Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 14 - WHOLESALE DISTRIBUTORS › Section 68-14-4 - Minimum required information for registration

Current through Register Vol. 43, No. 28, July 11, 2024
(a) Each wholesale distributor, virtual
			 wholesale distributor, third-party logistics provider, or outsourcing facility
			 shall provide the board with the following minimum information as part of the
			 registration requirements described in
			 K.S.A.
			 65-1645, and amendments thereto, and as part
			 of any renewal of any registration:
(1) The
			 name, commercial business address, and telephone number of the
			 registrant;
(2) each trade or
			 business name used by the registrant;
(3) the address, telephone number, and name
			 of the contact person for each facility used by the registrant for the storage,
			 handling, and distribution of prescription-only drugs or devices;
(4) the type of ownership or operation,
			 including partnership, corporation, or sole proprietorship;
(5) the name of each owner, operator,
			 facility manager, and designated representative of the registrant, including
			 the following:
(A) If a person, the name,
			 address, and date of birth of the person;
(B) if a partnership, the name, address, and
			 date of birth of each partner and the name of the partnership;
(C) if a corporation, the name, title,
			 address, and date of birth of each corporate officer and director, the
			 corporate name, and the name of the state of incorporation; and
(D) if a sole proprietorship, the name,
			 address, and date of birth of the sole proprietor and the name of the business
			 entity;
(6) a list of
			 all states where the registrant is registered as a wholesale distributor,
			 virtual wholesale distributor, third-party logistics provider, or outsourcing
			 facility;
(7) a copy of any current
			 DEA registration;
(8) all
			 disciplinary actions or sanctions by any state or federal agency against the
			 registrant or any principal, owner, director, officer, facility manager, or
			 designated representative thereof;
(9) if the facility is located outside of
			 Kansas, a record of the following:
(A) A
			 current registration in the state where the registrant is located;
(B) a satisfactory inspection conducted
			 within the previous 36-month period by the registering entity of the state
			 where the registrant is located. If no such inspection record is readily
			 available, the record of a satisfactory inspection conducted at the expense of
			 the registrant within the previous 36-month period by a third party recognized
			 by the board to inspect may be accepted; and
(C) a designated resident agent in Kansas for
			 service of process, the record of whom shall also be on file with the secretary
			 of state; and
(10) if
			 the registrant is an outsourcing facility, a record of the following:
(A) A current outsourcing facility
			 registration from the food and drug administration (FDA); and
(B) a current inspection report from an FDA
			 inspection conducted within the previous 24-month period that indicates
			 compliance with the requirements of the federal food, drug and cosmetic act,
			 including guidance documents and current good manufacturing practices
			 established by the FDA. If no such inspection record is readily available, the
			 record of a satisfactory inspection conducted at the expense of the registrant
			 within the previous 36-month period by a third party recognized by the board to
			 inspect may be accepted.