Board News and Announcements
FRIDAY, FEBRUARY 27, 2015 - RENEW NOW FOR 2015
Sunday, March 1, 2015 is the final day to renew your license or registration for the current year. Click here for 2015 renewal information and appropriate log-in links.
WEDNESDAY, FEBRUARY 25, 2015
GUIDANCE ON THE FEDERAL DRUG QUALITY AND SECURITY ACT. North Carolina pharmacists are aware that in November 2013, federal Drug Quality and Security Act became effective. Board staff periodically receive questions about DQSA’s operation and have created this guidance document (last updated February 25, 2015): http://www.ncbop.org/faqs/FAQsDQSA022515.pdf.
TUESDAY, FEBRUARY 3, 2015
NOTICE OF PUBLIC HEARING (MAY 12, 2015) ON PROPOSED AMENDMENT TO RULE 21 NCAC 46 .3301 - TECHNICIAN REGISTRATION. The Board proposes amending the technician registration statute to improve conformity to the statutory requirements of G.S. 90-85.15A, including those adopted in Session Law 2013-379.
A public hearing will be held on May 12, 2015 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 May 12, 2015 and/or by submitting a written objection by 9:00am on May 12, 2015 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 email@example.com. 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 .3301: http://www.ncbop.org/LawsRules/3301ProposedAmendmentTechnicianRegistrationJuly2015.pdf
THURSDAY, JANUARY 22, 2015 - UPCOMING BOARD ELECTION
The next Board election will take place in April/May 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. A pharmacist may be placed on the ballot by submitting a notice of intent to run signed by the would-be candidate and 10 North Carolina licensed pharmacists who reside in the Southeastern District. The election will be held in April and May 2015, and any necessary run-off election held in May and June 2015. More detail will follow. The successful candidate would assume office on May 1, 2016, after commissioning by the governor.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JANUARY 27, 2015.)
MONDAY, JANUARY 5, 2015
SUBSTITUTION OF EXTENDED RELEASE METHYLPHENIDATE PRODUCTS. As pharmacists are aware, in recent weeks the Food and Drug Administration (FDA) changed the Orange Book equivalency rating of extended release methylphenidate products manufactured by Mallinkrodt and Kudco from “AB” to “BX” due to concerns about bioavailability equivalency with Janssen Pharmaceuticals’ Concerta product. More details concerning FDA’s action, the reasons for it, and the consequences are found here: http://www.fda.gov/drugs/drugsafety/ucm422569.htm.
Note further that Janssen Pharmaceuticals manufactures an “authorized generic” of Concerta, which is marketed by Actavis under licensing agreement. Actavis’ product is not marketed under the Concerta name, but it is identical to Janssen’s Concerta. FDA’s Orange Book rating change does not apply to the Actavis product.
Board staff have received questions as a result of the FDA action (read Q & A here).
MONDAY, DECEMBER 22, 2014
AMENDED PHARMACY COMPOUNDING RULES GO INTO EFFECT ON JANUARY 1, 2015. The Board has completed its rulemaking to amend the rules governing pharmacy compounding. The amended rules were approved by the Rules Review Commission on December 17, 2014 and will go into effect on January 1, 2015. The Board appreciates the thoughtful commentary on the proposed rules from practitioners and others. The rules as amended may be found here: http://www.ncbop.org/LawsRules/FinalCompoundingRulesJan2015.pdf.
FRIDAY, DECEMBER 19, 2014
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. As of January 1, 2015, a Board rule amendment will become effective that allows registered nurses at local health departments to dispense epinephrine auto-injectors prescribed in compliance with the new statute. Read the updated guidance here: http://www.ncbop.org/faqs/Pharmacist/GuidanceEpinephrineAutoInjectorStatuteDec2014.pdf.
TUESDAY, DECEMBER 9, 2014
VOLUNTEER PHARMACY TECHNICIANS PRACTICING AT FREE CLINIC SITES DO NOT NEED TO COMPLETE A TECHNICIAN REGISTRATION. In October 2014, Board staff notified pharmacists of a situation in which a non-registered pharmacy technician practicing at a free clinic was found to have diverted controlled substances. That technician had previously surrendered her registration for engaging in similar diversion at an employing pharmacy. As a result, Board staff noted that, going forward, volunteer technicians at free clinics would be required to register as technicians and would need to complete that registration by February 28, 2015. This action was premature, and Executive Director Jay Campbell takes full responsibility, and apologizes, for the prematurity. Board Rule .3301(d) provides: “Volunteer pharmacy technicians providing services at a facility which has a pharmacy permit designated as a free clinic shall complete the training program described in G.S. 90-85.15A(b) but need not register with the Board.”
Accordingly, any change in registration requirement for volunteer pharmacy technicians would have to be accomplished by rule amendment. Technicians presently practicing solely in a volunteer capacity at a free clinic are not required to register with the Board. And any technician who has done so as a result of the October 2014 memo may contact the Board for a refund of the registration fee.
The incident that led to the October communication does show that appropriate tracking and vetting of volunteer pharmacy technicians needs to occur. And Board staff looks forward to engaging appropriate stakeholders on an appropriate solution.
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.
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 - Draft Guidance Revised Nov 2014
- Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Final Guidance for Outsourcing Facilities Preparing Sterile Compounds
- Final Rule Regarding and Adivsory Committee
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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