On Friday, December 21st, the DEA posted a Notice of Proposed Rulemaking for requirements to govern the secure disposal
of controlled substances by both DEA registrants and ultimate users.
The proposed
regulations would allow retail pharmacies, manufacturers, distributors,
reverse distributors to voluntarily administer mail-back programs and
maintain collection receptacles (all after obtaining authorization from
the DEA to be a "collector"). In addition, this proposed rule expands
the authority of authorized retail pharmacies to voluntarily maintain
collection receptacles at long term care facilities.
For complete information, including the proposed regulations, please visit: http://www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8.htm
SUMMARY: This rule proposes requirements to govern the secure disposal
of controlled substances by both DEA registrants and ultimate users.
These regulations would implement the Secure and Responsible Drug
Disposal Act of 2010 (Pub. L. 111-273) by expanding the options
available to collect controlled substances from ultimate users for
purposes of disposal to include: Take-back events, mail-back programs,
and collection receptacle locations. These proposed regulations contain
specific language to continue to allow law enforcement agencies to
voluntarily conduct take-back events, administer mail-back programs,
and maintain collection receptacles. These regulations propose to allow
authorized manufacturers, distributors, reverse distributors, and
retail pharmacies to voluntarily administer mail-back programs and
maintain collection receptacles. In addition, this proposed rule
expands the authority of authorized retail pharmacies to voluntarily
maintain collection receptacles at long term care facilities. This
proposed rule also reorganizes and consolidates existing regulations on
disposal, including the role of reverse distributors.
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before February 19, 2013. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after midnight Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling of comments,
please reference
"Docket No. DEA-316" on all electronic and written correspondence.
DEA encourages all comments be submitted electronically through
http://www.regulations.gov using the electronic comment form provided on
that
site. An electronic copy of this document is also available at the
http://www.regulations.gov Web site for easy reference. Paper comments
that duplicate the electronic submission are not necessary as all
comments submitted to http://www.regulations.gov will be posted for
public review and are part of the official docket record. Should you,
however, wish to submit written comments via regular or express mail,
they should be sent to the Drug Enforcement Administration, Attention:
DEA Office of Diversion Control (OD/DX), 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (202) 307-4654.
