Current through Register Vol. 49, No. 2, February 2024
1. The
Arkansas State Board of Pharmacy shall consist of six pharmacist members as
provided by Arkansas Stats.
17-97-201(a)
(1) and 17-91-201(d) plus a consumer member
and a senior Citizen consumer member as provided by Arkansas Stats.
17-91-201(a)(2). The qualifications, powers, and duties of the Board shall be
those enumerated by the provisions of Arkansas Stats. 17-91-201 through
17-91-208. ( 10-9-80, Revised 6/20/91)
5. Any person, corporation or partnership
operating a pharmacy in this state desiring to continue such operation must pay
a fee for a permit as established by law and/or regulation. If said fee is not
paid on or before February 1st of any year, a penalty of $20 shall be levied
for each month the pharmacy permit fee is delinquent. If said permit fee is
unpaid by April 1st of any year, the licensed pharmacy shall be expunged from
the records of the State Board of Pharmacy, and the owner and/or pharmacist in
charge thereof shall, within thirty days, remove all drug signs and legally
dispose of all prescription legend drugs. (10/9/80, amended 6/13/85, amended
6/20/91)
6. No owner or owners of a
drugstore, apothecary, pharmacy, etc., should allow any of its employees to
profess to the public in any manner that they are a licensed pharmacist when
they are not licensed. (10/9/80, amended 6/20/91)
9. A., F. 4. k. 3. add:
Each hospital pharmacy shall have available for personal and patient
use a current copy of the U.S.P. DI 3 book set including "Drug Information for
the Healthcare Professional" (2 volumes) and "Advice for the Patient" (1
volume), or the two volume set "Facts and Comparisons" (1 volume) and Patient
Drug Facts" (1 volume).
12.
A. Satisfactory proof of graduation and
receipt of the first professional undergraduate degree from a college of
pharmacy which has been approved by the Board of Pharmacy; or satisfactory
proof of graduation from a foreign college of pharmacy, completion of a
trans-script verification program, successful completion of a college of
pharmacy equivalency exam program equivalent to graduation from a Board of
Pharmacy approved College of Pharmacy, and a minimum score of 550 on the Test
of English as a Foreign Language (TOEFL) within two years of the completion of
the College of pharmacy equivalency exam.
B. Applicants will apply to the Board of
Pharmacy for an application blank which must be completed and returned to the
Board of Pharmacy office together with the fee of $25 plus cost of the exam as
determined by the Board, not less than 30 days before the examination is
scheduled.
D. Examination will be
held at the time and place set by the Board of pharmacy, and each applicant
will be notified in advance.
Upon the receipt of certification of the requirements as defined in
section A. of this regulation, and receipt of an application for examination
for licensure by the Board of Pharmacy, such applicant may practice pharmacy in
the State of Arkansas temporarily until such time as the first meeting of the
Board of Pharmacy for examination for licensure as a pharmacist.
The granting of the temporary permission to practice pharmacy upon such
certification, shall in no way entitle the recipient thereof to any rights of
tenure or permanent license and is purely discretionary and gratuity by the
Board.
E. The test or tests
shall be graded and reported, and a reported score of 75 or above is considered
passing.
19.
A. In order to provide for the protection of
the public health and safety, drug products which are offered for sale by, or
stored at the premises of any manufacturer, distributor, wholesaler, or
pharmacy located in Arkansas must have an approved new drug application (NDA)
or abbreviated new drug application (ANDA) disignation by the Federal Food and
Drug Administration pursuant to 21 USC 355 unless they are exempt from the
requirements for such a designation.
In order to protect the public health and safety, drug products offered
for sale by-or stored at the premises of-a manufacturer, wholesaler,
distributor, or pharmacy location in Arkansas which do not have the required
NDA or ANDA, or exemption therefrom referenced in the above paragraph, are
hereby declared to be contraband and subject to surrender to and destruction by
the Arkansas State Health Department.
B. Whenever it is made to appear to the Board
that any licensee of the Arkansas State Board of Pharmacy is in possession of a
stock of drugs which are contraband as defined above, a representative of the
Board shall confirm with the Federal Food and Drug Administration, by
telephone, that the particular drug or drugs involved do not have the required
NDA or ANDA and that they are not exempt from this requirement. Upon receipt of
this confirmation, the Board shall inform the owner, or person in charge, of
the contraband status of the drugs in question.
C. Retention, dispensing, promotion, or
advertisement of drug products by a licensee of the Board of Pharmacy, either
at their business premises or at any separate storage facility after
notification of their contraband status, shall constitute a direct and
immediate 'danger to the public health and safety and will be good and
sufficient cause for the suspension or revocation of any license issued by the
Board of Pharmacy and will also constitute good and sufficient cause for
revocation of any license issued by the Board of Pharmacy for knowingly
retaining, dispensing, promoting, or advertising any drug products which are
contraband under this regulation.
This suspension or revocation would occur only after proper hearings
are held by the Board of Pharamcy. (10/14/81, revised 6/20/91)
20. All certificates of
licensure issued by the Arkansas State Board of Pharmacy shall expire on the
31st day of December, following the date of issuance of the same. Every
licensed pharmacist engaged in the active practice of pharmacy shall pay to the
Board of Pharmacy annually, between January 1st and January 31st a minimum
renewal fee of $50. If the renewal fee for any pharmacist certificate be unpaid
by the first day of February of any year, the holder thereof must pay a penalty
of $20 for each month thereafter, provided, that if the renewal be unpaid by
April 1st of any year, such certificate shall be null and void, and the holder
thereof must be reinstated as a licensed pharmacist by satisfying the State
Board of Pharmacy that he is of the same moral character and temperate habits
as was required at the time of the original registration, and satisfy the Board
of Pharmacy that he is competent and qualified to compound and fill
prescriptions, and must pay a reinstatement fee of fifty dollars ($50) for each
delinquent year up to a maximum of two hundred dollars ($200) plus the current
year's renewal fee of fifty dollars ($50). (10/9/80, amended 10/14/81, Act of
1985, 6/20/91)
21. The Arkansas
State Board of Pharmacy shall meet the second Tuesday in February, the Second
Tuesday in June, and the second Tuesday in October of each year-unless changed
and announced in advance by the Board of Pharmacy. Examination of candidates
for licensure to practice pharmacy shall be on dates, time, and place as
determined by the Board of Pharmacy. (10/9/80, amended 6/20/91)
22. Every location holding a retail/wholesale
prophylactic license issued by the Board including pharmacies shall cause
periodic inspection and tests of prophylactics and contraceptives in order to
determine their condition and shall report damaged or inferior merchandise to
the Inspector of the Board of Pharmacy.
The Inspector of the Arkansas State Board of Pharmacy shall have free
access to inspect and test all prophylactics and contraceptives. And any such
merchandise considered to be out-dated, not properly labeled, or inferior in
any way, must be disposed of and cannot be sold, in order to protect the health
and welfare of the general public. (10/9/80, amended 6/20/91)
23. Every licensed pharmacist or intern who
shall fill or refill a prescription, shall attest that he has personally filled
said prescription by placing upon said prescription his signature with date
thereof.
All drustores or pharmacies must have on duty an Arkansas Licensed
Pharmacist a minimum of 40 hours per week. The said 40 hours per week must be
served by a single person and cannot be met by a combination of weekly hours or
two or more pharmacist with less than 40 hours each. (10/9/80, amended
10/14/81, 6/20/91)
27.
A. (2). Graduate Intern-An intern who has
graduated or completed requirements for examination as set forth in Regulation
12 A.
B. GRADUATION: Certification
from a Board-approved College of Pharmacy that the student has fulfilled all
requirements for graduation or has completed all foreign pharmacist
requirements as set forth in Regulation 12 A.
E. 2. All students accepted by and enrolled
as a student in the University of Arkansas College of Pharmacy shall be
licensed as an intern.
All students enrolled in Colleges of Pharmacy outside Arkansas shall
license as an intern in Arkansas prior to any participation in the practice of
Pharmacy as defined in
17-91-101,
17-91-301, and 17-91-307.
Provided that any licensed intern shall not participate in the practice
of Pharmacy as defined in
17-91-101,
17-901-301, and 17-91-307, until said intern has successfully completed the
first professional year on a 2-3 or 2-4 program of study or the second
professional year on a 1-4 program of study in a school or college of -pharmacy
approved by the Arkansas Board of Pharmacy. The intern license remains valid as
long as the intern maintains active student status in a Board-approved College
of Pharmacy and for one year (12 calendar months) after graduation from a
College of Pharmacy or completion of foreign pharmacist requirements as set
forth in Regulation 12 A. At this time, the intern license becomes void. The
graduate intern may not practice pharmacy until approval by the Board of
Pharmacy has been granted and another license as an intern in Arkansas has been
granted.
6. The Arkansas State Board
of Pharmacy examination will be offered upon graduation and proof of
participation in an approved extern clerkship program in a school curriculum,
or proof of completion of foreign pharmacist requirements as set forth in
Regulation 12 A.
7. After proving
eligibility to sit for the Board Examination, the candidate may practice
pharmacy in the State of Arkansas under limited supervision in a Class A
pharmacy. Failure to make a passing grade on the examination will reduce the
applicant to extern status for further training under the personal and physical
supervision of an assigned Preceptor or Alternate Preceptor.
RULES APPLYING TO PRECEPTOR:
9. Remove last paragraph. (Leave rest of
9.)
28.
A. Applications for pharmacy permits other
than annual renewal of existing permits, will be considered by the Board at any
meeting of the Board, and applications to be considered must be received in the
Board of Pharmacy office at least 14 days prior to the next scheduled meeting.
Provided that no store may open for business within thirty (30) days of
submission of original application. Applications for a pharmacy permit for a
new store must have the name and license number of the pharmacist in charge at
the time of submission and cannot be altered within 14 days of the
consideration meeting day. The pharmacist in charge of the new store
application cannot be the pharmacist in charge of another store at the time of
the meeting that the new store application is heard.
42. WHOLESALE DRUG DISTRIBUTORS REGULATION
A. DEFINITIONS. As used in this Regulation,
unless the context otherwise requires.
1.
'Board' means the Arkansas State Board of Pharmacy;
2. 'Person' includes individual, partnership,
corporation, business firm and association;
3. 'Controlled substance' means those
substances, drugs, or immediate precursors listed in Schedules I through VI of
the Uniform Controlled Substances Act,
5-64-101 et seq., and
revised by the coordinator pursuant to his authority under
5-64-214
-
5-64-216;
4.
a.
'Legend drug' means a drug limited by the federal Food, Drug, and
Cosmetic Act to being dispensed by or upon a medical practitioner's
prescription because the drug is:
i.
Habit-forming;
ii. Toxic or having
potential for harm;
iii. Limited in
its use to use under a practitioner's supervision by the new drug application
for the drug.
b. The
product label of a legend drug is required to contain the statement "CAUTION;
FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION."
c. A legend drug includes prescription drugs
subject to the requirement of the federal Food, Drug, and Cosmetic Act which
shall be exempt if certain specified conditions are met.
5. 'Prescription drug' means controlled
substances, legend drugs and veterinary legend drugs as defined
herein.
6. 'Blood' means whole
blood collected from a single donor and processed either for transfusion or
further manufacturing.
7. 'Blood
component' means that part of blood separated by physical or mechanical
means.
8. 'Manufacturer' means
anyone who is engaged in manufacturing, preparing, propagating, compounding,
processing, packaging, repackaging, or labeling of a prescription
drug.
9. 'Wholesale distribution'
means the distribution of prescription drugs to persons other than consumers or
patients, but does not include:
a.
Intracompany sales;
b. The purchase
or other acquisition by a hospital or other health care entity that is a member
of a group purchasing organization or from other hospitals or health care
entities that are members of such organizations;
c. The sale, purchase or trade of a drug or
an offer to sell, purchase, or trade a drug by a charitable organization
described in Section
501(c)(3) of the
federal Internal Revenue Code to a nonprofit affiliate of the organization to
the extent otherwise permitted by law;
d. The sale, purchase, or trade of a drug or
an offer to sell, purchase, or trade a drug among hospitals or other health
care entities that are under common control; for the purposes of this
regulation 'common control' means the power to direct or cause the direction of
the management and policies of a person or an organization whether by ownership
of stock or voting rights, by contract or otherwise;
e. The sale, purchase, or trade of a drug or
an offer to sell, purchase, or trade a drug for emergency medical reasons, for
purposes of this regulation, 'emergency medical reasons' includes transfers of
prescription drugs by a retail pharmacy or a hospital pharmacy to a hospital
pharmacy or a retail pharmacy to alleviate a temporary shortage;
f. The sale, purchase, or trade of a drug;
and offer to sell, purchase, or trade a drug; or the dispensing of a drug
pursuant to a prescription;
g. The
distribution of drug samples by manufacturers' representatives or distributors'
representatives; or
h. The sale,
purchase or trade of blood components intended for transfusion.
10. 'Wholesale distributor' means
any person engaged in wholesale distribution of prescription drugs, including
but not limited to manufacturers; repackers' own-label distributors; private
label distributors; jobbers; brokers; warehouses, including manufacturers' and
distributors' warehouses, chain drug warehouses, and wholesale drug warehouses;
independent wholesale drug traders; prescription drug repackagers; physicians;
dentists, veterinarians; birth control and other clinics; individuals;
hospitals; nursing homes and their providers; health maintenance organizations
and other health care providers; and retail and hospital pharmacies that
conduct wholesale distributions. A wholesale drug distributor shall not include
any for-hire carrier or person or entity hired solely to transport prescription
drugs.
11. 'Drug sample' means a
unit of a prescription drug that is not intended to be sold and is intended to
promote the sale of the drug.
12.
'Veterinary legend drugs' means drugs defined in
21 CFR 201.105
and bearing a label required to bear the cautionary statement, "CAUTION:
FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED
VETERINARIAN."
B. SALES
PERMIT REQUIRED. It shall be unlawful for any person to sell or offer for sale
by advertisement, circular, letter, sign, or oral solicitation or any other
means any prescription drug unless the person holds and possesses a permit
authorizing such sale as provided by this regulation.
C. WHOLESALE DISTRIBUTOR-PERMIT REQUIRED.
1. Every wholesale distributor who shall
engage in the wholesale distribution of prescription drugs, to include without
limitation, manufacturing in this state, shipping into this state or selling or
offering to sell in this state, shall register annually with the Arkansas State
Board of Pharmacy by application for a permit on a form furnished by the Board
and accompanied by a fee of two hundred dollars ($200). The Board may require a
separate license for each facility directly or indirectly owned or operated by
the same business entity within this state, or for a parent entity with
divisions, subdivisions, subsidiaries, and/or affiliate companies within this
state when operations are conducted at more than one (1) location and there
exists joint ownership and control among all the entities.
2.
a.
The permit may be renewed annually at a renewal permit fee of one
hundred dollars ($100).
b.
All permits issued under this section shall expire on December 31 of each
calendar year.
c. Each application
for the renewal of the permit must be made on or before December 31 of each
year, a penalty of twenty dollars ($20) per month from February 1 of any year
will by charged, provided that if the renewal is unpaid by April 1 of any year,
the license shall be null and void.
3. Each permit issued hereunder shall be
displayed by the holder thereof in a conspicuous place.
D. WHOLESALE DISTRIBUTORS-SHIPMENT TO CERTAIN
LICENSED PROFESSIONALS.
1. All wholesale
distributors must, before shipping to a recipient in this state any
prescription drug as defined in this regulation, ascertain that the person to
whom shipment is made is either a licensed physician licensed by the Arkansas
State Medical Board, a licensed Doctor of Dentistry, a licensed Doctor of
Veterinary Medicine, a licensed Doctor of Podiatry Medicine, a hospital
licensed by the State Board of Health, a licensed wholesale distributor as
defined in this regulation, a licensed pharmacy licensed by the Arkansas State
Board of Pharmacy, or other entity authorized by law to purchase or possess
prescription drugs.
2. No wholesale
distributor shall ship any prescription drug to any person after receiving
written notice from the board or other state or federal agency that the person
no longer holds a registered pharmacy permit or is not a licensed physician,
dentist, veterinarian or hospital.
E. MINIMUM REQUIRED INFORMATION FOR
LICENSURE.
1. The Arkansas Board of Pharmacy
requires the following from each wholesale drug distributor as part of the
initial licensing procedure and as part of any renewal of such license:
a. The name, full business address, and
telephone number of the licensee;
b. All trade or business names used by the
licensee;
c. Addresses, telephone
numbers, and the names of contact persons for the facility used by the license
for the storage, handling, and distribution of prescription drugs;
d. The type of ownership or operation (i.e.
partnership, corporation, or sole proprietorship); and e. The name(s) of the
owner and/or operator of the licensee, including:
i. If a person, the name of the
person;
ii. If a partnership, the
name of each partner, and the name of the partnership;
iii. If a corporation, the name and title of
each corporate officer and director, the corporate names, and the name of the
State of incorporation, and the name of the parent company, if any;
iv. If a sole proprietorship, the full name
of the sole proprietor and the name of the business entity.
2. Where operations are
conducted at more than one location by a single wholesale distributor, each
such location shall be licensed by the Arkansas Board of Pharmacy.
3. Changes in any information in this
regulation shall be submitted to the Arkansas Board of Pharmacy within 30 days
after such change.
F.
MINIMUM QUALIFICATIONS.
1. The Arkansas Board
of Pharmacy will consider the following factors in determining eligibility for
licensure of persons who engage in the wholesale distribution of prescription
drugs:
a. Any convictions of the applicant
under any Federal, State, or local laws relating to drug samples, wholesale or
retail drug distribution, or distribution of controlled substances;
b. Any felony convictions of the applicant
under Federal, State, or local laws;
c. The applicant's past experience in the
manufacture or distribution of prescription drugs, including controlled
substances;
d. The furnishing by
the applicant of false or fraudulent material in any application made in
connection with drug manufacturing or distribution;
e. Suspension or revocation by Federal,
State, or local government of any license currently or previously held by the
applicant for the manufacture or distribution of any drugs, including
controlled substances;
f.
Compliance with licensing requirements under previously granted licenses, if
any;
g. Compliance with the
requirements to maintain and/or make available to the State licensing authority
or to Federal, -State, or local law enforcement officials those records
required to be maintained by wholesale drug distributors;
h. Any other factors or qualifications the
Arkansas Board of Pharmacy considers relevant to and consistent with the public
health and safety.
2.
The Arkansas Board of Pharmacy reserves the right to deny a license to an
applicant if it determines that the granting of such a license would not be in
the public interest.
G.
PERSONNEL
The licensed wholesale distributor shall employ adequate personnel with
the education and experience necessary to safely and lawfully engage in the
wholesale distribution of drugs.
H. MINIMUM REQUIREMENTS FOR THE STORAGE AND
HANDLING OF PRESCRIPTION DRUGS AND FOR THE ESTABLISHMENT AND MAINTENANCE OF
PRESCRIPTION DRUG DISTRIBUTION RECORDS.
The following are required for the storage and handling of prescription
drugs, and for the establishment and maintenance of prescription drug
distribution records by wholesale drug distributors and their officers, agents,
representatives, and employees.
1.
Facilities. All facilities at which prescription drugs are stored, warehoused,
handled, held, offered, marketed or displayed shall:
a. Be of suitable size and construction to
facilitate cleaning, maintenance, and proper operations;
b. have storage areas designed to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
c. Have a designated and clearly identified
area for storage of prescription drugs that are outdated, damaged,
deteriorated, misbranded, or adulterated, or that are in immediate or sealed
secondary containers that have been opened;
d. Be maintained in a clean and orderly
condition; and
e. Be free from
infestation by insects, rodents, birds, or vermin of any kind.
2. Security.
a. All facilities used for wholesale drug
distribution shall be secure from unauthorized entry.
i. Access from outside the premises shall be
kept to a minimum and be well-controlled.
ii. The outside perimeter of the premises
shall be well-lighted.
iii. Entry
into areas where prescription drugs are held shall be limited to authorized
personnel.
b. All
facilities shall be equipped with an alarm system to detect entry after
hours.
c. All facilities shall be
equipped with a security system that will provide suitable protection against
theft and diversion. When appropriate, the security system shall provide
protection against theft or diversion that is facilitated or hidden by
tampering with computers or electronic records.
3. Storage. All prescription drugs shall be
stored at appropriate temperatures and under appropriate conditions in
accordance with requirements, if any in the labeling of such drugs with
requirement in the current edition of an official compendium.
a. If no storage requirements are established
for a prescription drug, the drug may be held at "controlled" temperature, as
defined in an official compendium, to help ensure that its identity, strength,
quality, and purity are not adversely affected.
b. Appropriate manual, electromechanical, or
electronic temperature and humidity recording equipment, devices, and/or logs
shall be utilized to document proper storage of prescription drugs.
c. The recordkeeping requirements in
paragraph 6 of this section shall be followed for all stored drugs.
4. Examination of materials.
a. Upon receipt, each outside shipping
container shall be visually examined for identity and to prevent the acceptance
of contaminated prescription drugs or prescription drugs that are otherwise
unfit for distribution. This examination shall be adequate to reveal container
damage that would suggest possible contamination or other damage to the
contents.
b. Each outgoing shipment
shall be carefully inspected for identity of the prescription drug products and
to ensure that there is no delivery of prescription drugs that have been
damaged in storage or held under improper conditions.
c. The recordkeeping requirements in
paragraph 6 of this section shall be followed for all incoming and outgoing
prescription drugs.
5.
Returned, Damaged, and Outdated Prescription Drugs.
a. Prescription drugs that are outdated,
damaged, deteriorated, misbranded, or adulterated shall be quarantined and
physically separated from other prescription drugs until they are destroyed or
returned to their supplier.
b. Any
prescription drugs whose immediate or sealed outer or sealed secondary
containers have been opened or used shall be identified as such, and shall be
quarantined and physically separated from other prescription drugs until they
are either destroyed or returned to the supplier.
c. If the conditions under which a
prescription drug has been returned cast doubt on the drug's safety, identity,
strength, quality, or purity, then the drug shall be destroyed, or returned to
the supplier, unless examination, testing or other investigation proves that
the drug meets appropriate standards of safety, identity, strength, quality,
and purity. In determining whether the conditions under which a drug has been
returned cast doubt on the drug's safety, identity, strength, quality, or
purity, the wholesale drug distributor shall consider, among other things, the
conditions under which the drug has been held, stored, or shipped before or
during its return and the condition of the drug and its container, carton, or
labeling, as a result of storage of shipping.
d. The recordkeeping requirements in
paragraph 6 of this section shall be followed for all outdate, damaged,
deteriorated, misbranded, or adulterated prescription drugs.
6. Recordkeeping.
a. Wholesale drug distributors shall
establish and maintain inventories and records of all transactions regarding
the receipt and distribution or other disposition of prescription drugs. These
records shall include the following information.
i. The source of the drugs, including the
name and principal address of the seller or transferor, and the address of the
location from which the drugs were shipped;
ii. The identity and quantity of the drugs
received and distributed or disposed of, and
iii. The dates of receipt and distribution or
other disposition of the drugs.
b. Inventories and records shall be made
available for inspection and photocopying by any official authorized by the
Arkansas Board of Pharmacy for a period of two years following disposition of
the drugs.
c. Records described in
this regulation that are kept at the inspection site or that can be immediately
retrieved by computer or other electronic means shall be readily available for
authorized inspection during the retention period. Records kept at a central
location apart from the inspection site and not electronically retrievable
shall be made available for inspection within two working days of a request by
any official authorized by the Arkansas Board of Pharmacy.
I. WRITTEN POLICIES AND
PROCEDURES.
Wholesale drug distributors shall establish, maintain, and adhere to
written policies and procedures, which shall be followed for the receipt,
security, storage, inventory, and distribution of prescription drugs, including
policies and procedures for identifying, recording, and reporting losses or
thefts, and for correcting all errors and inaccuracies in inventories.
Wholesale drug distributors shall include in their written policies and
procedures the following:
A. A
procedure whereby the oldest approved stock of a prescription drug product is
distributed first. The procedure, may permit deviation from this requirement if
such deviation is temporary and appropriate.
B. A procedure to be followed for handling
recalls and withdrawals of prescription drugs. Such procedure shall be adequate
to deal with recalls and withdrawals due to:
1. Any action initiated at the request of the
Food and Drug Administration or other Federal, State, or local law enforcement
of other government agency, including the Arkansas Board of Pharmacy;
2. Any voluntary action by the manufacturer
to remove defective or potentially defective drugs from the market;
or
3. Any action undertaken to
promote public health and safety by replacing of existing merchandise with an
improved product or new package design.
C. A procedure to ensure that wholesale drug
distributors prepare for, protect against, and handle any crisis that affects
security or operation of any facility in the event of strike, fire, flood, or
other natural disaster, or other situations of local, State, or national
emergency.
D. A procedure to ensure
that any outdated prescription drugs shall be segregated from other drugs and
either returned to the manufacturer or destroyed. This procedure shall provide
for written documentation of the disposition of outdated prescription drugs.
This documentation shall be maintained for two years after disposition of the
outdated drugs.
J.
RESPONSIBLE PERSONS.
Wholesale drug distributors shall establish and maintain lists of
officers, directors, managers, and other persons in charge of wholesale drug
distribution, storage, and handling, including a description of their duties
and a summary of their qualifications.
K. COMPLIANCE WITH FEDERAL, STATE, AND LOCAL
LAWS.
Wholesale drug distributors shall operate in compliance with applicable
Federal, State, and local laws and regulations.
Wholesale drug distributors that deal in controlled substances shall
register with the appropriate State Controlled substance authority and with the
Drug Enforcement Administration (DEA), and shall comply with all applicable
State, local, and DEA regulations.
L. SALVAGING AND REPROCESSING.
Wholesale drug distributors shall be subject to the provisions of any
applicable Federal, State, or local laws or regulations that relate to
prescription drug product salvaging or reprocessing, including Chapter
21,
parts 207, 210d, 211 of the Code of Federal Regulations.
M. APPLICABILITY.
Nothing in this regulation shall apply to the sale of chemicals or
poisons for use for nonmedical purposes or for uses as insecticides or
biologies or medicine used for the cure, mitigation, or prevention of disease
of animals or fowl or for agricultural uses which comply with the requirements
of the federal Food, Drug, and Cosmetic Act and all amendments thereto UNLESS
THOSE PRODUCTS ARE PRESCRIPTION DRUGS UNDER THIS REGULATION.
N. INSPECTION OF PREMISES AND RECORDS.
The Board may conduct inspections upon all premises, including delivery
vehicles, purporting or appearing to be used by a person licensed under this
regulation. The Board, in its discretion, may accept a satisfactory inspection
by the United States Food and Drug Administration (USFDA) or a state agency of
another state which the Board determines to be comparable to that made by USFDA
or the Arkansas Board of Pharmacy.
49. The Arkansas State Board of Pharmacy
participates in the National Association of Boards of Pharmacy Score Transfer
Program. The Score Transfer Program requires the applicant, or test candidate,
to submit a NABPLEX Score Transfer Form either before the administration date
of NABPLEX or within seven (7) days after the examination and fulfill other
state requirements for licensure in the state to which the scores are
transferred for licensure by examination in that state. Score Transfer Forms
will be available, upon request, from the Board of Pharmacy office.
If a candidate takes NABPLEX in another participating state, properly
transfers the score to Arkansas, and completes other requirements for
licensure, Arkansas will license the applicant by the examination
process.
The Arkansas Board will provide information related to states
participating, NABP fees, and Arkasnas fees.
50. ARKANSAS PHARMACY SUPPORT GROUP
A. Definitions. As used in this
(1) "Board" means the Arkansas State Board of
Pharmacy;
(2) "Board-approved
intervenors" means persons trained in intervention and designated by the Board
to implement the intervention process when necessary;
(3) "Committee" means a committee appointed
by the Board to formulate and administer the impaired pharmacists
program;
(4) "Impaired pharmacist"
means a pharmacist who is unable to practice pharmacy with reasonable skill,
competency, or safety to the public because of substance abuse;
(5) "Impaired pharmacist program" means a
plan approved by the Board for intervention, treatment and rehabilitation of an
impaired pharmacist;
(6)
"Intervention" means a process whereby an alleged impaired pharmacist is
confronted by the Board or Board-approved intervenors who provide documentation
that a problem exists and attempt to convince the pharmacist to seek evaluation
and treatment;
(7) "Rehabilitation"
means the process whereby an impaired pharmacist advances in an impaired
pharmacists program to an optimal level of competence to practice pharmacy
without endangering the public; and
(8) "Verification" means a process whereby
alleged professional impairment is identified or established.
B. Administration.
(a) The Board may appoint a committee to
organize and administer a program that shall fulfill two (2) functions:
(1) the program shall serve as a diversion
program to which the Board may refer licensees where appropriate in lieu of or
in addition to other disciplinary action; and
(2) the program shall also be a source of
treatment or referral for pharmacists who, on a strictly voluntary basis,
desire to avail themselves of its services.
(b) The Board may appoint a committee of five
(5) persons who are recovering pharmacists to serve three (3) year terms with
the initial members appointed to staggered terms.
(c) The Board will consider recommendations
from the Arkansas Pharmacy Support Group in making these appointments and any
person appointed to the Committee shall continue appointment based on continued
involvement in the Pharmacy Support Group.
C. Functions. The functions of the committee
shall include:
(1) evaluation of pharmacists
who request participation in the program;
(2) review and designation of treatment
facilities and services to which pharmacists in the program may be
referred;
(3) receipt and review of
information relating to the participation of pharmacists in the
program;
(4) assisting the
pharmacists' professional association in publicizing the program; and
(5) preparation of reports for the
Board.
D. Board
Referral.
(a) The Board shall inform each
pharmacist referred to the program by Board action of the procedures followed
in the program, of the rights and responsibilities of the pharmacist in the
program and of the possible consequences of noncompliance with the
program.
(b) The Board shall be
informed of the failure of a pharmacist to comply with any treatment provision
of program if the committee determines that the resumption of the practice of
pharmacy would pose a threat to the health and safety of the public.
(c) Participation in a program under this
section shall not be a defense to any disciplinary action which may be taken by
the Board. Further, no provision of this section shall preclude the Board from
commencing disciplinary action against a licensee who is terminated from a
program pursuant to this section.
(d) The Board shall be informed when
pharmacists who enter the program resume professional practice.
E. Review Activities. The Board
shall review the activities of the committee. As part of this evaluation, the
Board may review files of all participants in the impairment program. The Board
shall also resolve complaints voiced regarding the impaired pharmacists
program.
F. Civil Liability.
(a) All persons acting on behalf of the Board
in the impaired pharmacists program under this section shall be considers
"committee" and "behalf of the Board" and considered officers or employees of
the state.
(b) All patient records
shall be confidential and shall not be subject to public inspection except
pursuant to an order of a court of competent jurisdiction. However, the records
may be introduced as evidence in any relevant proceedings before the Board and
shall be produced upon Board request.
G. Funding. The Board is authorized to
provide up to five thousand dollars ($5,000) per year to the committee for
expenses incurred in management and operation of the program. Documentation of
the use of these funds shall be provided to the Board of Pharmacy for review
and comment.
Expenses considered for reimbursement by the Board shall be in the
areas of travel as determined by the Board, phone or other necessary
communication expenses, secretarial help, postage, food when traveling out of
town of residence and acting on behalf of the Pharmacy Support Group other than
meetings not to exceed $13.00 per day-unless specifically approved by the
Board, limited meeting room costs and other expenses deemed appropriate by the
"committee". Meal expense may be paid without an overnight stay.
It is recognized that the Board will also consider special and specific
requests for expenses to cover costs related to education or ability
enhancement of committee or intervenor members to improve the Group or better
serve the Group.
