North Carolina Administrative Code

21 NCAC 46 .2008 INFORMAL PROCEDURES (a) Before issuing a notice of hearing, the Board may conduct one or more conferences in which a member of the Board and the party or parties meet to consider the possibility of resolving the dispute or any other matter as may aid in the dispo…

21 NCAC 46 .2009 MOTIONS Except as otherwise provided in this Section, parties must file and serve motions related to a contested case at least ten days before the hearing, except those made during the hearing. The presiding officer may decide to hear pre-hearing motions either b…

21 NCAC 46 .2010 TYPES OF INTERVENTION History Note: Authority G.S. 90-85.6; 150B-38; Eff. July 1, 1988; Amended Eff. May 1, 1989; Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 2017; Repealed Eff. August 1, 2020.

21 NCAC 46 .2011 DISQUALIFICATION OF BOARD MEMBERS (a) If a Board member determines that personal bias or other reason for that Board member's disqualification exists in a contested case, that Board member shall decline to participate in the hearing or decision. (b) If any party …

21 NCAC 46 .2012 RESERVED FOR FUTURE CODIFICATION

21 NCAC 46 .2013 SUBPOENAS (a) A party shall file and serve a request for a subpoena, attaching a proposed subpoena. A form of subpoena is available on the Board's website at ncbop.org/lawandrules.htm. The Board may issue the subpoena in accordance with G.S. 150B-39(c). Subpoenas…

21 NCAC 46 .2014 WITNESSES All testimony at the hearing shall be under oath or affirmation and shall be recorded. The presiding officer may exclude witnesses from the hearing room so that they cannot hear the testimony of other witnesses. History Note: Authority G.S. 90-85.6; 150…

21 NCAC 46 .2015 FINAL DECISION In a contested case, the Board shall issue a final agency decision in compliance with G.S. 150B-42. All final agency decisions shall be drafted by Board staff or Board counsel and presented to the presiding officer. In the event that the presiding …

21 NCAC 46 .2016 PROPOSALS FOR DECISIONS (a) When an administrative law judge conducts a hearing pursuant to G.S. 150B-40(e), that statute governs the procedures before the administrative law judge. (b) Within 10 days after the proposal for decision is served on the parties under…

21 NCAC 46 .2017 REAPPLICATIONS, REINSTATEMENT, REHEARING, AND RECONSIDERATION (a) The following terms govern reapplication, reinstatement, rehearing, and other reconsideration requests from a final agency decision, unless otherwise expressly provided in that final agency decisio…

SECTION .2100 - ELECTIONS 21 NCAC 46 .2101 BOARD OF PHARMACY ELECTIONS: COMPOSITION AND DUTIES History Note: Authority G.S. 90-85.7; Eff. April 1, 1983; Repealed Eff. May 1, 1989.

21 NCAC 46 .2102 ELIGIBILITY TO VOTE Eligible voters for Board members shall be the pharmacists licensed in North Carolina and residing in North Carolina on October 31 of the year the election begins. History Note: Authority G.S. 90-85.7; 90-85.22; Eff. April 1, 1983; Amended Eff…

21 NCAC 46 .2103 GEOGRAPHIC REPRESENTATIONS Pharmacist members of the Board shall be elected from five geographic areas of the state. These five geographic areas are: (1) The Western District, consisting of Alexander, Alleghany, Ashe, Avery, Buncombe, Burke, Caldwell, Catawba, Ch…

21 NCAC 46 .2104 COMMITTEE ON NOMINATIONS In the event that no eligible candidates have petitioned for nomination, the Board may appoint an advisory committee on nominations in September of each year that an election for Board position(s) begins. Members of this committee shall s…

21 NCAC 46 .2105 NOMINATION BY PETITION Nominations may also be made by the petition of 10 eligible voters from a geographic area as specified in Rule .2103 of this Section. Any petition shall be filed in the Board office or postmarked before October 1 for the next election. Hist…

21 NCAC 46 .2106 CONSENT TO NOMINATION A person's name shall not be placed on the ballot without their written consent. History Note: Authority G.S. 90-85.7; Eff. April 1, 1983; Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 201…

21 NCAC 46 .2107 BALLOTS: CASTING AND COUNTING (a) The ballot casting period for each election for a Board position shall begin on the November 1 six months prior to the expiration of a Board member's five-year term of office and shall conclude the March 1 after the ballot castin…

21 NCAC 46 .2108 DETERMINATION OF ELECTION RESULTS The determination of election results under this Section shall be in accordance with G.S. 163-111(a)(1) and (b)(1). A copy of G.S. 163-111 is available at www.ncleg.gov. History Note: Authority G.S. 90-85.7; Eff. March 1, 1991; A…

21 ncac 46 .2109 DEVICE AND MEDICAL EQUIPMENT COMMITTEE REPRESENTATIVES History Note: Authority G.S. 90-85.6; 90-85.22; Eff. September 1, 1995; Amended Eff. April 1, 2003; Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 2017; Rep…

SECTION .2200 - CONTINUING EDUCATION 21 NCAC 46 .2201 HOURS: RECORDS: PROVIDERS: CORRESPONDENCE: RECIPROCITY (a) As a condition of license renewal, a pharmacist shall accumulate 15 hours of continuing education annually. (b) Five of these continuing education hours shall be obtai…

SECTION .2300 - PRESCRIPTION INFORMATION AND RECORDS 21 NCAC 46 .2301 PRESCRIPTION: DRUG ORDER REQUIREMENTS (a) Prescription orders shall include, but not be limited to: (1) date of issuance; (2) name and address of patient; (3) name, address and telephone number of prescriber ex…

21 NCAC 46 .2302 RECORDS OF DISPENSING (a) Records of dispensing for original and refill prescriptions shall be made and kept by pharmacies for three years and shall include: (1) the quantity dispensed, if the quantity of the refill is different than the quantity of the original;…

21 NCAC 46 .2303 RECORDS OF PRESCRIPTION FILLING AND REFILLING In a pharmacy with a manual system of recordkeeping of prescription filling and refilling, the dispensing pharmacist shall indicate by date and initial the filling or refilling of a prescription on the document. In a …

21 NCAC 46 .2304 AUTOMATED DATA PROCESSING SYSTEMS An automated data processing system may be employed as a record-keeping system in a pharmacy if the following conditions are met: (1) The system has the capability of producing sight-readable documents of all original and refille…

21 NCAC 46 .2305 SECURITY To maintain the confidentiality of patients' prescription orders, there must exist adequate safeguards or security of the records. History Note: Authority G.S. 90-85.6(a); 90-85.36; Eff. December 31, 1985; Amended Eff. May 1, 1989; Pursuant to G.S. 150B-…

section .2400 - DISPENSING IN HEALTH DEPARTMENT 21 NCAC 46 .2401 MEDICATION IN HEALTH DEPARTMENTS A registered nurse employed by a local health department may dispense prescription drugs or devices under the following conditions: (1) Drugs or devices may be dispensed only to heal…

21 NCAC 46 .2402 TRAINING OF HEALTH DEPARTMENT NURSES (a) No registered nurse may dispense drugs or devices or perform any duties pursuant to G.S. 90-85.34A prior to satisfactory completion of training acceptable to the Board. The Board may require registered nurses to complete a…

21 NCAC 46 .2403 DRUGS AND DEVICES TO BE DISPENSED History Note: Authority G.S. 90-12.7; 90-85.6; 90-85.34A; 115C-375.2A; Eff. March 1, 1987; Amended Eff. September 1, 2016; January 1, 2015; August 1, 2014; May 1, 1989; Pursuant to G.S. 150B-21.3A, rule is necessary without subst…

SECTION .2500 - MISCELLANEOUS PROVISIONS 21 NCAC 46 .2501 SUPERVISION In order to properly exercise the supervision of unlicensed personnel required by these rules, the responsible pharmacist must physically review the prescription order and the dispensed product before the produ…

21 ncac 46 .2502 RESPONSIBILITIES OF PHARMACIST-MANAGER (a) The pharmacist-manager shall assure that prescription legend drugs and controlled substances are safe and secure within the pharmacy. (b) Except as expressly provided in Rule .1616 of this Chapter, the pharmacist-manager…

21 NCAC 46 .2503 RESEARCH PARTICIPATION History Note: Authority G.S. 90-85.3(r); 90-85.6; Eff. May 1, 1989; Expired Eff. November 1, 2017 pursuant to G.S. 150B-21.3A.

21 NCAC 46 .2504 PATIENT COUNSELING (a) In order to ensure that a prescription is safe for a patient and to counsel a patient effectively, a reasonable effort shall be made to obtain, record, maintain, and update patient information that, in the pharmacist's professional judgment…

21 NCAC 46 .2505 VETERINARY PRESCRIPTION DRUGS A drug that under federal law is required, prior to being dispensed, to be labeled with the statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian" may be dispensed only by a license…

21 ncac 46 .2506 EXCEPTIONS TO HEALTH CARE PRACTITIONERS IDENTIFICATION REQUIREMENTS (a) A pharmacist is not required to wear a readily visible badge or other form of identification in the following direct patient care situations: (1) procedures requiring full sterile dress; or (…

21 NCAC 46 .2507 ADMINISTRATION OF VACCINES BY PHARMACISTS (a) An Immunizing Pharmacist shall administer only those vaccines or immunizations permitted by G.S. 90-85.15B and shall do so subject to all requirements of that statute and this Rule. (b) The following words and terms, …

21 NCAC 46 .2508 ELECTRONIC RECORDS Unless otherwise specified in the rules in this Section or other applicable law, any documentation required by the rules in this Section may be electronically created and maintained, provided that the system that creates and maintains the elect…

21 ncac 46 .2509 AVAILABILITY OF PHARMACY RECORDS A pharmacist may disclose pharmacy records to investigators of occupational licensing boards whose licensees have prescribing authority during the course of an investigation of such licensee as permitted by state or federal law. H…

21 NCAC 46 .2510 WAIVER OF ENFORCEMENT The Board may waive the enforcement of specific rules under the following circumstances: (1) The departure from ordinary practice is designed to have a positive impact on the delivery of pharmaceutical care or designed to reduce healthcare e…

21 NCAC 46 .2511 CHARGE FOR STATUS AFFIDAVIT The Board shall charge persons requesting a verified duplicate copy of any license, permit, or registration a fee of twenty-five dollars ($25.00). The Board shall furnish such affidavits free of charge to governmental entities. History…

21 NCAC 46 .2512 Pharmacist Work Conditions A permit holder shall not require a pharmacist to work longer than 12 continuous hours per work day. A pharmacist working longer than six continuous hours per work day shall be allowed during that time period to take a 30 minute meal br…

21 NCAC 46 .2513 DRUG, SUPPLIES AND MEDICAL DEVICE REPOSITORY PROGRAM (a) This Rule establishes the Drug, Supplies and Medical Device Repository Program as specified in G.S. 90-85.44. (b) Definitions. Any term defined in G.S. 90-85.44(a) shall have the same definition under this …

21 NCAC 46 .2514 ADMINISTRATION OF LONG-ACTING INJECTABLES (a) A "long-acting injectable" is drug product formulated to produce sustained release and gradual absorption of the active pharmaceutical ingredient over an extended period of time after administration by subcutaneous or…

21 NCAC 46 .2515 REMOTE WORK BY PHARMACY PERSONNEL (a) Pharmacy personnel may perform pharmacy practice remotely with respect to drugs, devices, or medical equipment dispensed by the permitted pharmacy location by which they are employed. Pharmacy personnel may not engage in phys…

21 NCAC 46 .2516 Emergency closure (a) The pharmacist-manager of a pharmacy has the responsibility and authority to cease some or all of the pharmacy operations when doing so is necessary to fill the pharmacist-manager's responsibility (a) for the safe, lawful and secure receipt …

SECTION .2600 – DEVICES 21 ncac 46 .2601 DISPENSING AND DELIVERY (a) Devices, as defined in G.S. 90-85.3(e), shall be dispensed only in a pharmacy as defined in G.S. 90-85.3(q) or other place registered with the Board pursuant to G.S. 90-85.22. Medical equipment, as defined in G.…

21 NCAC 46 .2602 ORDERS Devices as defined in G.S. 90-85.3(e), shall be dispensed to outpatients only pursuant to an order from a practitioner. Such orders shall comply in all pertinent respects with G.S. 106-134.1(a) and (b). Use of devices for outpatients shall be in compliance…

21 NCAC 46 .2603 EDUCATION AND TRAINING Persons, other than pharmacists, who are authorized to dispense devices and who dispense devices shall demonstrate to the Board's satisfaction that they have received sufficient education and training in dispensing devices so that they can …

21 NCAC 46 .2604 RECORDS (a) All orders and records for devices and medical equipment shall conform in all pertinent respects with Board Rules .2301 through .2305 of this Chapter and shall be maintained at the dispensing site. In addition to the requirements of those rules, the s…

21 ncac 46 .2605 REGISTRATION OF NON-PHARMACISTS (a) Registration of persons other than pharmacists dispensing devices or delivering medical equipment, pursuant to G.S. 90-85.22, shall be issued by the Board to the person in charge of the location dispensing the devices or delive…

21 NCAC 46 .2606 CONVEYING WARNINGS Persons in charge or pharmacists dispensing devices or delivering medical equipment, as defined in G.S. 90-85.22, shall be responsible for promptly conveying to patients all pertinent warnings issued by government agencies or manufacturers. His…