Board News and Announcements
FRIDAY, MARCH 7, 2014
FAYETTEVILLE MAN ARRESTED FOR OPERATING A FRAUDULENT MEDICAL CLINIC. News reports yesterday indicate that Cumberland County sheriff’s investigators arrested Wright Gillies and charged him with operating a fraudulent medical clinic (RF Medical Clinic, 705 Cumberland Street, Fayetteville). Authorities allege, among other things, that Mr. Gillies wrote prescriptions for patients of the fraudulent clinic. Pharmacists are advised to review their dispensing records for prescriptions written by Mr. Gillies – who was using the name “Dr. Graham Meyer” -- and take appropriate action. More information may be found here: http://www.wral.com/fayetteville-man-wanted-for-posing-as-doctor-surrenders/13457116/ and http://m.fayobserver.com/news/local/article_78853107-2c3c-5b0f-a5a6-157124508fbd.html?mode=jqm&_dc=436063551809.63873
SUNDAY, MARCH 2, 2014
The 2014 regular renewal period has ended. Any pharmacist, pharmacy technician, dispensing physician, or PA/NP who did not renew his/her license/registration by March 1 will be moved to INACTIVE status.
Pharmacies and DMEs may still renew - with a penalty - between now and March 31, 2014. Any permit not renewed by March 31 will be CLOSED. Follow the appropriate link below to renew your permit during this 30-day penalty phase:
THURSDAY, FEBRUARY 27, 2014
The next Board election will take place in April/May 2014. Two positions on the Board will be filled: The Northeastern District seat presently held by Gene Minton, and the Central District seat presently held by Lazelle Marks. They are serving their first five-year terms and thus are eligible to run for re-election.
Candidates must be a resident of the district from which they are elected at the time of the election.
The Northeastern District is composed of Bertie, Camden, Chowan, Currituck, Dare, Durham, Edgecombe, Franklin, Gates, Granville, Halifax, Hertford, Hyde, Martin, Nash, Northampton, Pasquotank, Perquimans, Tyrell, Vance, Wake, Warren, Washington, and Wilson Counties.
The Central District is composed of Anson, Cabarrus, Chatham, Davidson, Davie, Iredell, Lee, Mecklenburg, Montgomery, Moore, Randolph, Richmond, Rowan, Stanly, and Union Counties.
Nominations are open through March 15, 2014. A pharmacist resident in one of these counties may appear on the ballot by submitting a petition signed by ten (10) eligible voters from the appropriate district. The petition must be filed in the Board office by March 15, 2014. Any pharmacist interested in learning more about the duties of a Board member is encouraged to contact Jay Campbell, Executive Director.
All pharmacists licensed in North Carolina and residing in the state as of March 15, 2014 are eligible to vote. Voting will again be electronic and more details will follow in the coming weeks.
FRIDAY, FEBRUARY 21, 2014
CAUTION TO NORTH CAROLINA PHARMACIES CONCERNING “SECONDARY” WHOLESALER SOLICITATIONS FOR SHORTAGE DRUGS. Board of Pharmacy staff and staff of the Food and Drug Safety Division of the North Carolina Department of Agriculture has been made aware that at least one “secondary” wholesaler is soliciting pharmacies to purchase “shortage” drugs from a primary wholesaler and then resell them to the “secondary” wholesaler. There are several important issues that pharmacies should keep in mind:
(1) Any sales of this sort are wholesale prescription drug transactions. Any pharmacy engaged in such transactions that is not also a currently licensed prescription drug wholesaler would be in violation of North Carolina law.
(2) The “secondary” wholesaler has suggested that a pharmacy may engage in such transactions without being a wholesaler under a “5% rule” allowing sales to relieve shortages; any such suggestion is false. North Carolina law provides a limited mechanism whereby one pharmacy may, in an emergency situation, transfer a small amount of prescription drugs to another pharmacy to help that pharmacy through an emergency. North Carolina law does not provide a mechanism for a pharmacy to sell any amount of a prescription drug to a wholesaler for subsequent distribution to other pharmacies or wholesalers. More information may be found here: http://www.ncbop.org/faqs/Pharmacist/faq_Wholesalers.htm
(3) As most pharmacists are aware, Congress recently passed the Drug Quality and Security Act. Title II of that act, governing drug supply chain security, sets forth many federal law requirements for prescription drug wholesalers. Provisions of this statute are being rolled out gradually, but any pharmacy contemplating becoming a prescription drug wholesaler must be aware of these stringent requirements and prepared to meet them.
(4) The issue of “gray market” wholesaling of shortage prescription drugs is one that North Carolina authorities have worked closely with federal officials to monitor and address. A Congressional investigation into these practices, and their often significant threat to the public health and safety, was conducted last year. More information may be found here: http://democrats.oversight.house.gov/investigation-of-the-gray-market/
FRIDAY, FEBRUARY 21, 2014
NOTICE OF PUBLIC HEARING (JUNE 17, 2014) ON PROPOSED AMENDMENTS TO RULE 21 NCAC 46 .2401 AND .2403 - DISPENSING IN HEALTH DEPARTMENTS. Revisions required by Session Law 2013-23 and the Acting State Health Director's addition of naloxone to the recommended formulary of drugs to be dispensed by registered nurses in local health department clinics.
A public hearing will be held on June 17, 2014 at 9:00am at the NC Board of Pharmacy office, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.
Any person may object to the proposed amendment by attending the public hearing on June 17, 2014 and/or by submitting a written objection by 9:00am on June 17, 2014 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, e-mail firstname.lastname@example.org. The North Carolina Board of Pharmacy is interested in all comments pertaining to the proposed rule. All persons interested and potentially affected by the proposal are strongly encouraged to read this entire notice and make comments on the proposed rule.
If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.
• NOTICE OF TEXT/PUBLIC HEARING:
• PROPOSED RULE/AMENDMENT LANGUAGE:
MONDAY, FEBRUARY 17, 2014
MEDISCA RECALLING LOTS OF L-CITRULLINE. The Food and Drug Administration has alerted health professionals that Medisca is voluntarily recalling several lots of L-citrulline because testing shows that these lots do not contain any active ingredient. More information may be found here: http://www.fda.gov/Drugs/DrugSafety/ucm385964.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
WEDNESDAY, FEBRUARY 12, 2014
GOVERNOR’S PROCLAMATION OF STATE OF EMERGENCY AND EMERGENCY PRESCRIPTIONS. In anticipation of today’s winter storm, Governor McCrory has declared a state of emergency for the entire state of North Carolina. That act places certain requirements on health benefit plans regarding payment for emergency prescription drug refills. Pharmacists may find more information here: http://www.ncdoi.com/LS/Documents/Bulletins/2014/14-B-02%20-%20Extra%20Rx%20During%20State%20of%20Emergency.pdf The memo notes that anyone requiring further information should contact Deputy Commissioner of Insurance Ted Hamby at L&Hinbox@ncdoi.gov.
THURSDAY, JANUARY 23, 2014
REMINDER FROM THE NC DEPARTMENT OF HEALTH & HUMAN SERVICES DIVISION OF PUBLIC HEALTH - SINGLE DOSE VERSUS MULTI-DOSE VIALS. As the normal saline (NS) 0.9% bags for injection shortage continues, please take a minute to review the One & Only Campaign. The One & Only Campaign is a reminder of the importance for using single dose and multi-dose vials appropriately and the consequences for failing to do so. The newest information from the One & Only Campaign is at http://www.oneandonlycampaign.org/single-dose-multi-dose-vial-infographic. More information about the NS bag shortage can be found on the FDA website at: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314743.htm, and on the ASHP website at: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=993. As many institutions institute conservation measures in light of the shortage, please keep in mind that IV bags are considered single-dose and should never be used for more than one patient, even during periods of shortage.
FRIDAY, JANUARY 17, 2014
NORTH CAROLINA LAW PROHIBITS HEALTH CARE PROVIDERS FROM PAYING REFERRAL FEES. In recent days, Board staff has received several inquiries regarding the payment of referral fees to physicians for directing patients to a pharmacy. North Carolina law is clear: “A health care provider shall not financially compensate in any manner a person, firm, or corporation for recommending or securing the health care provider’s employment by a patient, or as a reward for having made a recommendation resulting in the health care provider’s employment by a patient. No health care provider who refers a patient of that health care provider to another health care provider shall receive financial or other compensation from the health care provider receiving the referral as a payment solely or primarily for the referral.” NCGS Section 90-401 (emphasis added). Violation of this statute “shall be grounds for the offending health care provider’s licensing board to suspend or revoke the health care provider’s license, to refuse to renew the health care provider’s license, or to take any other disciplinary action authorized by law.” NCGS Section 90-401. The North Carolina Medical Board emphasizes to its licensees that they “may not accept payment of any kind, in any form, from any source, such as a pharmaceutical company or pharmacist, an optical company, or the manufacturer of medical appliances and devices, for prescribing or referring a patient to said source.” (For the Medical Board’s full position statement, “Referral fees and fee splitting”, see http://www.ncmedboard.org/position_statements/detail/referral_fees_and_fee_splitting).
FRIDAY, JANUARY 17, 2014
UPDATE: ACETAMINOPHEN CONTAINING COMBINATION PRODUCTS –WHAT DOES THE FDA’S JANUARY 14, 2014 “DEADLINE” MEAN FOR DISPENSERS? On January 14, 2011, the FDA announced an effort to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. Specifically, FDA announced that manufacturers of prescription drugs containing more than 325 milligrams of acetaminophen would be given until January 14, 2014 to request that FDA withdraw approval of such products. FDA stated that, after January 14, 2014, it could take action to remove prescription drug products containing more than 325 milligrams of acetaminophen from the market. FDA has determined that products containing more than 325 milligrams of acetaminophen present an unreasonable risk of liver injury. FDA’s complete notice on this topic may be found here: https://www.federalregister.gov/articles/2011/01/14/2011-709/prescription-drug-products-containing-acetaminophen-actions-to-reduce-liver-injury-from. Several manufacturers have reformulated combination products (most often oxycodone and hydrocodone combination products) that previously contained 500 milligrams of acetaminophen. Others have not.
Some pharmacists have asked whether they may dispense a prescription for a combination product containing more than 325 milligrams of acetaminophen after January 14. The answer is yes, but some context is necessary. Again, as noted, FDA encouraged manufacturers voluntarily to withdraw and reformulate products containing more than 325 milligrams of acetaminophen. If a manufacturer has not done so by January 14, the FDA could take action to remove that manufacturer’s product from the market. But unless and until FDA does so, such products remain approved. Still, pharmacists must be aware of the safety risks that prompted FDA’s action. Appropriate counseling of patients and prescribers should occur. And pharmacists should also be mindful that reformulated products may have fewer generic alternatives available. In other words, where substitution is authorized for a now-325 milligram acetaminophen containing product, pharmacists must be careful not to inadvertently substitute a 500 milligram acetaminophen containing product.
Update: On January 15, 2014, FDA issued additional recommendations and information, including a statement of “intent to institute proceedings to withdraw approval of prescription combination products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.” That information may be found here: http://www.fda.gov/Drugs/DrugSafety/ucm381644.htm
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JANUARY 23, 2014.)
MONDAY, DECEMBER 30, 2013
INFORMATION FROM NORTH CAROLINA DIVISION OF MEDICAL ASSISTANCE REGARDING WAIVER OF CO-PAYS FOR MEDICAID RECIPIENTS. Board of Pharmacy staff often receive questions about whether and to what extent state and federal law permit a pharmacy to waive co-payments for Medicaid recipients. Board staff refer such questions (and others concerning North Carolina Medicaid issues) to staff of the North Carolina Division of Medical Assistance (“NCDMA”), which administers the North Carolina Medicaid program. Pharmacists and pharmacies should note, however, that the NCDMA published an article in the October 2013 edition of the Medicaid Pharmacy Newsletter on the subject of waiving of Medicaid co-payments to provide additional information in light of a new state law that went into effect on October 1, 2013. North Carolina Session Law 2013-145 (http://www.ncleg.net/Sessions/2013/Bills/Senate/HTML/S137v5.html) prohibits waiving of Medicaid co-payments as a regular business practice. NCDMA’s October newsletter, which contains the article at pages 5-7, may be found here. Pharmacists or pharmacies with additional questions should contact NCDMA for further information.
THURSDAY, DECEMBER 12, 2013
PROPER DOCUMENTATION OF RECEIPT OF SCHEDULE II CONTROLLED SUBSTANCES ORDERED USING CSOS
During recent pharmacy inspections, Board investigators have noted that multiple pharmacies have not properly documented receipt of schedule II controlled substance orders when using DEA’s Controlled Substance Ordering System (CSOS).
Board investigators have found the CSOS orders were properly placed in accordance with 21 Code of Federal Regulations (CFR) 1305.21 and 1305.22(a). However, upon receipt of the controlled substances, a copy of the E-222 form was printed and receipt of the order manually noted on paper. This paper receipt process violates 21 CFR 1305.22(g), although Board investigators have found these violations to be unintentional and are treating them as an educational issue, not a disciplinary one. Under that federal rule, when a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received, and that record must be electronically linked to the original order and archived.
Board staff strongly recommend that pharmacies ordering Schedule II controlled substances using CSOS, but unsure how to electronically link the receipt with the original order, contact the schedule II controlled substance supplier for assistance.
MONDAY, DECEMBER 9, 2013
AMENDED RULES GOVERNING AUTOMATED DISPENSING DEVICES NOW IN EFFECT. Amendments to Board of Pharmacy rules governing automated dispensing devices went into effect on December 1, 2013. The amended rules, which may be found here -- http://www.ncbop.org/LawsRules/rules.3400.pdf -- accomplish two primary changes: (1) all automated dispensing devices are now subject to a single, uniform set of standards; separate standards no longer govern “centralized” and “decentralized” automated dispensing devices; (2) the restocking provisions now allow, in certain circumstances, a registered nurse trained and authorized by the pharmacist-manager to conduct restocking tasks provided that an quality-assurance validated electronic verification process is in place.
FRIDAY, DECEMBER 6, 2013
FEDERAL DRUG QUALITY AND SECURITY ACT BRINGING CHANGES TO COMPOUNDING PHARMACY REGULATION. On November 27, 2013, the President signed into law the Drug Quality and Security Act (DQSA). DQSA focuses on two broad issues: (1) further refinement of the state and federal roles in regulating compounding pharmacy practices; and (2) creation and implementation of a national “track and trace” program intended to ensure integrity of the prescription drug supply chain. Compounding pharmacists undoubtedly have questions about the impact of this statute on their practices. Board staff will continue to provide information as available. Earlier this week, FDA issued guidance on the new statute. Compounding pharmacists are strongly advised to read FDA guidance. It may be found here:
- Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)
- Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)
FDA Compounding Statement: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm
TUESDAY, NOVEMBER 26, 2013
BOARD OF PHARMACY INSPECTION FORMS ON LINE. North Carolina pharmacists may find it beneficial to review Board of Pharmacy inspection forms as a means of self-monitoring compliance with pharmacy law. Those forms may be found here: http://www.ncbop.org/phcyinspectionforms.html.
FRIDAY, NOVEMBER 15, 2013
IMPORTANT REFRESHER INFORMATION CONCERNING EPINEPHRINE AUTO-INJECTORS. In the January 2011 Newsletter, at Item 2118, the Board issued the following information concerning the dispensing of epinephrine auto injectors:
* * *
As pharmacists are aware, there are several epinephrine auto injector products on the market – eg, EpiPen, Twinject, Adrenaclick. Because epinephrine auto injectors are used in emergency situations, it is crucial that pharmacists dispensing these devices ensure that the patient or the patient’s caregiver is adequately trained on their proper use at the time of dispensing. Pharmacists must not assume that the patient or patient’s caregiver has been trained by others.
Of course, if a prescriber writes for a particular epinephrine auto injector and signs the prescription “dispense as written” (or handwrites “brand medically necessary” where Medicaid patients are concerned), the pharmacist must dispense the indicated product.
If substitution is permitted, the pharmacist may do so as allowed by North Carolina law.
In either case, the pharmacist should be certain that the patient or patient’s caregiver has been trained on proper use of the particular device dispensed. Absent such training, a patient’s life could be placed in danger.
* * *
Board staff reiterates these crucial public safety points to pharmacists. New epinephrine auto injector products have entered the market since the January 2011.
Currently marketed epinephrine auto-injectors include: Twinject (0.15 mg and 0.3 mg per delivery); Adrenaclick (0.15 mg and 0.3 mg per delivery); Auvi-Q (0.15 mg and 0.3 mg per delivery); Epi-Pen (0.3 mg per delivery); Epi-Pen Jr. (0.15 mg per delivery). Each product carries an Orange Book “BX” rating with respect to other epinephrine auto injectors.
Lineage Therapeutics markets epinephrine injection, USP auto injector, in 0.15 mg and 0.3 mg strengths. This product is an Orange Book AB rated product to Adrenaclick only.
Critically, different epinephrine auto injectors have different operational instructions. When an auto injector is needed, seconds matter. Accordingly, it is imperative that pharmacists: (1) strictly follow relevant law governing substitution; and (2) train the patient or caregiver thoroughly on the proper use of the particular device prescribed and dispensed.
MONDAY, NOVEMBER 4, 2013
DRUG ENFORCEMENT ADMINISTRATION PROPOSED RULE TO MAKE TRAMADOL A SCHEDULE IV CONTROLLED SUBSTANCE. The DEA today published a proposed rule to classify tramadol a Schedule IV controlled substance. The proposal may be found here: http://www.deadiversion.usdoj.gov/fed_regs/rules/2013/fr1104.htm DEA will accept written or electronic comments through January 3, 2014. Information on how to submit comments is provided at this link.
THURSDAY, OCTOBER 24, 2013
ATTENTION ALL PHARMACY PERMIT HOLDERS: The NC Board of Pharmacy is gathering required information for Pharmacy Services that are provided by your pharmacy. Please answer the questions as they apply to the pharmacy services you provide.
Click on the link below. Log in with your permit number and PIN (last 4 digits of the permit number). Then select Pharmacy Services – Update Pharmacy Services Affidavit.
Note: This information is required, and it is important that you comply. Once the renewal period starts, (November 1, 2013), you will not be able to renew unless the information is answered. Chain pharmacies, please note: Each permitted location is required to answer and the corporate office will not be able to renew your permit location until you have done so.
Please direct questions to Wendy Watson: email@example.com.
MONDAY, JUNE 4, 2012 - REMINDER
On May 1, 2012, the NC Board of Pharmacy ceased accepting checks and American Express as forms of payment. THE BOARD ACCEPTS PAYMENT VIA VISA, MASTERCARD OR DISCOVER.
WEDNESDAY, FEBRUARY 22, 2012
CHANGES TO CONTINUING EDUCATION APPROVAL PROCESS BEGINNING MARCH 1, 2012
Beginning March 1, 2012, the Board of Pharmacy will no longer approve requests for continuing education courses that are not accredited by ACPE or the North Carolina Association of Pharmacists (“NCAP”). The reasons for the change in policy are two-fold: (1) the volume of such requests has increased substantially in the past two years, hindering Board staff’s ability to focus on the Board’s core functions; and (2) relatedly, Board staff is concerned about its ability to assess these requests for substantive acceptability as continuing education courses.
Continuing education programs approved by Board staff on or before February 29, 2012 will remain available on the Board CE page and may be used for 2013 license renewal.
Going forward, the Board will continue to provide credit for certain categories of non-ACPE, non-NCAP continuing education (e.g., Board Meeting Attendance, CPR Training, Precepting, Residency, Spanish or Other Foreign Language Class, Continuing Medical Education, Continuing Nursing Education, Continuing Dental Education). Those categories should be well known to North Carolina pharmacists and can be reviewed in the FAQ section of the Board website: (http://www.ncbop.org/faqs/Pharmacist/faq_ContEducation.htm).
Any pharmacist or organization in need of approval of a CE program may contact NCAP, which stands willing and able to provide accreditation services. Information about NCAP accreditation services may be found here: http://www.ncpharmacists.org/displaycommon.cfm?an=1&subarticlenbr=106.
THURSDAY, FEBRUARY 16, 2012
REMINDER: ACCREDITATION COUNCIL FOR PHARMACY EDUCATION (ACPE) REQUIRES PHARMACISTS TO OBTAIN A UNIQUE ID AS PART OF CPE MONITOR INITIATIVE. As the new year begins, Board staff reminds pharmacists that ACPE and the National Association of Boards of Pharmacy have launched “CPE Monitor” – an electronic system for pharmacists and pharmacy technicians to track completed continuing pharmacy education credits. Participation in CPE Monitor requires pharmacists to obtain an NABP e-Profile ID. The e-Profile ID is required by ACPE to receive continuing education credits from ACPE-accredited providers.
Click on the links below for more information:
- CPE Monitor: Information for Pharmacists & Pharmacy Technicians
- CPE Monitor & You
- Protecting Yourself from Identity Theft: Social Security Numbers and CPE Monitor
*Forget your NABP number or need to get one?
CLICK HERE for your NABP e-Profile.
Please note: North Carolina pharmacists will still be required to self-report all continuing education into their Board of Pharmacy account through their personal log-on at the Board’s website. ACPE (or ACPE providers) will not download continuing education information into your Board of Pharmacy account.
Health Advisories (last updated February 17, 2014) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated June 4, 2012) - 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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