Board News and Announcements
The NC Board of Pharmacy has a YouTube channel. Board meetings are live-streamed and past meetings are archived here.
NC BOARD OF PHARMACY STAFF HAVE CONSOLIDATED AND ORGANIZED BY TOPIC ALL COVID-19 UPDATES AS FOLLOWS:
TUESDAY, JANUARY 24, 2023
NORTH CAROLINA MEDICAID REMINDS PHARMACY PROVIDERS WITH EXPIRED NCTRACKS CREDENTIALS OF THE PROCESS FOR RENEWING THEM. Staff at the North Carolina Department of Health and Human Services has requested the Board to notify pharmacy providers of the following:
Beginning in May 2021, NC Medicaid started taking additional steps, as outlined in the NCTracks Changes to Provider Verification Process bulletin, to ensure providers meet their contractual obligation to maintain their credentials on their NCTracks provider enrollment record. Multiple bulletin articles were published to notify providers of the change, and providers receive four targeted reminders prior to their suspension notification. Regardless of these efforts to inform and assist providers with this responsibility, we continue to see a fairly large number suspended, and subsequently terminated, from the NC Medicaid program due to their expired credential.
For this reason, and as part of an additional outreach effort, we are notifying NC associations when the number of provider taxonomy suspensions exceed a defined threshold of unique providers on the report received at the end of each month.
On December 31, 2022, approximately 251 Pharmacy providers were suspended due to an expired credential. These providers have sixty days from the date of suspension to ensure that their license is renewed, and their NCTracks provider enrollment record is updated to avoid termination. Providers may update their NCTracks provider record through the Manage Change Request process. NCTracks User Guides and Fact Sheets offer basic instructions for making the necessary update and any additional questions may be referred to the NCTracks Call Center at 800-668-6696.
Affected pharmacies should use the resources above to resolve any issue. Board of Pharmacy staff have no involvement in the issuance, renewal, or cancellation of NC Medicaid credentials.
FRIDAY, JANUARY 13, 2023
CONGRESS ELIMINATES THE DATA-WAIVER PROGRAM AND THE REQUIREMENT FOR THE DATA-WAIVER “X” REGISTRATION NUMBERS ON PRESCRIPTIONS FOR BUPRENORPHINE FOR OPIOID USE DISORDER
On December 29, 2022, with the signing of the Consolidated Appropriations Act of 2023 (the Act), Congress eliminated the “DATA-Waiver Program.” Section 1262 removes the federal requirement for practitioners to
submit a Notice of Intent (have a waiver) to prescribe medications like buprenorphine, for the treatment of opioid use disorder (OUD). With this provision and effective immediately, SAMSHA will no longer be accepting NOIs (waiver applications).
All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law. North Carolina rules and laws do not conflict with this new authority for prescribing of buprenorphine for opioid use disorder with a current DEA registration.
DEA put out an informational document that states:
DEA fully supports this significant policy reform. In this moment, when the United States is suffering tens of thousands of opioid-related drug poisoning deaths every year, the DEA’s top priority is doing everything in our power to save lives. Medication for opioid use disorder helps those who are fighting to overcome opioid use disorder by sustaining recovery and preventing overdoses. At DEA, our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it. The elimination of the X-Waiver will increase access to buprenorphine for those in need.
All DEA registrants should be aware of the following:
· A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
· Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
· There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
Separately, the Act also introduced new training requirements for all prescribers. These requirements will not go into effect until June 21, 2023. The DEA and SAMHSA are actively working to provide further guidance and DEA will follow up with additional information on these requirements shortly. Importantly, these new requirements do not impact the changes related to elimination of the DATA-Waiver Program described above.
MONDAY, DECEMBER 19, 2022
OXYCODONE “RECALL” FRAUD ALERT. The Pharmaceutical Cargo Security Coalition is warning pharmacies and others of a fraud scam in which pharmacies and other healthcare facilities receive a letter, spoofed to appear that it is from a legitimate pharmaceutical distributor, claiming that a “precautionary” manufacturer recall of oxycodone hydrochloride is being conducted. At least one fraudulent notice assigns an NDC code (0406853001) to the “recalled” product. If a pharmacy or any pharmacy staff member receives any type of communication referring to any type of a recall, please document as much information about the notice as possible. The pharmacy should then reach out to a known contact of your distributor to determine if the request is legitimate. If a request is not legitimate, please contact law enforcement. You may also reach out to Chuck Forsaith at the Healthcare Distributors Alliance, email@example.com, (401) 623-1344.
WEDNESDAY, NOVEMBER 23, 2022
FDA ISSUES GUIDANCE ON COMPOUNDING AMOXICILLIN TO MITIGATE SHORTAGE. On November 22, the Food and Drug Administration issued guidance to pharmacies on compounding beta-lactam oral antibiotic suspensions to mitigate the effects of a shortage of amoxicillin oral antibiotic powder for suspension. FDA’s announcement is here. The guidance document is here.
FRIDAY, NOVEMBER 4, 2022
STATE AND FEDERAL PHARMACY LAW APPLICABLE TO WALK-IN IV THERAPY CLINICS. Board staff have fielded a number of inquiries from licensed medical professionals concerning clinics
that offer walk-in intravenous therapy services. This statement sets forth North Carolina law governing the need for pharmacy permits and the preparation of sterile drug products.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED DECEMBER 22, 2022.)
FRIDAY, OCTOBER 28, 2022
NC DHHS ISSUES INFORMATION TO CLINICIANS ON INCREASE IN ACTIVITY OF MULTIPLE RESPIRATORY VIRUSES OTHER THAN COVID-19. The North Carolina Department of Health and Human Services has issued an alert to clinicians detailing increased activity of multiple, non-COVID-19 respirator viruses including influenza, RSV, and rhinovirus/enterovirus. This alert provides advice to health-care providers on mitigating spread, identifying patients at particular risk, encouraging vaccinations where appropriate, and reporting suspected clusters of influenza, RSV, or severe respiratory illness: http://www.ncbop.org/PDF/NCDHHSIncreaseRespiratoryIllnessMemo102622.pdf.
WEDNESDAY, AUGUST 31, 2022
*REMINDER* NORTH CAROLINA BOARD OF PHARMACY INTERN REGISTRATION SYSTEM IS ACTIVE – PHARMACY STUDENTS, FGPEC-HOLDERS ACQUIRING PRACTICAL EXPERIENCE, AND OTHER QUALIFYING INTERNS MUST REGISTER BY SEPTEMBER 1, 2022. Revised Board of Pharmacy Rule .1503 requires that any person who wishes to serve as a pharmacy intern and obtain practical experience in North Carolina must register with the Board. A person may not, and will not, receive credit for any practical experience required for licensure and obtained in North Carolina unless and until registered as a pharmacy intern.
The registration period opened August 1, 2022, and persons who wish to obtain practical experience in North Carolina must be registered by September 1, 2022. There is no fee for intern registration.
Effective September 1, 2022, North Carolina pharmacists and pharmacies who host pharmacy interns as part of an academic experiential program or who host/employ pharmacy interns outside of an academic experiential program must verify that the would-be intern is, in fact, registered. Interns may print a Board-issued certificate after completing registration. Pharmacists and pharmacies should also use the Board’s License/Permit Verification tool to confirm intern status -- https://portal.ncbop.org/verification/search.aspx.
Pharmacy students. The substantial majority of pharmacy interns will be students who are currently enrolled in an ACPE-accredited school of pharmacy. Detailed registration instructions for incoming and currently-enrolled students are found here. Please consult those instructions before beginning the registration process. Note that you will need to have three documents for upload to complete a registration: (1) a photograph of yourself (passport type); (2) proof of enrollment from your school of pharmacy (please consult with the appropriate person(s) at your school to obtain the proof of enrollment); and (3) a signed (manual, not electronic) copy of a FERPA Waiver (found here) that will authorize the Board of Pharmacy to obtain certain enrollment and academic status information from your school of pharmacy. Note: While the majority of pharmacy students who are acquiring practical experience in North Carolina will be enrolled in a North Carolina-based school of pharmacy, not all will. The intern registration requirement applies to all enrolled pharmacy students acquiring practical experience in North Carolina, whether the school is located in North Carolina or in another state.
FGPEC-Holding Graduates of a Foreign School of Pharmacy. A graduate of a foreign school of pharmacy who has successfully completed the Foreign Pharmacy Graduate Equivalency Examination and the Test of English as a Foreign Language is eligible for pharmacy intern status and must register to acquire required practical experience. Detailed registration instructions for FGPEC-holding graduates of a foreign school of pharmacy are found here. Please consult those instructions before beginning the registration process. Note that you will need to have two documents for upload to complete a registration: (1) a photograph of yourself (passport type); and (2) your NABP-issued FPGEC certificate.
Other Categories of Pharmacy Intern. Three more categories of persons are required to register as a pharmacy intern, though these are likely to be a small percentage of interns:
- Graduates of an ACPE-Accredited School of Pharmacy Who Are Not Licensed in Any State, Have an Active Application for North Carolina Licensure, But Have Not Yet Passed the Licensure Exams. Any pharmacy school graduate who, come September 1, 2022, is practicing in a North Carolina pharmacy, has applied for licensure in North Carolina, but has not yet passed the NAPLEX and MPJE, will need to register as an intern. The registration application is accessed through your profile on the Board’s Licensure Gateway (https://portal.ncbop.org/). If you have any questions about the process, please contact Board licensing staff.
- Pharmacist Licensed in Another State Who Is Gaining Practical Experience Required to Reciprocate to North Carolina. Occasionally, a pharmacist seeking to reciprocate licensure from another state has been out of practice for a sufficiently long period of time that some refresher practical experience is required. A reciprocity applicant who falls into this category will be contacted by Board licensing staff when the application is reviewed. Such candidates must register as an intern prior to obtaining refresher practical experience. The registration application is accessed through your profile on the Board’s Licensure Gateway (https://portal.ncbop.org/). If you have questions about the process, please contact Board licensing staff.
- Pharmacist With An Inactive North Carolina License Who Is Gaining Practical Experience Required to Reinstate. Occasionally, a pharmacist seeking to reinstate a North Carolina license has been out of practice for a sufficiently long period of time that some refresher practical experience is required. A reinstatement applicant who falls into this category will be contacted by Board licensing staff when the application is reviewed. Such candidates must register as an intern prior to obtaining refresher practical experience. The registration application is accessed through your profile on the Board’s Licensure Gateway (https://portal.ncbop.org/). If you have questions about the process, please contact Board licensing staff.
WEDNESDAY, JULY 6, 2022
IMPORTANT INFORMATION/REMINDERS FROM THE NC HEALTH INFORMATION EXCHANGE AUTHORITY CONCERNING JANUARY 1, 2023 DEADLINE FOR PHARMACIES. In 2015, the North Carolina General Assembly enacted legislation requiring health care providers to connect and remit health care data for recipients of Medicaid, the State Employees Health Plan and CHIP to the North Carolina Health Information Exchange (“NC HealthConnex”) in order to continue to participate in state funded health care plans such as Medicaid, the State Employees Health Plan and CHIP. The deadline for pharmacies to connect and start sending claims data to NC HealthConnex is January 1, 2023.
The NC Health Information Exchange Authority (“NCHIEA”) recommends that providers begin the process of connecting as soon as possible. Below is information on the two forms of participation agreements for pharmacies, instructions on how to complete a participation agreement, and a link to NCHIEA’s How to Connect webpage. For further information and assistance, please do not hesitate to contact the NC HIEA via phone at (919) 754-6912 or email at firstname.lastname@example.org.
Links to the two types of participation agreements for pharmacies along with a short description of each:
- Full Participation Agreement for Pharmacies for NC HealthConnex Access and Data Use
- The full participation agreement for pharmacies allows pharmacy providers full use of NC HealthConnex, including electronic exchange of vaccine information.
- It also enables compliance with claims data connection and data submission provisions in the Statewide Health Information Exchange Act.
- Submission-Only Agreement for NC HealthConnex for Pharmacies
- The submission-only participation agreement for pharmacies enables a pharmacy to submit the claims data required by law in a one-way technical connection for compliance with the Statewide Health Information Exchange Act.
- This agreement prohibits all other data exchange services, including HIE query/data exchange and clinical registries.
- Submission-only participants must work with their EHR vendor to filter data to state-funded populations.
Instructions and contact information to use when completing a participation agreement:
- The participation agreement is an editable .PDF document with fillable fields for your organization-specific information. NCHIEA prefers this agreement to be completed and submitted electronically to email@example.com. Note: If the form fill functionality is used, you must save the document before emailing it to firstname.lastname@example.org.
- A participant may also send a completed and signed participation agreement in a hard copy to the address below. However, email is preferred. NC HIEA does not require two copies. The physical mailing address is:
N.C. Health Information Exchange Authority
Re: N.C. HIEA Participation Agreement
Mail Service Center 4101
Raleigh, NC 27699-4101
- For FAQs About NC HealthConnex Participation click here.
- For questions, please feel free to call NCHIEA at 919-754-6912 or email at email@example.com.
NCHIEA hosts a monthly How to Connect webinar that is a valuable resource in educating providers on the participation agreement and the overall process of getting connected to NC HealthConnex. Our next How to Connect webinar is on 7/25 from Noon to 1pm ET.
- Click here to visit NCHIEA’s How to Connect webpage and register for the next webinar.
THURSDAY, MAY 5, 2022
NOTICE TO OUT-OF-STATE PHARMACIES HOLDING A NORTH CAROLINA PHARMACY PERMIT CONCERNING PHARMACIST-MANAGER DESIGNATION. The Board of Pharmacy recently amended 21 NCAC 46.1607, Out-Of-State Pharmacies (“Rule .1607”). Under amended rule, effective May 1, 2022, the “pharmacist-manager for the out-of-state permit issued by this Board must be the same person as the pharmacist-manager (whether called a pharmacist-manager, a person-in-charge or otherwise) of the pharmacy on the permit issued by the pharmacy’s home state.”
All out-of-state permit holders must log into the Board’s Licensure Gateway, review the designated pharmacist-manager and, if necessary, complete a Pharmacist-Manager (PM) Change Request. Detailed instructions available here: http://www.ncbop.org/PDF/PMChangeforOutofStatePharmacies.pdf.
Health Advisories (last updated September 15, 2021) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated January 24, 2023) - 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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