Board News and Announcements

 

 

 

 

 

 

JULY 2015 NEWSLETTER

 

WEDNESDAY, JULY 1, 2015

FOOD AND DRUG ADMINISTRATION ANNOUNCES INTENT TO TAKE ACTION AGAINST COMPANIES MANUFACTURING AND DISTRIBUTING CERTAIN PRESCRIPTION OTIC PRODUCTS.  Today, the FDA announced its intent to take action against companies manufacturing the following unapproved prescription drug products:  (1) Single-ingredient otic drug products containing benzocaine; (2) fixed-dose combination otic drug products containing benzocaine and antipyrine; (3) fixed-dose combination otic drug products containing benzocaine, antipyrine, and zinc acetate; (4) fixed-dose combination otic drug products containing benzocaine, chloroxylenol, and hydrocortisone; (5) fixed-dose combination otic drug products containing chloroxylenol and pramoxine; and (6) fixed-dose combination otic drug products containing chloroxylenol, pramoxine, and hydrocortisone.  Any such product that was first marketed after September 19, 2011 is subject to immediate enforcement action.  Companies that marketed such products prior to September 19, 2011, are subject to immediate enforcement if those products are not listed with FDA in compliance with section 510 of the FD&C Act as of today (July 1, 2015).  Companies that marketed such products prior to September 19, 2011 and whose products are listed with the FDA in compliance with section 510 of the FD&C Act as of today (July 1, 2015) will not see enforcement action on products manufactured within 45 days of July 1, 2015 or that is shipped within 90 days of July 1, 2015.  This enforcement delay is intended to allow manufacturers to deplete current inventory and provide a transition period for patients using one of these products.

Pharmacies that have dispensed these products to patients should take note of FDA’s action and begin assisting patients and prescribers with a transition to different drug therapies.  More information is available from FDA here:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 


 

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.

 


 

WEDNESDAY, JUNE 24, 2015 - RUNOFF ELECTION RESULTS CERTIFIED

Please join the Board in congratulating Andrew (Andy) Bowman of Lillington for being elected by North Carolina pharmacists to represent the southeastern district. The Board certified the election results by conference call this morning. Click here to see vote counts in the runoff election.

Mr. Bowman's term will begin May 1, 2016, once officially appointed by Governor McCrory.

The Board and its staff congratulate Mr. Bowman and wish him every success in his mission to protect the public health and safety of North Carolina's citizens.

The Board also expresses its heartfelt appreciation to Jennifer Askew Buxton and to the four other candidates from the southeastern district. Their commitment to public service is evident by their candidacy and the showing of support that each garnered during the election.

 


FRIDAY, JUNE 19, 2015

AMENDED RULE .3301 CLARIFIES REGISTRATION REQUIREMENTS FOR TECHNICIANS WHO PRACTICE AT FREE OR CHARITABLE CLINICS.  Board Rule 21 NCAC 46.3301 has been amended to make clear that technicians who practice solely at free and charitable clinics must register with the Board and complete a training program, but such technicians are exempt from the technician registration fee.  The text of the amended rule may be found here:  http://www.ncbop.org/LawsRules/rules.3300.pdf.

 


 

MONDAY, JUNE 15, 2015

FDA Issues Draft Guidance on Use of Bulk Substances In Compounding for Animal Patients.  On May 19, 2015 the Center for Veterinary Medicine of the Food and Drug Administration (FDA CVM) issued a draft Guidance for Industry (GFI) #230 Compounding Animal Drugs From Bulk Drug Substances and rescinded Compliance Policy Guide (CPG) 608.400 Compounding of Drugs For Use In Animals. CPG 608.400 has been in effect since its inception in 1996 and was revised in 2003. FDA CVM issued GFI #230 in response to sweeping changes in compounding regulation caused by the Drug Quality and Security Act of 2013 in order to bring regulatory enforcement for animal compounding more in line with that for humans. GFI #230 now represents FDA CVM’s current thinking on use of bulk drug substances when compounding for non-human patients.

Board staff thanks Gigi Davidson, BSPh, DICVP, Director of Clinical Pharmacy Services at the NC State College of Veterinary Medicine, for preparing this summary and FAQ guidance.  Gigi also serves as Chair of the USP Compounding Expert Committee. Draft Guidance / FAQs on Use of Bulk Substances In Compounding for Animal Patients.

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JUNE 15, 2015.)

 


 

FRIDAY, MAY 15, 2015

NOTICE OF PUBLIC HEARING (SEPTEMBER 15, 2015) ON PROPOSED AMENDMENT TO RULE 21 NCAC 46 .2612 - STORAGE OF DEVICES AND MEDICAL EQUIPMENT. The Board proposes amending the rule regarding delivery of devices and medical equipment to provide that those items may be delivered from allowed storage sites without first taking those items to permitted locations, if delivery is performed by a bona fide employee of a permitted location.

A public hearing will be held on September 15, 2015 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 September 15, 2015 and/or by submitting a written objection by 9:00am on September 15, 2015 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 jcampbell@ncbop.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:
http://www.ncbop.org/LawsRules/2612ProposedAmendNoticeOfTextStorageDMEMay2015.pdf


PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .2612:
http://www.ncbop.org/LawsRules/2612ProposedAmendStorageDMEMay2015.pdf

 


 

WEDNESDAY, APRIL 1, 2015 - North Carolina Board of Pharmacy Announces a Recall of All Lots of Non- Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and Stability Assurance.

FOR IMMEDIATE RELEASE – April 1, 2015 – Fayetteville, NC.  The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. This recall order is due the pharmacy’s inability to ensure sterility, stability, and potency for these products.  In addition to ordering a recall, the Board of Pharmacy ordered the Prescription Center closed.  The Board has not received a complaint of an injury caused by any recalled product, but use of compounded products lacking assurance of sterility, stability, and potency places patients at risk. MORE INFORMATION HERE.

 


 

WEDNESDAY, MARCH 25, 2015

NOTICE OF PUBLIC HEARING (JUNE 16, 2015) ON PROPOSED AMENDMENT TO RULE 21 NCAC 46 .1801 - RIGHT TO REFUSE A PRESCRIPTION. The Board proposes amending the rule regarding refusal of a prescription in order to judge the validity of prescriptions by reference to the standards set by the occupational licensing boards of the prescribers, rather than by attempting to enumerate those standards in the rule, in light of changing standards set by other boards for those prescribers.

A public hearing will be held on June 16, 2015 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 16, 2015 and/or by submitting a written objection by 9:00am on June 16, 2015 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 jcampbell@ncbop.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:
http://www.ncbop.org/LawsRules/1801NoticeOfTextRightToRefuseRxJune2015.pdf


PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .1801: http://www.ncbop.org/LawsRules/1801ProposedAmendmentRightToRefuseRxJune2015.pdf

 


 

THURSDAY, MARCH 12, 2015

ATTENTION HOSPITAL PHARMACISTS AND PHYSICIANS: Sandoz Pharmaceuticals is recalling multiple lots of fomepizole injection apparently due to FDA concerns at one of the manufacturing facilities. For affected lots and Carolinas Poison Center recommendations for action, please see  http://www.ncpoisoncenter.org/body.cfm?id=36&action=detail&ref=93.

 


 

FRIDAY, MARCH 6, 2015

NORTH CAROLINA CONTROLLED SUBSTANCE REPORTING SYSTEM WEB-INTERFACE REDESIGN.  The Drug Control Unit of the Department of Health and Human Services, which administers the NC CSRS, has redesigned the CSRS web interface.  The aim is to provide users with a more intuitive interface, as well as provide convenient features like password reset, profile update, prescribing history, and easy to read reports.  More information about the redesign is found here: http://www.ncbop.org/PDF/NCControlledSubstanceReportingSystemRedesignMar2015.pdf.

The Drug Control Unit has also produced a short training video, which may be accessed here:  https://ncdmh-dhhs.webex.com/ncdmh-dhhs/ldr.php?RCID=8d0d101b90c441d3ad300d7fcfd01eee.

Pharmacists are reminded of the Board’s expectations with respect to CSRS accessibility and use:  http://www.ncbop.org/faqs/Pharmacist/faq_NCCSRS.htm.

 


 

FRIDAY, MARCH 6, 2015

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.  Board staff has developed a guidance document intended to reduce any confusion about this reporting requirement: http://www.ncbop.org/PDF/CompoundingRiskLevelsandCategoriesMar2015.pdf

 


 

TUESDAY, DECEMBER 9, 2014

VOLUNTEER PHARMACY TECHNICIANS PRACTICING AT FREE CLINIC SITES DO NOT NEED TO COMPLETE A TECHNICIAN REGISTRATION.  In October 2014, Board staff notified pharmacists of a situation in which a non-registered pharmacy technician practicing at a free clinic was found to have diverted controlled substances.  That technician had previously surrendered her registration for engaging in similar diversion at an employing pharmacy.  As a result, Board staff noted that, going forward, volunteer technicians at free clinics would be required to register as technicians and would need to complete that registration by February 28, 2015.  This action was premature, and Executive Director Jay Campbell takes full responsibility, and apologizes, for the prematurity.  Board Rule .3301(d) provides:  “Volunteer pharmacy technicians providing services at a facility which has a pharmacy permit designated as a free clinic shall complete the training program described in G.S. 90-85.15A(b) but need not register with the Board.”

Accordingly, any change in registration requirement for volunteer pharmacy technicians would have to be accomplished by rule amendment. Technicians presently practicing solely in a volunteer capacity at a free clinic are not required to register with the Board. And any technician who has done so as a result of the October 2014 memo may contact the Board for a refund of the registration fee.

The incident that led to the October communication does show that appropriate tracking and vetting of volunteer pharmacy technicians needs to occur. And Board staff looks forward to engaging appropriate stakeholders on an appropriate solution.

 


 

Health Advisories (last updated March 12, 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.


 

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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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