DEA Notice of Proposed Rulemaking: Regulations Governing the Secure Disposal of Controlled Substances by Both DEA Registrants and Ultimate Users.

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.

Board of Pharmacy 12/12/12 Meeting Summary

The Virginia Board of Pharmacy met on Wednesday, December 12th for their quarterly meeting.  VPhA members have access to VPhA's summary of the Board meeting.  To access this information, please click here.

The next Board of Pharmacy full meeting will be held on March 12, 2013 beginning at 9am.