Board News and Announcements
FRIDAY, JANUARY 4, 2019
FDA STATEMENT CONCERNING CBD PRODUCTS AFTER PASSAGE OF THE FARM BILL. A number of pharmacists have inquired about the status of CBD-containing products after passage of the Farm Bill late last month. On December 20, 2018, FDA Commissioner Scott Gottlieb issued a statement about what the Farm Bill changed – and, as importantly, did not change – when it comes to CBD products: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JANUARY 14, 2019.)
The February 2019 regular meeting of the NC Board of Pharmacy has been changed to Tuesday, February 26 and will begin at 10:00am. Please visit our meetings calendar here.
TUESDAY, JANUARY 1, 2019
2018 Licenses, Permits, and Registrations Are Now Expired; 60-Day "Grace Period" Clock Is Ticking!
All licenses, permits, and registrations that the Board issues expired on December 31. If you did not renew your license, permit, or registration - it has expired. North Carolina law, however, provides that you are not liable for unlicensed practice of pharmacy if you renew within 60 days of your license, permit, or registration expiring. So, if you renew by March 1, 2019, you are safe. Log in to your account(s) using the Board's Licensure Gateway, https://portal.ncbop.org/, and complete your renewal(s).
You will need a Visa, MasterCard, American Express, or Discover Card to pay for your renewal. You are required to print your own 2019 certificate.
PHARMACISTS: All pharmacists are required to have, at minimum, a total of 15 hours to renew. Five (5) of those hours must be LIVE hours and the remainder hours can be either live or correspondence.
Entry of your continuing education credits in your NC Board of Pharmacy CE profile is no longer required. You will simply attest that you have met the CE requirements when you renew.
DME PERMIT HOLDERS: The NC Board of Pharmacy DME Subcommittee is holding an election for the Medical Equipment representative seat. This seat is presently held by Doug Tonucci, who is seeking a second term on the committee and is the only candidate on the ballot. Once you log in to your account through the FACILITY MANAGEMENT tab, you will see a ballot link to cast your vote.
Answers to renewal-related Frequently Asked Questions may be found here:
TUESDAY, OCTOBER 23, 2018
NOTICE OF PUBLIC HEARING AND COMMENT PERIOD (JANUARY 15, 2019) ON PROPOSED AMENDMENTS TO RULES 21 NCAC 46 .2403 AND .2502 – DRUGS AND DEVICES TO BE DISPENSED AND RESPONSIBILITES OF PHARMACIST-MANAGER. Follow this link for details, including the proposed rule language and instructions for submitting comments.
*REMINDER* DEA POSITION ON TRANSFER OF "ON FILE" CONTROLLED SUBSTANCE PRESCRIPTIONS
Pharmacists continue to call Board staff with understandable confusion on whether and how “on file” controlled substance prescriptions that were never filled may be transferred. To recap:
In April 2017, word began swirling that DEA viewed transfers of “on file” controlled substances as not allowed. On July 7, 2017, Loren Miller, Associate Section Chief, Liaison and Policy Section, Diversion Control Division, Drug Enforcement Administration sent an email to Carmen Catizone, Executive Director of the National Association of Boards of Pharmacy, setting forth DEA’s view on the matter.
In that email (found here -- http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf), Mr. Miller states the view that 21 CFR 1306.25 allows a pharmacy, “once it has filled an original prescription for a controlled substance in Schedule III-V,” to “transfer the original prescription information to another DEA registered pharmacy for the purposes of allowing that second pharmacy to then dispense any remaining valid refills . . . .” Mr. Miller further stated that “an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered pharmacy.”
Mr. Miller then stated that, based on “the preamble” of an “interim final rule,” it is DEA’s “policy” that an electronic prescription for a controlled substance of any schedule may be “forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy” even if that prescription had not been filled.
To say that DEA’s positions in this matter create a mess is a gross understatement. First, while Mr. Miller’s reading of 21 CFR 1306.25 is textually plausible, it represents a departure from decades of standard pharmacy practice and there has been no suggestion from DEA or anyone else that the standard practice of transferring “on file” but unfilled (as opposed to once-filled) controlled substance prescriptions has caused or materially contributed to controlled substance abuse or misuse. Second, neither Mr. Miller’s email nor any language in the preamble he references contains so much as a hint as to what an appropriate mechanism for “forwarding” (and documenting the forwarding of) an unfilled electronic controlled substance prescription would be. Third, Mr. Miller’s email does not explain why “forwarding” an unfilled electronic controlled substance prescription is substantively different than transferring an unfilled controlled substance prescription, whether electronic, verbal, or written. Fourth, DEA’s position creates not only an incentive, but a practical necessity, for patients seeking to change their pharmacy of choice to obtain duplicate controlled substance prescriptions from their caregiver. Interpretations and policies that guarantee duplicate prescriptions for controlled substances in multiple pharmacies hardly seems consistent with the Controlled Substance Act’s purpose to create a controlled, closed distribution system and minimize controlled substance abuse and misuse.
All that said, however, DEA has shown no inclination to reconsider or clarify these positions. Where does that leave us?
(1) Though “forwarding” of unfilled electronic controlled substance prescriptions is available by “policy,” the lack of any guidance from DEA on how a “forwarding” should occur and be documented means that most pharmacies and pharmacists are reluctant to entertain the practice. And who can blame them?
(2) For unfilled verbal prescriptions for a Schedule III-V controlled substances, DEA’s position means that there is no mechanism for moving them from one pharmacy to another.
(3) For unfilled paper prescriptions for a Schedule III-V controlled substances, a pharmacy could return the original to the patient to physically carry to another pharmacy. Board staff understand completely the practical problems of this approach.
Some pharmacists have inquired why Board staff, the Board, or the North Carolina legislature have taken this position. As the above makes clear, none of the three are to blame. The present state of affairs is attributable solely, and entirely, to the DEA. Board staff will, of course, update pharmacists if the DEA sees reason and backs away from these positions. Until then, send your cards, letters, and calls to the DEA.
MONDAY, SEPTEMBER 10, 2018
DME SUBCOMMITTEE - UPCOMING ELECTION FOR MEDICAL EQUIPMENT REPRESENTATIVE SEAT
During the 2019 renewal period, the NC Board of Pharmacy DME Subcommittee will hold an election for the Medical Equipment representative seat. This seat is presently held by Doug Tonucci, who plans to seek a second term on the committee.
The Board is requesting nominations for this position between now and October 15, 2018. More about the election and nomination process may be found here.
THURSDAY, FEBRUARY 22, 2018
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 October 10, 2018) - 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.
Copyright © 2006 North Carolina Board of Pharmacy
site design IV Design