Board News and Announcements
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.
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.
FRIDAY, MAY 12, 2017
UPDATE TO STATEWIDE NALOXONE STANDING ORDER. Acting State Health Director Kelly Kimple, MD has updated the statewide standing order for naloxone to authorize participating pharmacies to dispense intramuscular injection formulations. The updated standing order is found here: https://www.naloxonesaves.org/files/2017/05/Statewide-Standing-Order-Dated-5-2-2017-signed.pdf
All pharmacists and pharmacies are reminded that comprehensive information about the dispensing and use of naloxone is found here: www.ncbop.org/faqs/Pharmacist/faq_NaloxoneDispensing.htm
WEDNESDAY, MAY 3, 2017
UPTICK IN ADVERTISEMENTS AND SALES PITCHES TO NORTH CAROLINA RESIDENTS AND EMPLOYERS CONCERNING IMPORTATION OF “CANADIAN” PRESCRIPTION DRUGS. Board staff have become aware of an uptick in advertisements and sales pitches to North Carolina residents and employers encouraging the purchase of prescription drugs from “Canadian” pharmacies. The public is reminded that federal law prohibits the importation of prescription drugs from foreign countries, except by the original manufacturer and even then only for emergency purposes. Moreover, the advertised “pharmacies” (which are often not pharmacies and are “Canadian” only insofar as the name includes “Canada” and the website includes a red maple leaf) are not licensed and overseen by the North Carolina Board of Pharmacy – and cannot be. Finally, importing drugs from “Canadian” or other foreign “pharmacies” is highly dangerous. These outfits are often purveyors of counterfeit, adulterated, dangerous products. Patients can be, and have been, seriously harmed by them. This 2003 paper from the National Association of Boards of Pharmacy outlines the public health and safety dangers of importing prescription drugs from foreign countries.
So, too, does this information for consumers from the FDA: https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143561.htm. Consumers are sometimes told by “Canadian” or other foreign pharmacies that FDA generally allows the importation of a “personal supply” of prescription drugs. This is not true. The FDA’s information for consumers discusses that, in rare circumstances, FDA will exercise discretion to not take action against an illegal importation. Those rare circumstances are when an “effective treatment may not be available domestically,” the patient’s own doctor works with the FDA to obtain the treatment not available domestically, and “there is no known commercialization or promotion to U.S. residents by those involved in the distribution of the product.” As the FDA makes clear, importation pursuant to promotions and/or because the medication is “cheaper – even though a drug with the same name is approved for sale in the United States –” does not fall into that set of rare circumstances.
Again, the importation of prescription drugs from foreign countries (Canada or anywhere else) is illegal and it is dangerous. Additional information for pharmacists and consumers concerning the dangers of on-line prescription drug purchases – whether from domestic or foreign sources – and how to avoid them may be found here: https://nabp.pharmacy/initiatives/dot-pharmacy/buying-medicine-online/. And, as always, consumers or pharmacists with questions are encouraged to call Board of Pharmacy staff for guidance.
APRIL 24, 2017
BOARD OF PHARMACY EXECUTIVE EMERITUS DAVID R. WORK PASSES AWAY. David R. Work, who served as the Board’s Executive Director from 1976 to 2006, passed away on Saturday, April 22, 2017. David is remembered, and will be forever remembered, as one of the giants of North Carolina pharmacy. His tenure as Executive Director saw enormous growth in the profession of pharmacy and seismic changes in the regulatory landscape. David navigated these changes expertly and, under his steady hand, the North Carolina Board emerged as, and remains, a progressive force for the advancement of the profession and protection of the public.
David’s influence ranged far beyond North Carolina. His years of service to the National Association of Boards of Pharmacy, including as President, allowed him to help craft the future of the profession at the national and international level.
Anyone who knew David will remember him as full of joy for life, possessed of a rapierlike wit, ever ready with his camera, and a constant source of sound advice. The Board members and staff, past and present, will miss him terribly. Our every thought turns to his daughters – Dana, Amy, and Susan – and their families.
The French philosopher Paul Valéry said, “A great man is one who leaves others at a loss after he is gone.” Today, we are all at a loss.
Visitation will be Friday, April 28 from 6:00 - 8:00pm at Walker's Funeral Home, 120 W. Franklin Street, Chapel Hill. A graveside service will be at 11:00am on Saturday at the Chapel Hill Memorial Cemetery. More information may be found here: http://www.walkersfuneralservice.com/obituaries/David-Work/#!/Obituary.
MONDAY, APRIL 24, 2017
NORTH CAROLINA DIVISION OF PUBLIC HEALTH ISSUES CLINICIAN GUIDANCE ON MUMPS TREATMENT. In recent weeks, the North Carolina Division of Public Health (NC DPH) has received reports of mumps cases from local health departments. The guidance (found here) from NC DPH is intended to aid all health care providers with regard to reporting, testing, prevention, and control measures for mumps: http://www.ncbop.org/PDF/MumpsClinicianGuidanceNCDHHS042117.pdf.
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.
TUESDAY, FEBRUARY 21, 2017
NC BOARD OF PHARMACY MANDATORY PERIODIC RULE REVIEW.
In accordance with N.C. Gen. Stat. § 150B-21.3A and 26 NCAC 05 .0206, the North Carolina Board of Pharmacy has adopted initial determinations of its rules for purposes of completing the mandatory periodic rule review. The report of its initial determinations is at the link below.
The Board will be accepting public comment on the initial rule designations until the close of business on Monday, May 1, 2017. If you wish to submit public comment about any of the proposed rule classifications, you may do so by either mailing a public comment to the attention of the Board’s Executive Director, Jay Campbell, by US Postal Service or other delivery service to 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, or by e-mail to email@example.com.
”Public comment” is defined by N.C. Gen. Stat. § 150B-21.3A(a)(5) as a written objection to all or part of a rule. Additionally, pursuant to N.C. Gen. Stat. § 150B-21.3A(c)(2), in order for the North Carolina Rules Review Commission to determine whether the public comment has merit, the public comment must address the specific substance of the rule and address any of the standards of Commission review, as set forth in N.C. Gen. Stat. § 150B‑21.9(a).
FRIDAY, FEBRUARY 3, 2017
NORTH CAROLINA STATEWIDE NALOXONE STANDING ORDER UPDATED. Pharmacies that participate in the statewide naloxone standing order are advised that the order has been reissued by Kelly Kimple, MD, to ensure continuity between the departure of Randall Williams, MD – the previous State Health Director – and his eventual successor. There has been no change in the content of the standing order. The updated order may be found here: https://www.naloxonesaves.org/files/2017/01/2017-Naloxone-Standing-Order.pdf
THURSDAY, JANUARY 26, 2017
FDA ISSUES FINAL GUIDANCE DOCUMENTS ON THE USE OF BULK DRUG PRODUCT FOR COMPOUNDING BY PHARMACIES AND OUTSOURCING FACILITIES. The Food and Drug Administration has issued final guidance on the use of bulk drug product for compounding by pharmacies (under Section 503A of the Food, Drug, and Cosmetic Act) and outsourcing facilities (under Section 503B of the Food, Drug, and Cosmetic Act). All compounders should give these documents their immediate attention:
- Interim Policy on Compounding (BY PHARMACIES) Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Interim Policy on Compounding (BY OUTSOURCING FACILITIES) Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
THURSDAY, JANUARY 26, 2017
PHARMACY TECHNICIAN CERTIFICATION BOARD SUSPENDS IMPLEMENTATION OF PLANNED 2020 ACCREDITED EDUCATION REQUIREMENT FOR PHARMACY TECHNICIANS. The Pharmacy Technician Certification Board (PTCB) is suspending the implementation of the accredited education requirement for pharmacy technicians. In 2013, PTCB announced that the requirement would take effect in 2020, but PTCB has “determined that additional deliberation and research are needed to address stakeholder input, develop supporting policy, and conduct further study of technician roles,” said Larry Wagenknecht, chair of the PTCB Board of Governors, and chief executive officer of the Michigan Pharmacists Association, in a news release. The role of pharmacy technicians is evolving, and PTCB is taking steps to support the pharmacy community.
MONDAY, JANUARY 23, 2017
PET MEDICATION SAFETY ALERT: FDA WARNS OF ILLNESSES AND DEATHS IN PETS EXPOSED TO PRESCRIPTION TOPICAL TREATMENTS
On January 18, 2017, the FDA published an alert for pet owners, veterinarians, health care providers, and pharmacists regarding the exposure of pets to the topical medication Fluorouracil 5% (5-FU).
The original alert can be found here at: http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm537434.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
This recommendation comes in light of the FDA receiving reports of five dogs having become ill and died after accidentally ingesting the topical medication. In one of the reported incidents, the dog experienced vomiting, seizures, and died within 12 hours of consuming the medication. Although there have not been any reports involving cats, they are expected to be extremely sensitive to the topical medication as well.
The FDA has recommended that people who use Fluorouracil use caution when applying in the medications and take the following protective measures to prevent their pets from ingesting the medication:
- Store all medications safely out of the reach of pets.
- Safely discard or clean any cloth or applicator that may retain medication and avoid leaving any residues of the medication on hands, clothing, carpeting or furniture.
- Consult your health care provider on whether it is appropriate to cover the treated area.
- If you are using topical medications containing Fluorouracil and your pet becomes exposed, consult a veterinarian immediately.
- If your pet shows signs such as vomiting, seizing or other illness, seek immediate veterinary care for your pet and be sure to provide the details of the exposure.
Additional information regarding the care and safety of pets can be found here: http://www.fda.gov/AnimalVeterinary/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
As a reminder, people using any topical medication should use caution when applying and storing the medication when there are household pets present, as very small amounts of exposure could be dangerous to these animals. In particular, owners should take caution when touching their pets or allowing them to be licked after the application of any topical substance.
Temporary Dispensing Sites Opened to Serve Patients Impacted by Hurricane Matthew Flooding - List updated January 20, 2017
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.)
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED MARCH 13, 2017.)
THURSDAY, NOVEMBER 3, 2016
PROPER IDENTIFICATION OF COMPOUNDING RISK LEVELS AND NOTIFICATION TO THE BOARD OF
PHARMACY. Pharmacies that hold a permit from the North Carolina Board of Pharmacy and that engage in any type of compounding are required to notify the Board. Such pharmacies must report (both on an initial permit application and as part of each annual renewal): (1) whether they compound; (2) a good-faith estimate of the percentage of the pharmacy’s dispensing that involves compounded products; (3) whether the pharmacy engages in non-sterile compounding; (4) whether the pharmacy engages in sterile compounding; and (5) what risk level of sterile compounding, as defined by USP <797>, the pharmacy performs. Accurate reporting of this information is crucial for at least two reasons: First, failure to provide accurate information in connection with seeking or renewing a permit is grounds to revoke or void a pharmacy permit. N.C.G.S. § 90-85.38. Second, the Board’s risk-based inspection intervals are driven by the scope and type of service provided at a pharmacy, particularly compounding services.
Please note: The estimate of the percentage of the pharmacy’s dispensing that involves compounded products does not affect a pharmacy’s inspection interval. That interval is determined by the type of compounding services provided, not the volume of compounding services provided. Board staff published a guidance document intended to reduce any confusion about this reporting requirement: http://www.ncbop.org/PDF/CompoundingRiskLevelsandCategoriesMar2015.pdf.
Pharmacists are also reminded that the Board Rule. 2801 requires any pharmacy that provides compounding services to maintain a reference library that includes current USP Standards for compounding and that the Pharmacist-Manager or Pharmacist-Manager’s designee pharmacist be knowledgeable in all compounding functions, including USP categories of compounding.
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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