Board News and Announcements
THURSDAY, NOVEMBER 20, 2014 - UPCOMING BOARD ELECTION / CANDIDATE INTEREST FORUM
The next Board election will take place in Spring of 2015. One position on the Board will be filled: The Southeastern District seat presently held by Robert (Joey) McLaughlin. Mr. McLaughlin will complete his second consecutive five-year term on April 30, 2016 and thus is term limited.
The Southeastern District comprises Beaufort, Bladen, Brunswick, Carteret, Columbus, Craven, Cumberland, Duplin, Greene, Harnett, Hoke, Johnston, Jones, Lenoir, New Hanover, Onslow, Pamlico, Pender, Pitt, Robeson, Sampson, Scotland, and Wayne Counties.
Nominations are open through March 15, 2015. Board staff encourages any actively licensed pharmacist living in one of these counties to find out more about the election process by attending an interest forum in January. Board staff will be available to answer questions and discuss what it means to serve on the Board.
The forum is scheduled for Thursday, January 8 at 7:00pm at the Best Western Plus Coastline Inn in Wilmington, NC. Address and directions may be found here: http://www.coastlineinn.com/maps_directions.html.
For ease of planning, please email Kristin Moore at the Board of Pharmacy office if you plan to attend or call 919.246.1050 ext. 209.
THURSDAY, NOVEMBER 13, 2014
PHARMACIST NEEDED FOR ORANGE COUNTY BOARD OF HEALTH. One major way citizens can have a positive impact on the future of Orange County is to volunteer to serve on the various advisory boards and commissions. Volunteers appointed by the Board of County Commissioners have an opportunity to influence the way of life in Orange County.
The Orange County Board of Commissioners is currently recruiting for a pharmacist position on the Orange County Board of Health. Applicants must reside in Orange County.
The Board of Health is the primary policy making, rule-making, and adjudicatory body for the Health Department and is charged to protect and promote the public health of Orange County. This function may include allocating resources, planning programs, enacting public health-related polices and advising the health director on health needs.
The Board of Health typically meets on the fourth Monday of each month from 7 to 9 pm. There are also occasional ad-hoc meetings that average less than two hours per month. An appointment is for three years, and a board member can serve two terms.
If interested, apply at www.orangecountync.gov/boards.
For additional information, call Dr. Colleen Bridger, Orange County Health Director, at 919-245-2412.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED NOVEMBER 17, 2014.)
WEDNESDAY, NOVEMBER 5, 2014 - EMERGENCY EPINEPHRINE AUTO-INJECTORS
BOARD OF PHARMACY STAFF ISSUES UPDATED GUIDANCE FOR SCHOOLS AND PHARMACIES CONCERNING THE SUPPLY OF EMERGENCY EPINEPHRINE AUTO-INJECTORS TO NORTH CAROLINA PUBLIC AND CHARTER SCHOOLS. On September 4, 2014, Board staff issued a guidance document to schools and pharmacies on implementation of the epinephrine auto-injector for schools statute. The statute became effective on November 1, 2014. Board staff has updated that guidance document to address a few questions with additional specificity. The updated guidance may be found here: http://www.ncbop.org/faqs/Pharmacist/GuidanceEpinephrineAutoInjectorStatuteNov2014.pdf.
SATURDAY, NOVEMBER 1, 2014 - RENEW NOW FOR 2015
THE 2015 REGULAR RENEWAL PERIOD BEGAN ON NOVEMBER 1, 2014 AND LASTS THROUGH DECEMBER 31, 2014.
All actively licensed pharmacists, actively registered technicians / PA/NPs / dispensing physicians, and active pharmacy and DME facility permit holders, click here for 2015 renewal information and appropriate log-in links.
THURSDAY, OCTOBER 30, 2014
BOARD OF PHARMACY FILES ANNUAL REPORT. North Carolina law requires the Board to file a report each year detailing virtually all aspects of operations. The Board submitted its 2013-14 Annual Report on October 29. It may be found here: http://www.ncbop.org/about/AnnualReport2013_14.pdf. Annual reports dating back to 2006-07 are available electronically here: www.ncbop.org/about/about.htm. Copies of earlier annual reports may be obtained by request.
WEDNESDAY, OCTOBER 22, 2014
BOARD OF PHARMACY ISSUES NEW GUIDANCE ON REGISTRATION OF TECHNICIANS WHO ASSIST AT FREE OR CHARITABLE CLINICS. For several years, a Board guidance statement advised that volunteer pharmacy technicians providing services at a facility designated as a free or charitable clinic were required to undergo statutorily-prescribed training, but need not register with the Board. A recent case has prompted the Board to rescind this guidance statement. As a result, all pharmacy technicians practicing in any pharmacy setting – including free or charitable clinics – must be registered with the Board of Pharmacy. Such registration must occur by the close of the 2015 renewal period, February 28, 2015. Detailed background and other information may be found here: http://www.ncbop.org/faqs/Board_Policy_Concerning_Technicians_at_Free_Charitable_Clinics_Oct2014.pdf.
WEDNESDAY, SEPTEMBER 3, 2014
NOTICE OF PUBLIC HEARING (NOVEMBER 18, 2014) ON PROPOSED AMENDMENTS TO RULES 21 NCAC 46 .2401 and .2403 - DISPENSING IN HEALTH DEPARTMENTS. Revisions required by Section 8.23 of the Current Operations and Capital Improvements Appropriations Act of 2014 (Session Law No. 2014-100), to permit public health department nurses to dispense epinephrine auto-injectors to school personnel.
A public hearing will be held on November 18, 2014 at 9:00am at the NC Board of Pharmacy office, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.
Any person may object to the proposed amendment by attending the public hearing on November 18, 2014 and/or by submitting a written objection by 9:00am on Novemer 18, 2014 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, e-mail firstname.lastname@example.org. The North Carolina Board of Pharmacy is interested in all comments pertaining to the proposed rule. All persons interested and potentially affected by the proposal are strongly encouraged to read this entire notice and make comments on the proposed rule.
If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.
• NOTICE OF TEXT/PUBLIC HEARING:
• PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .2401: http://www.ncbop.org/LawsRules/2401AmendedForEpipensAug2014.pdf
21 NCAC 46 .2403: http://www.ncbop.org/LawsRules/2403AmendedWithEpipenChangesAug2014.pdf
THURSDAY, JULY 3, 2014
FOOD AND DRUG ADMINISTRATION RELEASES ADDITIONAL GUIDANCE CONCERNING IMPLEMENTATION OF THE DRUG QUALITY AND SECURITY ACT. On Tuesday, July 1, 2014, the federal Food and Drug Administration released additional guidance concerning implementation of the Drug Quality and Security Act, including: (1) draft interim guidance concerning CGMP compliance for Section 503B outsourcing facilities; (2) a proposed rule revising FDA’s list of drug products that may not be compounded because they have been withdrawn or removed from the market for lack of safety or efficacy; (3) final guidance to compounding pharmacies on Section 503A; and (4) notice of reopening the nomination process for lists of bulk drug substances that may be used to compound drug products. More information, including links to the various documents, may be found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403507.htm
FRIDAY, DECEMBER 6, 2013
FEDERAL DRUG QUALITY AND SECURITY ACT BRINGING CHANGES TO COMPOUNDING PHARMACY REGULATION. On November 27, 2013, the President signed into law the Drug Quality and Security Act (DQSA). DQSA focuses on two broad issues: (1) further refinement of the state and federal roles in regulating compounding pharmacy practices; and (2) creation and implementation of a national “track and trace” program intended to ensure integrity of the prescription drug supply chain. Compounding pharmacists undoubtedly have questions about the impact of this statute on their practices. Board staff will continue to provide information as available. Earlier this week, FDA issued guidance on the new statute. Compounding pharmacists are strongly advised to read FDA guidance. It may be found here:
- Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)
- Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)
FDA Compounding Statement: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm
Health Advisories (last updated October 24, 2014) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated December 2013) - Check here regularly for the latest updates regarding Medicare/Medicaid.
The North Carolina Board of Pharmacy's mission is to protect the public health, safety and welfare in pharmaceutical matters. The Board sets standards for academic and practical experience programs prior to licensure, issues permits to operate pharmacies and DME facilities, and annually renews licenses, permits and registrations.
For more information, please see About the NCBOP.
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