Helene Relief & Recovery

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    NC DHHS DRUG CONTROL UNIT PROVIDES GUIDANCE ON REPORTING VETERINARY GABAPENTIN DISPENSING

    NC DHHS’ Drug Control Unit (DCU) announces that the North Carolina Controlled Substance Reporting System (CSRS) is launching state license failover for veterinary gabapentin reporting on January 8th, 2025. By March 1, 2025, state law requires all veterinary dispensations of gabapentin to be reported to the CSRS.

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    CERTAIN FEDERAL PREP ACT AUTHORIZATIONS FOR PHARMACISTS EXTENDED TO DECEMBER 31, 2029

    The US Department of Health and Human Services announced on December 11, 2024 that PREP Act authorizations for qualified pharmacists, pharmacy interns, and pharmacy technicians to order (for pharmacists) and administer (for pharmacists, interns, and technicians) COVID-19 vaccines, seasonal flu vaccines, and COVID-19 tests has been extended through December 31, 2029.

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    NC DHHS ISSUES NEW EDITION OF NORTH CAROLINA’S GUIDE TO DIABETES PREVENTION AND MANAGEMENT

    A new edition of North Carolina’s Guide to Diabetes Prevention and Management is available here.
    The guide is intended for individuals, community groups, employers, and healthcare providers to manage diabetes and minimize complications. The content covers basic information about diabetes, its effects on the North Carolina population, and how individuals can prevent and manage the disease.

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    NC CSRS (CONTROLLED SUBSTANCE REPORTING SYSTEM) TO LAUNCH CLINICAL ALERT PROGRAM
    ON DECEMBER 9, 2024

    The North Carolina Controlled Substance Reporting System (“CSRS”) is launching a “clinical alert” program on December 9, 2024. These are notifications for prescribers indicating that a patient has met or exceeded certain high-risk thresholds for controlled substance use and intended to assist healthcare providers in identifying patients potentially at risk of overdose or substance use disorder.

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    DEA EXTENDS TELEMEDICINE FLEXIBILITY AUTHORITY FOR CONTROLLED SUBSTANCES THROUGH DECEMBER 31, 2025

    On November 19, 2024, DEA published a temporary rule again extending COVID-era telemedicine flexibilities for controlled substance prescribing through December 31, 2025. More information here.

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    COVID-19 STATEWIDE STANDING ORDERS (SWSOs) WILL EXPIRE ON DECEMBER 31, 2024

    From the NC Department of Health and Human Services: The COVID-19 Statewide Standing Orders (SWSOs) authorized under North Carolina Session Law 2022-74, Sec. 9G.7.(a)-(e) and extended under Session Law 2023-65, Sec. 9G.7, will expire on December 31, 2024. No additional extensions have been provided. What does this mean for your pharmacy? 

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    BOARD MEMBER ELECTIONS FOR CENTRAL AND NORTHEASTERN DISTRICTS

    Two positions on the NCBOP are up for election this year - the Central and Northeastern districts. Follow the link below to read about the candidates or simply log in to the Licensure Gateway to cast your votes now. Although the voting period coincides with the license renewal period, November 1 through March 1, voting and renewing your license can occur separately during that timeframe. Your voice matters and voting takes less than a minute!

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    NC BOARD OF PHARMACY TO HOST SECOND ANNUAL COMPOUNDING SUMMIT IN FEBRUARY

    The Board will host its 2nd Annual Compounding Summit February 25-27th at the UNC Friday Center in Chapel Hill, NC . We have another great lineup of speakers presenting on the implementation of USP standards and how those standards apply in different compounding settings. We will be providing CE credit through NABP. In-person attendance is encouraged, but we do have a virtual option available. 

    2025 Compounding Summit details and registration
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    BOARD COMPLETES AMENDMENTS TO RULES GOVERNING HEALTH-CARE FACILITY PHARMACY PERMITS AND EMERGENCY DEPARTMENT DISPENSING

    The Board has completed amendments to two rules governing health-care facility pharmacy practice: Rule .1401, Registrations and Permits and Rule .1415, Emergency Department Dispensing.

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    2025 RENEWAL PERIOD - NOVEMBER 1 THROUGH DECEMBER 31

    The 2025 renewal period began on November 1 and runs through December 31, 2024 (with a grace period from January 1, 2025 through March 1, 2025.)

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    BOARD UPDATES PATIENT COUNSELING RULE

    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. 

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    DEA CONSIDERING EXTENSION OF RULE .1815 USE TO PROVIDE EMERGENCY REFILLS OF SCHEDULE 3, 4, AND 5 PRESCRIPTIONS.

    On October 3, 2024, the DEA issued an exception letter concurring in the use of Board Rule .1815 to provide one-time emergency refills of up to a 90-day supply of a Schedule 3, 4, or 5 substance 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 concurrence applies to patients in Helene-affected counties.

    More information
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    PHARMACISTS AND PHARMACY PERSONNEL WARNED OF SCAM COMMUNICATIONS PURPORTING TO BE FROM BOARD OF PHARMACY STAFF.

    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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    CMS ADOPTS SCRIPT STANDARD 2023011 – IMPLICATIONS FOR ELECTRONIC CONTROLLED SUBSTANCE PRESCRIPTION TRANSFERS

    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)

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    In coordination with the NC Professionals Health Program

    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.

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    NCBOP Rulemaking Notice: Proposed Amendments to 21 NCAC 46 .1401 and .1415

    A 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.

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Latest News

  • NC DHHS DRUG CONTROL UNIT PROVIDES GUIDANCE ON REPORTING VETERINARY GABAPENTIN DISPENSING

    DECEMBER 17, 2024

    NC DHHS’ Drug Control Unit (DCU) announces that the North Carolina Controlled Substance Reporting System (CSRS) is launching state license failover for veterinary gabapentin reporting on January 8th, 2025. By March 1, 2025, state law requires all veterinary dispensations of gabapentin to be reported to the CSRS. Some veterinarians may lack a Drug Enforcement Agency (DEA) or National Provider Identifier (NPI) number. To facilitate CSRS reporting of veterinary gabapentin dispensations in that circumstance, DCU will enable a failover allowing submissions using the veterinarian’s North Carolina license number. DCU has updated its Dispenser and Veterinarian Dispensers Guides (found here) to include the veterinary license failover process. DCU promises a Gabapentin Veterinary State License Failover Reporting FAQ to come. Board staff will update when that FAQ document is posted on DCU’s website. In the meantime, anyone with questions or concerns about DCU’s veterinary gabapentin reporting processes should contact Savannah Simpson or the CSRS inbox.

  • CERTAIN FEDERAL PREP ACT AUTHORIZATIONS FOR PHARMACISTS EXTENDED TO DECEMBER 31, 2029

    DECEMBER 13, 2024

    The United States Department of Health and Human Services announced on December 11, 2024 that PREP Act authorizations for qualified pharmacists, pharmacy interns, and pharmacy technicians to order (for pharmacists) and administer (for pharmacists, interns, and technicians) COVID-19 vaccines, seasonal flu vaccines, and COVID-19 tests has been extended through December 31, 2029. These authorities were previously scheduled to expire on December 31, 2024. Secretary Berrea noted, “As stated in prior amendments to this Declaration, licensed pharmacists, pharmacy interns and qualified pharmacy technicians are well positioned to provide continued access to [these vaccines and tests], particularly in certain areas or for certain populations that have too few primary-care providers or that are otherwise medically underserved.” US DHHS full statement is found here. A comprehensive guidance document on pharmacist and pharmacy technician immunization authority under PREP Act waivers and North Carolina state law is found here.

  • NC CSRS TO LAUNCH CLINICAL ALERT PROGRAM ON DECEMBER 9, 2024

    NOVEMBER 25, 2024

    The North Carolina Controlled Substance Reporting System (“CSRS”) is launching a “clinical alert” program on December 9, 2024. These are notifications for prescribers indicating that a patient has met or exceeded certain high-risk thresholds for controlled substance use and intended to assist healthcare providers in identifying patients potentially at risk of overdose or substance use disorder. CSRS provides more detail here.

    Pharmacists or others with questions about the program, its purposes, and its application should contact Savannah Simpson at NC DHHS: savannah.simpson@dhhs.nc.gov; 984-236-5340.

  • THE COVID-19 STATEWIDE STANDING ORDERS (SWSOs) WILL EXPIRE ON DECEMBER 31, 2024

    NOVEMBER 18, 2024

    From the NC Department of Health & Human Services: The COVID-19 Statewide Standing Orders (SWSOs) authorized under North Carolina Session Law 2022-74, Sec. 9G.7.(a)-(e) and extended under Session Law 2023-65, Sec. 9G.7, will expire on December 31, 2024. No additional extensions have been provided.

    What this means for your pharmacy:
    If your pharmacy currently uses the SWSOs issued by Dr. Elizabeth Tilson, NC State Health Director, to facilitate COVID-19 vaccinations, action is required to prevent disruptions in vaccine administration. Ensure that any changes needed to your pharmacy-specific vaccination protocol are in effect by January 1, 2025.

    Action Required:

    > Review and prepare to transition to pharmacy-specific protocols.

    > Finalize and implement any needed changes to your pharmacy’s vaccination protocols by January 1, 2025.

    > For more information about pharmacist and pharmacy technician vaccination authority, please see this BOP guidance document

    Thank you for your attention to this important change.

    In Health,
    NC Department of Health and Human Services

  • BOARD COMPLETES AMENDMENTS TO RULES GOVERNING HEALTH-CARE FACILITY PHARMACY PERMITS AND EMERGENCY DEPARTMENT DISPENSING

    november 1, 2024

    The Board has completed amendments to two rules governing health-care facility pharmacy practice.

    Rule .1401, Registrations and Permits. Board Rule .1401 now clarified that physically separate dispensing areas operated by a health care facility are not required to have a separate permit if those dispensing areas are either (a) contained in the same building as the permitted pharmacy or (b) contained in a building located on property contiguous to the permitted pharmacy. All physically separate dispensing areas for which the majority of its activity is dispensing or compounding drugs for a patient’s use outside of the health care facility must hold a separate permit. All health care facilities should review their dispensing areas to determine whether any satellite area no longer requires a permit or, particularly for “off-campus” areas, whether a satellite area now requires its own separate permit.

    Rule .1415, Emergency Department Dispensing. Board Rule .1415 now provides that, when a health care facility is closed for outpatient pharmacy service, non-pharmacy-personnel dispense no more than a seven-day supply or the smallest quantity prepacked by the manufacturer from a formulary of drugs for emergency department dispensing developed by the pharmacist-manager. The overall substance of Rule .1415 (who, what, when, where) is largely unchanged. Again, the chief change is the larger supply of a drug that may be dispensed from an emergency department to avoid disruption in patient care.

    Both amendments are effective today, November 1, 2024.

  • DEA CONSIDERING EXTENSION OF RULE .1815 USE TO PROVIDE EMERGENCY REFILLS OF SCHEDULE 3, 4, AND 5 PRESCRIPTIONS

    november 1, 2024

    On October 3, 2024, the DEA issued an exception letter (found here) concurring in the use of Board Rule .1815 to provide one-time emergency refills of up to a 90-day supply of a Schedule 3, 4, or 5 substance 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 concurrence applies to patients in Helene-affected counties. DEA’s concurrence is scheduled to expire on Sunday, November 3, but DEA stated in its letter that it would consider further extension if emergency conditions continued to exist at that time. In light of the extension of the Helene state of emergency to March 1, 2025, Board staff requested on October 25 that DEA extend the concurrence for the same period. DEA is considering that request, and Board staff expects to receive a decision soon. In the meantime, DEA staff agree that pharmacists may continue to rely on the October 3 concurrence pending a DEA decision on the extension. Board staff will provide more information when received from DEA.

  • 2025 RENEWAL PERIOD BEGAN ON NOVEMBER 1, 2024

    november 1, 2024

    The 2025 renewal period began today and runs through December 31, 2024 (with a grace period from January 1, 2025 through March 1, 2025.) If you choose to renew your license / permit / registration for 2025, follow this link to log in and begin the online renewal process.

    FAQs pertaining to license / permit / registration renewal may be found here.

  • HELENE STATE OF EMERGENCY EXTENDED THROUGH MARCH 1, 2025

    October 25, 2024

    On October 24, 2024, the General Assembly passed and Governor Cooper signed into law the Disaster Recovery Act of 2024. Section 3.1 of the Act extends the Governor’s declared state of emergency through March 1, 2025. Accordingly, waivers issued by the Board of Pharmacy to facilitate Helene relief and recovery remain in effect through March 1, 2025 unless the Board acts to terminate them prior to that date. A reminder that the Board has compiled Helene relief and recovery resources here.

  • HHS SECRETARY BECERRA PROVIDES UPDATE ON EFFORTS UNDERWAY TO MITIGATE SUPPLY CHAIN DISRUPTIONS CAUSED BY BAXTER FACILITY DAMAGE

    UPDATED THURSDAY, OCTOBER 17, 2024 WITH a response from usp

    10/17/24 - UPDATE FROM US PHARMACOPEIA (USP): "USP, with input from our Compounding Expert Committee members and stakeholders, is providing the following resources intended to support healthcare practitioners and scientific professionals to address shortages of manufactured intravenous fluids resulting from the consequences of Hurricane Helene” (follow this link for details.)

    10/15/24     - CDC HEALTH ADVISORY: Disruptions in Availability of Peritoneal Dialysis and Intravenous Solutions from Baxter International Facility in North Carolina. Follow this link for details.

    10/10/24 - Federal Department of Health and Human Services Secretary Becerra has issued this letter concerning federal efforts to mitigate sterile solutions supply chain disruptions attributable to significant damage to Baxter’s Marion, NC facility. FDA has established a continually updating information page here: https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina. Baxter has likewise established a continually updating information page here: https://www.baxter.com/baxter-newsroom/hurricane-helene-updates

  • DEA APPROVES USE OF BOARD RULE .1815 TO CREATE AND DISPENSE EMERGENCY REFILLS OF SCHEDULE 3, 4, AND 5 CONTROLLED SUBSTANCES

    October 3, 2024

    Board Rule .1815 authorizes pharmacists and DME providers to provide a one-time emergency refill of up to a 90-day supply when the pharmacist or DME provider 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 and DME providers 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.

  • NC DHHS DRUG CONTROL UNIT ISSUES EMERGENCY RULE AMENDMENT CONCERNING DISPOSAL OF UNUSED CONTROLLED SUBSTANCES RETURNED TO A PHARMACY FROM A NURSING FACILITY 

    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.

  • NEW BOARD RULE GOVERNING TEMPORARY CLOSURES IS NOW IN EFFECT

    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.

  • PHARMACISTS AND PHARMACY PERSONNEL WARNED OF SCAM COMMUNICATIONS PURPORTING TO BE FROM NCBOP STAFF

    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.

  • BOARD OF PHARMACY REINSTATES FIVE-HOUR CE CARRYOVER ALLOWANCE

    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.

  • CMS ADOPTS SCRIPT STANDARD 2023011 – IMPLICATIONS FOR ELECTRONIC CONTROLLED SUBSTANCE PRESCRIPTION TRANSFERS

    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.

  • BOARD STAFF NOTES CONCERN WITH A NUMBER OF RECIPROCITY APPLICATIONS SUBMITTED BY PHARMACISTS SEEKING TO PRACTICE AT NC HEALTH SYSTEMS

    JULY 18, 2024

    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. 

  • FDA ISSUES DRAFT GUIDANCE ON THE DRUG QUALITY AND SECURITY ACT’S WHOLESALING PROHIBITION FOR 503B OURSOURCING FACILITIES

    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.

  • DISPENSING OPTOMETRIST REGISTRATION SYSTEM OPEN EFFECTIVE MARCH 1, 2024

    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.

  • NC DEPARTMENT OF HEALTH & HUMAN SERVICES ISSUES UPDATED COVID TREATMENT MEMO

    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.

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