Beginning next month, consumers will have an easier time getting rid of unused painkillers and other addictive drugs, which DEA hopes will discourage people from flushing the drugs down the toilet, throwing them in the garage, or leaving them, forgotten, in their medicine cabinets. The new disposal methods include allowing people to drop off unwanted pills at pharmacies, some hospitals and long-term care facilities, and police stations. DEA’s Final Rule, which implements the Secure and Responsible Drug Disposal Act of 2010 (“the Disposal Act”) by expanding the options to collect controlled substances back from ultimate users, is expected to be released tomorrow and will take effect on October 9. The disposal methods include take-back events, mail-back programs, and drop-off locations. The new regulations:
- allow authorized retail pharmacies; hospitals and clinics with on-site pharmacies; manufacturers; distributors; reverse distributors; and narcotic treatment programs (NTPs), to place collection receptacles inside their establishments and to permit people to mail back unwanted controlled substance mediations;
- expand the authority of authorized pharmacies and hospitals/clinics to place collection receptacles inside long-term care facilities; and
- allow law enforcement agencies to place collection receptacles inside their stations, conduct drug take-back events, and administer mail-back programs. (Note that law enforcement agencies are not required to use collection receptacles that meet all of the specifications in the rule.)
DEA registrants that want to become controlled substances “collectors” will need authorization from the Agency to keep secure containers at their locations for controlled substances drop off or to conduct mail-back programs. A registrant may seek to modify its DEA registration to become a collector by making a written request by mail or online. Retail pharmacies and hospitals/clinics that become collectors will be allowed to put collection receptacles inside long-term care facilities for those facilities’ residents. For security reasons, collection receptacles must be securely fastened to a permanent structure. In addition, as a general rule, the collection receptacles must be placed in the immediate proximity of a designated area where controlled substances are stored and where an employee is present. Hospitals/clinics, which would have difficulty meeting that requirement, must place receptacles in locations that are regularly monitored by employees and are not in the proximity of any area where emergency or urgent care is provided. Collection receptacles must be accessible to the public because only the ultimate users of the drugs are authorized to place the controlled substances in a receptacle. Pharmacy and hospital staff cannot take the drugs and put them into a container. Registrants that choose to conduct mail-back programs must be able to destroy returned packages on site. And registrants must provide customers with mail-back packages. They can charge for the packaging, or provide the packaging for free. The new rule permits controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances. Other highlights of the Rule: Methods of Destruction: DEA is not requiring a specific method of destruction for controlled substances that are collected. Registrants are free to develop their own methods of destruction so long as, in the end, the drug is “non-retrievable”, which means the condition or state to which a controlled substance must be rendered following a process that permanently alters the 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. See 21 C.F.R. § 1300.05(b). Once a controlled substance is “non-retrievable,” it is not longer subject to DEA requirements. Long-Term Care Facilities: In addition to allowing retail pharmacies and hospitals/clinics with on-site pharmacies to place collection receptacles in LTCFs for residents, DEA is also implementing special security requirements for these collection receptacles to encourage their use. First, DEA is permitting sealed inner liners that have been removed from collection receptacles to be stored at LTCFs for up to three business days in a securely-locked, substantially constructed cabinet or in a securely-locked room with controlled access until the liners can be transferred for destruction. However, DEA is encouraging authorized collectors to schedule inner liner removals on the same day that medications are delivered, if possible, to make storage of sealed inner liners unnecessary. It is also important to note that collectors cannot transfer sealed inner liners from LTCFs to their registered locations (i.e., the pharmacy or hospital/clinic). DEA is concerned that pharmacy or hospital/clinic employees transporting large quantities of controlled substances pose a security risk. Therefore, collectors must deliver sealed inner liners to a reverse distributor or a distributor by common or contract carrier or by reverse distributor or distributor pick-up at the LTCF. Second, collectors will be allowed to have one of its employees and a supervisory level employee of the LTCF (e.g., a charge nurse, supervisor, or similar employee) install, remove, store, or transfer inner liners, or the collector can have two of its own employees do the work. DEA hopes that these modifications will result in expanded safe and secure disposal options for LTCF residents. DEA Registrant Disposal: DEA has modified DEA Form 41 and is requiring that the form to be used to record the destruction of controlled substances that remain in the closed system of distribution and to account for the destruction of controlled substances collected from consumers and other non-registrants pursuant to the Disposal Act. Reverse Distributors: DEA added a definition of “reverse distribute,” revised the definition of “reverse distributor”, and clarified that the security, inventory, and recordkeeping requirements for controlled substance destruction apply to some entities that reverse distribute even if they are not required to register as reverse distributors. In addition, DEA has extended the time that a registrant that reverse distributes has to destroy controlled substances to 30 days, from the proposed 14 days. Distributors may acquire controlled substances from collectors for the purpose of destruction, as a coincident activity to distribution. The rules are intended to expand the options available to safely and securely dispose of potentially dangerous prescription medications on a routine basis. Beginning in 2010, DEA has sponsored eight National Prescription Drug Take-Back events around the country that resulted in the collection of more than 4.1 millions pounds (over 2,100 tons) of medication at over 6,000 locations.