Current through Register Vol. 49, No. 2, February 2024
REGULATION 59
: FEES.
The fees charged by the Arkansas State Board of Pharmacy for the
various examinations, permits, licenses, certificates, and books issued by the
board shall be as follows:
(1) The fee
for examination to become a licensed pharmacist shall be twenty-five dollars
($25.00) plus the actual cost of the examination;
(2) The fee for a license as a licensed
pharmacist from another state by reciprocity (license transfer) shall be
two-hundred dollars ($200.00);
(3)
The fee for the initial license and renewal of a license as a licensed
pharmacist shall be fifty dollars ($50.00);
(4) The fee for issuance of a permit for the
first time to operate a pharmacy or drugstore shall be two-hundred dollars
($200.00);
(5) The fee for annual
renewal of a permit to operate a pharmacy or drugstore shall be one-hundred
dollars ($100.00);
(6) When there
is a change of ownership, a new permit must be obtained, and the fee shall be
one-hundred dollars ($100.00);
(7)
The fee for a certificate as a licensed pharmacist shall be ten dollars
($10.00);
(8) The fee for
certifying grades in connection with an application for reciprocity (license
transfer) shall be ten dollars ($10.00);
(9) The fee for issuance of, and annual
renewal of, a license as a wholesale dealer under the Arkansas Prophylactic
Law, § 20-63-101 et seq., shall be twenty-five dollars ($25.00);
(10) The fee for issuance of, and the annual
renewal of, a hospital pharmaceutical service permit shall be one-hundred
dollars ($100.00). The permit shall expire on December 31 of each
year;
(11) The fee for issuance of,
and the annual renewal of, an institutional pharmaceutical services permit
shall be twenty dollars ($20.00). The permit shall expire on December 31 of
each year;
(12) The fee for
issuance of, and the annual renewal of, a nursing home pharmacy consultant
permit shall be twenty dollars ($20.00). The permit shall expire on December 31
of each year;
(13) The fee for
intern licensure shall be twenty dollars ($20.00);
(14) The fee for change of pharmacist in
charge of any pharmacy, or change of consultant pharmacist in charge of any
institution shall be twenty-five dollars ($25.00);
(15) The fee for reinstatement of a
pharmacist licensure shall be fifty dollars ($50.00) for each delinquent year
up to a maximum of two-hundred dollars ($200.00) plus the fee for the current
year's license;
(16) The fee for
the Board of Pharmacy law book shall be twenty-five dollars ($25.00) except to
interns on initial licensure, and applicants for reciprocity, on a one-time
basis. A copy of each edition as revised shall be provided free to each
pharmacy permit holder;
(17) The
fee for a change of location inspection shall be one-hundred dollars
($100.00);
(18) The penalty for
late payment of renewal of a pharmacist, pharmacy, wholesaler distributor of
legend drugs and/or controlled substances, supplier of medical equipment,
legend devices, and/or medical gas, hospital pharmacy, institutional and
nursing home consultant permits shall be twenty dollars ($20.00) per month from
February 1, provided that if the renewal is unpaid by April 1 of any year, the
license shall be null and void;
(19) The fee for issuance of a Wholesale
Distributer of Legend Drugs and/or Controlled Substances permit shall be
two-hundred dollars ($200.00), and annual renewal shall be one-hundred dollars
($100.00), provided that if the renewal is unpaid by December 31, of any year,
the permit will expire. Penalties for late payment are defined in section
18 of
this regulation;
(20) The fee for
issuance of a permit to operate as a supplier of medical equipment, legend
devices, and/or medical gas shall be two-hundred dollars ($200), and annual
renewal shall be one-hundred dollars ($100), provided that, if the renewal is
unpaid by December 31 of any year, the permit will expire. Penalties for late
payment are defined in section
18 of
this regulation;
(21) The fee for
issuance of a temporary permit for pharmacist on active duty in a branch of the
armed forces shall be $25 and shall be administered as defined in regulation
13.
(22) The registration fee for a
pharmacy technician (pharmacist assistant) shall be $25.
(23) The fee for registration as a preceptor
shall be $20 every two years and shall expire on June 1 every other year.
All fees for examination for license shall be payable with the
application and shall not be subject to refund. All other fees are only
refundable if it is determined that there has been an overpayment.
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 as defined in regulation
59 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).
10. Any licensed Pharmacist whose certificate
has been lost or destroyed may procure a duplicate from the Arkansas State
Board of Pharmacy by filing an affidavit that said certificate has been lost or
destroyed, upon payment of a fee as defined in regulation 59.
(10/9/80)
13. Any person serving in
the armed forces within the State of Arkansas, who is a Licensed Pharmacist in
another state, may obtain a temporary permit to practice pharmacy in the State
of Arkansas by furnishing certified proof of his registration from the Board of
Pharmacy in his state of original registration, and the payment of a fee as
defined in regulation 59. This permit shall entitle the holder thereof to
practice in any store where an Arkansas Licensed Pharmacist is on duty a
minimum of 40 hours per week. The permit must be renewed at each succeeding
meeting of the Board. 10/09/80
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 as defined in regulation 59. 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 as defined in regulation 59 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 as defined in regulation 59 for each delinquent year up to
a maximum as defined in regulation 58 plus the current year's renewal fee.
10/09/80 (Revised 10/14/81, Act of 1985, and 6/20/91)
26. Hereafter no extern, intern, or student
of a pharmacy school shall be granted authority from this Board to practice
pharmacy in Arkansas and serve any internship period in Arkansas unless he is
licensed with the Arkansas State Board of Pharmacy and pays an intern licensure
fee as defined in regulation 59. The application for licensure
as an intern will be furnished by the Arkansas State Board of
Pharmacy.
27. The Board of Pharmacy
is charged with regulating the internship program made reference to in the
Arkansas Code §
17-92-301. The
Arkansas State Board of Pharmacy recognizes that in order to properly fulfill
its obligation to the profession of pharmacy and general welfare and protection
of the public health that it must implement and supervise an internship program
in the State of Arkansas.
From time to time, as is required to establish a viable internship
program, the Board will establish, publish, and disseminate criteria
establishing requirements and standards necessary, for qualifications for
licensure under Arkansas Code §
17-92-305,
§
17-92-307,
and Regulation 27.
Hereafter, every applicant for licensure by examination in Arkansas
must have 2,000 hours of acceptable internship training obtained after
beginning the professional college curriculum. Up to 1,500 hours of the
required 2,000 may be obtained in a training program as part of school
curriculum.
DEFINITIONS
A.
LICENSED INTERN: A person licensed by the Arkansas
State Board of Pharmacy, as a licensed Intern, and who is a student accepted by
and enrolled as a student in the University of Arkansas College of Pharmacy or
a student enrolled in an approved College of Pharmacy outside of Arkansas.
(1) Extern-An intern prior to graduation or a
graduate who has taken and failed the Board Exam.
(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.
C.
SUPERVISION: Shall mean that, in a pharmacy where
experience is being obtained, a certified Preceptor or Alternate Preceptor
supervises the practical experience with both personal and physical
supervision, and actually giving instruction to the Intern obtaining the
experience during the entire period of such experience.
D.
LIMITED
SUPERVISION: The pharmacist in a Class A pharmacy supervising a
Graduate Intern is within voice or telephone contact.
E.
CLASS A PHARMACY:
A pharmacy which has obtained at least 85 on its last Board inspection, and has
a pharmacy permit with a pharmacist on duty at least 40 hours per week.
(1) Any extern or intern receiving internship
training practice or experience in the State of Arkansas must be licensed as an
intern with the Arkansas State Board of Pharmacy. No credit for internship
training will be allowed prior to licensure as an intern. The intern licensure
application can be obtained from the office of the Board of Pharmacy. There is
a fee as defined in regulation 59 for licensure as an
intern.
(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 §
17-92-101,
§
17-92-301, and
§
17-92-307.
Provided that any licensed intern shall not participate in the practice
of Pharmacy as defined in §
17-92-101,
§
17-92-301, and
§
17-92-307,
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.
(3) The certificate of licensure as a
"licensed" intern must be displayed in the drugstore or pharmacy in which the
intern is being trained. Licensed interns shall not be left in sole charge of
the prescription department at any time. Violation of this regulation may
effect a cancellation of any and all internship toward licensure that may be
accrued by the pharmacy intern, and the revocation of the Preceptor's
certificate.
(4) For each pharmacy
setting where an intern practices pharmacy, the intern shall complete and file
with the Board of Pharmacy office, prior to any practice, a "Training Plan"
that is signed by the Preceptor pharmacist or supervising pharmacist (in the
case of a graduate intern) for that particular work situation. Such Training
Plan shall expire on May 1 of each year. At no time may a Preceptor supervise
more than one licensed intern.
(5)
Participation in a School or College of Pharmacy curriculum extern or clerkship
program, approved by the Board of Pharmacy, will be credited week for week
training.
(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.
(8) After presenting proof of 2,000 hours of
practical experience or training under Arkansas Board of Pharmacy approved
conditions, the intern may be designated as a candidate suitable for full
licensure if other conditions have been met.
Affidavits of one-year training must be submitted to the Board of
Pharmacy for full licensure, and can be obtained from the Board of Pharmacy
office.
Before permitting a student to participate in any way in the practice
of Pharmacy, the Preceptor must assure:
A. The Preceptor is licensed.
B. The Intern is currently
licensed.
C. The intern has filed a
current Training Plan. Reg. 27,4.b.) (Revised 6/22/84, 4/07/89, 6/20/91, and
4/10/92)
RULES APPLYING TO PRECEPTORS
The Arkansas internship training program requires that a pharmacist,
who has been duly certified by the Arkansas State Board of Pharmacy, may serve
as preceptor or alternate for an intern or extern.
The following requirements must be met to be certified by the State
Board of Pharmacy for serving as a Preceptor or Alternate:
1. Be an Arkansas Licensed Pharmacist
licensed for not less than two years and having been actively engaged in the
practice of Pharmacy for not less than two years immediately preceding the
application. One can be certified as an alternate without the two years
practice.
2. Be a full-time
pharmacist in a pharmacy which currently holds a Class A rating indicated by
the Inspection Sheet for pharmacies as outlined by the State Board of
Pharmacy.
3. For the initial
application as preceptor or alternate preceptor, the applicant must
satisfactorily complete a test on requirements and responsibilities of a
preceptor or alternate preceptor as developed and administered by the Board of
Pharmacy or its representatives.
4.
Have a pharmacy library (latest edition) which meets or exceeds the
requirements of the "Inspection Sheet" for pharmacies.
5. At least one preceptor from the internship
site shall be a member of an appropriate national pharmaceutical organization.
All preceptors and alternates shall be a member of at least one
professional state or national organization.
6. Must have not been convicted for any
violation of Arkansas Code §
17-92-311,
unless the Board officially grants exception.
7. Must have attended at least one
professional meeting during the previous calendar year.
8. Must agree to give immediate personal and
direct physical supervision to assigned intern. A preceptor or alternate cannot
supervise more than one intern at any specified time.
9. Renewal as a Preceptor or Alternate will
be required every two years by executive application and paying a fee as
defined in regulation
59.
Violation of any of the rules and requirements set forth above may
cause the Preceptor or Alternate to lose his certification as such, and may
also cause the intern to suffer loss of internship training credit. 10/09/80
(Revised 2/17/82, 12/12/86, 2/10/87, and 6/20/91)
29. When there
is a change of pharmacy permit for a change of ownership of the pharmacy and
the pharmacist in charge is changed, an inventory of all drugs now or hereafter
classified as Schedule 2, 3, 4, or 5, drugs under either Federal or State
Statutes shall be made by the Pharmacist in Charge and a copy of that inventory
signed by the Pharmacist in Charge shall be submitted with the application for
change of ownership and the fee for change of ownership as defined in
regulation
59. The inventory shall be made on the day the new
owner takes charge of the pharmacy.
When there is a change of pharmacy permit for a change of pharmacist in
charge, an inventory of all drugs now or hereafter classified as Schedule 2, 3,
4, or 5, drugs under either Federal or State Statutes will be made by the
exiting pharmacist in charge and a copy of that inventory signed by said
pharmacist shall be furnished to the Arkansas State Board of Pharmacy within
seven days after the pharmacist's last day to work at the pharmacy and a copy
left with the Controlled Substance Records of the Pharmacy. The new Pharmacist
in Charge as his first action in the pharmacy shall also inventory all drugs
now or hereafter classified as Schedule 2, 3, 4, or 5, drugs under Federal or
State Statutes and a copy of that inventory signed by the new Pharmacist in
Charge shall be provided to the Arkansas State Board of Pharmacy with the
application to change the pharmacy permit's Pharmacist in Charge.
It is acceptable and preferable if the inventory is made jointly by
both pharmacists, signed by both pharmacists, and supplied to the Arkansas
State Board of Pharmacy with the application for change of Pharmacist in
Charge.
Both copies of said inventory (exiting pharmacist and new pharmacist)
must be received by the Board before a new permit will be issued. 10/09/83
(Revised 6/25/80 and 6/20/96)
41. Out-of-State Pharmacies shall comply with
the following qualifications to be and remain licensed in Arkansas by the
Board.
1.
A. The pharmacy holds a current license in
good standing in the state(s) in which it is located.
B. Each pharmacist dispensing drugs into
Arkansas shall be licensed as a pharmacist in Arkansas or in the state where he
practices if that state has standards of licensure at least equivalent to those
of Arkansas.
2. A
pharmacist licensed in Arkansas or by the state where he practices having
standards of licensure at least equivalent to Arkansas standards shall be named
in the application as the pharmacy's contact person for communications by the
Board.
A. That pharmacist will be responsible
for receiving and maintaining publications distributed by the Board.
B. If at anytime the pharmacist so designated
shall leave the employment of the pharmacy or be absent from the pharmacy in
excess of 14 consecutive calendar days, the pharmacy shall promptly notify the
Board and designate another pharmacist to perform this function.
3. The Out-of-State Pharmacy shall
apply for licensure and renewal on forms approved by the Board. The Board may
require such information as reasonably necessary to carry out the provisions of
A.C.A. §
17-92-401,
including, without limitation, the name, address and position of each officer
and director of a corporation or of the owners if the pharmacy is not a
corporation.
Provided, however, the Board may grant an exemption from licensing
under A.C.A. §
17-92-401
upon application by any non-resident pharmacy which confines its dispensing
activity to isolated transactions. In determining whether to grant an
exemption, the Board shall consider:
(a) The number of prescriptions dispensed or
reasonably expected to be dispensed into Arkansas.
(b) The number of patients served or
reasonably expected to be served in Arkansas.
(c) Whether the pharmacy has promoted its
services in Arkansas.
(d) Whether
the pharmacy has a contract(s) with any employer(s) or organization(s) to
provide pharmacy services to employees or other beneficiaries in
Arkansas.
(e) Medical
necessity.
(f) The effect on the
health and welfare of persons in Arkansas.
(g) Any other relevant matters.
4. The pharmacy shall pay an
annual license fee as defined in regulation 59.
5. The pharmacy shall maintain records of
drugs dispensed to Arkansas addresses in such a manner so as to be readily
retrievable upon request. Said records shall be made available for inspection
by the Board or by Arkansas law enforcement authorities.
6. The pharmacy shall timely respond to any
request for information from the Board or law enforcement
authorities.
7. The pharmacy shall
maintain an incoming toll free telephone number for use by Arkansas customers
to be answered by a pharmacist with access to patient records. This service
shall be available a minimum of 40 hours a week, six days per week during
normal business hours. This telephone number plus others available for use
shall be printed on each container of drugs dispensed into Arkansas. The toll
free number shall have sufficient extensions to provide reasonable access to
incoming callers.
8. Generic drugs
shall be dispensed into Arkansas pursuant to the Arkansas Generic Substitution
Act; provided, however, nothing herein shall be construed to mandate that an
Out-of-State Pharmacy comply with the Arkansas Generic Substitution Act if such
compliance would cause the Out-of-State Pharmacy to violate the Generic
Substitution Act of the state wherein the facility of the dispensing
Out-of-State Pharmacy is located.
9. The facilities and records of the 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
using similar standards of the state where the pharmacy is located.
10. Each Out-of-State Pharmacy doing business
in Arkansas by dispensing and delivering or causing to be delivered
prescription drugs to Arkansas consumers shall designate a resident agent in
Arkansas for service of process.
11. Each Out-of-State Pharmacy doing business
in Arkansas shall comply with Board of Pharmacy Regulation #48 (Patient
Information, Drug Use Evaluation, and Patient Counseling).
Nothing herein shall be construed to mandate that an Out-of-State
Pharmacy comply with Board Regulation #48 if such compliance would cause the
Out-of-State Pharmacy to violate law or regulation of the state wherein the
facility of the dispensing Out-of-State Pharmacy is located. 10/09/90 (Revised
04/10/92)
42.
WOLESALE 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
or 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; 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; hospital; 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 as defined in regulation 59. 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
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 as defined
in regulation 59.
b. All
permits issued under this section shall expire on December 31, of each year. A
penalty, as defined in regulation 59, will be 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 on the
application for Iicensure 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 Iicensure of
persons who engage in the wholesale distribution of prescription drugs.
a. Any convictions of the applicant under any
Federal, State, or local laws regulation lo 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
operation;
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 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 notadversely 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 record keeping requirements in
paragraph six of this section shall be followed for all stored drugs.
4.
Examinations 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 record keeping requirements in
paragraph six 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 or shipping.
d. The record keeping requirements in
paragraph six of this section shall be followed for all outdated, damaged,
deteriorated, misbranded, or adulterated prescription drugs.
6.
Record keeping.
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 drug.
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 distributions 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. 6/22/84 (Revised 6/20/91)
REGULATION 57
57.
Medical Equipment, Legend Devices,
and/or Medical Gas Regulation
I.
Definitions:
(A) "Home Medical Equipment,
Legend Device, and Medical Gas Supplier" means a person, business, corporation,
agency, company, etc., licensed to supply home medical equipment, medical gases
and/or legend devices to patients on an order from medical practitioners
licensed to order, use, or administer these products and to other persons,
businesses, corporations, agencies, companies, etc., licensed to supply home
medical equipment, medical gases, and/or legend devices.
(B) "Home Medical Equipment Services" means
the delivery, installation, maintenance, replacement, and/or instruction in the
use of medical equipment, used by a sick or disabled individual, to allow the
individual to be maintained in a noninstitutional environment.
(C) "Legend Device," means a device which,
because of any potential for harmful effect or the method of its use, is not
safe -- except under the supervision of a practitioner. These devices, as
approved by F.D.A., may be labeled "Caution: Federal (USA) law restricts this
device to sale by or on the order of a physician."
(D)
(1)
"Medical Equipment" means technologically sophisticated medical devices
including but not limited to:
(a) Oxygen and
oxygen delivery systems;
(b)
Ventilators;
(c) Respiratory
disease management devices;
(d)
Electronic and computer driven wheelchairs and seating systems;
(e) Apnea monitors;
(f) Transcutaneous electrical nerve
stimulator (T.E.N.S.) units;
(g)
Low air loss cutaneous pressure management devices;
(h) Sequential compression devices;
(i) Neonatal home phototherapy
devices;
(j) Feeding
pumps;
(k) Electrically-powered
hospital beds;
(l) Infusion pumps;
and
(m) Patient
Lifts.
(2) The term
"medical equipment" does not include:
(a)
medical equipment used or dispensed in the normal course of treating patients
by hospitals, hospices, nursing facilities, or home health agencies;
(b) medical equipment used or dispensed by
health care professionals, licensed in Arkansas - provided the professional is
practicing within the scope of that professional's practice act;
(c) upper and lower extremity prosthetics and
related orthotics; or
(d) canes,
crutches, walkers, bathtub grab bars, standard wheelchairs, commode chairs, and
bath benches.
(E) "Medical Gas" means those gases and
liquid oxygen intended for human consumption.
(F) "Order" means an order issued by a
licensed medical practitioner legally authorized to order medical gases and/or
legend devices.
II.
Licensure Required:
(A) No person or entity,
subject to licensure, shall sell or rent or offer to sell or rent directly to
patients in this state any home medical equipment, legend devices, and/or
medical gases, unless the person or entity is licensed as required by Act 1101
The licensure requirements of this act will apply to all companies,
agencies, and other business entities that are in the business of supplying
medical equipment to patients in their home and which bill the patient or the
patient's insurance, Medicare, Medicaid, or other third-party payor for the
rent or sale of that equipment. The application for a license shall be on a
form, furnished by the Board, and shall be accompanied by payment of fee as
defined in regulation 59. The Board shall require a separate
license for each facility directly or indirectly owned or operated, within this
state, by the same person or business entity within this state, or for a parent
entity with divisions, subdivisions, subsidiaries, and/or affiliate companies
when operations are conducted at more than one location and there exists joint
ownership and control among all the entities.
(B)
(1) The
annual license renewal fee is defined in regulation 59.
(2) All licenses issued under this act shall
expire on December 31, of each calendar year.
(3) Each application for renewal of the
license must be made on or before December 31 of each year. Penalties for late
payment are defined in regulation 59. The license shall be considered null and
void if the fee is not paid by April 1 of each year.
(C) Each license issued hereunder shall be
displayed by the holder thereof in a conspicuous place.
III. Standards of Practice:
(A) Written policies and procedures must be
available for review and designed to meet all the following standards.
Documentation of all staff training must be kept in each employee's personnel
file. AH local, state, and federal regulatory agency policies concerning HME
and oxygen must be followed.
(1)
Order Intake: A home medical equipment (HME) provider
shall recognize the importance of order intake. The provider is responsible for
assuring that order intake personnel are appropriately trained in the
following:
(a) Identifying
equipment;
(b) Determining
patient/caregiver needs;
(c)
Determining referral sources needs;
(d) Knowing equipment coverage criteria based
on diagnosis;
(e) Responding
appropriately during a medical equipment emergency;
(f) Explaining service procedures;
(g) Billing third party; and
(h) Verifying insurance.
The provider must assure that only trained order intake personnel
receive referrals.
(2)
Selection of Appropriate
Equipment:
(a) When providing
equipment services for a patient, a provider shall consider: physician orders,
equipment needs of the patient, economic situation of the patient and
caregiver, and requirement of any third party payor source.
(b) A provider shall recognize those items
which require special fitting and evaluation, fitting of custom items shall be
performed within a reasonable time frame by specially trained
personnel.
(3)
Delivery and Set-Up/Patient and Caregiver Education:
(a) A provider shall maintain trained
personnel to coordinate order fulfillment and to schedule equipment services
with timely delivery. Documentation of training will be maintained.
(b) A provider shall assure delivery
personnel are appropriately trained to:
(A)
Conduct an environment/equipment compatibility assessment.
(B) Appropriately and safely set up the
equipment.
(C) Instruct patient and
caregivers in the safe operation and client maintenance of the
equipment.
(D) Recognize when
additional education and/or follow-up patient compliance monitoring is
appropriate.
(c) Written
instructions must be provided to the patient/caregiver upon delivery and
documentation of receipt of written instruction must be maintained in the
patient record.
(4)
Services During Use:
(a) A provider shall document that patients
are advised of service hours and emergency service procedures. If equipment
malfunction may threaten the customer's health, access to 24 hour per day, 365
days per year emergency service must be available for equipment maintenance or
replacement.
(b) A provider shall
establish a schedule at the time of the initial delivery for any appropriate
follow-up HME services such as periodic maintenance, supply delivery and other
related activities.
(5)
Retrieval/Disinfection/Maintenance:
(a) A provider shall assure that
state/federal requirements for equipment disinfection are followed including
red-tagging for bio-hazards, maintaining dirty equipment isolation, equipment
cleaning and disinfection areas and procedures, and appropriate staff training
on hazard prevention.
(b) Cleaning
and disinfection solutions must be bactericidal, tuberculocidal, and
viricidal.
(c) CDC Universal
precautions and OSHA regulations concerning equipment handling must be
followed.
(d) Create and implement
a preventative maintenance program based on manufacturers' guidelines which
include appropriate record keeping. Trained staff must be utilized.
(6)
Patient
Record:
(a) A supplier must
maintain a record for each customer when required by state or federal law or
when a physician's order is required.
(b) The patient record must include an intake
form and applicable physician's orders.
(c) Records should be safeguarded from loss
and kept confidential.
(d)
Documentation of proper patient/caregiver instruction must be maintained in the
patient record.
(7)
Patient Rights:
(a)
The patient has the right to considerate and respectful service.
(b) The patient has the right to obtain
service without regard to race, creed, national origin, sex, age, disability,
diagnosis or religious affiliation.
(c) Subject to applicable law, the patient
has the right to confidentiality of all information pertaining to his/her
medical equipment and service. Individuals or organizations not involved in the
patient's care may not have access to the information without the patient's
written consent.
(d) The patient
has the right to a timely response to his/her request for HME
services.
(e) The patient has the
right to select the HME supplier of his/her choice.
(f) The patient has the right to voice
grievances without fear of termination of service or other reprisals.
(g) The patient has the right to expect
reasonable continuity of service.
(h) The patient has the right to an
explanation of charges for equipment and supplies.
(8)
Quality
Assurance:
(a) There is an
ongoing continuous quality improvement program designed to monitor and evaluate
quality of patient care, improvement of patient services, if applicable, and
resolution of identified problems.
(b) Continuous quality improvement activities
are defined in a written plan.
(c)
Issues monitored should be determined by evaluating all complaints or incidents
and items that are high volume, high risk or problem prone.
(9) Liability insurance coverage
for products provided and operations of each licensed entity is required in the
amount of at least $500,000.
(B) Prohibited Practices -- The following
practices are prohibited:
(1)
Patient Freedom of Choice:
(a) Participation in any plan, agreement, or
arrangement which eliminates the patient's right to select a provider, licensed
under this act, of their choice shall be considered a violation of this
regulation.
(2)
Bribes Kickbacks and Rebates:
(a) It shall be considered a violation of
this regulation for anyone to knowingly and willfully offer, pay, solicit or
receive any payment in return for referring an individual to another person for
the furnishing, or arranging for the furnishing, of any item or service covered
by this regulation. (10/13/95)
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 as defined in regulation
59shall 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).
10. Any licensed Pharmacist whose certificate
has been lost or destroyed may procure a duplicate from the Arkansas State
Board of Pharmacy by filing an affidavit that said certificate has been lost or
destroyed, upon payment of a fee as defined in regulation
59.(10/9/80)
13.
Any person serving in the armed forces within the State of Arkansas, who is a
Licensed Pharmacist in another state, may obtain a temporary permit to practice
pharmacy in the State of Arkansas by furnishing certified proof of his
registration from the Board of Pharmacy in his state of original registration,
and the payment of a fee as defined in regulation 59. This permit shall entitle
the holder thereof to practice in any store where an Arkansas Licensed
Pharmacist is on duty a minimum of 40 hours per week. The permit must be
renewed at each succeeding meeting of the Board. 10/09/80
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 as defined in
regulation 59. 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 as
defined in regulation 59 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 as defined in
regulation 59 for each delinquent year up to a maximum as defined in regulation
58 plus the current year's renewal fee. 10/09/80 (Revised 10/14/81, Act of
1985, and 6/20/91)
26. Hereafter no
extern, intern, or student of a pharmacy school shall be granted authority from
this Board to practice pharmacy in Arkansas and serve any internship period in
Arkansas unless he is licensed with the Arkansas State Board of Pharmacy and
pays an intern Iicensure fee as defined in regulation 59. The application for
Iicensure as an intern will be furnished by the Arkansas State Board of
Pharmacy.
27. The Board of Pharmacy
is charged with regulating the internship program made reference to in the
Arkansas Code
17-92-301. The
Arkansas State Board of Pharmacy recognizes that in order to properly fulfill
its obligation to the profession of pharmacy and general welfare and protection
of the public health that it must implement and supervise an internship program
in the State of Arkansas.
From time to time, as is required to establish a viable internship
program, the Board will establish, publish, and disseminate criteria
establishing requirements and standards necessary for qualifications for
licensure under Arkansas Code $
17-92-305,
§
17-92-307,
and Regulation 27.
Hereafter, every applicant for licensure by examination in Arkansas
must have 2,000 hours of acceptable internship training obtained after
beginning the professional college curriculum. Up to 1,500 hours of the
required 2,000 may be obtained in a training program as part of school
curriculum.
DEFINITIONS
A.
LICENSED INTERN: A person licensed by the Arkansas
State Board of Pharmacy, as a licensed Intern, and who is a student accepted by
and enrolled as a student in the University of Arkansas College of Pharmacy or
a student enrolled in an approved College of Pharmacy outside of Arkansas.
(1) Extern-An intern prior to graduation or a
graduate who has taken and failed the Board Exam.
(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.
C.
SUPERVISION: Shall mean that, in a pharmacy where
experience is being obtained, . a certified Preceptor or Alternate Preceptor
supervises the practical experience with both personal and physical
supervision, and actually giving instruction to the Intern obtaining the
experience during the entire period of such experience.
D.
LIMITED
SUPERVISION: The pharmacist in a Class A pharmacy supervising a
Graduate Intern is within voice or telephone contact.
E.
CLASS A PHARMACY:
A pharmacy which has obtained at least 85 on its last Board inspection, and has
a pharmacy permit with a pharmacist on duty at least 40 hours per week.
(1) Any extern or intern receiving internship
training practice or experience in the State of Arkansas must be licensed as an
intern with the Arkansas State Board of Pharmacy. No credit for internship
training will be allowed prior to licensure as an intern. The intern licensure
application can be obtained from the office of the Board of Pharmacy. There is
a fee as defined in regulation 59 for licensure as an intern.
(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 §
17-92-101,
§
17-92-301, and
§
17-92-307.
Provided that any licensed intern shall not participate in the practice
of Pharmacy as defined in §
17-92-101,
§ 517-92-301. and §
17-92-307,
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.
(3) The certificate of licensure as a
"licensed" intern must be displayed in the drugstore or pharmacy in which the
intern is being trained. Licensed interns shall not be left in sole charge of
the prescription department at any time. Violation of this regulation may
effect a cancellation of any and all internship toward licensure that may be
accrued by the pharmacy intern, and the revocation of the Preceptor's
certificate.
(4) For each pharmacy
setting where an intern practices pharmacy, the intern shall complete and file
with the Board of Pharmacy office, prior to any practice, a "Training Plan"
that is signed by the Preceptor pharmacist or supervising pharmacist (in the
case of a graduate intern) for that particular work situation. Such Training
Plan shall expire on May 1 of each year. At no time may a Preceptor supervise
more than one licensed intern.
(5)
Participation in a School or College of Pharmacy curriculum extern or clerkship
program, approved by the Board of Pharmacy, will be credited week for week
training.
(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.
(8) After presenting proof of 2,000 hours of
practical experience or training under Arkansas Board of Pharmacy approved
conditions, the intern may be designated as a candidate suitable for full
licensure if other conditions have been met.
Affidavits of one-year training must be submitted to the Board of
Pharmacy for full licensure, and can be obtained from the Board of Pharmacy
office.
Before permitting a student to participate in any way in the practice
of Pharmacy, the Preceptor must assure:
A. The Preceptor is licensed.
B. The Intern is currently
licensed.
C. The intern has filed a
current Training Plan.
Reg. 27,4.b.) (Revised 6/22/84, 4/07/89, 6/20/91, and 4/10/92)
RULES APPLYING TO PRECEPTORS
The Arkansas internship training program requires that a pharmacist,
who has been duly certified by the Arkansas State Board of Pharmacy, may serve
as preceptor or alternate for an intern or extern.
The following requirements must be met to be certified by the State
Board of Pharmacy for serving as a Preceptor or Alternate:
1. Be an Arkansas Licensed Pharmacist
licensed for not less than two years and having been actively engaged in the
practice of Pharmacy for not less than two years immediately preceding the
application. One can be certified as an alternate without the two years
practice.
2. Be a full-time
pharmacist in a pharmacy which currently holds a Class A rating indicated by
the Inspection Sheet for pharmacies as outlined by the State Board of
Pharmacy.
3. For the initial
application as preceptor or alternate preceptor, the applicant must
satisfactorily complete a test on requirements and responsibilities of a
preceptor or alternate preceptor as developed and administered by the Board of
Pharmacy or its representatives.
4.
Have a pharmacy library (latest edition) which meets or exceeds the
requirements of the "Inspection Sheet" for pharmacies.
5. At least one preceptor from the internship
site shall be a member of an appropriate national pharmaceutical organization.
All preceptors and alternates shall be a member of at least one
professional state or national organization.
6. Must have not been convicted for any
violation of Arkansas Code §
17-92-311,
unless the Board officially grants exception.
7. Must have attended at least one
professional meeting during the previous calendar year.
8. Must agree to give immediate personal and
direct physical supervision to assigned intern. A preceptor or alternate cannot
supervise more than one intern at any specified time.
9. Renewal as a Preceptor or Alternate will
be required every two years by executive application and paying a fee as
defined in regulation 59.
Violation of any of the rules and requirements set forth above may
cause the Preceptor or Alternate to lose his certification as such, and may
also cause the intern to suffer loss of internship training credit. 10/09/80
(Revised 2/17/82, 12/12/86, 2/10/87, and 6/20/91)
29. When there is a change of pharmacy permit
for a change of ownership of the pharmacy and the pharmacist in charge is
changed, an inventory of all drugs now or hereafter classified as Schedule 2,
3, 4, or 5, drugs under either Federal or State Statutes shall be made by the
Pharmacist in Charge and a copy of that inventory signed by the Pharmacist in
Charge shall be submitted with the application for change of ownership and the
fee for change of ownership as defined in regulation 59. The inventory shall be
made on the day the new owner takes charge of the pharmacy.
When there is a change of pharmacy permit for a change of pharmacist in
charge, an inventory of all drugs now or hereafter classified as Schedule 2, 3,
4, or 5, drugs under either Federal or State Statutes will be made by the
exiting pharmacist in charge and a copy of that inventory signed by said
pharmacist shall be furnished to the Arkansas State Board of Pharmacy within
seven days after the pharmacist's last day to work at the pharmacy and a copy
left with the Controlled Substance Records of the Pharmacy. The new Pharmacist
in Charge as his first action in the pharmacy shall also inventory all drugs
now or hereafter classified as Schedule 2, 3, 4, or 5, drugs under Federal or
State Statutes and a copy of that inventory signed by the new Pharmacist in
Charge shall be provided to the Arkansas State Board of Pharmacy with the
application to change the pharmacy permit's Pharmacist in Charge.
It is acceptable and preferable if the inventory is made jointly by
both pharmacists, signed by both pharmacists, and supplied to the Arkansas
State Board of Pharmacy with the application for change of Pharmacist in
Charge.
Both copies of said inventory (exiting pharmacist and new pharmacist)
must be received by the Board before a new permit will be issued. 10/09/83
(Revised 6/25/80 and 6/20/96)
41. Out-of-State Pharmacies shall comply with
the following qualifications to be and remain licensed in Arkansas by the
Board.
1.
A. The pharmacy holds a current license in
good standing in the state(s) in which it is located.
B. Each pharmacist dispensing drugs into
Arkansas shall be licensed as a pharmacist in Arkansas or in the state where he
practices if that state has standards of licensure at least equivalent to those
of Arkansas.
2. A
pharmacist licensed in Arkansas or by the state where he practices having
standards of licensure at least equivalent to Arkansas standards shall be named
in the application as the pharmacy's contact person for communications by the
Board.
A. That pharmacist will be responsible
for receiving and maintaining publications distributed by the Board.
B. If at anytime the pharmacist so designated
shall leave the employment of the pharmacy or be absent from the pharmacy in
excess of 14 consecutive calendar days, the pharmacy shall promptly notify the
Board and designate another pharmacist to perform this function.
3. The Out-of-State Pharmacy shall
apply for licensure and renewal on forms approved by the Board. The Board may
require such information as reasonably necessary to carry out the provisions of
A.C.A.
17-92-401,
including, without limitation, the name, address and position of each officer
and director of a corporation or of the owners if the pharmacy is not a
corporation.
Provided, however, the Board may grant an exemption from licensing
under A.C.A.
17-92-401
upon application by any non-resident pharmacy which confines its dispensing
activity to isolated transactions. In determining whether to grant an
exemption, the Board shall consider:
(a) The number of prescriptions dispensed or
reasonably expected to be dispensed into Arkansas.
(b) The number of patients served or
reasonably expected to be served in Arkansas.
(c) Whether the pharmacy has promoted its
services in Arkansas.
(d) Whether
the pharmacy has a contract(s) with any employer(s) or organization(s) to
provide pharmacy services to employees or other beneficiaries in
Arkansas.
(e) Medical
necessity.
(f) The effect on the
health and welfare of persons in Arkansas.
(g) Any other relevant matters.
4. The pharmacy shall pay an
annual license fee as defined in regulation 59.
5. The pharmacy shall maintain records of
drugs dispensed to Arkansas addresses in such a manner so as to be readily
retrievable upon request. Said records shall be made available for inspection
by the Board or by Arkansas law enforcement authorities.
6. The pharmacy shall timely respond to any
request for information from the Board or law enforcement
authorities.
7. The pharmacy shall
maintain an incoming toll free telephone number for use by Arkansas customers
to be answered by a pharmacist with access to patient records. This service
shall be available a minimum of 40 hours a week, six days per week during
normal business hours. This telephone number plus others available for use
shall be printed on each container of drugs dispensed into Arkansas. The toll
free number shall have sufficient extensions to provide reasonable access to
incoming callers.
8. Generic drugs
shall be dispensed into Arkansas pursuant to the Arkansas Generic Substitution
Act; provided, however, nothing herein shall be construed to mandate that an
Out-of-State Pharmacy comply with the Arkansas Generic Substitution Act if such
compliance would cause the Out-of-State Pharmacy to violate the Generic
Substitution Act of the state wherein the facility of the dispensing
Out-of-State Pharmacy is located.
9. The facilities and records of the 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
using similar standards of the state where the pharmacy is located.
10. Each Out-of-State Pharmacy doing business
in Arkansas by dispensing and delivering or causing to be delivered
prescription drugs to Arkansas consumers shall designate a resident agent in
Arkansas for service of process.
11. Each Out-of-State Pharmacy doing business
in Arkansas shall comply with Board of Pharmacy Regulation #48 (Patient
Information, Drug Use Evaluation, and Patient Counseling).
Nothing herein shall be construed to mandate that an Out-of-State
Pharmacy comply with Board Regulation #48 if such compliance would cause the
Out-of-State Pharmacy to violate law or regulation of the state wherein the
facility of the dispensing Out-of-State Pharmacy is located. 10/09/90 (Revised
04/10/92)
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
or 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; 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; hospital; 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 as defined in regulation 59. 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 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 as defined
in regulation 59.
b. All
permits issued under this section shall expire on December 31, of each year, a
penalty as defined in regulation 59 will be 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 on the
application for licensure 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 regulation 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
operation;
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 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 notadversely 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 record keeping requirements in
paragraph six 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 record keeping requirements in
paragraph six 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 or shipping.
d. The record keeping requirements in
paragraph six of this section shall be followed for all outdated, damaged,
deteriorated, misbranded, or adulterated prescription drugs.
6.
Record keeping.
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.
e. 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 drug.
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 distributions 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 nonniedical 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. 6/22/84 (Revised 6/20/91)