LICENSURE GATEWAY

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

FDA ENDS CLOZAPINE REMS PROGRAM

FEBRUARY 28, 2025

On February 24, the FDA announced an immediate end to the Clozapine REMS program. FDA noted: “Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk. Eliminating the REMS is expected to decrease the burden on the health care delivery system and improve access to clozapine.” This is, obviously, a seismic shift in the provision of clozapine to patients. Pharmacists should stay attuned to updates as this change rolls out. More information from FDA is available here, and from the Clozapine REMS site here. The North Carolina Clozapine Network (https://www.med.unc.edu/psych/cecmh/education-and-training/north-carolina-clozapine-network-nccn/) will also be providing information and updates for health care providers.

PHARMACISTS AND PHARMACY PERSONNEL WARNED OF SCAM COMMUNICATIONS PURPORTING TO BE FROM NCBOP STAFF

FEBRUARY 18, 2025

They’re back! Pharmacists are once again reporting to Board staff that they are receiving calls from individuals purporting to be Board investigators/inspectors. The Board’s telephone number, (919) 246-1050, is often what appears on caller ID. Such calls as of late inform the pharmacist that they are the target of an investigation involving illegal drug activity and the caller sometimes claims to be part of a larger FBI (or SBI, DEA or other agency) investigation. The details vary, but these calls appear to be an attempt to get the recipient to disclose personal information.

Board staff reminds practitioners that the names of all the Board’s investigators are listed on the NCBOP’s website, and if they are unsure or suspicious when contacted by someone claiming to be a Board staff member (whether by phone, email, or other communication) that they should contact the Board immediately. To be sure, Board staff frequently contact pharmacists and pharmacy staff on all manner of issues. But, again, if you are suspicious about the true identity of the caller, please reach out to the Board office directly.

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.

THE COVID-19 STATEWIDE STANDING ORDERS (SWSOs) WILL EXPIRE ON DECEMBER 31, 2024

NOVEMBER 18, 2024

From the NC Department of Health & Human Services: The COVID-19 Statewide Standing Orders (SWSOs) authorized under North Carolina Session Law 2022-74, Sec. 9G.7.(a)-(e) and extended under Session Law 2023-65, Sec. 9G.7, will expire on December 31, 2024. No additional extensions have been provided.

What this means for your pharmacy:
If your pharmacy currently uses the SWSOs issued by Dr. Elizabeth Tilson, NC State Health Director, to facilitate COVID-19 vaccinations, action is required to prevent disruptions in vaccine administration. Ensure that any changes needed to your pharmacy-specific vaccination protocol are in effect by January 1, 2025.

Action Required:

> Review and prepare to transition to pharmacy-specific protocols.

> Finalize and implement any needed changes to your pharmacy’s vaccination protocols by January 1, 2025.

> For more information about pharmacist and pharmacy technician vaccination authority, please see this BOP guidance document

Thank you for your attention to this important change.

In Health,
NC Department of Health and Human Services

HELENE STATE OF EMERGENCY EXTENDED THROUGH MARCH 1, 2025

October 25, 2024

On October 24, 2024, the General Assembly passed and Governor Cooper signed into law the Disaster Recovery Act of 2024. Section 3.1 of the Act extends the Governor’s declared state of emergency through March 1, 2025. Accordingly, waivers issued by the Board of Pharmacy to facilitate Helene relief and recovery remain in effect through March 1, 2025 unless the Board acts to terminate them prior to that date. A reminder that the Board has compiled Helene relief and recovery resources here.

HHS SECRETARY BECERRA PROVIDES UPDATE ON EFFORTS UNDERWAY TO MITIGATE SUPPLY CHAIN DISRUPTIONS CAUSED BY BAXTER FACILITY DAMAGE

UPDATED THURSDAY, OCTOBER 17, 2024 WITH a response from usp

10/17/24 - UPDATE FROM US PHARMACOPEIA (USP): "USP, with input from our Compounding Expert Committee members and stakeholders, is providing the following resources intended to support healthcare practitioners and scientific professionals to address shortages of manufactured intravenous fluids resulting from the consequences of Hurricane Helene” (follow this link for details.)

10/15/24 - CDC HEALTH ADVISORY: Disruptions in Availability of Peritoneal Dialysis and Intravenous Solutions from Baxter International Facility in North Carolina. Follow this link for details.

10/10/24 - Federal Department of Health and Human Services Secretary Becerra has issued this letter concerning federal efforts to mitigate sterile solutions supply chain disruptions attributable to significant damage to Baxter’s Marion, NC facility. FDA has established a continually updating information page here: https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina. Baxter has likewise established a continually updating information page here: https://www.baxter.com/baxter-newsroom/hurricane-helene-updates

DEA APPROVES USE OF BOARD RULE .1815 TO CREATE AND DISPENSE EMERGENCY REFILLS OF SCHEDULE 3, 4, AND 5 CONTROLLED SUBSTANCES

October 3, 2024

Board Rule .1815 authorizes pharmacists and DME providers to provide a one-time emergency refill of up to a 90-day supply when the pharmacist or DME provider is unable to obtain refill authorization from the prescriber due to the prescriber’s inability to provide medical services to the patient. This authority was specifically created for times of emergency like those in western North Carolina. Pharmacists and DME providers are encouraged to use it to assist patients in affected counties. The DEA has issued an exception letter allowing Rule .1815 to be used to create and dispense emergency refills of Schedule 3, 4, and 5 substances (found here). This exception is in effect for 30 days (until November 3, 2024), though DEA states that it will consider a further extension if emergency conditions continue to exist at that time. Board staff thanks DEA Agent Stevie Ikner and DEA Assistant Administrator Tom Prevoznik for their quick response to this patient need.

*REMINDER* CONTROLLED SUBSTANCE PRESCRIPTION FORMATS. The North Carolina STOP Act requires that prescriptions for “targeted controlled substances” to be transmitted electronically unless an exception applies. One exception is “technical failure or other circumstance preventing electronic transmission.” For obvious reasons, transmission or receipt of electronic prescriptions in Helene-affected counties is likely to be problematic. Accordingly, the STOP Act’s electronic transmission provisions are not a reason to decline filling a controlled substance prescription issued for a legitimate medical purpose in the ordinary course of medical practice. More STOP Act information is found here.

*REMINDER* VERBAL SCHEDULE 2 PRESCRIPTIONS IN EMERGENCIES. Pharmacists are reminded that, in the case of an “emergency situation,” federal law (21 CFR 1306.11(d)) allows a pharmacist to dispense a Schedule II controlled substance upon receiving oral authorization from the prescriber, provided that: (1) the amount is limited to that adequate to treat the patient during the emergency period; (2) the prescription is immediately reduced to writing by the pharmacist; (3) if the prescriber is not known to the pharmacist, the pharmacist makes a reasonable effort to determine the oral authorization came from a DEA-registered prescriber; and (4) within 7 days, the prescriber causes a written prescription to be delivered to the dispensing pharmacist.

This information, and other Helene response updates, are being compiled on the BOP’s website here: https://www.ncbop.org/heleneaftermath.html.

The Board continues to compile a resource listing pharmacies in Helene-affected counties that have resumed operation. The list is found here -- https://www.ncbop.org/emergencyoperatingpharmacieshelene.html -- and it includes a link for pharmacies to let the Board know that they are operational.

NC DHHS DRUG CONTROL UNIT ISSUES EMERGENCY RULE AMENDMENT CONCERNING DISPOSAL OF UNUSED CONTROLLED SUBSTANCES RETURNED TO A PHARMACY FROM A NURSING FACILITY 

September 25, 2024

NCDHHS’ Drug Control Unit (DCU) has long had a rule that governs how unused controlled substances returned from a nursing facility to the dispensing pharmacy may be destroyed. On July 26, 2024, Stericycle, the owners of the only incinerator in North Carolina that is capable of destroying controlled substances to the point that they are non-retrievable, notified long-term care pharmacies in North Carolina that they will no longer accept bookings for witnessed destruction of controlled substances. Stericycle’s business decision to no longer provide long-term care pharmacies the option of destruction of unused controlled substances from nursing homes by an incinerator within the State was not foreseen by the DCU. To help ensure safe, secure, and timely disposal and destruction of unused controlled substances in North Carolina, DCU has promulgated an emergency amendment to its disposal regulation, 10A NCAC 26E .0406, to provide immediate clarity regarding the use of federally recognized options for disposing of and destroying unused controlled substances from nursing homes, including outsourcing the destruction to reverse distributors. More information on the amended rule, its operation, and points of contact at DCU are found here and here.

NEW BOARD RULE GOVERNING TEMPORARY CLOSURES IS NOW IN EFFECT

September 18, 2024

NEW BOARD RULE GOVERNING TEMPORARY PHARMACY CLOSURES IS NOW IN EFFECT. Unforeseen circumstances can, and do, arise that require a pharmacy to temporarily cease operations. Unexpected closures create hardships for patients, who may suddenly find themselves without access to pharmacy care and without direction to alternatives. New Board Rule .2516, effective August 1, 2024, sets forth patient protection requirements that pharmacies must meet when a temporary closure occurs. This FAQ reviews Rule .2516’s who, what, when, where, and how for temporary pharmacy closures.

BOARD OF PHARMACY REINSTATES FIVE-HOUR CE CARRYOVER ALLOWANCE

September 6, 2024

The renewal period for 2025 licensure opens on November 1, 2024. With that fast approaching date, some welcome news for those who begin to sweat the continuing education requirement at the end of the year! The Board has completed an amendment to Rule .2201. Paragraph (c) of that rule states:

“A pharmacist who accumulates more than the required 15 hours of continuing education in a single year may carry forward up to five surplus hours to be applied to the following year's continuing education requirements.”

The amendment is in effect. So, a pharmacist who acquired more than 15 hours of continuing education in 2023 may carry over up to five of those surplus hours to 2024 and apply them to renewal for 2025 licensure.

CMS ADOPTS SCRIPT STANDARD 2023011 – IMPLICATIONS FOR ELECTRONIC CONTROLLED SUBSTANCE PRESCRIPTION TRANSFERS

JULY 25, 2024

(RE)SETTING THE STAGE

On July 27, 2023, Drug Enforcement Administration (DEA) issued a final rule governing the transfer of electronic prescriptions for controlled substances prior to initial fill. 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) and (2)

DEA commentary accompanying the rule asserted that SCRIPT Standard Version 2017071 enables the transfer of CS prescriptions between pharmacies in a way that satisfies these rule requirements. In a February 14, 2024 letter to stakeholders, Surescripts confirmed that SCRIPT Standard Version 2017071 does not do what DEA thinks that it does – and never has. Surescripts stated that SCRIPT Standard Version 2023011 is capable of transferring CS prescriptions in a way that complies with DEA’s rule, but the Centers for Medicare & Medicaid Services must finalize a rule allowing the industry to adopt this updated SCRIPT standard.

UPDATE

On June 17, 2024, Centers for Medicare & Medicaid Services (CMS) issued a final rule for health information technology standards to adopt the SCRIPT Standard Version 2023011. The updated SCRIPT Standard Version will allow electronic controlled substance prescriptions transfers between pharmacies in a way that complies with DEA’s rule. CMS’ adoption is found here.

WHAT NOW

Pharmacies should communicate with their technology vendors to determine when and how their systems will be updated to incorporate SCRIPT Standard Version 2023011.

BOARD STAFF NOTES CONCERN WITH A NUMBER OF RECIPROCITY APPLICATIONS SUBMITTED BY PHARMACISTS SEEKING TO PRACTICE AT NC HEALTH SYSTEMS

JULY 18, 2024

Board staff have noted (another) uptick in license reciprocity applications in which the applicant admits having engaged in acts constituting the practice of pharmacy in a North Carolina health-system facility prior to licensure in the state. Upon questioning, the applicant usually responds with some variation of “I engaged in pharmacy practice, but only under the supervision of a North Carolina-licensed pharmacist.” This is a reminder to health-system pharmacies that there is no provision in law by which a pharmacist not licensed to practice pharmacy in North Carolina may engage in pharmacy practice within North Carolina. There is no “under the supervision of a North Carolina licensed pharmacist” exception. And applicants for licensure by reciprocity are not, and are not eligible to become, pharmacy interns. This is unlicensed practice of pharmacy, and a health-system that has allowed it to occur has aided an abetted the unlicensed practice of pharmacy.

Board staff have reached out to various health-systems about this issue in recent years, but doing so has not impacted the practice. Accordingly, Board staff will begin treating these issues as potential disciplinary matters. Please ensure that no pharmacist in a North Carolina health-system facility engages in acts constituting the practice of pharmacy unless and until the pharmacist is licensed in North Carolina. 

FDA ISSUES DRAFT GUIDANCE ON THE DRUG QUALITY AND SECURITY ACT’S WHOLESALING PROHIBITION FOR 503B OURSOURCING FACILITIES

JUNE 29, 2023

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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act. The title page of the draft guidance contains instructions to submit comments and suggestions within 60 days.