NC DHHS ISSUES MEMO TO CLINICIANS ON EMERGING SUBSTANCES IN THE ILLICIT DRUG SUPPLY

JUNE 2026

North Carolina clinicians should be aware of the increasing detection of medetomidine, a potent veterinary sedative, and cychlorphine, a highly potent synthetic opioid, in the illicit opioid supply. Both substances have recently been identified in fentanyl and polysubstance drug samples across the United States, including reports in North Carolina. More details are found here.

BOARD STAFF ISSUES FAQ GUIDANCE ON RECENTLY AMENDMENT VALIDATING TECHNICIAN QUALIFICATIONS AND AUTHORITY

APRIL 2026

Effective May 1, 2026, amendment to the validating technician rule (21 NCAC 46.1418), expanded the pharmacy practices in which validating technicians may operate, provided new qualification pathways for validating technician status, and expanded tasks that validating technicians may perform. An FAQ guidance on these changes is found here.

DRUG ENFORCEMENT ADMINISTRATION PROVIDES MATERIALS TO SUPPORT FENTANYL FREE AMERICA INITIATIVE

APRIL 2026

The federal Drug Enforcement Administration (DEA) is distributing materials to assist the public in reducing fentanyl overdoses. Pharmacists may find this information useful in their practices.

*UPDATE* CDC ACCEPTS ACIP-RECOMMENDATIONS FOR ADMINISTRATION OF COVID-19 VACCINE; PHARMACISTS’ ABILITY TO ADMINISTER BY PROTOCOL NOW EFFECTIVE

UPDATED TUESDAY, OCTOBER 7, 2025

On October 6, 2025, the Acting Director of the CDC accepted The Advisory Committee on Immunization Practices’ recommendations concerning the COVID-19 vaccine. More information here. Accordingly, immunizing pharmacists’ authority to administer the COVID-19 vaccination to adult patients by protocol, to patients age 7 to 18 by protocol, and to patients age 6-18 by prescription is now effective. Below is an overall update on pharmacist authority to administer COVID-19 vaccine to patients who request it.

1. Administration of COVID-19 Vaccine to Patients Age 18 and Older Pursuant to Prescription. The Pharmacy Practice Act grants immunizing pharmacists authority to administer vaccines. G.S. 90-85.15B. A fuller description of that authority is found here.

An immunizing pharmacist may “administer vaccinations or immunizations to persons at least 18 years of age pursuant to a specific prescription.” G.S. 90-15.15B(a). Accordingly, a pharmacist may administer the COVID vaccine to any patient over age 18 upon receiving a prescription to do so.

On September 12, 2025, State Health Director Larry Greenblatt issued standing orders that pharmacists may deploy to satisfy the prescription requirement for administering COVID vaccine to patients age 18 and up who wish to receive it. The standing orders (one for each of the current COVID vaccine formulations) are found here on NC DHHS’s website. Dr. Greenblatt’s standing order bridged the challenge presented by the delay in ACIP recommendation. In light of ACIP recommendations becoming effective, Dr. Greenblatt’s order will sunset on Monday, October 13, 2025. Pharmacies may continue to use the order until that date while making any necessary adjustments to their protocols or procedures for COVID vaccine administration. Once the standing order sunsets, pharmacists may of course continue to administer COVID-19 vaccine to patients who present a prescription from a provider.

2. Protocol-Based Administration of COVID Vaccine to Adults Age 18 and Up, and Pediatric Patients Age 7 to 18, Now Effective. The Pharmacy Practice Act authorizes immunizing pharmacists to administer vaccines “recommended by the Advisory Committee on Immunization Practices” to patients age 18 or older pursuant to protocol, G.S. 90-85.15B(a1), and to patients age 7-18 by protocol and with parental or legal guardian permission, G.S. 90-85.15B(b1).

CDC has now accepted ACIP’s recommendation that COVID vaccine be administered by health-care providers pursuant to shared clinical decision-making, which “means that the clinical decision to vaccinate should be made on patient characteristics that unlike age are difficult to incorporate in recommendations, including risk factors for the underlying disease as well as the characteristics of the vaccine itself and the best available evidence of who may benefit from vaccination.”

Vaccination is recommended for every patient age 65 or older who wishes to obtain it.

ACIP’s recommendation “emphasized that the risk-benefit of vaccination in individuals under age 65 is most favorable for those who are at an increased risk for severe COVID-19 and lowest for individuals who are not at increased risk . . . .” CDC advises providers presented with a request for a vaccine: “Some health care providers may choose to discuss immunizations recommended for shared clinical decision-making with all or most of their patients who could receive it, while some providers may be more selective when discussing these immunizations with their patients. Health care providers should also be receptive to patient-initiated conversations about these immunizations.” More on the shared clinical-decision making process is found here. NC DHHS’ August 2025 update on FDA’s 2025-2026 COVID vaccine approvals – found here – includes links to information about high-risk conditions that counsel in favor of vaccination for a patient under age 65.

Pharmacies should review their protocols and make any changes needed to reflect ACIP recommendations.

3. Prescription-Based Administration of COVID Vaccine to Patients Age 6 to 18 Now Effective. The Pharmacy Practice Act authorizes immunizing pharmacists to administer vaccines to patients age 6 to 18 pursuant to prescription order “in accordance with recommendations by the Advisory Committee on Immunizations.” G.S. 90-85.15(c). In light of ACIP’s COVID vaccine recommendations, immunizing pharmacists may exercise this authority. Board of Pharmacy staff advise that pharmacists may treat the issuance of a prescription to a patient age 6 to 18 as evidence that the prescriber and patient/parent/guardian have already engaged in shared clinical decision-making.

NORTH CAROLINA CSRS TO LAUNCH PHARMACY COMPLIANCE PROGRAM ON SEPTEMBER 3, 2025

AUGUST 21, 2025

On September 3rd, 2025, NC DHHS CSRS will begin contacting pharmacies or dispensers with outstanding dispensation errors from the previous quarter in accordance with NC General Statute 90-113.73 (e). Registered NC CSRS users with a dispenser role type receive automated dispensation error notifications based upon dispensation errors associated with their profile Employer DEA. Dispensers receive notifications each day error(s) exists for 30 days. NC DHHS CSRS staff will contact by phone or email pharmacies or dispensers from the previous calendar quarter regarding outstanding errors requiring correction. Failure to correct these errors may result in civil penalties.

Resources are available to assist with error correction. Dispensers may visit the NC DHHS CSRS webpage for the NC Dispensers Guide and NC Veterinary Dispensers Guide.

For questions regarding error correction or for technical assistance, please contact NC DHHS CSRS at nccsrs@dhhs.nc.gov.

POST-HIV EXPOSURE PROTOCOL AMENDED

JULY 23, 2025

Acting on request from the North Carolina Department of Public Health, the Pharmacy and Medical Boards have approved changes to the Post-HIV Exposure Prophylaxis Protocol that qualifying immunizing pharmacists may deploy in practice. These changes conform the protocol to most recent CDC guideline. The updated protocol is found here.  Overall guidance on qualified immunizing pharmacist protocol-based authority (including links to all statewide protocols) is found here.

STATEWIDE PHARMACIST STANDING ORDERS UPDATED TO REFLECT NEW STATE HEALTH DIRECTOR

JULY 16, 2025

The North Carolina State Health Director’s Epinephrine Auto Injector Standing Order and the North Carolina Standing Order for Opioid Antagonists (found here) have been resigned by new State Health Director Dr. Larry Greenblatt.

Pharmacists are reminded that the statewide protocols under which qualified pharmacists may initiate nicotine replacement therapy, self-administered hormonal contraceptives, prenatal vitamins, post-HIV exposure prophylaxis, and glucagon are not standing orders from the State Health Director. A qualified pharmacist exercising authority under these protocols must use the pharmacist’s/pharmacy’s NPI number for tracking and billing. More information on this protocol authority is found here.

PHARMACY AND MEDICAL BOARDS APPROVE SLIGHT CHANGES TO STATEWIDE PHARMACIST-INITIATED HORMONAL CONTRACEPTIVE PROTOCOL

june 11, 2025

Effective May 20, 2025, the Pharmacy and Medical Boards approved slight changes to the statewide protocol governing pharmacist initiation of hormonal contraceptive therapy. The revised protocol is found here. The North Carolina Association of Pharmacists’ Hormonal Contraceptive Toolkit (https://www.ncpharmacists.org/hormonal-contraception-toolkit) has been updated to reflect these changes, and NCAP has produced an excellent short video explaining the changes (https://www.youtube.com/watch?v=WGTgLL79a7Q). Broader guidance on qualifying immunizing pharmacists’ authority to initiate certain drug therapy is found here in the Board website’s FAQ section.

DEA DELAYS EFFECTIVE DATE OF TWO NEW RULES CONCERNING PRESCRIBING CONTROLLED SUBSTANCES VIA TELEMEDICINE

APRIL 4, 2025

The Drug Enforcement Administration has delayed the effective date of two final rules titled “Expansion of Buprenorphine Treatment via Telemedicine Encounter” and “Continuity of Care via Telemedicine for Veterans Affairs Patients” to December 31, 2025. More information found here: https://www.federalregister.gov/documents/2025/03/24/2025-05007/expansion-of-buprenorphine-treatment-via-telemedicine-encounter-and-continuity-of-care-via

As a result of this delay, The Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (https://www.federalregister.gov/documents/2024/11/19/2024-27018/third-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled) remains in effect and continues to allow practitioners to prescribe controlled substances via telemedicine through December 31, 2025.

FDA ISSUES CLARIFYING STATEMENTS AND DEADLINES ON GLP-1 COMPOUNDING

MARCH 25, 2025

A federal litigation brought by the Outsourcing Facilities Association challenged FDA’s determinations that GLP-1 shortages have ended. On March 5, 2025, the federal district court overseeing the litigation denied the Outsourcing Facilities Association’s request for a preliminary injunction to bar the FDA from declaring an end to the shortages.

On December 19, 2024, FDA issued a statement that that it would exercise enforcement discretion and not take action concerning compounded tirzepatide while the litigation was pending. With the litigation’s end, compounding copies of approved tirzepatide products is no longer allowed.

On February 21, 2025, FDA issued a statement concerning compounded semaglutide products. FDA has determined that shortages of semaglutide injection products have resolved. To avoid unnecessary disruption to patient treatment, FDA announced that it would not take action against compounders for violations of the Food and Drug Cosmetic Act until the following dates:

• For state-licensed 503A compounding pharmacies, sixty (60) days from the February 21 statement – April 22, 2025.

• For 503B outsourcing facilities, ninety (90) days from the February 21 statement – May 22, 2025.

For more details, please see: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize | FDA

BOARD INTRODUCES CHANGES TO THE TRANSFER-OF-OWNERSHIP PHARMACY PERMITTING PROCESS TO BETTER FACILITATE CONTINUITY OF OPERATIONS

MARCH 19, 2025

Board Rule .1603 requires a pharmacy to obtain a new permit prior to the closing of a qualifying transfer-of-ownership transaction. Comprehensive information and instruction on the transfer-of-ownership process – and the consequences of not following the process – are found in the FAQs located here. A continuity of operations challenge in the transfer-of-ownership context frequently arises, however. The new pharmacy needs to have a permit number assigned to complete tasks such as DEA registration transfer and enrollment with third-party payor programs. To date, the new pharmacy permit number was not assigned until the close of the transfer-of-ownership transaction, creating a possibility that the new pharmacy would have to delay operations until these tasks were completed. Board staff has programmed changes to the transfer-of-ownership process whereby, after a review of a transfer-of-ownership application is completed and approved, the new pharmacy’s permit number is assigned provisionally. The pharmacy may use the permit number to complete continuity of operations tasks. Once the transfer-of-ownership application closes, the “provisional” status is removed and the new pharmacy may begin practice under that permit number. This guidance explains the what, why, and how of the revised process.

NIOSH RELEASES UPDATED LIST OF HAZARDOUS DRUGS IN HEALTH CARE SETTINGS

MARCH 11, 2025

On December 19, 2024, the CDC: National Institute for Occupational Safety and Health (NIOSH) released its updated 2024 list of Hazardous Drugs in Healthcare Settings. This list is designed to assist employers in identifying drugs that are hazardous to the health and safety of workers who handle these drugs. The new list can be found here: NIOSH 2024.

For rules and guidance concerning USP chapter <800> operation in compounding and non-compounding operations, see FAQs here: https://www.ncbop.org/faqs/general-pharmacy-faqs.html#faqcompounding

NC CONTROLLED SUBSTANCE REPORTING SYSTEM LAUNCHES DISPENSATION ERROR NOTIFICATION PROGRAM

February 14, 2025

NC CONTROLLED SUBSTANCE REPORTING SYSTEM LAUNCHES DISPENSATION ERROR NOTIFICATION PROGRAM. The Drug Control Unit of the NC Department of Health and Human Services will launch a Dispensation Error Notification program on February 26. Registered CSRS users with the role type of Pharmacist, Pharmacist in Charge, Dispensing Physician and Veterinarian (dispensing) will receive automated emails regarding their pharmacy’s NC CSRS data submissions if the file or record(s) contain error(s). Users will continue to receive notifications each day error(s) exists for the previous 30 days of submissions. This new feature will not replace any notifications sent to PMP Clearinghouse account holders.

A FAQ document on this program is found here. An example of an error notification is found here.

Pharmacists with questions should contact the NC CSRS team at nccsrs@dhhs.nc.gov.

*UPDATE* NC DHHS DRUG CONTROL UNIT PROVIDES GUIDANCE ON REPORTING VETERINARY GABAPENTIN DISPENSING

JANUARY 8, 2025

NC DHHS’ Drug Control Unit (DCU) announces that the North Carolina Controlled Substance Reporting System (CSRS) is launching state license failover for veterinary gabapentin reporting on January 8th, 2025. By March 1, 2025, state law requires all veterinary dispensations of gabapentin to be reported to the CSRS. Some veterinarians may lack a Drug Enforcement Agency (DEA) or National Provider Identifier (NPI) number. To facilitate CSRS reporting of veterinary gabapentin dispensations in that circumstance, DCU will enable a failover allowing submissions using the veterinarian’s North Carolina license number. DCU has updated its Dispenser and Veterinarian Dispensers Guides (found here) to include the veterinary license failover process. DCU has also published a Gabapentin Veterinary State License Failover Reporting FAQ (found here). Anyone with questions or concerns about DCU’s veterinary gabapentin reporting processes should contact Savannah Simpson or the CSRS inbox.