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

*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.

CERTAIN FEDERAL PREP ACT AUTHORIZATIONS FOR PHARMACISTS EXTENDED TO DECEMBER 31, 2029

DECEMBER 13, 2024

The United States Department of Health and Human Services announced on December 11, 2024 that PREP Act authorizations for qualified pharmacists, pharmacy interns, and pharmacy technicians to order (for pharmacists) and administer (for pharmacists, interns, and technicians) COVID-19 vaccines, seasonal flu vaccines, and COVID-19 tests has been extended through December 31, 2029. These authorities were previously scheduled to expire on December 31, 2024. Secretary Berrea noted, “As stated in prior amendments to this Declaration, licensed pharmacists, pharmacy interns and qualified pharmacy technicians are well positioned to provide continued access to [these vaccines and tests], particularly in certain areas or for certain populations that have too few primary-care providers or that are otherwise medically underserved.” US DHHS full statement is found here. A comprehensive guidance document on pharmacist and pharmacy technician immunization authority under PREP Act waivers and North Carolina state law is found here.

NC CSRS TO LAUNCH CLINICAL ALERT PROGRAM ON DECEMBER 9, 2024

NOVEMBER 25, 2024

The North Carolina Controlled Substance Reporting System (“CSRS”) is launching a “clinical alert” program on December 9, 2024. These are notifications for prescribers indicating that a patient has met or exceeded certain high-risk thresholds for controlled substance use and intended to assist healthcare providers in identifying patients potentially at risk of overdose or substance use disorder. CSRS provides more detail here.

Pharmacists or others with questions about the program, its purposes, and its application should contact Savannah Simpson at NC DHHS: savannah.simpson@dhhs.nc.gov; 984-236-5340.

BOARD COMPLETES AMENDMENTS TO RULES GOVERNING HEALTH-CARE FACILITY PHARMACY PERMITS AND EMERGENCY DEPARTMENT DISPENSING

november 1, 2024

The Board has completed amendments to two rules governing health-care facility pharmacy practice.

Rule .1401, Registrations and Permits. Board Rule .1401 now clarified that physically separate dispensing areas operated by a health care facility are not required to have a separate permit if those dispensing areas are either (a) contained in the same building as the permitted pharmacy or (b) contained in a building located on property contiguous to the permitted pharmacy. All physically separate dispensing areas for which the majority of its activity is dispensing or compounding drugs for a patient’s use outside of the health care facility must hold a separate permit. All health care facilities should review their dispensing areas to determine whether any satellite area no longer requires a permit or, particularly for “off-campus” areas, whether a satellite area now requires its own separate permit.

Rule .1415, Emergency Department Dispensing. Board Rule .1415 now provides that, when a health care facility is closed for outpatient pharmacy service, non-pharmacy-personnel dispense no more than a seven-day supply or the smallest quantity prepacked by the manufacturer from a formulary of drugs for emergency department dispensing developed by the pharmacist-manager. The overall substance of Rule .1415 (who, what, when, where) is largely unchanged. Again, the chief change is the larger supply of a drug that may be dispensed from an emergency department to avoid disruption in patient care.

Both amendments are effective today, November 1, 2024.

DEA CONSIDERING EXTENSION OF RULE .1815 USE TO PROVIDE EMERGENCY REFILLS OF SCHEDULE 3, 4, AND 5 PRESCRIPTIONS

november 1, 2024

On October 3, 2024, the DEA issued an exception letter (found here) concurring in the use of Board Rule .1815 to provide one-time emergency refills of up to a 90-day supply of a Schedule 3, 4, or 5 substance when the pharmacist is unable to obtain refill authorization from the prescriber due to the prescriber’s inability to provide medical services to the patient. This concurrence applies to patients in Helene-affected counties. DEA’s concurrence is scheduled to expire on Sunday, November 3, but DEA stated in its letter that it would consider further extension if emergency conditions continued to exist at that time. In light of the extension of the Helene state of emergency to March 1, 2025, Board staff requested on October 25 that DEA extend the concurrence for the same period. DEA is considering that request, and Board staff expects to receive a decision soon. In the meantime, DEA staff agree that pharmacists may continue to rely on the October 3 concurrence pending a DEA decision on the extension. Board staff will provide more information when received from DEA.

WALLACE NELSON RECEIVES 2024 BOWL OF HYGEIA AWARD

JULY 25, 2024

The North Carolina Association of Pharmacists presented Wallace E. Nelson with the 2024 Bowl of Hygeia Award at its annual convention. Established in 1958, the Bowl of Hygeia Award is sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations. Participating state pharmacy associations recognize one pharmacist annually for an outstanding record of community civic leadership. NCAP Executive Director Penny Shelton praised Wallace, noting that he has “walked the talk his entire career finding ways to serve and give back at extraordinarily high levels.”

Wallace is a native of Hertford. He began his post-secondary education at the College of the Albemarle and is a 1976 graduate of the UNC School of Pharmacy. His professional career began in retail pharmacy before joining Chowan Hospital in Edenton and Bertie Hospital in Windsor. He has served, and continues to serve, both hospitals at all levels for over forty years, thirty-six as Director of Pharmacy.

The state’s pharmacists elected Wallace to serve on the North Carolina Board of Pharmacy in 2000. He served two five-year terms, through 2010, and was again elected to the Board in 2020. Board members have selected him as President several times.

Wallace’s record of community service outside of pharmacy is long and diverse. He is a member of the Perquimans County Board of Education and Board of County Commissioners, where he currently serves as Chairman. He is actively involved in the North Carolina Association of County Commissioners and will be installed as President Elect in August 2024 and as President in 2025. Past appointments by Governors Martin, Hunt, McCrory, and Cooper, include the College of the Albemarle Board of Trustees, North Carolina Marine Industrial Authority, as well as several Governor’s Councils, Institutes and Legislative Study Commissions.

Wallace has been previously recognized for his community and state service. In 2010 Governor Perdue named Wallace to the Order of the Long Leaf Pine, the state’s highest honor for those who have made significant contributions to the state and their communities through exemplary service and exceptional accomplishments. In 2011 the North Carolina School Boards Association tapped Wallace to receive the Raleigh Dingman Award, the highest honor bestowed on a school board member.

Wallace and his wife Freda (a retired educator) are the parents of Ethan (a practicing dentist), Lauren (a human resources manager), and the grandparents of Reagan and Harrison.

BURGLARIES REPORTED AT MULTIPLE NORTH CAROLINA PHARMACIES

JULY 19, 2024

Multiple independent pharmacies in North Carolina have been burglarized. The burglars gained access using a sledgehammer or other means to open a hole in the pharmacy's exterior wall, including brick and cinder block. Once inside, the individuals crawled to stay below the motion sensor to access the controlled substance safe. The safes have been breached via crowbars and a Sawzall-type tool. These burglaries have occurred typically in the early hours of Monday mornings.

If you experience a loss of any prescription medication, controlled or otherwise, from your pharmacy, complete the North Carolina Board of Pharmacy Drug Disaster & Loss Report within ten (10) days of the loss or theft. This FAQ outlines the requirements in such cases.

FAREWELL AND THANK YOU TO BOARD MEMBER ANDY BOWMAN

july 5, 2024

Board members and staff thank Andy Bowman for eight years of superlative service to the Board and the citizens of North Carolina. The state’s pharmacists elected Dr. Bowman in 2016, and he became the first graduate of the Campbell University College of Pharmacy and Health Sciences to serve on the Board. The state’s pharmacists returned Dr. Bowman to a second term on the Board in 2021. He twice served as the Board’s president.

Dr. Bowman has accepted an exciting personal and professional opportunity with the Appalachian College of Pharmacy where he will serve as assistant dean for strategic partnerships and engagement. This new opportunity will require Dr. Bowman’s relocation to Virginia.

Dr. Bowman’s impact on the practice of pharmacy in North Carolina has been profound. In addition to serving on the Board, he taught generations of students at the Campbell University College of Pharmacy and Health Sciences. He served in leadership positions at the North Carolina Association of Pharmacists, the North Carolina Pharmacist Recovery Network (and its successor, the North Carolina Professionals Health Program), the American Society for Pharmacy Law, and the Harnett County Pharmaceutical Association.

North Carolina pharmacy is better because of Dr. Bowman’s long and broad service. He will be missed. Board members and staff wish him and his wife, Sarah, every success in this new phase.

DISPENSING OPTOMETRIST REGISTRATION SYSTEM OPEN EFFECTIVE MARCH 1, 2024

FEBRUARY 27, 2024

Optometrists may now register with the NC Board of Pharmacy to dispense certain prescription drugs. G.S. § 90-127.4. Dispensing optometrists may dispense prescription drugs to their own patients only for the diagnosis and treatment of abnormal conditions of the eye and its adnexa. G.S. § 90-127.4(a) & (c). Dispensing optometrists may not compound medications, nor may they dispense controlled substances. G.S. § 90-127.4(a).

Dispensing optometrists must register with the Board of Pharmacy prior to beginning dispensing activities and must renew that registration annually. G.S. § 90-85.26B. The initial registration fee is $75, as is the annual renewal fee. G.S. § 90-85.24(a)(20).

A dispensing optometrist must comply in all respects with relevant laws and regulations that apply to pharmacists governing the distribution of drugs, including packaging, labeling, and record keeping. G.S. § 90-85.26B. The Board of Pharmacy may discipline a dispensing optometrist’s registration for violation of these laws and regulations. The Board of Optometry may discipline an optometrist’s license to practice optometry. G.S. § 90-85.25B.

Step-by-step instructions for completing a dispensing optometrist registration are found here.

REMINDER TO PHARMACY PROVIDERS: NORTH CAROLINA MEDICAID LAUNCHING NEW MANAGED CARE BEHAVIORAL HEALTH AND INTELLECTUAL/DEVELOPMENTAL DISABILITIES TAILORED HEALTH PLANS ON JULY 1

JUNE 18, 2024

Details about these new plans may be found here. Questions about these new plans should be directed to North Carolina Medicaid.