Board News and Announcements
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
WEDNESDAY, NOVEMBER 27, 2013
ACETAMINOPHEN CONTAINING COMBINATION PRODUCTS –WHAT DOES THE FDA’S APPROACHING JANUARY 14, 2014 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.
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.
MONDAY, NOVEMBER 25, 2013
The NC Board of Pharmacy has an opening for an entry level Investigator/Inspector. The primary duties of the position will be to conduct inspections of retail pharmacies in the Southeastern part of North Carolina.
NC Board of Pharmacy Website Survey -
Board staff would like to thank everyone who participated in our website survey. We received over 1,600 responses. Your feedback is key to our efforts at improving the site and making it a better resource for pharmacists, the pharmacy community, and consumers.
MONDAY, NOVEMBER 18, 2013
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:
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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.
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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.
FRIDAY, NOVEMBER 15, 2013
The next Board election will take place in the Spring of 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. (Click here for a district map and a list of counties that comprise these two districts.)
Nominations are open through March 15, 2014. Board staff encourages any actively licensed pharmacist living in these two districts to find out more about the election process by attending one of two planned forums (one in each of the two districts, see below) in early 2014. Board Staff will be available to answer questions and discuss what it means to serve on the Board.
- The first forum will be held on Thursday, January 16, 2014 at 6:30pm at The McKimmon Center in Raleigh. Address and directions are found here: https://onece.ncsu.edu/mckimmon/contact.jsp.
- The second forum will be held on Thursday, January 30, 2014 at 7:00pm at the Embassy Suites – Charlotte/Concord. Address and directions are found here: http://www.embassysuitesconcord.com/get-here/.
For ease of planning, please email Kristin Moore at the Board of Pharmacy office if you plan to attend and indicate which of the two forums. Or call 919.246.1050 ext. 209.
PHARMACISTS - OBTAIN CONTINUING EDUCATION HOURS FOR YOUR 2014 LICENSE RENEWAL
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED NOVEMBER 20, 2013.)
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.
2014 RENEWAL PERIOD - NOVEMBER 1 THROUGH DECEMBER 31, 2013
All pharmacists, pharmacy technicians, dispensing physicians, NPs, PAs, pharmacy permit holders, and DME permit holders may now renew your license / registration / permit for 2014. Please click here for details and log-in links.
FRIDAY, OCTOBER 25, 2013
Food and Drug Administration Recommends Reclassification of Hydrocodone Combination Products to Schedule II. On October 24, the FDA stated its intent to recommend to the United States Department of Health and Human Services that all hydrocodone combination products be reclassified as Schedule II controlled substances. FDA plans to make the formal recommendation in December. At that point, the Drug Enforcement Administration will begin a process leading to a final decision on rescheduling. Board staff will update pharmacists as the process moves forward. FDA’s statement may be found here: http://www.fda.gov/Drugs/DrugSafety/ucm372089.htm
THURSDAY, OCTOBER 24, 2013
State Auditor Report - The North Carolina State Auditor's Office has released its report of the NC Board of Pharmacy's audit. The report, and the Board's response, may be found here: http://www.ncauditor.net/EpsWeb/Reports/FiscalControl/FCA-2013-8151.pdf
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: firstname.lastname@example.org.
WEDNESDAY, OCTOBER 23, 2013
NOTICE OF PUBLIC HEARING (JANUARY 21, 2014) ON PROPOSED ADOPTION OF RULE 21 NCAC 46 .3501 - REPORTS FROM THE CONTROLLED SUBSTANCES REPORTING SYSTEM. Rulemaking required by Session Law 2013-152, Section 3, in order to receive reports from the Department of Health and Human Services of data from the controlled substances reporting system.
A public hearing will be held on January 21, 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 January 21, 2014 and/or by submitting a written objection by 9:00 a.m. on January 21, 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 email@example.com. 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:
TUESDAY, OCTOBER 8, 2013
CAUTION TO NC PHARMACISTS REGARDING TELEPHONE INQUIRIES ABOUT OXYCODONE INVENTORIES. A North Carolina pharmacy was robbed approximately two weeks ago. Prior to the robbery, a person called the pharmacy to ask the price of oxycodone products and to ask how many oxycodone tablets the pharmacy had on the shelves. Board staff strongly encourages pharmacists and pharmacy staff not to tell a caller how “many” of a controlled substance the pharmacy has in stock. Doing so potentially identifies the pharmacy as a robbery target.
MONDAY, JUNE 10, 2013
Pharmacists licensed in North Carolina may now apply for access to the NC Controlled Substances Reporting System (CSRS) through the Board of Pharmacy’s website. Click here to learn more about the NC CSRS, which is administered by the NC Department of Health and Human Services’ Drug Control Unit.
REGISTER TO ACCESS THE CSRS:
If you are not already registered, CLICK HERE to log in using your license number and PIN (last 4 digits of your Social Security Number), then from the main menu select “CS Reporting.” Follow the prompts from there to complete and submit the application.
Please note that pharmacists typically do not hold an individual DEA number, so pharmacists are advised to provide the DEA number of the pharmacy where they practice most often.
The completed application will go directly to the NC DHHS Drug Control Unit. Accordingly, pharmacists with questions should address them to firstname.lastname@example.org or (919) 733-1765.
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 September 6, 2013) - 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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