LICENSURE GATEWAY

The Gateway is a single portal to manage licenses, permits, and registrations with the North Carolina Board of Pharmacy. Access printable documents, update information, submit applications, and more.

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Upcoming NC Board of Pharmacy Elections

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.
More Election Info

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Joey McLaughlin to Fulfill Andy Bowman’s Remaining Board Term

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.
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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. Read More

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Wallace Nelson Receives Bowl of Hygeia Award

The North Carolina Association of Pharmacists presented Wallace E. Nelson with the 2024 Bowl of Hygeia Award at its annual convention. Established in 1958, the Bowl of Hygeia Award is sponsored by the APhA Foundation and the National Alliance of State Pharmacy Associations. Participating state pharmacy associations recognize one pharmacist annually for an outstanding record of community civic leadership. NCAP Executive Director Penny Shelton praised Wallace, noting that he has “walked the talk his entire career finding ways to serve and give back at extraordinarily high levels.
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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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Burglaries Reported at Multiple North Carolina Pharmacies

Multiple independent pharmacies in North Carolina have been burglarized. The burglars gained access using a sledgehammer or other means to open a hole in the pharmacy's exterior wall, including brick and cinder block.
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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.
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NC Board of Pharmacy Joins Instagram

You already follow us on Twitter/X. Now the Board is happy to introduce our new Instagram page. Follow us for news updates, information, photos, live streaming and more!
Follow us on Instagram - @NCBoardofPharmacy

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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. Read More

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FDA Issues Draft Guidance on DQSA’s Wholesaling Prohibition for 503B Outsourcing Facilities

Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Read More

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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. Read More

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Dispensing Optometrist Registration System Now Open

Optometrists who dispense certain prescription drugs may now register with the Board of Pharmacy. The initial registration fee is $75 and requires an annual renewal. Read More

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NC Board of Pharmacy YouTube Channel

Board meetings are live-streamed and past meetings are archived here.
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Latest News

UPCOMING BOARD ELECTIONS - NORTHEASTERN AND CENTRAL DISTRICTS

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.

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

JULY 30, 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.

WALLACE NELSON RECEIVES 2024 BOWL OF HYGEIA AWARD

JULY 25, 2024 The North Carolina Association of Pharmacists presented Wallace E. Nelson with the 2024 Bowl of Hygeia Award at its annual convention. Established in 1958, the Bowl of Hygeia Award is sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations. Participating state pharmacy associations recognize one pharmacist annually for an outstanding record of community civic leadership. NCAP Executive Director Penny Shelton praised Wallace, noting that he has “walked the talk his entire career finding ways to serve and give back at extraordinarily high levels.”

Wallace is a native of Hertford. He began his post-secondary education at the College of the Albemarle and is a 1976 graduate of the UNC School of Pharmacy. His professional career began in retail pharmacy before joining Chowan Hospital in Edenton and Bertie Hospital in Windsor. He has served, and continues to serve, both hospitals at all levels for over forty years, thirty-six as Director of Pharmacy.

The state’s pharmacists elected Wallace to serve on the North Carolina Board of Pharmacy in 2000. He served two five-year terms, through 2010, and was again elected to the Board in 2020. Board members have selected him as President several times.

Wallace’s record of community service outside of pharmacy is long and diverse. He is a member of the Perquimans County Board of Education and Board of County Commissioners, where he currently serves as Chairman. He is actively involved in the North Carolina Association of County Commissioners and will be installed as President Elect in August 2024 and as President in 2025. Past appointments by Governors Martin, Hunt, McCrory, and Cooper, include the College of the Albemarle Board of Trustees, North Carolina Marine Industrial Authority, as well as several Governor’s Councils, Institutes and Legislative Study Commissions.

Wallace has been previously recognized for his community and state service. In 2010 Governor Perdue named Wallace to the Order of the Long Leaf Pine, the state’s highest honor for those who have made significant contributions to the state and their communities through exemplary service and exceptional accomplishments. In 2011 the North Carolina School Boards Association tapped Wallace to receive the Raleigh Dingman Award, the highest honor bestowed on a school board member.

Wallace and his wife Freda (a retired educator) are the parents of Ethan (a practicing dentist), Lauren (a human resources manager), and the grandparents of Reagan and Harrison.

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 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.

BOARD SELECTS JOEY McLAUGHLIN TO FULFILL ANDY BOWMAN’S REMAINING BOARD TERM

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.

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.