Board News and Announcements
The North Carolina Board of Pharmacy's monthly meetings are live-streamed via YouTube. Follow the link below to subscribe to the Board's YouTube channel. (Meeting dates found here.)
MONDAY, SEPTEMBER 19, 2016
NOTICE OF PUBLIC HEARING AND COMMENT PERIOD (JANUARY 17, 2017) ON PROPOSED AMENDMENTS TO RULE 21 NCAC 46 .2201 -- CONTINUING EDUCATION - HOURS: RECORDS: PROVIDERS: CORRESPONDENCE: RECIPROCITY. The Board has proposed the rule amendment in order to facilitate easier continuing education recordkeeping requirements for pharmacists, as well as to allow for more efficient reporting of continuing education hours to the Board and more efficient and accurate review and audit of those records by the Board. In addition, the Board has proposed to decrease the number of “contact” continuing education hours that must be received, as well as to formalize certain exemptions provided by the Board.
A public hearing will be held on January 17, 2017 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 17, 2017 and/or by submitting a written objection by 9:00am on January 17, 2017 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 - http://www.ncbop.org/LawsRules/2201NoticeOfTextCEHours091916.pdf.
• PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .2201: http://www.ncbop.org/LawsRules/2201ProposedLanguageCEHours091916.pdf.
FRIDAY, SEPTEMBER 2, 2016
RECENT AMENDMENT TO FEDERAL CONTROLLED SUBSTANCES ACT ALLOWS PARTIAL FILLS OF A SCHEDULE II CONTROLLED SUBSTANCE PRESCRIPTION. The recently enacted Comprehensive Addiction and Recovery Act of 2016 (“CARA”) amends the federal Controlled Substances Act to allow a pharmacist to partially fill a Schedule II controlled substance prescription.
As pharmacists know, DEA rules previously allowed a Schedule II partial fill only if the pharmacy could not supply the full quantity of the prescription and the pharmacy provided the remainder within 72 hours (with an exception for terminally ill patient).
CARA allows partial fills of Schedule II prescriptions if: (1) state law does not prohibit partial fills of Schedule II prescriptions (North Carolina law does not prohibit partial fills of this sort); (2) the prescription is written and filled in compliance with federal and state law; (3) the partial fill is requested by the patient or the prescriber; and (4) the total quantity dispensed in all partial fills does not exceed the total quantity prescribed.
The total amount of the prescription may be filed no later than 30 days from the date of the prescription. If, however, the Schedule II partial fill is the product of an emergency oral prescription, the 72-hour complete fill restriction remains.
Board staff have, over the years, received many questions about (and expressions of frustration with) the now-amended federal law on Schedule II partial fills. CARA’s amendment should provide a means of better serving patients and decreasing the amount of unwanted and unused Schedule II prescription medications in households.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED SEPTEMBER 6, 2016.)
WEDNESDAY, AUGUST 3, 2016
FDA Releases Draft Guidance, "Insanitary Conditions at Compounding Facilities."
The U.S. Food & Drug Administration (FDA) today issued a draft guidance, Insanitary Conditions at Compounding Facilities, that identifies examples of insanitary conditions that can result in patient harm.
"FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions. The draft guidance has a public comment period of 60 days."
Please follow this link to review FDA's guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM514666.pdf
THURSDAY, JULY 7, 2016
FDA ISSUES TWO DRAFT GUIDANCE DOCUMENTS REGARDING HUMAN DRUG COMPOUNDING. The U.S. Food and Drug Administration announced today that it has issued two draft guidance documents regarding human drug compounding. The draft guidance documents are:
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The draft documents are applicable to State-licensed pharmacies, Federal facilities, outsourcing facilities and physicians who compound drugs. Each draft guidance has a public comment period of 90 days.
Health Advisories (last updated March 7, 2016) - 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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