Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.06-003 - Regulation 01 - General Operations

Current through Register Vol. 49, No. 6, June, 2024
ARKANSAS STATE BOARD OF PHARMACY REGULATIONS
REGULATION 1
-GENERAL OPERATIONS
01-00-0001
-DESCRIPTION OF THE
		  BOARD
The Arkansas State Board of Pharmacy shall consist of six
			 pharmacist members as provided by Arkansas Code
			 17-92-201(a)(1) and
			 (2), AND
			 17-92-201(d)
			 plus a consumer member and a senior citizen consumer member as provided by
			 Arkansas Code
			 17-92-201(a)(3).
			 The qualifications, powers, and duties of the Board shall be those enumerated
			 by the provisions of A.C.A.
			 17-92-201
			 through
			 17-92-208.
			 (10/9/80, amended 6/20/91)
01-00-0002
-LOCATION OF BOARD
		  OFFICES
The office of the Arkansas State Board of Pharmacy shall be
			 located at 101 East Capitol, Suite 218, Little Rock, Arkansas. All
			 communications thereto may be addressed to Arkansas State Board of Pharmacy,
			 101 East Capitol, Suite 218, Little Rock, AR 72201. (10/9/89)
01-00-0003
-REQUESTS FOR
		  INFORMATION
Any person or persons seeking information respecting the Arkansas
			 State Board of Pharmacy or desiring to submit complaints or charges thereto or
			 make request thereof shall do so by filing with the Board an instrument in
			 writing, signed by the writer and containing a return address. Communications
			 need not be typed but should be legible. (10/9/80)
01-00-0004
-LICENSEES GOVERNED BY
		  PHARMACY PRACTICE ACT
Except wherein items of practice and procedure are specifically
			 set out in these regulations, the practice and procedure before the Arkansas
			 State Board of Pharmacy shall be governed by the provisions of the Pharmacy
			 Practice Act. (10/9/80)
01-00-0005
-CERTIFICATES OF
		  LICENSURE--EXPIRATION
(a) All retail
		  pharmacy permits, out-of-state pharmacy permits, specialty pharmacy permits,
		  and pharmacist licenses shall expire on December 31 of the first odd-numbered
		  year following the date of their issuance.
(b) All preceptor permits shall expire on
		  June 1 of the second calendar year following the date of their
		  issuance.
(c)
(1) An intern license issued to a student
		  intern shall expire six (6) months following graduation or when the intern is
		  issued a pharmacist license, whichever occurs first.
(2) Intern licenses issued to foreign
		  graduates shall expire on December 31 of the second calendar year following the
		  date of issuance or when the intern is issued a pharmacist license, whichever
		  occurs first.
(d)
		  Non-renewable provisional licenses and provisional registrations shall expire
		  six months after the date of issuance or upon issuance of a pharmacist, intern
		  or technician license, whichever comes first.
(e) All pharmacy technician permits, hospital
		  pharmacy permits, ambulatory care center pharmaceutical services permits,
		  wholesale distributors of legend or controlled substance permits, wholesale
		  distributors of medical equipment, legend devices, and medical gases permits,
		  institutional pharmaceutical services permits, List I chemical permits, nursing
		  home consultant pharmacist permits, and charitable clinic permits shall expire
		  on December 31 of the first even-numbered year following the date of the
		  issuance of the permit, license, registration, or certificate.
(f) Charitable clinic permits shall expire on
		  December 31 of the first even-numbered year following the date of the issuance
		  of the permit, license, registration, or certificate.
(g) Every license, permit, registration, and
		  certificate not renewed within ninety (90) days after expiration thereof shall
		  be null and void.
(1) Every licensed
		  pharmacist engaged in the active practice of pharmacy shall pay to the Board of
		  Pharmacy a renewal fee as defined in regulation 01-00-0007. If the renewal fee
		  for any pharmacist license is unpaid by the first day of February following the
		  date of expiration, the holder thereof must pay a penalty as defined in
		  regulation 01-00-0007 for each month thereafter, provided that if the renewal
		  is unpaid by the first day of April following the date of expiration, such
		  certificate shall be null and void and the holder must be reinstated as a
		  licensed pharmacist by satisfying the State Board of Pharmacy that he or she 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 or she is
		  competent and qualified to compound and fill prescriptions, and must pay a
		  reinstatement fee as defined in regulation 01-00-0007 for each delinquent year
		  up to a maximum as defined in regulation 01-00-0007 plus the current year's
		  renewal fee.
(2) Every registered
		  pharmacy technician shall pay to the Board of Pharmacy a renewal fee as defined
		  in regulation 01-00-0007. If the renewal fee for any pharmacy technician
		  registration is unpaid by the first day of February following the date of
		  expiration, the holder thereof must pay a penalty as defined in regulation
		  01-00-0007 for each month therafter, provided that if the renewal is unpaid by
		  the first day of April following the date of expiration, such registration
		  shall be null and void. The pharmacy technician may be reinstated as a pharmacy
		  technician upon payment of a reinstatement fee as defined in regulation
		  01-00-0007 plus the renewal fee.
(3)
		  Every nursing home consultant shall pay to the Board of Pharmacy a renewal fee
		  as defined in regulation 01-00-0007. If the renewal fee for the nursing home
		  consultant is unpaid by the first day of February following the date of
		  expiration, the holder thereof must pay a penalty as defined in regulation
		  01-00-0007 for each month therafter, provided that if the renewal is unpaid by
		  the first day of April following the date of expiration, such registration
		  shall be null and void.
(4) Every
		  preceptor shall pay to the Board of Pharmacy a renewal fee as defined in
		  regulation 01-00-0007. If the renewal fee for the preceptor license is unpaid
		  by the first day of July following the date of expiration, the holder thereof
		  must pay a penalty as defined in regulation 01-00-0007 for each month
		  therafter, provided that if the renewal is unpaid by the first day of September
		  following the date of expiration, such registration shall be null and
		  void.
(5) Every licensed pharmacy,
		  hospital, ambulatory care center, wholesale distributor, List I chemical or
		  supplier of medical equipment, legend device or medical gas shall pay to the
		  Board of Pharmacy a renewal fee as defined in regulation 01-00-0007. If the
		  renewal fee for any pharmacy or business license is unpaid by the first day of
		  February following the date of expiration, the holder thereof must pay a
		  penalty as defined in regulation 01-00-0007 for each month therafter, provided
		  that if the renewal is unpaid by the first day of April following the date of
		  expiration, such license shall be null and void.
(10/09/80, Revised 10/14/81, Act of 1985, 6/20/91, 8/23/96, and
			 11/13/2006)
01-00-0006
-BOARD OF PHARMACY MEETING
		  REQUIREMENTS
The Arkansas State Board of Pharmacy shall meet the second
			 Tuesday and Wednesday in February, the second Tuesday and Wednesday in June or
			 at the time of the Annual Meeting of the Arkansas Pharmacists Association in
			 June, and the second Tuesday and Wednesday in October of each year-unless
			 changed and announced in advance by the Board of Pharmacy. Examination of
			 candidates for licensure to practice pharmacy shall be on dates, and at times
			 and places as determined by the Board of Pharmacy. (10/09/80 Revised 6/20/91,
			 and 11/13/2006)
01-00-0007
-FEES CHARGED BY THE BOARD OF PHARMACY
(a) 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 upon examination 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);
(3)
(A) The fee for the initial issuance of a
		  license as a licensed pharmacist shall be seventy-five dollars
		  ($75.00);
(B) The fee for the
		  renewal of a license as a licensed pharmacist shall be seventy-five dollars
		  ($75.00) per year;
(4)
(A)
(i) The
		  fee for issuance of a permit for the first time to operate an in-state pharmacy
		  shall be three hundred dollars ($300);
(ii) The fee for renewal of a permit to
		  operate an in-state pharmacy shall be one hundred fifty dollars ($150) per
		  year;
(iii) When there is a change
		  of ownership of an in-state pharmacy, a new permit must be obtained, and the
		  fee shall be one hundred fifty dollars ($150);
(B)
(i) The
		  fee for issuance of a permit for the first time to operate a specialty pharmacy
		  shall be three hundred dollars ($300);
(ii) The fee for renewal of a permit to
		  operate a specialty pharmacy shall be one hundred fifty ($150) per year;
(iii) When there is a change in
		  ownership in a specialty pharmacy, a new permit must be obtained and the fee
		  shall be one hundred fifty dollars ($150);
(C)
(i) The
		  fee for issuance of a permit for the first time to operate an out-of-state
		  pharmacy shall be three hundred dollars ($300);
(ii) The fee for renewal of a permit to
		  operate an out-of-state pharmacy shall be one hundred fifty dollars ($150) per
		  year;
(iii) When there is a change
		  in ownership in an out-of-state pharmacy or drug store, a new permit must be
		  obtained, and the fee shall be one hundred fifty dollars
		  ($150);
(5) The
		  fee for a certificate as a licensed pharmacist shall be ten dollars
		  ($10.00);
(6) The fee for certifying
		  grades in connection with an application for reciprocity (license transfer)
		  shall be ten dollars ($10.00);
(7)
(A) The fee for issuance of a hospital
		  pharmaceutical service permit shall be three hundred dollars ($300), and the
		  fee for the renewal of a hospital pharmaceutical service permit shall be one
		  hundred fifty dollars ($150) per year.
(B) When there is a change of ownership of a
		  hospital pharmacy, a new permit must be obtained and the fee shall be one
		  hundred fifty dollars ($150);
(C)
(i) The fee for issuance of an ambulatory
		  care center pharmaceutical service permit shall be three hundred dollars
		  ($300), and the fee for the renewal of an ambulatory care center pharmaceutical
		  service permit shall be one-hundred fifty dollars ($150) per year.
(ii) When there is a change in ownership of
		  an ambulatory care center pharmacy, a new permit must be obtained and the fee
		  shall be one hundred fifty dollars ($150);
(8)
(A) The
		  fee for issuance of an institutional pharmaceutical services permit shall be
		  thirty-five dollars ($35.00);
(B)
		  The fee for the renewal of an institutional pharmaceutical services permit
		  shall be thirty-five dollars ($35.00) per year;
(9)
(A) The
		  fee for issuance of, and the reinstatement of a nursing home pharmacy
		  consultant permit shall be thirty-five dollars ($35.00);
(B) The fee for the renewal of a nursing home
		  consultant pharmacist permit shall be thirty-five dollars ($35.00) per
		  year;
(10) The fee for
		  intern registration shall be forty-five ($45.00) dollars.
(11) The fee for change of pharmacist in
		  charge of any pharmacy, or other facility as described at §
										17-92-403
		  shall be thirty-five dollars ($35.00);
(12) The fee for reinstatement of a
		  pharmacist license shall be seventy-five dollars ($75.00) for each delinquent
		  year up to a maximum of three hundred dollars ($300);
(13) The fee for the Arkansas State 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;
(14) The fee for a change of
		  location inspection shall be one hundred dollars ($100);
(15) The penalty for late payment of renewal
		  of any permit, license, registration or certificate, unless specifically stated
		  in this regulation, shall be twenty dollars ($20.00) per month beginning the
		  first day of the second month after expiration, provided that if the renewal is
		  not paid by the first day of the fourth month after expiration, the license
		  shall be null and void;
(16)
(A) The fee for issuance of a wholesale
		  distributor of legend drugs and/or controlled substances permit shall be
		  three-hundred dollars ($300), and renewal shall be one-hundred fifty dollars
		  ($150) per year;
(B) When there is a
		  change in ownership of a wholesale distributor of legend drugs and/or
		  controlled substances, a new permit must be obtained and the fee shall be one
		  hundred fifty dollars ($150);
(17)
(A)
		  The fee for the original issuance of a pharmacy technician's permit shall not
		  exceed thirty-five ($35.00);
(B) The
		  fee for the renewal of a pharmacy technician's permit shall not exceed
		  thirty-five dollars ($35.00) per year;
(18) The reinstatement fee for a pharmacy
		  technician's permit shall not exceed forty dollars ($40.00); and
(19)
(A)
		  The application fee for a license to sell, rent, offer to sell, or rent
		  directly to patients in this state any home medical equipment, legend devices,
		  or medical gases shall not exceed two-hundred fifty dollars ($250);
(B) The license renewal fee shall not exceed
		  one hundred twenty-five dollars ($125);
(C) The change of ownership fee shall not
		  exceed one hundred twenty-five dollars ($125).
(20) The fee for issuance of a temporary
		  permit for a pharmacist on active duty in a branch of the armed forces shall
		  not exceed twenty-five dollars ($25.00) and shall be administered as defined in
		  regulation 02-00-0004.
(21) The fee
		  for registration as a preceptor shall be twenty dollars ($20.00) every two
		  years. (22)
(A) The fee for a permit for
		  wholesale distributors of List I chemicals shall not exceed three hundred
		  dollars ($300), and the renewal shall not exceed one hundred fifty dollars
		  ($150) per year.
(B) When there is a
		  change of ownership of a wholesale distributor of List I chemicals, a new
		  permit must be obtained and the fee shall not exceed one hundred fifty dollars
		  ($150).
(b) 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.
(c) Should any license, certificate, or
		  registration not be renewed within ninety (90) days after expiration thereof,
		  it may be reinstated by the board as authorized in this section upon payment of
		  the renewal fee and reinstatement fee. However, the following are not subject
		  to reinstatement if not renewed within ninety (90) days after expiration:
(1) pharmacy permits.
(2) out of state pharmacy permits.
(3) specialty pharmacy permits.
(4) hospital permits.
(5) ambulatory care center pharmacy
		  permits.
(6) wholesale distributors
		  of legend drugs and/or controlled substance permits, or both; and
(7) suppliers of medical equipment, legend
		  devices, and/or medical gas licenses.
(8) institutional pharmacy permits
(9) List I chemical permits
(10) charitable clinic
		  permits.
(d)
(1) All retail pharmacy permits, out of state
		  pharmacy permits, specialty pharmacy permits, and pharmacist licenses expiring
		  in odd-numbered years shall be renewed every two (2) years.
(2) All pharmacy technician permits, hospital
		  pharmaceutical service permits, ambulatory care center pharmaceutical services
		  permits, wholesale distributors of legend or controlled substance permits,
		  wholesale distributors of medical equipment, legend devices, and medical gases
		  permits, wholesale distributors of List I chemicals, institutional
		  pharmaceutical services permits, nursing home consultant pharmacists permits,
		  charitable clinic permits and any other permit, license, registration, or
		  certificate issued by the board expiring in even-numbered years and not covered
		  in subdivision (d) (1) of this section shall be renewed every two (2)
		  years.
(3) The fee for any biennial
		  renewal term will be the amount of two (2) annual renewal fees for the
		  applicable license, permit, registration, or certification as provided in
		  subsection (a) of this section.
(4)
		  If the initial licensure, permit, certificate, or registration occurs in the
		  first year of a biennial renewal term, the applicant shall pay the appropriate
		  initial fee and the applicable annual fee for the license, permit, certificate,
		  or registration for the second year in the renewal term, as provided in
		  subsection (a) of this section.
(5)
		  If the initial licensure, permit, certificate, or registration occurs in the
		  second year of the biennial renewal term, the applicant will only pay the
		  original fee and will not be responsible for the renewal fee until the biennial
		  renewal period for the license, permit, certificate, or registration. 8/23/96
		  (Revised 6/19/97 8/19/99, 6/2001, and 11/13/2006)
01-00-0008
-DECLARATORY ORDER
(a) Scope-When a regulation, statute or order
		  enforced by the Board of Pharmacy or its application will injure or threatens
		  to injure a person in his person, business, or property, that person may file a
		  petition for a declaratory order as to the applicability of that regulation,
		  statute or order pursuant to this regulation.
(b) Petition-Contents-The petition for a
		  declaratory order shall contain the following:
(1) The venue, a heading specifying the
		  subject matter and name of the petitioner and the name of the
		  pleading;
(2) The name, address, and
		  telephone number of the petitioner and whether petitioner is licensed by the
		  Board under A.C.A. §
										17-92-101
etseq.;
(3) The
		  name, address, and telephone number of petitioner's attorney, if any;
(4) A statement of the injury to result from
		  the regulation, statute or order or the application thereof to the
		  petitioner;
(5) The declaratory
		  ruling that the petitioner seeks;
(6) The regulation, statute or order which is
		  the subject of the petition;
(7) The
		  facts relevant to the order which petitioner seeks; said statement of facts
		  shall be complete, specific and particularized to the issue
		  presented;
(8) Memorandum of law and
		  legal authorities in support of the order the petitioner seeks;
(9) The name, address and telephone number of
		  each person known to the petitioner who may have a specific personal interest
		  in the application of the regulation, statute or order or who may be adversely
		  affected by the declaratory order sought by the petitioner;
(10) The signature of petitioner or
		  petitioner's attorney, if any; and
(11) All documents pertinent to the petition
		  shall be attached thereto.
(c) Filing of the Petition.
(1) The original and three copies of each
		  petition shall be in writing and shall be delivered in person or by mail to the
		  Executive Director of the Board during regular business hours at the Board's
		  offices. The Executive Director shall mark said petition as having been
		  received by the Board and return a file-marked copy to petitioner.
(2) In order to determine whether to issue a
		  declaratory order, the Board will consider any pertinent issues including,
		  without limitation, the following:
(A) whether
		  the petition substantially conforms to section (b) above or is not supported by
		  a memorandum of law in support of the petition;
(B) whether the petition is
		  frivolous;
(C) whether the matter is
		  within the jurisdiction of the Board;
(D) whether there is a genuine controversy of
		  material fact, the resolution of which is necessary before any declaratory
		  order may issue;
(E) whether the
		  order will terminate a controversy or remove uncertainties as to the
		  applicability to petitioner of any regulation, statute or order by the
		  Board;
(F) whether the petition
		  involves any subject, question or issue which the subject of a formal or
		  informal matter or investigation currently pending before the Board, a court or
		  other agency of this state or the federal government;
(G) whether the petition seeks a ruling on a
		  moot or hypothetical question, speculative facts or will result in an advisory
		  ruling or opinion;
(H) whether the
		  issue presented is of such complexity that the Board has had insufficient
		  opportunity or resources to develop a fully matured opinion;
(I) whether a declaratory order would provide
		  a broad interpretation of a regulation, statute or order applicable to an
		  entire class of persons;
(J) whether
		  the promulgation of a regulation or an adjudication would be more appropriate
		  to resolve the question; and
(K)
		  any other pertinent matter.
(e) Parties
(1) Petitioner, persons identified in section
		  b (9) and the Board shall be parties to a proceeding for a declaratory
		  order.
(2) Any other person may seek
		  leave of the Board to intervene in such proceeding and leave to intervene will
		  be granted at the sole discretion of the Board.
(3) A petition to intervene shall be filed in
		  the manner as set forth the same matters as required by section b herein. Any
		  reference to "petitioner" herein also refers to any person who has been granted
		  leave to intervene, unless the context clearly indicates to the
		  contrary.
(f) Disposition
		  of Petition. The Board may:
(1) Decide the
		  issue solely upon the facts presented in the petition; in such case the
		  decision will apply only to the extent of the facts presented in the petition
		  and amended to the petition;
(2)
		  Require that additional information be submitted before the petition will be
		  considered; in such event the additional facts will be considered as an
		  amendment to the petition;
(3)
		  Require the petitioner to provide notice of the pendency of the proceeding to
		  persons who may be necessary parties as well as other persons;
(4) Schedule a time, date and place at which
		  the Board will conduct a hearing on the petition for the purpose of obtaining
		  additional facts or inquiring into any facts set forth in the petition; notice
		  of the hearing and purpose therefore shall be provided to the
		  petitioner.
(5) Schedule a date,
		  time and place at which the petitioner and other persons may make an oral
		  presentation on the petition;
(6)
		  Consider the petition and any attachments without oral presentation; and/or
(g) Order
(1) The Board shall state its decision in
		  writing signed by the President or other person designated by the
		  Board.
(2) The Board's decision
		  deciding the issue presented by the petition shall include findings of fact and
		  conclusions of law supporting the declaratory order; the decision may be in the
		  form of a letter or pleading.
(3)
		  The Board's decision shall be rendered and entered as promptly as reasonably
		  practicable considering the facts, circumstances, complexity and other factors
		  pertinent to the proceeding.
(4) The
		  order shall be served upon the petitioner and any other parties to the
		  proceeding by certified mail, return receipt requested. (Adopted
		  8/19/99)
01-00-0009
-INSPECTOR'S WARNING
		  NOTICE
(a) Purpose. An inspector's
		  warning notice protects public health by allowing registrants to expeditiously
		  correct violations of laws and rules, and report these corrections to the Board
		  in writing.
(b) Recipient. A warning
		  notice may be issued to any person or facility holding a permit, license,
		  registration, certificate, or credential issued by the Arkansas State Board of
		  Pharmacy that is found to be violating any Arkansas Code pertaining to the
		  practice of pharmacy or any regulation of the Arkansas State Board of Pharmacy
		  as well as any other applicable state or federal law, rule, or
		  regulation.
(c) Issuance. An
		  inspector may issue a warning notice at the time a violation is
		  found.
(d) Filing. The warning
		  notice shall become an integral part of a file.
(e) Failure to respond. A recipient's failure
		  to satisfactorily respond to a warning notice may be referred by the Executive
		  Director of the Board for review and hearing.
(f) Board review of two warning notices. Any
		  registrant receiving two or more warning notices within a twelve-month period
		  may be referred to the Board for review and hearing. (Adopted
		  2/2001)