Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.96-005 - Reg. 59 - Fees

Current through Register Vol. 49, No. 6, June, 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)