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NORTH CAROLINA DIVISION OF PUBLIC HEALTH ISSUES CLINICIAN ALERT ON CIPROFLOXACIN- AND PENICILLIN-RESISTANT STRAINS OF MENINGOCOCCAL DISEASE IN THE CHARLOTTE METROPOLITAN REGION.  The North Carolina Division of Public Health (NC DPH) is alerting clinicians in North Carolina to an increase in ciprofloxacin- and penicillin-resistant strains of invasive meningococcal disease caused by Neisseria meningitidis serogroup Y (NmY) in the Charlotte Metropolitan region.

Since February 2023, two cases of invasive meningococcal disease have been found to be resistant to ciprofloxacin and penicillin in residents of Mecklenburg County and one case in a resident of neighboring York County, South Carolina. These cases meet the threshold to recommend discontinuing the use of ciprofloxacin for prophylaxis of close contacts per CDC’s updated guidance.

Providers in the Charlotte Metropolitan region including Cabarrus, Gaston, Iredell, Lincoln, Mecklenburg, Rowan, and Union Counties should discontinue the use of ciprofloxacin for prophylaxis of close contacts of invasive meningococcal disease cases and prescribe rifampin, ceftriaxone, or azithromycin instead. Providers treating residents from Chester, Lancaster, or York counties in South Carolina should also follow this guidance for patients being treated in North Carolina medical facilities.

Clinicians should contact their local health departments or the Communicable Disease Branch epidemiologist on-call 24/7 number (919-733-3419) for questions.




NORTH CAROLINA DHHS REMINDS PHARMACIES THAT EUA-LABELED PAXLOVID PRODUCT IS NOT AUTHORIZED AFTER MARCH 8, 2024.  NC DHHS has communicated the following to providers who have EUA-labeled Paxlovid product in inventory.  Questions should be directed to NC DHHS’s COVID-19 Testing and Treatment Team at

Dear Providers,  

As a reminder, all EUA-labeled Paxlovid will no longer be authorized after March 8, 2024. To ensure continued access to Paxlovid and to avoid potential supply chain issues, we strongly encourage you to begin purchasing commercial product now, if not done already.  
For EUA-labeled product in your current inventory, please follow the guidance below:  

  1. Check the true expiration date online at and dispose of any expired product. 
  2. Return any non-expired EUA-labeled product as soon as possible. Returning product will ensure a credit to the USG inventory as NDA-labeled supply. In other words, all non-expired product will be replaced with NDA-labeled product for use in the USG Patient Assistance Program, so no product will be wasted. The deadline to return EUA-labeled product is February 29th. For specific information on Paxlovid returns, including to request pre-paid shipping visit, email, or call 877-740-6148. 

Take action now to understand the Paxlovid Patient Support Program: 
ALL patients should continue to have access to Paxlovid at little to no cost via the PAXCESS Patient Support Program. 

For more information and to enroll patients, visit or call 1-877-C19-PACK. 
As a reminder, pharmacies must enroll with Assist Rx to participate in the USG Patient Assistance portion of PAXCESS. USG PAP dispensing sites will be reimbursed for any Paxlovid dispensed, along with a dispensing fee. To enroll, visit, or email

We encourage all providers to periodically visit the COVID-19 Therapeutics Provider Hub for the most up-to-date information and guidelines related to COVID-19 therapeutic distribution in NC. As always, feel free to contact us at with any questions.  

We appreciate your continued support,
North Carolina Department of Health and Human Services
COVID-19 Testing & Treatment Team




*UPDATE* TRANSFER OF ON-FILE, UNFILLED CONTROLLED SUBSTANCE PRESCRIPTIONS.   On July 27, 2023, the DEA issued a final rule governing the transfer of electronic controlled substance prescriptions prior to initial fill.  The rule is here.

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)&(2).

DEA commentary accompanying the rule asserted that SCRIPT Standard Version 2017071 enables the transfer of controlled substance prescriptions between pharmacies in a way that satisfies these rule requirements.  Board staff received a number of comments that DEA’s assertion was fanciful, and that SCRIPT Standard Version 2017071 does no such thing.  In a February 14, 2024 letter to stakeholders, Surescripts has confirmed that SCRIPT Standard Version 2017071 does not do what DEA thinks that it does – and never has.   Surescripts states that SCRIPT Standard Version 2022011 is capable of transferring controlled substance prescriptions in a way that complies with the DEA rule, but the Centers for Medicare and Medicaid Services must adopt a rule allowing the industry to adopt this updated SCRIPT standard.  Surescripts hopes that will happen soon (full Surecripts letter found here)  Until then, friends . . .

Questions regarding implementation of the DEA transfer  rule should be directed to DEA's Greensboro office at (336) 632-4297.




*UPDATE*  NORTH CAROLINA DRUG CONTROL UNIT ISSUES FAQ GUIDANCE ON REPORTING GABAPENTIN TO THE CSRS. Last fall, the General Assembly passed, and the Governor signed into law, a statute making gabapentin a drug whose dispensing must be reported to the Controlled Substance Reporting System (CSRS).  Gabapentin becomes reportable on March 1, 2024.  The Drug Control Unit, which administers the CSRS, has created and updated a FAQ document (found here) providing instructions, including instructions on how a pharmacy that does not hold a DEA registration may register for access to the CSRS to report gabapentin dispensing. Pharmacists with additional questions should contact the Drug Control Unit.




Thank you to all registrants. As of today, we are no longer taking in-person registrations, although registration to attend the summit virtually is open until February 26. Please contact Krystal Stefanyk, NCBOP Director of Inspections, for questions.



MARCH 2024 COMPOUNDING SUMMIT. The North Carolina Board of Pharmacy is hosting its first Compounding Summit on March 6-8, 2024. We have great speakers lined up to present on the implementation of USP standards and how they apply to their different professions.  We will be providing CE credit through NABP.

An informational flyer and agenda may be found here. To register, please complete this form.



NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS - Check our CE page often for upcoming CE programs in your area. (LAST UPDATED FEBRUARY 9, 2024.)




STATE AND FEDERAL PHARMACY LAW APPLICABLE TO WALK-IN IV THERAPY CLINICS. Board staff have fielded several inquiries from licensed medical professionals concerning clinics that offer walk-in intravenous therapy services. This guidance document sets forth North Carolina law governing the need for pharmacy permits and the preparation of sterile drug products.




FDA WARNS CONSUMERS NOT TO PURCHASE OR USE NEPTUNE’S FIX OR ANY TIANEPTINE PRODUCT. The FDA has issued a warning that consumers not purchase or use tianeptine containing products. Tianeptine is not an FDA-approved substance, but is often sold at convenience stores, gas stations, and the like with claims that it will improve mental function and treat anxiety, depression, pain, opioid use disorder, and other conditions.  FDA continues to receive severe adverse event reports associated with use of tianeptine products.  Pharmacists should be aware of this danger and prepared to advise patients who indicate they are using tianeptine products or ask about them. 




NORTH CAROLINA MEDICAID REMINDS PHARMACY PROVIDERS OF THE NEED TO RENEW PROVIDER ENROLLMENT CREDENTIALS.  On January 10, North Carolina Medicaid released the following concerning pharmacy eligibility to serve as Medicaid providers.  All questions should be directed to North Carolina Medicaid.

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, 2023, approximately 115 Pharmacist 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. 







A public hearing will be held on March 12, 2024 at 9:30AM at the NC Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.

Follow this link for details and instructions/deadline for submitting comments.




DEA RULEMAKING IN 2023.  In 2023, the federal Drug Enforcement Administration (“DEA”) completed three rulemakings that significantly impact pharmacy practice.  Each have been discussed individually on the BOP website, but this article in the National Association of Boards of Pharmacy’s Innovations magazine summarizes all three well:  DEA Updates:  Three New Rules Every Pharmacist Should Know.




*REMINDER*  FDA EXTENDED EXPIRATION DATES FOR SOME COVID-19 THERAPEUTICS. Pharmacists are reminded that the federal Food and Drug Administration (FDA) has exercised authority from time to time to extend expiration dates of certain lots of COVID-19 therapeutics. More information on these extended expiration dates is found here.  This FDA resource includes links to a searchable and downloadable table listing original and, if applicable, extended expiration dates for bamlanivimab, bebtelovimab, etesevimab, Evusheld, Lagevrio (molnupiravir), REGEN-COV, and sotrovimab.  Also included is a link to Paxlovid expiry data from Pfizer.

When dispensing a COVID-19 therapeutic to a patient or caregiver, it is crucial that the pharmacist specifically point out, if applicable, that an expiration date printed on the packaging has been extended.  Failure to do so could either or both confuse the patient/caregiver and cause the patient to not take/receive the therapy.  A handful of patients have filed complaints against pharmacists and pharmacies because they believed their COVID-19 therapeutic was expired when dispensed.  In each case, the product’s expiration date had been extended by FDA, but the pharmacist had not pointed this out and counseled the patient at the time of dispensing. 






Reason for Proposed Action:

S.L. 2023-129 gave optometrists the authority to dispense certain drugs to their patients, and required any dispensing optometrists to register with the Board of Pharmacy. In order to satisfy NCGS 93B-15, the Board has proposed adding dispensing optometrists to the list of registrants who are entitled to an extension of time to renew their registrations in the event of military deployment.

A public hearing will be held on January 8, 2024 at 10:00am at the NC Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.

Any person may object to the proposed rule changes by attending the public hearing on January 8, 2024 and/or by submitting a written objection by February 13, 2024 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, e-mail

If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or email. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 984-236-1850.




BOARD IMPLEMENTS DIRECT-TO-PATIENT DISPENSING SYSTEM RULES.  The Board of Pharmacy has completed its rulemaking on the authorization for, and regulation of, the use of direct-to-patient (DTP) dispensing systems.  Board Rule .1821 provides that authorization and the standards that apply to use of DTP systems. Board Rule .1616 authorizes limited-service permits to be issued for operation of a DTP system when the system is not located on-site at the home pharmacy.

Board staff has completed programming to implement a limited-service permit application for an off-site DTP system, as well to allow an existing pharmacy to notify the Board that it will deploy an on-site DTP system.    

Detailed guidance on the rules and standards governing DTP systems, as well as step-by-step instructions to add an on-site DTP system to an existing pharmacy’s services or to apply for an off-site DTP system limited-service permit are found here.

The general limited-service permit guidance document has also been updated to include information on DTP system permits.



IMMUNIZING PHARMACISTS’ AUTHORITY TO ADMINISTER COVID-19 AND FLU VACCINES TO PEDIATRIC PATIENTS.  With flu and COVID vaccine season upon us, a number of pharmacists have reached out to Board staff about immunizing pharmacist authority to administer flu and COVID vaccine to pediatric patients.  With all the recent changes to North Carolina law and PREP Act declarations, it can be confusing.  Here is the skinny on flu and COVID vaccine authority:

  1. PREP Act declarations authorizing pharmacists to administer flu and COVID vaccine to patients age 3 and older are still in effect, and will be until December 31, 2024.
  2. State law now allows immunizing pharmacists to administer flu and COVID vaccine to patients age 7 and older pursuant to protocol and parental permission.  State law allows immunizing pharmacists to administer any ACIP-recommended vaccine to patients 6 and older pursuant to prescription and parental permission.
  3. So, for flu and COVID – immunizing pharmacists can administer to patients 3 and older and can do that under their own authority under the PREP Act.   Immunizing pharmacists can also use Dr. Tilson’s statewide standing order ( to do this for COVID vaccine (which typically makes billing and recordkeeping easier).  These paths are available until December 31, 2024.
  4. After December 31, 2024, immunizing pharmacists can administer flu and COVID vaccine pursuant to protocol, but only to patients age 7 or older, or pursuant to prescription for patients age 6 or older.

For a comprehensive overview of immunizing pharmacist authority, see the FAQ guidance here:



PHARMACIST ADMINISTRATION OF RSV VACCINE TO ADULT PATIENTS BY PROTOCOL.  Under state law, a qualified immunizing pharmacist may administer any vaccine recommended by the Advisory Committee on Immunization Practices (“ACIP”) to patients 18 years or older pursuant to protocols developed in compliance with Board Rule .2507(b)(12).  ACIP has recommended RSV vaccine for adults 60 or older: Accordingly, qualified immunizing pharmacists may administer RSV vaccine to this patient population pursuant to protocol.  Immunizing pharmacists must, however, update their protocols with their supervising physician as required by Rule .2507(b)(12) prior to doing so.  Additional information about immunizing pharmacist authority to administer vaccines is found here:




NC DHHS ISSUES UPDATED COVID-19 TREATMENT GUIDANCE.  COVID-19 cases are rising in North Carolina.  NC DHHS has issued updated treatment guidance to health care providers, found here.





COVID-19 Vaccine Commercialization
FDA authorization and/or approval and the Advisory Committee on Immunization Practices (ACIP)/Centers for Disease Control and Prevention (CDC) recommendation of the updated, monovalent (XBB 1.5) 2023-2024 COVID-19 vaccine is expected the week of September 11, 2023.  ACIP is scheduled to vote on the 2023-2024 COVID-19 vaccine on September 12, 2023.

Once ACIP recommends the updated COVID-19 vaccines and CDC’s director approves, the current bivalent COVID-19 vaccines will no longer be authorized for use. At that time, you will be required to stop administering the bivalent doses and waste any remaining doses on hand following your agency’s disposal policies as well as appropriately waste inventory in NCIR.  Administration of non-authorized products is considered a vaccine administration error and must be reported to the Vaccine Adverse Events Reporting System (VAERS).
Follow this link for more detailed information.




FDA AND DEA ISSUE PUBLIC LETTER CONCERNING PERSISTENT SHORTAGES OF STIMULANT MEDICATIONS.  On August 1, FDA and DEA released a joint letter to the public discussing the persistent shortages of stimulant medications, factors contributing to those shortages, and FDA/DEA plans to mitigate them.  Read more here:  FDA/DEA Joint Letter to the Public.



MONDAY, JULY 10, 2023

United States Pharmacopeia (USP) has published the chapter revisions for USP <795> and <797> for non-sterile and sterile compounding. USP has also published the newly developed chapter <825>, which sets standards for compounding radiopharmaceuticals. These chapters, along with USP Chapter <800> Handling of Hazardous Drugs, will become enforceable for compounding operations on November 1, 2023.  Over the next few months, Board Staff will be posting guidance documents about these revisions and our updated inspection forms that reflect these revisions.

In the meantime, you can find additional resources on these USP Chapters. 

USP <800>:
USP <825>:

With respect to USP Chapter <800> and non-compounding activities involving hazardous medications, pharmacists are reminded:

The NC Board of Pharmacy views compliance with USP <800> for non-compounding activities involving hazardous medications as a best practice. As pharmacists know, USP Chapter <800> standards are designed to protect pharmacists, pharmacy staff, patients, and the public from the harmful effects of exposure to hazardous medications.

As USP Chapter <800> standards for non-compounding activities become commonly followed, North Carolina law is likely to reflect that doing so is considered standard of practice. In that case, failure to comply may be evidence of negligence. Therefore, you are encouraged to evaluate (and to continue to re-evaluate) to what extent compliance reflects the appropriate standard of care. Board staff will continue to make observations during inspections to help identify potential risk for handling Hazardous Medications, and will provide education on how to comply with USP Chapter <800> standards to minimize risk to pharmacy staff, patients, and the public. These observations regarding USP Chapter <800> compliance in non-compounding activities involving Hazardous Medications will not, by themselves, serve as a basis for disciplinary action by the Board. The Board's full position statement may be found here.

Board Staff have created helpful educational information that addresses the identification of Hazardous Drugs, instructions on conducting an Assessment of Risk, and templates for non-compounding pharmacies to develop Standard Operating Procedures (SOPs) addressed in USP<800>. This informational material is for pharmacies that DO NOT compound with hazardous medications and may be found here.



FRIDAY, JUNE 30, 2023

SL 2023-65 ENACTS SEVERAL PROVISIONS THAT AFFECT PHARMACY PRACTICE.  On June 29, 2023, the Governor signed into law SL 2023-65, which impacts pharmacy practice in several respects:




FDA ISSUES DRAFT GUIDANCE ON THE DRUG QUALITY AND SECURITY ACT’S WHOLESALING PROHIBITION FOR 503B OURSOURCING FACILITIES.  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: The title page of the draft guidance contains instructions to submit comments and suggestions within 60 days.




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:

DEA’s proposed rule for Expansion of Induction of Buprenorphine via Telemedicine Encounter is found here: Each notice includes timelines and instructions for public comment.



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.


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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.


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