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Board Rule .1815 authorizes pharmacists to provide a one-time emergency refill of up to a 90-day supply when the pharmacist is unable to obtain refill authorization from the prescriber due to the prescriber’s inability to provide medical services to the patient. This authority was specifically created for times of emergency like those in western North Carolina.
If you are a pharmacy in one of the counties affected by Hurricane Helene and are open and available to provide services to patients, consider notifying Board staff. Board staff will post availability for the public to access. Please either send an email to emergency@ncbop.org with pharmacy details and address or complete this form and submit to emergency@ncbop.org:
NC Board of Pharmacy staff are receiving notice from pharmacies in western North Carolina that are operating and serving patients. We will continue posting updates as we receive them.
Monday, September 30 - From NCDHHS Division of Public Health, Public Health Preparedness and Response Branch: Our partners in the NC Office of Emergency Medical Services (OEMS) are looking for pharmacists to assist with medical response operations in Western NC related to Hurricane Helene. We really need your help!
NCDHHS’ Drug Control Unit (DCU) has long had a rule that governs how unused controlled substances returned from a nursing facility to the dispensing pharmacy may be destroyed. On July 26, 2024, Stericycle, the owners of the only incinerator in NC that is capable of destroying controlled substances to the point that they are non-retrievable, notified long-term care pharmacies in NC that they will no longer accept bookings for witnessed destruction of controlled substances.
Follow the link below for Governor Cooper’s declaration of emergency and for additional information on how pharmacy personnel should prepare now.
The Board has completed an update of Rule .2504, which governs patient counseling. The updates meet two primary objectives: (1) reorganizing the rule to track the typical dispensing process, providing greater clarity on its requirements; and (2) clarifying the rule’s operation in different practice settings and that, where appropriate, technological means of counseling may be used. Pharmacists are encouraged to review the revised rule.
Unforeseen circumstances can, and do, arise that require a pharmacy to temporarily cease operations. Unexpected closures create hardships for patients, who may suddenly find themselves without access to pharmacy care and without direction to alternatives. New Board Rule .2516, effective August 1, 2024, sets forth patient protection requirements that pharmacies must meet when a temporary closure occurs.
Pharmacists are once again reporting to Board staff that they are receiving calls from individuals purporting to be Board investigators/inspectors. The Board’s phone number, (919) 246-1050, is often what appears on caller ID. Such calls inform the pharmacist that they are the target of an (FBI or other agency) investigation involving illegal drug activity. More below.
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The renewal period for 2025 licensure opens on November 1, 2024. With that fast approaching date, some welcome news for those who begin to sweat the continuing education requirement at the end of the year!
Thanks to those pharmacists who attended one of our recent Candidate Interest Q&A sessions. Two Board positions are up for election this year, the Northeastern and Central district seats. Candidates who wish to stand for election are required to submit a petition signed by ten (10) pharmacists residing in the relevant district to the Board office by October 1, 2024. Contact Kristin Moore at the Board office for petition/signature logistics.
Board members and staff thank Andy Bowman for eight years of superlative service to the Board and the citizens of North Carolina. Dr. Bowman has accepted a position with the Appalachian College of Pharmacy which requires his relocation to Virginia. With Dr. Bowman’s departure, the Board elected Robert “Joey” McLaughlin, Jr. to fulfill the unexpired term. We welcome Mr. McLaughlin back to Board service.
Pharmacists are once again reporting to Board staff that they are receiving calls from individuals purporting to be Board investigators/inspectors. The Board’s phone number, (919) 246-1050, is often what appears on caller ID. Such calls inform the pharmacist that they are the target of an (FBI or other agency) investigation involving illegal drug activity. More below.
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Board staff have noted (another) uptick in license reciprocity applications in which the applicant admits having engaged in acts constituting the practice of pharmacy in a North Carolina health-system facility prior to licensure in the state.
On June 17, 2024, Centers for Medicare & Medicaid Services (CMS) issued a final rule for health information technology standards to adopt the SCRIPT Standard Version 2023011. The updated SCRIPT Standard Version will allow electronic controlled substance prescriptions transfers between pharmacies in a way that complies with DEA’s rule. (More below)
The NCBOP and NCPHP established the L. Stanley Haywood Recovery Fund in 2018. It provides financial support to qualifying pharmacy personnel in need of substance use assessment, treatment, and monitoring services. Learn more about donating or applying for assistance.
Read MoreProhibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.
Read MoreA public hearing will be held at 9:30AM on Tuesday, July 9, 2024 at the Board’s office to consider these changes.
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Board meetings are live-streamed and past meetings are archived here.
October 3, 2024
Board Rule .1815 authorizes pharmacists to provide a one-time emergency refill of up to a 90-day supply when the pharmacist is unable to obtain refill authorization from the prescriber due to the prescriber’s inability to provide medical services to the patient. This authority was specifically created for times of emergency like those in western North Carolina. Pharmacists are encouraged to use it to assist patients in affected counties. The DEA has issued an exception letter allowing Rule .1815 to be used to create and dispense emergency refills of Schedule 3, 4, and 5 substances (found here). This exception is in effect for 30 days (until November 3, 2024), though DEA states that it will consider a further extension if emergency conditions continue to exist at that time. Board staff thanks DEA Agent Stevie Ikner and DEA Assistant Administrator Tom Prevoznik for their quick response to this patient need.
*REMINDER* CONTROLLED SUBSTANCE PRESCRIPTION FORMATS. The North Carolina STOP Act requires that prescriptions for “targeted controlled substances” to be transmitted electronically unless an exception applies. One exception is “technical failure or other circumstance preventing electronic transmission.” For obvious reasons, transmission or receipt of electronic prescriptions in Helene-affected counties is likely to be problematic. Accordingly, the STOP Act’s electronic transmission provisions are not a reason to decline filling a controlled substance prescription issued for a legitimate medical purpose in the ordinary course of medical practice. More STOP Act information is found here.
*REMINDER* VERBAL SCHEDULE 2 PRESCRIPTIONS IN EMERGENCIES. Pharmacists are reminded that, in the case of an “emergency situation,” federal law (21 CFR 1306.11(d)) allows a pharmacist to dispense a Schedule II controlled substance upon receiving oral authorization from the prescriber, provided that: (1) the amount is limited to that adequate to treat the patient during the emergency period; (2) the prescription is immediately reduced to writing by the pharmacist; (3) if the prescriber is not known to the pharmacist, the pharmacist makes a reasonable effort to determine the oral authorization came from a DEA-registered prescriber; and (4) within 7 days, the prescriber causes a written prescription to be delivered to the dispensing pharmacist.
This information, and other Helene response updates, are being compiled on the BOP’s website here: https://www.ncbop.org/heleneaftermath.html.
The Board continues to compile a resource listing pharmacies in Helene-affected counties that have resumed operation. The list is found here -- https://www.ncbop.org/emergencyoperatingpharmacieshelene.html -- and it includes a link for pharmacies to let the Board know that they are operational.
September 30, 2024
From NCDHHS Division of Public Health, Public Health Preparedness and Response Branch: Our partners in the NC Office of Emergency Medical Services (OEMS) are looking for pharmacists to assist with medical response operations in Western NC related to Hurricane Helene. We really need your help! If you are interested is assisting, please use the following link to sign up
-https://nc.readyop.com/fs/4efP/11ea5584.
Deployment for at least 3 consecutive days is preferred. Please use the comments section to provide details about your availability.
If you have questions, please send an email to OEMSSupportCell@dhhs.nc.gov.
September 25, 2024
NCDHHS’ Drug Control Unit (DCU) has long had a rule that governs how unused controlled substances returned from a nursing facility to the dispensing pharmacy may be destroyed. On July 26, 2024, Stericycle, the owners of the only incinerator in North Carolina that is capable of destroying controlled substances to the point that they are non-retrievable, notified long-term care pharmacies in North Carolina that they will no longer accept bookings for witnessed destruction of controlled substances. Stericycle’s business decision to no longer provide long-term care pharmacies the option of destruction of unused controlled substances from nursing homes by an incinerator within the State was not foreseen by the DCU. To help ensure safe, secure, and timely disposal and destruction of unused controlled substances in North Carolina, DCU has promulgated an emergency amendment to its disposal regulation, 10A NCAC 26E .0406, to provide immediate clarity regarding the use of federally recognized options for disposing of and destroying unused controlled substances from nursing homes, including outsourcing the destruction to reverse distributors. More information on the amended rule, its operation, and points of contact at DCU are found here and here.
September 25, 2024
Today, Governor Roy Cooper declared a State of Emergency ahead of Hurricane Helene as North Carolina prepares for severe weather impacts that could threaten life and property across North Carolina through Saturday morning. The NC Department of Insurance reminds health benefit plans of compliance requirements for operations under a state of emergency for purposes of obtaining extra prescriptions during a state of emergency or disaster.
Helene is forecast to cause significant impacts including flash flooding, numerous landslides, damaging debris flows, slope failures across steep terrain, and riverine flooding across portions of western North Carolina and portions of central North Carolina. Flooding may occur in areas that do not typically flood. All North Carolinians should be weather aware and prepared. Tropical storm force winds are possible across western North Carolina late Thursday into Friday. With already saturated soils, trees could fall causing widespread power outages. There is a potential for tornadoes with this storm system. Tornadoes from tropical systems can quickly spin up with little warning.
Pharmacists and pharmacies are reminded that the Board of Pharmacy has exercised its authority under G.S. 90-85.25(a) to waive certain requirements of the North Carolina Pharmacy Practice Act to facilitate the provision of patient care during a declared emergency. The Board’s emergency waiver is now in effect and is found here. That waiver allows pharmacists and nationally-certified technicians who hold a license in good standing in another state to practice in North Carolina to assist during the period of the declared emergency. The waiver also authorizes relocations of pharmacies as needed to provide continuity of care. Certain notifications to the Board are required. Now is the time to review the waiver and begin taking action to implement plans to ensure continuity of patient care. The referenced notification email address – emergency@ncbop.org – is open.
Board staff are certainly aware of the significant public health issues created by such weather emergencies. And Board staff are aware of the often superhuman efforts that pharmacists and pharmacies expend to ensure that patient needs are being met as well as possible under these circumstances. Be assured: Board members and staff support your efforts to ensure that patient needs are being met. Board members and staff understand – and support – you, and know that you will use your compassion and good judgment to deal with the crisis. Board staff are available at any time – 919-246-1050.
September 18, 2024
NEW BOARD RULE GOVERNING TEMPORARY PHARMACY CLOSURES IS NOW IN EFFECT. Unforeseen circumstances can, and do, arise that require a pharmacy to temporarily cease operations. Unexpected closures create hardships for patients, who may suddenly find themselves without access to pharmacy care and without direction to alternatives. New Board Rule .2516, effective August 1, 2024, sets forth patient protection requirements that pharmacies must meet when a temporary closure occurs. This FAQ reviews Rule .2516’s who, what, when, where, and how for temporary pharmacy closures.
September 10, 2024
They’re back! Pharmacists are once again reporting to Board staff that they are receiving calls from individuals purporting to be Board investigators/inspectors. The Board’s telephone number, (919) 246-1050, is often what appears on caller ID. Such calls as of late inform the pharmacist that they are the target of an investigation involving illegal drug activity and the caller sometimes claims to be part of a larger FBI (or SBI, DEA or other agency) investigation. The details vary, but these calls appear to be an attempt to get the recipient to disclose personal information.
Board staff reminds practitioners that the names of all the Board’s investigators are listed on the NCBOP’s website, and if they are unsure or suspicious when contacted by someone claiming to be a Board staff member (whether by phone, email, or other communication) that they should contact the Board immediately. To be sure, Board staff frequently contact pharmacists and pharmacy staff on all manner of issues. But, again, if you are suspicious about the true identity of the caller, please reach out to the Board office directly.
September 6, 2024
The renewal period for 2025 licensure opens on November 1, 2024. With that fast approaching date, some welcome news for those who begin to sweat the continuing education requirement at the end of the year! The Board has completed an amendment to Rule .2201. Paragraph (c) of that rule states:
“A pharmacist who accumulates more than the required 15 hours of continuing education in a single year may carry forward up to five surplus hours to be applied to the following year's continuing education requirements.”
The amendment is in effect. So, a pharmacist who acquired more than 15 hours of continuing education in 2023 may carry over up to five of those surplus hours to 2024 and apply them to renewal for 2025 licensure.
UPDATED August 30, 2024
Thanks to those pharmacists who joined Board staff at one of two recent Candidate Interest Q&A sessions. The Board is now accepting petitions from eligible pharmacists wishing to appear on the ballot in either the Northeastern or Central district. Petitions must be received in the Board office by October 1. Follow this link for all election details.
JULY 25, 2024
(RE)SETTING THE STAGE
On July 27, 2023, Drug Enforcement Administration (DEA) issued a final rule governing the transfer of electronic prescriptions for controlled substances prior to initial fill. Among other things, the DEA rule provides that for a valid transfer to occur: “The prescription must be transferred from one retail pharmacy to another retail pharmacy in its electronic form. At no time may an intermediary convert an electronic prescription to another form (e.g., facsimile) for transmission.” Furthermore, the rule states: “The contents of the prescription required by this part must not be altered during transfer between retail pharmacies. Any change to the content during transfer, including truncation or removal of data, will render the electronic prescription invalid.” 21 CFR § 1306.08(f)(1) and (2)
DEA commentary accompanying the rule asserted that SCRIPT Standard Version 2017071 enables the transfer of CS prescriptions between pharmacies in a way that satisfies these rule requirements. In a February 14, 2024 letter to stakeholders, Surescripts confirmed that SCRIPT Standard Version 2017071 does not do what DEA thinks that it does – and never has. Surescripts stated that SCRIPT Standard Version 2023011 is capable of transferring CS prescriptions in a way that complies with DEA’s rule, but the Centers for Medicare & Medicaid Services must finalize a rule allowing the industry to adopt this updated SCRIPT standard.
UPDATE
On June 17, 2024, Centers for Medicare & Medicaid Services (CMS) issued a final rule for health information technology standards to adopt the SCRIPT Standard Version 2023011. The updated SCRIPT Standard Version will allow electronic controlled substance prescriptions transfers between pharmacies in a way that complies with DEA’s rule. CMS’ adoption is found here.
WHAT NOW
Pharmacies should communicate with their technology vendors to determine when and how their systems will be updated to incorporate SCRIPT Standard Version 2023011.
JULY 18, 2024
BOARD STAFF NOTES CONCERN WITH A NUMBER OF RECIPROCITY APPLICATIONS SUBMITTED BY PHARMACISTS SEEKING TO PRACTICE AT NORTH CAROLINA HEALTH SYSTEMS. Board staff have noted (another) uptick in license reciprocity applications in which the applicant admits having engaged in acts constituting the practice of pharmacy in a North Carolina health-system facility prior to licensure in the state. Upon questioning, the applicant usually responds with some variation of “I engaged in pharmacy practice, but only under the supervision of a North Carolina-licensed pharmacist.” This is a reminder to health-system pharmacies that there is no provision in law by which a pharmacist not licensed to practice pharmacy in North Carolina may engage in pharmacy practice within North Carolina. There is no “under the supervision of a North Carolina licensed pharmacist” exception. And applicants for licensure by reciprocity are not, and are not eligible to become, pharmacy interns. This is unlicensed practice of pharmacy, and a health-system that has allowed it to occur has aided an abetted the unlicensed practice of pharmacy. Board staff have reached out to various health-systems about this issue in recent years, but doing so has not impacted the practice. Accordingly, Board staff will begin treating these issues as potential disciplinary matters. Please ensure that no pharmacist in a North Carolina health-system facility engages in acts constituting the practice of pharmacy unless and until the pharmacist is licensed in North Carolina.
july 5, 2024
With Dr. Bowman’s departure, the Board is required to select a pharmacist to fulfill the remainder of his term of service. The pharmacist members of the Board solicited nominations from qualified pharmacists. After reviewing these pharmacists’ submissions, as well as holding a public interview and discussion session for all candidates at the May 21, 2024 business meeting, pharmacist members elected Robert J. “Joey” McLaughlin, Jr, to fulfill the unexpired term, which runs through April 30, 2026.
Mr. McLaughlin is from New Bern, NC, and is the president and chief executive officer of Realo Drugs, which operates several community retail pharmacies and a device and medical equipment facility. Mr. McLaughlin’s practice background is broad, and he is a well-liked and well-respected member of the North Carolina pharmacy community. Mr. McLaughlin previously served on the Board from 2006-2016, and his service was exemplary.
Board members and staff also thank Jennifer Buxton, Jason Foil, Karen Harrell-Tosto, Wes Hickman, Amanda Lingerfelt, Brian Moore, and Jack Pate for their candidacies.
JUNE 29, 2023
On June 27, 2023 the federal Food and Drug Administration (“FDA”) issued a draft guidance document titled “Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B states that an outsourcing facility is not eligible for the statutory exemptions for its compounded product if the product is sold or transferred by an “entity other than the outsourcing facility that compounded such drug.” Board staff have received calls from time to time inquiring whether this provision prohibits pharmacies from purchasing a compounded prescription product from a 503B outsourcing facility and then dispensing it to a patient pursuant to an individual patient prescription. FDA’s draft guidance states, among other things, that the following situations would not be subject to Section 503B’s wholesaling prohibition:
* An outsourcing facility distributes a drug it compounded (without obtaining a patient-specific prescription) to a health care professional who administers it in a health care setting (e.g., in a hospital or the physician’s office)
* An outsourcing facility distributes a drug it compounded (without obtaining a patient-specific prescription) to a hospital or health system, health clinic, or physician’s office, and it is administered within that hospital or health system, health clinic, or physician’s office.
* An outsourcing facility distributes a drug it compounded (without obtaining a patient-specific prescription) to a hospital or health system, health clinic, or physician’s office where it is used as office stock to dispense to patients pursuant to prescriptions.
* An outsourcing facility distributes a drug it compounded to a state-licensed pharmacy, federal facility, or licensing physician, which subsequently dispenses the drug pursuant to a prescription.
The draft guidance is found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act. The title page of the draft guidance contains instructions to submit comments and suggestions within 60 days.
FEBRUARY 27, 2024
Optometrists may now register with the NC Board of Pharmacy to dispense certain prescription drugs. G.S. § 90-127.4. Dispensing optometrists may dispense prescription drugs to their own patients only for the diagnosis and treatment of abnormal conditions of the eye and its adnexa. G.S. § 90-127.4(a) & (c). Dispensing optometrists may not compound medications, nor may they dispense controlled substances. G.S. § 90-127.4(a).
Dispensing optometrists must register with the Board of Pharmacy prior to beginning dispensing activities and must renew that registration annually. G.S. § 90-85.26B. The initial registration fee is $75, as is the annual renewal fee. G.S. § 90-85.24(a)(20).
A dispensing optometrist must comply in all respects with relevant laws and regulations that apply to pharmacists governing the distribution of drugs, including packaging, labeling, and record keeping. G.S. § 90-85.26B. The Board of Pharmacy may discipline a dispensing optometrist’s registration for violation of these laws and regulations. The Board of Optometry may discipline an optometrist’s license to practice optometry. G.S. § 90-85.25B.
Step-by-step instructions for completing a dispensing optometrist registration are found here.
MARCH 11, 2024
Today (March 11, 2024), NC DHHS issued an updated COVID-19 treatment provider memo. Included in this memo is a reminder that EUA-labeled Paxlovid is no longer authorized for use, information about PAXCESS – a program that can help patients with financial barriers obtain Paxlovid, an update on clinical data on the efficacy of antiviral treatments, and a note on the large portion of the North Carolina population considered high risk based on age or health conditions. The memo is found here.