LICENSURE GATEWAY

FDA WARNS OF COUNTERFEIT OZEMPIC IN THE US DRUG SUPPLY CHAIN

APRIL 21, 2025

Counterfeit Product Identified: Novo Nordisk, manufacturer of Ozempic, has identified several hundred units of counterfeit Ozempic (semaglutide) injection 1 mg that have been illicitly distributed outside of their secure and authorized supply chain within the US. The FDA confirmed seizure of some identified counterfeit units on April 9, 2025, and has issued a public warning to both consumers and healthcare professionals concerning this counterfeit product. The potential for further circulation of these dangerous counterfeit products remains a serious concern.

The counterfeit products bear the lot number PAR0362 and a serial number commencing with the initial eight digits 51746517. While the lot number PAR0362 itself is authentic and associated with genuine Ozempic, it is exclusively when this specific lot number is found in combination with a serial number starting with "51746517" that the product is confirmed to be counterfeit and must be immediately removed from circulation and not dispensed under any circumstances.

The precise contents and safety profile of the seized counterfeit products are currently under rigorous investigation by both the FDA and Novo Nordisk. However, based on previous incidents involving counterfeit medications, the use of these products carries substantial and unknown health risks for patients. Notably, a prior counterfeit Ozempic incident in December 2023 revealed the presence of counterfeit needles lacking confirmed sterility, thereby introducing a significant risk of infection.

Thorough visual examination of the seized counterfeit product has revealed that the fraudulent activity extends beyond the medication itself. Critical components such as the needles, pen labels, external packaging, and the accompanying product inserts intended for both patients and healthcare professionals have also been expertly counterfeited.

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

april 17, 2025

Don’t fall victim to scammers! Pharmacists continue to report 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 and the names of the “investigator” 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.

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

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.

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.