CHAPTER 46 ‑ BOARD OF PHARMACY
SECTION .0100 ‑ ORGANIZATION OF THE BOARD
21 NCAC 46 .0101 GENERAL PURPOSE OF THE BOARD
21 NCAC 46 .0102 ELECTION OF THE BOARD
21 NCAC 46 .0103 MEETINGS OF THE BOARD
21 NCAC 46 .0104 QUORUMS
21 NCAC 46 .0105 OFFICE OF THE BOARD
21 NCAC 46 .0106 FISCAL YEAR
History Note: Authority G.S. 90‑56; 90‑57;
90‑58;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Amended Eff. August 16, 1981;
Repealed Eff. April 1, 1983.
SECTION .0200 ‑ GENERAL
DEFINITIONS
21 NCAC 46 .0201 SCOPE OF DEFINITIONS
21 NCAC 46 .0202 BOARD: OFFICERS
21 NCAC 46 .0203 DRUGS
21 NCAC 46 .0204 POISONS
21 NCAC 46 .0205 NONPOISONOUS DOMESTIC REMEDIES
21 NCAC 46 .0206 PATENT OR PROPRIETARY PREPARATION
21 NCAC 46 .0207 PHARMACY OR DRUGSTORE
21 NCAC 46 .0208 ORIGINAL DRUGSTORE PERMIT
21 NCAC 46 .0209 PERSON
21 NCAC 46 .0210 PHARMACIST OR DRUGGIST
21 NCAC 46 .0211 ASSISTANT PHARMACIST
21 NCAC 46 .0212 PHARMACY EXTERN
21 NCAC 46 .0213 PHARMACY INTERN
21 NCAC 46 .0214 LICENSED PHARMACIST INTERN
21 NCAC 46 .0215 DULY ACCREDITED SCHOOL OR COLLEGE OF
PHARMACY
21 NCAC 46 .0216 GRADUATE OF AN ACCREDITED SCHOOL OR
COLLEGE OF PHARMACY
21 NCAC 46 .0217 TWO YEARS COLLEGE TRAINING
21 NCAC 46 .0218 GROSS IMMORALITY
21 NCAC 46 .0219 HABITUAL INDULGENCE
21 NCAC 46 .0220 IMMEDIATE SUPERVISION
21 NCAC 46 .0221 TEMPORARY ABSENCE
21 NCAC 46 .0222 PHARMACEUTICAL SERVICES
21 NCAC 46 .0223 COMPOUNDING
21 NCAC 46 .0224 DISPENSING
21 NCAC 46 .0225 ADMINISTERING
21 NCAC 46 .0226 HOSPITAL PHARMACY
21 NCAC 46 .0227 PRESCRIPTION
History Note: Authority G.S. 90‑57; 90‑61;
90‑61.1; 90‑65; 90‑71; 90‑72; 90‑73; 90‑75;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Repealed Eff. April 1, 1983.
SECTION .0300 ‑ HOSPITALS: OTHER HEALTH FACILITIES
21 NCAC 46 .0301 DEFINITION: OTHER PLACE
21 NCAC 46 .0302 REGISTRATION AND PERMITS
21 NCAC 46 .0303 PERSONNEL: EQUIPMENT: AND INSPECTION
21 NCAC 46 .0304 PHARMACIST‑MANAGER
21 NCAC 46 .0305 SUPERVISION: SCHEDULE OF ATTENDANCE
BY PHARMACIST
21 NCAC 46 .0306 HEALTH CARE FACILITIES NOT EMPLOYING
A PHARMACIST
21 NCAC 46 .0307 SUPERVISION OF DRUGS IN AREAS
OUTSIDE A PHARMACY
21 NCAC 46 .0308 ACCESS TO DRUG STOCKS: RECORDS:
EMERGENCY DRUG KITS
21 NCAC 46 .0309 MEDICATION IN HOSPITAL EMERGENCY
DEPARTMENTS
21 NCAC 46 .0310 PRACTITIONERS OF MEDICINE EXCEPTED
21 NCAC 46 .0311 MINIMAL STANDARDS FOR PHARMACY
SERVICE
21 NCAC 46 .0312 FEDERAL AND STATE STATUTES CONTROL
History Note: Authority G.S. 90‑18.1; 90‑57;
90‑75;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Repealed Eff. April 1, 1983.
SECTION .0400 ‑ EXAMINATIONS: ADMISSION REQUIREMENTS
21 NCAC 46 .0401 APPLICATION
21 NCAC 46 .0402 AGE
21 NCAC 46 .0403 EXPERIENCE IN PHARMACY
21 NCAC 46 .0404 EDUCATION
21 NCAC 46 .0405 EXAMINATION
21 NCAC 46 .0406 RULES OF EXAMINATION CONDUCT
21 NCAC 46 .0407 PARTIAL EXAMINATION
History Note: Authority G.S. 90‑57; 90‑61;
90‑61.1;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Amended Eff. January 1, 1982; October 21, 1981; January
15, 1981; May 4, 1980;
Repealed Eff. April 1, 1983.
SECTION .0500 ‑ LICENSES AND PERMITS
21 NCAC 46 .0501 PHARMACY OR DRUGSTORE PERMITS
21 NCAC 46 .0502 FAILURE TO COMPLY: PENALTY
21 NCAC 46 .0503 DRUGSTORES IN TOWNS OF LESS THAN 800
POPULATION
21 NCAC 46 .0504 ABSENCE FROM PRACTICE
History Note: Authority G.S. 90‑57; 90‑71;
90‑75;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Amended Eff. May 4, 1980;
Repealed Eff. April 1, 1983.
21 NCAC 46 .0505 RECIPROCAL LICENSURE
History Note: Authority G.S. 90‑57; 90‑64;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Amended Eff. August 16, 1981; January 15, 1981;
Repealed Eff. January 1, 1982.
21 NCAC 46 .0506 LICENSE BY RECIPROCITY
History Note: Authority G.S. 90‑57; 90‑64;
Eff. March 1, 1982;
Repealed Eff. April 1, 1983.
SECTION .0600 ‑ DRUGS DISPENSED BY NURSE OR PHYSICIAN'S
ASSISTANT
21 NCAC 46 .0601 DISPENSING BY REGISTERED NURSE OR
PHYSICIAN'S ASSISTANT
21 NCAC 46 .0602 DISPENSING SUPERVISED BY LICENSED
PHARMACIST
21 NCAC 46 .0603 DRUGS TO BE DISPENSED
21 NCAC 46 .0604 PREPACKAGING OF DRUG PRODUCTS
DISPENSED
21 NCAC 46 .0605 RECORDS OF DISPENSING
History Note: Authority G.S. 90‑18.1; 90‑57;
90‑75;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Repealed Eff. April 1, 1983.
SECTION .0700 ‑ FORMS
21 NCAC 46 .0701 DEFINITION
21 NCAC 46 .0702 APPLICATION FOR PHARMACIST'S LICENSE
21 NCAC 46 .0703 APPLICATION FOR PHARMACY PERMIT
21 NCAC 46 .0704 RENEWAL OF PHARMACIST'S LICENSE
21 NCAC 46 .0705 REPLACEMENT OF CERTIFICATES
21 NCAC 46 .0706 RECIPROCITY DATA QUESTIONNAIRE
21 NCAC 46 .0707 APPLICATION FOR RECIPROCITY
21 NCAC 46 .0708 REGISTRATION FOR PRACTICAL PHARMACY
TRAINING
21 NCAC 46 .0709 PRACTICAL PHARMACY EXPERIENCE
21 NCAC 46 .0710 CERTIFICATE OF EXPERIENCE OUTSIDE
NORTH CAROLINA
21 NCAC 46 .0711 CERTIFICATE OF GRADUATION
History Note: Authority G.S. 90‑57; 90‑61;
90‑64; 90‑66; 90‑75;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Repealed Eff. April 1, 1983.
SECTION .0800 ‑ ADMINISTRATIVE HEARING PROCEDURES
21 NCAC 46 .0801 RIGHT TO HEARING
21 NCAC 46 .0802 REQUEST FOR HEARING
21 NCAC 46 .0803 GRANTING OR DENYING HEARING REQUESTS
21 NCAC 46 .0804 NOTICE OF HEARING
21 NCAC 46 .0805 WHO SHALL HEAR CONTESTED CASES
21 NCAC 46 .0806 PETITION FOR INTERVENTION
21 NCAC 46 .0807 TYPES OF INTERVENTION
21 NCAC 46 .0808 DISQUALIFICATION OF HEARING OFFICERS
History Note: Authority G.S. 1A‑1, Rule 24; 90‑57;
90‑65; 150A‑2(2); 150A‑23(a);
150A‑23(2); 150A‑32;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977
Amended Eff. August 16, 1981;
Repealed Eff. April 1, 1983.
SECTION .0900 ‑ ADMINISTRATIVE HEARINGS: DECISIONS:
RELATED RIGHTS AND PROCEDURES
21 NCAC 46 .0901 FAILURE TO APPEAR
21 NCAC 46 .0902 SIMPLIFICATION OF ISSUES
21 NCAC 46 .0903 SUBPOENAS
21 NCAC 46 .0904 FINAL DECISIONS IN ADMINISTRATIVE
HEARINGS
21 NCAC 46 .0905 PROPOSALS FOR DECISIONS
History Note: Authority G.S. 90‑57; 150A‑25(a);
150A‑33(5); 150A‑34(a); 150A‑43;
150A‑72;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Amended Eff. August 16, 1981;
Repealed Eff. April 1, 1983.
SECTION .1000 ‑ RULEMAKING PROCEDURES
21 NCAC 46 .1001 PETITIONS
21 NCAC 46 .1002 NOTICE
21 NCAC 46 .1003 HEARINGS
21 NCAC 46 .1004 EMERGENCY RULES
21 NCAC 46 .1005 DECLARATORY RULINGS
21 NCAC 46 .1006 RULES AND REGULATIONS SEVERABLE
History Note: Authority G.S. 90‑57; 150A‑12;
150A‑16; 150A‑17;
Eff. February 1, 1976;
Readopted Eff. September 22, 1977;
Amended Eff. August 16, 1981;
Repealed Eff. April 1, 1983.
SECTION .1100 ‑ ELECTIONS
21 NCAC 46 .1101 BOARD OF PHARMACY ELECTIONS:
COMPOSITIONS AND DUTIES
21 NCAC 46 .1102 ELIGIBILITY TO VOTE
21 NCAC 46 .1103 GEOGRAPHIC REPRESENTATIONS
21 NCAC 46 .1104 COMMITTEE ON NOMINATIONS
21 NCAC 46 .1105 NOMINATION BY PETITION
21 NCAC 46 .1106 CONSENT TO NOMINATION
21 NCAC 46 .1107 BALLOTS: CASTING AND COUNTING
History Note: Authority G.S. 90‑55(a),(b);
Eff. January 1, 1982;
Repealed Eff. April 1, 1983.
SECTION .1200 ‑ ORGANIZATION OF THE BOARD
21 NCAC 46 .1201 GENERAL PURPOSE OF THE BOARD
(a) The purpose of the Board is to regulate the practice of
pharmacy in North Carolina in order to safeguard and protect the life and
health of the people of North Carolina, and in order to promote the public
welfare.
(b) The Board regulates the practice of pharmacy:
(1) by determining the qualifications of
persons seeking to practice pharmacy and authorizing persons who have met the
statutory requirements to so practice; and
(2) by enforcing the provisions
of laws governing the practice of pharmacy and places for rendering
pharmaceutical services, and those duly enacted rules designed to ensure a high
degree of competency in the practice of pharmacy.
History Note: Authority G.S. 90‑85.2; 90‑85.6;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1202 ELECTION OF OFFICERS OF THE BOARD
Election of officers of the Board shall be held in May of
each year.
History Note: Authority G.S. 90‑85.6; 90‑85.8;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1203 MEETINGS OF THE BOARD
The Board shall meet at least twice each year at a place
designated by the Board for the purpose of examining candidates for a license
to practice pharmacy in North Carolina and may hold such other examination meetings
as it may deem appropriate, and in addition may regularly meet at other times
for the purpose of transacting business and holding hearings. Special meetings
of the Board may be called by the president, the executive director, or two or
more members of the Board when deemed necessary, and notice shall be given to
each member of the Board of the time and place of such special meetings and the
business to be transacted at such meetings.
History Note: Authority G.S. 90‑85.6; 90‑85.9;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1204 OFFICE OF THE BOARD
History Note: Authority G.S. 90-85.6;
Eff. April 1, 1983;
Amended Eff. November 1, 2003; July 1, 1996; May 1, 1989;
Repealed Eff. October 1, 2010.
21 NCAC 46 .1205 FISCAL YEAR
The fiscal year of the Board shall be from October 1st
through September 30th of the following calendar year.
History Note: Authority G.S. 90‑85.6;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1206 FEES
The fees provided for in G.S. 90‑85.24 as maximum fees
which the Board is entitled to charge and collect are hereby established as the
fees for each of the items in G.S. 90‑85.24.
History Note: Authority G.S. 90‑85.6; 90‑85.24;
Eff. November 1, 1983;
Amended Eff. May 1, 1989.
SECTION .1300 ‑ GENERAL DEFINITIONS
21 NCAC 46 .1301 SCOPE OF DEFINITIONS
21 NCAC 46 .1302 BOARD: OFFICERS
21 NCAC 46 .1303 PHARMACY PERMIT
21 NCAC 46 .1304 DRUGGIST
21 NCAC 46 .1305 PHARMACY INTERN
21 NCAC 46 .1306 DULY APPROVED SCHOOL OR COLLEGE OF PHARMACY
21 NCAC 46 .1307 GRADUATE/APPROVED SCHOOL/COLLEGE OF
PHARMACY
21 NCAC 46 .1308 TWO YEARS COLLEGE WORK
21 NCAC 46 .1309 INDULGENCE IN THE USE OF DRUGS
21 NCAC 46 .1310 SUPERVISION
21 NCAC 46 .1311 INSTITUTIONAL PHARMACY
21 NCAC 46 .1312 PHARMACIST MANAGER
21 NCAC 46 .1313 LIMITED SERVICE PHARMACY PERMIT
21 NCAC 46 .1314 APOTHECARY
21 NCAC 46 .1315 DRUGSTORE
21 NCAC 46 .1316 UNDERGRADUATE PROFESSIONAL DEGREE IN
PHARMACY
History Note: Authority G.S. 90‑85.3; 90‑85.6;
90‑85.8; 90‑85.13; 90‑85.15; 90‑85.15(b);
90‑85.21; 90‑85.38(3); 90‑85.40(a);
Eff. April 1, 1983;
Amended Eff. January 1, 1985; March 1, 1984; April 1,
1983;
Repealed Eff. May 1, 1989.
21 ncac 46 .1317 DEFINITIONS
The definitions of various terms used in this Chapter are
found in G.S. 90, Article 4A, and as follows:
(1) Ambulation Assistance Equipment. Devices that aid
in walking, excluding canes, crutches, and walkers.
(2) Approved School or College of Pharmacy. A school
or college of pharmacy accredited by the American Council on Pharmaceutical
Education, or a foreign school with a professional pharmacy degree program of
at least five years approved by the Board pursuant to G.S. 90-85.13.
(3) Auxiliary Drug Inventory. A secure, segregated,
supplementary source for drugs to be used solely for the purpose of providing
adequate drug availability when the pharmacy is closed or the pharmacist is
unavailable.
(4) Board. As defined in G.S. 90-85.3(b).
(5) Certified technician. A technician who has passed
a pharmacy technician certification board exam, or its equivalent, that has
been approved by the Board according to the rules in this Chapter.
(6) Consultant Pharmacist. A licensed pharmacist who,
in collaboration with the supervising physician and nurse practitioner or
assistant to the physician, develops a retrospective drug utilization review
program that:
(a) reviews the appropriateness of the choice of
medication(s) for the patient and the patient's therapeutic regimen, including
choice of medication, dose, frequency, and route of administration;
(b) identifies and resolves therapeutic
duplication in the patient's medication regimen; and
(c) considers patient-specific medication
contraindications.
The consultant
pharmacist holds himself available for consultation in person, by telephone, or
by other means of direct communication at all times when drugs are dispensed.
(7) Diagnostic equipment. Equipment used to record
physiological information while a person goes about normal daily living or
while asleep in order to document a disease process. Early pregnancy tests
(EPTs), thermometers, glucose meters, and cholesterol equipment are not
included as diagnostic equipment.
(8) Drug review or Pharmaceutical care assessment. An
onsite review of a patient's or resident's record by a licensed pharmacist that
involves interpretation and evaluation of the drug therapy and other pharmaceutical
care services to achieve intended medication outcomes and minimize negative
effects of drug therapy.
(9) Duplicate as used in G.S. 90-85.24. Any license,
permit, or registration issued or reissued by the Board that is identical to a
previously issued license, permit, or registration, including a permit reissued
due to a change in pharmacist-manager.
(10) Emergency Drugs. Those drugs whose prompt use and
immediate availability are generally regarded by physicians as essential in the
proper treatment of unforeseen adverse changes in a patient's health or
well-being.
(11) Employee. A person who is or would be considered an
employee under the North Carolina Workers' Compensation Act. This definition
applies to locations both within and outside of this State holding pharmacy or
device and medical equipment permits and without regard to the number of
persons employed by the permit holder.
(12) Executive Director. The Secretary-Treasurer and
Executive Director of the Board.
(13) Graduate of an Approved School or College of
Pharmacy. A person who has received an undergraduate professional degree in
pharmacy from an approved school or college of pharmacy, or a person who has
graduated from a foreign professional school of pharmacy and has successfully
completed the Foreign Pharmacy Graduate Equivalency Examination offered by the
National Association of Boards of Pharmacy and the Test of English as a Foreign
Language.
(14) HMES. Home medical equipment supplier.
(15) Health Care Facility. Any organization whose
primary purpose is to provide a physical environment for patients to obtain
health care services. This shall include:
(a) a hospital;
(b) a long-term care facility;
(c) a mental health facility;
(d) a drug abuse treatment center;
(e) a penal institution; or
(f) a hospice.
(16) Health Care Facility Pharmacy. A pharmacy permitted
by the Board that provides services to a Health Care Facility.
(17) Indulgence in the Use of Drugs. The use of narcotic
drugs or other drugs affecting the central nervous system or the use of
intoxicating beverages to an extent as to deprive the user of reasonable
self-control or the ability to exercise such judgment as might reasonably be
expected of an average prudent person.
(18) Internet Pharmacy.
(a) A pharmacy that maintains an Internet web
site for the purpose of selling or distributing prescription drugs; or
(b) A pharmacy that uses the internet, either
itself, or through agreement with a third party, to communicate with or obtain
information from patients; uses such communication or information, in whole or
in part, to solicit, fill or refill prescriptions; or otherwise uses such
communication or information, in whole or in part, to engage in the practice of
pharmacy as defined in G.S. 90-85.3(r).
Notwithstanding
Sub-items (a) and (b) above, a pharmacy shall not be deemed an Internet
pharmacy if it maintains an Internet web site for the following purposes only:
(i) To post mere advertisements that do not
attempt to facilitate, directly or through agreement with a third party, an
actual transaction involving a prescription drug;
(ii) To allow a patient to communicate a request
for a refill of a legitimate prescription originally filled by the pharmacy
that maintains the Internet web site;
(iii) To allow a customer to research drug
interactions and clinical pharmacology information; or
(iv) To allow a patient to send an electronic
mail message to a pharmacist licensed in North Carolina.
(19) Limited Service Pharmacy Permit. A pharmacy permit
issued by the Board to an applicant who wishes to render in an institutional
setting pharmaceutical services not limited to scope and kind but to time and
conditions under which such services are rendered.
(20) Medication Therapy Management Services and Related
Functions. Services and functions included in the practice of pharmacy as part
of monitoring, recording and reporting drug therapy and device usage.
(21) Medication Administration Record. A record of drugs
administered to a patient.
(22) Medication Order. An order for a prescription drug
or other medication or a device for a patient from a person authorized by law
to prescribe medications.
(23) Mobility equipment. Devices that aid a person in
self-movement, other than walking, including manual or power wheelchairs and scooters.
(24) Oxygen and respiratory care equipment. Equipment or
devices used to administer oxygen or other legend drugs, maintain viable
airways or monitor cardio-respiratory conditions or events, including the
following:
(a) compressed medical gases;
(b) oxygen concentrators;
(c) liquid oxygen;
(d) nebulizers;
(e) compressors;
(f) aerosol therapy devices;
(g) portable suction machines;
(h) nasal continuous positive airway pressure
(CPAP) machines;
(i) Bi-phasic positive pressure devices
(BiPAP);
(j) infant monitors, such as apnea monitors and
cardio-respiratory monitors;
(k) positive and negative pressure mechanical
ventilators; and
(l) pulse oximeters.
(25) Patient Medication Profile. A list of all prescribed
medications for a patient.
(26) Pharmacist. Any person within the definition set
forth in G.S. 90-85.3(p), including any druggist.
(27) Pharmacist-Manager. The person who accepts
responsibility for the operation of a pharmacy in conformance with all statutes
and rules pertinent to the practice of pharmacy and distribution of drugs by
signing the permit application, its renewal or addenda thereto.
(28) Pharmacy. Any place within the definition set forth
in G.S. 90-85.3(q), including any apothecary or drugstore.
(29) Pharmacy Intern. Any person who is registered with
the Board under the internship program of the Board to acquire pharmacy
experience or enrolled in approved academic internship programs. A pharmacy
intern working under a pharmacist preceptor or supervising pharmacist may,
while under supervision, perform all acts constituting the practice of
pharmacy.
(30) Place of residence. Any place used as an
individual's temporary or permanent home.
(31) President. The President of the Board.
(32) Rehabilitation environmental control equipment. Equipment
or devices that permit a person with disabilities to control his or her
immediate surroundings.
(33) Rehabilitation Services. Services and equipment
required to maintain or improve functional status and general health as
prescribed by the physician which are uniquely specified for each individual's
lifestyle. The people involved in this process include the patient, caregiver,
physician, therapist, rehabilitation equipment supplier and others who impact
on the individual's life style and endeavors.
(34) Signature. A written or electronic signature or
computerized identification code.
(35) Two Years of College Work. Attendance at a college
accredited by an accrediting agency recognized by the United States Department
of Education for two academic years of not fewer than eight and one-half months
each and the completion of work for credit leading to a baccalaureate degree or
its equivalent and that would permit the student to advance to the next class.
(36) Undergraduate Professional Degree in Pharmacy. A
B.S. or Pharm. D. degree.
(37) Vice-President. The Vice-President of the Board.
History Note: Authority G.S. 90‑85.3; 90‑85.6;
90‑85.8; 90‑85.13; 90‑85.14; 90‑85.15; 90‑85.21;
90‑85.38; 90‑85.40;
Eff. May 1, 1989;
Amended Eff. March 1, 2013; February 1, 2007; March 1,
2004; April 1, 1999; May 1, 1997; September 1, 1995; September 1, 1993; October
1, 1990; January 1, 1990.
SECTION .1400 ‑ HOSPITALS: OTHER HEALTH FACILITIES
21 NCAC 46 .1401 REGISTRATION AND PERMITS
(a) Registration Required. All places providing services
which embrace the practice of pharmacy shall register with the North Carolina
Board of Pharmacy as provided in G.S. 90‑85.21 and acquire a permit to do
so. Application for such registration and permit shall be on forms provided by
the Board. If the Board is satisfied that proper facilities and adequately
trained and properly licensed personnel have been obtained which will assure
compliance with all laws regulating the compounding and distribution of drugs,
the practice of pharmacy and the rules of the Board, a permit shall be issued
by the Board attesting such registration.
(b) Exemptions. Nothing in these rules shall be construed
to require the registration with the Board of those health care facilities in
which there occurs only the administration of drugs.
(c) Separate Registration Required. The dispensing of
drugs from separate locations owned by a health care facility, such as
satellite pharmacies, outside clinics, health maintenance organizations, or
physician's offices owned by the health care facility shall require separate
registration if any one of the following criteria exists:
(1) The drugs dispensed at the location are
ordinarily and customarily obtained from a source outside of the health care
facility;
(2) The pharmacist-manager is controlled and
supervised from a source other than the health care facility pharmacy; or
(3) The routine activity at the location is
dispensing drugs to outpatients.
(d) Any pharmacy that provides compounding or dispensing
services to one or more health care facilities for individual patient
administration bearing any labeled name other than that under which it is
registered shall require a separate registration.
(e) Health care facilities which do not have a pharmacy
permit shall secure their pharmaceutical services through a pharmacist holding
a current license from the Board.
History Note: Authority G.S. 90‑85.6; 90‑85.21;
Eff. April 1, 1983;
Amended Eff. May 1, 1997; May 1, 1989; March 1, 1984.
21 NCAC 46 .1402 SUPERVISION OF DRUGS IN AREAS
OUTSIDE OF PHARMACY
21 NCAC 46 .1403 INSTITUTIONAL PHARMACY DRUG
INVENTORIES AND EMERGENCY KITS
21 NCAC 46 .1404 MEDICATION IN INSTITUTIONAL
EMERGENCY DEPARTMENTS
History Note: Authority G.S. 90-18.1; 90-18.2; 90‑85.6;
90‑85.21;
Eff. April 1, 1983;
Amended Eff. April 1, 1992; May 1, 1989; March 1, 1984;
Repealed Eff. May 1, 1997.
21 NCAC 46 .1405 STANDARDS FOR PHARMACY SERVICE
History Note: Authority G.S. 90‑85.2; 90‑85.6;
Eff. March 1, 1984;
Repealed Eff. May 1, 1989.
21 NCAC 46 .1406 AUTOMATIC STOP ORDERS
History Note: Authority G.S. 90‑85.2; 90‑85.3(r);
90‑85.6;
Eff. March 1, 1984;
Amended Eff. May 1, 1989;
Repealed Eff. May 1, 1997.
21 NCAC 46 .1407 INSTITUTIONAL FORMULARY
History Note: Authority G.S. 90‑85.2; 90‑85.3(r);
90‑85.6;
Eff. March 1, 1984;
Repealed Eff. May 1, 1989.
21 NCAC 46 .1408 INSTITUTIONAL DISCHARGE MEDICATION
OPTION
History Note: Authority G.S. 90‑85.6; 90‑85.32;
Eff. March 1, 1984;
Amended Eff. May 1, 1989;
Repealed Eff. May 1, 1997.
21 NCAC 46 .1409 RESEARCH PARTICIPATION
History Note: Authority G.S. 90‑85.3(r); 90‑85.6;
90‑85.34;
Eff. March 1, 1984;
Repealed Eff. May 1, 1989.
21 NCAC 46 .1410 PERSONNEL
(a) The health care facility pharmacy must be directed by a
legally qualified pharmacist, hereinafter referred to as the
pharmacist-manager, who shall be responsible for meeting the requirements set
forth by Federal and State law, this Section, 21 NCAC 46.2502, and other
applicable Rules of the Board. The pharmacist-manager shall be thoroughly
familiar with the specialized functions of health care facility pharmacy
practice. The pharmacist-manager shall be an employee of the health care
facility or contracted for by the health care facility in which the pharmacy is
located.
(b) The pharmacist-manager shall be assisted by a
sufficient number of pharmacists and supportive personnel to operate such
pharmacy competently, safely, and to meet the needs of the patients of the
health care facility.
(c) The pharmacist-manager shall ensure that an adequate
number of qualified and trained pharmacists are employed. The pharmacist-
manager shall develop and implement written policies and procedures to specify
the duties to be performed by such pharmacists.
(d) The pharmacist-manager shall ensure that a sufficient
number of qualified, trained, and adequately supervised supportive personnel
are employed to provide technical services, as well as ensuring that all such
functions and activities are performed competently, safely, and without risk of
harm to patients. The relationship between the supervising pharmacist and the
supportive personnel shall be such that the pharmacist is fully aware of and
responsible for all activities involved in the preparation and dispensing of
medications prior to release to the patient, including the maintenance of
appropriate records.
(e) Secretarial and clerical support shall be provided to
assist with record keeping, report submission and other administrative duties.
History Note: Authority G.S. 90-85.6; 90-85.21;
Eff. May 1, 1997.
21 NCAC 46 .1411 RESPONSIBILITIES OF THE
PHARMACIST-MANAGER
(a) The pharmacist-manager shall establish written
procedures for the safe and effective distribution of pharmaceutical products.
Procedures shall be reviewed annually to assure they reflect current practice
in the facility. A copy of such procedures shall be available in the pharmacy.
(b) The pharmacist-manager is responsible for the safe and
effective distribution of, control over and accountability for drugs, including
intravenous and irrigation solutions. The pharmacist-manager may delegate
responsibilities to other health care facility staff for ordering,
distributing, and accounting for pharmaceutical materials to achieve this
purpose. Whenever there is a violation of the rules in this Section, the
facility's pharmacy permit is subject to action by the Board. In addition to
the requirements of 21 NCAC 46 .2502, the pharmacist-manager is responsible
for:
(1) the development of policies and procedures
for the compounding, admixture, labeling, and dispensing of parenteral
medications in the health care facility, including relevant education and
training of all pharmacy and nursing personnel involved in the preparation of
parenteral medications;
(2) the establishment of specifications or use
of compendia specifications for procurement of all pharmaceuticals, including
drugs, chemicals, and biologicals used in direct patient care, subject to
approval of the appropriate committee of the health care facility;
(3) participation in development and
maintenance of a drug formulary when required by the health care facility;
(4) participation in those aspects of
pharmaceutical care that affect drug distribution and control;
(5) preparing, packaging, compounding and
labeling all drugs;
(6) assuring that drugs are dispensed only by a
pharmacist or other persons allowed by law to dispense and that supportive
pharmacy personnel are directed and supervised in compliance with all applicable
laws and regulations;
(7) the development and implementation of
policies and procedures to ensure that discontinued drugs; outdated drugs;
drugs recalled; containers with worn, illegible, or missing labels; or products
that are otherwise unusable are returned to the pharmacy for disposition in
compliance with all applicable laws and regulations;
(8) maintaining records and reports required by
law to ensure patient health, safety and welfare;
(9) developing and implementing policies and
procedures that effectively address the safeguarding and handling of all drugs
and devices, as defined in G.S. 90-85.3(e), throughout the health care
facility, or other locations where legend drug products are transferred,
including medications that originate from a source outside the facility. When
discrepancies in controlled substance counts are identified:
(A) they shall be reviewed, and a report of this action,
including steps taken to prevent recurrence, where possible, shall be provided
to the pharmacist-manager within 24 hours of occurrence. This report shall be
maintained by the pharmacist-manager; and
(B) they shall be reported to the Board and the Drug
Enforcement Administration in compliance with all applicable laws and
regulations;
(10) developing and implementing policies and
procedures to ensure that auxiliary medication inventories are inspected in
accordance with the pharmacy's policies;
(11) all drugs and devices dispensed by the
pharmacy as defined in G.S. 90-85.3(e) that are ordered for and used within the
health care facility; and
(12) maintaining policies and procedures
regarding drug samples and patient's personal medications.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.32;
Eff. May 1, 1997;
Amended Eff. March 1, 2013.
21 NCAC 46 .1412 PHYSICAL REQUIREMENTS
A health care facility pharmacy shall have sufficient floor
space allocated to it to ensure that drugs are prepared in sanitary, well
lighted, and enclosed places. It shall have equipment and physical facilities
for proper compounding, dispensing, and storage of drugs, including parenteral
preparations. In addition to the requirements of Section .1600 of this Chapter,
the equipment and physical facilities shall include the following:
(1) Dispensing areas;
(2) Compounding areas that comply with Section .2800 of
this Chapter;
(3) Receiving and storage areas;
(4) Packaging and repackaging areas;
(5) Office space sufficient to allow for administrative
functions without interference with the safe compounding and dispensing of
medications and security of the pharmacy;
(6) Storage. All drugs shall be stored in designated
areas within the pharmacy or decentralized pharmacy sufficient to provide
sanitation to prevent contamination, moisture control, and security to prevent
access from unauthorized personnel. Controlled substances shall be stored in
compliance with applicable Federal and State laws and regulations. Alcohol and
flammables shall be stored in areas that shall meet basic local building code
requirements for the storage of volatile substances and all other laws,
ordinances, or regulations that may apply; and
(7) Security. All areas occupied by the health care
facility pharmacy, to include auxiliary drug supplies and unit dose carts,
shall remain secured at all times.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.32;
Eff. May 1, 1997;
Amended Eff. January 1, 2015; March 1, 2013.
21 NCAC 46 .1413 ABSENCE OF PHARMACIST
(a) When a health care facility pharmacy is not open 24
hours a day, seven days a week, arrangements shall be made in advance by the pharmacist-manager
for provision of drugs and pharmaceutical care to the medical staff, other
authorized personnel, and patients of the health care facility by use of an
"on call" pharmacist accessible to the facility during all absences,
and auxiliary medical inventories as described in Rule .1414(d) of this
Section. In addition, one or both of the options in Subparagraphs (a)(1) and
(2) may be authorized by the pharmacist-manager to assure access to drugs and
pharmaceutical care in the absence of a pharmacist:
(1) a contractual arrangement with another
health care facility, pharmacy, or pharmacist; or
(2) a nurse trained and authorized by the
pharmacist-manager to remove drugs or devices from the pharmacy in the absence
of a pharmacist. Entry into the pharmacy in the absence of a pharmacist shall
occur only if the drug needed is not in the auxiliary medication inventory.
The pharmacist-manager shall maintain a current list of authorized persons and
document the initial orientation, continuing education, and quality control
processes on an ongoing basis. The pharmacist-manager shall maintain a list of
restricted medications that shall not be taken from the pharmacy and may only
be removed after contacting the "on call" pharmacist to verify the
appropriateness and accuracy of the medication order and medication removed
from the pharmacy at the time of removal. For medications not on the
restricted list, an "on call" pharmacist must be accessible for
questions by the authorized nurse. Within 24 hours, a pharmacist shall verify
the accuracy and appropriateness of the medication order and the medication
removed from the pharmacy.
(b) A record of drugs or devices removed from auxiliary
medication inventories or from pharmacy inventory shall be maintained for three
years in the health care facility in compliance with all applicable laws and
regulations. The pharmacist-manager shall at least quarterly verify the
accuracy of the records.
(c) Supportive personnel approved by the pharmacist-manager
may be present in the pharmacy at other than regular service hours to perform
clerical, repackaging and distributive functions according to written policies
and procedures if the drugs so handled are not permitted to leave the pharmacy
until all work performed has been checked and certified as being correct by the
pharmacist.
(d) Only drugs in unit-of-use packaging shall be removed
from the auxiliary medication inventory or from the pharmacy; they shall be
used for administration to a specific patient only, in amounts sufficient to
meet the needs for immediate therapeutic requirements. Controlled substances
may be stocked and removed from auxiliary medication inventories; controlled
substances may not be removed from the pharmacy in the absence of a
pharmacist. Drugs shall be pre-labeled by the pharmacist with drug name,
strength, lot number and expiration date. A copy of written orders for new
medications shall be provided to the pharmacy.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.32; 90-85.33; 90-85.34;
Eff. May 1, 1997;
Amended Eff. March 1, 2013; August 1, 2000.
21 ncac 46 .1414 DRUG DISTRIBUTION AND CONTROL
(a) MEDICATION ORDERS.
(1) Pharmacists shall dispense medications from
a health care facility pharmacy only upon receipt of a medication order. A
mechanism shall be in place to verify the authenticity of the medication
order. Oral orders shall be recorded immediately and signed within the time
frame established by regulatory agencies and health care facility policies and
procedures.
(2) All medication orders shall be received and
reviewed by a pharmacist and shall contain the:
(A) patient's name, location and other identifying
information such as history or medical records number;
(B) medication name, strength, dosage form, route of and
directions for administration. In the absence of a facility policy on
interpretation of routes of administration, the route of administration must be
specified;
(C) discernible quantity to be dispensed. Medical
orders issued from a health care facility shall, in the absence of a different
indicated quantity or facility policy, be deemed to authorize dispensing of a
30-day supply;
(D) date the order was written; and
(E) prescriber's signature as set out in Subparagraph
(a)(1) of this Rule (may include electronic signature or verification).
(3) The health care facility pharmacy and the
pharmacist-manager shall ensure that medication orders for patients requiring
continuous drug therapy are entered into a patient medication profile, either
manual or automated. The medication profile shall contain the:
(A) patient's name, location, and clinical data required
for safe dispensing and administration of medication orders, such as age,
height, weight, sex, and allergies;
(B) medication name, strength, dosage form, route of,
and directions for administration;
(C) medication start date;
(D) medication discontinuance date; and
(E) identification of pharmacist responsible for or
verifying technician entry of the medication order.
(4) Abbreviations used in medication orders
shall be agreed to, jointly adopted, and published by the medical, nursing,
pharmacy, and medical records staff of the health care facility.
(5) A method to protect the health care
facility patients from indefinite, open-ended medication orders must be
provided. The prescriber shall be notified that the order shall be stopped
before such action takes place by one or more of the following:
(A) the routine monitoring of patient's drug therapy by
a pharmacist;
(B) a health care facility-approved, drug class-specific,
automatic stop order policy covering those drug orders not specifying a number
of doses or duration of therapy; or
(C) a health care facility-approved automatic
cancellation of all medication orders after a predetermined time interval
unless rewritten by the prescriber.
(6) Health care facilities that credential
practitioners for prescribing privileges within the facility shall provide the
health care facility pharmacy with credentialing information annually or
immediately upon discharge or when privileges are suspended or terminated.
(b) DISPENSING. In health care facilities with 24 hour
pharmacy services, all dispensing shall be done by a pharmacist. In health care
facilities without 24 hour pharmacy services, Rules .1413 and .1417 of this Section
apply in the absence of a pharmacist.
(c) LABELING.
(1) The health care facility pharmacy and the
pharmacist dispensing the drug shall ensure that all drugs dispensed from
within a health care facility pharmacy are labeled and identified up to the
point of administration;
(2) When a drug is added to a parenteral
admixture, it shall be labeled with a distinctive supplementary label
indicating the name and amount of the drug added, expiration date, and
expiration time, if applicable. For admixtures prepared outside the health
care facility pharmacy, the pharmacist-manager shall develop policies and
procedures for preparation and labeling.
(d) AUXILIARY MEDICATION INVENTORIES.
(1) The pharmacist-manager of the health care
facility pharmacy shall, in consultation with medical staff, develop a list of
drugs and devices that may be stocked in auxiliary medication inventories
(which may include patient care unit medication inventories, ancillary drug
cabinet inventories, and emergency kits) located at the health care facility.
This list shall include those drugs and devices that may be required to meet
the immediate therapeutic needs of patients, but that are not reasonably
available from the health care facility pharmacy in sufficient time to prevent prolonged
discomfort or risk of harm to the health care facility's patients.
(2) The pharmacist-manager of the health care
facility pharmacy shall develop, implement, and monitor compliance with
policies and procedures that ensure auxiliary medication inventories are
accessed only in compliance with all applicable laws and regulations and only
by licensed health-care professionals or those authorized by North Carolina law
to administer medications. If an auxiliary medication inventory is accessed in
an unauthorized manner, the health care facility personnel who become aware of
the access shall notify the health care facility pharmacy's pharmacist-manager.
(3) An auxiliary medication inventory shall
contain drugs and devices only in amounts sufficient to meet immediate
therapeutic needs of patients.
(4) Drugs and devices contained in an auxiliary
medication inventory shall be labeled with the name, strength, lot number,
manufacturer, and expiration date. A listing of the drugs and devices
contained within an auxiliary medication inventory, including the name,
strength, and quantity of each, shall be attached.
(5) When an auxiliary medication inventory is
accessed, the health care facility personnel who become aware of the access
shall provide a copy of both the record of withdrawal and patient medication
order to the health care facility pharmacy's pharmacist-manager. The record of
withdrawal shall contain:
(A) the date of the removal;
(B) the name, strength, dosage form, and quantity of
drug or device removed;
(C) the name of the patient for whom the drug or device
was ordered; and
(D) the name or other identification of the authorized
person who removed the drug or device.
(6) The health care facility's
pharmacist-manager shall ensure that auxiliary medication inventories are
reviewed on a schedule set by the health care facility pharmacy's policies to
ensure the purity, potency, and integrity of drugs and devices contained
within;
(7) An auxiliary medication inventory
containing controlled substances must comply with 10A NCAC 26E .0408.
(e) RESERVED.
(f) RESERVED.
(g) RESERVED.
(h) RESERVED.
(i) RESERVED.
(j) RECORDS.
(1) The pharmacist-manager shall, in addition
to the requirements for preserving prescription orders as set forth in G.S.
90-85.26, develop a system of daily accountability for medication compounding
and dispensing that permits the identification of the responsible pharmacists
and pharmacy technicians. Readily retrievable records of accountability shall
be maintained for at least 30 days. This system shall identify all personnel
who perform these activities and the pharmacist responsible for:
(A) interpretation and appropriateness of new medication
orders;
(B) profile entry of new medication orders;
(C) dispensing of new medication orders including stat
doses;
(D) daily cart fills;
(E) intravenous admixtures;
(F) compounded medications; and
(G) assessing the quality of pharmacy procedures for preparation and release of drugs and devices
for replenishment of auxiliary medication inventories and automated dispensing
devices in locations outside the pharmacy.
(2) Upon notification of medication errors
resulting from the administration of an incorrect medication or dose, the
pharmacist-manager shall document the medication error. Documentation shall
include chronological information and include documentation on health care
facility forms. These documents shall be archived in a readily retrievable
manner, open for inspection, for a period of three years.
(3) Upon notification of information that
reasonably suggests that there is a probability a prescription drug or device
dispensed from a location holding a permit has caused or contributed to the
death of a patient (see 21 NCAC 46 .2502(k)), the pharmacist-manager shall
retain all documents, labels, vial, supplies, substances, and internal
investigative reports relating to the event. All such items shall be
maintained by the health care facility, accessible to the pharmacist-manager,
and open to the Board of Pharmacy.
(4) The pharmacist-manager shall maintain
records of ordering, receiving, dispensing, or transfer of controlled
substances. These records shall include the following:
(A) Invoices or other documents verifying the ordering
and receipt of controlled substances;
(B) Perpetual inventories of controlled substances
transferred to auxiliary medication inventories and automated dispensing
devices. These inventories shall record the transfer date; the location
transferred to; the identity of the drug; the strength, dosage form, and
quantity transferred; and the transferring pharmacist's name;
(C) Records of disposition of a controlled substance
prepared for a patient but not used, including documentation of the details of
the destruction or other disposition and identification of the individuals
involved in that destruction or other disposition;
(D) A record of controlled substances dispensed directly
to the patient to include the patient's name; date dispensed; dispensing
pharmacist's name; name, strength, dosage form, and quantity of the drug
dispensed. The records shall also document drugs returned and credited; and
(E) A perpetual inventory on all controlled substances
awaiting destruction or return to a vendor.
(5) Automated systems may be used to collect
and store information required by Subparagraph (j)(4) of this Rule provided
such system allows for the immediate retrieval of original medication order
information and dispensing history consistent with criteria cited in 21 CFR
.1306.
(6) With the exception of Subparagraph (j)(l)
of this Rule, all records required by this Section shall be maintained for a
period of three years. Such records shall be archived in a uniform manner,
retrievable to the pharmacy within 48 hours, and open for review, copying, or
seizure by a member or designated employee of the Board.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.32; 90-85.33; 90-85.34;
Eff. May 1, 1997;
Amended Eff. March 1, 2013; February 1, 2005; April 1,
2003; April 1, 1999; August 1, 1998.
21 NCAC 46 .1415 MEDICATION IN HEALTH CARE FACILITY
EMERGENCY DEPARTMENTS
(a) In those health care facilities having 24 hour
outpatient pharmacy service, all drugs dispensed to outpatients including
emergency department patients must be dispensed by a pharmacist.
(b) When drugs are not otherwise available from a
pharmacist, drugs may be dispensed for use outside the emergency department by
the physician, registered nurse under physician supervision, or a person
authorized to prescribe and dispense drugs pursuant to G.S. 90-18.1 or 90-18.2
subject to the following:
(1) Drugs shall be dispensed only to a
registered patient of the emergency department;
(2) The pharmacist-manager shall develop and
supervise a system of control and accountability of all drugs administered in,
or dispensed from the emergency department;
(3) The pharmacist-manager, in conjunction with
the committee responsible for policy in the emergency department, shall develop
an emergency department formulary which may be dispensed from the emergency
department for patients receiving care in that department. This formulary
shall consist of drugs of the nature and type to meet the immediate needs of
emergency department patients, and quantities in each container shall be
limited to not more than a 24 hour supply or the smallest
commercially-available quantity;
(4) Drugs shall be prepackaged in safety
closure containers and shall be pre-labeled by the pharmacist to comply with
Rule .1414(d)(4) of this Section. Prior to dispensing, the following
information shall be placed on the label:
(A) the name, address, and telephone number of the
health care facility pharmacy;
(B) the dispensing date;
(C) the full name of patient;
(D) the generic or trade name, or in the absence of a
brand name, the established name of the product dispensed;
(E) directions for use to the patient;
(F) the name of physician prescribing and dispensing
the product; and
(G) required precautionary or further accessory
cautionary information as may be desirable for proper use and safety to the
patient;
(5) A perpetual record of dispensing of all
drugs, including drug samples and starter packages, shall be maintained as part
of the pharmacy's records for three years. The pharmacist-manager or designee
shall verify the accuracy of these records at least once a month. The record
shall contain the following:
(A) the date dispensed;
(B) the patient's name;
(C) the physician's name; and
(D) the name, strength, dosage form, quantity, and dose
of the drug dispensed.
(6) The physician shall sign all orders for
medication within the time frame established by regulatory agencies and health
care facility policies and procedures.
(c) The physician, registered nurse under physician
supervision, or person who is authorized to prescribe and dispense drugs
pursuant to G.S. 90-18.1 or 90-18.2 shall comply with all rules governing the
dispensing of medications including patient counseling as defined in 21 NCAC 46
.2504.
History Note: Authority G.S. 90-85.6; 90-18.1; 90-18.2;
90-85.21; 90-85.32; 90-85.33;
Eff. May 1, 1997;
Amended Eff. March 1, 2013.
21 NCAC 46 .1416 REPACKAGING
(a) Drugs which are prepackaged from within a health care
facility pharmacy for subsequent dispensing or administration shall be labeled
to include:
(1) the generic or trade name, strength, and
quantity of drug;
(2) identification of the manufacturer, and lot
or control number;
(3) the expiration date of the drug being
repackaged; and
(4) cautionary notations, if applicable.
(b) A batch number assigned by the pharmacy may be placed
on the label in lieu of the manufacturer's name and lot number, provided that
the pharmacy maintains a readily retrievable record which identifies, by batch
number, the manufacturer, manufacturer's expiration date, and lot number of the
drug.
(c) The pharmacy shall have and use facilities, personnel,
operational practices, packaging material, and control procedures to assure
that the purity, integrity, safety, and effectiveness of the drugs are not
affected by such repackaging. All repackaging must be performed by or under
the supervision of a pharmacist.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.32; 90-85.33;
Eff. May 1, 1997.
21 NCAC 46 .1417 REMOTE MEDICATION ORDER PROCESSING
SERVICES
(a) Purpose. The purpose of this Rule is to set out
requirements under which health care facility pharmacies may contract for the
provision of remote medication order processing services.
(b) Definitions of terms in this Rule:
(1) "Remote medication order processing
services" consists of the following:
(A) receiving, interpreting, or clarifying medication
orders;
(B) entering data and transferring medication order
information;
(C) performing drug regimen review;
(D) interpreting clinical data;
(E) performing therapeutic interventions; and
(F) providing drug information concerning medication
orders or drugs.
(2) "Remote medication order processing
pharmacy" is a pharmacy permitted by the Board that provides remote
medication order processing services.
(3) "Remote site" is a site located
within the United States that is electronically linked to a health care
facility licensed by the State of North Carolina for the purpose of providing
remote medication order processing services.
(c) Outsourcing. A health care facility pharmacy may
outsource medication order processing services to a remote medication order
processing pharmacy provided the pharmacies have the same owner or the pharmacy
has entered into a written contract or agreement with a remote medication order
processing pharmacy that outlines the services to be provided and the
responsibilities and accountabilities of each pharmacy in compliance with
federal and state laws and regulations. The pharmacy providing the remote
processing of medication orders shall notify the Board of Pharmacy prior to
providing such services.
(d) Training. A pharmacy providing remote medication order
processing must ensure that all pharmacists providing such services have been
trained on each outsourcing pharmacy's policies and procedures relating to
medication order processing. The training of each pharmacist shall be
documented by the pharmacist-manager to ensure competency and to ensure that
performance is at least at the same level of performance as pharmacists in the
outsourcing pharmacy. The training shall include policies on drug and food
allergy documentation, abbreviations, administration times, automatic stop
orders, substitution, and formulary compliance. The pharmacies shall jointly
develop a procedure to communicate changes in the formulary and changes in
policies and procedures related to medication order processing.
(e) Access.
(1) The pharmacies shall share common
electronic files or have technology to allow secure access to the pharmacy's
information system and to provide the remote site with access to the
information required to process a medication order.
(2) Pharmacists employed by or otherwise acting
as an agent for a remote medication order processing pharmacy may provide those
services from a remote site. Both the pharmacist providing those services from
a remote site and the remote medication order processing pharmacy on whose
behalf the pharmacist is providing such services are responsible for compliance
with all statutes, rules, policies, and procedures governing the provision of
remote mediation order processing services.
(f) Communication. The pharmacies shall jointly define the
procedures for resolving problems detected during the medication order review
and communicating these problems to the prescriber and the nursing staff
providing direct care.
(g) Recordkeeping. A pharmacy using remote order entry
processing services shall maintain records of all orders entered into their
information system including orders entered from a remote site. The system
shall have the ability to audit the activities of the individuals remotely
processing medication orders.
(h) Licensure. All remote medication order processing
pharmacies shall be permitted by the Board. An out-of-state remote medication
order processing pharmacy must be registered with the Board as an out-of-state
pharmacy. All pharmacists located in this State or employed by an out-of-state
remote medication order processing pharmacy providing services in this State
shall be licensed by the Board.
(i) Policy and Procedure Manual. All remote medication
order processing pharmacies shall maintain a policy and procedure manual. Each
remote medication order processing pharmacy, remote site, and health care
facility pharmacy shall maintain those portions of the policy and procedure
manual that relate to that pharmacy's or site's operations. The manual shall:
(1) outline the responsibilities of each of the
pharmacies;
(2) include a list of the name, address,
telephone numbers, and all permit numbers of the pharmacies involved in remote
order processing; and
(3) include policies and procedures for:
(A) protecting the confidentiality and integrity of
patient information;
(B) maintaining records to identify the name(s),
initials, or identification code(s) and specific activity(ies) of each
pharmacist who performed any processing;
(C) complying with federal and state laws and
regulations;
(D) operating a quality improvement program for pharmacy
services designed to objectively and systematically monitor and evaluate the
quality and appropriateness of patient care, pursue opportunities to improve
patient care, and resolve identified problems;
(E) annually reviewing the written policies and
procedures and documenting such review; and
(F) annually reviewing the competencies of pharmacists
providing the remote order review service.
(j) Nothing in this Rule shall be construed to relieve a
health care facility pharmacy of the need to provide on-site pharmacy services
required for licensure as specified in the Pharmacy Practice Act and rules
promulgated thereunder.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.21A; 90-85.26; 90-85.32; 90-85.34;
Eff. February 1, 2006;
Amended Eff. December 1, 2015; March 1, 2013.
21 NCAC 46 .1418 SUPERVISION OF UNIT DOSE MEDICATION
SYSTEMS
(a) The purpose of this Section is to set out requirements
in the event that pharmacists elect to supervise designated pharmacy
technicians' validation of stocking and prepackaging functions in acute care
hospital pharmacy practice settings as a means of facilitating pharmacists'
delivery of clinical services.
(b) A Hospital's pharmacist-manager is responsible for the
oversight of all validation of floor stock and unit dose distribution systems,
and that responsibility may not be delegated pursuant to 21 NCAC 46 .1411. In
the event that the Hospital's pharmacist-manager elects to utilize Validating
Technicians in the filling of floor stock and unit dose distribution systems,
the pharmacist-manager shall develop written policies and procedures that:
(1) permit a Validating Technician to validate
only the following functions of other registered pharmacy technicians in filling
floor stock and unit dose distribution systems for inpatients in a Hospital:
(A) stocking of patient care unit medication
inventories;
(B) stocking of ancillary drug cabinet inventories;
(C) stocking of automated dispensing or drug supply
devices;
(D) stocking of emergency kits; and
(E) prepackaging of prescription drugs within the
Hospital pharmacy;
(2) establish the parameters for pharmacist
supervision of pharmacy technician validation functions;
(3) establish facility-specific training for
pharmacy technician validation functions;
(4) establish an ongoing evaluation and
assessment program to ensure that pharmacy technician validation functions are
performed safely and accurately; and
(5) establish a recordkeeping system that shall
permit the identification of the Validating Technician who performs activities
authorized by this Rule. Readily retrievable records generated by this system
shall be maintained for the period of time specified in 21 NCAC 46 .1414(j)(1)
and (2).
(c) With respect to compounded or admixed prescription
drugs (whether sterile or non-sterile), a Validating Technician may validate
the filling of floor stock and unit dose distribution systems only after a
pharmacist has verified that the compounded or admixed prescription drugs have
been prepared correctly.
(d) This Rule does not authorize a pharmacy technician to
perform any act requiring the exercise of professional judgment by a
pharmacist.
(e) Validating Technician. For the purposes of this Rule,
a Validating Technician shall be a pharmacy technician who:
(1) is registered with the Board and trained as
specified in G.S. 90-85.15A;
(2) is a certified technician;
(3) holds either:
(A) an associate's degree in pharmacy technology
conferred by either an institution within the North Carolina Community College
System or System;
(B) an associate's degree in pharmacy technology
conferred by an institution accredited by one of the regional accrediting
agencies recognized by the United States Department of Education; or
(C) an associate's degree in pharmacy technology
conferred by a program accredited by the American Society of Health System
Pharmacists; and
(4) assists pharmacists with the preparation,
dispensing and distribution of prescription medications that will be
administered by a licensed health care provider to an inpatient in a Hospital
under this Rule.
(f) Hospital. For the purposes of this Rule, a Hospital is
either:
(1) a hospital licensed by the North Carolina
Medical Care Commission; or
(2) a psychiatric hospital operated by the
Secretary of the Department of Health and Human Services.
(g) Pursuant to G.S. 90-85.15A(c), the Board approves a
pharmacist's supervision of more than two pharmacy technicians where the
additional technicians are Validating Technicians. This Rule does not relieve
the pharmacist-manager of the obligation to request and receive written Board
approval for a pharmacist's supervision of more than two pharmacy technicians
where the additional technicians are certified pharmacy technicians but are not
Validating Technicians.
(h) A pharmacy technician performing validation functions
described in this Rule as part of a Board-approved 21 NCAC 46 .2510 pilot
project at Broughton State Hospital or Wake Forest University Baptist Medical
Center may continue to perform such functions for a period of three years from
this Rule's original effective date, after which time the pharmacy technician
must meet all of the requirements specified in Paragraph (e) of this Rule to
continue performing such functions.
History Note: Authority G.S. 90-85.6; 90-85.15A;
90-85.21; 90-85.26; 90-85.32; 90-85.33; 90-85.34;
Eff. June 18, 2011.
SECTION .1500 ‑ ADMISSION REQUIREMENTS: EXAMINATIONS
21 NCAC 46 .1501 APPLICATION
(a) All applications for examination shall be made on forms provided by the Board, filed with the
Board 45 days prior to the date of the examination, and accompanied by the
required fee.
(b) All applicants shall
submit to the Board a signed release form, completed Fingerprint Record Card,
and such other form(s) required to perform a criminal history check at the time
of application.
History Note: Legislative Objection Lodged Eff. March
29, 1983;
Authority G.S. 90‑85.6; 90‑85.15; 90‑85.24;
Eff. April 1, 1983;
Curative Eff. April 1, 1983;
Amended Eff. July 1, 2005; May 1, 1989.
21 NCAC 46 .1502 AGE
Proof of age must be shown by birth certificate, biblical
records, or other acceptable proof.
History Note: Authority G.S. 90‑85.15; 93B‑9;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1503 EXPERIENCE IN PHARMACY
(a) An applicant for license must show that he has received
1500 hours of practical experience under the supervision of a licensed
pharmacist which has been acquired after the satisfactory completion of two
years of college work. The Board shall accept hours of experience certified by
the school from which the applicant has graduated.
(b) All practical pharmacy experience to be acceptable must
be acquired under the general conditions approved by the Board as follows:
(1) All practical pharmacy experience must be
validated through registration in the internship program administered by the
Board.
(2) Persons working under the supervision of
registered pharmacists and expecting to qualify for the registered pharmacist
examination must notify the Board within five days of the beginning and the
ending of such employment.
(3) The Board shall not allow credit for claims
of practical experience required under the pharmacy laws, unless such claims
can be corroborated by records on file in the Board's office showing the
beginning and the ending of the practical experience claimed as supplied by the
applicant during this training period.
(4) Practical experience shall be credited only
when it has been obtained in a location holding a pharmacy permit, or a
location approved by the Board for that purpose.
(c) The pharmacist intern, or student, and the pharmacist
preceptor, or supervising pharmacist, shall at all times comply with the Board's
rules and the laws governing the practice of pharmacy and the distribution of
drugs. Failure of the pharmacist intern to do so is grounds to disqualify the
period of experience from counting toward the minimum requirements. A
pharmacist preceptor who causes or permits a pharmacist intern to violate the
Board's rules or the laws governing the practice of pharmacy and the
distribution of drugs forfeits his right to supervise such experience for a
period of time determined by the Board. A pharmacist who has been found in
violation of laws, rules, or regulations governing the practice of pharmacy and
the distribution of drugs cannot serve as a preceptor without the approval by
the Board.
(d) The Board may accept training in pharmacy gained in
another state pursuant to internship registration in this or another state if
the Board is satisfied that such training is equivalent.
History Note: Authority G.S. 90-85.6; 90-85.14;
90-85.15; 90-85.38;
Eff. April 1, 1983;
Amended Eff. March 1, 2004; September 1, 1993; April 1,
1992; October 1, 1990; May 1, 1989.
21 NCAC 46 .1504 EDUCATION
All applicants shall furnish on forms provided by the Board
satisfactory evidence that they have received an undergraduate professional
degree from an approved school.
History Note: Legislative Objection Lodged Eff. March
29, 1983;
Authority G.S. 90‑85.15;
Eff. April 1, 1983;
Curative Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1505 EXAMINATION
(a) The applicant shall pass the following examinations:
(1) a national examination;
(2) a jurisprudence examination; and
(3) a practical examination which includes an
error and omission section.
(b) For the purpose of grading or rating, the answers,
which shall be legible, shall be valued by marks or points based on their
importance, as determined by the judgment of the examiners.
(c) In order to pass, a score of 75 or more is required on each
examination. Candidates who obtain a score of 75 or more on each examination
are deemed to have passed the respective examination provided that the
candidate obtains a passing score on the remaining examinations within the next
following two calendar years. If the examination is taken outside of North
Carolina, the examination score shall be properly transferred to North
Carolina. A candidate who fails to pass all three examinations in the two
calendar year period must retake and pass all three examinations within a two
calendar year period.
(d) At the time of the examination, the Board may designate
certain questions which, if missed, shall require the candidate to obtain
continuing education. The continuing education required will be specified by
the Board and must be obtained by the candidate prior to issuance of a
pharmacist license.
History Note: Authority G.S. 90-85.15; 90-85.16;
Eff. April 1, 1983;
Amended Eff. April 1, 2004; April 1, 2003; July 1, 1996;
December 31, 1985.
21 NCAC 46 .1506 RULES OF EXAMINATION CONDUCT
Candidates must not communicate in any way with another
candidate, or give, receive, or use any information concerning the examination,
except as specifically directed by the examiner. Any candidate who fails to
observe this Rule shall be disqualified for the remainder of the examination
and shall forfeit the right to have graded any examination he might have taken
thus far. Candidates taking the examination must follow the instructions given
for each examination. Incorrect spelling, grammar, or illegible handwriting
may affect the final rating. Time allotted for completion of each division of
the examination shall be announced at the time of the examination.
History Note: Authority G.S. 90‑85.6; 90‑85.15;
90‑85.16;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1507 PARTIAL EXAMINATION
History Note: Authority G.S. 90-85.6; 90-85.15;
90.85.16;
Eff. April 1, 1983;
Amended Eff. May 1, 1989;
Repealed Eff. January 1, 2009.
21 NCAC 46 .1508 PREREQUISITES FOR DISEASE STATE
MANAGEMENT EXAMINATION
History Note: Authority G.S. 90-85.6; 90-85.34;
Eff. August 1, 2000;
Repealed Eff. July 1, 2005.
SECTION .1600 - LICENSES
AND PERMITS
21 NCAC 46 .1601 PHARMACY PERMITS
(a) Applications for pharmacy permits, whether original or
renewal, shall be made upon forms provided by the Board. The Board shall not
issue any original or annual renewal pharmacy permit until the Board is
satisfied that:
(1) The pharmacist-manager is sure that at all
times adequate qualified personnel have been secured by the management of the
store to properly render pharmaceutical service in the manner prescribed by
law.
(2) The pharmacy posts in a location
conspicuous to the public the specific hours that a pharmacist is on duty in
the pharmacy. This requirement does not apply to hospitals, nursing homes, and
similar institutions subject to the provisions of Section .1400 of this
Chapter.
(3) The pharmacist-manager shall be responsible
for obtaining and maintaining equipment in the pharmacy adequate to meet the
pharmaceutical care needs of the pharmacy's patients.
(4) The pharmacist-manager shall be responsible
for obtaining and maintaining a reference library in the pharmacy. The library
shall include current references, either hard copy or electronically
accessible, covering:
(A) State and federal statutes and rules relating to the
practice of pharmacy and the legal distribution of drugs;
(B) Drug interactions, adverse effects, therapeutic use,
dosing and toxicology;
(C) Patient-oriented reference materials for counseling
in proper drug usage as specified in 21 NCAC 46 .2504;
(D) Equivalent drug products as defined in G.S.
90-85.27; and
(E) Any reference materials otherwise required by state
or federal law, including any otherwise required in these Rules.
(5) The pharmacy is equipped with sanitary
appliances including lavatory facilities with hot and cold running water; is
well lighted; and is kept in a clean, orderly, and sanitary condition.
(6) All prescription medications are labeled in
accordance with G.S. 106-134 and 106-134.1.
(b) In addition to the requirements for issuance and
renewal of a pharmacy permit imposed by statute and rules of the Board, a
permit shall not be issued or renewed to any person to operate a pharmacy
wherein the prescriptions of medical practitioners are compounded or dispensed
and distributed when such distribution is effected by mail and the
practitioner-pharmacist-patient relationship does not exist, until the Board is
satisfied that:
(1) The pharmacy maintains records of
prescriptions compounded or dispensed and distributed in manner that is readily
retrievable;
(2) During the pharmacy's regular hours of
operation but not less than six days per week, for a minimum of forty hours per
week, a toll-free telephone service is provided to facilitate communication
between patients and a pharmacist at the pharmacy who has access to the
patient's records. This toll-free number must be disclosed on the label affixed
to each container of dispensed drugs;
(3) The pharmacy complies with all lawful
orders, directions, and requests for information from the Boards of pharmacy of
all states in which it is licensed and all states into which it distributes
prescription drugs;
(4) The pharmacy complies with all United
States Pharmacopeia and Food and Drug Administration requirements regarding the
storage, packaging, and shipping of prescription medications. The
pharmacist-manager and all other pharmacists employed in the pharmacies
permitted pursuant to this Paragraph shall be subject to all Federal and State
statutes and regulations concerning the dispensing of prescription medications
including 21 NCAC 46 .1801 and .1805 and 21 CFR 1306.01, 1306.05, and 1306.21.
(c) The Board shall not issue an original or renewal permit
to any person to operate a drugstore or pharmacy as a department in or a part
of any other business serving the general public (except hospitals, nursing
homes, and similar institutions subject to the provisions of Section .1400 of
this Chapter) unless such pharmacy facility:
(1) is physically separated from such other
business;
(2) is separately identified to the public both
as to name and any advertising;
(3) completes all transactions relative to such
pharmacy within the registered facility; and
(4) meets the same requirements for
registration as all other pharmacies.
(d) In addition to all of the other requirements for
issuance and renewal of a pharmacy permit imposed by statute and rules of the
Board, the Board shall not issue any original or annual renewal pharmacy permit
to any Internet pharmacy until the Board is satisfied that:
(1) The Internet pharmacy is certified by the
National Association of Boards of Pharmacy as a Verified Internet Pharmacy
Practice Site (VIPPS);
(2) The Internet pharmacy has certified the
percentage of its annual business conducted via the Internet on a form provided
by the Board, when it applies for permit or renewal; and
(3) The Internet pharmacy has provided the
Board with the names, addresses, social security numbers, phone numbers,
facsimile numbers, email addresses, and titles of all principal corporate
officers of the Internet pharmacy; the names, addresses, social security
numbers, phone numbers, facsimile numbers, email addresses, and titles of all
principal officers of any company, partnership, association, or other business
entity holding any ownership interest in the Internet pharmacy; the names,
addresses, social security numbers, phone numbers, facsimile numbers, email
addresses, and titles of any individual holding any ownership interest in the
Internet pharmacy.
This Paragraph does not relieve an out-of-state pharmacy
from compliance with all provisions of 21 NCAC 46 .1607 governing out-of-state
pharmacies.
(e) Permits to operate pharmacies, whether original or
renewal, shall be issued to the pharmacist-manager of such pharmacy pursuant to
a joint application of the owner and pharmacist-manager for the conduct and
management of said pharmacy. The issuance of said permit shall not be complete
and the permit shall not be valid until it has been countersigned by the
pharmacist-manager as represented in the application. The permit so issued is
valid only so long as the pharmacist-manager to whom it was issued assumes the
duties and responsibilities of pharmacist-manager. Permits may be reissued at
any time to a successor pharmacist-manager pursuant to the proper amendment of
the application for the permit.
(f) Upon application, the Board may issue and renew
separate permits for pharmacies operating at one location. Records for each
permitted pharmacy must be maintained separately. Prior to issuance of an
original permit, each pharmacy shall submit a plan to the Board that shall
assure accountability for the actions of each pharmacy at the location.
History Note: Authority G.S. 90-85.6; 90-85.21;
132-1.10;
Eff. April 1, 1983;
Amended Eff. November 1, 2012; April 1, 2007; April 1,
2003; April 1, 1999; October 29, 1998; July 1, 1996; September 1, 1995; May 1,
1989; August 1, 1988; March 1, 1984.
21 NCAC 46 .1602 LICENSE BY RECIPROCITY
(a) An applicant for licensure without examination, must
have:
(1) Originally been licensed as a pharmacist by
an examination equivalent to the North Carolina examination specified in Rule
.1505(a)(1) of this Chapter;
(2) Achieved scores on an equivalent
examination, such as the NABPLEX examination, which would qualify for licensure
in this state at the time of examination; and
(3) Been licensed by a state which deems
licensees from this state to be equivalent to the extent that they are suitable
for licensure in that state without further substantial examination.
(b) All applicants shall submit to the Board a signed
release form, completed Fingerprint Record Card, and such other form(s)
required to perform a criminal history check at the time of application.
(c) The Board shall require an applicant for licensure
without examination who has not practiced pharmacy within two years prior to
application to obtain additional continuing education, practical pharmacy
experience, successfully complete one or more parts of the Board's licensure
examination, or a combination of the foregoing, as the Board deems necessary to
ensure that the applicant can safely and properly practice pharmacy.
(d) The Board shall also restrict licenses granted pursuant
to this Rule for such period of time as the Board deems necessary to ensure
that the applicant can safely and properly practice pharmacy.
History Note: Authority G.S. 90-85.6; 90-85.20;
Eff. April 1, 1983;
Amended Eff. February 1, 2006; July 1, 2005; March 1,
2004; April 1, 2003, July 1, 1996; May 1, 1989.
21 ncac 46 .1603 WHEN NEW PERMIT REQUIRED
A new pharmacy, device, or medical equipment permit is
required for a new location, a change to a different or successor business
entity, or a change resulting in a different person or entity owning more than
50 percent interest in the permit holder or any entity in the chain of
ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of
this Section. A new permit is required if there is a change in the authority
to control or designate a majority of the members or board of directors of a
nonprofit corporation holding a pharmacy permit or any nonprofit corporation in
the chain of ownership above the permit holder.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.22;
Eff. May 1, 1989;
Amended Eff. March 1, 2004; April 1, 2001; August 1,
1998; April 1, 1997; September 1, 1995.
21 NCAC 46 .1604 WHEN NEW PERMIT NOT REQUIRED
(a) A new pharmacy, device or medical equipment permit is
not required in the following situations:
(1) the permit holder is a publicly-traded
corporation and continues to hold the permit; or
(2) the permit holder is a corporation which is
a wholly-owned subsidiary, and any change in the ownership of any corporation
in the chain of ownership above the permit holder is due to the stock of such
corporation being publicly-traded.
(b) A permit which has been served with a notice of hearing
for a pending disciplinary proceeding before the Board may not be surrendered.
History Note: Authority G.S. 90-85.6; 90-85.21;
90-85.22;
Eff. May 1, 1989;
Amended Eff. June 1, 2004; April 1, 2001; August 1, 1998;
May 1, 1997; September 1, 1995.
21 NCAC 46 .1605 CHARGE FOR VERIFICATION FOR
REINSTATEMENT
The Board shall charge persons requesting written
verification for reinstatement of a pharmacy license or permit or a device and
medical equipment permit a fee of twenty-five dollars ($25.00) per verification.
History Note: Authority G.S. 90-85.6; 90-85.17;
90-85.21; 90-85.22; 150B-19(5)(e);
Eff. September 1, 1993;
Amended Eff. February 1. 2006; September 1, 1995.
21 ncac 46 .1606 REQUIREMENT OF PERSONAL APPEARANCE
Prior to issuance of any original permit or device and
medical equipment permit, the following persons must appear personally at the
Board office on the first Monday of the month, the Monday before the monthly
Board meeting, or such other time as scheduled with the Board's staff:
(1) the pharmacist-manager for the applicant pharmacy;
and
(2) the person in charge of the facility applying for
the device and medical equipment permit.
History Note: Authority G.S. 90-18.1; 90-18.2;
90-85.3(a),(r); 90-85.6; 90-85.21; 90-85.22;
Eff. April 1, 1994;
Amended Eff. April
1, 2003; April 1, 1999; September 1, 1995.
21 NCAC 46 .1607 OUT-OF-STATE PHARMACIES
(a) In order to protect the public health and safety and
implement G.S. 90-85.21A, the following provisions apply to out-of-state
pharmacies that ship, mail, or deliver in any manner a dispensed legend drug
into this State.
(b) Such pharmacies shall:
(1) Maintain, in readily retrievable form,
records of prescription drugs dispensed to North Carolina residents;
(2) Supply all information requested by the
Board in carrying out the Board's responsibilities under the statutes and rules
pertaining to out-of-state pharmacies;
(3) During the pharmacy's regular hours of
operation but not less than six days per week, for a minimum of 40 hours per
week, provide a toll-free telephone service to facilitate communication between
patients and pharmacists at the pharmacy who have access to the patient's
records. This toll-free number must be disclosed on the label affixed to each
container of dispensed drugs;
(4) Comply with all USP and FDA requirements
regarding the storage, packaging, and shipping of prescription medications;
(5) Develop policies governing:
(A) normal delivery protocols and times;
(B) the procedure to be followed if the patient's
medication is not available at the out-of-state pharmacy, or if delivery will
be delayed beyond the normal delivery time;
(C) the procedure to be followed upon receipt of a
prescription for an acute illness, which shall include a procedure for delivery
of the medication to the patient from the out-of-state pharmacy at the earliest
possible time (such as courier delivery), or an alternative that assures the
patient the opportunity to obtain the medication at the earliest possible time;
and
(D) the procedure to be followed when the out-of-state
pharmacy is advised that the patient's medication has not been received within
the normal delivery time and that the patient is out of medication and requires
interim dosage until mail prescription drugs become available;
(6) Disclose the location, names, and titles,
of all principal corporate officers, if incorporated, and if unincorporated,
partners, or owners of the pharmacy. Disclose the names and license numbers of
all pharmacists dispensing prescription legend drugs to an ultimate user in
this State, the names and, if available, license or registration numbers of all
supportive personnel employed by the out-of-state pharmacy who assist such
pharmacists in such dispensing. A report containing this information shall be
made on an annual basis and within 30 days of each change of any principal office,
pharmacist-manager of any location dispensing prescription legend drugs to an
ultimate user in this State, principal corporate officer if incorporated, and
if unincorporated, partner or owner of the pharmacy. A new registration shall
be required for a change of ownership of an established pharmacy to a successor
business entity which results in a change in the controlling interest in the
pharmacy;
(7) Submit evidence of possession of a valid
license, permit, or registration as a pharmacy in compliance with the laws of
the state in which the pharmacy is located. Such evidence shall consist of one
of the following:
(A) a copy of the current license, permit, or
registration certificate issued by the regulatory or licensing agency of the
state in which the pharmacy is located; or
(B) a letter from the regulatory or licensing agency of
the state in which the pharmacy is located certifying the pharmacy's compliance
with the pharmacy laws of that state;
(8) Designate a resident agent in North Carolina for service of process. Any such out-of-state pharmacy that does not so
designate a resident agent shall be deemed to have appointed the Secretary of
State of the State of North Carolina to be its true and lawful attorney upon
whom process may be served. All legal process in any action or proceeding
against such pharmacy arising from shipping, mailing or delivering prescription
drugs in North Carolina shall be served on the resident agent. In addition, a
copy of such service of process shall be mailed to the out-of-state pharmacy by
certified mail, return receipt requested, at the address of the out-of-state
pharmacy as designated on the registration form filed with the Board. Any
out-of-state pharmacy which does not register in this State, shall be deemed to
have consented to service of process on the Secretary of State as sufficient
service.
(c) The facilities and records of an out-of-state pharmacy
shall be subject to inspection by the Board; provided however, the Board may
accept in lieu thereof satisfactory inspection reports by the licensing entity
of the state in which the pharmacy is located.
(d) An out-of-state pharmacy shall comply with the statutes
and regulations of the state in which the pharmacy is located.
(e) Any person who ships, mails, or delivers prescription
drugs to North Carolina residents from more than one out-of-state pharmacy
shall register each pharmacy separately.
(f) Prior to original registration, a pharmacist who is an
authorized representative of the pharmacy's owner must appear personally at the
Board office on the first Monday of the month, the Monday before the monthly
Board meeting, or such other time as scheduled with the Board's staff. Such
authorized pharmacist may represent all pharmacies having the same ownership.
(g) An out-of-state pharmacy shall report to the Board
information that reasonably suggests that there is a probability that a
prescription drug or device dispensed from such out-of state pharmacy has
caused or contributed to the death of any patient. The report shall be filed
in writing on a form provided by the Board within 14 days of the pharmacy
becoming aware of the death. The Board may not disclose the identity of any
person or entity making the report, except when it is necessary to protect life
or health of any person. No such report in possession of the Board shall be
discoverable or admissible into evidence or otherwise used in any civil action
involving private parties, except as otherwise required by law.
(h) The Board may, in accordance with Chapter 150B of the
General Statutes, issue a letter of reprimand or suspend, restrict, revoke, or
refuse to grant or renew registration to an out-of-state pharmacy if such
pharmacy has:
(1) made false representations or withheld
material information in connection with obtaining registration;
(2) been found guilty of or plead guilty or
nolo contendere to any felony in connection with the practice of pharmacy or
the distribution of drugs;
(3) made false representations in connection
with the practice of pharmacy that endanger or are likely to endanger the
health or safety of the public, or that defraud any person;
(4) failed to comply with this Rule;
(5) been the subject of a negligence complaint
resulting from the dispensing of prescription drugs to a resident of North Carolina and based on an investigation of such complaint been found to be negligent:
(A) by the Board of Pharmacy of the state in which the
pharmacy is located;
(B) by the North Carolina Board of Pharmacy if the Board
of Pharmacy of the state where the pharmacy is located failed to initiate an
investigation of such complaint within 45 days after referral of the complaint
from the North Carolina Board of Pharmacy; or
(C) by the North Carolina Board of Pharmacy if the Board
of Pharmacy of the state where the pharmacy is located initiates an
investigation of such complaint within 45 days, but later advises the North
Carolina Board that it will not make a determination of negligence or that it
has made no determination of the issue of negligence within one year after
referral of the complaint and has discontinued any active investigation or
proceeding for such determination. In any disciplinary proceeding based on
negligence, the standard of practice shall be that applicable in the state in
which the pharmacy is located. In disciplinary proceedings pursuant to Part
(h)(5)(A) of this Rule, the Board shall adopt the findings of negligence by the
Board of Pharmacy of the state in which the pharmacy is located as part of the
Board’s final decision without producing its own evidence of negligence.
(i) An out-of-state pharmacy shall notify the Board within
five days of receipt of any order or decision by a Board of Pharmacy imposing
disciplinary action on the pharmacy. Notwithstanding the provisions of
Paragraph (h) of this Rule, if the permit or registration in the state where
the pharmacy is located is suspended or revoked, then the pharmacy’s registration
in North Carolina will be immediately suspended or revoked for the same period
of time.
(j) An out-of-state pharmacy registration shall expire on
December 31 of each year.
(k) The fees provided for in G.S. 90-85.21A as maximum fees
which the Board is entitled to charge and collect are hereby established as the
fees for each original registration and for annual renewal of each
registration.
History Note: Authority G.S. 90-85.6; 90-85.21A;
90-85.26; 90-85.28; 90-85.29; 90-85.30; 90-85.32;
Eff. July 1, 1994;
Amended Eff. March 1, 2006.
21 NCAC 46 .1608 DEVICE AND MEDICAL EQUIPMENT PERMITS
(a) Applications for device and medical equipment permits,
whether original or renewal, shall be made upon forms provided by the Board. The
Board shall not issue any original or annual renewal device and medical
equipment permit until the Board is satisfied that:
(1) Adequate qualified personnel have been
secured by the management of the facility to properly render device and medical
equipment services in the manner prescribed by law.
(2) Such personnel shall be maintained during
the period for which the permit is issued.
(3) If the applicant dispenses medical oxygen
to a patient, then the applicant must reasonably ensure that the following
medical equipment is maintained:
(A) Sufficient backup of oxygen in that patient's home
and supplies for equipment serviced to maintain continuation of therapy for 24
hours; and
(B) An oxygen analyzer in the permitted facility, if
concentrators are dispensed.
(4) Suitable facilities shall be maintained to
house inventory, to allow for fabrication work space, and to record and file
prescription orders as required by law.
(5) A copy of the pharmacy laws of North
Carolina, including the North Carolina Pharmacy Practice Act and the rules of
the Board shall be present in the facility at all times.
(6) The facility is equipped with a functioning
lavatory where hot and cold running water or hand washing appliances or
waterless hand cleaner are available.
(7) The facility is kept in a clean, orderly,
and sanitary condition.
(8) The applicants' services are accessible to
its customer base.
(9) All prescription medications are labeled in
accordance with G.S. 106‑134 and 106‑134.1.
(10) The applicant complies with all USP and FDA
requirements regarding the storage, packaging, and shipping of prescription
medications, including medical oxygen.
(11) The applicant's services are available 24
hours, seven days per week when essential to the maintenance of life or when
the lack of such services might reasonably cause harm.
(12) The applicant implements and maintains a
written procedure at each location for handling complaints and problems, which
includes a complaint file documenting complaints and problems and resolution of
the complaints or problems.
(13) The applicant complies with local/state fire
and building laws.
(14) The applicant complies with current
Occupational Safety and Health Administration (OSHA) laws and requirements as
enforced by the NC Department of Labor/Division of OSHA, including the approach
to infection control known as "Universal Precautions."
(b) Device and medical equipment permits, whether original
or renewal, shall be issued to the person in charge of the facility pursuant to
a joint application of the owner and person in charge. The issuance of said
permit shall not be complete and the permit shall not be valid until it has
been countersigned by the person in charge as represented in the application. The
permit so issued is valid only so long as the person in charge to whom it was
issued assumes his duties and responsibilities. Permits may be reissued at any
time to a successor person in charge pursuant to the proper amendment of the
application for the permit. The hours of operation shall be posted
conspicuously at the facility for public viewing. The person in charge or the
designee of the person in charge shall be present at the facility during the
hours of operation of the facility. The person in charge shall notify the
Board in writing of a change in the facility address within 30 days from the
date of the change.
(c) When a device and medical equipment dispensing facility
is to be closed permanently, the person in charge shall inform the Board of the
closing and arrange for the proper disposition of devices and medical equipment
and return the permit to the Board's offices within 10 days of the closing
date. The person in charge, jointly with the owner (if the owner is someone
other than the person in charge), shall provide for the orderly transfer of
records to another permit holder for maintenance of patient therapy and inform
the public of such transfer by posted notice or otherwise.
(d) Charitable organizations providing devices and medical
equipment at no charge must register with the Board. The Board shall waive the
fee for a permit upon a showing that the organization meets the Internal
Revenue Service charitable purpose requirements for exemption from taxation and
that at least 75 percent of the organization's funds are used for a charitable
purpose. Loaner closets providing device and medical equipment at no charge,
excluding oxygen or other life support devices, must register with the Board
but are exempt from the fee for device and medical equipment permits.
History Note: Authority G.S. 90‑85.6; 90‑85.22;
Eff. September 1, 1995;
Amended Eff. April 1, 2007.
21 NCAC 46 .1609 PERMIT RENEWAL
Permits issued by the Board expire on December 31 and become
invalid 60 days following expiration.
History Note: Authority G.S. 90-85.6; 90-85.21;
Eff. September 1, 1995.
21 NCAC 46 .1610 REINSTATEMENT OF FORFEITED LICENSING
PRIVILEGES
An individual whose licensing privileges have been forfeited
pursuant to G.S. 15A-1331, shall immediately surrender to the Board office his
or her permit or license, current renewal certificate, and wallet card. In
order to have the licensing privileges reinstated, the individual must appear
before the Board and submit evidence that it would be in the public interest to
reinstate the licensing privileges and that he or she can safely and properly
practice pharmacy.
History Note: Authority G.S. 15A-1331A; 90-85.19;
Eff. September 1, 1995.
21 NCAC 46 .1611 FEE FOR SUBMITTAL OF DISHONORED AND
RETURNED CHECK
(a) Any person, firm or corporation submitting to the Board
a check which is subsequently returned to the Board because of insufficient
funds or because there is no account open at the bank shall be charged a fee of
twenty-five dollars ($25.00) for processing the check.
(b) Until such time as the payor of the returned check pays
the amount of the check and pays the prescribed fee, the payor shall not be
eligible to take an examination, review an examination, obtain a license or
permit or have his license or permit renewed.
(c) Any license or permit which has been issued based on
the payment of a check which is subsequently returned to the Board for reasons
stated in Paragraph (a) of this Rule shall be declared invalid until such time
as the payor pays the amount of the check and pays the prescribed fee.
(d) Payment to the Board of the amount of the returned
check and the prescribed fee shall be made in the form of cash, a cashier's
check, or money order.
(e) All examination, license and permit, and license and
permit renewal applications provided by the Board shall contain information in
a conspicuous place thereon advising the applicant of the applicable fee for
returned checks.
History Note: Authority G.S. 25-3-506;
Eff. September 1, 1995;
Amended Eff. February 1, 2006.
21 NCAC 46 .1612 REINSTATEMENT OF LICENSES AND
PERMITS
(a) All licenses and registrations issued to individuals
that are not renewed by March 1 of the succeeding year, lapse and are subject
to the maximum reinstatement and renewal fees set out in G.S. 90-85.24 in order
to be reinstated. All permits and registrations issued to locations that are
reinstated after March 1 and prior to April 1 of the succeeding year are
subject to the maximum reinstatement and renewal fees set out in G.S. 90-85.21A
and 90-85.24. After March 31, permits and registrations issued to locations
shall submit new applications and are subject to the maximum original
registration fees. This Rule also applies to licenses, registrations, and
permits reinstated following voluntary surrender or disciplinary action by the
Board.
(b) All applicants shall submit to the Board a signed
release form, completed Fingerprint Record Card, and such other form(s)
required to perform a criminal history check at the time of application.
(c) The Board shall require applicants for reinstatement of
a lapsed license who have not practiced pharmacy within two years prior to
application for reinstatement to obtain continuing education in addition to
that required by Rule .2201 of this Chapter, practical pharmacy experience,
successfully complete one or more parts of the Board's licensure examination,
or a combination of the foregoing, as the Board deems necessary to ensure that
the applicant can safely and properly practice pharmacy.
(d) The Board shall also restrict licenses reinstated
pursuant to G.S. 90-85.19 for such period of time as the Board deems necessary
to ensure that the applicant can safely and properly practice pharmacy.
History Note: Authority G.S. 90-85.19; 90-85.24;
Eff. April 1, 1999;
Amended Eff. March 1, 2006; July 1, 2005.
21 NCAC 46 .1613 EXTENSION
PERIOD FOR CERTAIN MEMBERS OF THE ARMED FORCES
(a) Definitions:
(1) "Eligible licensee" means a
pharmacist who holds a license in good standing from the Board of Pharmacy, who
serves the armed forces of the United States, and who is eligible for an
extension of time in which to file a tax return pursuant to G.S. 105-249.2.
"Eligible licensee" includes a pharmacist who holds a Clinical
Pharmacist Practitioner credential or who is a pharmacist vaccinator.
(2) "Eligible registrant" means a
pharmacy technician, dispensing physician, dispensing nurse practitioner or
dispensing physician assistant who holds a registration in good standing from
the Board of Pharmacy, who serves the armed forces of the United States, and
who is eligible for an extension of time in which to file a tax return pursuant
to G.S. 105-249.2.
(3) "Extension period" means the time
period specified in 26 U.S. Code 7508.
(4) "Good standing" means a license
or registration that is not suspended, revoked or subject to a current
disciplinary order.
(b) Extension of time to pay license or registration
renewal fee and waiver of continuing education requirements:
(1) An eligible licensee or registrant shall
notify the Board of eligibility for the extension period before his or her
current license or registration expires. Upon such notification, the Board
shall maintain the license or registration in active status through the
extension period.
(2) If an eligible licensee or registrant fails
to notify the Board of eligibility for the extension period before his or her
current license or registration expires, upon receipt and acceptance of a
renewal application within the extension period and presentation of proof that
the licensee or registrant was an eligible licensee or registrant on the date
that is the deadline for renewal, the expired license or registration shall be
deemed retroactively to have not expired.
(3) Notwithstanding 21 NCAC 46 .1612(a) and
.3301(a), an eligible licensee or registrant who submits a renewal application
and pays the renewal fee required by the Board within the extension period
shall not be deemed to hold a lapsed license or registration subject to
reinstatement fees.
(4) Notwithstanding 21 NCAC 46 .2201, .3101(d)
and .2507(d), an eligible licensee may renew his or her license within the
extension period despite failing to complete the specified continuing education
requirements.
(5) A licensee or registrant shall provide
proof of eligibility for the extension period when the licensee or registrant
submits the renewal application.
History Note: Authority G.S. 90-18.1; 90-18.2; 90-85.6;
90-85.15A; 90-85.17; 90-85.21(b); 90-85.24; 90-85.26A; 93B-15;
Eff. April 1, 2010.
21 NCAC 46 .1614 SUSPENSION OF AUTHORITY TO EXPEND
FUNDS
In the event that the Board's authority to expend funds is
suspended pursuant to G.S. 93B-2(d), the Board shall continue to issue and
renew licenses, registrations and permits and collect all fees set forth in
G.S. 90-85.24, but all fees tendered shall be placed in an escrow account
maintained by the Board for this purpose. Once the Board's authority is
restored, the funds shall be moved from the escrow account into the general
operating account.
History Note: Authority G.S. 90-85.6; 90-85.24;
Eff. August 1, 2010.
SECTION .1700 ‑ DRUGS DISPENSED BY NURSE OR PHYSICIAN'S
ASSISTANT
21 NCAC 46 .1701 DISPENSING BY REGISTERED NURSE OR
PHYSICIAN'S ASSISTANT
21 NCAC 46 .1702 DISPENSING SUPERVISED BY LICENSED
PHARMACIST
History Note: Authority G.S. 90‑18.1; 90‑18.2;
90‑85.6;
Eff. April 1, 1983;
Amended Eff. May 1, 1989;
Repealed Eff. April 1, 1997.
21 NCAC 46 .1703 DRUGS TO BE DISPENSED
(a) The nurse practitioner may dispense any and all drugs
that the nurse practitioner is authorized by law to prescribe.
(b) The physician assistant may dispense any and all drugs
that the physician assistant is authorized by law to prescribe.
(c) The pharmacist shall prepare a plan to ensure that
there are adequate amounts of each of the drugs dispensed by a nurse
practitioner or physician assistant, and that such drugs are properly stored
and packaged.
(d) All drugs dispensed by a nurse practitioner or
physician assistant must be dispensed from a place holding a current pharmacy
permit from the Board as required by G.S. 90-85.21.
(e) The consulting pharmacist shall be available for
consultation in person, by telephone, or other means of direct communication at
all times when drugs are dispensed.
(f) All drugs dispensed by the nurse practitioner or
physician assistant shall be prepackaged in safety closure containers and shall
be appropriately prelabeled (including necessary auxiliary labels) by the
pharmacist with all information required by law except the name of the patient
and the directions for use. The name of the patient and directions for use of
the drugs shall be placed on the label by the nurse practitioner or physician
assistant at the time it is delivered to the patient or his agent.
History Note: Authority G.S. 90‑18.1; 90‑18.2;
90‑85.6;
Eff. April 1, 1983;
Amended Eff. April 1, 1999; May 1, 1997; May 1, 1989.
21 NCAC 46 .1704 PREPACKAGING OF DRUGS DISPENSED
21 NCAC 46 .1705 RECORDS OF DISPENSING
History Note: Authority G.S. 90‑18.1; 90‑18.2;
90‑85.6; 90‑85.36;
Eff. April 1, 1983;
Amended Eff. September 1, 1995; May 1, 1989;
Repealed Eff. April 1, 1997.
21 NCAC 46 .1706 RETROSPECTIVE REVIEW AND
CONSULTATION
All drugs dispensed by a nurse practitioner or physician
assistant shall be retrospectively reviewed by a pharmacist on a weekly basis.
The reviewing pharmacist may advise and consult with the dispensing nurse
practitioner, physician assistant, or supervising physician about potential
drug therapy concerns which may result from:
(1) therapeutic duplication;
(2) drug-disease contraindication;
(3) interactions between or among drugs, including serious
interactions with prescription or over-the-counter drugs;
(4) incorrect drug dosage or duration of drug
treatment;
(5) interactions between drugs and allergies; and
(6) clinical abuse or misuse.
History Note: Authority G.S. 90-18.1; 90-18.2; 90-85.6;
Eff. April 1, 1999.
SECTION .1800 - PRESCRIPTIONS
21 NCAC 46 .1801 EXERCISE OF PROFESSIONAL JUDGMENT IN
FILLING PRESCRIPTIONS
(a) A pharmacist or device and medical equipment dispenser
shall have a right to refuse to fill or refill a prescription order if doing so
would be contrary to his or her professional judgment.
(b) A pharmacist or device and medical equipment dispenser
shall not fill or refill a prescription order if, in the exercise of professional
judgment, there is or reasonably may be a question regarding the order's
accuracy, validity, authenticity, or safety for the patient.
(c) A prescription order is valid only if it is a lawful
order for a drug, device, or medical equipment issued by a health care provider
for a legitimate medical purpose, in the context of a patient-prescriber
relationship, and in the course of legitimate professional practice as
recognized by the occupational licensing board governing the health care
provider.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. April 1, 1983;
Amended Eff. August 1, 2015; February 1, 2007; March 1,
2004; April 1, 2003; September 1, 1995.
21 NCAC 46 .1802 PRESCRIPTION REFILLS
(a) Authorization for prescription refills is presumed to
be within the prescribed dosage or normal therapeutic use. Refilling
prescriptions more frequently than the prescribed dosage would require, or
refilling prescriptions in significant excess of normal therapeutic use, may be
considered as negligence under G.S. 90-85.38(a)(9).
(b) If deemed appropriate in the pharmacist's professional
judgment, a patient may receive upon request drug quantities in excess of the
face amount of a prescription for a non-controlled substance, up to the total
amount authorized. The pharmacist shall not dispense in excess of the face
amount of a prescription for a controlled substance or psychotherapeutic drug
without authorization from the prescriber.
History Note: Authority G.S. 90‑85.6; 90‑85.32;
Eff. April 1, 1983;
Amended Eff. September 1, 1993; May 1, 1989.
21 NCAC 46 .1803 PRESCRIPTION RECORDS
All records pertaining to the filling and refilling of
prescriptions shall be available to designated employees of the Board during
normal business hours.
History Note: Authority G.S. 90‑85.6; 90‑85.32;
90‑85.36;
Eff. April 1, 1983.
21 ncac 46 .1804 PRESCRIPTION: RECEIVING AND
DISPENSING
(a) In order to assure that the
practitioner-pharmacist-patient relationship exists and to promote the safe and
secure distribution of drugs and devices from a pharmacy, prescription orders
may be received for filling and refilling only by a pharmacist or a bona fide
employee of the pharmacy. The pharmacist-manager of the pharmacy shall be
ultimately responsible for the safe, lawful and secure receipt of prescription
orders and delivery of prescription drugs. Notwithstanding the provisions of
this Rule, prescription drugs also may be delivered by mail in accordance with
the provisions of 21 NCAC 46 .1601(b).
(b) In filling or refilling prescription orders, the
pharmacist shall not be required to deal with parties, including managed care
companies and insurance providers, outside the practitioner-pharmacist-patient
relationship.
(c) In order to promote the safe and secure distribution of devices
and medical equipment from a facility holding a device and medical equipment
permit, prescription orders for devices and medical equipment may be received
for filling and refilling only by the person in charge of the facility holding
the device and medical equipment permit or a bona fide employee of the facility.
The person in charge shall be ultimately responsible for the safe, lawful and
secure receipt of prescription orders and delivery of devices and medical
equipment. Unless the location also holds a pharmacy permit, a facility
holding a device and medical equipment permit shall not acquire, receive,
store, or deliver prescription drugs.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. December 1, 1983;
Amended Eff. April 1, 2004; August 1, 2000; September 1,
1995; May 1, 1989; August 1, 1988.
21 NCAC 46 .1805 DISPENSING DRUGS WITHOUT A
PRESCRIPTION
The dispensing of or any delivery of a prescription drug,
including the surrender of control or possession in any manner which results in
a delivery of a prescription drug, without a valid prescription order is
unlawful. Refilling a prescription for a prescription drug without
authorization is unlawful.
History Note: Authority G.S. 90‑85.3(s); 90‑85.6;
90‑85.32;
Eff. March 1, 1984;
Amended Eff. May 1, 1989.
21 NCAC 46 .1806 TRANSFER OF PRESCRIPTION INFORMATION
(a) The transfer of original prescription information for
the purpose of refill dispensing is permissible between pharmacies subject to
the following requirements:
(1) the transfer is communicated directly from
either a pharmacist or certified technician to either a pharmacist or certified
technician and not by only one pharmacist or certified technician gaining
access to an information file containing data for several locations, unless all
locations accessed are under common ownership or accessed pursuant to
contractual agreement of the pharmacies;
(2) the transferring pharmacist or certified
technician invalidates the prescription and any remaining refills at the transferring
pharmacy by marking the word "void" on the face of the prescription
or its equivalent;
(3) the transferring pharmacist or certified
technician records the name and address of the pharmacy to which it was
transferred and the name of the pharmacist or certified technician receiving
the prescription information on the reverse of the invalidated prescription;
(4) the transferring pharmacist or certified
technician records the date of the transfer and the name of the pharmacist or
certified technician transferring the information.
(b) The pharmacist or certified technician receiving the
transferred prescription information shall reduce to writing the following:
(1) The word "transfer" on the face
of the transferred prescription;
(2) All information required to be on a
prescription, including:
(A) Date of issuance of original prescription;
(B) Number of refills authorized on original
prescription;
(C) Date and time of transfer;
(D) Number of valid refills remaining and date of last refill;
(E) Pharmacy's name, address and original prescription
number from which the prescription information was transferred;
(F) Name of transferring pharmacist or certified
technician; and
(G) Manufacturer or brand of drug dispensed.
(c) The transferred prescription, as well as the original,
must be maintained for a period of three years from the date of last refill.
(d) Dispensing is permitted only within the original
authorization for refills and no dispensing on such transfer shall occur beyond
that authorized on the original prescription. Any dispensing beyond that
originally authorized or one year, whichever is less, may occur only on a new
prescription.
(e) The requirements of Paragraphs (a) and (b) of this Rule
may be facilitated by use of a computer or data system without reference to an
original prescription document. The system must be able to identify transferred
prescriptions and prevent subsequent prescription refills at that pharmacy.
(f) This Rule applies to the transfer of prescriptions
issued by prescribers in other states, provided that the pharmacist or
certified technician receiving the prescription actually knows or reasonably
should know that a physician-patient relationship exists and dispensing the
drug is in the patient's best interests.
(g) All records pertinent to this Rule shall be readily
retrievable.
(h) A system must be in place that will allow only
authorized access by a pharmacist or certified technician to all records
pertinent to this Rule and will indicate on the prescription record when and by
whom such access was made.
(i) The transfer of original prescription information for
the purpose of refill dispensing is permissible between device and medical equipment
permit holders so long as the transferring permit holder provides all records
and documentation necessary for dispensing and does not interfere with the
service and claims processing procedures of the receiving permit holder.
History Note: Authority G.S. 90-85.6(a); 90-85.32;
Eff. December 31, 1985;
Amended Eff. June 1, 2004; September 1, 1995; July 1,
1992; May 1, 1989.
21 NCAC 46 .1807 FACSIMILE TRANSMISSION OF
PRESCRIPTION ORDERS
History Note: Authority G.S. 90‑85.6(a); 90‑85.32;
Eff. October 1, 1990;
Amended Eff. September 1, 1995;
Repealed Eff. March 1, 2004.
21 NCAC 46 .1808 REPACKAGED PHARMACEUTICALS
A drug product which is manufactured and sold by a
manufacturer as a generic drug product shall be considered a generic drug
product, though subsequently repackaged and given a brand name.
History Note: Authority G.S. 90‑85.6(a); 90‑85.32;
Eff. December 1, 1991.
21 NCAC 46 .1809 EMERGENCY PRESCRIPTION REFILLS
In the event a pharmacist or device and medical equipment
permit holder receives a request for a prescription refill and the pharmacist
or permit holder is unable to obtain refill authorization from the prescriber,
the pharmacist or permit holder may dispense a one-time emergency refill of up
to a 30 day supply of the prescribed medication, provided that:
(1) The prescription is not for a Schedule II
controlled substance;
(2) The medication is essential to the maintenance of
life or to the continuation of therapy in a chronic condition;
(3) In the pharmacist's or permit holder's professional
judgment, the interruption of therapy might reasonably produce undesirable
health consequences;
(4) The dispensing pharmacist or permit holder creates
a written order containing all of the prescription information required by
Section .2300 of these Rules and signs that order;
(5) The dispensing pharmacist or permit holder notifies
the prescriber or the prescriber's office of the emergency dispensing within 72
hours after such dispensing.
History Note: Authority G.S. 90-85.6; 90-85.25;
90-85.32;
Eff. September 1, 1993;
Amended Eff. April 1, 1999; September 1, 1995.
21 NCAC 46 .1810 COMPOUNDING
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. September 1, 1995;
Amended Eff. August 1, 1998;
Repealed Eff. January 1, 2015.
21 NCAC 46 .1811 EXCESSIVE DISPENSING OF PRESCRIPTION
DRUGS
Pharmacists shall not dispense and permit holders shall not
allow a pharmacist to dispense prescription drugs at such a rate per hour or
per day as to pose a danger to the public health or safety.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. July 1, 1996.
21 NCAC 46 .1812 CHANGES IN PRESCRIPTION ORDERS
A permit holder or registrant requesting a change from the
prescription drug originally prescribed to a different prescription drug shall
disclose to the prescriber at the time of the request any business relationship
between the permit holder or registrant and the manufacturer of the requested
prescription drug.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. April 1, 1997.
21 NCAC 46 .1813 TRANsMISSION OF PRESCRIPTION ORDERS
(a) Prescription orders may be transmitted by using a
facsimile machine ("FAX") or by other electronic transmission from a
prescriber to a pharmacy. "Electronic transmission" means
transmission of the digital representation of information by way of electronic equipment.
(b) All prescription drug orders transmitted by FAX or by
electronic transmission shall:
(1) be transmitted directly to a pharmacist or
certified technician in a pharmacy of the patient's choice with no intervening
person altering the content of the prescription drug order;
(2) identify the transmitter's phone number for
verbal confirmation, the time and date of transmission, and the identity of the
pharmacy intended to receive the transmission;
(3) be transmitted by an authorized
practitioner or his designated agent and contain either a written signature or an
electronic signature unique to the practitioner;
(4) be deemed the original prescription drug
order, provided it meets all requirements of federal and state laws and regulations;
and
(5) if a refill order, contain all information
required for original prescription orders except for the prescriber's
signature.
(c) The prescribing practitioner may authorize his agent to
transmit by FAX or by electronic transmission a prescription drug order to a
pharmacist or certified technician in a pharmacy provided that the identity of
the transmitting agent is included in the order.
(d) The pharmacist shall exercise professional judgment
regarding the accuracy, validity, and authenticity of a prescription drug order
transmitted by FAX or by electronic transmission consistent with federal and
state laws and regulations.
(e) All equipment for receipt of prescription drug orders
by FAX or by electronic transmission shall be maintained so as to ensure
against unauthorized access.
(f) Prescriptions may be transferred by FAX or by electronic
transmission if all the requirements of Rule .1806 of this Section are met.
(g) No agreement between a prescriber and a pharmacy or
device and medical equipment permit holder shall require that prescription
orders be transmitted by FAX or by electronic transmission from the prescriber
to only that pharmacy or device and medical equipment permit holder.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. August 1, 1998;
Amended Eff. March 1, 2004.
21 ncac 46 .1814 AUTOMATED DISPENSING OR DRUG SUPPLY
DEVICES
(a) Automated dispensing or drug supply devices may be used
in health care facility pharmacies and where a pharmacy permit exists for a
patient profile dispensing system, provided the utilization of the devices is
under the supervision of a pharmacist. The pharmacist-manager shall develop
and implement procedures to assure safe and effective use of medications and
shall assure that:
(1) only authorized personnel, as indicated by
written policies and procedures, may obtain access to the drug inventories;
(2) a system of accountability exists for all
drugs contained therein and the purity, potency, and integrity of the drugs is
preserved;
(3) requirements for controlled substances
security are met; and
(4) prior to the drug being released for access
by the nurse, the pharmacist enters the medication order into a computerized
pharmacy profile that is interfaced to the automated dispensing unit, so that
drug allergy screening, therapeutic duplication, and appropriate dose
verification is done prior to the drug being administered.
(b) Notwithstanding the provisions of 21 NCAC 46 .2501, a
pharmacist is required to supervise only the following activities pursuant to
this Rule:
(1) The packaging and labeling of drugs to be
placed in the dispensing devices. Such packaging and labeling shall conform to
all requirements pertaining to containers and label contents;
(2) The placing of previously packaged and
labeled drug units into the dispensing device; and
(3) The restocking of automated dispensing
devices.
(c) Only persons authorized by the pharmacist-manager may
remove drugs from the dispensing devices and only in the quantity of doses
needed to satisfy immediate patient needs. Should a violation of the foregoing
occur, the pharmacist-manager shall conduct an investigation and report any
violations to the entity having jurisdiction over these issues.
(d) Bar code scanning of drug packaging and storage units
may be utilized as a quality control mechanism if this technology is available
in the automated dispensing system.
(e) An automated dispensing or drug supply device that is
used solely as an Auxiliary Medication Inventory as defined in 21 NCAC 46
.1414(d) shall be governed by the requirements of that Rule.
History Note: Authority G.S. 90-85.6; 90-85.32;
90-85.33;
Eff. April 1, 1999;
Amended Eff. March 1, 2013; August 1, 2002.
21 NCAC 46 1815 EMERGENCY
PRESCRIPTION REFILL DUE TO INTERRUPTION OF MEDICAL SERVICES
In the event a pharmacist or device and medical equipment
permit holder receives a request for a prescription refill and the pharmacist
or permit holder is unable to readily obtain refill authorization from the
prescriber because of the prescriber's inability to provide medical services to
the patient, the pharmacist or permit holder may dispense a one-time emergency
supply of up to 90 days of the prescribed medication, provided that:
(1) The prescription is not for a Schedule II
controlled substance;
(2) The medication is essential to the maintenance of
life or to the continuation of therapy in a chronic condition;
(3) In the pharmacist's or permit holder's professional
judgment, the interruption of therapy might reasonably produce undesirable
health consequences;
(4) The dispensing pharmacist or permit holder creates
a written order entered in the pharmacy's automated data processing system
containing all of the prescription information required by Section .2300 of
these Rules and signs that order;
(5) The dispensing pharmacist or permit holder
notifies, or makes a good faith attempt to notify, the prescriber or the
prescriber's office of the emergency dispensing within 72 hours after such
dispensing.
History Note: Authority G.S. 90-85.6; 90-85.25;
90-85.32;
Temporary Adoption Eff. October 29, 1998;
Eff. August 1, 2000.
21 NCAC 46 .1816 PROCEDURES FOR CENTRALIZED
PROCESSING OF PRESCRIPTION ORDERS
(a) A pharmacy permitted by the Board may process a request
for the filling or refilling of a prescription order received by a pharmacy
within this State, provided:
(1) The pharmacy that is to fill or refill the
prescription either has a contract with the pharmacy which received the
prescription or has the same owner as the other pharmacy.
(2) The prescription container:
(A) is clearly labeled with all information required by
Federal and State laws and regulations; and
(B) clearly shows the name and address of the pharmacy
refilling the prescription and the name and address of the pharmacy which
receives the refilled prescription for dispensing to the patient.
(3) The patient is provided with written
information, either on the prescription label or with the prescription
container, that describes which pharmacy to contact if the patient has any
questions about the prescription or medication.
(4) Both pharmacies maintain complete and
accurate records of the prescription, including:
(A) the name of the pharmacist who fill or refills the
prescription;
(B) the name of the pharmacy filling or refilling the
prescription; and
(C) the name of the pharmacy that received the fill or
refill request.
(5) The pharmacy that fills or refills the
prescription and the pharmacy that receives the prescription for dispensing to
the patient share a common electronic file.
(6) The originating pharmacy is responsible for
compliance with the requirements of Federal and State laws and regulations
regarding recordkeeping and patient counseling.
(b) Nothing in this Rule shall be construed as barring a
pharmacy from also filling new prescriptions presented by a patient or a
patient's agent or transmitted to it by a prescriber.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. August 1, 2000.
21 ncac 46 .1817 PROOF OF IDENTIFICATION
(a) As a precondition to filling any prescription or
dispensing any drug, a pharmacist or person acting at the direction of a
pharmacist may demand, inspect and record proof of identification, including
valid photographic identification, from any patient presenting a prescription
or any person acting on behalf of the patient. Valid photographic
identification includes but is not limited to the following:
(1) A valid motor vehicle operator's license;
(2) A valid identification card;
(3) A valid United States passport; or
(4) Other valid, tamper-resistant, photographic
identification.
(b) A pharmacist or person acting at the direction of a
pharmacist may exercise discretion and refuse to fill any prescription or
dispense any drug if unsatisfied as to the legitimacy or appropriateness of any
prescription presented, the validity of any photographic identification or the
identity of any patient presenting a prescription or any person acting on
behalf of the patient. Refusal to fill pursuant to this Paragraph shall be
noted on the prescription by the pharmacist or person acting at the direction
of a pharmacist.
History Notes: Authority G.S. 90‑85.6; 90‑85.32;
Eff. August 1, 2002.
21 ncac 46 .1818 PRESCRIPTION LABELS
Prescription labels shall list at a minimum the generic name
of the drug, even if the generic drug is unavailable to dispense or even if the
substitution of a generic drug is not authorized.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. January 1, 2006.
SECTION .1900 ‑ FORMS
21 NCAC 46 .1901 DEFINITION
For use in the discharge of the statutory duties of the
Board, it has adopted certain official forms which are described in this
Section. Forms referred to in this Chapter are those forms described in this
Section, and are available from the Board's office.
History Note: Authority G.S. 90‑85.6;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1902 APPLICATION FOR PHARMACIST'S LICENSE
The form for application for a pharmacist's license is
"Application for Examination and Registered Pharmacist Certificate."
All applicants for admission to the examination for licensure as a pharmacist
shall submit this form. In addition to the normal questions of identification,
this form requests responses on education, experience, prior activity, proof of
qualifications and character.
History Note: Authority G.S. 90‑85.6; 90‑85.15;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1903 APPLICATION FOR PHARMACY PERMIT
The form for application for pharmacy permit is entitled
"Application for Registration and Permit to Conduct a Pharmacy." All
persons who desire to conduct a pharmacy shall complete this form for original and
renewal applications. Information requested includes facility name and address,
type of organization (i.e., proprietorship, corporation, non‑profit
hospital, government), ownership, supervised personnel, pharmacist personnel,
and hours of service.
History Note: Authority G.S. 90‑85.6; 90‑85.21;
Eff. April 1, 1983.
21 NCAC 46 .1904 RENEWAL OF PHARMACIST'S LICENSE
The form for application for renewal of a pharmacist's
license is entitled "Pharmacist License Annual Renewal Notice," and
must be completed and returned to the Board yearly for those individuals who
desire to continue their license to practice pharmacy. This form requests
updated information on the registrant's activity, nature of practice, and other
matters.
History Note: Authority G.S. 90‑85.6; 90‑85.17;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1905 REPLACEMENT OF CERTIFICATES
The form for application for replacement of certificates is
entitled "Order for Certificate of Registration." In addition to the
ordinary identification information, this form requires the completion of an affidavit
describing the loss or destruction of the original certificate.
History Note: Authority G.S. 90‑85.6;
Eff. April 1, 1983.
21 NCAC 46 .1906 RECIPROCITY DATA QUESTIONNAIRE
The form for application to initiate reciprocity procedures
is entitled "Reciprocity Data Questionnaire" and begins the process
of reciprocating a pharmacist's license to North Carolina from another state. Along
with the usual identification material, it requests information on education,
experience, and other activities necessary to determine the person's
eligibility to reciprocate.
History Note: Authority G.S. 90‑85.6; 90‑85.20;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1907 APPLICATION FOR RECIPROCITY
Following receipt from the applicant for reciprocity of the
Data Questionnaire, the form for application for reciprocity, entitled
"Preliminary Application for Reciprocal Licensure," will be mailed to
the applicant by the Board to facilitate reciprocity through the National
Association of Boards of Pharmacy. The form is printed by the National
Association of Boards of Pharmacy and is distributed as a service to applicants
by the North Carolina Board.
History Note: Authority G.S. 90‑85.6; 90‑85.20;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1908 REGISTRATION FOR PRACTICAL PHARMACY
TRAINING
The form for registration for practical pharmacy training is
entitled "Application for Registration in Pharmacy Training
Program." This form must be completed by individuals at the beginning of
the training necessary to be eligible for examination for licensure.
Information requested includes identification, education, experience,
supervising personnel, and location, along with approximate hours of training
per week.
History Note: Authority G.S. 90‑85.6; 90‑85.15;
Eff. April 1, 1983.
21 NCAC 46 .1909 PRACTICAL PHARMACY EXPERIENCE
The form for certification of experience in North Carolina
is entitled "Practical Pharmacy Experience Affidavit," and is used to
certify training in North Carolina. This form requires information necessary to
certify the hours completed and the preceptor responsible for training.
History Note: Authority G.S. 90‑85.6; 90‑85.15;
Eff. April 1, 1983.
21 NCAC 46 .1910 CERTIFICATE OF EXPERIENCE OUTSIDE
NORTH CAROLINA
History Note: Authority G.S. 90‑85.6; 90‑85.15;
Eff. April 1, 1983;
Amended Eff. May 1, 1989;
Repealed Eff. July 1, 1996.
21 NCAC 46 .1911 CERTIFICATE OF GRADUATION
The form certifying graduation is entitled "Certificate
of Graduation from College or School of Pharmacy" and must be completed by
all candidates for licensure. This form provides for listing of dates of attendance
and date of graduation, and is to be completed by a responsible official of the
school or college.
History Note: Authority G.S. 90‑85.6; 90‑85.15;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .1912 APPLICATION FOR REGISTRATION AS A
DISPENSING PHYSICIAN
The form for application for registration as a dispensing
physician is entitled "Application for Registration with the Pharmacy
Board as a Dispensing Physician", and appears in G.S. 90‑85.21(b).
All applicants for registration as a dispensing physician shall complete this
form for original and renewal applications. Information requested includes
name and address of dispensing physician, physician's North Carolina license
number, whether the physician is currently practicing in a professional
association registered with the North Carolina Board of Medical Examiners, the
name and registration number of the professional corporation, if applicable,
and a certification that the information given is correct and complete.
History Note: Authority G.S. 90‑85.6; 90‑85.21;
Eff. February 1, 1991.
21 NCAC 46 .1913 APPLICATION FOR DEVICE DISPENSING
PERMIT
The form for application for a permit to dispense devices is
entitled "Application for Permit to Dispense Devices". All
applicants for a "Device Dispensing Permit" shall complete this form
for original and renewal applications. Information requested includes name and
address of place dispensing devices, name and address of person in charge of
permit, history of person in charge of permit, examples of prescription devices
dispensed from location during the last year, and two attestations by persons
not employed or supervised by device dispenser.
History Note: Authority G.S. 90‑85.6; 90‑85.22;
Eff. February 1, 1991.
SECTION .2000 ‑ ADMINISTRATIVE PROVISIONS
21 NCAC 46 .2001 RIGHT TO HEARING
(a) When the
Board acts or proposes to act, other than in rulemaking or declaratory ruling
proceedings, in a manner which will affect the rights, duties, or privileges of
a specific, identifiable person, such person has the right to an administrative
hearing. When the Board proposes to act in such a manner, it shall give such
person notice of the right to a hearing by mailing by certified mail to that
person at the last known address of that person a notice of the proposed action
and a notice of a right to a hearing.
(b) Prior to
issuing the notice called for in Paragraph (a) of this Rule, and with the
consent of the party or parties, the Board may attempt to settle disputes
through the informal procedures set out in Rule .2008(a) of this Section.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑22; 150B‑38; 150B‑41;
Eff. April 1, 1983;
Amended Eff. October 1, 1990; May 1, 1989; July 1, 1988;
March 1, 1987.
21 NCAC 46 .2002 RULES AND REGULATIONS SEVERABLE
21 NCAC 46 .2003 RULE‑MAKING
History Note: Authority G.S. 90‑85.6; 150A‑11;
150A‑14;
Eff. April 1, 1983;
Repealed Eff. May 1, 1989.
21 ncac 46 .2004 REQUEST FOR HEARING
(a) Any time an individual believes that individual's
rights, duties, or privileges have been affected substantially by the Board’s
administrative action, but has not received notice of a right to an
administrative hearing, that individual may file a formal request for a
hearing.
(b) Before an individual may file a request, that
individual is encouraged to exhaust all reasonable efforts to resolve the issue
informally with the Board.
(c) Subsequent to such informal action, if still
dissatisfied, the individual may submit a request to the Board's office, with
the request bearing the notation: REQUEST FOR ADMINISTRATIVE HEARING. The
request shall contain the following information:
(1) name and address of the petitioner;
(2) a concise statement of the action taken by
the Board which is challenged;
(3) a concise statement of the way in which the
petitioner has been aggrieved; and
(4) a clear and specific statement of request
for a hearing.
(d) A request for administrative hearing must be submitted
to the Board's office within 60 days of receipt of notice of the action taken
by the Board which is challenged. The request will be acknowledged promptly
and, if deemed appropriate by the Board in accordance with 21 NCAC 46 .2005, a
hearing shall be scheduled.
History Note: Authority G.S. 90-85.6; 150B-38;
Eff. September 1, 1988;
Amended Eff. August 1, 2002.
21 NCAC 46 .2005 GRANTING OR DENYING HEARING REQUEST
(a) The Board
will grant a request for a hearing if it determines that the party requesting
the hearing is a "person aggrieved" within the meaning of G.S. 150B‑2(6).
(b) The denial
of request for a hearing will be issued immediately upon decision, and in no
case later than 60 days after the submission of the request. Such denial shall
contain a statement of the reasons leading the Board to deny the request.
(c) Approval
of a request for a hearing will be signified by the issuing of a notice as
required by G.S. 150B‑38(b) and explained in Rule .2006 of this Section.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38;
Eff. July 1, 1988.
21 NCAC 46 .2006 NOTICE OF HEARING
(a) The Board
shall give the party or parties in a contested case a notice of hearing not
less than 15 days before the hearing. Said notice shall contain the following
information, in addition to the items specified in G.S. 150B‑38(b):
(1) the
name, position, address and telephone number of a person at the offices of the
Board to contact for further information or discussion;
(2) the
date, time, and place for a pre‑hearing conference, if any; and
(3) any
other information deemed relevant to informing the parties as to the procedure
of the hearing.
(b) If the
Board determines that the public health, safety or welfare requires such
action, it may issue an order summarily suspending a license or permit. Upon
service of the order, the licensee or permit holder to whom the order is
directed shall immediately cease the practice of pharmacy or cease the
dispensing of devices and medical equipment in North Carolina. The Board shall
promptly give notice of hearing pursuant to G.S. 150B‑38 following
service of the order. The suspension shall remain in effect pending issuance
by the Board of a final agency decision pursuant to G.S. 150B‑42.
History Note: Authority G.S. 90‑85.6; 150B‑3(c);
150B‑11; 150B‑38;
Eff. July 1, 1988;
Amended Eff. September 1, 1995; May 1, 1989.
21 NCAC 46 .2007 WHO SHALL HEAR CONTESTED CASES
(a) All
administrative hearings shall be conducted by the Board, a panel consisting of
a majority of the members of the Board, or an administrative law judge
designated to hear the case pursuant to G.S. 150B‑40(e).
(b) Matters
involving device and medical equipment permit holders shall be initially heard
by a device and medical equipment subcommittee. The subcommittee shall be
elected pursuant to Section .2100 of this Chapter. Prior to issuing a notice
of hearing, the subcommittee and the party or parties may agree to follow the
informal procedures set out in Rule .2008 of this Section.
(c) After
hearing the matter, the device and medical equipment subcommittee shall propose
a recommended decision to the Board. Sanctions shall be consistent with G.S.
90-85.38. If the Board accepts the recommended decision, it shall constitute a
final agency decision for the right to judicial review. If the Board rejects
the recommended decision, the Board may propose an alternative decision or
schedule the matter for a formal hearing before the Board.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38; 150B‑40;
Eff. July 1, 1988;
Amended Eff. September 1, 1995.
21 NCAC 46 .2008 INFORMAL PROCEDURES
(a) Prior to issuing a notice of hearing, the Board or the
device and medical equipment subcommittee and the party or parties may agree to
conduct a conference in which a member of the Board or the device and medical equipment
subcommittee and the party or parties meet to consider the possibility of
disposing of the dispute without a hearing or any other matter as may aid in
the prompt disposition of the dispute. If such a conference is held, the
Board, or the device and medical equipment subcommittee, may direct one or more
of the following dispositions:
(1) Submission to the Board with a
recommendation to dismiss with no action;
(2) Submission
to the Board with a recommendation to resolve by consent; or
(3)
Scheduling, with appropriate notice, for contested case hearing.
All recommendations of dismissal must be approved by the
Board. Any consent order proposed may dispose of the dispute or set forth such
matters as were agreed to between the parties that may expedite the hearing.
All matters contained in the consent order must be agreed to by the party or
parties and approved by the Board at its next regular meeting. The Board
member or member of the device and medical equipment subcommittee who
participated in the conference may participate in Board discussions concerning
any recommendation made, but may not vote upon the recommendation. The Board
member who participated in the conference shall disqualify himself or herself
in accordance with 21 NCAC 46 .2011 of this Section from participation in any
hearing or decision in the matter discussed in the conference if the matter
results in a contested case hearing before the Board.
(b) After issuance of a notice of hearing, the Board or the
device and medical equipment subcommittee and the party or parties may agree in
advance to simplify the hearing by: decreasing the number of issues to be
contested at the hearing; accepting the validity of certain proposed evidence;
accepting the findings in some other case with relevance to the case at hand;
or agreeing to such other matters as may expedite the hearing.
History Note: Authority G.S. 90-85.6; 150B-41;
Eff. July 1, 1988;
Amended Eff. April 1, 2001; September 1, 1995; October 1,
1990; May 1, 1989.
21 NCAC 46 .2009 PETITION FOR INTERVENTION
(a) A person
desiring to intervene in a contested case must file a written petition with the
Board's office. The request should bear the notation: PETITION TO INTERVENE
IN THE CASE OF (Name of case).
(b) The petition
must include the following information:
(1) the
name and address of petitioner;
(2) the
business or occupation of petitioner, where relevant;
(3) a
full identification of the hearing in which petitioner is seeking to intervene;
(4) the
statutory or non‑statutory grounds for intervention;
(5) any
claim or defense in respect of which intervention is sought; and
(6) a
summary of the arguments or evidence petitioner seeks to present.
(c) The moving
party must serve copies of the petition on all parties to the case.
(d) If the
Board determines to allow intervention, notice of that decision will be issued
promptly to all parties, and to the petitioner. In cases of discretionary
intervention, such notification will include a statement of any limitations of
time, subject matter, evidence or whatever else is deemed necessary which are
imposed on the intervenor.
(e) If the
Board's decision is to deny intervention, the petitioner will be notified
promptly. Such notice will be in writing, identifying the reasons for the
denial, and will be issued to the petitioner and all parties.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38;
Eff. July 1, 1988;
Amended Eff. May 1, 1989.
21 NCAC 46 .2010 TYPES OF INTERVENTION
(a)
Intervention of Right. A petition to intervene as of right, as provided in the
North Carolina Rules of Civil Procedure, Rule 24, will be granted if the
petitioner meets the criteria of that rule and their petition is timely.
(b) Permissive
Intervention. A petition to intervene permissibly as provided in the North
Carolina Rules of Civil Procedure, Rule 24, will be granted if the petitioner
meets the criteria of that rule and the Board determines that:
(1) There
is sufficient legal or factual similarity between the petitioner's claimed
rights, privileges, or duties and those of the parties to the hearing; and
(2) Permitting
intervention by the petitioner as a party would aid the purpose of the hearing.
(c) Discretionary
Intervention. The Board may allow discretionary intervention with whatever
limits and restrictions are deemed appropriate.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38;
Eff. July 1, 1988;
Amended Eff. May 1, 1989.
21 NCAC 46 .2011 DISQUALIFICATION OF BOARD MEMBERS
(a) Self‑disqualification.
If for any reason a Board member determines that personal bias or other factors
renders that Board member unable to hear a contested case and perform all
duties in an impartial manner, that Board member shall voluntarily decline to
participate in the hearing or decision.
(b) Petition
for disqualification. If for any reason any party in a contested case believes
that a Board member is personally biased or otherwise unable to hear a
contested case and perform all duties in an impartial manner, the party may
file a sworn, notarized affidavit with the Board. The title of such affidavit
should bear the notation: AFFIDAVIT OF DISQUALIFICATION OF BOARD MEMBER IN THE
CASE OF (Name of case).
(c) Contents
of affidavit. The affidavit must state all facts the party deems to be
relevant to the disqualification of the Board member.
(d) Timeliness
of affidavit.
(1) An
affidavit of disqualification will be considered timely if filed ten days
before commencement of the hearing. Any other affidavit will be considered
timely provided it is filed at the first opportunity after the party becomes
aware of facts which give rise to a reasonable belief that a Board member may
be disqualified under this Rule.
(2) Where
an affidavit for disqualification is filed less then ten days before or during
the course of a hearing, the hearing shall continue with the challenged Board
member sitting. Petitioner shall have the opportunity to present evidence
supporting his petition, and the petition and any evidence relative thereto
presented at the hearing shall be made a part of the record. The Board, before
rendering its decision, shall decide whether the evidence justifies
disqualification. In the event of disqualification, the disqualified member
will not participate in further deliberation or decision of the case.
(e) Procedure
for determining disqualification.
(1) The
Board will appoint a Board member to investigate the allegations of the affidavit.
(2) The
investigator will report findings to the Board and make recommendations.
(3) The
Board shall decide whether to disqualify the challenged individual.
(4) The
person whose disqualification is to be determined will not participate in the
decision but may be called upon to furnish information to the other members of
the Board.
(5) When
a Board member is disqualified prior to the commencement of the hearing or
after the hearing has begun, such hearing will continue with the remaining
members sitting provided that the remaining members still constitute a majority
of the Board.
(6) If
three or more members of the Board are disqualified pursuant to this Rule, the
Board shall petition the Office of Administrative Hearings to appoint an
administrative law judge to hear the contested case pursuant to G.S. 150B‑40(e).
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38; 150B‑40;
Eff. July 1, 1988;
Amended Eff. May 1, 1989.
21 NCAC 46 .2012 RESERVED FOR FUTURE CODIFICATION
21 NCAC 46 .2013 SUBPOENAS
(a) Requests
for subpoenas for the attendance and testimony of witnesses or for the
production of documents, either at a hearing or for the purposes of discovery,
shall be made in writing to the Board and shall identify any document sought
with specificity, and shall include the full name and home or business address
of all persons to be subpoenaed and, if known, the date, time, and place for
responding to the subpoena. The Board shall issue the requested subpoenas
within three days of receipt of the request.
(b) Subpoenas
shall contain: the caption of the case; the name and address of the person
subpoenaed; the date, hour and location of the hearing in which the witness is
commanded to appear; a particularized description of the books, papers, records
or objects the witness is directed to bring with him to the hearing, if any;
the identity of the party on whose application the subpoena was issued; the
date of issue; the signature of one of the members of the Board or the Board's
executive director; and a "return of service." The "return of
service" form as filled out, shows the name and capacity of the person
serving the subpoena, the date on which the subpoena was delivered to the
person directed to make service, the date on which service was made, the person
on whom service was made, the manner in which service was made, and the
signature of the person making service.
(c) Subpoenas
shall be served by the sheriff of the county in which the person subpoenaed
resides, when the party requesting such subpoena prepays the sheriff's service
fee. The subpoena shall be issued in duplicate, with a "return of
service" form attached to each copy. A person serving the subpoena shall
fill out the "return of service" form for each copy and properly
return one copy of the subpoena, with the attached "return of
service" form completed, to the Board.
(d) Except as
otherwise stated in a particular subpoena, any person receiving a subpoena from
the Board may object thereto by filing a written objection to the subpoena with
the Board's office.
(e) Such
objection shall include a concise, but complete, statement of reasons why the
subpoena should be revoked or modified. These reasons may include lack of
relevancy of the evidence sought, or any other reason sufficient in law for
holding the subpoena invalid, such as that the evidence is privileged, that
appearance or production would be so disruptive as to be unreasonable in light
of the significance of the evidence sought, or other undue hardship.
(f) Any such
objection to a subpoena must be served on the party who requested the subpoena
simultaneously with the filing of the objection with the Board.
(g) The party
who requested the subpoena, in such time as may be granted by the Board, may file
a written response to the objection. The written response shall be served by
the requesting party on the objecting witness simultaneously with filing the
response with the Board.
(h) After
receipt of the objection and response thereto, if any, the Board shall issue a
notice to the party who requested the subpoena and the party challenging the
subpoena, and may notify any other party or parties of an open hearing, to be
scheduled as soon as practicable, at which time evidence and testimony may be
presented, limited to the narrow questions raised by the objection and
response.
(i) Promptly
after the close of such hearing, a majority of the Board members with voting
authority, or an administrative law judge assigned to the case pursuant to G.S.
150B‑40(e), will rule on the challenge and issue a written decision. A
copy of the decision will be issued to all parties and made a part of the
record.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38; 150B‑39;
Eff. September 1, 1988.
21 NCAC 46 .2014 WITNESSES
Any party may
be a witness and may present witnesses on the party's behalf at the hearing.
All oral testimony at the hearing shall be under oath or affirmation and shall
be recorded. At the request of a party or upon the Board's own motion, 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; 150B‑11;
150B‑38; 150B‑40;
Eff. July 1, 1988.
21 NCAC 46 .2015 FINAL DECISION
In all cases
heard by the Board, the Board will issue its decision within 60 days after its
next regularly scheduled meeting following the close of the hearing. This
decision will be the prerequisite "final agency decision" for the
right to judicial review.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38; 150B‑42;
Eff. July 1, 1988;
Amended Eff. May 1, 1989.
21 NCAC 46 .2016 PROPOSALS FOR DECISIONS
(a) When an
administrative law judge conducts a hearing pursuant to G.S. 150B‑40(e),
a "proposal for decision" shall be rendered within 45 days of the
hearing pursuant to the rules of the Office of Administrative Hearings, 26 NCAC
3 .0026. Any party may file written exceptions to this "proposal for
decision" and submit their own proposed findings of fact and conclusions
of law. The exceptions and alternative proposals must be filed within ten days
after the party has received the "proposal for decision" as drafted
by the administrative law judge.
(b) Any
exceptions to the procedure during the hearing, the handling of the hearing by
the administrative law judge, rulings on evidence, or any other matter must be
written and refer specifically to pages of the record or otherwise precisely
identify the occurrence to which exception is taken. The exceptions must be
filed with the Board within ten days of the receipt of the proposal for
decision. The written exceptions should bear the notation: EXCEPTIONS TO THE
PROCEEDINGS IN THE CASE OF (Name of case).
(c) Any party
may present oral argument to the Board upon request. The request must be
included with the written exceptions.
(d) Upon
receipt of request for further oral argument, notice will be issued promptly to
all parties designating the time and place for such oral argument.
(e) Giving due
consideration to the proposal for decision and the exceptions and arguments of
the parties, the Board may adopt the proposal for decision or may modify it as
the Board deems necessary. The decision rendered will be a part of the record
and a copy thereof given to all parties. The decision as adopted or modified
becomes the "final agency decision" for the right to judicial review.
Said decision will be rendered by the Board within 60 days of the next
regularly scheduled meeting following the oral arguments, if any. If there are
no oral arguments presented, the decision will be rendered within 60 days of
the next regularly scheduled Board meeting following filing of the written
exceptions.
History Note: Authority G.S. 90‑85.6; 150B‑11;
150B‑38; 150B‑40;
Eff. July 1, 1988;
Amended Eff. May 1, 1989.
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
(a) Eligible voters for Board members shall be the
pharmacists licensed in North Carolina and residing in North Carolina on March
15 immediately prior to the election.
(b) Eligible voters for the device and medical equipment
subcommittee shall be all device and medical equipment permit holders in North
Carolina and residing in North Carolina on March 15 immediately prior to the
election.
History Note: Authority G.S. 90‑85.7; 90-85.22;
Eff. April 1, 1983;
Amended Eff. September 1, 1995; May 1, 1989.
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, Cherokee, Clay,
Cleveland, Gaston, Graham, Haywood, Henderson, Jackson, Lincoln, Macon,
Madison, McDowell, Mitchell, Polk, Rutherford, Swain, Transylvania, Watauga,
Wilkes and Yancey Counties;
(2) The Northern District, consisting of Alamance,
Caswell, Forsyth, Guilford, Orange, Person, Rockingham, Stokes, Surry and
Yadkin Counties;
(3) The Central District, consisting of Anson,
Cabarrus, Chatham, Davidson, Davie, Iredell, Lee, Mecklenburg, Montgomery,
Moore, Randolph, Richmond, Rowan, Stanly and Union Counties;
(4) The Northeastern District, consisting of Bertie,
Camden, Chowan, Currituck, Dare, Durham, Edgecombe, Franklin, Gates, Granville,
Halifax, Hertford, Hyde, Martin, Nash, Northampton, Pasquotank, Perquimans,
Tyrell, Vance, Wake, Warren, Washington and Wilson Counties; and
(5) The Southeastern District, consisting of Beaufort,
Bladen, Brunswick, Carteret, Columbus, Craven, Cumberland, Duplin, Greene,
Harnett, Hoke, Johnston, Jones, Lenoir, New Hanover, Onslow, Pamlico, Pender,
Pitt, Robeson, Sampson, Scotland and Wayne Counties.
History Note: Authority G.S. 90‑85.7;
Eff. April 1, 1983;
Amended Eff. May 1, 1989.
21 NCAC 46 .2104 COMMITTEE ON NOMINATIONS
The Board may appoint an advisory committee on nominations
in January of each year. Members of this committee shall submit at least two
names of eligible candidates for each position to be filled on the Board and on
the device and medical equipment subcommittee by March 1 for the next election.
History Note: Authority G.S. 90‑85.7;
Eff. April 1, 1983;
Amended Eff. July 1, 1996; May 1, 1989.
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, such
document to be filed in the Board office or postmarked before March 10 for the
next election. Nominations shall be closed on March 15th.
History Note: Legislative Objection Lodged Eff. March
29, 1983;
Authority G.S. 90‑85.7;
Eff. April 1, 1983;
Curative Eff. April 1, 1983;
Amended Eff. May 1, 1989.
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.
21 NCAC 46 .2107 BALLOTS:
CASTING AND COUNTING
(a) The Board shall provide a ballot to all eligible
voters in April of each year that there is an election for Board position(s).
The Board shall employ the following method for balloting:
(1) The Board shall provide
access to an electronic ballot to all eligible voters; and
(2) A paper ballot shall be mailed, with return
envelope, to any eligible voter who makes a written
request for a paper ballot in lieu of access to an electronic ballot and whose
request is actually received by the Board on or before April 20.
(b) A description
of a nominee's qualifications shall be accessible to all
eligible voters casting their ballots electronically. The same description of
the nominee's qualifications shall accompany each paper ballot sent pursuant to
Subparagraph (a)(2) of this Rule.
(c) On or
before May 15, all ballots shall be cast electronically, physically delivered
to the Board office or postmarked, if the ballot is sent
by U.S. mail.
(d) Ballots
received shall be counted and certified by the Board of Pharmacy at the next
regularly scheduled Board meeting following an election. The
Board of Pharmacy shall determine the validity of any challenged ballot, and electronic or mechanical devices may be used in compiling
election results. No person running for election or reelection may participate
in the counting and certification of ballots for the election or reelection
involving that person.
(e) The Executive
Director shall convey the certified election results to the Governor.
History Note: Authority G.S. 90-85.7;
Eff. April 1, 1983;
Amended Eff. January 1, 2009; April 1, 2003.
21 NCAC 46 .2108 DETERMINATION OF ELECTION RESULTS
The determination of election results shall be in accordance
with G.S. 163-111, which is adopted herein by reference and includes subsequent
amendments and editions. A copy of G.S. 163-111 is available for inspection at
the Board office and may be obtained from the Board office for a cost of 25
cents ($.25) per page.
History Note: Authority G.S. 90-85.7;
Eff. March 1, 1991;
Amended Eff. December 1, 2001.
21 ncac 46 .2109 DEVICE AND MEDICAL EQUIPMENT
COMMITTEE REPRESENTATIVES
(a) The device and medical equipment committee shall consist
of the following:
(1) a representative of the medical equipment
suppliers;
(2) a representative of the medical oxygen
suppliers;
(3) a representative of the rehabilitation
technology suppliers; and
(4) two Board members appointed by the
President of the Board.
(b) All device and medical equipment permit holders are
eligible to vote for one representative in each category specified in
Subparagraphs (a)(1)-(3) of this Rule. The representative must practice in the
particular area for which he or she is nominated, but need not practice
exclusively in that area.
(c) The representatives specified in Subparagraphs
(a)(1)-(3) of this Rule shall be elected or appointed to terms of five years,
and may not serve more than two consecutive five-year terms. The committee may
establish a staggered schedule for the elections. In case of death,
resignation or removal from the committee, the remaining members of the
committee shall elect a representative who meets the criteria for the position.
History Note: Authority G.S. 90-85.6; 90-85.22;
Eff. September 1, 1995;
Amended Eff. April
1, 2003.
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) Eight of these continuing education hours shall be
obtained through contact programs. Contact programs are those in which there
is an opportunity for live two-way communication between the presenter and
attendee. An on-line continuing education course may satisfy this contact-hour
requirement provided that the live two-way communication standard is met.
(c) A pharmacist who accumulates more than the required 15
hours of continuing education in a single year may carry forward up to five
surplus hours to be applied to the following year's continuing education
requirements.
(d) A pharmacist shall preserve all continuing education
records for three years.
(e) Upon license renewal, the pharmacist shall report
continuing education hours on a form provided by the Board. The Board may
require a pharmacist to submit records, reports of accredited hours and
certificates of credit on a random basis pursuant to a continuing education
audit.
(f) All continuing education shall be obtained through
accredited continuing education courses. The Board shall approve continuing
education courses as accredited if they provide education on matters that will
maintain or increase the participant's professional competence and proficiency
as a pharmacist.
(g) Continuing education shall not serve as a barrier to
reciprocity; however all licensees by reciprocity must observe the continuing
education standards specified in this Rule within the first renewal period
after licensure in this state.
History Note: Authority G.S. 90-85.6; 90-85.17;
90-85.18;
Eff. January 1, 1985;
Amended Eff. January 1, 2008; April 1, 2005; August 1,
2004; August 1, 1998; September 1, 1993; May 1, 1989.
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 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.
(b) Information in Subparagraphs (a)(2),
(a)(3), (a)(4), (a)(6) and (a)(7) may be stored in a readily retrievable data
file specifically compiled for use in the pharmacy, which is not a commercial
publication, in lieu of the requirements of the named Subparagraphs.
History Note: Authority G.S. 90‑85.6(a); 90‑85.32;
90‑106(h);
Eff. December 31, 1985;
Amended Eff. May 1, 1989.
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;
(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.
(b) Records in institutional pharmacies may be made and
kept as part of the patient's medical record.
History Note: Authority G.S. 90‑85.6(a); 90‑85.26;
90‑85.30; 90‑85.35; 90‑106(h);
Eff. December 31, 1985;
Amended Eff. March 1, 2013; May 1, 1989.
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 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.
History Note: 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.
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 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.
History Note: 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.
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.
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 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.
90-106.2; 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;
(2) No drugs or devices may by dispensed except at
health department clinics;
(3) The health department shall secure the services of
a pharmacist-manager who shall be responsible for compliance with all statutes,
rules, and regulations governing the practice of pharmacy and dispensing of
drugs at the health department;
(4) Only the general categories of drugs or devices
listed in Rule .2403 of this Section may be dispensed by a health department
registered nurse;
(5) All drugs or devices dispensed pursuant to G.S.
90-85.34A and these rules shall be packaged, labeled, and otherwise dispensed
in compliance with state and federal law, and records of dispensing shall be
kept in compliance with state and federal law. The pharmacist-manager shall
verify the accuracy of the records at least weekly, and where health department
personnel dispense to 30 or more patients in a 24-hour period per dispensing
site, the pharmacist-manager shall verify the accuracy of the records within 24
hours after dispensing occurs.
History Note: Authority G.S. 90-85.6; 90-85.34A;
90-106.2; 115C-375.2A;
Eff. March 1, 1987;
Amended Eff. January 1, 2015; August 1, 2014; May 1,
1989.
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 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.
History Note: Authority G.S. 90‑85.6; 90‑85.34A;
Eff. March 1, 1987;
Amended Eff. May 1, 1989.
21 NCAC 46 .2403 DRUGS AND DEVICES TO BE DISPENSED
(a) Pursuant to the provisions of G.S. 90-85.34A(a)(3),
prescription drugs and devices included in the following general categories may
be dispensed by registered nurses in local health department clinics when
prescribed for the indicated conditions:
(1) Anti-tuberculosis drugs, as recommended by
the North Carolina Department of Health and Human Services in the North
Carolina Tuberculosis Policy Manual (available at www.ncdhhs.gov), when used
for the treatment and control of tuberculosis;
(2) Anti-infective agents used in the control
of sexually-transmitted diseases as recommended by the United States Centers
for Disease Control in the Sexually Transmitted Diseases Treatment Guidelines
(available at www.cdc.gov);
(3) Natural or synthetic hormones and
contraceptive devices when used for the prevention of pregnancy;
(4) Topical preparations for the treatment of
lice, scabies, impetigo, diaper rash, vaginitis, and related skin conditions;
(5) Vitamin and mineral supplements;
(6) Opioid antagonists prescribed pursuant to
G.S. 90-106.2; and
(7) Epinephrine auto-injectors prescribed
pursuant to G.S. 115C-375.2A.
(b) Regardless of the provisions set out in this Rule, no
drug defined as a controlled substance by the United States Controlled
Substances Act, 21 U.S. Code 801 through 904, or regulations enacted pursuant
to that Act, 21 CFR 1300 through 1308, or by the North Carolina Controlled
Substances Act, G.S. 90-86 through 90-113.8, may be dispensed by registered
nurses pursuant to G.S. 90-85.34A.
History Note: Authority G.S. 90-85.6; 90-85.34A;
90-106.2; 115C-375.2A;
Eff. March 1, 1987;
Amended Eff. January 1, 2015; August 1, 2014; May 1,
1989.
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 product is
delivered to the patient or person acting on the patient's behalf.
History Note: Authority G.S. 90‑85.6; 90‑85.40(a);
Eff. May 1, 1989.
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) The pharmacist‑manager employed or otherwise
engaged to supply pharmaceutical services may have a flexible schedule of
attendance but shall be present for at least one‑half the hours the
pharmacy is open or 32 hours a week, whichever is less. A pharmacist employee
not meeting this requirement may serve as pharmacist-manager of the permit
holder temporarily for a period not to exceed 90 days from the departure date
of the previous pharmacist-manager, if the pharmacist employee is present at
least 20 hours per week in the pharmacy.
(c) Whenever a change of ownership or change of pharmacist‑manager
occurs, the successor pharmacist‑manager shall complete an inventory of
all controlled substances in the pharmacy within 10 days. A written record of
such inventory, signed and dated by the successor pharmacist‑manager,
shall be maintained in the pharmacy with other controlled substances records
for a period of three years.
(d) The pharmacist‑manager shall develop and
implement a system of inventory record‑keeping and control which will
enable that pharmacist‑manager to detect any shortage or discrepancy in
the inventories of controlled substances at that pharmacy at the earliest
practicable time.
(e) The pharmacist‑manager shall maintain authority
and control over any and all keys to the pharmacy and shall be responsible for
the security of the pharmacy. A pharmacy shall be secured to prohibit
unauthorized entry if no pharmacist will be present in the pharmacy for a
period of 90 minutes or more.
(f) These duties are in addition to the specific duties of
pharmacist‑managers at institutional pharmacies and pharmacies in health
departments as set forth in the Rules in this Chapter.
(g) A person shall not serve as pharmacist‑manager at
more than one pharmacy at any one time except for limited service pharmacies.
(h) When a pharmacy is to be closed permanently, the
pharmacist‑manager shall inform the Board and the United States Drug
Enforcement Administration of the closing, arrange for the proper disposition
of the pharmaceuticals and return the pharmacy permit to the Board's offices
within 10 days of the closing date. If possible, notice of the closing shall
be given to the public by posted notice at the pharmacy at least 30 days prior
to the closing date and 15 days after the closing date. Such notice shall
notify the public that prescription files may be transferred to a pharmacy of
the patient's or customer's choice during the 30 day period prior to the
closing date. During the 30 day period prior to the closing date, the
pharmacist-manager, and the pharmacy's owner (if the owner is other than the
pharmacist-manager), shall transfer prescription files to another pharmacy
chosen by the patient or customer, upon request. Absent specific instructions
from the patient or customer, the pharmacist‑manager, and the pharmacy's
owner (if the owner is other than the pharmacist‑manager), shall transfer
prescription files to another pharmacy for maintenance of patient therapy and
shall inform the public of such transfer by posted notice at the pharmacy for
15 days after the closing date, if possible. Controlled substance records
shall be retained for the period of time required by law.
(i) If possible, the pharmacist-manager shall ensure that
notice of the temporary closing of any pharmacy for more than 14 consecutive
days is given to the public by posted notice at the pharmacy at least 30 days
prior to the closing date, and 15 days after the closing date. Such notice
shall notify the public that prescription files may be transferred to a
pharmacy of the patient's or customer's choice during the 30 day period prior
to the closing date. During the 30 day period prior to the closing date, the
pharmacist-manager, and the pharmacy's owner (if the owner is other than the
pharmacist-manager), shall transfer prescription files to another pharmacy
chosen by the patient or customer, upon request.
(j) The pharmacist‑manager shall prepare a plan to
safeguard prescription records and pharmaceuticals and minimize the
interruption of pharmacy services in the event of a natural disaster such as
hurricane or flood.
(k) The pharmacist‑manager shall separate from the
dispensing stock all drug products more than six months out of date.
(l) The pharmacist‑manager shall report to the Board
of Pharmacy information that reasonably suggests that there is a probability
that a prescription drug or device dispensed from a location holding a permit
has caused or contributed to the death of a patient or customer. This report
shall be filed in writing on a form provided by the Board within 14 days of the
owner representative or pharmacist‑manager's becoming aware of the event.
The pharmacist-manager shall retain all documents, labels, vials, supplies,
substances and internal investigative reports relating to the event. All such
items shall be made available to the Board upon request.
(m) The Board shall not disclose the identity of a
pharmacist‑manager who makes a report under Paragraph (l) of this Rule,
except as required by law. No report made under Paragraph (l) of this Rule
shall not be released except as required by law.
(n) In any Board proceeding, the Board shall consider
compliance with Paragraph (l) of this Rule as a mitigating factor and
noncompliance with Paragraph (l) of this Rule as an aggravating factor.
(o) The pharmacist-manager shall ensure that all starter
doses of medication supplied to doctors' offices from the pharmacy are
accompanied by written materials advising the patient that such doses of
medication may be supplied by any pharmacy. Starter doses shall be limited to
a 24 hour dose supply per patient.
History Note: Authority G.S. 90‑85.6; 90‑85.21;
90‑85.25; 90-85.26; 90-85.32;
Eff. May 1, 1989;
Amended Eff. April 1, 2006; February 1, 2005; August 1, 2002;
December 1, 2001; April 1, 2001; April 1, 1999; July 1, 1996; March 1, 1992;
October 1, 1990.
21 NCAC 46 .2503 RESEARCH PARTICIPATION
Pharmacists are encouraged to participate in research
efforts, including protocol dosing, precision and time of drug administration,
obtaining informed consent and other activities connected with investigational drug
studies.
History Note: Authority G.S. 90‑85.3(r); 90‑85.6;
Eff. May 1, 1989.
21 NCAC 46 .2504 PATIENT COUNSELING
(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.
(b) An offer to counsel shall be made on new or transfer
prescriptions at the time the prescription is dispensed or delivered to the
patient or representative. Ancillary personnel may make the offer to counsel,
but the pharmacist must personally conduct counseling if the offer is
accepted. Counseling by device and medical equipment permit holders must be
conducted by personnel proficient in explaining and demonstrating the safe and
proper use of devices and equipment. The person in charge shall be responsible
for ensuring that all personnel conducting counseling are proficient in
explaining and demonstrating the safe and proper use of devices and equipment
and for documenting the demonstration of such proficiency. The offer shall be made
orally and in person when delivery occurs at the pharmacy. When delivery
occurs outside of the pharmacy, whether by mail, vehicular delivery or other
means, the offer shall be made either orally and in person, or by telephone
from the pharmacist to the patient. If delivery occurs outside of the
pharmacy, the pharmacist shall provide the patient with access to a telephone
service that is toll-free for long-distance calls. A pharmacy whose primary
patient population is accessible through a local measured or toll-free exchange
need not be required to offer toll-free service. Counseling may be conducted
by the provision of printed information in a foreign language if requested by
the patient or representative. Professional judgment shall be exercised in
determining whether or not to offer counseling for prescription refills. An
offer to counsel shall be communicated in a positive manner to encourage
acceptance.
(c) In order to counsel patients effectively, a reasonable
effort shall be made to obtain, record, and maintain significant patient
information, including:
(1) name, address, telephone number;
(2) date of birth (age), gender;
(3) medical history:
(A) disease state(s);
(B) allergies/drug reactions;
(C) current list on non-prescription and prescription
medications, devices, and medical equipment.
(4) comments relevant to the individual's drug
therapy.
A "reasonable effort" shall mean a good faith
effort to obtain from the patient or representative the foregoing patient
information. Ancillary personnel may collect, record, and obtain patient
profile information, but the pharmacist or person in charge of the facility
holding the device and medical equipment permit must review and interpret
patient profile information and clarify confusing or conflicting information.
Professional judgment shall be exercised as to whether and when individual
patient history information should be sought from other health care providers.
(d) Once patient information is obtained, this information
shall be reviewed and updated by the pharmacist or person in charge of the
facility holding the device and medical equipment permit before each
prescription is filled or delivered, typically at the point-of-sale or point of
distribution to screen for potential drug therapy problems due to:
(1) therapeutic duplication;
(2) drug-disease contraindication;
(3) drug-drug interactions, including serious
interactions with prescription or over-the-counter drugs;
(4) incorrect drug dosage or duration of drug
treatment;
(5) drug-allergy interactions; and
(6) clinical abuse/misuse.
(e) Unless refused by the patient or representative,
patient counseling shall be provided as follows:
(1) counseling shall be "face to face"
by the pharmacist, or personnel of a device and medical equipment permit holder
when possible;
(2) alternative forms of patient information
may be used to supplement patient counseling;
(3) patient counseling, as described in this
Rule, shall be required for outpatient and discharge patients of hospitals,
health maintenance organizations, health departments, and other institutions;
however, compliance with this Rule in locations in which non-pharmacists are authorized
by law or regulations to dispense may be accomplished by such authorized
non-pharmacists; and
(4) patient counseling, as described in this
Rule, shall not be required for inpatients of hospitals or other institutions
where a nurse or other licensed health care professional administers the
medication(s).
(f) Pharmacists that distribute prescription medication by
mail, and where the practitioner-pharmacist-patient relationship does not
exist, shall provide counseling services for recipients of such medication in
accordance with this Rule.
(g) Records resulting from compliance with this Rule,
including documentation of refusals to receive counseling, shall be maintained
for three years in accordance with Section .2300 of this Chapter.
(h) Personnel of device and medical equipment permit
holders shall give written notice of warranty, if any, regarding service after
the sale. The permit holder shall maintain documentation demonstrating that
the written notice of warranty was given to the patient.
(i) Offers to counsel and patient counseling for inmates
need not be "face to face", but rather, may be conducted through a
correctional or law enforcement officer or through printed material. A pharmacist
or a device and medical equipment permit holder dispensing drugs or devices or
delivering medical equipment to inmates need not comply with Paragraph (c) of
this Rule. However, once such patient information is obtained, the
requirements of Paragraph (d) of this Rule shall be followed.
History Note: Authority G.S. 90-85.6; 90-85.22;
90-85.32; 42 U.S.C. 1396r-8(g);
Eff. January 4, 1993;
Amended Eff. June 1, 2004; July 1, 1996; September 1,
1995.
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 licensed veterinarian or by a pharmacist from a
pharmacy pursuant to prescription or order of a licensed veterinarian.
History Note: Authority G.S. 90-85.3; 90-85.6;
Eff. September 1, 1995.
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
(2) procedures requiring other protective
clothing or covering.
(b) Identification of a pharmacist may be limited to first
name only with reference to licensure or other professional designation when
the full name identification may:
(1) place the personal safety of the pharmacist
in jeopardy; or
(2) interfere with the therapeutic relationship
between the pharmacist and client(s).
History Note: Authority G.S. 90-640;
Eff. August 1, 2002.
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, 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 or a Pharmacy Intern who is
under the direct, in-person supervision of an Immunizing Pharmacist; or
(B) the patient at the direction of either an Immunizing
Pharmacist or a health care provider authorized by North Carolina law to
prescribe the vaccine.
(2) "Immunizing Pharmacist" shall
have the meaning provided in G.S. 90-85.3(i1).
(3) "Pharmacy Intern" shall have the
meaning provided in 21 NCAC 46 .1317(28).
(4) "Physician" means an M.D. or D.O.
currently licensed with the North Carolina Medical Board who is responsible for
the supervision of the Immunizing Pharmacist pursuant to the Written Protocol
between the Immunizing Pharmacist and the Physician.
(5) RESERVED
(6) RESERVED
(7) RESERVED
(8) RESERVED
(9) RESERVED
(10) RESERVED
(11) RESERVED
(12) "Written Protocol" is a document
prepared, signed, and dated by the Physician and Immunizing Pharmacist that
shall contain the following:
(A) the name of the Physician responsible for
authorizing the Written Protocol;
(B) the name of the Immunizing Pharmacist authorized to
administer vaccines;
(C) the immunizations or vaccinations that may be
administered by the Immunizing Pharmacist;
(D) the screening questionnaires and safety procedures
that shall at least include the then-current minimum standard screening
questionnaire and safety procedures adopted by the Medical Board, the Board of
Nursing, and the Board of Pharmacy pursuant to S.L. 2013-246, s. 6, and
available at the Board of Pharmacy's office and on its website (www.ncbop.org).
(E) the procedures to follow, including any drugs
required by the Immunizing Pharmacist for treatment of the patient, in the
event of an emergency or adverse event following vaccine administration;
(F) the reporting requirements by the Immunizing
Pharmacist to the Physician, including content and time frame; and
(G) the locations at which the Immunizing Pharmacist may
administer immunizations or vaccinations.
The Physician and the
Immunizing Pharmacist shall review the Written Protocol at least annually and
revise it if necessary.
(c) An Immunizing Pharmacist who, because of physical
disability, is unable to obtain a current provider level CPR certification pursuant
to G.S. 90-85.3(i1)(1), may administer vaccines in the presence of a pharmacy
technician or pharmacist who holds a current provider level CPR certification.
(d) With each dose of vaccine, either the Immunizing
Pharmacist or a Pharmacy Intern shall give the most current vaccine information
regarding the purpose, risks, benefits, and contraindications of the vaccine to
the patient or legal representative. The Immunizing Pharmacist or Pharmacy
Intern must ensure that the patient or legal representative has the opportunity
to read, or to have read to him or her, the information provided and to have
any questions answered prior to administration of the vaccine.
(e) In agreeing to serve as a supervising Physician, the
Physician shall agree to meet the following requirements:
(1) be responsible for the formulation or
approval of the Written Protocol and review the Written Protocol and the
services provided to patients under the Written Protocol, as set out in Subparagraph
(b)(12) of this Rule;
(2) be accessible to the Immunizing Pharmacist
or be available through direct telecommunication for consultation, assistance,
direction, and provide back-up coverage; and
(3) receive periodic status reports from the
Immunizing Pharmacist, including any problems or complications encountered.
(f) The following requirements pertain to drugs
administered by an Immunizing Pharmacist:
(1) Drugs administered by an Immunizing
Pharmacist under the provisions of this Rule shall be in the legal possession
of:
(A) a pharmacy, which shall be the pharmacy responsible
for drug accountability, including the maintenance of records of administration
of the immunization or vaccination; or
(B) the Physician, who shall be responsible for drug
accountability, including the maintenance of records of administration of the
immunization or vaccination;
(2) Drugs shall be transported and stored at
the proper temperatures indicated for each drug;
(3) Immunizing Pharmacists, while engaged in
the administration of vaccines under the Written Protocol, shall have in their
custody and control the vaccines identified in the Written Protocol and any
other drugs listed in the Written Protocol to treat adverse events; and
(4) After administering vaccines at a location
other than a pharmacy, the Immunizing Pharmacist shall return all unused
prescription medications to the pharmacy or Physician responsible for the
drugs.
(g) Record Keeping and Reporting.
(1) An Immunizing Pharmacist shall maintain the
following information, readily retrievable, in the pharmacy records in
accordance with the applicable rules and statute regarding each administration:
(A) the name, address, and date of birth of the patient;
(B) the date of the administration;
(C) the administration site of injection (e.g., right
arm, left leg, right upper arm);
(D) route of administration of the vaccine;
(E) the name, manufacturer, lot number, and expiration
date of the vaccine;
(F) dose administered;
(G) the name and address of the patient's primary health
care provider, as identified by the patient; and
(H) the name or identifiable initials of the Immunizing
Pharmacist.
(2) An Immunizing Pharmacist shall document the
annual review with the Physician of the Written Protocol as required in this
Rule.
(3) An Immunizing Pharmacist shall report
adverse events associated with administration of a vaccine to either the
prescriber, when administering a vaccine pursuant to G.S. 90-85.15B(a), or the
patient's primary care provider, if the patient identifies one, when
administering a vaccine pursuant to G.S. 90-85.15B(b).
(h) The Immunizing Pharmacist shall maintain written
policies and procedures for handling and disposal of used or contaminated
equipment and supplies.
History Note: Authority G.S. 90-85.3; 90-85.6; 90-85.15B;
Eff. April 1, 2003;
Emergency Amendment Eff. May 11, 2004;
Temporary Amendment approved by RRC October 21, 2004;
Amended Eff. February 1, 2008; November 1, 2005; November
1, 2004;
Emergency Amendment Eff. October 9, 2009;
Temporary Amendment Eff. December 29, 2009;
Amended Eff. September 1, 2014; March 1, 2012.
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 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.
History Note: 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.
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.
History Note: Authority G.S. 90-85.6; 90-85.36;
Eff. March 1, 2004.
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 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.
History Note: Authority G.S. 90-85.6; 90-85.34;
150B-19(6);
Eff. July 1, 2004.
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 Note: Authority G.S. 90-85.24(a)(16);
Eff. March 1, 2006.
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 break and one additional 15 minute break.
History Note: Authority G.S. 90-85.2; 90-85.6(a);
90-85.21(a); 85-32(a);
Eff. April 1, 2007.
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 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.
(d) Drugs, Supplies and Medical Devices Eligible for
Donation.
(1) A participating pharmacy or dispensing
physician may accept donation of a drug, supply or medical device meeting the
criteria specified in G.S. 90-85.44(c).
(2) The following categories of drugs, supplies
and medical devices shall not be accepted by a participating pharmacy or
dispensing physician:
(A) A controlled substance, unless acceptance of a
donated controlled substance is authorized by federal law.
(B) Any prescription drug or medical device subject to a
restricted distribution system mandated by the United States Food and Drug
Administration.
(C) Biologicals, unless donated by the manufacturer or a
prescription drug wholesaler. A pharmacy may donate a biological if the
biological has been stored according to the manufacturer's labeling and has not
previously been dispensed to a patient or other person.
(D) Compounded drugs or parenteral admixtures.
(E) Any drug requiring refrigerated storage, unless
donated by either (a) the manufacturer, (b) a prescription drug wholesaler or
(c) a pharmacy that has stored the drug according to the manufacturer's
labeling and has not previously dispensed the drug to a patient or other
person.
(e) Required Records.
(1) A participating pharmacy or dispensing
physician that dispenses donated drugs, supplies or medical devices to an
eligible patient shall maintain a written or electronic inventory of each
donated drug, supply and medical device that shall include the following:
(A) The name, strength, dosage form, number of units,
manufacturer's lot number and expiration date.
(B) The name, address and phone number of the eligible
donor providing each drug, supply or medical device.
(2) A participating pharmacy or dispensing
physician shall keep all donated drugs, supplies and medical devices physically
separated from other inventory. The physically separate storage area for
donated drugs, supplies and medical devices shall be identified.
(3) In addition to all records required for
dispensing a prescription drug, supply or medical device under the North
Carolina Pharmacy Practice Act and rules, a participating pharmacy or
dispensing physician that dispenses donated drugs, supplies or medical devices
to an eligible patient shall note – either on the face of a written
prescription or in the electronic record of a prescription – that a donated
prescription drug, supply or medical device was dispensed to the patient.
(4) A participating pharmacy or dispensing
physician that dispenses donated drugs, supplies or medical devices to an
eligible patient shall maintain patient-specific written or electronic
documentation of any dispensing of a donated non-prescription drug, supply or
medical device.
(f) Eligible Patient.
(1) A participating pharmacy or dispensing
physician shall establish and maintain a written patient eligibility policy
that shall conform to the priorities specified in G.S. 90-85.44(f).
(2) Donated drugs, supplies or medical devices
shall be dispensed to patients who are residents of North Carolina and meet the
participating pharmacy's or dispensing physician's eligibility criteria.
(g) Handling Fee.
(1) A participating pharmacy or dispensing
physician may charge a prescription drug handling fee to an eligible patient
that shall not exceed the co-payment established by North Carolina Medicaid and
required of a North Carolina Medicaid beneficiary who receives the same
prescription drug in the same quantity.
(2) A participating pharmacy or dispensing
physician may charge a medical device or supply handling fee to an eligible
patient that shall not exceed the co-payment established by North Carolina
Medicaid and required of a North Carolina Medicaid beneficiary to whom a
brand-name prescription drug is dispensed.
(3) Nothing in this Rule shall require a
participating pharmacy or dispensing physician to charge an eligible patient a
handling fee, nor shall a participating pharmacy or dispensing physician charge
a handling fee where doing so is otherwise prohibited by law.
(h) Confidentiality of Records.
(1) A participating pharmacy or dispensing
physician that dispenses donated drugs, medical devices or supplies to an
eligible patient shall remove or alter any labeling or other material from a
donated drug, supply or medical device that could identify the patient to whom
the donated product was originally dispensed so that the identity of that
patient cannot be determined.
(2) Records required by this Rule shall be
governed by the confidentiality provisions of G.S. 90-85.36 and the Health
Insurance Portability and Accountability Act of 1996.
(3) Records required by this Rule shall be
maintained by the participating pharmacy or dispensing physician for a period
of three years.
History Note: Authority G.S. 90-85.6; 90-85.26;
90-85.32; 90-85.44;
Eff. June 1, 2010.
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.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.
History Note: 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.
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 with G.S. 90‑85.3(t).
History Note: Authority G.S. 90‑85.3(e),(r); 90‑85.6;
90‑85.22;
Eff. October 1, 1990;
Amended Eff. April 1, 1997.
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 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.
History Note: Authority G.S. 90‑85.3(e), (l1),
(r); 90‑85.6; 90‑85.22;
Eff. October 1, 1990;
Amended Eff. September 1, 1995.
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 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.
History Note: 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.
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 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.
History Note: Authority G.S. 90-85.3(e); (11), (r);
90-85.6; 90-85.22;
Eff. October 1, 1990;
Amended Eff. April 1, 2004; September 1, 1995.
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.
History Note: Authority G.S. 90‑85.3(e), (l1),
(r); 90‑85.6; 90‑85.22;
Eff. October 1, 1990;
Amended Eff. September 1, 1995.
21 NCAC 46 .2607 AVAILABILITY OF RECORDS
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.
History Note: Authority G.S. 90‑85.3(e),(r); 90‑85.6;
90‑85.22;
Eff. October 1, 1990;
Amended Eff. February 1, 2007.
21 NCAC 46 .2608 DISPENSING OF MEDICAL OXYGEN
Compressed medical oxygen and liquid oxygen equipment shall
be dispensed and controlled according to state and federal laws.
History Note: Authority G.S. 90-85.3(e),(l1),(r);
90-85.6; 90-85.22;
Eff. September 1, 1995.
21 NCAC 46 .2609 REHABILITATION EQUIPMENT
(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.
History Note: Authority G.S. 90-85.3(e),(l1),(r);
90-85.6; 90-85.22;
Eff. September 1, 1995;
Amended Eff. April 1, 1999; April 1, 1997.
21 NCAC 46 .2610 MEDICAL GAS, OXYGEN AND RESPIRATORY
RELATED EQUIPMENT
(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.
(b) Medical gas, oxygen and respiratory related equipment
suppliers shall comply with the following recall procedures:
(1) Ensure that lot numbers and expiration
dates are affixed to each cylinder delivered;
(2) Maintain a tracking system for all medical
oxygen and gas delivered;
(3) Document all equipment serial numbers and
model numbers to ensure that equipment can be retrieved if a recall is
initiated; and
(4) Maintain records for equipment that
requires FDA tracking.
(c) Medical gas, oxygen and respiratory related equipment
suppliers shall comply with the following maintenance and cleaning
requirements:
(1) Maintain documentation demonstrating that a
function and safety check of equipment was performed prior to set up;
(2) Maintain an established protocol for
cleaning and disinfecting equipment which addresses both aerobic and anaerobic
pathogens;
(3) Maintain a Material Safety Data Sheet
(MSDS) on file for solutions and products used in cleaning and disinfecting
procedures;
(4) Maintain segregated areas on the premises
and in delivery vehicles for clean, dirty, and contaminated equipment;
(5) Clean and disinfect equipment according to
manufacturers' specifications; and
(6) Instruct the patient on proper cleaning
techniques as specified by the manufacturer.
(d) Medical gas, oxygen and respiratory related equipment
suppliers shall implement a comprehensive preventative maintenance program
which includes the following:
(1) Procedures for problem reporting, tracking,
recall, and resolution;
(2) Performance of service as specified by the
manufacturer and the documentation of such performance in the service records;
and
(3) Routine inspection, service, and
maintenance of equipment located in the patient's/customer's home according to
manufacturers' specifications.
(e) Medical gas, oxygen and respiratory related equipment
suppliers shall maintain repair logs to document repair and maintenance of
equipment, including, but not limited to, oxygen concentrators, infant
monitors, and mechanical ventilators. The following information shall be documented
in the repair log:
(1) type of equipment;
(2) manufacturer;
(3) model;
(4) serial number;
(5) date of repair;
(6) specific repair made; and
(7) name of person or company performing the
repair.
(f) Medical gas, oxygen and respiratory related equipment
suppliers shall maintain testing equipment to ensure accurate calibration.
Testing equipment shall be appropriate for the level of service offered.
Scales used to weigh liquid oxygen reservoirs shall be properly maintained to
ensure accuracy.
(g) Medical gas, oxygen, and respiratory related equipment
suppliers shall implement a written procedure at each location for handling
complaints and problems, which includes a complaint file documenting complaints
and problems and resolutions of the complaints or problems.
(h) Medical gas, oxygen, and respiratory related equipment
suppliers shall comply with the following counseling requirements:
(1) Utilize orientation checklists to review:
(A) Instructions for use of the equipment,
(B) Safety precautions,
(C) Cleaning procedures,
(D) Maintenance procedures, and
(E) Return demonstrations on back up oxygen systems
delivered;
(2) Instruct the patient about emergency and
routine contact procedures; and
(3) Deliver and review written instruction
materials to ensure that the patient receives adequate information in order to
properly operate the equipment.
(i) A written plan of service shall be developed,
implemented, and documented in the patient record. The plan of service shall
include, but is not limited to, an assessment of the safety of the home
environment, the caregiver or patient ability to comply with the prescription,
and the caregiver or patient ability to operate and clean the equipment as
instructed.
History Note: Authority G.S. 90-85.3(e),(l1),(r); 90-85.6;
90-85.22;
Eff. September 1, 1995.
21 NCAC 46 .2611 MEDICAL EQUIPMENT
(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.
(b) Medical equipment suppliers shall implement a
preventative maintenance program for rental equipment which includes the
following:
(1) Procedures for problem reporting, tracking,
recall, and resolution;
(2) Performance of service as specified by the
manufacturer and the documentation of such performance in the service records;
and
(3) Maintain documentation of repair and
maintenance of equipment. The following information shall be documented in the
repair log:
(A) Type of equipment;
(B) Manufacturer;
(C) Model;
(D) Serial number;
(E) Date of repair;
(F) Specific repair made; and
(G) Name of person or company performing the repair.
(c) In addition to Section .2500 of this Chapter providers
of parenteral and enteral nutrition services shall comply with the following
counseling requirements:
(1) Utilize orientation checklists to review:
(A) Instructions for use of the equipment;
(B) Safety precautions;
(C) Cleaning procedures;
(D) Maintenance procedures; and
(E) Return demonstrations on equipment delivered.
(2) Instruct the patient about emergency and
routine contact procedures;
(3) Deliver and review with the patient written
instruction materials to ensure that the patient receives adequate information
to properly operate the equipment; and
(4) A written plan of service shall be
developed, implemented, and documented in the patient record. The plan of
service shall include, but is not limited to, the assessment of the safety of
the home environment, the caregiver or patient's ability to comply with the
prescription, and the caregiver or patient's ability to operate and clean the
equipment as instructed.
History Note: Authority G.S. 90-85.3(e)(l1)(r);
90-85.6; 90-85.22;
Eff. May 1, 1997;
Amended Eff. April 1, 1999; August 1, 1998.
21 NCAC 46 .2612 STORAGE OF DEVICES AND MEDICAL
EQUIPMENT
(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.
History Note: Authority G.S. 90-85.6; 90-85.22;
90-85.32;
Eff. March 1, 2004;
Amended Eff. November 1, 2015; February 1, 2007.
21 NCAC 46 .2613 DEVICES AND MEDICAL EQUIPMENT IN
POSSESSION OF PERMIT HOLDERS
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.
History Note: Authority G.S. 90-85.6; 90-85.22;
90-85.32;
Eff. April 1, 2007.
SECTION .2700 ‑ NUCLEAR PHARMACY
21 NCAC 46 .2701 REQUIREMENTS
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.
History Note: Authority G.S. 90‑85.6;
Eff. October 1, 1990.
21 NCAC 46 .2702 DEFINITIONS
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.
(7) Radiopharmaceutical Quality Assurance. The
performance of appropriate chemical, biological and physical tests on potential
radiopharmaceuticals and the interpretation of the resulting data to determine
their suitability for use in humans and animals, including internal test
assessment, authentication of product history and the keeping of proper
records.
(8) Radiopharmaceuticals. Radioactive drugs shall
include any article that exhibits spontaneous decay or disintegration of an
unstable atomic nucleus, usually accompanied by the emission of ionizing
radiation and any nonradioactive reagent kit or nuclide generator that is
intended for use in the preparation of any such article.
(9) Radiopharmaceutical Service. The procurement,
storage, handling, preparation, labeling, quality assurance testing,
dispensing, delivery, record-keeping and disposal of radiopharmaceuticals and
other radioactive materials.
(10) Test Assessment. Conducting quality assurance
evaluation necessary to ensure the integrity of the test.
History Note: Authority
G.S. 90‑85.6; 90-85.34;
Eff. October 1, 1990;
Amended Eff. February 1, 2005.
21 NCAC 46 .2703 OBTAINING A NUCLEAR PHARMACY PERMIT
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.
History Note: Authority
G.S. 90‑85.6; 90-85.34;
Eff. October 1, 1990;
Amended Eff. February 1, 2005.
21 NCAC 46 .2704 REQ FOR PHARMACIES PROVIDING
RADIOPHARMACEUTICAL SERVICES
(a) The permit to operate a pharmacy providing
radiopharmaceutical services shall be issued by the Board only to a qualified
nuclear pharmacist. All personnel performing tasks in the preparation and
distribution of radiopharmaceuticals shall be under the direct supervision of a
qualified nuclear pharmacist. A qualified nuclear pharmacist shall be
responsible for all operations of the pharmacy related to radiopharmaceutical
services and shall be in personal attendance at all times that the pharmacy
renders radiopharmaceutical services.
(b) In emergency situations, and in the absence of a
qualified nuclear pharmacist, designated qualified licensed professionals as
identified by the pharmacist-manager in established written policies and
procedures may have access to the area designated as the nuclear pharmacy area,
and these individuals may prepare single doses of radiopharmaceuticals for the
immediate emergency only and must document such activities.
(c) The nuclear pharmacy area shall be secured from entry
by unauthorized personnel as identified by the pharmacist-manager in
established written policies and procedures.
(d) Nuclear pharmacies shall maintain records of
acquisition, inventory and disposition of all radiopharmaceuticals in
accordance with Section .2300 of this Chapter and the applicable regulations of
the North Carolina Division of Radiation Protection.
(e) All pharmacies handling radiopharmaceuticals shall
provide a radioactive storage and product decay area that provides sufficient
protection from radioactivity of all areas surrounding the nuclear pharmacy
area. Floor plans shall be submitted and approved by the Board staff before a
nuclear pharmacy permit is issued.
(f) Radiopharmaceuticals are to be dispensed only upon a
prescription or medication order from a licensed medical practitioner
authorized to possess, use and administer radiopharmaceuticals.
(g) The library of a nuclear pharmacy shall contain, in
addition to the volumes required by Rule .1601(a)(3) of this Chapter, copies of
current state and federal regulations governing the safe storage, handling,
use, dispensing, transport, and disposal of radiopharmaceuticals.
(h) All pharmacies performing Radiopharmaceutical Services
shall have in effect a procedures manual setting forth the procedures and
policies of the pharmacy regarding Radiopharmaceutical Quality Assurance. This
manual shall at all times be readily available for review by Board personnel.
(i) Permit holders must obtain licensure from the North
Carolina Division of Radiation Protection and the number of that license.
Copies of the Division's inspection report shall be made available upon request
for inspection by Board personnel.
History Note: Authority
G.S. 90‑85.6; 90-85.34;
Eff. October 1, 1990;
Amended Eff. February 1, 2005.
21 NCAC 46 .2705 LAbELING REQUIREMENTS OF
RADIOPHARMACEUTICALS
(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.
(b) No radiopharmaceutical may be dispensed unless a
tamper-evident seal is applied and a label is affixed to the delivery container
of each dose bearing the following information:
(1) The standard radiation symbol.
(2) The words "Caution - Radioactive
Material."
(3) The radionuclide and chemical form.
(4) The volume if in liquid form.
(5) The requested activity and the calibration
date and time.
(6) The prescription number.
(7) Labels for radiolabeled blood components
and therapeutic dosages must always contain the patient's name at the time of
dispensing.
Where the patient's name is not
available at the time of dispensing for diagnostic dosing, a 72-hour exemption
is allowed to obtain the name of the patient. No later than 72 hours
after dispensing the radiopharmaceutical, the patient's name must be associated
with the prescription in a readily retrievable manner and must be retained for
a period of three years.
(8) The name and address of the nuclear
pharmacy.
(9) The name of the end authorized user, must
also be a prescriber.
(10) The lot number of the preparation.
History Note: Authority
G.S. 90‑85.6; 90-85.34;
Eff. January 1, 2005.
21 NCAC 46 .2706 PROHIBITIONS
(a) No person shall utilize unit-dose transport containers
for radioactive dosages without an effective mechanism to avoid contamination
of the transport container with blood or other biohazardous substances.
(b) No person shall re-use a unit-dose transport container
that has been contaminated with blood or other biohazardous substances.
Any unit-dose transport container that is returned with the tamper-evident seal
broken and the unit-dose syringe included must be considered to be
contaminated.
History Note: Authority G.S. 90‑85.6; 90-85.34;
Eff. January 1, 2005.
SECTION .2800 – COMPOUNDING
21 NCAC 46 .2801 COMPOUNDING
(a) A pharmacy may dispense a compounded drug preparation
to a patient only pursuant to a prescription that is valid and complies with
all requirements of the law, including 21 NCAC 46 .1801. In advance of
dispensing the compounded drug preparation, a pharmacy shall prepare the
compounded drug preparation only:
(1) upon the pharmacy's receipt of a valid
prescription order for an individual patient; or
(2) in anticipation of a prescription order
based on an established history of receiving prescription orders for the
compounded drug preparation. Any compounded drug preparation prepared in
anticipation of a prescription order shall not be dispensed until the pharmacy
receives a valid prescription order for an individual patient.
(b) Compounded drug preparations shall not be offered to
other entities for resale.
(c) A pharmacy may supply compounded drug products to
practitioners authorized by law to prescribe drugs for those practitioners to
administer to those practitioners' patients. Such compounding for office use
shall comply with applicable federal law.
(d) The preparation, labeling, and dispensing of
non-sterile compounded drug preparations shall comply with the standards
established by United States Pharmacopeia chapter , including all
United States Pharmacopeia chapters and standards incorporated into chapter
by reference and including all subsequent amendments and editions
of the same, governing both the non-sterile compounded drug preparations and
the physical and environmental conditions under which non-sterile compounded
drug preparations are prepared, labeled, and dispensed.
(e) The preparation, labeling, and dispensing of sterile
compounded preparations shall comply with standards established by United
States Pharmacopeia chapter , including all United States
Pharmacopeia chapters and standards incorporated into chapter by
reference and including all subsequent amendments and editions of the same,
governing both the sterile compounded products and the physical and
environmental conditions under which sterile compounded products are prepared,
labeled, and dispensed.
(f) A pharmacy that prepares, labels, or dispenses sterile
compounded preparations shall maintain a reference library in the pharmacy
including the current United States Pharmacopeia standards and references on
the compatibility, stability, storage, handling, and preparation of compounded
drugs. These references may be either hard copy or electronically accessible.
(g) In a pharmacy where compounded drug preparations are
prepared, labeled, or dispensed, the pharmacist-manager or the
pharmacist-manager's designated pharmacist shall be knowledgeable in the
specialized functions of preparing, labeling, and dispensing compounded drug
preparations. If the pharmacist-manager chooses to designate another
pharmacist for this purpose, the pharmacist-manager shall notify the Board on
the pharmacy's permit application and, in writing, within 15 days of any change
in the designation. Notwithstanding the pharmacist-manager's designation of
another pharmacist as knowledgeable in the specialized functions of preparing,
labeling, and dispensing compounded drug preparations, the pharmacist-manager
shall be responsible for ensuring the pharmacy's compliance with all statutes,
rules, and standards that govern such activities.
(h) In addition to complying with all recordkeeping and
labeling requirements specified or referred to by United States Pharmacopeia
chapters or , a pharmacy that prepares, labels, or
dispenses compounded drug preparations shall create and maintain a record-keeping
system that enables the pharmacy immediately upon request to identify every
compounded drug preparation prepared, labeled, or dispensed in the past three
years. This recordkeeping system may be created and maintained electronically
in compliance with 21 NCAC 46 .2508.
(i) The pharmacist-manager of a pharmacy that prepares,
labels, or dispenses compounded drug preparations shall comply with all quality
assurance requirements and standards of United States Pharmacopeia chapters
and .
(j) In addition to the requirements of this Section, the
compounding of radiopharmaceutical drug products shall comply with Section
.2700 of this Chapter.
(k) United States Pharmacopeia chapters or
may be inspected at the offices of the Board during its normal
hours of operation. Copies also may be obtained from the U.S. Pharmacopeial
Convention (www.usp.org), as part of the "USP on Compounding: A Guide for
the Compounding Practitioner," as an electronic publication, that cost one
hundred dollars ($100.00) as of the effective date of the last amendment to
this Rule.
History Note: Authority G.S. 90-85.6; 90-85.32;
Eff. October 1, 1990;
Amended Eff. January 1, 2015; April 1, 2003.
21 NCAC 46 .2802 DEFINITIONS
21 NCAC 46 .2803 REQ/PHARMACIES DISPENSING STERILE
PHARMACEUTICALS
21 NCAC 46 .2804 RESPONSIBILITIES OF
PHARMACIST-MANAGER
21 NCAC 46 .2805 LABELING
21 NCAC 46 .2806 RECORDS AND REPORTS
21 NCAC 46 .2807 ANTI-NEOPLASTIC AGENTS
21 NCAC 46 .2808 QUALITY ASSURANCE
History Note: Authority G.S. 90-85.6.
Eff. October 1, 1990;
Amended Eff. March 1, 2013; February 1, 2006; April 1,
2003; September 1, 1995;
Repealed Eff. January 1, 2015.
SECTION .2900 ‑ PRODUCT SELECTION
21 NCAC 46 .2901 RETURN OF OUTDATED DRUGS
(a) Adequate provisions for return of outdated drugs in both
full and partial containers as provided in G.S. 90-85.28(a)(5) means that drugs
can be returned up to six months after the labeled expiration date for full
credit or replacement. A finding by the Board that a manufacturer does not
meet this standard causes that manufacturer's products to be ineligible for use
in product selection.
(b) This Rule does not apply to drugs whose only Food and
Drug Administration-approved indication is for use as an antidote to
biological, chemical, or radiological poisoning.
History Note: Authority G.S. 90-85.6; 90-85.28(a)(5);
Eff. October 1, 1991;
Amended Eff. July 1, 2011.
SECTION .3000 - DISPOSAL OF UNWANTED DRUGS
21 NCAC 46 .3001 PROCEDURE FOR DISPOSING OF DRUGS
(a) All registrants under G.S. 90-85.21 shall develop and
implement policies and procedures to insure that all out-dated, improperly
labeled, adulterated, damaged or unwanted drugs or drug containers with worn,
illegible or missing labels are destroyed or disposed of so as to render them
unusable.
(b) Any permit holder in possession of outdated,
adulterated or unwanted drugs other than controlled substances may dispose or
destroy such drugs by returning them to the manufacturer, by incineration at a
properly permitted facility, or by any other means approved by the Board which
will assure protection against unauthorized possession or use. Destructions
under this Paragraph taking place at the permit holder's premises shall be
witnessed by a licensed pharmacist and documented.
(c) Any permit holder in possession of any controlled
substance and desiring or required to dispose of such substance may file a
written request on a form provided by the Board for authority and instructions
to dispose of such substance. If destruction under this Paragraph takes place
at the permit holder's premises such destruction shall be jointly witnessed by
at least two licensed pharmacists approved by the Board. All destructions of
controlled substances shall be documented and the document shall be retained by
the permit holder for a period of at least three years. Copies of the document
shall be sent to the Drug Enforcement Administration.
History Note: Authority G.S. 90-85.6; 90-85.21;
Eff. October 1, 1993.
section .3100 – clinical pharmacist practitioner
21 NCAC 46 .3101 CLINICAL PHARMACIST PRACTITIONER
(a) Definitions. As used in this Rule:
(1) "Medical Board" means the North
Carolina Medical Board.
(2) "Pharmacy Board" means the North
Carolina Board of Pharmacy.
(3) "Joint Subcommittee" means the
subcommittee composed of four members of the Pharmacy Board and four members of
the Medical Board to whom responsibility is given by G.S. 90-6(c)
to develop rules to govern the provision of drug therapy management by the
Clinical Pharmacist Practitioner in North Carolina.
(4) "Clinical Pharmacist Practitioner or
CPP" means a licensed pharmacist who is approved to provide drug therapy
management, including controlled substances, under the direction of, or under the supervision of a
licensed physician who has provided written instructions for a patient and
disease specific drug therapy which may include ordering, changing,
substituting therapies or ordering tests. Only a pharmacist approved by the
Pharmacy Board and the Medical Board may legally identify himself as a CPP.
(5) "Supervising Physician" means a
licensed physician who, by signing the CPP agreement, is held accountable for
the on-going supervision and evaluation of the drug therapy management
performed by the CPP as defined in the physician, patient, pharmacist and
disease specific written agreement.
(6) "Approval" means authorization by
the Medical Board and the Pharmacy Board for a pharmacist to practice as a CPP
in accordance with this Rule.
(7) "Continuing Education or CE" is
defined as courses or materials which have been approved for credit by the American
Council on Pharmaceutical Education.
(8) "Clinical Experience approved by the
Boards" means work in a clinical pharmacy practice setting which includes
experience consistent with the components listed in Parts (b)(2)(A), (B), (C),
(D), (E), (H), (I), (J), (N), (O), and (P) of this Rule. Clinical
experience requirements must be met only through activities separate from the
certificate programs referred to in Parts
(b)(1)(B) of this Rule.
(b) CPP application for approval.
(1) The requirements for application for CPP
approval include that the pharmacist:
(A) has an unrestricted and current license to practice
as a pharmacist in North Carolina;
(B) meets one of the following qualifications:
(i) has earned Certification from the Board of
Pharmaceutical Specialties, is a Certified Geriatric Pharmacist as certified by
the Commission for Certification in Geriatric Pharmacy or has completed an
American Society of Health System Pharmacists (ASHP) accredited residency
program, which includes two years of clinical experience approved by the
Boards; or
(ii) has successfully completed the course of study
and holds the academic degree of Doctor of Pharmacy and has three years of
clinical experience approved by the Boards and has completed a North Carolina
Center for Pharmaceutical Care (NCCPC) or American Council on Pharmaceutical
Education (ACPE) approved certificate program in the area of practice covered
by the CPP agreement; or
(iii) has successfully completed the course of study
and holds the academic degree of Bachelor of Science in Pharmacy and has five
years of clinical experience approved by the Boards and has completed two NCCPC
or ACPE approved certificate programs with at least one program in the area of practice covered by the CPP agreement;
(C) submits the required application and the fee to the
Medical Board;
(D) submits any information deemed necessary by the
Medical Board in order to evaluate the application; and
(E) has a signed supervising physician agreement.
If for any reason a CPP discontinues working in the approved
physician arrangement, the CPP shall notify both Boards in writing within 10
days and the CPP's approval shall automatically terminate or be placed on an
inactive status until such time as a new application is approved in accordance
with this Subchapter.
(2) All certificate programs referred to in
Subpart (b)(1)(B)(i) of this Rule must contain a core curriculum including the
following components:
(A) communicating with healthcare professionals and
patients regarding drug therapy, wellness, and health promotion;
(B) designing, implementing, monitoring, evaluating, and
modifying or recommending modifications in drug therapy to insure effective,
safe, and economical patient care;
(C) identifying, assessing and solving medication-related
problems and providing a clinical judgment as to the continuing effectiveness
of individualized therapeutic plans and intended therapeutic outcomes;
(D) conducting
physical assessments, evaluating patient problems, ordering and monitoring medications
and laboratory tests;
(E) referring patients to other health professionals as
appropriate;
(F) administering medications;
(G) monitoring patients and patient populations
regarding the purposes, uses, effects and pharmacoeconomics of their medication
and related therapy;
(H) counseling patients regarding the purposes, uses,
and effects of their medication and related therapy;
(I) integrating relevant diet, nutritional and
non-drug therapy with pharmaceutical care;
(J) recommending, counseling, and monitoring patient
use of non-prescription drugs, herbal remedies and alternative medicine
practices;
(K) using, ordering, and instructing on the use of
devices, and durable medical equipment;
(L) providing emergency first care;
(M) retrieving, evaluating, utilizing, and managing data
and professional resources;
(N) using clinical data to optimize therapeutic drug
regimens;
(O) collaborating with other health professionals;
(P) documenting interventions and evaluating
pharmaceutical care outcomes;
(Q) integrating
pharmacy practice within healthcare environments;
(R) integrating national standards for the quality of
healthcare; and
(S) conducting outcomes and other research.
(3) The completed application for approval to
practice as a CPP shall be reviewed by the Medical Board upon verification of a
full and unrestricted license to practice as a pharmacist in North Carolina.
(A) The application shall be approved and at the time of
approval the Medical Board shall issue a number which shall be printed on each prescription
written by the CPP; or
(B) The application shall be denied; or
(C) The application shall be approved with restrictions.
(c) Annual Renewal.
(1) Each CPP shall register annually on the
anniversary of his or her birth date by:
(A) verifying a current Pharmacist license;
(B) submitting the renewal fee as specified in
Subparagraph (j)(2) of this Rule;
(C) completing the Medical Board's renewal form; and
(D) reporting continuing education credits as specified
by the Medical Board.
(2) If the CPP has not renewed within 30 days
of the anniversary of the CPP's birth date,
the approval to practice as a CPP shall lapse.
(d) Continuing Education.
(1) Each CPP shall earn 35 hours of practice
relevant CE each year approved by the Pharmacy Board.
(2) Documentation of these hours shall be kept
at the CPP practice site and made available for inspection by agents of the
Medical Board or Pharmacy Board.
(e) The supervising physician who has a signed agreement
with the CPP shall be readily available for consultation with the CPP and shall
review and countersign each order written by the CPP within seven days.
(f) The written CPP agreement shall:
(1) be approved and signed by both the
supervising physician and the CPP and a copy shall be maintained in each practice
site for inspection by agents of either Board upon request;
(2) be specific in regard to the physician, the
pharmacist, the patient and the disease;
(3) specify the predetermined drug therapy
which shall include the diagnosis and product selection by the patient's
physician; any modifications which may be permitted, dosage forms, dosage
schedules and tests which may be ordered;
(4) prohibit the substitution of a chemically
dissimilar drug product by the CPP for the product prescribed by the physician without
first obtaining written consent of the
physician;
(5) include a pre-determined plan for emergency
services;
(6) include a plan and schedule for weekly
quality control, review and countersignature of all orders written by the CPP
in a face-to-face conference between the physician and CPP;
(7) require that the patient be notified of the
collaborative relationship; and
(8) be terminated when patient care is
transferred to another physician and new orders shall be written by the
succeeding physician.
(g) The supervising physician of the CPP shall:
(1) be fully licensed with the Medical Board
and engaged in clinical practice;
(2) not be serving in a postgraduate medical
training program;
(3) be approved in accordance with this
Subchapter before the CPP supervision occurs; and
(4) supervise no more than three pharmacists.
(h) The CPP shall wear a nametag spelling out the words "Clinical
Pharmacist Practitioner".
(i) A CPP may be censured or reprimanded, and his or her
approval may be restricted, suspended, revoked, annulled, denied or terminated
by the Medical Board or the Pharmacy Board. The pharmacist may be censured or
reprimanded, and the pharmacist's license may be restricted, suspended,
revoked, annulled, denied, or terminated by the Pharmacy Board, in accordance
with provisions of G.S. 150B if either Board
finds one or more of the following:
(1) the CPP has held himself or herself out, or
permitted another, to represent the CPP as a licensed physician;
(2) the CPP has engaged, or attempted to engage,
in the provision of drug therapy management other than at the direction of, or
under the supervision of, a physician licensed and approved by the Medical
Board to be that CPP's supervising physician;
(3) the CPP has performed, or attempted to
provide, medical management outside the approved drug therapy agreement or for
which the CPP is not qualified by education and training to perform;
(4) the CPP commits any act prohibited by G.S.
90-85.38 as determined by the Pharmacy Board or G.S. 90-14(a)(1), (a)(3) through
(a)(14) and (c) as determined by the Medical Board; or
(5) the CPP has failed to comply with any of
the provisions of this Rule.
Any modification of treatment for financial gain on the part
of the supervising physician or CPP shall be grounds for denial of Board
approval of the agreement.
(j) Fees:
(1) An application fee of one hundred dollars
($100.00) shall be paid at the time of initial application for approval and
each subsequent application for approval to
practice.
(2) The fee for annual renewal of approval, due
on the CPP's anniversary of birth date is fifty dollars ($50.00).
(3) No portion of any fee in this Rule is
refundable.
History Note: Authority G.S. 90-6;
90-18; 90-18.4; 90-85.3; 90-85.18; 90-85.26A;
Eff. April 1, 2001;
Amended Eff. April 1, 2007; March 1, 2004; October 1,
2001.
SECTION .3200 – peer review agreements
21 NCAC 46 .3201 DEFINITIONS
The following definitions apply to this Subchapter:
(1) "Board" means the North Carolina Board of
Pharmacy.
(2) "Committee" means the Board of Directors
established to function as a supervisory and advisory body to the Program.
(3) "Impairment" means mental illness,
chemical dependency, physical illness, and aging problems.
(4) "Program" means program established by
agreements between special impaired pharmacist peer review organizations and
the Board.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001.
21 ncac 46 .3202 PEER REVIEW AGREEMENTS
Peer review activities shall include investigation, review
and evaluation of records, reports, complaints, litigation, and other
information about the practices and practice patterns of pharmacists licensed
by the Board and pharmacy technicians registered by the Board. Peer review
activities shall also include programs for impaired pharmacists and pharmacy
technicians. Peer review agreements may cover some or all of these activities,
as deemed appropriate by the Board.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001;
Amended Eff. March 1, 2004.
21 ncac 46 .3203 DUE PROCESS
Any action taken pursuant to a peer review agreement must afford
the subject pharmacist or pharmacy technician all due process rights enumerated
in the Administrative Procedure Act, G.S. 150B.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001;
Amended Eff. March 1, 2004.
21 ncac 46 .3204 RECEIPT AND USE OF INFORMATION OF
SUSPECTED IMPAIRMENT
(a) Information concerning suspected impairments may be
received by the Program through reports by pharmacists, pharmacy technicians, family
members, and others, and through self-referral.
(b) Upon receipt of information of a suspected impairment,
the Program shall initiate an investigation.
(c) The Program may conduct routine inquiries regarding
suspected impairments.
(d) Pharmacists or pharmacy technicians suspected of
impairment may be required to submit to personal interviews before any person
authorized by the Program.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001;
Amended Eff. March 1, 2004.
21 ncac 46 .3205 INTERVENTION AND REFERRAL
(a) When, following an investigation, impairment is
confirmed, an intervention shall be conducted using techniques designed to
assist the pharmacist or pharmacy technician in acknowledging responsibility
for dealing with the impairment. The pharmacist or pharmacy technician shall
be referred to a treatment source.
(b) Methods and objectives of interventions shall be decided
on a case-by case basis.
(c) Interventions shall be arranged and conducted as soon as
possible. In cases referred by the Board a representative of the Board may be
present.
(d) Treatment sources shall be evaluated before receiving
case referrals from the Program.
(e) Intervention outcomes, including treatment contracts
that are elements of an intervention, shall be recorded by the Program.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001;
Amended Eff. March 1, 2004.
21 ncac 46 .3206 MONITORING TREATMENT
A treatment source receiving referrals from the Program
shall be monitored as to its ability to provide:
(1) medical and non-medical staffing;
(2) treatment; and
(3) post-treatment support.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001.
21 ncac 46 .3207 MONITORING REHABILITATION AND
PERFORMANCE
(a) Monitoring requirements for each pharmacist or pharmacy
technician shall be designated by the Program. Pharmacists and pharmacy
technicians may be tested regularly or randomly, on Program demand.
(b) Treatment sources may be required to submit reports
regarding a pharmacist's or pharmacy technician's rehabilitation and
performance to the Program.
(c) Impaired pharmacists and pharmacy technicians may be
required to submit to periodic personal interviews before any person authorized
by the Program.
(d) Case records shall be maintained by the Program.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001;
Amended Eff. March 1, 2004.
21 NCAC 46 .3208 MONITORING POST-TREATMENT SUPPORT
(a) Post-treatment support may include family counseling,
advocacy and other services and programs deemed appropriate to improve
recoveries.
(b) Treatment sources' post-treatment support shall be monitored
by the Program on an ongoing basis.
(c) The Program's post-treatment support shall be monitored
by the Program on an ongoing basis.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001.
21 ncac 46 .3209 REPORTS OF INDIVIDUAL CASES TO THE
BOARD
(a) Upon investigation and review of a pharmacist licensed
by the Board or pharmacy technician registered by the Board, the Program shall
report immediately to the Board detailed information about any pharmacist or
pharmacy technician as required under G.S. 90-85.41(d).
(b) The Program shall submit quarterly a report to the Board
on the status of all pharmacists and pharmacy technicians then involved in the
Program who have been previously reported by the Board. The Program shall
submit monthly to the Board a report on the status of any pharmacist or
pharmacy technician previously reported to the Board then in active treatment.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001;
Amended Eff. March 1, 2004.
21 ncac 46 .3210 PERIODIC REPORTING OF STATISTICAL
INFORMATION
Statistical information concerning suspected impairments,
impairments, self-referrals, post-treatment support and other demographic and
substantive information collected through Program operations shall be included
in comprehensive statistical reports compiled and annually reported to the
Board by the Program.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001.
21 NCAC 46 .3211 CONFIDENTIALITY
Any nonpublic information acquired, created, or used in good
faith by the Program shall be treated according to G.S. 90-85.41.
History Note: Authority G.S. 90‑85.6; 90‑85.41;
Eff. April 1, 2001.
21 NCAC 46 .3301 REGISTRATION
(a) Following initial registration with the Board,
registration of a pharmacy technician shall be renewed annually through the
Board's electronic renewal process and shall expire on December 31. It shall be
unlawful to work as a pharmacy technician more than 60 days after expiration of
the registration without renewing the registration. A registration expired for
more than 60 days due to non-renewal shall be reinstated only if the applicant
meets the requirements of 21 NCAC 46 .1612.
(b) The current registration of a pharmacy technician shall
be available for inspection by agents of the Board.
(c) Pharmacy technicians who provide services solely at a
free clinic as defined in G.S. 90-85.44 shall register with the Board and
complete the training program described in G.S. 90-85.15A, but are exempt from
the pharmacy technician registration fee.
History Note: Authority G.S. 90-85.6; 90-85.15A;
Eff. April 1, 2003;
Amended Eff. February 1, 2006; February 1, 2005;
Temporary Amendment Eff. March 28, 2006;
Amended Eff. July 1, 2015; July 1, 2006.
SECTION .3400 – AUTOMATED DISPENSING ON DruG SUPPLY DEVICES
21 NCAC 46 .3401 DEFINITIONS
For purposes of this Section, the following terms are
defined as follows:
(1) "Automated medication system" means a
robotic, mechanical, or computerized device that is not used for drug compounding
and is designed to:
(a) Distribute drugs in a licensed health care
facility that holds a pharmacy permit; or
(b) Package drugs for final distribution by a
pharmacist.
(2) "Distribution" means the process of
providing a drug to an individual authorized to administer drugs and licensed
as a health care provider in the state of North Carolina pursuant to an order
issued by an authorized prescriber.
(3) "Override medication" means:
(a) A drug that may be removed from an automated
medication system prior to pharmacist review because the Multidisciplinary
Committee has determined that the clinical status of the patient would be
compromised by delay; or
(b) A drug determined by the Multidisciplinary
Committee to have a low risk of drug allergy, drug interaction, dosing error,
or adverse patient outcome, which may be removed from an automated medication
system independent of a pharmacist's review of the medication order or clinical
status of the patient.
(4) "Physician controlled medication" is a drug
ordered, prepared and administered by a physician or under the physician's
direct supervision.
History Note: Authority G.S. 90-85.6; 90-85.32; 90-85.33;
Eff. April 1, 1999;
Amended Eff. February 1, 2005; August 1, 2002;
Recodified from 21 NCAC 46 .1814 Eff. February 1, 2005;
Amended Eff. December 1, 2013.
21 NCAC 46 .3402 GENERAL
REQUIREMENTS FOR THE USE OF AUTOMATED MEDICATION SYSTEMS
(a) The pharmacist-manager shall assure compliance with all
requirements of the Pharmacy Practice Act and this Section.
(b) The pharmacist-manager shall be responsible for:
(1) Maintaining a record of each transaction or
operation;
(2) Controlling access to the automated
medication system;
(3) Maintaining policies and procedures for:
(A) Operating the automated medication system;
(B) Training personnel who use the automated medication
system;
(C) Maintaining patient services whenever the automated
medication system is not operating; and
(D) Defining a procedure for a pharmacist to grant
access to the drugs in the automated medication system or to deny access to the
drugs in the automated medication system.
(4) Securing the automated medication system;
(5) Assuring that a patient receives the
pharmacy services necessary for appropriate pharmaceutical care;
(6) Assuring that the automated medication system
maintains the integrity of the information in the system and protects patient
confidentiality;
(7) Establishing a procedure for stocking or
restocking the automated medication system; and
(8) Insuring compliance with all requirements
for packaging and labeling.
(c) A pharmacist shall perform prospective drug use review
and approve each medication order prior to administration of a drug except an override
medication or a physician controlled medication.
(d) A pharmacist shall perform retrospective drug use
review for an override medication.
(e) The pharmacist-manager shall convene or identify a
Multidisciplinary Committee, which is charged with oversight of the automated
medication system. The Multidisciplinary Committee shall:
(1) Include the pharmacist-manager or the
pharmacist-manager's designee;
(2) Establish the criteria and process for
determining which drug qualifies as an override medication; and
(3) Develop policies and procedures regarding
the operation of the automated medication system.
(f) A pharmacy utilizing an automated medication system may
distribute patient-specific drugs within the health care facility without
verifying each individual drug selected or packaged by the system, if:
(1) The initial medication order has been
reviewed and approved by a pharmacist; and
(2) The drug is distributed for subsequent
administration by a health care professional permitted by North Carolina law to
administer drugs.
(g) The pharmacist-manager shall be responsible for
establishing a quality assurance program for the automated medication system.
The program shall provide for:
(1) Review of override medication utilization;
(2) Investigation of any medication error
related to drugs distributed or packaged by the automated medication system;
(3) Review of any discrepancy or transaction
reports and identification of patterns of inappropriate use or access of the
automated medication system;
(4) Review of the operation of the automated
medication system;
(5) Integration of the automated medication
system quality assurance program with the overall continuous quality
improvement program of the pharmacy; and
(6) Assurance that individuals working with the
automated medication system receive appropriate training on operation of the
system and procedures for maintaining pharmacy services when the system is not
in operation.
(h) The pharmacist-manager shall maintain, for at least
three years, the following records related to the automated medication system
in a readily retrievable manner:
(1) Transaction records for all non-controlled
drugs or devices distributed by the automated medication system;
(2) Transaction records from the automated
medication system for all controlled substances dispensed or distributed; and
(3) Any report or analysis generated as part of
the quality assurance program required by Paragraph (g) of this Rule.
History Note: Authority G.S. 90-85.6; 90-85.32;
90-85.33;
Eff. February 1, 2005;
Amended Eff. December 1, 2013.
21 NCAC 46 .3403 MULTIDISCIPLINARY
COMMITTEE FOR DECENTRALIZED AUTOMATED MEDICATION SYSTEMS
History Note: Authority G.S. 90-85.6; 90-85.32;
90-85.33;
Eff. February 1, 2005;
Repealed Eff. December 1, 2013.
21 NCAC 46 .3404 STOCKING OR RESTOCKING OF AN
AUTOMATED MEDICATION SYSTEM
(a) Responsibility for accurate stocking and restocking of
an automated medication system lies with the pharmacist-manager and with any
pharmacist tasked with supervising such functions as specified in Subparagraph
(b)(2) of this Rule.
(b) The stocking or restocking of an automated medication
system, where performed by someone other than a pharmacist, shall follow one of
the following procedures to ensure correct drug selection:
(1) A pharmacist shall conduct and document a
daily audit of drugs placed or to be placed into an automated medication system
by a pharmacy technician, which audit may include random sampling.
(2) A bar code verification, electronic
verification, or similar verification process shall be utilized to assure
correct selection of drugs placed or to be placed into an automated medication
system. The utilization of a bar code, electronic, or similar verification
process shall require an initial quality assurance validation, followed by a
quarterly quality assurance review by a pharmacist. When a bar code
verification, electronic verification, or similar verification process is
utilized as specified in this section, stocking and restocking functions may be
performed by a pharmacy technician or by a registered nurse trained and
authorized by the pharmacist-manager.
(c) The pharmacist performing the quality assurance review
shall maintain a record of the quality assurance process that occurred and the
pharmacist approval of the drug stocking, restocking or verification process.
(d) Medication Reuse. Any drug that has been removed from
the automated medication system shall not be replaced into the system unless:
(1) the drug's purity, packaging, and labeling
have been examined according to policies and procedures established by the
pharmacist-manager to determine that reuse of the drug is appropriate; or
(2) specific drugs, such as multi-dose vials,
have been exempted by the Multidisciplinary Committee.
History Note: Authority G.S. 90-85.6; 90-85.32;
90-85.33;
Eff. February 1, 2005;
Amended Eff. December 1, 2013.
21 NCAC 46 .3405 CENTRALIZED AUTOMATED MEDICATION
SYSTEMS
21 NCAC 46 .3406 QUALITY ASSURANCE PROGRAM
21 NCAC 46 .3407 RECORD KEEPING
21 NCAC 46 .3408 COMPLIANCE
History Note: Authority G.S. 90-85.6; 90-85.32;
90-85.33;
Eff. February 1, 2005;
Repealed Eff. December 1, 2013.
SECTION .3500 – CONTROLLED SUBSTANCES REPORTING SYSTEM
21 NCAC 46 .3501 REPORTS FROM THE CONTROLLED
SUBSTANCES REPORTING SYSTEM
The Department of Health and Human Services may submit a
report to the Board of Pharmacy if it receives information that the Department
of Health and Human Services believes provides a basis to investigate whether a
pharmacy, pharmacist or technician has dispensed prescriptions for controlled
substances in a manner that may violate laws governing the dispensing of
controlled substances or the practice of pharmacy.
History Note: Authority G.S. 90-85.6; 90-85.12;
90-113.74;
Eff. March 1, 2014.
