2021 RENEWAL PERIOD: NOVEMBER 1, 2020 – DECEMBER 31, 2020
Now is the time to renew your pharmacist license, technician registration, NP/PA or dispensing physician registration, DME or pharmacy permit for 2021.
Log in now through the Licensure Gateway to complete your renewal.
Please note: Pharmacists will not be licensed on Thursday, December 24, 2020 due to the closure of the office for the holidays.
ELECTION FOR NC BOARD OF PHARMACY’S SOUTHEASTERN DISTRICT SEAT
The Board is holding an election for the Southeastern District seat and voting coincides with the licensure renewal period. Actively licensed pharmacists living in North Carolina are eligible to vote. Once logged in to your pharmacist profile, click on the election tile to cast your vote.
FRIDAY, DECEMBER 11, 2020
COVID-19 VACCINATION CONTINUING EDUCATION OPPORTUNITY FOR PHARMACISTS AND PHARMACY TECHNICIANS. The Board and the Campbell University College of Pharmacy & Health Sciences have partnered to provide a 2-hour (in two 1-hour parts) continuing education program on COVID-19 vaccination. We are grateful to State Health Director Betsey Tilson and Division of Public Health Pharmacist Amanda Fuller Moore, who are serving as faculty. With the approaching roll out of COVID-19 vaccines, the critical role that pharmacies will play in the mass vaccination campaign, and the need for immunizing pharmacists and qualified pharmacy technicians to obtain training, this is a timely and important opportunity. The program is available without cost to pharmacists and pharmacy technicians. More information, program details, and a link to online registration may be found here: https://cmetracker.net/CAMPBELL/Publisher?page=pubOpen#/moreInfo.
THURSDAY, DECEMBER 10, 2020
FEDERAL DRUG ENFORCEMENT ADMINISTRATION PUBLISHES PROPOSED RULES ON SCHEDULE II PARTIAL FILLS. The 2016 Comprehensive Addiction and Recovery Act set forth new requirements governing partial fills of Schedule II controlled substance prescriptions. The DEA has announced proposed rules to clarify CARA’s terms and to better inform patients and health care providers of the scenarios in which partial Schedule II fills are permitted. Comments on the proposed rule will be accepted until February 2, 2021, 60 days after the publication of the proposed rule. Further details, including how to submit comments and the complete text of the proposed rule, are available in the DEA’s announcement in the Federal Register: http://www.ncbop.org/PDF/DEAProposedRulesImplementingPartialCIIFills.pdf.
WEDNESDAY, DECEMBER 9, 2020
THEY’RE BACK! PHARMACISTS AND PHARMACY PERSONNEL SHOULD BE MINDFUL OF SCAM COMMUNICATIONS PURPORTING TO BE FROM BOARD OF PHARMACY STAFF
Back in the summer, and then again last month, Board staff received information about a handful of instances in which someone pretending to be an NCBOP investigator or “Board Officer” has called a pharmacist. It’s happening again.
Board staff was notified that someone impersonating a Board Investigator called a pharmacist and gave a fake name and a fake NCBOP badge number as “proof” of identity. The scammer is using a phone number spoofer so that the NCBOP main line – (919) 246-1050 – appears on caller ID.
TUESDAY, DECEMBER 8, 2020
SUPERVISION OF PHARMACY INTERNS AND QUALIFIED PHARMACY TECHNICIANS ADMINISTERING VACCINES OR ASSISTING WITH VACCINATION EFFORTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. As pharmacists know, under North Carolina law pharmacy interns may administer vaccines under the supervision of a pharmacist. 21 NCAC 46. 2507. Under the United States Department of Health and Human Services’ PREP Act declarations, pharmacy interns and qualified pharmacy technicians may administer vaccines under the supervision of a pharmacist. http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf; http://www.ncbop.org/PDF/PREPActCOVIDVaccination090920.pdf; http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf.
Board staff have received a number of inquiries concerning what constitutes proper supervision of a pharmacy intern or qualified pharmacy technician who is administering vaccines or otherwise assisting with a vaccination effort. To facilitate the safe, rapid deployment of pharmacy personnel to administer vaccines during the COVID-19 public health emergency, the Board’s Executive Director has exercised authority delegated to him in the Board’s Emergency Services Waiver to waive enforcement of Rule .2507’s requirement that supervision be “direct [and] in-person,” and that the supervision be provided only by a pharmacist. However, pharmacy interns and qualified pharmacy technicians must be supervised by a pharmacist or certain other health care providers who are present at the same facility and available to assist, and ultimate supervision must be provided by a pharmacist who is responsible for the administration.
Accordingly, a waiver is granted as follows: Supervision of a pharmacy intern or qualified pharmacy technician who is administering vaccines or otherwise assisting with a vaccination effort shall be deemed adequate if either: (a) a supervising pharmacist is on site and readily available to assist as needed; or (b) another licensed health care provider authorized to administer vaccines is on site and readily available to assist as needed, and a supervising pharmacist is readily available by phone or other telecommunications method for consultation as needed.
The decision whether and how to implement a supervision alternative described above lies with the responsible pharmacist-manager.
FRIDAY, DECEMBER 4, 2020
*UPDATE* EPIDIOLEX’S STATUS AS A CONTROLLED SUBSTANCE IN NORTH CAROLINA. As pharmacists know, in April 2020 the federal Drug Enforcement Administration (DEA) announced its intent to deschedule Epidiolex (previously a Schedule V controlled substance). On August 21, 2020, the DEA concluded that rulemaking process. Accordingly, under federal law, Epidiolex is no longer a controlled substance — https://www.deadiversion.usdoj.gov/fed_regs/rules/2020/fr0821.htm. But what about under North Carolina law? For now, Epidiolex remains a Schedule V controlled substance under state law.
The organization with authority to schedule or deschedule controlled substances under North Carolina law is NC DHHS’ Commission for Mental Health, Developmental Disabilities, and Substance Abuse Services. G.S. 90-88 states that the Commission may add, delete, or reschedule substances on its own motion or petition of any interested party. G.S. 90-88(d) provides the default:
If any substance is designated, rescheduled or deleted as a controlled substance under federal law, the Commission shall similarly control or cease control of, the substance under this Article unless the Commission objects to such inclusion. The Commission, at its next regularly scheduled meeting that takes place 30 days after publication in the Federal Register of a final order scheduling a substance, shall determine either to adopt a rule to similarly control the substance under this Article or to object to such action. No rule-making notice or hearing as specified by Chapter 150B of the General Statutes is required if the Commission makes a decision to similarly control a substance. However, if the Commission makes a decision to object to adoption of the federal action, it shall initiate rule-making procedures pursuant to Chapter 150B of the General Statutes within 180 days of its decision to object.
With the DEA’s descheduling decision now final, the Commission can now make a decision whether to do the same under North Carolina law. The Commission received a presentation on Epidiolex at its August 27, 2020 meeting — https://files.nc.gov/ncdhhs/documents/files/Commission-for-MHDDSAS-August-2020-Agenda-Final.pdf. The Commission may consider this matter at its November 19, 2020 meeting. *UPDATE* At the Commission’s November 19, 2020 meeting, it considered this matter further but did not take any action. Board staff understands the practical problems – and potential patient access issues – created by this continuing federal/North Carolina scheduling disparity, and staff have communicated those concerns to the Commission. That said, Epidiolex remains a Schedule V controlled substance under the North Carolina Controlled Substances Act. Board staff will provide further updates if and when the Commission takes the matter up again.
THURSDAY, NOVEMBER 19, 2020
BOARD OF PHARMACY WELCOMES INPUT ON SIGNING THE FOOD AND DRUG ADMINISTRATION’S FINAL MEMORANDUM OF UNDERSTANDING ADDRESSING INTERSTATE DISTRIBUTION OF COMPOUNDED HUMAN DRUG PRODUCTS. On October 27, 2020, the FDA published the final version of its “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration” in the Federal Register. State boards of pharmacy have until October 26, 2021 to sign the MOU, after which compounding pharmacies in states that opt not to sign will be subject to the Drug Quality and Security Act’s 5% limitation on the interstate distribution of compounded human drugs. A detailed description of the MOU is found in the Federal Register notice: https://public-inspection.federalregister.gov/2020-23687.pdf
In the coming months, the Board of Pharmacy will decide whether to sign the MOU. The Board welcomes input from pharmacists and pharmacies on that decision.
Board staff asks that commenters specifically consider the following when providing input:
- The terms of the MOU are final, and were fixed after two rounds of public comment in 2015 and 2018 (the Board provided comments each time). Accordingly, suggestions for changes in the terms of the MOU cannot be acted upon. Please provide input on the MOU as it is written.
- The National Association of Boards of Pharmacy is creating an Information Sharing Network that can be used by state boards of pharmacy to satisfy compounding data collection and reporting requirements under the MOU. More information here: https://nabp.pharmacy/members/compounding-pharmacy-information-sharing-project/ If the Board signs the MOU, it is strongly considering joining this Network.
- If the Board signs the MOU, to fulfill the requirements that allow compounding pharmacies to distribute more than 5% of their compounded products interstate, it will need to promulgate a rule requiring reporting of compounding data through the Network (or any other system the Board selects).
The Board would like to hear any thoughts by February 1, 2021 so that it can make a timely decision. All comments should be submitted via electronic mail to firstname.lastname@example.org.
WEDNESDAY, NOVEMBER 18, 2020
IMMUNIZING PHARMACIST CONTINUING EDUCATION REQUIREMENTS UNDER THE US DHHS PREP ACT DECLARATION VERSUS REQUIREMENTS UNDER NORTH CAROLINA LAW. As pharmacists know, the US DHHS has issued declarations under the PREP Act authorizing pharmacists to order and administer ACIP-recommended pediatric vaccines and COVID vaccines: http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf; http://www.ncbop.org/PDF/PREPActCOVIDVaccination090920.pdf
Board staff have received questions about the immunizing pharmacist CE requirements under the federal authorization versus CE requirements under North Carolina law. Under the PREP Act declaration, the licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period (annually in North Carolina). This CE requirement differs somewhat from North Carolina law. North Carolina law requires an immunizing pharmacist to maintain “documentation of three hours of continuing education every two years, designed to maintain competency in the disease states, drugs, and vaccine administration.” G.S. §90-85.3(i1)(3). Any pharmacist exercising authority granted under the PREP Act must slightly increase his/her immunization-related CE and acquire two (2) hours in 2020 and two (2) hours in 2021 (assuming, as is likely, that the federally-declared COVID-19 public health emergency remains in effect into 2021).
More information about this requirement, and several others, is found in the two guidance documents linked above.
WEDNESDAY, NOVEMBER 18, 2020
QUALIFIED PHARMACY TECHNICIANS MAY ADMINISTER ACIP-RECOMMENDED PEDIATRIC VACCINES AND COVID-19 VACCINES UNDER PHARMACIST SUPERVISION REGARDLESS OF WHO ORDERED THE VACCINE. Pharmacists are aware that US DHHS has issued a declaration under the PREP Act authorizing qualified pharmacy technicians to administer ACIP-recommended pediatric vaccines and COVID-19 vaccines under the supervision of a qualified pharmacist: http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf.
Board staff have been asked whether, under the PREP Act declaration, a qualified pharmacy technician may only administer a vaccine that a qualified pharmacist has ordered. The answer is no. The PREP Act declaration permits a qualified pharmacy technician to administer these vaccines under the supervision of a qualified pharmacist. The authority is not conditioned on the identity of the health care provider who ordered or prescribed the vaccine. So long as a valid order for the vaccine exists – by way of pharmacist order, physician order, state-authorized standing order, or other legal order – and the qualified technician is supervised by a pharmacist, the technician may administer the vaccine.
More information about technician authority to administer these vaccines is found in the guidance document linked above.
SUNDAY, NOVEMBER 15, 2020
DEA RELEASES UPDATED VERSION OF ITS PHARMACIST’S MANUAL. The federal Drug Enforcement Administration has released a new version of its Pharmacist’s Manual — https://www.deadiversion.usdoj.gov/pubs/manuals/(DEA-DC-046)(EO-DEA154)_Pharmacist_Manual.pdf The Manual is an extremely valuable resource for pharmacists. In addition to the new version of the Manual, the DEA’s Diversion Control Division website remains a rich resource for information and guidance on the federal Controlled Substances Act — https://www.deadiversion.usdoj.gov/index.html.
FRIDAY, OCTOBER 30, 2020
ATTENTION ALL PHARMACY AND DME PERMIT HOLDERS – NABP E-PROFILE NUMBERS FOR 2021 RENEWAL:
As permit holders know, in July 2020 Board staff advised that, per Board Rule .1615, all pharmacy and DME permit holders would have to obtain and report an NABP e-Profile number as a condition of the 2021 permit renewal. Board staff appreciate permit holders’ diligence in obtaining those numbers. Discussions with permit holders and NABP staff concerning that process, pointed out a path for Board staff to work with NABP on assigning e-Profile numbers for all existing NC pharmacy and DME permit holders that did not already have one (or had reported an invalid e-Profile number). That process has been completed. Any current permit holder may view its e-profile number by accessing the Board’s Licensure Gateway — https://portal.ncbop.org/ — under Facility Management and logging in under the permit. The e-Profile number will display at the top of the permit profile, along with other information about the permit. During the 2021 renewal season (beginning November 1), the permit’s assigned e-profile number will auto populate on the renewal form. If you have any questions/concerns, please contact Missy Betz, Director of Licensing, email@example.com. Note: All applicants for new pharmacy or DME permits will have to obtain an NABP e-profile number. Instructions here: https://nabp.pharmacy/help/i-need-to-create-an-e-profile-for-my-facility-how-do-i-go-about-doing-this/.
FRIDAY, OCTOBER 23, 2020
*UPDATE* COVID-19 DRUG PRESERVATION RULE AND OSELTAMIVIR AND AZITHROMYCIN. As pharmacists know, the Pharmacy, Medical, and Nursing Boards have in place temporary rules to prevent and alleviate potential shortages of drugs during the COVID-19 pandemic. The Board’s current rule may be found here: http://www.ncbop.org/COVID19.html#ERMCDS. As pharmacists also know, the current rule is a temporary one, and a permanent COVID-19 Drug Preservation rulemaking is underway: http://www.ncbop.org/rulemakings.htm.
The proposed permanent rule requested by the Secretary of NCDHHS and the State Health Director removes oseltamivir and azithromycin from the restricted drugs list because the State Health Director has determined that North Carolina is unlikely to suffer future shortages of these drugs because of the COVID-19 pandemic. In light of this determination by the State Health Director, the fact that the proposed rule excludes them (but because of timing issues will not become effective until April 2021), and the onset of cold, flu, and (non-COVID-19) respiratory infection season, Board of Pharmacy staff will exercise discretion and will not enforce provisions of the temporary COVID-19 Drug Preservation Rule as they apply to oseltamivir and azithromycin only. The other provisions of the temporary COVID-19 Drug Preservation Rule will continue to be enforced. The North Carolina Medical Board is taking the same position with respect to the prescriber-side COVID-19 Drug Preservation Rule.
THURSDAY, OCTOBER 22, 2020
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES DECLARATION UNDER PUBLIC READINESS AND EMERGENCY PREPAREDNESS (“PREP”) ACT AUTHORIZING QUALIFIED PHARMACY TECHNICIANS TO ADMINISTER ACIP-RECOMMENDED VACCINES TO PEDIATRIC PATIENTS AND FDA-APPROVED COVID-19 VACCINES TO PATIENTS AGED THREE YEARS AND OLDER DURING THE PUBLIC HEALTH EMERGENCY. On October 21, 2020, USDHHS issued another declaration under the PREP Act authorizing “qualified pharmacy technicians” to administer ACIP-recommended vaccines to patients ages three (3) to eighteen (18) and FDA-approved COVID-19 vaccines to patients ages three (3) years or older under the supervision of a qualified pharmacist. (https://www.hhs.gov/sites/default/files/prep-act-guidance.pdf) Note: This declaration also clarified the ability of qualified pharmacy interns to administer such vaccines, but, for purposes of North Carolina, those clarifications do not change pharmacy intern administration authority as discussed in the two Board guidance documents linked above. Board of Pharmacy guidance on implementing this declaration here: http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf.
For prior guidance on implementing USDHHS declarations authorizing pharmacists to order and administer ACIP-recommended pediatric vaccines and COVID-19 vaccines see there — http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf — and here —
MONDAY, OCTOBER 12, 2020
PHARMACISTS UPDATING THEIR IMMUNIZER STATUS. Many Pharmacists are updating their immunizer status in order to administer vaccines.
Note: A pharmacist who completed an immunization certification course, but has not been administering vaccines does not need to retake the course. The immunizing pharmacist must have a current provider-level CPR certification prior to administering vaccines, must begin obtaining required biennial immunization-specific CE, and must obtain training to participate in North Carolina Immunization Registry as required by the immunizing pharmacist statute.
Here’s how to update the Board that you are a certified vaccinator:
- Log in on the Licensure Gateway page with your username and password
- Once logged in, scroll to the bottom of the page and click on the Pharmacist tile
- On the next page, under License Options, there is a tile for Vaccinator. If it’s white, then that means we don’t have you listed as a vaccinator in our database. If it’s green, then we do have you listed as a vaccinator. To change the color of the box, click on it.
MONDAY, OCTOBER 12, 2020
CANDIDATES FOR THE BOARD’S SOUTHEASTERN DISTRICT ELECTION. The next Board of Pharmacy election is scheduled to begin November 1, 2020. One position on the Board will be filled, the Southeastern District seat.
Seven pharmacists from the Southeastern District submitted petitions to appear on the ballot and they are:
J. Andrew (Andy) Bowman
Robert (Joey) McLaughlin
All pharmacists actively licensed by the Board and living in North Carolina at the time of the election will be eligible to vote. Beginning November 1, pharmacists will simply log in to the Board’s Licensure Gateway and select from the list of candidates.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED DECEMBER 11, 2020.)
SEPTEMBER 17, 2020
ADOPTION OF 21 NCAC 46 .1819 COVID-19 DRUG PRESERVATION RULE
Reasons for Proposed Action: On March 10, 2020, the Governor of North Carolina, by issuing Executive Order No. 116, declared a state of emergency to coordinate a response and enact protective measures to help prevent the spread of COVID-19. COVID-19 is respiratory disease that can result in serious illness or death. COVID-19, previously unidentified in humans, spreads easily from person to person. Once an outbreak of COVID-19 begins, it is difficult to contain. The World Health Organization, the Center for Disease Control and Prevention, and the United States Department of Health and Human Services have declared COVID-19 a public health threat and emergency. The search for potential treatments for COVID-19 has caused shortages and threatens to cause further shortages in certain drugs. On March 24, 2020, the North Carolina State Health Director requested that the Medical Board, the Board of Nursing and the Board of Pharmacy adopt the COVID-19 Drug Preservation Rule in order to alleviate shortages and ensure that these drugs are available to patients who need them. This rule was adopted as an emergency and then a temporary rule. The State Health Director has requested that the rule be adopted as a permanent rule because the state of emergency and corresponding potential drug shortages now may potentially extend beyond the expiration of the temporary rule. The Board intends to repeal the rule upon the conclusion of the state of emergency. The State Health Director has determined that the State is unlikely to suffer future shortages of two of the drugs previously listed in the temporary and emergency rule, and that those drugs may be removed from the list, while the others should remain.
A public hearing will be held on December 16, 2020 at 10:00am by video/teleconference. The public can participate on Teams at https://tinyurl.com/y27ovmlt, or may call 336-604-5350, conference ID 755 889 266#.
Any person may object to the proposed amendments by attending the public hearing on December 16, 2020 and/or by submitting a written objection by 12:00PM (noon) on December 17, 2020 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 firstname.lastname@example.org.
The North Carolina Board of Pharmacy is interested in all comments pertaining to the proposed rules and rule changes. All persons interested and potentially affected by the proposals are strongly encouraged to read this entire notice and make comments on the proposed rules. If an objection is not resolved prior to the adoption of the rules, 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 facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.
TUESDAY, SEPTEMBER 15, 2020
EMERGENCY AUTHORIZATION FOR OUT-OF-STATE PHARMACISTS AND OUT-OF-STATE CERTIFIED TECHNICIANS TO PRACTICE IN NORTH CAROLINA SUNSETS ON DECEMBER 31, 2020. On March 10, 2020, the Board of Pharmacy activated an emergency services waiver that authorized a pharmacist or nationally-certified pharmacy technician who has a license or registration in good standing in another state to practice in North Carolina without being licensed or registered by this Board. The waiver was made operational through the National Association of Boards of Pharmacy Passport program. The Board has determined that the waiver is no longer required to ensure the provision of pharmacy services in North Carolina. Accordingly, the waiver will sunset on December 31, 2020. Any out-of-state pharmacist or pharmacy technician who is providing services in North Carolina pursuant to this waiver, and who wishes to continue doing so after December 31, 2020, must obtain a North Carolina license to practice pharmacy or North Carolina technician registration. More information on the license/registration application process found here, http://www.ncbop.org/pharmacists_forms.htm, and here, http://www.ncbop.org/technicians_forms.htm.
THURSDAY, SEPTEMBER 10, 2020
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES DECLARATION UNDER PUBLIC READINESS AND EMERGENCY PREPAREDNESS (“PREP”) ACT AUTHORIZING PHARMACISTS TO ORDER AND ADMINISTER COVID-19 VACCINES TO PATIENTS AGED THREE YEARS AND OLDER DURING THE PUBLIC HEALTH EMERGENCY. On September 9, 2020 the U.S. Department of Health and Human Services issued a declaration (https://www.hhs.gov/sites/default/files/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf) authorizing pharmacists “to order and administer,” and a “supervised pharmacy intern acting under the supervision of [a] qualified pharmacist” “to administer” FDA-approved COVID-19 vaccines, when available, to patients ages three (3) years or older during the federally-declared public health emergency. This update describes the conditions under which pharmacists and pharmacy interns may exercise that authority, and how these conditions differ from existing North Carolina law: http://www.ncbop.org/PDF/PREPActCOVIDVaccination090920.pdf.
WEDNESDAY, AUGUST 26, 2020
PHARMACISTS EXERCISING U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES-GRANTED AUTHORITY TO ORDER AND ADMINISTER PEDIATRIC VACCINES. As detailed in the August 20, 2020 Board of Pharmacy update, the U.S. Department of Health and Human Services issued a declaration under the PREP Act authorizing pharmacists to order and administer certain vaccines to patients ages three (3) to eighteen (18). More detail about that grant of authority and its intersection with North Carolina law is found here: http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf. Some pharmacists have asked, when ordering and administering vaccines under this grant of authority, who the documented prescriber should be. The answer is the pharmacist exercising this authority. Again, HHS authorized pharmacists to order and administer these vaccines, notwithstanding any state law to the contrary.
THURSDAY, AUGUST 20, 2020
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES DECLARATION UNDER PUBLIC READINESS AND EMERGENCY PREPAREDNESS (“PREP”) ACT AUTHORIZING PHARMACISTS TO ORDER AND ADMINISTER VACCINES TO PATIENTS AGED THREE THROUGH 18 YEARS DURING THE COVID-19 HEALTH EMERGENCY. On August 19, 2020 the U.S. Department of Health and Human Services issued a declaration (https://www.hhs.gov/sites/default/files/third-amendment-declaration.pdf) authorizing pharmacists “to order and administer,” and a “supervised pharmacy intern” “to administer” certain vaccines to patients ages three (3) to eighteen (18) during the federally-declared COVID-19 public health emergency. The purpose of this declaration is to mitigate a potential “decrease in rates of routine childhood vaccinations . . . due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.” This update describes the conditions under which pharmacists and pharmacy interns may exercise that authority, and how these conditions differ from existing North Carolina law: http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf.
TUESDAY, AUGUST 11, 2020
FDA UPDATES TEMPORARY POLICIES FOR COMPOUNDING OF ALCOHOL-BASED HAND SANITIZER PRODUCTS. FDA has issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products.
FDA has updated its guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP).
Any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohol’s source.
The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities.
The updated guidances also include an additional denaturant formula. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Consumer and health care personnel safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, especially as we seek to facilitate an increase in the supply of hand sanitizer.
Additionally, with a recommendation from the agency, the United States Pharmacopeia (USP) issued a notice of intent to revise alcohol monographs to include a Limit of Methanol test in the identification (ID) section.
For questions, contact FDA at COVID-19-Hand-Sanitizers@fda.hhs.gov.
MONDAY, AUGUST 3, 2020
NOTICE CONCERNING TRANSFER OF OWNERSHIP APPLICATIONS
Board Rule 21 NCAC 46.1603 provides:
A new pharmacy, device, or medical equipment permit is required for a new location, if there is a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 percent interest in the permit holder, or any entity in the chain of ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of this Section. A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit or any nonprofit corporation in the chain of ownership above the permit holder.
This means, if a change of ownership requiring a new permit occurs – and the pharmacy has not obtained the new permit by the effective date of the transfer of ownership – the previous permit becomes void (i.e. no longer active) as of the effective date of the transfer of ownership.
Any permit subsequently acquired would not operate retroactively. It will operate from the date of issue forward. That means that an untimely transfer of ownership would result in a pharmacy operating without a permit for a period of time, which could result in Board action for unlicensed practice of pharmacy and other collateral consequences.
Transfer of ownership permit applicants must note that a new owner of a pharmacy may not operate using an old permit under a “power of attorney” or similar.
To facilitate an orderly transfer, permit applications must be filed well in advance (6-8 weeks) of the planned transaction And, of course, permit applications proceed most quickly when they are complete, correct, and the applicant pharmacist-manager responds quickly to requests for information from Board staff. The applicant pharmacist-manager needs to monitor the permit application status and keep Board staff apprised of any changes to the transaction date. Failure to do these things can lead to significant delays in permit review and, as noted above, transferring ownership prior to a new permit’s issuance voids the existing permit.
FRIDAY, JULY 31, 2020
*UPDATED* ATTENTION ALL PERMIT HOLDERS – NABP E-PROFILE NUMBER REQUIRED FOR 2021 RENEWAL. Board Rule .1615 (found here) requires all pharmacy and DME permit applicants and holders to obtain and report an e-Profile number issued by the National Association of Boards of Pharmacy (NABP) as a condition of permit issuance or renewal.
When the 2021 permit renewal period opens on November 1, 2020, all pharmacy and DME permits will be required to provide their business e-Profile number on the renewal application. If a business e-Profile number is not provided, the pharmacy or DME facility will be unable to complete the renewal process.
Pharmacies and DME facilities may obtain an e-Profile number without cost. Directions for doing so are found here.
Board staff strongly encourage all pharmacies and DME facilities that do not already have a business e-Profile number to obtain one now to avoid delays during the permit renewal process.
Once you have obtained an NABP business e-Profile number for your pharmacy or DME facility, you may immediately add it to your facility’s Board profile by logging in to the Board’s Licensure Gateway — https://portal.ncbop.org/ — under ”Facility Management” and clicking on the blue “gear”. Board staff recommend that you add the e-Profile number to your facility’s profile before the renewal period opens on November 1, 2020.
Troubleshooting. A few pharmacists have reached out to the Board and are experiencing technical difficulties obtaining a business e-Profile number from NABP. The issue seems to arise when a pharmacist uses the same computer, browser, and email address that the pharmacist uses to access their personal e-Profile number. NABP staff have identified that the cookies/cached information of the personal e-Profile log-in as creating the problem. NABP staff recommend the following steps prior to creating a business e-Profile:
- Clear the cookies/cache on your current internet browser
- Use a different internet browser (Google Chrome and Firefox are preferable)
- Create the business e-profile number with a different email address than the one used for your personal e-profile number
If problems persist with business e-Profile creation, please contact NABP’s Accreditation and Inspection staff at 847-391-4539 for assistance.
THURSDAY, JULY 16, 2020
FDA ADDS DEXAMETHASONE SODIUM PHOSPHATE TO LIST OF DRUGS THAT MAY BE COMPOUNDED TEMPORARILY DURING THE COVID-19 PANDEMIC. The federal Food and Drug Administration has added dexamethasone sodium phosphate to the lists of drugs for temporary compounding by outsourcing facilities and pharmacies during the COVID-19 public health emergency. These updates help address shortages and access concerns affecting some drugs urgently needed for hospitalized COVID-19 patients. The updated lists are referenced in the following guidances:
The guidance for temporary compounding of certain drugs by outsourcing facilities during the COVID-19 public health emergency includes timely product reporting by outsourcing facilities compounding drugs covered by the guidance. Hospitals can use this information, which FDA posts on its website, to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19.
TUESDAY, JULY 14, 2020
PHARMACIES MAY NOT MAKE CLAIMS THAT SUPPLEMENTS OR OTHER PRODUCTS TREAT COVID-19 OR PROMOTE “IMMUNITY” TO COVID-19. Board staff have been made aware of a handful of instances of pharmacies bundling dietary supplements and other products and marketing them as a treatment for COVID-19 or as a means of conferring or enhancing immunity to COVID-19. Pharmacists are reminded that under both the federal and North Carolina Food Drug & Cosmetic Acts, any product that is marketed to prevent, mitigate, diagnose, treat or cure a disease is a “drug.” Marketing products as a treatment for COVID-19, or as something that will mitigate COVID-19 infection, would make the product marketed an unapproved drug whose sale is prohibited under state and federal law. Such claims would subject a pharmacy and pharmacist to potential action by the Board of Pharmacy, the Food and Drug Administration, and other law enforcement agencies.
TUESDAY, JULY 7, 2020
NC DHHS ISSUES STATEWIDE STANDING ORDER FOR DIAGNOSTIC COVID-19 TESTING. State Health Director Dr. Betsey Tilson has issued a statewide standing order for COVID-19 diagnostic testing, found here: Statewide Standing Order for Diagnostic COVID-19 Testing. Under North Carolina law and the federal CARES Act, pharmacists already have authority to order COVID-19 diagnostic tests, but Dr. Tilson’s order may prove helpful in expediting testing.
Dr. Tilson has also issued a temporary order and associated guidance that, among other things, requires all healthcare providers ordering or conducting COVID-19 diagnostic tests to report all results, positive or negative. That order is found here: State Health Director Temporary Order. The associated guidance is found here: Guidance for reporting.
Finally, NC DHHS has issued patient guidance for isolation and quarantine while waiting for, and after receiving, COVID-19 diagnostic testing results: Isolation and Quarantine. The patient guidance document is also available in Spanish.
Pharmacists ordering or administering COVID-19 diagnostic tests should review these documents. These resources, and many others, are found at the NC DHHS COVID-19 Response web page.
TUESDAY, JUNE 30, 2020
MILITARY-TRAINED PHARMACIST OR PHARMACY TECHNICIAN? PHARMACIST OR PHARMACY TECHNICIAN SPOUSE OF AN ACTIVE DUTY MEMBER OF THE ARMED FORCES? A qualifying military-trained or military-spouse pharmacist license or pharmacy technician applicant is exempt from the initial application fee. These FAQs give more detail: http://www.ncbop.org/faqs/MilitaryFeeWaiverFAQs.pdf.
MONDAY, JUNE 22, 2020
NC DHHS WEEKLY COVID-19 COLLECTION, TESTING, AND PROCESSING CAPACITY SURVEY. Each week, the North Carolina Department of Health and Human Services and the State’s COVID-19 Test Surge Workgroup will assess North Carolina’s COVID-19 collection, testing, and processing capacity. Every Monday a survey will be distributed to stakeholders engaged in these activities across the State and should take ten to fifteen minutes to complete. See more…
TUESDAY, JUNE 16, 2020
LIVE CONTINUING EDUCATION IN THE TIME OF COVID. As pharmacists know, Board Rule .2201 requires fifteen hours of continuing pharmacy education each year as a condition of licensure renewal. Five (5) of those hours must be live. Board staff have fielded occasional calls from pharmacists concerned about this requirement in the time of COVID. Pharmacists are reminded that the Board has always accepted remote continuing education as live if it is, in fact, live and allows attendees to participate in real time: http://www.ncbop.org/faqs/Pharmacist/faq_InternetCE.htm. These types of CE programs are widely, and readily, available. See more…
TUESDAY, JUNE 16, 2020
BOARD ISSUES WAIVER AND CLARIFICATION CONCERNING PHARMACY INTERN STATUS FOR 2020 PHARMACY SCHOOL GRADUATES. Today, exercising authority granted by G.S. 90-85.25, the Board of Pharmacy waived — for 2020 graduates of an ACPE-approved school of pharmacy who have applied for licensure in North Carolina — language limiting status as a “pharmacy intern” to students “enrolled in approved academic internship programs.” The waiver ensures that 2020 pharmacy school graduates retain intern status — and therefore the ability to perform all acts constituting the practice of pharmacy while under supervision by a North Carolina licensed pharmacist — through the end of the year while completing the licensure process. The waiver also clarifies the meaning of “under supervision.” The full waiver is found here.
THURSDAY, JUNE 11, 2020
BOARD OF PHARMACY WELCOMES NEW PUBLIC MEMBER MISCHELLE JOHNSON CORBIN. The Board is pleased to announce that Governor Cooper has appointed Mischelle Johnson Corbin to a five-year term as the Board’s public member. Ms. Corbin is a graduate of South Carolina State University in Orangeburg, SC where she represented her school as a student-athlete; playing for the conference champion women’s tennis team. She earned a Bachelor of Science Degree in Computer Science and worked for the State of North Carolina, Department of Cultural Resources as a programmer for a year. See more…
TUESDAY, JUNE 9, 2020
NC DHHS UPDATES PROVIDER GUIDANCE ON COVID-19 TESTING. NC DHHS today released updated provider guidance on COVID-19 testing (which replaces the May 15 guidance document). This updated guidance comes as community transmission of COVID-19 has increased as Phase 2 easing has led to more opportunities for transmission. More information found here.
THURSDAY, JUNE 4, 2020
FDA ALERTS HEALTH CARE PROFESSIONALS TO THE TEMPORARY ABSENCE OF WARNING STATEMENT ON THE VIAL CAPS OF TWO NEUROMUSCULAR BLOCKING AGENTS. Follow this link for a listing of the drugs affected, example images of the caps, and additional information and resources.
MONDAY, JUNE 1, 2020
NC DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES REQUEST FOR QUALIFICATIONS FROM VENDORS TO PROVIDE COVID-19 TESTING AND CONTACT TRACING. NCDHHS is seeking to create a pool of qualified vendors to support the response to COVID-19 by providing diagnostic and antibody testing including specimen collection and laboratory processing, and contact tracing. See more…
WEDNESDAY, MAY 6, 2020
COVID-19 RECOVERY ACT AND IDENTIFICATION FOR CONTROLLED SUBSTANCE DISPENSING. The General Assembly passed, and Governor Cooper signed into law, the COVID-19 Recovery Act on Monday, May 4, 2020. Among many other things, this statute “extend[s] for a period of five months the validity of [a drivers license] that expired on or after March 1, 2020, and before August 1, 2020. A [drivers license] extended under this section shall expire five months from the date it otherwise expires . . . .” See more…
MONDAY, MAY 4, 2020
IMPORTANT INFORMATION FOR CANDIDATES FOR PHARMACIST LICENSURE BY EXAMINATION. During the declared state of emergency to respond to the COVID-19 pandemic, the North Carolina Board of Pharmacy will not require licensure by exam applicants to submit a Certificate of Graduation with an affixed school seal. Moreover, licensure by exam applicants may submit the certificate of graduation electronically, by uploading it to their application through the BOP Portal. Applicants with questions about this process should contact Board licensing staff.
MONDAY, MAY 4, 2020
FDA CLARIFIES THAT NO COVID-19 ANTIBODY TESTS HAVE BEEN AUTHORIZED FOR ADMINISTRATION AT THE POINT-OF-CARE OR IN CLIA-WAIVED LABORATORIES . Today (May 4, 2020), the FDA announced revisions to its March 16, 2020 policy concerning COVID-19 antibody tests. As many pharmacists know, on March 16, the FDA announced a policy of “not objecting” to the introduction of certain COVID-19 antibody tests into the market prior to FDA review of those tests. Since that time, “FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH.” Accordingly, FDA has clarified its guidance. See more…
TUESDAY, APRIL 28, 2020 – CAROLINA COMMUNITY TRACING COLLABORATIVE FORMED
NCDHHS announces the formation of the Carolina Community Tracing Collaborative, a new partnership with Community Care of North Carolina and the North Carolina Area Health Education Centers to expand contact tracing.
Contact tracing is the process of supporting patients and notifying contacts of exposure in order to stop chains of transmission. Our local health departments are North Carolina’s experts in this essential detective work. The new Collaborative will hire and train staff that will support local health department’s contact tracing efforts. This will allow North Carolina to meet the goal of doubling the number of contact tracers. See more…
*UPDATED JUNE 9, 2020*
WEDNESDAY, APRIL 22, 2020
CDC UPDATES COVID-19 TRANSMISSION PREVENTION GUIDANCE FOR PHARMACIES. The CDC has updated its guidance (most recently May 28, 2020) for pharmacies to mitigate COVID-19 transmission risks. Key take-aways:
- Everyone entering the pharmacy should wear a face covering, regardless of symptoms. Cloth face coverings should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the mask without assistance.
- Pharmacists and pharmacy technicians should always wear a facemask while they are in the pharmacy for source control.
- Pharmacy personnel with fever or other symptoms of COVID-19 should stay home until they have recovered.
- Exercise caution with all patient contact activities. Encourage electronic or telephonic transmission of prescription orders; avoid touching objects handled by patients where possible.
- If conducting COVID-19 testing, coordinate with local and state public health staff to operationalize and prioritize patient testing. Ensure appropriate training of personnel and provide personnel with appropriate PPE.
- Approach administration of adult vaccinations based on local conditions and using the FDA’s Framework for Healthcare Systems Providing Non-COVID-19 Clinical Care During the COVID-19 Pandemic.
- Special considerations for clinics that are co-located in pharmacies.
The full guidance document is found here: https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html
Pharmacist-managers are reminded:
BOARD ISSUES ADDITIONAL GUIDANCE TO PHARMACIST-MANAGERS TAKING IN-PHARMACY MEASURES TO REDUCE THE RISK OF COVID-19 TRANSMISSION. North Carolina law requires that a pharmacy, among other things, be “kept in a clean, orderly, and sanitary condition.” 21 NCAC 46.1601. “Sanitary” conditions plainly include conditions sufficient to minimize the risk of transmission of communicable disease within a pharmacy.
Under North Carolina law, the pharmacist-manager is the person to whom the Board issues a pharmacy permit (NCGS 90-85.21) and is, therefore, “the person who accepts responsibility for the operation of a pharmacy in conformance with all statutes and rules pertinent to the practice of pharmacy.” 21 NCAC 46.1317(27).
The Board’s Expanded Emergency Services Waiver issued on March 17, 2020 stated, in part:
The Board strongly supports efforts by pharmacies and pharmacists to adjust work flows and processes within a pharmacy to reduce the risk of person-to-person coronavirus transmission. Such efforts might include, but are not limited to: not physically handling patient identifications at the point of dispensing; not requiring a physical signature for pick-up of a prescription; increasing use of prescription delivery service; limiting the number of patients physically entering a pharmacy; enforcing social distancing within a pharmacy.
The Board emphasizes that the pharmacist-manager is the person authorized by law to ensure compliance with these standards. Improper interference with a pharmacist-manager’s carrying out these duties and responsibilities subjects a pharmacy permit to potential disciplinary action, up to and including revocation. Likewise, a person licensed by, or registered with, the Board who improperly interferes with a pharmacist-manager’s carrying out these duties and responsibilities is subject to potential disciplinary action, up to and including revocation.
WEDNESDAY, APRIL 22, 2020
LICENSEES AND REGISTRANTS MAY DONATE TO THE L. STANLEY HAYWOOD RECOVERY FUND.
The NC Board of Pharmacy and the NC Professionals Health Program (NCPHP) established the L. Stanley Haywood Recovery Fund in April 2018. The Fund provides financial support to qualifying pharmacists and pharmacy personnel in need of substance use assessment, treatment, and monitoring services. Stan Haywood, who passed away in May 2018, served for thirteen years as a member of the Board of Pharmacy and well understood the public health toll of untreated substance use disorders. He championed proactive efforts to lessen this toll, including his spearheading the Fund’s creation.
In coordination with NCPHP, Board staff have created a way for individuals licensed or registered with the NC Board of Pharmacy to contribute to this Fund at any time and in any amount. Simply log in to the Board’s Licensure Gateway and select the blue tile labeled Donate to Stan Haywood Recovery Fund to be taken directly to NCPHP’s donation site.
TUESDAY, APRIL 21, 2020
CDC ISSUES GUIDANCE ON SPOTTING COUNTERFEIT RESPIRATORY PROTECTION EQUIPMENT. As pharmacists are well aware, acquiring adequate PPE during this pandemic is a challenge. See more…
TUESDAY, APRIL 21, 2020
FDA ISSUES TEMPORARY POLICY FOR COMPOUNDING OF CERTAIN DRUGS FOR HOSPITALIZED PATIENTS BY PHARMACY COMPOUNDERS NOT REGISTERED AS OUTSOURCING FACILITIES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. The FDA has issued a guidance explaining a temporary policy regarding state-licensed pharmacies and federal facilities compounding certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance helps address reported issues with accessing certain FDA-approved drugs used for hospitalized patients with COVID-19. See more…
THURSDAY, APRIL 16, 2020
USP ISSUES OPERATIONAL CONSIDERATIONS FOR STERILE COMPOUNDING DURING COVID-19 PANDEMIC. USP has issued guidance for sterile compounders during the COVID-19 pandemic designed to mitigate potential supply disruptions and shortages of drug products. The guidance focuses on assignment of beyond-use dates (BUDs), certification and recertification matters, and cleaning and disinfecting matters. The guidance is found here.
Board staff have updated the overall BOP COVID-19 compounding guidance document to incorporate the latest USP guidance.
WEDNESDAY, APRIL 15, 2020
WHAT SHOULD PHARMACIES DO IF THEY SUSPECT THAT A SUPPLIER IS PRICE GOUGING? Board staff have received messages from some pharmacists concerned about offers for sale of medication or supplies (including, especially, personal protective equipment (PPE)) at prices that beggar belief. See more…
THURSDAY, APRIL 9, 2020
GOVERNOR COOPER ISSUES EXECUTIVE ORDER THAT PLACES OCCUPANCY LIMITATIONS ON RETAIL ESTABLISHMENTS — INCLUDING PHARMACIES. Governor Cooper today issued Executive Order 131 as part of the state’s continuing response to the COVID-19 pandemic. An FAQ summarizing the order is available here.
*UPDATED JUNE 9, 2020*
THURSDAY, APRIL 9, 2020
FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES GUIDANCE FOR PHARMACISTS TO ORDER AND ADMINISTER COVID-19 TESTS. HHS’ Office of the Assistant Secretary for Health has issued guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to order and administer COVID-19 tests including serology tests that FDA has authorized: https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf Some questions likely to arise:
1. What COVID-19 tests has FDA authorized? FDA has authorized certain in vitro diagnostics for detection and/or diagnosis of COVID-19. More information is found here: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
2. Does North Carolina law prohibit a pharmacist from ordering and administering COVID-19 tests as authorized by HHS? No. As long reported by Board staff, North Carolina law does not prevent pharmacists practicing from administering CLIA-waived tests (http://www.ncbop.org/faqs/Pharmacist/faq_CLIAwaivedTests.htm) A COVID-19 test that has received an emergency use authorization (EUA) for use by health care providers at the point of care is deemed to be a CLIA-waived test and “for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver or Certificate of Compliance.” https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#5e81a899c3e46
3. (Updated June 9, 2020): Who should receive COVID-19 tests under this authorization? HHS’ guidance reminds all health care providers that Priority 1 for testing is hospitalized patients and healthcare facility workers with symptoms. Priority 2 for testing are symptomatic patients in long-term facilities; symptomatic patients over age 65; symptomatic patients with underlying health conditions; and symptomatic first responders. Priority 3 for is testing individuals in the surrounding community of rapidly increasing hospital cases to decrease community spread and ensure health of essential workers — symptomatic critical infrastructure patients; other symptomatic individuals; healthcare facility workers and first responders; mildly symptomatic individuals in communities experiencing high numbers of COVID-19 hospitalizations. Asymptomatic individuals are a non-priority. More information is found here: https://www.cdc.gov/coronavirus/2019-ncov/downloads/priority-testing-patients.pdf.
NC DHHS’ most recent provider guidance on COVID-19 testing is found here (updated June 9, 2020.)
Critical to appropriate management of the pandemic is consistency in the who, what, when, where, and how of testing among health care providers. Pharmacists must follow NC DHHS guidance and policies, and should frequently check NC DHHS’ COVID-19 resource page for updates: https://www.ncdhhs.gov/divisions/public-health/covid19/covid-19-guidance.
4. To whom should a pharmacist administering COVID-19 tests report results? Pharmacists must report COVID-19 test results to the patient and the patient’s health care provider. Board staff will update this FAQ with any additional reporting requirements from DHHS or other public health authorities.
5. What precautions must a pharmacist administering COVID-19 tests take? As is true for any health care worker, pharmacists administering COVID-19 tests must use “appropriate combinations of engineering and administrative controls, safe work practices, and personal protective equipment (PPE) to prevent worker exposures.” More information is found here: https://files.nc.gov/ncdhhs/documents/files/covid-19/NC-DPH-Respiratory-Protection-Guidance-March-2020.pdf and here: https://www.osha.gov/SLTC/covid-19/controlprevention.html
Furthermore, pharmacists-managers are reminded of their authority and responsibility to manage infection transmission risk in a pharmacy: http://www.ncbop.org/COVID19.html#BOPWGD
* * *
Pharmacists are encouraged to return to this guidance periodically, as it is a potentially fast-changing area.
THURSDAY, APRIL 2, 2020
FDA REQUESTS REMOVAL OF ALL RANITIDINE (ZANTAC) PRODUCTS FROM THE MARKET. On March 1, 2020, the FDA announced a request that manufacturers withdraw all prescription and OTC ranitidine products from the market immediately. FDA has determined that NDMA contaminant in some ranitidine products increases when the products are stored at higher than room temperatures, potentially exposing consumers to unacceptable levels. As a result of this withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the United States. More information here: https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
MONDAY, MARCH 30, 2020
MUTUAL DRUG COMPILING A LIST OF PHARMACISTS AND PHARMACY PERSONNEL TO ASSIST SHORT-STAFFED PHARMACIES DURING STATE OF EMERGENCY. To mitigate any possible pharmacy staffing shortages during the COVID-19 outbreak, Mutual Drug is compiling a list of pharmacists, technicians, delivery drivers, and other pharmacy personnel who may be able to assist if a pharmacy becomes short-staffed. Please note that this resource will be made available to all pharmacies who may have a need. If you are willing to step in to assist a local pharmacy please complete the form below. Please contact Patrick Brown with any questions at email@example.com or 919-598-4970.
FRIDAY, MARCH 27, 2020
BOARD ANNOUNCES NEW PROCESS FOR OUT-OF-STATE PHARMACISTS AND OUT-OF-STATE CERTIFIED TECHNICIANS TO OBTAIN AUTHORIZATION TO PRACTICE IN NORTH CAROLINA DURING THE DECLARED STATE OF EMERGENCY. When Governor Cooper declared a state-wide emergency on March 10, 2020 to coordinate response to the COVID-19, that triggered operation of the Board’s Emergency Services Waiver. The Emergency Services Waiver allows a pharmacist or nationally-certified technician who has a license and registration in good standing in another state to practice in North Carolina during the declared emergency without being licensed or registered with the Board, provided the pharmacist and pharmacist-technician is pre-cleared to do so.
Effective immediately, out-of-state pharmacists and out-of-state certified technicians who wish to practice in North Carolina during the declared state of emergency must obtain an NABP Passport to do so. See more…
THURSDAY, MARCH 26, 2020
BOARD STAFF UPDATES GUIDANCE ON HAND SANITIZER PREPARATION. Recognizing dwindling availability of USP-grade alcohol to prepare hand sanitizer, the United States Pharmacopeia has updated its guidance to pharmacies with best practices on substitution. FDA has also issued guidance to industry on ethanol manufacturing for inclusion in hand sanitizer products (found here.) Board staff updated its garb- and sanitizer shortage document to reflect the new USP and FDA guidance. The updated guidance is found here.
TUESDAY, MARCH 24, 2020
STATEWIDE SHELTER-IN-PLACE ORDER EFFECTIVE MONDAY, MARCH 30, 5 PM. Governor Cooper has announced a state-wide shelter-in-place order that takes effect Monday, March 30, at 5 pm. The Order permits pharmacies to remain open as essential businesses. The Order does not require employees of an essential business to have documentation to report to work under the Order. See this FAQ on the Order.
COVID-19 PANDEMIC UPDATES: TEMPORARY PHARMACY CLOSURES AND RELOCATIONS. Follow this link for updates on North Carolina pharmacies temporarily closing or relocating their operations as part of COVID-19 emergency plans. Updated 6/5/20.
TUESDAY, MARCH 24, 2020
BOARD PASSES EMERGENCY RULES TO MITIGATE CERTAIN DRUG SHORTAGES. On March 10, 2020, the Governor of North Carolina, by issuing Executive Order No. 116, declared a state of emergency to coordinate a response and enact protective measures to help prevent the spread of COVID-19. COVID-19 is respiratory disease that can result in serious illness or death. The search for potential treatments for COVID-19 has caused shortages and threatens to cause further shortages in certain drugs. On March 24, 2020, the North Carolina Secretary of Health and Human Services and the State Health Director requested that the Medical Board and the Board of Pharmacy adopt the COVID-19 Drug Preservation Rule in order to alleviate shortages and ensure that these drugs are available to patients who need them. The Pharmacy Board’s emergency rule is found here.
TUESDAY, MARCH 24, 2020
BOARD ISSUES ADDITIONAL GUIDANCE TO PHARMACIST-MANAGERS TAKING IN-PHARMACY MEASURES TO REDUCE THE RISK OF COVID-19 TRANSMISSION. North Carolina law requires that a pharmacy, among other things, be “kept in a clean, orderly, and sanitary condition.” 21 NCAC 46.1601. “Sanitary” conditions plainly include conditions sufficient to minimize the risk of transmission of communicable disease within a pharmacy. See more…
MONDAY, MARCH 23, 2020
PRESCRIPTIONS FOR HYDROXYCHLOROQUINE, CHLOROQUINE, AZITHROMYCIN, KALETRA, AND OTHER MEDICATIONS. Board staff and public health officials at the North Carolina Department of Health and Human Services are aware of numerous reports from pharmacists across the state concerning new prescriptions for hydroxychloroquine, chloroquine, azithromycin, Kaletra, and potentially other medications – often in large quantities with a high number of refills — to respond to the COVID-19 pandemic. Reports include these prescriptions being issued by prescribers for themselves and family members, and for persons who have not been exposed to or infected by the COVID-19 virus. See more…
MONDAY, MARCH 23, 2020
FDA ISSUES GUIDANCE CONCERNING REMS REQUIREMENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. The Food and Drug Administration (FDA) has issued guidance to health care professionals concerning REMS adherence during the COVID-19 public health emergency. See more…
FRIDAY, MARCH 20, 2020
NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES CALLS FOR HEALTH CARE VOLUNTEERS. DHHS Secretary Mandy Cohen issued this call for volunteers today (March 20, 2020):
As you know we are facing an unprecedented crisis from COVID-19 that has already had devastating consequences internationally. With the virus now spreading in North Carolina, we need to bolster our health care system to ensure we can care for those impacted by the virus. A crucial component is recruiting volunteers to supplement our health care workforce. I am writing today to ask you to register as a volunteer. See more…
FRIDAY, MARCH 20, 2020
UPDATE ON TEMPORARY REACTIVATION OF LICENSE TO PRACTICE PHARMACY. Exercising its authority under NCGS 90-95.15(a) to waive provisions of the Pharmacy Practice Act and regulations during a declared emergency, the Board has created a pathway for the temporary reactivation of certain pharmacist licenses to provide patient care during the state of emergency. See more…
FRIDAY, MARCH 20, 2020
DRUG ENFORCEMENT ADMINISTRATION (DEA) POSTS COVID-19 RESPONSE GUIDANCE TO HEALTH CARE PRACTITIONERS. DEA has issued the following statement and guidance information to practitioners:
The mission of Drug Enforcement Administrations (DEA), Diversion Control Division is to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs. See more…
THURSDAY, MARCH 19, 2020
STATE EPIDEMIOLOGIST ASSESSES THAT COMMUNITY TRANSMISSION OF COVID-19 IS OCCURRING IN COMMUNITIES ACROSS NORTH CAROLINA: RECOMMENDATIONS FOR PHARMACIES. State Epidemiologist Zack Moore has issued a bulletin assessing that community transmission of COVID-19 is now occurring in communities across North Carolina. Dr. Moore recommends that practices and healthcare facilities consider this latest assessment in implementing response plans to limit risks of person-to-person transmission. See more…
TUESDAY, MARCH 17, 2020
BOARD OF PHARMACY EXPANDS EMERGENCY SERVICES WAIVER TO ADDRESS USE OF REMOTE OPERATIONS AND ALTERATIONS TO IN-PHARMACY WORKFLOWS. Today (March 17, 2020), the Board of Pharmacy expanded its Emergency Services Waiver to authorize the use of certain remote operations as means of reducing the risk of person-to-person coronavirus transmission and to preserve pharmacists’ ability to provide patient care. The expanded waiver also provides support and encouragement for pharmacies seeking to adjust work flows and processes within a pharmacy to reduce the risk of person-to-person coronavirus transmission.
The expanded Emergency Services Waiver is found here.
The baseline Emergency Services Waiver is found here.
GOVERNOR COOPER DECLARES STATE OF EMERGENCY TO COORDINATE RESPONSE AND PROTECTIVE ACTIONS TO PREVENT THE SPREAD OF COVID-19. On March 10, 2020, Governor Cooper declared a state-wide state of emergency to coordinate response to the COVID-19 (coronavirus) outbreak: http://www.ncbop.org/PDF/NCEO116StateOfEmergencyCOVID19_031020.pdf.
As a result of Governor’s declaration and the specific recommendations for Triangle-area businesses and organizations from the North Carolina Department of Health and Human Services, the Board of Pharmacy’s Tuesday, March 17, meeting will be held by teleconference. The meeting will be largely informational. The Board of Pharmacy office will not be open to the public on March 17. *SEE BELOW FOR DIAL-IN INSTRUCTIONS. All agenda items requiring a personal appearance before the Board will be rescheduled for a later meeting.
The Governor’s emergency declaration also triggers operation of the Board’s Emergency Services Waiver order: http://www.ncbop.org/PDF/NCBOPEmergencyServicesWaiver.pdf. That waiver speaks specifically to pharmacists and nationally-certified technicians who are not licensed in North Carolina providing services in North Carolina during the declared emergency and to pharmacies that need to temporarily relocate as a result of the declared emergency. All pharmacists are encouraged to review the waiver.
Board staff will continue to update the pharmacy community as necessary.
CDC situation summary and FAQs may be found here: https://www.cdc.gov/coronavirus/2019-ncov/index.html.
Interim guidance for healthcare professionals: https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html.
SUNDAY, MARCH 15, 2020
Information for providers from Wake County Medical Director, Dr. Kim McDonald regarding recognizing and testing patients for COVID-19. Memo with important information for providers and links to other resources; and FAQs available here.
SATURDAY, MARCH 14, 2020
FDA ISSUES GUIDANCE TO INDUSTRY ON PREPARATION OF ALCOHOL-BASED HAND SANITIZER PRODUCTS DURING THE PUBLIC HEALTH EMERGENCY. The federal Food and Drug Administration issued guidance to pharmacies today on the preparation of alcohol-based hand sanitizer products during the public health emergency. Board staff have fielded a number of calls and emails from pharmacies prior to this guidance and have consistently advised that pharmacies should exercise professional judgment and follow best practices in preparing hand sanitizer products during the COVID-19 pandemic response. Today’s guidance from the FDA establishes those best practices.
FRIDAY, MARCH 13, 2020
BOARD OF PHARMACY OFFICE CLOSED TO THE PUBLIC UNTIL FURTHER NOTICE. Consistent with recommendations from public health authorities and Governor Cooper’s declared state of emergency responding to the COVID-19 pandemic, the Board of Pharmacy office is closed to the public until further notice. Each of the Board’s application and other processes are available to our regulated community and the public through the Board’s website and by contacting Board staff, who remain available by phone and by e-mail. Board staff will continue to provide updates on the Board’s website and through the Board’s Twitter account, Follow @NCBOPNews.
THURSDAY, MARCH 12, 2020
UNITED STATES PHARMACOPEIA (USP) APPEALS PANEL ISSUES DECISIONS ON APPEALS CONCERNING REVISED CHAPTERS <795> AND <797>, AND NEW CHAPTER <825> USP announced today (March 12, 2020) that its appeals panel issued final decisions concerning appeals to revisions of revised chapters <795> and <797>, and new chapter <825>. More information concerning those decisions and their impact at the USP level is found here: https://www.usp.org/sites/default/files/usp/document/our-work/compounding/decisions-appeals-fs.pdf
How do these decisions affect the Board’s current enforcement of USP chapter standards governing compounding? At this point, they do not. The Board’s December 12, 2019 statement continues to be current:
1. Existing USP chapters <795> and <797> will continue to be enforced. Board inspections and investigative staff will continue to use the inspection forms and tools mapped to existing USP chapter requirements (found here: http://www.ncbop.org/phcyinspectionforms.html). As pharmacists know, under both federal law (the Drug Quality and Security Act) and Board rule (21 NCAC 46.2801), compounding activities must conform with the standards in these chapters. The revised chapters will be enforced when they go into effect. USP did not set a new effective date in its announcement today.
2. Board staff did not begin inspecting for compliance with USP chapter <800> standards in compounding activities on December 1, 2019, and will not being inspecting for such compliance as a result of today’s USP Appeals Panel decisions. Chapter <800> was not subject to an appeal and went into effect on December 1, 2019. Nonetheless, both the DQSA and Board rule .2801 require compliance with chapters <795> and <797> and other chapters incorporated into them. Existing chapters <795> and <797> do not incorporate chapter <800>. Revised chapters <795> and <797> do. Accordingly, Board staff will begin inspecting for compliance with chapter <800> standards at such time as the revised chapters go into effect. The USP Appeals Panel decisions remand revised chapters <795> and <797> to the Compounding Expert Committee for further study and engagement. The Panel decisions do not set an effective date for revised chapters <795> and <797>. Pharmacies that have already implemented changes to comply with chapter <800> are commended for doing so. And pharmacies working toward chapter <800> compliance are strongly encouraged to take the time afforded by this delay to finalize those preparations. For a review of prior Board statements concerning USP <800>, see http://www.ncbop.org/PDF/BoardPositionStatementforUSP800UPDATEDMarch2019.pdf and http://www.ncbop.org/PDF/NCBOP_USP_800_Statement.pdf
THURSDAY, MARCH 12, 2020
NORTH CAROLINA DEPARTMENT OF INSURANCE ISSUES BULLETIN CONCERNING INSURER RESPONSIBILITIES FOR EMERGENCY REFILL PAYMENT DURING STATE OF EMERGENCY. Pharmacists and pharmacies should review this memo from the North Carolina Department of Insurance reminding insurers of their responsibilities to cover emergency prescription refills during a declared state of emergency: http://www.ncbop.org/PDF/EmergencyDeclarationBulletinDeptofInsurance031220.pdf.
WEDNESDAY, FEBRUARY 26, 2020
BOARD OF PHARMACY STATEMENT CONCERNING SUPERVISING PHYSICIAN INFORMATION ON PRESCRIPTIONS ISSUED BY PHYSICIAN ASSISTANTS AND NURSE PRACTITIONERS. The North Carolina Medical Board’s rules governing Physician Assistants (PAs) and Nurse Practitioners (NPs) state that prescriptions issued by these practitioners must contain the name of the practitioner’s supervising physician (PAs and NPs) and the phone number of the supervising physician (PA only). 21 N.C.A.C. 32S.0212(5)(c); 21 NCAC 32M.0109(5)(A). In recent months, a number of pharmacists have inquired whether a prescription from a PA or an NP lacking this information is “illegal,” “invalid,” or otherwise ineligible for dispensing by a pharmacist.
The answer is no. The Medical Board’s requirements are imposed on a PA or NP for purposes of the Medical Board’s supervision of those practitioners. The absence of a supervising physician’s name and telephone number does not render a PA- or NP-issued prescription “invalid,” “illegal,” or otherwise ineligible for dispensing under the North Carolina Food Drug and Cosmetic Act or the North Carolina Pharmacy Practice Act. These statutes set forth requirements for a valid prescription under North Carolina law – and neither requires supervising physician information to be included on PA- or NP-issued prescriptions.
Accordingly, if the Medical Board wished to take action against a practitioner that it regulates for failure to include this information on a prescription, that is the Medical Board’s prerogative. But, again, that information’s presence or absence does not affect a PA- or NP-issued prescription’s eligibility for dispensing by a pharmacist. And if a pharmacist has concerns about a PA- or NP-issued prescription that the pharmacist cannot resolve after discussion with the prescriber, the Medical Board maintains an online database that readily identifies each and every PA’s supervising physician(s): https://wwwapps.ncmedboard.org/Clients/NCBOM/Public/LicenseeInformationSearch.aspx. Likewise, the North Carolina Board of Nursing maintains an online database that readily identifies each and every NP’s supervising physician(s): https://portal.ncbon.com/licenseverification/search.aspx.
TUESDAY, SEPTEMBER 24, 2019
PHARMACY AND PHARMACIST-MANAGER RESPONSIBILITIES FOR PHARMACY INTERNS. As pharmacists know, under North Carolina law, a student who is enrolled in a school of pharmacy is not required to register as a pharmacy technician. See NCGS § 90-85.15A(e). A student enrolled in a school of pharmacy is considered a “pharmacy intern” an is authorized to “perform all acts constituting the practice of pharmacy” while “working under a pharmacist preceptor or supervising pharmacist.” 21 NCAC 46.1317(29).
In recent months, Board staff have become aware of two instances in which a person working in a pharmacy as a “pharmacy intern” was not (and never had been) a student enrolled in a school of pharmacy. In both cases, investigations continue.
In the meantime, pharmacist-managers are reminded that, as the person who “accepts responsibility for the operation of a pharmacy in conformance with all statutes and rules pertinent to the practice of pharmacy” (21 NCAC 46.1317(27), your duties include vetting employees working as pharmacy interns to ensure that they are actually enrolled in a school of pharmacy. The risk to the public of an unqualified person “performing all acts constituting the practice of pharmacy” is obvious. A “pharmacy intern” who is not enrolled in a school of pharmacy is engaged in the unlicensed practice of pharmacy (which is a criminal offense) and the Pharmacy Practice Act specifically authorizes action on a pharmacist’s license or a pharmacy’s permit where either have “aided and abetted an individual to engage in the practice of pharmacy without a license.” NCGS § 90-85.38(a)(9).
OPIOID PUBLIC SERVICE ANNOUNCEMENT CAMPAIGN – ADS AVAILABLE FOR DOWNLOAD
Beginning February 8, 2018, the Board of Pharmacy opened an opioid public service announcement campaign on Wilmington and Greenville-area television stations and on social media platforms. The advertisements feature Joe Adams, a pharmacist and past president of the National Association of Boards of Pharmacy, sharing his deeply personal story of losing his son to an opioid overdose in 2014. These ads emphasize the important of obtaining help and the critical role pharmacists can play.
The ads come in 30-second, 60-second, and 6-minute versions, and are available for download here. Board members and staff welcome and encourage pharmacists using these ads to educate their patients and communities about proper medication use and the dangers of opioid abuse.
The Board thanks Third Wheel Media of Chapel Hill and the National Association of Boards of Pharmacy (NABP) for their tremendous efforts on this issue. Pharmacists will note that texting “abuse” to 555888, as instructed in the ads, will result in a reply text providing a link to an NABP-created and hosted page containing resources for pharmacists to share with patients and their communities. That page may be accessed directly here: https://nabp.pharmacy/homepage/prescription-drug-safety/.
These ads are the first phase of a multi-media campaign. Board staff will continue to keep pharmacists updated as the campaign progresses.
Please contact Board staff at 919.246.1050 with questions.
The North Carolina Board of Pharmacy’s monthly meetings are live-streamed via YouTube. Follow the link below to subscribe to the Board’s YouTube channel. Meeting dates found here.
Health Advisories (last updated June 4, 2020) – Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated January 3, 2018) – Check here regularly for the latest updates regarding Medicare/Medicaid.
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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