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On Dec. 21, the Drug Enforcement Administration (DEA) issued proposed regulation for the secure disposal of controlled substances by DEA-authorized registrants and patients (or others on their behalf).
The National Association of Chain Drug Stores (NACDS) and National Community Pharmacists Association (NCPA) have submitted comments in response to the proposed rule, expressing support, and concerns, about how consumers should dispose of unwanted controlled substances.
NACDS said it supports mail-back programs but not the need for unique identification numbers on the mail-back packages for tracking purposes. Because many consumers may lose or never even use the packages, tracking would become unnecessary. Plus, DEA would then consider unreturned packages as evidence of diversion, which would make collectors reluctant to participate in the program.
If DEA decided to keep the requirement for identification numbers in the final rule, the association recommends clarification that only the collectors that issue the packages, and no other entity (such as a pharmacy), would be responsible for tracking them.
NACDS also cited concerns with the requirements for collection receptacles at registered locations or authorized long-term care facilities (LTCF). The association suggested that DEA allow one authorized employee, instead of two, to perform or supervise the removal of the receptacle’s inner liner; or, one authorized employee and one hazardous waste transporter employee for pharmacies or one employee for LTCFs. NACDS also called for clarification on how a person can legally dispose of a decedent’s medication.
The association raised concerns about the storage and transportation of pharmaceutical waste in the collection receptacles as well, urging DEA to sync its proposed rule with the rules of other federal agencies and state requirements.
NCPA touted its Dispose My Meds program as a way that community pharmacies have been able to create voluntary non-controlled medication disposal programs, and anticipates that this type of program can be expanded to include the collection of controlled substances, and on a more frequent basis.
Like NACDS, NCPA cited concerns about collection receptacles and their proper storage and disposal and offered suggestions on how to make the process more practical, such as using a sealed, tamper-evident receptacle for extra security.
The association also cited the logistical challenges behind placing collection receptacles at LTCFs, such as the potential for stockpiling and liability concerns, and offered possible solutions.
NCPA also asked for clarification on what constitutes a registered location. “If the LTCF is considered a registered location when the retail pharmacy applies for a modification in registration to become an authorized collector, reverse distributors should be allowed to pick up the contents of collection receptacles directly from registered LTCF locations for disposal,” wrote the author, Ronna B. Hauser, PharmD, vice president of policy and regulatory affairs.
In addition, the association recommended that DEA work with LTCFs to develop standards that would allow more facilities to operate their own disposal systems.
Both NACDS and NCPA stressed their commitment to the safe, secure, and lawful disposal of controlled substances to help curb drug abuse and diversion and their willingness to work with DEA to help facilitate these actions.
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