ARLINGTON, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association gave their take on a proposed Drug Enforcement Administration rule to establish a process for the disposal of controlled substances.
In their comments to the DEA on Wednesday, NACDS and NCPA expressed support for the agency’s efforts to devise a safe, secure way for consumers to return unused medications to authorized entities for destruction. Both pharmacy industry groups, however, had some concerns about the DEA rule.
In December, the DEA published a proposed rule to govern the secure disposal of controlled substances by DEA registrants, including pharmacies, and users, including patients and others on their behalf.
NACDS expressed support for mail-back programs so that patients can mail unwanted controlled substances to be disposed of properly. Yet the association cited a burden on community pharmacies in tracking unique identification numbers on mail-back packages.
Also, NACDS stressed the importance of ensuring that the requirements for maintaining collection receptacles in drug stores are easily administered by the pharmacy and are aligned with other laws and regulations concerning pharmaceutical and hazardous waste.
"We hope that we have been able to share with DEA helpful commentary as DEA finalizes
the requirements for the disposal and destruction of controlled substances," NACDS stated in its comments to the agency. "In particular, we ask DEA to reconsider the overly burdensome proposed requirements for collection receptacles and to clarify potential pharmacy penalties for unintentional noncompliance with the provisions of the proposed rule."
NCPA pointed to its successful Dispose My Meds program for community pharmacies to enable consumers to safely discard noncontrolled substances. But the association noted that challenges remain for effective disposal programs for controlled substances in drug stores and long-term care facilities.
In particular, NCPA asked the DEA for clarification on the agency’s intent that the retail pharmacy registrant category include closed-door long-term care pharmacies. The association, too, said in its remarks to the agency that the rule isn’t clear on whether the take-back program for long-term care facilities is voluntary, as it is on the retail pharmacy side.
NCPA also urged the DEA to reconsider its requirements for the collection receptacles and inner liners, in terms of security and placement.
"NCPA and its members fully support efforts to dispose properly of unused, unwanted or expired medications through safe, secure and environmentally responsible voluntary disposal programs, including controlled substances," NCPA stated. "Community pharmacists understand the challenge consumers face in properly disposing of unused or expired medication. Patients want a solution to the problems associated with unused medications."
