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.

OPEN PUBLIC COMMENT PERIOD: Periodic Review of Board of Pharmacy Regulations - Comment Period Ends December 5th

Public comment periods have now opened to receive comments on regulations governing agencies under the Virginia Board of Health Professions.  This includes the Board of Pharmacy and the Prescription Monitoring Program regulations.  To view ALL of the open comment periods, please click here and scroll down to the "Secretariat: Health and Human Resources" and look for the comment periods scheduled to Close on December 5th.

The Virginia Board of Pharmacy will be conducting a periodic review of its regulations.  The first step to the review process is to receive feedback from the public on the regulations.  Beginning in 2013, the Board will review the regulations and take into consideration public comments received during the 30 day comment period.  The regulations to be reviewed are:

• 18VAC110-20: Virginia Board of Pharmacy Regulations
• 18VAC110-30: Regulations for Practitioners of the Healing Arts to Sell Controlled Substances
• 18VAC110-40: Regulations Governing Collaborative Practice Agreements
• 18VAC110-50: Regulations Governing Wholesale Distributors, Manufacturers and Warehousers

The review is part of the Governor's Regulatory Reform Project with the goal of:

1. Repealing regulations that are unnecessary or no longer in use;
2. Reducing unnecessary regulatory burdens on individuals, businesses, and other regulated groups; and  
3. Identifying statutes that require unnecessary or overly burdensome regulations. 

Further, the Board is seeking comment on whether this regulation should be terminated, amended, or retained in its current form.
 
Public comment is sought on the review of any issue relating to this regulation, including whether the regulation (i) is necessary for the protection of public health, safety, and welfare or for the economical performance of important governmental functions; (ii) minimizes the economic impact on small businesses in a manner consistent with the stated objectives of applicable law; and (iii) is clearly written and easily understandable. 
 
The comment period began November 5, 2012 and ends on December 5, 2012. 
 
Comments may be submitted online to the Virginia Regulatory Town Hall at: http://www.townhall.virginia.gov/L/Forums.cfm.

• Click here to submit comments concerning Board of Pharmacy Regulations
• Click here to submit comments concerning Regulations for Practitioners of the Healing Arts to Sell Controlled Substances
• Click here to submit comments concerning Regulations governing Collaborative Practice Agreements 
• Click here to submit comments concerning Regulations governing Wholesale Distributors, Manufacturers and Warehousers  

Comments may also be sent to:
Elaine J. Yeatts, Agency Regulatory Coordinator
Department of Health Professions
9960 Mayland Drive, Suite 300
Henrico, VA 23233
 
FAX: (804) 527-4434
EMAIL: elaine.yeatts@dhp.virginia.gov

In addition to the Board of Pharmacy's periodic review, comments are also encouraged for the following regulations impacting pharmacy:

• Regulations Governing the Health Practitioners' Monitoring Program for the Department of Health Professions
• Click here for more information
• Regulations Governing the Prescription Monitoring Program
• Click here for more information

Following the close of the public comment period, a report of the periodic review will be posted on the Town Hall and published in the Virginia Register of Regulations.

FDA reports voluntary recall of all Ameridose drug products

The U.S. Food and Drug Administration announced today (October 31) that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo disclaimer icon. A complete list of all products subject to this recall can be accessed at www.ameridose.com disclaimer icon.

For more information on this voluntary recall, please click here for the complete FDA news release.

Presentation by CMS on "The 2012 Medicare Open Enrollment Period & The DMEPOS Competitive Bidding Program, Round 2" - Thursday, October 25th - Richmond

On Thursday, October 25, 2012 from 2:00 – 3:00 PM the Philadelphia Regional Office of the Centers for Medicare & Medicaid Services and The Virginia Bureau of Insurance will be hosting a meeting on: The 2012 Medicare Open Enrollment Period & The DMEPOS Competitive Bidding Program, Round 2

Featuring: Nancy B. O’Connor, Regional Administrator
Philadelphia Regional Office, The Centers for Medicare &

Medicaid Services

Thursday, October 25, 2012 from 2:00 – 3:00 PM

Hosted at the Virginia Bureau of Insurance
1300 East Main Street
Richmond, VA 23219
Court Room A

Please RSVP to: melissa.herd@cms.hhs.gov or 215-861-4165.