Board News and Announcements
TUESDAY, JULY 11, 2017
BOARD OF PHARMACY ISSUES GUIDANCE TO PHARMACISTS ON IMPLEMENTATION OF THE STRENGTHEN OPIOID MISUSE PREVENTION (“STOP”) ACT. The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention (“STOP”) Act. The STOP Act is an effort to combat the opioid abuse and misuse epidemic. The STOP Act makes changes to the laws governing controlled substance prescribing, controlled substance dispensing, and the North Carolina Controlled Substance Reporting System (“CSRS”). This FAQ guidance discusses those changes: http://www.ncbop.org/PDF/GuidanceImplementationSTOPACTJuly2017.pdf.
TUESDAY, JULY 11, 2017
DEA ISSUES GUIDANCE STATEMENT ON TRANSFER OF “ON FILE” CONTROLLED SUBSTANCE PRESCRIPTIONS. On April 12, Board staff posted an item concerning apparent confusion over the ability to transfer “on file” controlled substance prescriptions that have not been filled. That notice stated that “if personnel at the DEA issue formal policy guidance” regarding such transfers, Board staff would advise pharmacists accordingly. This email from Loren Miller, Associate Section Chief, Liaison and Policy Section, Diversion Control Division, Drug Enforcement Administration to Carmen Catizone, Executive Director, National Association of Boards of Pharmacy spells out DEA’s policy on this issue: http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JULY 26, 2017.)
FRIDAY, JULY 7, 2017
Patients Receiving Eculizumab (Soliris®) at High Risk for Invasive Meningococcal Disease Despite Vaccination. The CDC has issued a health advisory regarding the risk for invasive meningococcal disease in patients receiving eculizumab (Soliris). Investigations of invasive meningococcal disease should include inquiring about a history of receipt of eculizumab. Healthcare providers should maintain a high index of suspicion for meningococcal disease in patients taking eculizumab who present with any symptoms consistent with either meningitis or meningococcemia, even if the patient’s symptoms initially appear mild, and irrespective of the patient’s meningococcal vaccine or antimicrobial prophylaxis status.
THURSDAY, JULY 6, 2017
The NCBOP was contacted by a North Carolina pharmacist in Wake County regarding a large prescription forgery ring. Information indicated the ring involved individuals from the western part of NC, who are forging prescriptions for Phenergan w/Codeine. The prescriptions bear the information of Alexis Benjamin, PA-C, DEA# MB2207252.
THURSDAY, JUNE 29, 2017
NOTICE TO PHARMACISTS, TECHNICIANS AND PERMIT HOLDERS CONCERNING NABP E-PROFILE NUMBERS; NOTICE TO PHARMACISTS CONCERNING CSRS ACCESS REGISTRATION
Pharmacists and Technicians Need to Act **NOW** to Obtain an NABP e-Profile Number, or to Recover One Previously Obtained
New Board Rule .1516 (21 NCAC 46.1615) requires all pharmacists, technicians, pharmacies, and DME facilities to obtain and report to the Board a National Association of Boards of Pharmacy e-Profile Number. Combined with the changes to the CE rules going into effect on January 1, 2018 (more info here: http://www.ncbop.org/faqs/Pharmacist/CEFAQChangesEff010118.pdf), this rule will further simplify the CE tracking process for pharmacists. This requirement will also make it easier for Board staff to access and track information on continuing education fulfillment, pharmacy and DME facility inspections, and out-of-state disciplinary actions. Note that there is no cost to obtain an e-Profile number.
All pharmacists are required to report an NABP e-Profile Number in order to renew their licenses for 2018. The vast majority of pharmacists already have an e-Profile number, as one is required to obtain credit for ACPE-accredited continuing education coursework. Any pharmacist who does not have an e-Profile number or who does not remember his/her e-Profile number can obtain one (or recover one) through NABP at no cost. Detailed instructions are found here: http://www.ncbop.org/PDF/NABPeProfileInstructionsRPhandTechJune2017.pdf.
All pharmacy technicians are required to report an NABP e-Profile Number in order to renew their registrations for 2018. All PTCB-certified technicians already have an e-Profile number, which was assigned at the time of certification. Registered technicians may obtain one through NABP. Any technician who does not have an NABP e-Profile Number or who does not remember his/her NABP e-Profile Number can obtain one (or recover one) through NABP at no cost. Detailed instructions are found here: http://www.ncbop.org/PDF/NABPeProfileInstructionsRPhandTechJune2017.pdf.
Pharmacies and DME Facilities
Pharmacies and DME facilities will not be required to obtain and report an NABP e-Profile Number to renew permits for 2018. Board staff is working with NABP staff to determine the most efficient method for pharmacies and DME facilities to obtain an e-Profile number. At such time as that process is developed, information will follow from Board staff. For now, pharmacies and DME facilities do not need to contact NABP about obtaining an e-Profile number. Again, when a process is in place for assignment of e-Profile numbers to pharmacies and DME facilities, Board of Pharmacy staff will communicate that to pharmacies and DME facilities.
CSRS ACCESS REGISTRATION
Pharmacists Should Act **NOW** To Register for Access to the North Carolina Controlled Substance Reporting System
The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention (“STOP”) Act.
Among other things, the STOP Act requires all pharmacists to register for access to the North Carolina Controlled Substance Reporting System (“CSRS”), with a narrow exemption.
As a condition of renewing a pharmacist license for 2018, a pharmacist must attest either: (a) he/she has registered for CSRS access; or (b) he/she is not employed in a pharmacy practice setting where Schedule II, III, or IV controlled substances are dispensed from a North Carolina-based facility or to North Carolina patients.
Any pharmacist who does not already have a CSRS access registration should immediately apply for one. Pharmacists can access a simple, on-line application here: https://www.ncdhhs.gov/divisions/mhddsas/ncdcu/csrs#csrs4
MONDAY, JUNE 26, 2017
Notice of Request for Early Review by Rules Review Commission and Right to Object
The Board of Pharmacy is engaged in the process of periodic review of its rules under N.C. Gen. Stat. Section 150B-21.3A. The Board has proposed whether each one of its rules should remain in the Administrative Code, be removed or be readopted; has received public comments on those categorizations; has considered those public comments; and has adopted a final report categorizing its rules.
The next step in the process is for the North Carolina Rules Review Commission (the “RRC”) to review that report and issue a final determination on the categorization of the rules. That review is currently scheduled for June 2018. However, because the Board has already prepared its final report and would like to accelerate the process of streamlining its regulations, the Board has asked the RRC to reschedule its review of our final classifications for the rules to an earlier date. At its August 17, 2017 meeting, the RRC will consider whether to reschedule the RRC’s review to an earlier date. The Board has requested that the review occur at the RRC’s meeting on September 21, 2017.
You have a right to submit public comments on our request for early review of our final rule classifications. The only matter currently before the RRC is whether the review will occur in June 2018, as scheduled, or on an earlier date. The substance of the categorizations will not be reviewed until September 21, 2017 (if the Board’s request is granted).
The RRC will consider objections from the public when it decides whether to grant our early review request. You have a right to submit public comments on our request for early review of our final rule classifications. If you have an objection to the early review request, you should submit it in writing to the RRC before its August 17, 2017 meeting. You can submit your objection:
- By email to: email@example.com.
- By USPS to: NC Rules Review Commission, 6714 Mail Service Center, Raleigh, NC 27699-6700.
- In person or by delivery service to: NC Rules Review Commission, 1711 New Hope Church Road, Raleigh NC, 27609.
FRIDAY, JUNE 9, 2017
LUPIN PHARMACEUTICALS RECALLS LOT L600518 MIBELAS 24 FE TABLETS. Pharmacists should be aware that Lupin Pharmaceuticals Inc. announced that it has voluntarily recalled lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.
As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The reversing the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order.
More information may be found here: https://www.fda.gov/safety/recalls/ucm560904.htm
FRIDAY, MAY 26, 2017
North Carolina Board of Pharmacy Executive Director Jack "Jay" Campbell Elected Treasurer of the National Association of Boards of Pharmacy's 2017-2018 Executive Committee. Read more here: https://nabp.pharmacy/nabp-2017-2018-executive-committee-inaugurated-113th-annual-meeting/
THURSDAY, MAY 18, 2017
VIRGINIA REGULATIONS IMPOSE RESTRICTIONS ON PRESCRIBING BUPRENORPHINE WITHOUT NALOXONE (BUPRENORPHINE MONO-PRODUCT). In March 2017, the Virginia Board of Medicine passed emergency regulations governing the prescribing of opioids and buprenorphine. Those regulations are found here: www.ncbop.org/PDF/PrescribingOpioidsBuprenophine03152017.doc. Since those regulations went into effect, several North Carolina pharmacies have contacted Board staff to report a surge in patients with Virginia addresses presenting prescriptions for buprenorphine mono-product from North Carolina-based clinics. Pharmacists are reminded of their obligation to use good, professional judgment when assessing whether a prescription for a controlled substance was written for a legitimate medical purpose in the ordinary course of medical practice. A red flag for potentially illegitimate controlled substance prescribing is often a patient who travels a significant distance to obtain a controlled substance prescription and may also travel a significant distance seeking a pharmacy that will dispense the prescription. Pharmacists are also reminded of resources on the Board website, including a “Red Flags” educational video (http://www.ncbop.org/faqs/Pharmacist/faq_RedFlagsCS.html) and an education pocket card (http://www.ncbop.org/faqs/Pharmacist/faq_DrugDiversion.htm).
TUESDAY, MAY 16, 2017
BOARD ISSUES UPDATED GUIDANCE ON THE SALE OF HEMP-DERIVED PRODUCTS. The North Carolina Industrial Hemp Commission has issued rules that govern “industrial hemp products.” As a result, the Board has updated its Guidance to North Carolina Pharmacies on the Sale of Products Derived From Hemp. This updated guidance (found here) replaces the guidance document issued on March 30, 2017.
WEDNESDAY, APRIL 12, 2017
TRANSFER OF SCHEDULE III, IV, AND V CONTROLLED SUBSTANCES. Board staff has become aware in recent days that some pharmacies have heard, or have been told, that federal law prohibits a pharmacy from transferring a Schedule III, IV, or V controlled substance prescription that was placed on file at the pharmacy, but never filled. The asserted basis is 21 CFR 1306.25, which discusses transfers of these prescriptions for “refill purposes.” Notwithstanding, the Board of Pharmacy has never taken the position that such transfers will subject a pharmacy to discipline. Nor is Board staff aware of any DEA action taken against a pharmacy for transferring a valid Schedule III, IV, or V prescription to the pharmacy of the patient’s choice for purposes of initial fill. If personnel at the DEA issue formal policy guidance stating an intent to enforce the CSA rule in a way that would prohibit such transfers, Board staff will advise pharmacists accordingly.
THURSDAY, MARCH 30, 2017
CE RULE CHANGES TO BECOME EFFECTIVE JANUARY 1, 2018. The Board has completed a rulemaking making changes to the continuing education requirements for licensure renewal. Board staff have received a number of good questions about the transition process. This FAQ guidance answers them.
TUESDAY, FEBRUARY 21, 2017
AMENDMENTS TO CONTINUING EDUCATION RULE .2201 TO GO INTO EFFECT JANUARY 1, 2018.
Board rule .2201, CONTINUING EDUCATION -- HOURS: RECORDS: PROVIDERS: CORRESPONDENCE: RECIPROCITY has been amended and will go into effect on January 1, 2018. The current version of the rule remains in effect until December 31, 2017. Please follow this link for rule language, both current and as amended January 1, 2018.
Please note that pharmacists will receive information from the Board in the coming weeks on implementation of the new rules for 2018.
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 July 2017) - 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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