reglab/statecodes huggingface dataset:
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2300 - PRESCRIPTION INFORMATION AND RECORDS › Section 46 .2301 - PRESCRIPTION: DRUG ORDER REQUIREMENTS

Current through Register Vol. 39, No. 2, July 15, 2024
(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 except that indication of the name of the prescriber is sufficient
				if a data file specified in (b) of this Rule is current and in
				effect;
(4) Drug Enforcement Agency
				(DEA) number of prescriber in the case of controlled substances;
(5) name, strength, dosage form and quantity
				of drug prescribed;
(6) refills if
				authorized or, in institutions, the stop date;
(7) route of administration of drug
				prescribed; and
(8) directions for
				use.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2300 - PRESCRIPTION INFORMATION AND RECORDS › Section 46 .2302 - RECORDS OF DISPENSING

Current through Register Vol. 39, No. 2, July 15, 2024
(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;
(2) the date of dispensing;
(3) the serial number (or equivalent in an
				institution);
(4) the
				identification of the pharmacist responsible for dispensing; and
(5) records of refills to date.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2300 - PRESCRIPTION INFORMATION AND RECORDS › Section 46 .2303 - RECORDS OF PRESCRIPTION FILLING AND REFILLING

Current through Register Vol. 39, No. 2, July 15, 2024
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 pharmacy with an automated data processing system as provided in Rule .2304
				  of this Section, a designation of the dispensing pharmacist filling or
				  refilling each prescription is required as provided in Rule .2304 of this
				  Section. Information must be kept for three years. This does not preclude the
				  use of unlicensed personnel entering information in a data system provided that
				  supervision is maintained pursuant to Board rules.
Authority
				  G.S.
				  90-85.6(a);
				  90-85.26;
				  90-85.32;
Eff.
				  December 31, 1985;
Amended Eff. March 1, 2013; May 1,
				  1989;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2300 - PRESCRIPTION INFORMATION AND RECORDS › Section 46 .2304 - AUTOMATED DATA PROCESSING SYSTEMS

Current through Register Vol. 39, No. 2, July 15, 2024
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 refilled prescription
				information. The term "sight-readable" means that a regulatory agent is able to
				examine the record and read the information. In administrative proceedings
				before the Board, records must be provided in a readable paper printout
				form.
(2) Information includes the
				prescription requirements and records of dispensing as indicated in Rules .2301
				and .2302 of this Section.
(3) The
				individual pharmacist responsible for completeness and accuracy of the entries
				to the system provides documentation of the fact that prescription information
				entered into the computer is correct.
(4) Documentation in Item (3) of this Rule is
				provided in the pharmacy within 72 hours of date of dispensing.
(5) An auxiliary recordkeeping system is
				established for the documentation of refills if the automated data processing
				system is inoperative for any reason. When the automated data processing system
				is restored to operation, the information regarding prescriptions filled,
				refilled or transferred during the inoperative period shall be entered into the
				automated data processing system within the time equal to the number of
				inoperative days times three; for example, if the system were inoperative for
				five days then all interim data shall be entered within 15 days of the last
				inoperative day. However, nothing in this Item precludes the pharmacist from
				using professional judgment for the benefit of a patient's health and safety.
				The auxiliary record keeping system shall be backed up at least
				weekly.
(6) The pharmacy makes
				arrangements with the supplier of data processing services or materials to
				assure that the pharmacy continues to have adequate and complete prescription
				and dispensing records if the relationship with the supplier is terminated for
				any reason. A pharmacy shall assure continuity in the maintenance of
				records.
(7) A current version of
				drug interactions software is used and policies and procedures are established
				to address overriding the software's alerts of any drug interactions.
Authority
				  G.S.
				  90-85.6(a);
				  90-85.26;
				  90-85.32;
				  90-107;
Eff. December
				  31, 1985;
Amended Eff. March 1, 2013; April 1, 1999; May 1,
				  1989;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2300 - PRESCRIPTION INFORMATION AND RECORDS › Section 46 .2305 - SECURITY

Current through Register Vol. 39, No. 2, July 15, 2024
To maintain the confidentiality of patients' prescription
				  orders, there must exist adequate safeguards or security of the
				  records.
Authority
				  G.S.
				  90-85.6(a);
				  90-85.36;
Eff.
				  December 31, 1985;
Amended Eff. May 1, 1989;
Pursuant
				  to G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2400 - DISPENSING IN HEALTH DEPARTMENT › Section 46 .2401 - MEDICATION IN HEALTH DEPARTMENTS

Current through Register Vol. 39, No. 2, July 15, 2024
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
				health department patients, with the exception of:
(a) opioid antagonists, which may be
				dispensed either to health department patients or to others as permitted by
				G.S.
				90-12.7; and
(b) epinephrine auto-injectors, which may be
				dispensed either to health department patients or to school personnel as
				permitted by
				G.S.
				115C-375.2A;
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2400 - DISPENSING IN HEALTH DEPARTMENT › Section 46 .2402 - TRAINING OF HEALTH DEPARTMENT NURSES

Current through Register Vol. 39, No. 2, July 15, 2024
(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 additional training regarding substantive changes in the law governing
				labelling and packaging of prescription drugs and devices.
(b) Proposed curricula for initial training
				for registered nurses secured by health departments must be submitted to the
				Board for its approval no later than 60 days prior to the date training is to
				commence. No registered nurses may be enrolled in any such proposed training
				course until written Board approval is obtained. Initial training must include,
				but need not be limited to, instruction in labelling and packaging of
				prescription drugs and devices.
(c)
				Written proposals shall be sent to the Board's offices, and shall include the
				following information:
(1) description of
				topics or courses to be covered;
(2) instructor for each topic or course, and
				his or her qualifications and credentials;
(3) anticipated duration of each topic or
				course.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2400 - DISPENSING IN HEALTH DEPARTMENT › Section 46 .2403 - REPEALED - DRUGS AND DEVICES TO BE DISPENSED

Current through Register Vol. 39, No. 2, July 15, 2024
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
				  substantive public interest Eff. October 3, 2017;
Amended Eff.
				  March 1, 2019;
Repealed Eff. October 1,
				  2022.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2501 - SUPERVISION

Current through Register Vol. 39, No. 2, July 15, 2024
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 product is
				  delivered to the patient or person acting on the patient's
				  behalf.
Authority
				  G.S.
				  90-85.6;
				  90-85.40(a);
Eff. May 1, 1989;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2503 - EXPIRED - RESEARCH PARTICIPATION

Current through Register Vol. 39, No. 2, July 15, 2024
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.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2504 - PATIENT COUNSELING

Current through Register Vol. 39, No. 2, July 15, 2024
(a) "Patient
				Counseling" shall mean the effective communication of information, as defined
				in this Rule, to the patient or representative in order to improve therapeutic
				outcomes by maximizing proper use of prescription medications, devices, and
				medical equipment. All provisions of this Rule shall apply to device and
				medical equipment permit holders, except Subparagraph (a)(8) of this Rule and
				except where otherwise noted. Specific areas of patient counseling include, but
				are not limited to, those matters listed in this Rule that in the exercise of
				the pharmacist's or device and medical equipment permit holder's professional
				judgment are considered significant:
(1)
				name, description, and purpose of the medication;
(2) route, dosage, administration, and
				continuity of therapy;
(3) special
				directions for use by the patient;
(4) common severe side or adverse effects or
				interactions and therapeutic contraindications that may be encountered,
				including their avoidance, and the action required if they occur;
(5) techniques for self-monitoring drug
				therapy;
(6) proper
				storage;
(7) prescription refill
				information; and
(8) action to be
				taken in the event of a missed dose.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2505 - VETERINARY PRESCRIPTION DRUGS

Current through Register Vol. 39, No. 2, July 15, 2024
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 licensed veterinarian or by a pharmacist from a pharmacy
				  pursuant to prescription or order of a licensed veterinarian.
Authority
				  G.S.
				  90-85.3;
				  90-85.6;
Eff.
				  September 1, 1995;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2506 - EXCEPTIONS TO HEALTH CARE PRACTITIONERS IDENTIFICATION REQUIREMENTS

Current through Register Vol. 39, No. 2, July 15, 2024
(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
(2) procedures requiring other protective
				clothing or covering.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2507 - ADMINISTRATION OF VACCINES BY PHARMACISTS

Current through Register Vol. 39, No. 2, July 15, 2024
(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, when used
				in this Rule, have the following meanings:
(1) "Administer" means the direct application
				of a drug to the body of a patient by injection, inhalation, ingestion, or
				other means by:
(A) an Immunizing
				Pharmacist;
(B) a Pharmacy Intern
				or registered pharmacy technician who is under the supervision of an Immunizing
				Pharmacist; or
(C) the patient at
				the direction and under the direct, in-person supervision of either an
				Immunizing Pharmacist or a health care provider authorized by North Carolina
				law to prescribe the vaccine.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2508 - ELECTRONIC RECORDS

Current through Register Vol. 39, No. 2, July 15, 2024
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 electronic record:
(1) is capable of printing the documentation
				so that the pharmacist-manager can provide it to the Board within 48 hours of a
				request;
(2) contains security
				features to prevent unauthorized access to the records; and
(3) contains daily back-up functionality to
				protect against record loss.
Authority
				  G.S.
				  90-85.6;
				  90-85.26;
				  90-85.30;
				  90-85.32;
				  90-85.33;
				  90-85.35;
				  90-85.36;
				  90-85.47;
				  90-106;
				  90-107;
Eff. March 1,
				  2013;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2509 - AVAILABILITY OF PHARMACY RECORDS

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
				  G.S.
				  90-85.6;
				  90-85.36;
Eff. March
				  1, 2004;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2510 - WAIVER OF ENFORCEMENT

Current through Register Vol. 39, No. 2, July 15, 2024
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
				expenditures;
(2) Patient health
				and safety are not compromised by the waiver;
(3) A policy and procedure manual detailing
				the type and method of operation, hours of operation, and method of
				documentation of continuing pharmacist control accompanies the application;
				and
(4) The waiver is subject to
				continuing compliance with the conditions approved by the Board.
Authority
				  G.S.
				  90-85.6;
				  90-85.34;
				  150B-19(6);
Eff. July 1, 2004;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2511 - CHARGE FOR STATUS AFFIDAVIT

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
				  G.S.
				  90-85.24(a)(16);
Eff. March 1, 2006;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2512 - PHARMACIST WORK CONDITIONS

Current through Register Vol. 39, No. 2, July 15, 2024
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 break and one additional 15 minute break.
Authority
				  G.S.
				  90-85.2;
				  90-85.6(a);
				  90-85.21(a);
				  85-32(a);
Eff. April 1, 2007;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2513 - DRUG, SUPPLIES AND MEDICAL DEVICE REPOSITORY PROGRAM

Current through Register Vol. 39, No. 2, July 15, 2024
(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 Rule.
(c) Requirements For a Pharmacy to
				Participate in Accepting and Dispensing Donated Drugs, Supplies and Medical
				Devices.
(1) Any pharmacy or free clinic
				holding a valid, current North Carolina pharmacy permit may accept and dispense
				donated drugs, supplies and medical devices in accordance with the requirements
				of this Rule and
				G.S.
				90-85.44.
(2) A dispensing physician registered with
				the Board in compliance with
				G.S.
				90-85.21(b) and providing
				services to patients of a free clinic that does not hold a pharmacy permit may
				accept and dispense donated drugs, supplies and medical devices in accordance
				with the requirements of this Rule and
				G.S.
				90-85.44.
(3) A participating pharmacy or dispensing
				physician shall notify the Board in writing of such participation at the time
				participation begins and annually on its permit or registration renewal
				application.
(4) A participating
				pharmacy or dispensing physician that ceases participation in the program shall
				notify the Board in writing within 30 days of doing so and shall submit a
				written report detailing the final disposition of all donated drugs, supplies
				and medical devices held by the participating pharmacy or dispensing
				physician.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2514 - ADMINISTRATION OF LONG-ACTING INJECTABLES

Current through Register Vol. 39, No. 2, July 15, 2024
(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 intramuscular
				injection.
(b) "Administer" means
				the direct application of a drug to the body of a patient by injection by:
(1) an Immunizing Pharmacist;
(2) a pharmacy intern who is under the
				direct, in-person supervision of an Immunizing Pharmacist; or
(3) the patient at the direction and under
				the direct, in-person supervision of either an Immunizing Pharmacist or a
				health care provider authorized by North Carolina law to prescribe the
				long-acting injectable.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2500 - MISCELLANEOUS PROVISIONS › Section 46 .2515 - REMOTE WORK BY PHARMACY PERSONNEL

Current through Register Vol. 39, No. 2, July 15, 2024
(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
				physical acts in the dispensing process in remote locations outside the
				permitted pharmacy location. The pharmacist-manager must ensure that pharmacy
				personnel are able to perform at the same level of competence, attention, and
				proficiency as if the personnel were physically present in the pharmacy,
				including having secure access to the pharmacy's information system, and that
				all applicable state and federal laws, rules, and regulations are
				followed.
(b) Out-of-state permit
				holders may permit remote pharmacy practice by their own employees with respect
				to drugs, devices, or medical equipment dispensed by those pharmacy locations
				into the State of North Carolina only to the extent permitted by the laws of
				the states in which they are located.
(c) This Rule does not include services
				provided by someone who is not an employee of the permitted pharmacy location
				that is dispensing the drug, device, or medical equipment. Any such remote
				medication order entry services are governed by Rule .1816 of this
				Chapter.
Authority
				  G.S.
				  90-85.6;
				  90-85.21;
				  90-85.21A;
				  90-85.26;
				  90-85.32;
				  90-85.34;
Eff. May 1,
				  2022.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2601 - DISPENSING AND DELIVERY

Current through Register Vol. 39, No. 2, July 15, 2024
(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.S.
				90-85.3(l1) shall be
				delivered only by 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. Devices dispensed in hospitals and
				medical equipment delivered by hospitals are presumed to be the responsibility
				of the hospital pharmacy unless otherwise registered. This Rule shall apply
				only to entities engaged in the regular activity of delivering medical
				equipment.
(b) A pharmacy
				dispensing and delivering devices and medical equipment and not holding a
				device and medical equipment permit shall operate its device and medical
				equipment business at the same physical location as the pharmacy and through
				the same legal entity that holds the pharmacy permit. The pharmacist-manager
				shall be responsible for the dispensing and delivery of devices and medical
				equipment.
(c) Device and medical
				equipment permits shall not be issued to applicants located on residential
				property.
Authority
				  G.S.
				  90-85.3(e), (l1), (r);
				  90-85.6;
				  90-85.22;
Eff. October
				  1, 1990;
Amended Eff. March 1, 2006; March 1, 2004; October 1,
				  1995;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2602 - ORDERS

Current through Register Vol. 39, No. 2, July 15, 2024
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 with
				  G.S.
				  90-85.3(t).
Authority
				  G.S.
				  90-85.3(e),(r);
				  90-85.6;
				  90-85.22;
Eff. October
				  1, 1990;
Amended Eff. April 1, 1997;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2603 - EDUCATION AND TRAINING

Current through Register Vol. 39, No. 2, July 15, 2024
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 safely and properly dispense devices.
				  Persons, other than pharmacists, who are authorized to deliver medical
				  equipment and who deliver medical equipment shall demonstrate to the Board's
				  satisfaction that they have received sufficient education and training in the
				  delivery of medical equipment so that they can safely and properly deliver
				  medical equipment.
Authority
				  G.S.
				  90-85.3(e), (l1), (r);
				  90-85.6;
				  90-85.22;
Eff. October
				  1, 1990;
Amended Eff. September 1, 1995;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2604 - RECORDS

Current through Register Vol. 39, No. 2, July 15, 2024
(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 serial numbers for all devices dispensed and all medical equipment
				delivered to outpatients shall be preserved as part of the records; provided,
				that this requirement shall not apply to disposable devices and medical
				equipment.
(b) All prescriptions
				and refill orders for devices and medical equipment shall be maintained at the
				dispensing site for at least three years.
(c) All device and medical equipment permit
				holders shall maintain a file copy of every item sold or rented with a serial
				number or tracking number or code in compliance with FDA Medical Device
				Tracking requirements.
Authority
				  G.S.
				  90-85.3(e),(l1),(r);
				  90-85.6;
				  90-85.22;
Eff. October
				  1, 1990;
Amended Eff. April 1, 1999; September 1, 1995;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2605 - REGISTRATION OF NON-PHARMACISTS

Current through Register Vol. 39, No. 2, July 15, 2024
(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 delivering medical
				equipment. This person shall have responsibilities comparable to those of a
				pharmacist-manager pursuant to Board Rule .2502 of this Chapter, as applicable.
				Persons in charge shall keep on file for three years on the premises of each
				place where devices are dispensed or medical equipment is delivered all
				information related to warranties provided by manufacturers and the
				availability of repairs; provided, that this requirement shall not apply to
				disposable devices and medical equipment. A person shall be in charge of only
				one location.
(b) A person in
				charge shall not:
(1) commit a
				felony;
(2) commit any act as a
				principal in a business entity that causes such entity to be excluded from
				participation in a federal or state program.
If a person in charge commits the conduct set out in
				  Paragraphs (b)(1) and (b)(2) of this Rule while he or she is a person in
				  charge, he or she shall no longer serve as a person in charge for the existing
				  permit or for any other device and medical equipment permit.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2606 - CONVEYING WARNINGS

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
				  G.S.
				  90-85.3(e), (l1), (r);
				  90-85.6;
				  90-85.22;
Eff. October
				  1, 1990;
Amended Eff. September 1, 1995;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2607 - AVAILABILITY OF RECORDS

Current through Register Vol. 39, No. 2, July 15, 2024
All records required to be kept by statute or rule shall be
				  available to Board inspectors or agents as provided in Rule .1803 of this
				  Chapter. All records, including prescription orders, equipment information, and
				  patient counseling documentation, shall be archived in a readily retrievable
				  manner and open for review, copying or seizure by the Board or its designated
				  employees within 48 hours of a request for inspection for a period of three
				  years.
Authority
				  G.S.
				  90-85.3(e),(r);
				  90-85.6;
				  90-85.22;
Eff. October
				  1, 1990;
Amended Eff. February 1, 2007;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2608 - DISPENSING OF MEDICAL OXYGEN

Current through Register Vol. 39, No. 2, July 15, 2024
Compressed medical oxygen and liquid oxygen equipment shall
				  be dispensed and controlled according to state and federal
				  laws.
Authority
				  G.S.
				  90-85.3(e),(l1),(r);
				  90-85.6;
				  90-85.22;
Eff.
				  September 1, 1995;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2609 - REHABILITATION EQUIPMENT

Current through Register Vol. 39, No. 2, July 15, 2024
(a)
				Rehabilitation equipment suppliers shall follow the provisions of this Rule
				rather than the provisions of
				21 NCAC
				46 .2611.
(b) Rehabilitation equipment suppliers shall:
(1) Solicit information from the physician,
				physical therapist, occupational therapist, registered nurse and other medical
				or educational personnel, as to the results of their assessment and evaluation
				of the patient's physical, functional and associated needs as well as the
				specific goals to be met by the enabling technology;
(2) In consultation with the referring health
				professional(s), patient, patient's family and other primary care providers,
				delineate the appropriate choices of commercially available and custom
				fabricated equipment to meet the specified needs of the patient;
(3) Participate in the measurement of the
				patient, utilizing appropriate instruments and techniques to assure the fit and
				function of the selected equipment;
(4) Deliver, fit and adjust the prescribed
				equipment;
(5) Instruct the patient
				and family in the safe and proper use and care of the equipment
				provided;
(6) Provide service and
				support for the equipment delivered through knowledgeable, skilled and trained
				service personnel and within 72 hours, provide a response to patient requests
				for repair service on equipment supplied; however, such service and support
				need not be provided unless the patient=s account is current;
(7) Provide a specific, written statement of
				warranty on the equipment provided, including commercial warranties and those
				for adapted or custom fabricated items;
(8) Maintain liability insurance of at least
				one million dollars ($1,000,000) worth of coverage and when involved in the
				design, fabrication or substantial modification of commercially available
				equipment, also maintain product liability insurance; and
(9) Utilize written, quality assurance
				procedures including, but not limited to:
(A)
				Reviewing custom designed and fabricated equipment and interfacing techniques
				with commercial equipment to assure compatibility and safety;
(B) Understanding the properties of the
				materials being used in custom designed and modified equipment to assure long
				term durability;
(C) Documenting
				goals and objectives of the referring medical or education personnel, as well
				as short and long term effectiveness of the equipment in meeting those goals
				and objectives; and
(D) Documenting
				complaints and problems as required in Rule .1608(a)(12) of this
				Chapter.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2610 - MEDICAL GAS, OXYGEN AND RESPIRATORY RELATED EQUIPMENT

Current through Register Vol. 39, No. 2, July 15, 2024
(a) Medical gas, oxygen and respiratory
				related equipment suppliers shall:
(1) Comply
				with all applicable home medical equipment laws of North Carolina;
(2) If transporting oxygen and other medical
				gases in cylinder or liquid form, comply with all current Department of
				Transportation rules and regulations;
(3) If transfilling medical oxygen systems,
				comply with Food and Drug Administration (FDA) and all state agency
				requirements regarding transfilling and repackaging;
(4) Demonstrate that oxygen provided in
				cylinder or liquid form meets minimal purity standards for medical grade
				oxygen;
(5) Comply with local/state
				fire and building laws; and
(6)
				Meet the following safety inspection requirements:
(A) Demonstrate that each piece of
				oxygen/respiratory equipment has been checked, is free of defect, and operates
				within the manufacturers' specifications;
(B) Refrain from modifying equipment to the
				extent that the modification might reasonably cause harm;
(C) Maintain all electrical components so
				that they do not present a fire or shock hazard; and
(D) Ensure that all appropriate warning
				labels or labeling, including tags, are present on the equipment
				provided.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2611 - MEDICAL EQUIPMENT

Current through Register Vol. 39, No. 2, July 15, 2024
(a) Medical
				equipment suppliers shall:
(1) Document
				information from the physician or other medical personnel as to the patient's
				specific needs to be met by the equipment delivered as well as the
				effectiveness of the equipment in meeting those needs;
(2) In consultation with the referring health
				professional(s), patient, patient's family and other primary care providers,
				delineate the appropriate choices of commercially available equipment to meet
				the specified needs of the patient;
(3) Participate in the measurement of the
				patient, utilizing appropriate instruments and techniques to assure the fit and
				function of the selected equipment;
(4) Deliver, fit and adjust the prescribed
				equipment;
(5) Instruct the patient
				or family in the safe and proper use and care of the equipment provided in
				compliance with Rule .2504 of this Chapter;
(6) Provide service and support for the
				equipment dispensed or delivered and, within 72 hours, provide a response to
				patient requests for repair service on equipment supplied; however, such
				service and support need not be provided unless the patient=s account is
				current;
(7) Maintain liability
				insurance of at least one million dollars ($1,000,000) worth of
				coverage;
(8) Demonstrate that each
				item sold or rented has been checked, is free of defect, and operates within
				the manufacturers' specifications;
(9) Refrain from modifying equipment to the
				extent that the modification might reasonably cause harm;
(10) Maintain all electrical components so
				that they do not present a fire or shock hazard;
(11) Ensure that all appropriate warning
				labels or labeling, including tags, are present on the equipment
				provided;
(12) Maintain
				documentation demonstrating that a function and safety check of equipment was
				performed prior to set up;
(13)
				Maintain an established protocol for cleaning and disinfecting equipment which
				addresses both aerobic and anaerobic pathogens including procedures to prevent
				cross-contamination; and
(14) Clean
				and disinfect equipment according to manufacturers' specifications.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2612 - STORAGE OF DEVICES AND MEDICAL EQUIPMENT

Current through Register Vol. 39, No. 2, July 15, 2024
(a)
				Devices and medical equipment shall be stored at the location holding the
				pharmacy or device and medical equipment permit or a location that is within 50
				miles of the permitted location. Devices and medical equipment shall not be
				stored on residential property.
(b)
				A device and medical equipment storage site not holding a pharmacy or device
				and medical equipment permit shall not provide any devices, medical equipment,
				or services directly to patients. An employee of a permitted location who has
				been trained as required by Rule .2603 of this Chapter may travel from the
				permitted site to a storage site, retrieve devices or medical equipment from
				the storage site, and deliver devices or medical equipment to
				patients.
(c) Device and medical
				equipment storage sites shall be subject to inspection by the Board under the
				same standards applicable to permitted sites.
Authority
				  G.S.
				  90-85.6;
				  90-85.22;
				  90-85.32;
Eff. March
				  1, 2004;
Amended Eff. November 1, 2015; February 1,
				  2007;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2600 - DEVICES › Section 46 .2613 - DEVICES AND MEDICAL EQUIPMENT IN POSSESSION OF PERMIT HOLDERS

Current through Register Vol. 39, No. 2, July 15, 2024
Dispensed devices and medical equipment in the possession of
				  permit holders shall bear a patient-specific prescription label. Permit holders
				  may not collect prescription drugs from a patient or caregiver, nor may a
				  permit holder store prescription drugs on behalf of a patient or
				  caregiver.
Authority
				  G.S.
				  90-85.6;
				  90-85.22;
				  90-85.32;
Eff. April
				  1, 2007;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2700 - NUCLEAR PHARMACY › Section 46 .2701 - REQUIREMENTS

Current through Register Vol. 39, No. 2, July 15, 2024
No pharmacist shall receive, possess or dispense radioactive
				  drugs, except in accordance with the applicable federal statutes and
				  regulations and these Rules. The requirements of these Rules are in addition
				  to, and not in substitution for, other applicable provisions of the regulations
				  of any federal or state agency with authority for regulating the use and
				  distribution of radioactive materials.
Authority
				  G.S.
				  90-85.6;
Eff. October 1,
				  1990;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2700 - NUCLEAR PHARMACY › Section 46 .2702 - DEFINITIONS

Current through Register Vol. 39, No. 2, July 15, 2024
For purposes of these Rules, the following terms are defined
				  as follows:
(1) Authentication of
				Product History. Identifying the purchasing source, the ultimate fate, and any
				intermediate handling of any component of a radiopharmaceutical or other
				radioactive drug.
(2) Nuclear
				Pharmacy. A pharmacy holding a permit issued by the North Carolina Board of
				Pharmacy and licenses issued by the Nuclear Regulatory Commission (NRC) and
				other state regulatory agencies, where prescriptions for radiopharmaceutical
				products are filled, compounded, or dispensed.
(3) Nuclear Pharmacy Practice. A
				patient-oriented service that embodies the scientific knowledge and
				professional judgment required to improve and promote health through the
				assurance of the safe and efficacious use of radiopharmaceuticals.
(4) Nuclear Pharmacy Technician. Any person
				involved in the dispensing of a radiopharmaceutical, not satisfying the
				definition of Qualified Licensed Professional; any such person must be
				registered as a Pharmacy Technician with the State Board of Pharmacy.
(5) Qualified Licensed Professional. A
				non-pharmacist possessing a valid license issued by the North Carolina Medical
				Board, the North Carolina Board of Nursing, the North Carolina Dental Board or
				the North Carolina Board of Veterinary Medicine, and who has sufficient
				training and experience to safely handle and dispense radiopharmaceuticals as
				defined by the respective requirements of the regulations of the NRC or the
				state nuclear regulatory agencies.
(6) Qualified Nuclear Pharmacist. A
				pharmacist currently licensed by the Board who meets the following standards:
(a) Certification as a nuclear pharmacist by
				the "Board of Pharmaceutical Specialties"; or
(b) Meets minimum standards of training for
				"authorized user status" of radioactive material in accordance with the
				licensure guide of the United States Nuclear Regulatory Commission or the
				appropriate state nuclear regulatory agencies as follows:
(i) Has received a minimum of 200 contact
				hours of instruction in nuclear pharmacy and the safe handling and use of
				radioactive materials from an approved college of pharmacy, including
				instruction in the following areas: radiation physics and instrumentation;
				radiation protection; mathematics of radioactivity; radiation biology; and
				radiopharmaceutical chemistry; and
(ii) Has a minimum of 500 hours of clinical
				nuclear pharmacy training under the supervision of a qualified nuclear
				pharmacist.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2700 - NUCLEAR PHARMACY › Section 46 .2703 - OBTAINING A NUCLEAR PHARMACY PERMIT

Current through Register Vol. 39, No. 2, July 15, 2024
In order to obtain a nuclear pharmacy permit, the person
				  seeking such a permit shall submit an application to the Board certifying that
				  he or she is a pharmacist currently licensed by the Board and that he or she is
				  a qualified nuclear pharmacist as defined in Rule .2702 of this Section. The
				  application shall describe the location, time and manner by which the contact
				  hours required by Rule .2702(6) of this Section were obtained by the applicant
				  and shall be submitted under oath.
Authority
				  G.S.
				  90-85.6;
				  90-85.34;
Eff. October
				  1, 1990;
Amended Eff. February 1, 2005;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.
North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2700 - NUCLEAR PHARMACY › Section 46 .2705 - LABELING REQUIREMENTS OF RADIOPHARMACEUTICALS

Current through Register Vol. 39, No. 2, July 15, 2024
(a) In addition to other labeling
				requirements of the Board for non-radioactive drugs described in this Chapter,
				the container of a radiopharmaceutical shall also be labeled with:
(1) The standard radiation symbol;
(2) The words "CAUTION - RADIOACTIVE
				MATERIALS";
(3) The radionuclide of
				the radiopharmaceutical contained therein;
(4) The chemical form of the
				radiopharmaceutical contained therein;
(5) The amount of radioactivity of the
				radiopharmaceutical contained therein and the date and time of the calibration
				of that radioactivity;
(6) The date
				and time of the expiration of the radiopharmaceutical contained
				therein;
(7) If the
				radiopharmaceutical is a liquid, the volume;
(8) If the radiopharmaceutical is a solid,
				the number of capsules or weight contained therein;
(9) If the radiopharmaceutical is a gas, the
				number of ampules, vials, or syringes contained therein;
(10) The name, address and telephone number
				of the nuclear pharmacy dispensing the radiopharmaceutical;
(11) The prescription or lot number;
				and
(12) The name of the
				pharmaceutical.