controlled substances in their home may still bring such drugs to a take-back event at a local police department. However, the new rule offers additional options for the disposal of controlled substances, including “mail-back” programs and collection receptacles at authorized entities known as “collectors.”
Effective October 9, 2014, the following entities may be authorized collectors for the operation of a take-back or disposal program: retail pharmacies (defined as any entity registered with the DEA as a retail pharmacy), hospitals and clinics with on-site pharmacies, narcotic treatment programs, registered manufacturers, distributors, and reverse distributors. The new rule also permits retail pharmacies and authorized hospitals and clinics to place collection receptacles at long-term care facilities. Some of the collectors, such as hospitals and narcotic treatment programs, must meet additional security requirements on monitoring and placement of collection receptacles, due to an increased risk of drug diversion.
To become an authorized collector, DEA registrants such as retail pharmacies may modify their DEA registration and meet the new legal and security requirements for mail-back programs and collection receptacles. To acquire controlled substances with the intent of focusing on destruction services, DEA registrants must register as reverse distributors. Entities performing reverse distribution will be subject to security, inventory, and recordkeeping requirements under the rule regardless of whether the company is a DEA-registered reverse distributor.
The new rule also sets standards for the destruction of controlled substances. Reverse distributors must destroy controlled substances within 30 calendar days after receiving such drugs. Additionally, the DEA has implemented a “non-retrievable” standard for registrants that destroy controlled substances. The agency considers controlled substances to be non-retrievable and no longer subject to DEA regulations once the drug has been permanently altered so that it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.