Pharmaceuticals - Controlled Substances
This section summarizes regulations published in the Federal Register September 9, 2014 by the U.S. Drug Enforcement Administration (DEA) regarding the disposal of controlled substances. The final rule was published in accordance with the Controlled Substance Act (CSA), as amended by the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”). The rule became effective on October 9, 2014. Among other entities, this rule affects hospitals and long-term care facilities (LTCFs).
Controlled substances are drugs that have some potential for abuse or dependence. These drugs are regulated by the DEA to help fight against abuse. The CSA divides controlled substance drugs into five categories called schedules:
Schedule I includes drugs that have no accepted medical use, such as heroin.
Schedule II drugs are used medically but have high abuse potential, such as morphine, and their purchase, storage, and use requirements are very strictly monitored.
Schedules III through V are drugs with decreasing abuse potential, ranging from sedatives to cough suppressants, such as codeine.
Impacts on Hospitals
Under the new rule, registered and "authorized" hospitals/clinics with an on-site pharmacy may voluntarily establish a program to accept unwanted controlled substances from ultimate users (“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.”). This is accomplished by maintaining "collection receptacles" at the authorized hospital/clinics. In addition, the rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities.
This rules does not alter methods by which hospitals dispose of "pharmaceutical wastage" (e.g., drugs dispensed to a patient and not fully used, such as a single dose vial or syringe with remaining controlled substance). Hospitals should continue to use existing policies regarding this wastage (e.g., two witness and record of destruction). Hospital pharmaceutical wastage should not be disposed of in collection receptacles. See DEA's clarification letter. Also, controlled substances that are collected from ultimate users must not be co-mingled with a registrant’s inventory/stock of controlled substances (i.e., registrants may not dispose of controlled substance inventory in a collection receptacle).
The new rule contains design specifications for collection receptacles and their removable "inner liners" that are intended to prevent misuse and prevent loss of contents. Provisions of the rule also require collection receptacles to be locked or inaccessible to the public when they cannot be monitored by an employee. The installation and removal of the inner liner of the collection receptacle must be performed by or under the supervision of at least two employees of the authorized collector.
An authorized collector may collect pharmaceutical controlled substances and non-controlled substances. Controlled and non-controlled pharmaceuticals may be co-mingled in a single collection receptacle, however it is not required.
Collected pharmaceutical controlled substances must shipped to a reverse distributor registered with DEA or be rendered “non-retrievable” by the hospital/clinic in compliance with all applicable federal, state, tribal and local laws. In either case, Form DEA-41 must be used for recordkeeping. However, the new regulations do not require a particular method of destruction, so long as the desired result is achieved. This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, and consistent with preventing the diversion of such substances.
Impacts on Long-Term Care Facilities
An authorized hospital/clinic with an on-site pharmacy or a retail pharmacy may install, manage and maintain a collection receptacle at long-term care facilities (LTCFs). A LTCF may dispose of a current or former resident’s pharmaceutical controlled substances into those receptacles. If someone dies while in lawful possession of pharmaceutical controlled substances, any person lawfully entitled to dispose of the decedent's property may dispose of the decedent’s pharmaceutical controlled substances. Both pharmaceutical controlled substances and non-controlled substances may be placed in the receptacles. When disposing of pharmaceutical controlled substances by transferring those substances into a collection receptacle, disposal must occur immediately, but no longer than three business days after discontinuation of use by the LTCF resident.
Management of the collection receptacles must follow certain prescribed rules:
- Only registered and authorized retail pharmacies and hospitals/clinics with an on-site pharmacy may install, manage, and maintain collection receptacles at long-term care facilities and remove, seal, transfer, and store, or supervise the removal, sealing, transfer, and storage of sealed inner liners.
The installation, removal, transfer, and storage of inner liners must be performed either:
- by or under the supervision of one employee of the authorized collector and one supervisor-level employee of the long-term care facility (e.g., a charge nurse or supervisor) designated by the authorized collector; or
- by or under the supervision of two employees of the authorized collector.
Upon removal, sealed inner liners may be stored at the LTCF for up to three business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access.
DEA is permitting authorized hospitals/clinics and retail pharmacies to store inner liners that have been sealed upon removal from a collection receptacle at LTCFs in a securely locked, substantially constructed cabinet or a securely locked room with controlled access for up to three business days until the liners can be transferred for destruction.
In cases where no hospital/clinic with an on-site pharmacy or retail pharmacy will install or maintain a collection receptacle at a particular LTCF, all currently legal methods of disposal can continue to be used (e.g., mail-back programs or disposal via flushing or otherwise discarding).
Federal Register September 9, 2014. Final rule.
Disposal Regulations: Registrant Fact Sheet
Disposal Act: Long Term Care Facility Fact Sheet