Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.96-003 - Reg. 42 - Wholesale Distributor Permit Required (Re. 28, 29)

Current through Register Vol. 49, No. 6, June, 2024
REGULATION 42
		  SECTION C (Proposed Amendments)
C. WHOLESALE
		  DISTRIBUTOR-PERMIT REQUIRED.
1. Every
		  wholesale distributor who shall engage in the wholesale distribution of
		  prescription drugs, to include without limitation, manufacturing in this state,
		  shipping into this state or selling or offering to sell in this state, shall
		  register annually with the Arkansas State Board of Pharmacy by application for
		  a permit on a form furnished by the Board and accompanied by a fee of $200. The
		  Board may require a separate license for each facility directly or indirectly
		  owned or operated by the same business entity within this state, or for a
		  parent entity with divisions, subdivisions, subsidiaries, and/or affiliate
		  companies within this state when operations are conducted at more than one
		  location and there exists joint ownership and control among all the
		  entities.
2.
A. The permit may be renewed annually at a
		  renewal permit fee of $100.
B. All
		  permits issued under this section shall expire on December 31, of each year, a
		  penalty of $20 per month from February 1, of any year will be charged, provided
		  that if the renewal is unpaid by April 1, of any year, the license shall be
		  null and void.
3.
A. Upon a change of ownership of a wholesale
		  distributor, as set out herein, a new permit shall be secured by the new
		  owner(s). The new owner(s) can continue operation of the wholesale distributor
		  for fourteen (14) days after the effective date of the change of ownership;
		  after said fourteen (14) day period the permit issued to the prior owner shall
		  be void and the operation of the wholesale distributor in Arkansas shall cease.
B. A change of ownership of a
		  wholesale distributor occurs under, but is not limited to, the following
		  circumstances:
1. A change of ownership of a
		  wholesale distributor, owned by a SOLE PROPRIETOR, is deemed to have occurred
		  when:
a. The business is sold and the sale
		  becomes final or the new owner assumes control of the wholesale
		  distributor-which ever occurs first.
b. The proprietor enters into a partnership
		  with another individual or business entity.
2. A change of ownership of a wholesale
		  distributor, owned by a PARTNERSHIP, is deemed to have occurred when:
a. There is an addition or deletion of one or
		  more partners in a partnership to which a wholesale distributor's license has
		  been issued.
b. The business is
		  sold and the sale becomes final or the new owner assumes control of the
		  wholesale distributor-which ever occurs first.
3. A change of ownership of a wholesale
		  distributor, owned by a CORPORATION, is deemed to have occurred when:
a. An individual or business acquires or
		  disposes of twenty percent (20%) of the corporation's outstanding shares of
		  voting stock, (this shall not apply to any corporation the voting stock of
		  which is actively traded on any securities exchange or in any over the counter
		  market); or
b. The corporation
		  merges with another business or corporation (The corporation awning the
		  wholesale distributor is required to notify the Arkansas State Board of
		  Pharmacy if a change of ownership or merger occurs within the parent
		  corporation of the corporation which owns the wholesale distributor); or
c. The corporations's charter
		  expires or is forfeited.
d. The
		  business is sold and the sale becomes final or the new owner assumes control of
		  the wholesale distributor-which ever occurs first.
4. Each permit issued
		  hereunder shall be displayed by the holder thereof in a conspicuous
		  place.
28. Licensed pharmacy
		  permits will be considered by the Board upon written application in such forms
		  as may be adopted by the Board. The permit will be issued in the name of the
		  licensed pharmacist who shall be directly responsible to the Board of Pharmacy
		  for the operation of the prescription department.
A. Applications for pharmacy permits other
		  than annual renewal of existing permits, will be considered by the Board the
		  second Tuesday of February, The second Tuesday of June and the second Tuesday
		  of October of each year, and applications to be considered must be received in
		  the Board of Pharmacy office at least 14 days prior to the next scheduled
		  meeting. Provided that no store may open for business within 30 days of
		  submission of original application. Applications for a pharmacy permit for a
		  new store must have the name and license number of the pharmacist in charge at
		  the time of submission and cannot be altered within 14 days of the
		  consideration-meeting day. The pharmacist in charge of the new store
		  application cannot be the pharmacist in charge of another store at the time of
		  the meeting that the new store application is heard. The pharmacist in charge
		  and a representative of ownership shall appear before the Board when the
		  pharmacy application is heard.
B.
		  In any building, firm, or place of business where the pharmacy is a leased
		  operation, and/or in situations where the pharmacist in charge does not own a
		  substantial part of the business and is not manager of the total operation,
		  and/or where the pharmacy is a department in a larger business that is not a
		  drugstore or pharmacy, the prescription department shall be completely
		  separated from the remainder of the building by some type of partition and said
		  department shall be arranged and constructed so that the public will not have
		  access to any legend drugs or medicine.
The prescription area or department of any pharmacy, firm or
			 place of business must be constructed so that it may be Locked to prevent
			 unauthorized persons from entering it in the absence of a licensed pharmacist,
			 (or other authorized prescription personnel.)
A copy of the signed lease must be submitted with the application
			 of the original permit, and at such other times as the original lease is
			 changed or renewed.
C. No
		  pharmacy permit shall be issued or continued for the conduct of a pharmacy or
		  drugstore unless the premises are equipped with the necessary appliances for
		  maintenance of proper sanitation and kept in a clean, sanitary and orderly
		  manner.
D. Pharmacists, employed
		  and in charge of pharmacies or drugstores, are required to notify the Board of
		  Pharmacy and surrender for cancellation the permit issued in their names
		  immediately upon the termination of such employment. It shall be the duty of
		  the owner of such pharmacies or drugstores to immediately notify the Board upon
		  the termination of employment of licensed pharmacists and to cause the
		  surrender of permit as indicated. The further operation of the pharmacy or
		  drugstore in the absence of a replacement and the issuance of a new permit is
		  forbidden by law and each day so operated will be considered a separate
		  offense.
E. The permit licenses the
		  pharmacy or drugstore to which it is issued and is not transferable. It is
		  issued on the application of the owner and the Licensed pharmacist in charge,
		  on the sworn statement that it will be conducted in accordance with the
		  provisions of law.
F. When a
		  licensed pharmacist in whose name a permit has been issued leaves the
		  employment of such pharmacy or drugstore, he will be held responsible for
		  proper notification to the Board of Pharmacy of such termination of his
		  services within five days in addition to providing the Board of Pharmacy with
		  an inventory of controlled drugs as defined in Regulation 29. Neglect on his
		  part to so notify the Board and to provide said inventory will operate to
		  prevent his securing a permit to take charge or operate another pharmacy or
		  drugstore at a subsequent date.
G.
		  When the licensed pharmacist in whose name a permit has been issued to a
		  pharmacy for any reason ceases to be actually the person who has responsible
		  supervision over said pharmacy or drugstore the permit becomes void, and must
		  be surrendered to the Board before a duplicate will be issued to said pharmacy.
		  Where there is merely a change of licensed pharmacist one replacing the other
		  as the pharmacist in charge, a duplicate permit will be issued upon proper
		  application and payment of a $25.00 fee.
H.
1. Upon
		  a change of ownership of a pharmacy as set out herein, a new permit shall be
		  secured by the new owner(s). The new owner(s) can continue operation of the
		  pharmacy for fourteen (14) days after the effective date of the change of
		  ownership; after the said fourteen (14) day period, the permit issued to the
		  prior owner shalI be void and same shalI be surrendered to the Executive
		  Director of the Board of Pharmacy.
2. A change of ownership of a pharmacy occurs
		  under, but is not limited to the following circumstances:
A. A change of ownership of a pharmacy, owned
		  by a SOLE PROPRIETOR, is deemed to have occurred when:
1. The pharmacy is sold and the sale becomes
		  final or the new owner assumes control of the pharmacy-which ever occurs
		  first.
2. The proprietor enters
		  into a partnership with another individual or business entity.
B. A change of ownership of a
		  pharmacy, owned by a PARTNERSHIP, is deemed to have occurred when:
1. There is an addition or deletion of one or
		  more partners in a partnership to which a pharmacy license has been
		  issued.
2. The pharmacy is sold and
		  the sale becomes final or the new owner assumes control of the pharmacy-which
		  ever occurs first.
C. A
		  change of ownership of a pharmacy, owned by a CORPORATION, is deemed to have
		  occurred when:
1. An individual or business
		  acquires or disposes of twenty percent (20%) or more of the corporation's
		  outstanding shares of voting stock. (This shall not apply to any corporation
		  the voting stock of which is actively traded on any securities exchange or in
		  any over the counter market); or
2.
		  The corporation merges with another business or corporation; (The corporation
		  owning the pharmacy is required to notify the Arkansas State Board of Pharmacy
		  if a change of ownership or merger occurs within the parent corporation of the
		  corporation which owns the pharmacy); or
3. The corporation's charter expires or is
		  forfeited; or
4. The pharmacy is
		  sold and the sale becomes final or the new owner assumes control of the
		  pharmacy-which ever occurs first.
I. Pharmacies or drugstores opening for
		  business must first secure a permit and be licensed with the Board of Pharmacy
		  before they may lawfully conduct a pharmacy or drugstore. A fee of $200 is
		  charged for issuing such original permit. All pharmacies or drugstores must
		  register with the Board annually and secure an annual permit and pay a Renewal
		  fee of $100. The annual registration takes place on January 1 of each
		  year.
J. Permits must be pasted in
		  a conspicuous place. This requirement is not met when a permit is locked in a
		  safe, placed in a desk drawer, or otherwise hidden away.
K. No pharmacy permit shall be issued to any
		  store or pharmacy when the licensed pharmacist in charge of the prescription
		  department is not on duty in that pharmacy a minimum of 40 hours per week. A
		  pharmacist in charge of a retail pharmacy may act as a consultant or part-time
		  pharmacist.
L. The pharmacist in
		  charge is responsible for the security and accountability of all drugs, legend
		  and/or controlled, stored in said drugstore and is responsible for the validity
		  and legality of all prescriptions upon which drugs are dispensed in said
		  drugstore or pharmacy. Dispensing of drugs classified as controlled drugs under
		  any of the schedules classifying drugs under either state or federal law
		  governing controlled substances is the primary responsibility of the Pharmacist
		  in Charge and is also the responsibility of such other pharmacist, interns or
		  students as may have dispensed said drugs. In the event of a shortage of said
		  drugs revealed by an accountability inventory of either federal or state
		  agencies, the Pharmacist in Charge shall be held primarily responsible for such
		  shortage and shall be subject to disciplinary action by the State Board of
		  Pharmacy. Any other pharmacists, interns, or students causing or aiding or
		  abetting the said unlawful shortage of said drugs shall also be subject to
		  disciplinary action by the State Board of Pharmacy.
M. No store may open for business, nor may it
		  be inspected for the purpose of obtaining a permit, prior to the approval by
		  the Board.
N. Any pharmacist, when
		  making his or her initial application to be licensed as Pharmacist in Charge,
		  must satisfactorily complete a test on the requirements and responsibilities of
		  a Pharmacist in Charge. The test shall be developed and administered by the
		  Board of Pharmacy or its representatives.
O. The Pharmacist in Charge named on any
		  licensed pharmacy permit or pharmacist on call as designated by the Pharmacist
		  in Charge, shall have immediate access to the pharmacy at all times and if
		  requested by Board of Pharmacy Inspectors he/she shall show satisfactory proof
		  of access.
The responsibility to assure compliance with this regulation
			 rests both with the pharmacist and with the pharmacy owner if they are not the
			 same. 10/09/80 (Revised 2/17/82, 6/13/85, 2/10/87, 4/07/89, 6/20/91, and
			 6/20/96)
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. 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 Statues 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)