Board News and Announcements
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.)
WEDNESDAY, AUGUST 10, 2016 - OPEN POSITION AT THE NC BOARD OF PHARMACY
The North Carolina Board of Pharmacy has a position open for an Accounting Manager. Please follow this link for details about the position and instructions for submitting a resume and cover letter of interest: http://www.ncbop.org/EmploymentOpportunities.htm.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED AUGUST 12, 2016.)
WEDNESDAY, AUGUST 3, 2016
FDA Releases Draft Guidance, "Insanitary Conditions at Compounding Facilities."
The U.S. Food & Drug Administration (FDA) today issued a draft guidance, Insanitary Conditions at Compounding Facilities, that identifies examples of insanitary conditions that can result in patient harm.
"FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions. The draft guidance has a public comment period of 60 days."
Please follow this link to review FDA's guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM514666.pdf
MONDAY, JULY 11, 2016 - AUTOMATED DISPENSING MACHINE BREAK-INS
Pharmacists in North Carolina should be aware that there have been several attempted and successful break ins on automated dispensing machines at multiple hospitals in Western NC. Pharmacies that house automated dispensing machines should increase their inventories and inspection of all your medication units. These break ins seem to happen late at night in units that are not operating 24 hours a day. Please report any losses to the North Carolina Board of Pharmacy and to law enforcement.
THURSDAY, JULY 7, 2016
FDA ISSUES TWO DRAFT GUIDANCE DOCUMENTS REGARDING HUMAN DRUG COMPOUNDING. The U.S. Food and Drug Administration announced today that it has issued two draft guidance documents regarding human drug compounding. The draft guidance documents are:
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The draft documents are applicable to State-licensed pharmacies, Federal facilities, outsourcing facilities and physicians who compound drugs. Each draft guidance has a public comment period of 90 days.
MONDAY, JUNE 27, 2016
BILL MIXON ELECTED TO SECOND TERM ON THE BOARD OF PHARMACY. Voting in the run-off election for the Board’s Western District seat closed on Friday. Pharmacists elected Bill Mixon to a second five-year term on the Board, to begin on May 1, 2017. The voting results are summarized in the table below. The Board expresses its heartfelt gratitude to Cathy Huie for her commitment to service.
As pharmacists know, Keith Vance was elected to the Board’s Northern District last month. Dr. Vance will begin serving a five-year term on May 1, 2017.
The Board will next hold elections in the spring of 2019, for the Northeastern and Central District seats.
GUIDANCE ON PHARMACY’S USE OF CLIA-WAIVED RAPID DIAGNOSTIC TESTS. Board staff have received numerous questions about pharmacies’ ability to perform “rapid diagnostic” and other “CLIA-waived” tests.
Some point-of-care tests for things like streptococcus infection, blood glucose levels, and cholesterol levels are approved by the FDA as so-called “CLIA-waived” tests. CLIA refers to the Clinical Laboratory Improvement Amendments Act, a federal statute that, as the name suggests, governs clinical laboratories.
When FDA approves an in vitro diagnostic device, it may designate the device as approved “for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that . . . employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or . . . the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.” 42 USC § 263a(d)(3). If so deemed by the FDA, these tests may be performed in a laboratory that has applied for a waiver of CLIA requirements. Id. § 263(a)(d)(2). CLIA-waived tests don’t require, as a condition of FDA approval, any sort of “prescription” or medical order.
Unlike some states, North Carolina law does not impose a separate layer of regulations on top of CLIA. If a facility – including a pharmacy – meets the criteria to perform CLIA-waived tests, and obtains from the federal Centers for Medicare and Medicaid Services a CLIA waiver, then that facility may perform any CLIA-waived tests. More information about the CLIA waiver process may be found here: https://www2.ncdhhs.gov/DHSR/ahc/clia/cliafaq.html
Staff is of the opinion that there is nothing in the law that would prevent a pharmacy that applies for, and obtains, a CLIA waiver from performing CLIA-waived tests. Of course, a pharmacy performing a CLIA-waived test cannot allow its pharmacists to use the results of a CLIA-waived test to prescribe drug therapy independently, or to do anything with the test results besides provide them to the patient and/or communicate them to the patient’s provider of choice. (The exception would be a CPP whose agreement with the supervising physician authorizes the CPP to act on test results.)
MONDAY, JUNE 20, 2016
STATE LAW ESTABLISHING STATEWIDE STANDING ORDER FOR NALOXONE DISPENSING SIGNED INTO LAW ON MONDAY, JUNE 20, 2016. The North Carolina General Assembly has passed, and Governor McCrory has signed into law, a bill that will allow the State Health Director, Dr. Randall Williams, to issue a statewide standing order for naloxone dispensing – a standing order that any pharmacy in North Carolina may use. This standing order will allow any licensed North Carolina pharmacist who chooses to participate to dispense naloxone to patients who are at risk of an opioid overdose or to their friends or family members or to people in a position to help them.
The North Carolina Department of Health and Human Services (“NC DHHS”) has set up a website to educate pharmacists and the public about the statewide standing order. It may be found at www.naloxonesaves.org. Pharmacists and pharmacies should review the information on the website immediately.
The website includes instructions for pharmacies that wish to dispense under the standing order to notify NC DHHS that they intend to do so. Pharmacies dispensing under a standing order (whether through the State Health Director or through their own standing order) will be listed on the website after contact information is provided to DHHS.
There is likely to be significant media attention to the new law and members of the public may approach your pharmacy to obtain naloxone through the standing order. If you have any questions about the standing order that are not answered by the www.naloxonesaves.org website, you may contact Board of Pharmacy staff or Anna Stein, DHHS Legal Specialist (firstname.lastname@example.org).
TUESDAY, MAY 24, 2016
CHANGES TO THE RULES GOVERNING CLINICAL PHARMACIST PRACTITIONERS: WHAT DO THEY ENTAIL?
The Medical and Pharmacy Boards recently collaborated on a series of changes to the rules governing Clinical Pharmacist Practitioners (21 N.C.A.C. 46.3101). The chief aims of the amendments are: (1) transfer primary administrative responsibility for CPP application, renewal, and monitoring to the Board of Pharmacy; (2) bring supervising physician consulting and oversight responsibilities in line with those for nurse practitioners and physician assistants; and (3) allow CPPs to designate “primary” and “back-up” supervising physicians, something particularly helpful for CPPs who service patients in a group practice.
This document answers some questions that are likely to arise immediately among presently-approved CPPs and CPP candidates currently seeking approval: http://www.ncbop.org/faqs/Pharmacist/AmendedCPPrules3101FAQ.pdf.
Health Advisories (last updated March 7, 2016) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated May 12, 2015) - 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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