Board News and Announcements
WEDNESDAY, FEBRUARY 3, 2016 - USP CHAPTER <800>
UNITED STATES PHARACOPEIA (USP) PUBLISHES CHAPTER <800> SETTING STANDARDS FOR HANDLING HAZARDOUS DRUGS IN HEALTH CARE SETTINGS
On February 1, 2016, USP published the final version of chapter <800>, which sets forth standards for handling hazardous drugs in health care settings – including, obviously, pharmacies. Chapter <800> helps ensure patient safety, worker safety, and environmental protection. These standards apply to healthcare personnel who handle hazardous drugs, and to all entities that store, prepare, transport, or administer hazardous drugs. The standards become effective on July 1, 2018. After that, Board of Pharmacy staff will be inspecting and enforcing these new standards, which are incorporated by reference into USP chapters <795> and <797> governing compounding. You can access the USP <800> standards through this link: http://www.ncbop.org/faqs/USPChapt800HazardousDrugsFeb2016.pdf.
TUESDAY, FEBRUARY 2, 2016
BOARD ELECTIONS - SPRING 2016
The next Board member elections are scheduled for spring 2016. Board staff hosted two question-and-answer sessions in January - one in Greensboro (Northern District) and one in Asheville (Western District).
Two district seats will be up for election this year: (1) the Western District, which consists of Alexander, Alleghany, Ashe, Avery, Buncombe, Burke, Caldwell, Catawba, Cherokee, Clay, Cleveland, Gaston, Graham, Haywood, Henderson, Jackson, Lincoln, Macon, Madison, McDowell, Mitchell, Polk, Rutherford, Swain, Transylvania, Watauga, Wilkes, and Yancey counties; and (2) the Northern District, which consists of Alamance, Caswell, Forsyth, Guilford, Orange, Person, Rockingham, Stokes, Surry, and Yadkin counties. These two seats are presently held by Board members Bill Mixon and Carol Yates Day, respectively.
Candidates who wish to stand for election may submit a petition signed by 10 pharmacists residing in the relevant district to the Board of Pharmacy by March 10, 2016. To be eligible, the candidate must be a licensed pharmacist residing in one of the counties that comprise the district at the time of election.
All pharmacists licensed in North Carolina and residing in the state as of March 15, 2016 will be eligible to vote in this election. Voting is not limited to pharmacists who reside in the Northern and Western Districts.
MONDAY, JANUARY 4, 2016
RENEWAL PERIOD CONTINUES THROUGH MARCH 1, 2016
The 2016 license/permit renewal period began on November 1, 2015. The Board allows a 60-day grace period beyond the December 31 deadline to renew without penalty. If you have not yet renewed your license, registration, or permit for the current year, please follow this link to log in and renew now:
http://www.ncbop.org/2016renewals.html (All renewal details here, including FAQs, Continuing Education information, etc.)
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED FEBRUARY 4, 2016.)
MONDAY, DECEMBER 14, 2015
BOARD OF PHARMACY ENTERS INTO AN AGREEMENT WITH THE NORTH CAROLINA PHYSICIANS HEALTH PROGRAM TO SERVE AS AN EVALUATION AND MONITORING PROGRAM FOR PHARMACISTS AND PHARMACY PERSONNEL WITH SUBSTANCE ABUSE ISSUES. Earlier this fall, the Board of Pharmacy entered into an agreement with the North Carolina Physicians Health Program (“NCPHP”) to serve as an evaluation and monitoring program for pharmacists and pharmacy personnel. NCPHP is well positioned to serve as a resource for professionals and to facilitate early intervention before impairment or other professional consequences occur. Over the coming weeks, current clients of North Carolina Pharmacy Recovery Network (“NCPRN”) will be transitioned to NCPHP, and more information will be distributed about NCPHP, its team, and its services.
With this transition, the Board of Pharmacy is ending its agreement with NCPRN, and the Board does so with extreme gratitude for NCPRN’s tremendous work for its clients, the profession of pharmacy, and the public health and safety. The transition to NCPHP ensures that these same services – and more – will continue to be available for pharmacists and pharmacy personnel in North Carolina.
More information about NCPHP may be found here: http://www.ncphp.org/.
THURSDAY, DECEMBER 10, 2015
Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination
AUDIENCE: Health Professional, Anesthesiology, Pain Management, Neurology, Pharmacy
ISSUE: FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City, Zhejiang Province, China, may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs.
BACKGROUND: Taizhou manufactures APIs for repackagers and distributors, some of which sell these products to compounding facilities in the United States. FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in injectable drugs. Based on available information, the affected API may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with the affected baclofen, especially when administered directly into the spinal column. For example, use of baclofen API contaminated with particulate matter can result in serious injury if injected directly into the spinal column and may also clog pumps used to administer the medication. There is also a potential risk that the baclofen API may be contaminated by endotoxin or microorganisms. FDA is continuing to investigate this incident.
RECOMMENDATION: FDA recommends that no baclofen API from Taizhou be used to manufacture or compound any injectable drugs. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the MedWatch Safety Alert, including a link to the FDA Statement, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm476514.htm
TUESDAY, NOVEMBER 24, 2015
AMENDED RULE 21 NCAC 46 .1417 EFFECTIVE DECEMBER 1, 2015 - REMOTE MEDICATION ORDER PROCESSING SERVICES. Board Rule 21 NCAC 46.1417 has been amended as a result of a petition for rulemaking submitted by a pharmacy permit holder, in order for the Board to receive public comment on the proposed amendment. Health care facility pharmacies are currently permitted to contract for remote medication order processing only during periods when pharmacists are not present in those pharmacies. The amended rule permits health care facility pharmacies to contract for remote medication order processing to supplement pharmacy services during periods when pharmacists are present in those pharmacies, if done pursuant to the applicable law and rules. The text of the amended rule may be found here: http://www.ncbop.org/LawsRules/rules.1400.pdf.
THURSDAY, NOVEMBER 19, 2015
NORTH CAROLINA DRUG CONTROL UNIT LETTERS TO PRESCRIBERS CONCERNING CONTROLLED SUBSTANCE PRESCRIBING. The NC Drug Control Unit, which administers the Controlled Substance Reporting System, has begun sending unsolicited educational letters to prescribers regarding their patients who have reached a predetermined threshold of obtaining controlled substances from various pharmacies and prescribers.
The letter instructs the prescriber to review the patient’s controlled substances prescription history report available at the NC CSRS practitioner access website, https://nccsrsph.hidinc.com. If the prescriber is not registered with the NC CSRS, the notification contains instructions on how to register in order to access the patient’s report.
More information may be found in this statement from the Drug Control Unit.
WEDNESDAY, NOVEMBER 18, 2015
NOTICE OF PUBLIC HEARING (MARCH 14, 2016) ON PROPOSED AMENDMENTS TO RULE 21 NCAC 46.3101 -- CLINICAL PHARMACIST PRACTITIONER. The Board of Pharmacy and the Medical Board have proposed joint rule changes to the Clinical Pharmacist Practitioner rules, with two principal purposes: (1) to adjust the supervisory procedures to be more effective, in light of experience with the program; and (2) to shift the registration processing function to the Board of Pharmacy.
A public hearing will be held on March 14, 2016, at 5:00pm 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 March 14, 2016 and/or by submitting a written objection by 5:00pm on March 14, 2016 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, email 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 AND PROPOSED RULE (AMENDED LANGUAGE): http://www.ncbop.org/LawsRules/3101CPPNoticeOfTextandPropLanguageNov2015.pdf
TUESDAY, JUNE 30, 2015
FDA Issues the Drug Supply Chain Security Act (DSCSA) Implementation: Product Tracing Requirements for Dispensers - Compliance Policy Guidance
The Drug Supply Chain Security Act (DSCSA) requires dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. Today FDA issued the DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy Guidance. This document announces that FDA does not intend to take enforcement action against dispensers who, prior to November 1, 2015:
1. accept ownership of certain human, finished prescription drugs without receiving the transaction information, transaction history, and a transaction statement (product tracing information) prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); or
2. do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.
Under the DSCSA, a dispenser cannot accept ownership of certain human, finished prescription drugs unless the previous trading partner provides specific information (product tracing information) about those drugs. Additionally, dispensers must provide, capture and maintain the product tracing information associated with such drugs for all qualifying transactions they engage in.
However, FDA recognizes that some dispensers may need more time beyond the July 1st deadline to work with trading partners, to ensure they can properly receive, capture and maintain the product-tracing information required by law.
FDA posted a supporting webinar, “DSCSA Updates and Readiness Check: DSCSA Requirements for Dispensers and other Trading Partners,” and plans to host a series of stakeholder calls in the coming weeks.
Please check http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm to find the latest activities on the DSCSA.
Health Advisories (last updated December 10, 2015) - 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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