Board News and Announcements

 

 

 

 

 

 

JULY 2015 NEWSLETTER

 

THURSDAY, JULY 23, 2015

NOTICE OF PUBLIC HEARING (SEPTEMBER 15, 2015) AND COMMENT PERIOD (OCTOBER 19, 2015) ON PROPOSED AMENDMENT TO RULE 21 NCAC 46. 1417 -- REMOTE MEDICATION ORDER PROCESSING SERVICES.  The Board has proposed the rule amendment 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 proposed rule amendment would permit 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.

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 October 19, 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 comment period was initially to end on September 15, 2015, but has been extended to October 19, 2015 at 9:00am, so that the Board may receive any additional comments.  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 - NOTE THAT COMMENT PERIOD EXTENDED TO OCTOBER 19, 2015 AT 9:00AM: http://www.ncbop.org/LawsRules/1417NoticeOfTextRemoteMedOrderProcJuly2015.pdf

PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .1417: http://www.ncbop.org/LawsRules/1417ProposedRuleLanguageRemoteMedOrderProcJuly2015.pdf

 


 

TUESDAY, JULY 7, 2015

AMENDMENTS TO PHARMACY TECHNICIAN RULES WERE EFFECTIVE JULY 1, 2015.  Amendments to Board Rule .3301, which speaks to pharmacy technician registration, went into effect on July 1, 2015.  Among other things, amended Rule .3301 clarifies that pharmacy technicians who provide services solely at a free clinic (as defined at G.S. 90-85.44) are required to register as technicians, but are exempt from the registration fee.  Implementation of a fee-exempt registration will require a programming change to the Board’s on-line registration system for technicians.  Accordingly, Board staff does not expect technicians practicing solely at free clinics to register until the programming change has been completed.  When the programming is completed, Board staff will provide notice on the Board’s website as well as through the Board’s listserv.  Pharmacist-managers with questions are welcome to call or email Board staff with any questions.  Thank you to pharmacists and technicians who each day provide terrific service to North Carolina citizens at free and charitable clinics.

 


 

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.

 


 

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

 


 

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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