Section .0100 ‑ Organization Of The Board

Link to law: http://reports.oah.state.nc.us/ncac/title 21 - occupational licensing boards and commissions/chapter 46 - pharmacy/chapter 46 rules.html
Published: 2015

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
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Repealed Eff.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Repealed Eff.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.