Board News and Announcements

APRIL 2023 NCBOP/NABP NEWSLETTER

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NC BOARD OF PHARMACY STAFF HAVE CONSOLIDATED AND ORGANIZED BY TOPIC ALL COVID-19 UPDATES AS FOLLOWS:

UPCOMING MEETINGS - JUNE 13, 2023:

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JUNE 13, 2023 AT 9AM -- ON THE FOLLOWING PROPOSED ACTIONS:

ADOPTION OF 21 NCAC 46 .1821 DIRECT-TO-PATIENT DELIVERY SYSTEMS

AMENDMENT TO 21 NCAC 46 .1616 LIMITED SERVICE PERMITS

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The NC Board of Pharmacy will convene on Tuesday, June 13, 2023 at 12:00pm and will immediately move into closed session to discuss possible summary suspensions.

MONDAY, MAY 22, 2023

GENERAL ASSEMBLY PASSES AND GOVERNOR SIGNS INTO LAW NEW VACCINATION AUTHORITY FOR PHARMACISTS, PHARMACY INTERNS, AND PHARMACY TECHNICIANS. On May 19, 2023, S.L. 2023-15 became law. Among other things, the statute amends the North Carolina Pharmacy Practice Act to expand the authority of pharmacists, pharmacy interns, and pharmacy technicians to administer vaccines. This document details this expanded state law vaccination authority and discusses how it intersects with two other sources of authority for pharmacist-administered vaccinations – declarations under the federal PREP Act and the State Health Director’s standing orders for pharmacist-administered COVID-19 vaccines.

WEDNESDAY, MAY 17, 2023

NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES XYLAZINE EXPOSURE GUIDANCE. Xylazine is a veterinary sedative that is not approved for human use. It is increasingly found as a component of drug products sold in the illicit opioid trade. NC DHHS’ communication contains comprehensive guidance on xylazine, its use, symptoms of xylazine use, treatment modalities, and patient information resources.

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS - Check our CE page often for upcoming CE programs in your area. (LAST UPDATED JUNE 5, 2023.)

FRIDAY, APRIL 28, 2023

*UPDATED* STATEMENT CONCERNING SEMAGLUTIDE COMPOUNDING. On April 28, 2023, FDA officials clarified semaglutide’s shortage status. This statement has been updated to reflect that FDA clarification. In response to several inquiries, Board staff have assembled a statement concerning if, when, and how semaglutide may be compounded: http://www.ncbop.org/PDF/SemaglutideCompounding.pdf.

THURSDAY, APRIL 27, 2023

*REMINDER* FDA APPROVES ADDITIONAL DOSE OF UPDATED COVID-19 VACCINE FOR CERTAIN PATIENTS. Immunizing pharmacists are reminded that on April 20, 2023, the FDA approved an additional booster dose of the updated COVID-19 vaccine for patients age 65 or older and patients with a compromised immune system. The North Carolina Department of Health and Human Services has detailed information here: https://www.ncdhhs.gov/news/press-releases/2023/04/20/new-guidance-only-updated-covid-19-vaccines-now-available-people-high-risk-may-receive-additional.

More information from FDA found here: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and.

Updated standing orders from State Health Director Tilson are available here: https://www.dph.ncdhhs.gov/HDSO-pharmacists.htm.

FRIDAY, APRIL 14, 2023

FEDERAL DHHS ANNOUNCES INTENT TO EXTEND PREP ACT DECLARATIONS THROUGH DECEMBER 2024. This afternoon (and, of course, immediately after Board staff sent out a weekly email and the April newsletter), the United States Department of Health and Human Services announced its intent, in the coming weeks, to extend PREP Act declarations authorizing pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and flu vaccines to patients age 3 and older, and to perform COVID-19 tests. Activities relating to providing COVID-19 countermeasures pursuant to a federal agreement are likewise to be extended to December 2024. The PREP Act extension will not, however, extend the federal authorization for COVID-19 vaccination by recently retired providers and students; nor will it extend the ability of pharmacists to administer COVID-19 vaccinations across state lines. Finally, the PREP Act authorization for pharmacists and pharmacy interns to administer routine childhood vaccinations will expire with the end of the public health emergency on May 11, 2023. More information found here: https://www.hhs.gov/about/news/2023/04/14/factsheet-hhs-announces-amend-declaration-prep-act-medical-countermeasures-against-covid19.html.

THURSDAY, MARCH 30, 2023

ONE-TIME TRAINING REQUIREMENT ON THE TREATMENT AND MANAGEMENT OF PATIENTS WITH OPIOID OR OTHER SUBSTANCE USE DISORDERS FOR PRACTITIONERS HOLDING INDIVIDUAL DEA REGISTRATIONS. The Drug Enforcement Administration (DEA) has outlined the requirements for DEA-registered practitioners to meet the new, one-time Medication Access and Training Expansion Act (MATE Act) training requirement that will be tied to their initial or renewal DEA registration, effective June 27, 2023. This requirement applies to practitioners holding individual DEA registrations. A pharmacist who is not an individual DEA registrant – i.e., practice pharmacy under the DEA registration of the employing pharmacy – is not required to obtain this training. But pharmacists such as Clinical Pharmacist Practitioners who are individual DEA registrants that prescribe controlled substances are subject to the requirement.

In December 2022, Congress passed the Consolidated Appropriations Act of 2023 that included three bills to help manage and support patients with opioid or substance use disorder. The MATE Act, which was part of this legislation, requires new and renewing DEA-registered practitioners to complete a one-time, eight-hour training on opioid or other substance use disorders. Practitioners must affirm that they have completed this new training requirement on the date of their next scheduled DEA registration submission on or after June 27, 2023.

There are three ways that practitioners may meet this requirement, which are outlined in DEA's letter. The letter also defines which accredited groups may provide training to meet the requirement, key points related to the training, and a list of practitioners who have been deemed as already satisfied the training. Recommendations for curricular elements in substance use disorders training is also available on the Substance Abuse and Mental Health Services Administration website.

For more information on the MATE Act training requirements, please visit DEA's diversion control website. If you have any additional questions on this issue, please contact the Diversion Control Division Policy Section at ODLP@dea.gov or 571/362-3260.

THURSDAY, MARCH 23, 2023

DEA PUBLISHES PROPOSED RULES FOR PERMANENT TELEMEDICINE FLEXIBILITIES INVOLVING CONTROLLED SUBSTANCES. The DEA has published proposed rules concerning the practice of telemedicine involving controlled substances. On February 24, the DEA announced “Proposed Rules for Permanent Telemedicine Flexibilities.” Among other things, these proposed rules would allow telemedicine prescribing of a 30-day supply of Schedule III-V non-narcotic controlled substances, or a 30-day supply of buprenorphine for the treatment of opioid use disorder. DEA’s proposed rule for Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation is found here: https://www.govinfo.gov/content/pkg/FR-2023-03-01/pdf/2023-04248.pdf.

DEA’s proposed rule for Expansion of Induction of Buprenorphine via Telemedicine Encounter is found here: https://www.govinfo.gov/content/pkg/FR-2023-03-01/pdf/2023-04217.pdf. Each notice includes timelines and instructions for public comment.

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.

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.

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.

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.

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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.