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:
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 NOVEMBER 18, 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.
FRIDAY, OCTOBER 14, 2022
SURVEY TO ASSESS USE OF, AND NEEDS CONCERNING, STATE STANDING ORDERS IMPLEMENTING IMMUNIZING PHARMACISTS’ AUTHORITY TO DISPENSE, DELIVER, OR ADMINISTER HORMONAL CONTRACEPTIVES, NICOTINE REPLACEMENT THERAPY PRODUCTS, POST-EXPOSURE PROPHYLAXIS MEDICATIONS, PRENATAL VITAMINS, AND GLUCAGON.
As pharmacists know, last fall the General Assembly passed and Governor Cooper signed into law S.L. 2021-110, which confers on qualified pharmacists the ability to dispense, deliver or administer certain therapeutics. (For a complete overview of S.L. 2021-110 see: http://www.ncbop.org/PDF/SL2021110GuidanceAug2021.pdf) In April 2022, State Health Director Betsey Tilson issued standing orders implementing this new authority.
The Board of Pharmacy and the North Carolina Association of Pharmacists have collaborated on a survey to assess pharmacists’ awareness of S.L. 2021-110 and its provisions allowing immunizing pharmacist in NC to dispense, deliver, or administer certain medications pursuant to the North Carolina State Health Director’s Standing Orders. We would like to invite you to take part in a brief online survey. This survey is confidential.
This brief survey should take less than 10 minutes to complete. Your participation is very important to us. Results of this survey will serve to aid the development of statewide protocols, future advocacy efforts, and the creation of education and other resources necessary to enhance pharmacists’ scope of practice.
To participate in the survey, please click the following link: HERE
Or copy and paste the URL below into your internet browser:
If you have questions or concerns about this survey, please contact Dr. Cheryl Viracola at firstname.lastname@example.org.
TUESDAY, SEPTEMBER 13, 2022
NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JANUARY 4, 2023 -- ON THE FOLLOWING PROPOSED ACTIONS:
Read more at http://www.ncbop.org/rulemakings.htm.
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.
MONDAY, JULY 11, 2022
*UPDATE* GUIDANCE TO REVISED BOARD RULE GOVERNING INTER-PHARMACY REMOTE MEDICATION ORDER PROCESSING. The Board of Pharmacy has completed a rulemaking to amend Rule .1816, now titled “Centralized Pharmacy Services.” The amended rule broadens the availability of remote medication order processing (“RMOP”) arrangements among pharmacies to all pharmacy practice types. The full rule is found here: 21 NCAC 46.1816.
Board staff have updated the guidance to inter-pharmacy remote medication order processing under Rule .1816. The updates are two-fold: (1) noting that Board staff began enforcing the rule on July 1, 2022; and (2) providing detailed instructions on how a pharmacy must notify the Board prior to beginning an RMOP arrangement through the Board’s Licensure Gateway.
A related reminder: As discussed in the guidance document linked below, all pharmacies participating in an RMOP arrangement must hold a North Carolina pharmacy permit. A pharmacy that wishes to engage in an RMOP arrangement that does not hold a North Carolina pharmacy permit must file an application and obtain a permit prior to engaging in RMOP services.
The updated inter-pharmacy RMOP guidance is found here. It provides a detailed overview of the revised rule governing inter-pharmacy RMOP arrangements. Please note: This guidance document only concerns RMOP serves arranged among two pharmacies. A different rule -- 21 NCAC 46.2515 -- authorizes and governs intra-pharmacy remote services (i.e., a pharmacy uses its own personnel to provide off-site services). A guide to Rule .2515’s operation is found here: Intra-Pharmacy RMOP Guidance.
This document – http://www.ncbop.org/PDF/HowToRegisterAsNABPVerifyHolder.pdf - provides detailed instructions on how out-of-state pharmacists who are performing RMOP services, and who are not individually licensed to practice pharmacy in North Carolina, may obtain an NABP Verify credential and register with the Board of Pharmacy, as required by revised Rule .1816.
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 email@example.com.
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 firstname.lastname@example.org. Note: If the form fill functionality is used, you must save the document before emailing it to email@example.com.
- 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 firstname.lastname@example.org.
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.
FRIDAY, MAY 20, 2022
FROM THE NC DEPARTMENT OF HEALTH AND HUMAN RESOURCES DIVISION OF CHILD AND FAMILY WELL-BEING - INFANT FORMULA SHORTAGE INFORMATION. Leaders from across North Carolina, including the Governor’s Office, NCDHHS, retailers, health care providers, community organizations and others are working to support North Carolina families and ensure that there is access to safe, healthy nutrition for babies. In general, supply in North Carolina is currently adequate to meet the need for standard formulas. However, certain brands of formula and certain specialized formulas may not be available in all areas, and families may struggle to find the specific formula that they usually buy. State and federal partners are acting to further increase supply. At NCDHHS, we have prioritized actions to educate families and health care providers about alternative formula options and to work with manufacturers to ensure availability of supply for most products.
Actions Pharmacists Can Take:
- Share information, resources and tips with customers and health care providers at www.ncdhhs.gov/formula. Please find a family-facing fact sheet and provider guidance document on this page.
- Please contact NCDHHS at 1-800-662-7030 if you are having difficulty with on-shelf supply, ordering of standard or specialty formulas, or have other insights on the shortage.
- Consider exploring additional infant formula products that may be available for order. The provider guidance includes a formula equivalency table for your reference.
Actions NCDHHS is taking:
- Sharing information, resources and tips with families and health care providers at www.ncdhhs.gov/formula
- Through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), NCDHHS is helping to connect families participating in WIC directly to needed formula and placing bulk orders with manufacturers on behalf of local WIC agencies and the families they serve.
- Using flexibility from the federal government to make it easier for WIC participants to access available formula. North Carolina is already using available USDA rule waivers to help retailers continue to serve WIC-enrolled families during the shortage and help families return or exchange formulas included in the recall.
- Working with the federal government to waive additional rules for the WIC program to make it easier for WIC participants to access available formula. North Carolina has requested waivers that would give WIC-enrolled families more flexibility to purchase other types of formula and in a wider variety of sizes based on availability and health care provider recommendations.
- Providing guidance to local WIC agencies and health care providers to make it easier for health care providers to give WIC-enrolled families several options of formula types and sizes on a single prescription to meet their children’s specialized formula needs.
- Monitoring the formula supply across the state and keeping our partner organizations updated.
- Working with retailers across the state to assess their supply and to post materials to help educate consumers about formula options.
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.
TUESDAY, APRIL 26, 2022
BOARD PROMULGATES NEW RULE GOVERNING INTRA-PHARMACY REMOTE OPERATIONS. The Board has completed a rulemaking to create new Rule .2515, “Remote Work By Pharmacy Personnel.” The rule authorizes, and governs, a pharmacy’s use of its own pharmacy personnel employees to perform certain remote operations. The rule is effective May 1, 2022. The Board’s March 17, 2020 Expanded Emergency Services Waiver, issued as a result of the COVID-19 public health emergency, previously authorized intra-pharmacy remote operations. New Rule .2515 does not differ materially from the waiver provisions concerning intra-pharmacy remote operations. Accordingly, Rule .2515 (and not the waiver) will govern this practice come May 1. Detailed guidance to Rule .2515 is found here. Please note: A different rule, Rule. 1816, governs inter-pharmacy remote medication order processing arrangements. Detailed guidance to that rule is found here: Inter-Pharmacy RMOP Guidance.
THURSDAY, APRIL 21, 2022
FDA SEEKS PUBLIC COMMENT ON PROPOSAL TO REQUIRE THAT OPIOID ANALGESICS USED IN OUTPATIENT SETTINGS BE DISPENSED WITH PRE-PAID MAIL-BACK ENVELOPES AND THAT PHARMACISTS PROVIDE EDUCATION ON OPIOID DISPOSAL. FDA is seeking comment on proposed changes to its Opioid Analgesic Risk Evaluation and Mitigation Strategy to require opioids be dispensed with pre-paid envelopes to return unused medication to DEA-registered disposal facilities and that pharmacists educate patients on opioid disposal. FDA is exploring these proposals as a means of increasing disposal of unused opioids, which are a diversion risk, in a manner that mitigates environmental risks. FDA is accepting comments through June 21, 2022. More detail on FDA’s proposal is found here: https://www.fda.gov/news-events/press-announcements/fda-considers-new-approach-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary.
MONDAY, APRIL 11, 2022
STATE HEALTH DIRECTOR ISSUES STANDING ORDERS TO IMPLEMENT QUALIFIED PHARMACISTS’ AUTHORITY TO PROVIDE CERTAIN THERAPEUTICS. As pharmacists know, the General Assembly passed and Governor Cooper signed into law S.L. 2021-110, which confers on qualified pharmacists the ability to dispense, deliver, or administer certain therapeutics. (For a complete overview of S.L. 2021-110, see: http://www.ncbop.org/PDF/SL2021110GuidanceAug2021.pdf)
State Health Director Betsey Tilson has issued five standing orders under this new authority:
- Nicotine replacement therapy that is approved by the United States Food and Drug Administration
- Self-administered oral or transdermal contraceptives* (see note below regarding training requirements)
- Prenatal vitamins
- Post-exposure prophylaxis medications for the prevention of human immunodeficiency virus (HIV)
- Glucagon for the treatment of severe hypoglycemia
Futher details and links to each of the standing orders and their accompanying documents may be found here: https://ncpublichealth.info/HDSO-pharmacists.htm.
*As the Oral and Transdermal Hormonal Contraceptives standing order notes, immunizing pharmacists “who provide contraception products in accordance with this standing order must also complete North Carolina Hormonal Contraception Training Program.” The North Carolina Association of Pharmacists has produced this training program, which is now available here: https://ncap.memberclicks.net/2022-hormonal-contraception-training-and-toolkit. The Board of Pharmacy has agreed to fund the training program for up to 6,000 North Carolina resident pharmacists over the next 12 months. NCAP will maintain records of pharmacists who have completed this training.
Once an immunizing pharmacist has completed the North Carolina Hormonal Contraception Training Program, the pharmacist must report that to the Board by logging on to their profile at the Board’s Licensure Gateway, selecting the “Pharmacist” tile under “Licenses & Registrations”, and clicking on the “Contraceptive Trained” option:
MONDAY, MARCH 28, 2022
STATE HEALTH DIRECTOR UPDATES NALOXONE STANDING ORDER. State Health Director Betsey Tilson has updated the naloxone standing order for pharmacists. The chief update is that the standing order now authorizes pharmacists to dispense “FDA-approved naloxone products used in accordance with approved directions” and references a list of such products and directions. The standing order directs pharmacists that “product selection should be made based on patient preference, availability, insurance coverage, and other pertinent factors.” The revised standing order is found here: https://publichealth.nc.gov/docs/NCNaloxoneStandingOrderforPharmacistsMarch2022.pdf. The list of FDA-approved naloxone products is available here: https://publichealth.nc.gov/docs/NaloxoneProductsforPharmacistDispensing.pdf (the product list is also linked through the standing order itself). Additional resources for safe and proper dispensing of naloxone are found here: https://naloxonesaves.org/.
Health Advisories (last updated September 15, 2021) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated March 2, 2022) - 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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