Board News and Announcements

 

 

 

APRIL 2017 NEWSLETTER

 

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:

New Board Rule Requires Pharmacists, Technicians, Pharmacies, and DME Facilities to Obtain an NABP e-Profile Number.  New Board Rule .1516 (21 NCAC 46.1615) requires all pharmacists, technicians, pharmacies, and DME facilities to obtain and report an National Association of Boards of Pharmacy e-Profile number.  This requirement will 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.  More information about the process will be published in the coming weeks.  Note that there is no cost to obtain an e-Profile number.  Important information to know now: 

Pharmacists
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.  More detailed information will follow to pharmacists on July 1.

Technicians
All PTCB-certified technicians also have an e-Profile number, which was assigned at the time of certification. Registered technicians may obtain one through NABP.  More detailed information on how technicians may obtain (or recover) an e-Profile number will follow on July 1.

Pharmacies and DME Facilities
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.

 


 

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/

 


 

TUESDAY, MAY 23, 2017

FREE CORRESPONDING RESPONSIBILITY CE PROGRAM JUNE 26 AT THE UNC FRIDAY CENTER - LIVE OR ATTEND VIA WEBINAR

The UNC Eshelman School of Pharmacy,  the North Carolina Board of Pharmacy, and the North Carolina Association of Pharmacists will be hosting a CE Program:  Prescription Drug Abuse, the Federal Controlled Substances Act and the Legal Obligation of Corresponding Responsibility. Joseph Rannazzisi will be presenting this 2 hour CE event on June 26, 2017. Joseph spent 29 years in drug law enforcement and has provided training concerning illicit drugs, pharmaceuticals, pharmaceutical control, corresponding responsibility, security, and many other topics. This course is free of charge and will be at the UNC Friday Center with both live and online attendance options.

Follow this link to register today.

Prescription Drug Abuse, the Federal Controlled Substances Act and the Legal Obligation of Corresponding Responsibility
This course provides an overview of the diversion, trafficking and abuse of prescription opioids from the perspective of both a regulator and pharmacist. Using opioid diversion and abuse as a foundation, the course explains the interplay between the Federal Controlled Substances Act (CSA) and its implementing regulations. The presentation focuses on the elements of a prescription, the legal obligations of a prescriber and the corresponding responsibility of the pharmacist to determine if a prescription is effective/valid through the identification and resolution of prescription “red flags” prior to dispensing a controlled substance. Participants will be exposed to the DEA inspection/investigative process to include DEA inspections, Orders to Show Cause, Immediate Suspension Orders and administrative hearings. The participant will also be exposed to administrative scheduling of a controlled substance and controlled substance quotas. More details and registration information can be found on our webpage here.

Feel free to contact us with any questions.

Thank you,
UNC Eshelman School of Pharmacy Continuing Education
919-843-4028

 


 

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).  

 


 

WEDNESDAY, MAY 17, 2017

OPIOID OVERDOSE PREVENTION SUMMIT JUNE 27-28. The Division of Public Health and the Division of Mental Health, Developmental Disabilities, and Substance Abuse Services invite you to be part of the solution to address opioid misuse, addiction, and overdose in NC. Join us June 27-28 in Raleigh as we hear from national, state and local leaders. Engage in interactive discussions with colleagues and community leaders during one of our 24 breakout sessions on topics including local, state, and national efforts; social determinants; innovative policies; prevention efforts; harm reduction; criminal justice; and treatment.

Register now at opioidpreventionsummit.org.

 



NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JUNE 12, 2017.)


 

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.)

https://www.youtube.com/channel/UC8Kgn3mOzRT8s0FJwsu8U0g

 


 

Health Advisories (last updated June 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.


 

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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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